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Ten Tips for A Successful Use of Total Product Life Cycle (TPLC) Reports

The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide existing data to medical device manufacturers that will enable them to proactively address quality related issues as early as possible. The TPLC database allows users to search by type of device (product code) and provides a report that identifies the related 510(k) clearances for that particular product code, recall reports, and medical device reporting (MDR) information for the product code selected. What does that mean? Ultimately, companies should have quality systems that incorporate TPLC information into all aspects of their system; such as supplier qualification/monitoring, risk management, design controls, corrective and preventive action, and complaint handling. Incorporating this information throughout the entire life cycle of the device will bring devices to market more efficiently and with less issues post-launch.
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Ten Tips for Successful Integration of Risk Management & Usability Engineering

Even though Risk Management and Usability Engineering are clearly two separate processes with unique requirements, they are interdependent and must communicate with each other during the entire product lifecycle. Risk Management identifies the risk of a medical device’s potential hazards and provides input to the design requirements. The process determines the likelihood and severity of those potential hazards, analyzing the device’s design, function and manufacture. Usability Engineering identifies and assesses risks associated with using the device. Controls used to develop product and usability specifications are established to mitigate the associated risks. The user interface, operation manual and/or instructions for use play key roles in Usability. Together, they help to ensure safe and effective medical devices are brought to the market. Their implementation takes time and effort, but is well worth the investment if field issues are mitigated.
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510(k) Submissions-Ten Tips for a Successful Submission

The process of submitting a 510(k), demonstrating that your device is substantially equivalent to a device that is already cleared, can be daunting. Typically designed to be a 90-day review by the FDA, the entire process could take several months if adequate information is not supplied to the FDA. Their requests for additional information need to be met satisfactorily and in full, or you risk delaying your release schedule and going into a total of three rounds of questioning. If you have not adequately addressed the FDA’s concerns after three rounds of questions, your device will be found not substantially equivalent (NSE) to the predicate device(s). Ideally, you’ll avoid rejection and an NSE letter, and your device will gain clearance into the market, keeping your release on schedule and your investors happy.
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Successful Regulatory Strategy-Ten Tips

Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical for a new product’s market success. An inaccurate or lack of regulatory strategy can lead to the product not being cleared for market in the desired countries, not being released to market on time because of regulatory hiccups that were not anticipated, and/or being released to the market with inadequate claims such that the product does not fulfill the need of the target market, thereby not selling. Many times during development there are disconnects between marketing expectations and engineering development plans. A thorough regulatory strategy will not only document the regulatory pathways, but also align the new product development team on critical product requirements (intended use, claims, indications, release countries, etc.) and tracks risk items for the selected regulatory pathways. A regulatory strategy is one location where these items can be aligned on at least at the highest product requirement level to ensure a smooth start for development. Periodic updates are very important. When changes are proposed in design, intended use, or claims or changes occur in the regulatory environment, an update to the strategy and proactive communication to the product development team will maintain alignment of the regulatory activities and business strategies, creating an efficient pathway to market.
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CAPA - Best Practice Sharing

Healthy CAPAs = Competitive Advantage
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Implementing a Successful Recall Process - Ten Tips

In the medical device arena, recalls are a fact of life and competitors love to find out that you’ve had one. Regardless of recall classification (Class I, II, or III), a recall procedure is instrumental in working in concert with a company’s post-market surveillance and agreements with suppliers. Companies should not assume there is never going to be an issue with a product and not have these procedures in place up front.
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Warning Letters - Ten Tips

Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not addressed effectively and expediently.
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Q-Sub | FDA | Guidance Document | Pre-Sub | PMA | 510(k) | Pre-Submission

Pre-Submission Program – Final Guidance

On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de novo, etc.). The sponsor may submit a pre-submission application to the FDA requesting answers to various questions about the marketing application or clinical trial design of their device. The sponsor may request a written response, teleconference, or meeting. The FDA has committed respond to the sponsor within 75 to 90 days.
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Affordable Breakthrough Innovations

Innovative ideas for medical devices are often costly for manufacturers to make and for patients to own. However, not all innovative medical devices will cost you an arm and a leg.
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guidance documents | 23andMe | FDA | Custom Device Exemptions

Guidance Documents for 2014

In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can expect to see in 2014:
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FDA | medical device | PMA

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat”. 1 The final rule also defines “pediatric patients” and “pediatric subpopulations”. Per the final rule, “pediatric patients” is defined as a patient who is 21 years old or younger at the time of treatment or diagnosis. “Pediatric subpopulation” means on for the following populations: neonate, infants, children, or adolescents.
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FDA | 510(k) review | 510(k) | CDRH

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right!
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3D Printing in Medicine

As if 3D printers for rapid prototyping weren’t cool enough, researchers at the University of Wollongong and St. Vincent’s Hospital Melbourne, part of Australian Research Council Centre of Excellence for Electromaterials Science (ACES), have been using 3D printing to make some pretty exciting advances in tissue engineering and orthopedic surgery.
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Regulatory News - Report on FDA Device Review Process

As part of FDA’s Performance Goals and Procedures adopted under MDUFA III (The Medical Device User Fee Act of 2012), the FDA agreed to participate with the medical device industry in an independent assessment of the process for the review of medical device submissions. The key objective of this task was to develop a set of recommendations for FDA to implement with the potential to have a significant impact on review times. The recently released report, prepared by Booz Allen, identifies four broad areas where the agency should improve its methods for premarket review of medical devices:
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Transhumanism | Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Conclusion

Trans∙hu∙man∙ism /tranz’hyoomənizm// Noun The belief or theory that the human race can evolve beyond its current physical and mental limitations, especially by means of science and technology.1  
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Medical Devices | military

Devices for the Military

This past weekend I travelled to the Chicago-land area to attend my brother’s graduation from Northern Illinois University and commissioning into the US Army. He will be reporting to Fort Leonard Wood, Missouri for officer training as part of the Army Corps of Engineers. This has been a very proud and exciting time for all of us.
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Veterinary Medical Devices - FDA Regulations

I recently worked on a project that involved writing a regulatory strategy for a device used on animals. This was a new area for me and I got interested in learning even more about the topic afterwards. I was curious as to how big of a market veterinary devices were, as well as what type of regulations were around developing and selling devices for veterinary use.
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Transhumanism | Transhumanism - Science from Fiction

Transhumanism – Science from Fiction: Part III – Not So Vulcan Mind Melds

Not So Vulcan Mind Melds
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Getting to Know You

You probably think you know yourself pretty well, right? Of course. You’re a (circle all that apply) super cool/ witty/ charming/ good-looking/ intelligent person, and humble about it too, but what does your DNA say about you? DNA is an incredibly complex storage structure for information about us – genetic information about how we develop and function, who we physiologically are and have the potential to become. So much of that information is a mystery to us, but what if it wasn’t? What if you knew all of the traits you carry and where they came from, how your body would respond to any medication, and what health conditions you are predisposed to encounter? It would be incredibly useful (not to mention extremely interesting) to discover all of this about yourself, although I have a feeling that a large percentage of the population would turn hypochondriac.
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Transhumanism | Cyborg

Transhumanism - Science from Fiction: Part II - Rise of the Cyborg

The Cyborgs Are Coming!
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Devices remain unclassified

I read a really interesting article this week written by Josh Rising called "The Loophole That Keeps Precarious Medical Devices in Use". The articles explains how when the Medical Device Amendments of 1976 were implemented, dozens of marketed medical devices were left unclassified. The 1976 Amendments immediately took actions on newly developed devices and classified devices already on the market as "medium-risk" devices until the FDA could take the time to evaluate the real risk of those devices on an individual basis.
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culture of quality | quality

A Culture of Quality

As quality professionals, we are always looking for ways to improve the quality of products, and reduce the cost of quality mishaps. But how do you actually climb to the top of that mountain of high quality while still maintaining a marketable product?
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Not-So-Blind Ambition

Can you imagine what a GPS for blind people would be like? We may not be there yet, but a research project at the University of Arkansas could be the next best thing. Dr. Cang Ye and his team are making over the standard white cane often used by the visually impaired into a high-tech portable navigation device using sophisticated laser technology. They are incorporating a 3D imaging sensor system called Flash LADAR (laser detection and ranging) into the cane, which will inform the user of key environmental factors such as possible obstacles.1
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RAPS 2013 Series: MDSAP

Of all of the seminars I attended at the RAPS 2013 Conference in Boston, the Medical Devices Single Audit Program ("MDSAP") was arguably the best. The overview of MDSAP - done well by Kim Trautman of the FDA and Mike Ward from Health Canada - was thorough and well done; however, it was the overall conclusion and closing remarks from Elisabeth George of Philips Healthcare and Paul Brooks of BSI that made this an engaging session.
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Quality Control for Blood Transfusions

Over the years, major advances in blood transfusion safety measures have drastically reduced the risk of viral transmission via allogeneic blood. Although correlation doesn’t necessarily imply causation, it’s tempting to believe that this may have something to do with the thriving, pervasive (and quite frankly, annoying) presence of vampires in contemporary pop culture, but that’s a topic for another day. Since this reduction in viral risk, the greatest residual threat of disease transmitted by blood transfusion is bacterial contamination.1
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Diabetes | Artificial Pancreas | FDA | Artificial Organ | PMA

First Artificial Pancreas receives FDA Approval

Upon my nightly adventures of surfing the World Wide Web I came across this article on the Popular Science website announcing the FDA’s approval of the Medtronic MiniMed 530G Insulin pump, praisingly dubbed the first artificial pancreas. The Medtronic device was officially approved by the FDA on September 26, 2013 through the Premarket Approval (PMA) pathway. According to the FDA Approval Letter the MiniMed 530G System is intended for continuous delivery of basal Insulin (at user selectable rates) and administration of Insulin boluses (in user selectable amounts) for the management of Diabetes mellitus in persons, sixteen years of age and older, requiring Insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of Insulin when the sensor glucose value falls below a predefined threshold value.
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medical device manufacturers | device manufacturers | Affordable Care Act | medical device news | Medical Device Tax

On the Edge of Our Seats

As the government shutdown dragged onward, nobody was watching the outcomes more than medical device manufacturers. For device manufacturers – there was and still is a lot at stake. And make no mistake – the medical device tax is part of the hot debate in Washington right now. Part of the 2010 Affordable Care Act included a 2.3% tax on medical devices. The tax has caught a lot of attention from both Republicans and Democrats – part of the most recent House GOP proposal to end the partial government shutdown actually includes a deal to suspend this medical device tax for two years. The revenue from this tax is to be utilized to help fund the Affordable Care Act. The tax has not been fully supported by either party – back in 2010, 30 Democrats joined Republicans and opposed the medical device tax. However, there are very worthy arguments against the device tax & defending the device tax, which I will not explore in this article but are referenced on Newsreplubic.com. (Source: News Republic “Is Obamacare’s Medical-Device Tax Up for Negotiation?”) Why hasn’t the tax been nixed in general you might ask? Mainly, we haven’t found an alternative source of tax revenue that would replace what the medical device tax would provide, as it raises approximately $30 billion over 10 years and is a large part of the funding for the Affordable Care Act. In most recent news (Late Tuesday, 10/15), the tax has been cut from the latest House Republican offer; meaning the two year delay might be scrapped altogether. However – it has been in and out of several offers from both Republicans and Democrats for the last several months. (Source: The Washington Post “GOP leaders nix medical device tax delay”). As of this most recent news – it is not looking good for device manufacturers as far as delaying the tax; however, as we’ve already found out – a lot can change in a short amount of time. -SJG
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Medical Devices | Artificial | Larynx | cancer | Clinical Studies

Deep Breaths

The standard treatment for patients with cancer of the larynx is to have a tracheostomy tube installed. Tracheostomy tubes are Class II devices, under 21 CFR 868.5800. According to ProTip CEO Maurice Beranger, this technology has not changed in 140 years. Tracheostomy tubes impair a patient’s ability to breathing through the upper airway and talk normally.
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Government Shutdown - Impact on Medical Devices

On October 1st, 2013, the Government of the United States began shutting down operations due to an impasse in congress regarding government funding appropriations. Practically speaking for the medical device industry, the shutdown puts businesses, medical professionals, and, ultimately, patients in a lurch as new medical technology cannot get to market.
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Bionic | Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Part I - Bionic Body Parts

Advancements in biotechnology have made things of science fiction into reality. Back in the 70’s, bionic body parts were thought to be donned only by the Six Million Dollar Man1 and The Bionic Woman2. Fast forward forty years and bionic body parts are more science than fiction. As LiveScience.com said, “Scientists are getting closer to creating a bionic human, or at least a $6 million one.”3
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Telehealth

In the world in we live, where communication is becoming further removed from face to face interaction, medicine is utilizing telecommunications technologies to advance treatment and care for patients.
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FDA | medical device | Risk-Benefit | Patient Preference

FDA gives Voice to the People

The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making process on medical devices. I became aware of this effort by the FDA when recently reading this article which describes CDRH’s program called Patient Preference Initiative.
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RAPS 2013: Education Series

Last week, R&Q attended the RAPS 2013 Conference held in Boston, MA. We were thrilled with the event - a big "Thank You" is due to RAPS for putting on such a great event. A few of our team members were granted the opportunity to attend the seminars that RAPS arranged to allow regulatory professionals opportunities to continue their career development path, or simply keep up to date with current events. R&Q is dedicated to the same goals as well. As a result, check-in with our blog over the next few weeks as we recap some of the more critical updates from RAPS and expound on any further developments since the conference. Happy reading! -RTK
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Canada | change in contract manufacturer | health canada | medical device | license amendment fax back form | registration triggers | registration | change in country of origin

License Amendment Triggers in Canada

Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or manufacturing process are common re-registration triggers. It all depends on the specific regulations of the country involved.
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Medical Devices | artificial knee | running | biomechanics

Pounding the Pavement

Earlier this year I joined a running club, Steel City Road Runners (come run with us!). I’m still a newbie, but I really enjoy the challenge that running provides. This past week, the Boston Marathon announced to applicants who would be awarded the last 5,000 spots in the 2014 Boston Marathon. It was really inspiring to see many of the people in my group be awarded these spots, I know how hard they have worked, and I’ve pounded the pavement with them more than once.
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R&Q at RAPS 2013!

Good morning!
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FDA Releases Mobile Medical Applications Guidance Document

This week must be the week of the FDA publications. In the same week the UDI final rule and guidance were published, the FDA has also released the guidance document on the FDA's plan for enforcement regarding Mobile Medical Applications. The FDA's final thoughts on how they'll regulate mobile medical applications will likely surprise many of their critics.
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Retraining the Brain – A New Approach to Treatment for Schizophrenia

Schizophrenia is a debilitating neurocognitive disease that affects about 2.4 million people in the United States alone.1 Schizophrenic patients exhibit impaired working memory, attention, problem solving capabilities, and general social functions. Frequent negative hallucinations and delusions coupled with the inability to think clearly often lead them to lose their grip on reality, increasing the likelihood of suicide attempts in this group to 40 times that of the general population.1 Traditionally, physicians have prescribed various antipsychotic medications to keep the hallucinations and delusions under control, although the underlying disordered cognition remains untreated. However, Pitt assistant professor of social work and psychiatry Shaun M. Eack and his colleague, physician Matcheri Keshavan, are investigating an exciting nondrug therapy intending to rehabilitate schizophrenic patients by enhancing their cognition, essentially retraining their brains.1 Eack and Keshavan are continuing innovative research started by Gerard Hogarty, the late professor of psychiatry at the University of Pittsburgh School of Medicine. Hogarty was known for his use of Cognitive Enhancement Therapy (CET), originally used for rehabilitation of people with traumatic brain injuries, to improve cognition in schizophrenic patients.1 CET mainly involves computer-based exercises that leverage the brain’s neuroplasticity to improve the cognitive functions in which schizophrenics are deficient.1 Initial research has displayed promising results – neuroimaging scans of patients’ brains after CET showed decreased brain atrophy and increased growth of new brain tissue compared with brain scans before CET.1 This groundbreaking research produced the first evidence of a clear structural neurobiological effect on schizophrenic patients’ brains by a nondrug treatment.1 Initial study participants also saw improvements in social functions, task performance, work readiness, and general activities of daily life. While the research is still ongoing to gather additional evidence of the therapy’s effectiveness, the initial results indicate that there is hope for those suffering from schizophrenia to regain cognitive abilities and see functional improvements beyond those afforded by traditional drug treatments. -KB Image credit: Life Mental Health @ Flickr 1 Levin, Steve. "Think Again." Pitt Magazine Fall (2013): 18-21. Print.
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UDI Documents Released by FDA

The rule and guidance document for Unique Device Identifiers ("UDI") on medical devices and some combination product that contain devices has been released.
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EU marketing approval system

The European marketing approval system for medical devices is less stringent than other regions of the world and because of that, at times it is viewed as a more attractive market for device manufacturers. However over the past few months, a new proposal has come up in Europe that could drastically change the approval process.
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Regulatory and Quality Solutions | RQS | regulatory | Regulatory Pathways

Same Road (Regulatory Pathway), Different Car (Medical Device)..Similar Success (Clearance,Approval)

As you might expect, here at RQS the responsibilities and duties of providing our clients with the support they need often involves traveling for on-site visits. For the time being, most of the travel takes place within the greater metropolitan area of the cities in which we currently have offices: Cleveland and Pittsburgh. Our Pittsburgh team makes rounds to their Pittsburgh-based clients and our Cleveland team makes rounds to their Cleveland-based clients. However, in order to best meet our clients’ needs, there is a fair bit of interchanging resources between our offices. Employees, some more than others, travel within the two metropolitan areas providing support to clients in both regions, as needed. Having been one of our Pittsburgh-based employees who has frequently traveled to Cleveland for client support, I thought I would use this blog post to reminisce on the journey.
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Transhumanism | Transhumanism - Science from Fiction

Transhumanism - Science from Fiction: Intro

What do Jean Grey and Professor Xavier of X-Men, Vulcan “mind-melds” from Star Trek, the Six-Million Dollar Man, Darth Vader and Jedi mind tricks from George Lucas’ Star Wars, The Bionic Woman adapted from Martin Caidin’s Cyborg, Inspector Gadget, Replicants from the 1980’s movie Blade Runner, and Neo (along with his comrades) from The Matrix, all have in common?
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International Labeling Requirements

It used to be much easier to have an international device on the market that complies with the regulations of the multi-country international market. With a properly localized multi-language Instructions for Use, the regulations of most international countries were met with one finished good. However, international regulations are becoming increasingly complex. In addition, more and more countries have difficult labeling requirements that are specific to their country.
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Brain disease | iso 14971 | risk management | Harm | Sequence of Events | Hazardous Situation | sterilization | Hazard

Foreseeing the Risks

On the news this morning, I heard a story that got me thinking about risk management. The headline was “Eight N.H. patients possibly exposed to fatal brain disease”. Further research about the situation reveals just how complex this case is.
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Personalized Orthopedics

As part of a growing trend toward personalized healthcare, the medical device community has contributed “cutting edge” technologies enabling a variety of custom orthopedic procedures. Let’s take a look at a couple of the players! One exciting new development in customized orthopedic implant procedures is the 510(k) clearance of Zimmer’s Patient Specific Instruments Shoulder device in August.1 This system works in tandem with Zimmer’s Trabecular MetalTM Reverse Shoulder base plate implant system in reverse shoulder arthroplasty procedures, using 3D visualization software to enable surgeons to create patient-specific surgical plans and corresponding surgical instrument guides.1 In addition, Zimmer’s ContinuumTM Acetabular System provides surgeons with the ability to customize hip implants with the load bearing technology best suited to each patient.2 Late last year Pittsburgh’s own Blue Belt Technologies received FDA 510(k) clearance for its NavioPFS™ robot-assisted orthopedic surgical system.3 In June the company also gained clearance for the STRIDE™ Unicondylar Knee implant system, which is meant to be used with the NavioPFSTM system in personalized, minimally invasive, partial knee replacement procedures.3 I may be 27, but my joints already don’t move like they used to! It’s encouraging to see advances in medical technology that personalize orthopedic implants to the needs of patients and minimize the impact to their daily lives. -KB Image credit: Libertas Academica @ Flikr 1 Zimmer Holdings, Inc. Zimmer Receives FDA Clearance For Patient Specific Instruments (PSI) Shoulder. -- WARSAW, Ind., Aug. 23, 2013 /PRNewswire/ --. PR Newswire, 23 Aug. 2013. Web. 02 Sept. 2013. 2 Zimmer Holdings, Inc. New Hip Implant Provides Personalized Fit. -- WARSAW, Ind., March 11 /PRNewswire-FirstCall/ --. PR Newswire, 11 Mar. 2010. Web. 02 Sept. 2013. 3 Simmons, Abby. "News Brief: Carnegie Mellon Spinoff, Blue Belt Technologies Inc., Receives FDA Clearances-Carnegie Mellon News - Carnegie Mellon University." Carnegie Mellon News (25 June 2013): n. pag. Carnegie Mellon News. 25 June 2013. Web. 02 Sept. 2013.
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FDA guidance document on RF Wireless Technology in Medical Devices

With the growing use of incorporating wireless technology into medical devices, the FDA has issued a final guidance Radio Frequency Wireless Technology in Medical Devices. This guidance document is meant to cover a wide range of medical devices that use wireless technology from imaging and systems used in a hospital or clinical setting to devices implanted or applied directly on the patient's body. The guidance document recommends certain design control and testing measures as well as post-market maintenance monitoring that can be taken in order to ensure safety to the patient.
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Improved machines based on human biology

Today, when I was thinking of a blog topic, I had a moment of clarity. I realized that I regularly peruse the news and media for evidence of how machines and medical devices help humans, improve human life, and how humans utilize machines and technology to help solve problems. I also realized that I rarely I encounter a news article that discusses how something was improved upon, by being modeled after a human or a biological human factor.
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Genome | Medical Advancement | HeLa | Henrietta Lacks

Recognition for Contributions in Medical Advancement 60 years in the making

In my Bioethics course during my undergraduate years, we had discussed the curious case of Henrietta Lacks: a 31 year old African American mother who contributed to numerous modern day medical advancements upon her death without her or her family’s knowledge. I noticed that Henrietta’s story was currently in the news and learned that from these New York Times articles ( here and here) that she had finally (somewhat) been given credit for her contribution to science and medicine. You are probably wondering how this story even makes a little bit of sense. How can someone who has died contribute to progress in medicine without even knowing? Allow me an opportunity to explain the very interesting story of Henrietta Lacks and how she lives on through medical research.
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Medical Devices | Reliability | Use Case | HALT | quality

Reliability – From Bike Racks to Medical Devices

Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to secure the bike and the plastic strap was broken. The strap is not removable or replaceable, so for now I’ll have to stick to running. Luckily, I have my receipt and the manual that came with the bike rack – and it says there is a lifetime warranty. I wrote a short note to the company explaining my situation and am hoping to get a positive response.
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massage therapy | medical industry | massage | Insurance | therapy

Vacation Revelation

I am in TopSail North Carolina this week enjoying the ocean, sun and family! (Yes: in that order)
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class iia | EU | disease management | mobile platform | mobile medical applications | health management | FDA | Substantial Equivalence | verizon wireless | software platform | medical applications | software technologies | medical application

Mobile Medical Applications - Most Reliable Apps, Internationally?

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!
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Fear Factor: Audits

Why is it that when you drop the A-bomb (audit) people just seem to instinctively cringe. Is this a learned behavior or one that has been passed down since men began assessing each other for acceptance?
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medical corporation | pittsburgh pa | staying power | fagan | medical device | Pittsburgh Technology Council | quality solutions

Device Idea to Staying Power in the Market

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RQS Ohio Social Event - August 14, 2013

Please join RQS for a happy hour networking event! Drinks and appetizers will be provided and prizes will be given away to winning attendees during the event.
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guidance | CDER

Guidance document clean-up! - CDER

I read an interesting article on the RAPS website this morning about a new initiative set by the FDA to clean-up certain guidance documents. This means finalizing draft guidance documents, withdrawing or updating/revising outdated guidance documents. This initiative is taking place in the Center for Drug Evaluation and Research (CDER) department.
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Draft Guidance on Medical Device Reporting for Manufacturers - Issued 07/09/13

Earlier last month, FDA released a new draft guidance that addresses many questions and answers pertaining to the sometimes tricky world of medical device reporting for medical device manufacturers. (1-4) The draft guidance, “Draft Guidance on Medical Device Reporting for Manufacturers(3),” aims to clarify a wide array of requirements of the MDR. It has been over 15 years since the last MDR draft guidance was published by the FDA.(1-3) Since 1997, industry has seen a variety of “text book” examples of medical device reporting - some good and some bad – and many lessons have been learned.When the draft guidance that was issued on 07/09/13 is final, it will supersede “Medical Device Reporting for Manufacturers” issued in 1997.(3-4)
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nutrition | supplements

Super Supplements or Scary Supplements: Consumers are the Judge

While doing my usual read-through of the headlines on USA Today, I recently came across an article about a USA Today investigation examining the works of Matt Cahill, a supplement designer with a dark history in developing risky products. As an individual who tries to maintain a healthy lifestyle and enjoys working out, the findings of this investigation made me question the supplements I have been using. As most people who do, I take supplements (ie vitamins, protein powder, fish oil) to enhance my diet with nutrients and help me maximize the benefits gained from hitting the gym. However, as I have come to learn from this article we the consumers need to be proactive in determining and choosing supplements that are safe to take.
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standards | iso 14971 | risk management | Standards Compliance

“It’s like getting your high school diploma…”

Recently, I had the opportunity to attend a Risk Management Conference hosted by the FDAnews. At the beginning of the conference, we all went around the room and introduced ourselves, and indicated why we were there. Not surprisingly, a majority of people were there to have a better understanding of the new EN version of ISO 14971 - EN ISO 14971:2012, and learn how to implement it into their daily risk management activities.
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Just Say No

So you think you’re a bargain shopper, huh? Did you secretly get a rush when you had a coupon for that high-end toothpaste AND found it on sale? Most bargain shopping comes with few, if any, downsides. (Ok, so maybe you had to evict a family of angry possums from that couch you picked up in the neighbor’s trash pile, but hey – you can stand a little inconvenience for something free!) But when it comes to your health, how much are you willing to risk for a bargain? In order to off-set rising out-of-pocket healthcare costs, many consumers shop around for cheaper medications, often purchasing counterfeit pharmaceuticals through unregulated channels without even knowing it. These drugs often look exactly like their legitimate counterparts but may contain incorrect doses of the active ingredients or incorrect ingredients altogether.1 Patients looking to save a few bucks could be putting themselves at serious risk, as modified or diluted medications have potential to weaken the immune system and expedite the spread of disease.2 The issue may be more widespread than we realize though…
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FDA Medical Device Reporting Update

One of the ways that I try to stay in touch with the world of medical device regulations is by subscribing to the CDRH (Center for Devices and Radiological Health) mailing lists (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm135906.htm). This service helps keep you abreast of the recalls, safety, device clearances and updates to regulations.
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Ombudsman | CDRH

How the FDA handles complaints

Complaints from end users to medical device manufacturers are unfortunately a common occurrence. Medical device manufacturers are expected to handle these complaints efficiently and effectively by keeping the end user or patient’s safety in mind. However not a lot of people think about how the FDA has to handle complaints from medical device manufacturers.
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biosense | 21 cfr | fda guidance | mobile medical applications | FDA | medical device | submission type | mobile application | medical applications | regulatory strategy | medical application

Mobile Medical Applications: Make Sure uChek with FDA

The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile application. The device is a mobile medical application for phones that takes a picture of urinalysis strips and compares the color against a standard to make a determination about the status of a patients urine. It also includes a box that controls external light to ensure better quality of the results. From a "fan" standpoint, it's an awesome device and technology. You can see it demo-ed during the TED talk given by the company's CEO.
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fundamentals of engineering

Documentation 101: Life as an Engineer

As a recent college graduate working in the medical device industry, I quickly learned that life as an engineer is different than what is envisioned and different than what is taught in the hundreds of undergraduate programs across the nation. Today, students graduate with undergraduate training that provides them with a solid foundation in the technical fundamentals of engineering. Four years of rigorous training leave students with a relevant skill set in the math and sciences to succeed in engineering work. However engineering work and work as an engineer, as I have come to experience, are related but different.
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Croatia Joins the EU

As of June 30th, Croatia has now been formally added to the list of EU governed / regulated countries making for a total of 27 European Union countries.
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A Vaccine for Colon Cancer

As a University of Pittsburgh graduate, I was excited to read in the spring issue of Pitt Magazine about a promising advance in cancer prevention research at my alma mater. Immunologist Olivera Finn and her research team at Pitt have been studying potential cancer prevention methods since 1991, and they have announced a breakthrough in their research of a colon cancer vaccine.1
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The Importance of Production Equivalence

In today's world of always looking for ways to get something done faster there appears to be one area where speed has begun to do some harm. This area happens to be related to production equivalence. Quite simply, production equivalence is the evidence that a manufacturer provides to convey that the product has been created per provided requirements and under appropriate controls (i.e. process validation).
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cybersecurity | premarket submissions | risk analysis approach | patient data | security breach | mobile apps | medical device design

Cybersecurity

My recent work has involved providing regulatory assistance to software medical devices. One thing I have been learning about is how security and privacy is handled with these types of products. Often times I have experienced clients grouping regulatory affairs with privacy and security. Project teams have looked to the regulatory engineers for guidance on how to handle privacy and security of patient data used within the software. This was a new area of focus for me. In my research on privacy and security I looked a lot to internal experts on these to subjects, in addition the FDA has issued a draft guidance titled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
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My Day at FDA

For today's show-and-tell, I'm bringing a picture of me at FDA:
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FDA Inspections Database

The Food and Drug Administration (FDA) recently released its new data set for the Inspections Database. 1-2 The Inspections Database makes available the most recent inspection (up to two years of inspections) of a company. The final inspection classification for clinical trial investigators and Institutional Review Boards (IRB), as well as manufacturing, processing, and packing facilities’ final inspection classifications are disclosed.3 The inspection classification of facilities that hold an FDA-regulated and currently marketed product is also listed on the FDA inspection database.
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start ups | vcs | due diligence | investments | Angel Investors | exit strategy | venture capitalists | Venture Capitalist | Start-Up Device | Medical Device Start-up | angel group

Funding Your Start-Up Medical Device Company

Over the last few months, several of the potential clients I’ve met with have been start-up device companies. Typically, I find that start-ups will have a fantastic product idea that can positively impact countless lives – but, often, they do not have a clear plan for how they are going to get a Series A or Series B funding. While there are many ways to attract funding (VCs, Angels, Family/Friends, Grants, etc.) in this article I’m going to focus on Angel investors – after I recently read a great article on MedCity News (http://medcitynews.com/2013/06/success-with-an-angel-syndicate-how-one-pharma-startup-raised-16m-without-vcs/) about a company that raised a $16M series B round without a dollar from Venture Capitalists – done entirely through Angel investors. One website that is a great way for new companies to try to look for angel investors is AngelList. (www.angellist.com ). What I like about this website – it allows companies to not only look for new angels to partner with, but companies can also present to angel groups, all online. When approaching Angels for investments, device companies need to have a clear plan. Expect the angel group to do extremely thorough due diligence – the days of writing blank checks are simply over. They’ll want to know exactly how much money you need, and what exactly you intend to do with it. They’ll want to know how your product is a solution to the industry, how you can quickly grow it, and they are going to want to know your exit strategy. It can take multiple meetings with angels to get funding, and the process can typically take anywhere from 1 – 3 months. The key is to be patient, and also do your homework on appropriate angel groups you should be talking to (for instance – if you are a device company, don’t be targeting angel groups that typically invest in Consumer Retail Products). Offering angels shares in your company is a good way to
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congenital heart defects | RQS | heart to heart | medical technology | quality solutions | birth defect | north park

Congenital Heart Walk

This weekend my family and I are going to go to the Congenital Heart Walk at 9:45 a.m. at the boathouse in North Park. This walk is to raise awareness for Congenital Heart Defects, America’s #1 birth defect. Regulatory and Quality Solutions is a sponsor of this event; it is very close to our hearts since it involves our esteemed friend and colleague, Deb Gimbel.
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software system | regulatory focus | www.fda.gov | FDA | FDA website | maude database | software | regulatory | Graematter | Regulatory Intelligence

Regulatory Intelligence

How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any appreciable amount of time on the www.fda.gov. Albeit a great source of information, it is a complex web of blue pages, and it takes a very large amount of time (and money!) to find the information you are looking for.
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Eye Spy

Every time I visit my optometrist I see advertisements for colored contact lenses. I’m pretty happy with the green I’ve got so I’ve never tried another color. Did you know that contact lenses, even the purely decorative ones that don’t correct your vision, are considered medical devices? Whether you want to match your eyes to your clothes, your husky dog, or your favorite sports team, the FDA has some advice for you.1
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Consumer Medical Device Adverse Event Reporting

Recently I went trolling through the FDA website and stumbled upon an article entitled "Wanted: Consumers to Report Problems (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm#report). It's a great article that at its core, is a plea to the consumers of medical devices to aide in the reporting of discovered adverse events related to the use of medical device products. At first this plea seemed odd to me in that with the technology that we possess nowadays why is it so difficult to get this information. In a environment that has essentially made the masses into amateur journalists via Twitter, Facebook, Pinterest, blogs, etc. why does the FDA need to ask for this assistance. Most of the time people, on their own accord, blow the whistle. Yet the fact that this article exists should highlight an opportunity for improvement in the medical device field.
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AGILE

Integration Phase - AGILE vs. Regulatory

An AGILE software development process allows for adaptive development through incremental changes in the software. This means that there are more releases and upgrades of the software in the field. Within the AGILE process there is time allotted for the integration phase. This means after development and initial testing of software features the team decides which features will be integrated into the core software. This obviously has to happen after development and successful testing but prior to official V&V testing and release.
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Race for the Place and RQS Cares

After reading Steve’s blog, "Why RQS Cares- The Race for the Place" and learning more about Race for the Place/The Gathering Place, I knew that I wanted to participate in this event. Soon thereafter, I was registered and ready to participate in RQS Cares’ first Ohio-based charity event!
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submissions | FDA | medical device | team members | regulatory | 510(k) | approval time | medicaldevice | customer success | collective experience | regulatory professionals | fda clearance

510(K) Success!

RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we obtained it.
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Mobile Medical Applications - More Apples, More Hassles

Could it get much worse for mobile medical applications and their developers trying to utilize phones and tablets as point-of-care medical devices? OK, surely it could, but this story can't make it any easier.
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Medical Devices | medical device industry | FDA | K97-1 | Guidance Document | regulatory | 510(k)

FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about what I would change to make it more straight forward. While I can appreciate how difficult it is to make general rules that can apply to an infinite variety of products, there are sections of this document that could certainly be clarified.
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Medical Device Report | Complaint Handling | MedWatch | Complaints | FDA | medical device | MDR | Adverse Event | Post Market Vigilance

Complaint Handling Solutions

In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues. So in this post, I’m going to point you to two very good resources that I found that give further insight into how to know if you have a problem, and how to fix your system.
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Medical Cybercrime

I saw an episode of Elementary a couple weeks ago in which a hired assassin killed someone by hacking into his pacemaker and cranking up the voltage to cause a heart attack. Initially I thought maybe crime shows were just stepping up their game, trying to find more creative ways to kill people off. But I still wondered if it was really possible. These days many medical devices, whether implanted or not, are connected to the internet so that doctors can collect data regarding patient health and treatment. However, these devices are more vulnerable than we realize.
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internal auditor | quality system procedures | quality procedures | compliance | internal audits

Internal Audits, the After-Thought of a Quality System

Why is it that Internal Audits are forgotten, or even worse feared? Why is it so many organizations of today place so much focus on the creation of Quality Procedures, Work Instructions, Forms, etc. but do not place the same focus on conducting internal audits of the quality system? Is it human nature? We all tend to be "gung-ho" about projects at the start, but the passion, and therefore the quality of the work, so often deteriorates over time.
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AGILE | medical device | 62304 | software development

Using AGILE in Medical Device Software Development

In school I was always taught that the medical device development process followed the waterfall model. However since entering the work force I have started to see other methods of development for different types of devices. I have recently been working with software medical devices. My client is constantly updating the software device by either adding new features or fixing defects. There is continuous development which means frequent pushes to market for this standalone software medical device. Because of this continuous improvement and continuous innovation....is the waterfall approach the best for development or will it hold up the innovation process?
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MedCon 2013

At the beginning of this month, MedCon 2013 was hosted in Cincinnati, OH by Xavier University. The three day conference was held Wednesday May 1st, 2013 through Friday May 3rd, 2013.
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low heart rate | congenital heart defects | congenital heart defect | heart block | pacemaker | adult congenital heart association | rqs cares | heart foundation

Why RQS Cares - Congenital Heart Walk

Today we feature a post from Deb Gimbel on why RQS Cares has chosen to support the Congenital Heart Walk. Seven years ago, my niece Riley was born with a congenital heart defect known as complete heart block, which is an interference in the signals between the heart chambers, resulting in an extremely low heart rate. After Riley’s first birthday, the doctor’s decided she needed a pacemaker since her heart rate had declined since birth. At the age of one, she received her first pacemaker and thrived. Today, Riley is an energetic seven year old, who loves to dance, play soccer and bake! Unfortunately, there is no cure for complete heart block, so Riley will need a pacemaker her whole life. The Children’s Heart Foundation is a non-profit organization that raises money in support of research for congenital heart defects (CHD), including complete heart block. Even though there is no cure today for Riley, we hope that through the Pittsburgh Heart Walk and other fundraising efforts, someday a cure will be found. As a “heart mom”, my sister, Lori, is passionate about the Pittsburgh Heart Walk that supports both the Children’s Heart Foundation and the Adult Congenital Heart Association. In her words: Having a child with a CHD is knowing your child's condition has no cure, your child will face a lifetime of obstacles and your child has no promise of a healthy tomorrow. Through Riley's CHD, I've become ingrained in the heart community, finding an extended family that is supportive and strong. I plan the walk to give the Pittsburgh heart community a chance to gather, to remember and fight against this killer of children. I work each day for the Children's Heart Foundation to give my child, and every child with CHD, a chance at a healthy tomorrow. Congenital heart defects are the #1 birth defect in the US and around the world. My family participates every year in the Heart Walk, not only in support of my niece Riley, but for all of those children who are born with CHDs. Our fundraising efforts can help support future research and give CHD kids a brighter future. Come walk with us! - Deb Gimbel
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Localization Issues

Last month Serbia changed its localization so that The Instructions for Use and labeling of medical devices must be written in the Serbian language. There was no grace period for this change, it was effective immediately. Conversely, Korea has also indicated that their localization is changing. Korean Instructions for Use and a Korean Label with regulatory information is now required. However, Korea has given a grace period to manufacturers until November 2013. At that point, the absolute deadline will be re-evaluated.
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Training, a Test of Endurance

I was blessed enough this weekend to run the Pittsburgh Half-Marathon with my wife, her dad, and her cousin. I had such a blast running in my favorite city in gorgeous weather with 30,000 other crazy people!
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cancer | gathering place | diagnosis treatment | race for the place | cancer survivor | brain cancers

Why RQS Cares - The Race for the Place

  Today we feature a post from Steve Keverline on why RQS Cares has chosen to support The Race for The Place. My father, sister and I stood in the hospital room by my mother’s side. We were anxious to learn the cause of her recent dizzy spells and loss of appetite. She had a CT scan earlier that day and we waited patiently to talk to the doctor to see what he had to say. The CT scan showed a baseball-sized tumor in her lower left lobe of her brain. Immediately, the doctor diagnosed it as an advanced (grade 4) glioblastoma multiforme, one of the worst and most aggressive brain cancers. The doctor was direct and told us my mother had three months to live, and while surgery may extend this, her prognosis was not good. I was devastated when I heard the news. How could the one I love so much be diagnosed with such a terrible form of cancer? I would do anything to make her better, but I didn’t know what to say or what to do. I was in shock and scared. I worried for her and for what the future may yield. Finding out someone you love has cancer can be very stressful and overwhelming. You want to assure them everything will be okay and they will get better, but the reality is it’s not in your control. Emotions vary from denial to anger, fear, sadness, anxiety and depression. Without a support network that can educate and help you and the victim work through the fears and concerns about cancer and its treatment, your emotions can spin out of control. Organizations such as the Gathering Place[1] can help you feel more in control and less worried about what lay ahead. They assist the victim, family and friends cope through all stages of the cancer including diagnosis, treatment, hospitalization, recurrence and end of life. In the case of my mother’s diagnosis, we did not believe that three months was acceptable. We spent countless hours researching the disease, looking for potential treatments, networking and talking to others. She wanted to fight it and we agreed that as long as her quality of life remained good we would do everything we could to support the fight for one more day together. After two brain surgeries, multiple chemo therapy drugs, radiation, an investigational drug and clinical study using a novel magnetic field device, she maintained a good quality of life for 14 months giving us the opportunity to share together another grandson’s concert, another granddaughter’s play, another Christmas and her 76th birthday. Nothing beautiful in this world is ever lost, because all precious things live on in memory. Steve Keverline 1 – The Gathering Place is a nonprofit, community-based cancer support center to fill an unmet need in the greater Cleveland community. The programs and services offered address the social, emotional, physical, and spiritual needs of individuals with cancer and their support network. The mission of The Gathering Place is to support, educate and empower individuals and families touched by cancer through programs and services provided free of charge.
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When Will Academia Catch-up to the Needs of the Medical Device Industry?

This past weekend I had a really great discussion with some neighborhood friends that really didn't know much of my background (where had I grown up, gone to school, etc.) and the question came up "what did you study in college?" This is a question that I'm sure everyone has been asked, especially during the early years of your professional career. My area of study was Plastics Engineering and Technology and upon stating that 99% of the time people are like "what the heck is that?" I'm very used to this response and it's usually followed by "how did you decide to do this?' or "is there really a need for that degree?"
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Medical Device Report | Complaint Handling | warning letter | MedWatch | Complaints | FDA | medical device | MDR | Adverse Event | Post Market Vigilance

Who’s watching your MedWatching?

Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.
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Everyday Usability – Alarm Clock Edition

I’ve always had a rocky relationship with my alarm clock, specifically the snooze button. In my current clock it’s built into the base (not the display, where all the cool buttons hang out), and it’s angled, narrow and difficult to locate in a semi-conscious state. I pretty much have to wake up completely, steady the clock with one hand, wait for my eyes to focus, locate the snooze button with the other hand, and press very precisely at just the right angle in order to access 10 more blissful minutes of uninterrupted rest. It was probably designed like this on purpose to force people to wake up (as alarm clocks are intended after all), which would have been very clever if the off switch weren’t so ridiculously easy to find and flip in one smooth motion without missing a beat of REM sleep.
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Biocompatibility | Medical Devices | premarket submissions | G95-1 | standard iso | ISO 10993-1 | FDA | draft guidance document | Guidance Document | biological evaluation | iso 10993 | fda clearance

New Biocompatibility Draft Guidance

FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1 was issued in 1995 in the span of 18 years a lot has changed regarding FDA’s view on biocompatibility.
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harmonized symbols | Medical Devices | medical device labels | standards development organization | labeling | regulators | labeling products | FDA | medical device | labels | regulatory structure | biological product | sdo

Crash Those Symbols - FDA Proposed Rule

Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!
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shock | FDA | medical device | tachycardia | fibrillation | electrodes | sudden cardiac arrest | cardiac emergency | electrode pads | heart rhythms | american red cross | aeds

Proposed Order on AEDs

Automated external defibrillators (AEDs) can save the lives of individuals suffering from a cardiac arrest event. Sudden cardiac arrest can happen to anyone and at any time. According to the American Red Cross, over 350,000 people will suffer from sudden cardiac arrest this year.1
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congenital heart walk | children's heart foundation | fundraising event | RQS | congenital heart disease | chd | acha | promising research | heart foundation | heart disease

RQS Cares - Congenital Heart Walk

RQS is happy to announce that RQS Cares is organizing a group for the Congenital Heart Walk event occurring on June 22nd, 2013 in Allison Park, PA. The race serves as a community gathering and fundraising event for ACHA, an organization to improve the quality of life and extend the lives of congenital heart disease survivors, and the Children's Heart Foundation, an organization to fund the most promising research to advance the diagnosis, treatment, and prevention of congenital heart disease.
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RQS | runners | registrations | gathering place | walkers | race for the place | cancer survivor

RQS Cares - Race for the Place

RQS is happy to announce that RQS Cares is organizing a group for the Race for the Place 5K run / 1 mile walk event occurring on June 2nd, 2013 in Beachwood, OH. The race serves as a fundraising event for The Gathering Place - an organization focused on supporting, educating, and empowering individuals and families touched by cancer by means of free programs and services.
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quality management | medical device companies | corporate quality | management reviews | Quality System | quality manager | corporate policy | manufacturing process | executive management team | quality policy

Quality Systems Becoming the Culture of a Company

The culture of a company is what drives the organization – it can change and adapt, but ultimately, if a strong management team doesn’t drive a company’s culture – the company risks losing its identity. For medical device companies, establishing a culture around the Quality System is one effective way to set up for success. Everybody in the organization plays a part of the Quality System – so building the culture around Quality will include and impact everyone.
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HPFB | medical device companies | wikipedia | money | TGA | regulatory risk | medical device industry | investors | FDA | medical device | ANVISA | engineering projects | open source projects | crowd source

Crowd Source in Medical Devices?

Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known example), but other examples are appearing more frequently, including in the medical device industry.
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mammogram | Medical Devices | mammograms | usability | medical device | breast cancer screening | human factors | regulatory | Women in Bio | quality | Breast Cancer

Human Factors

Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked about how they hate to come and get their annual mammograms. They talked about the pain of it, joked about the embarrassment of it - there was even a suggestion that they should serve wine in the waiting room instead of coffee. But each also showed a deep appreciation for the necessity of breast cancer screening - telling stories of aunts and mothers who were saved by it. Finally one woman told us that she was 39 when a mammogram detected her breast cancer for the first time. She was able to get minor surgery and was put on a regimen of annual mammograms. Six years after, she got breast cancer again. Again the mammogram was able to catch it early. She said she was now 57 years old and she felt like she owed 18 years of life to her doctor who suggested she get a mammogram at 39. There is no doubt about it; mammograms save people’s lives.
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investors | patent | patent application | first to file | medical device | patent office | law | Innovation | first to invent | us patent law | patent system

Patent Law Changes

For over 200 years, the US has operated under a “first to invent” rule. This means that if two innovators independently submit a patent for the same exact invention, the person who can prove that they invented it first is the one who is awarded the patent.
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ergonomics society | alarms | usability | false positives | alarm systems | medical device | iec 60601 | human factors

An Alarming Trend

If you’ve ever spent any appreciable amount of time in a hospital or other medical care facility, you may have been driven temporarily insane by the never-ending chorus of medical device alarms. I was recently reminded of a few nights I spent in the hospital with my dad a year or so ago. Just when I thought I was drifting off to sleep, one of the infusion pumps delivering his pain medication would go off and wake both of us up. This got me thinking about alarm fatigue, and the drain that so many medical device alarms must have on medical staff, not to mention patients and family.
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FDA's Guidance of User Fees and Refunds for Premarket Notification Submissions 510(k)s

This morning I was welcomed by receiving an email from the FDA CDRH News stating that new guidance was released regarding user fees and refunds for pre-market notification submissions 510(k)s. Some of the takeaways I had were:
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Japan PMDA | EU | audits | TGA | GHTF | FDA | health canada | quality improvements | iso 13485

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.
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audit | medical device

Audit Training

I recently had the opportunity to receive some training in auditing of medical device companies. In this training I was able to gain experience from an auditor's perspective as well as an auditee's perspective on how an audit is performed. This training was important to me because auditing is a huge part of the regulated medical device industry whether it is internal audits, audits from notified bodies or the FDA coming in and auditing products and processes. One of my goals during the training session was to see from both the auditor and auditee's perspective how questions are asked and then answered as well as what specifically an auditor looks for and how they write up findings or observations.
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trade | MDD | Medical Devices | trade deadline | trade-off | nhl | iso 14971 | risk management | 14971 | FDA | business risk | cmdr

Medical Device Development: Trades

As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to follow all hockey writers in the next 24 hours or so, I find myself thinking about trades in medical devices.
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Excise Tax | budget resolution | bipartisan vote | medical device manufacturers | us senate committee | senate committee on finance | u s senate | FDA | medical device | bipartisan support | government | affordable care | Medical Device Tax | bipartisan

Bipartisan Repeal of Medical Device Excise Tax

Bipartisan support, in today’s world of politics, might seem a little hard to believe. However, the U.S. Senate passed an amendment that repeals the medical device tax last month (Thursday, March 21, 2013). The bill was passed by a bipartisan vote of 79 to 20. 1 This impressive bipartisan support may suggest increasing support for industry.
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3d printing | FDA | medical device | 510(k) | additive manufacturing | oxford performance materials

Medical “Wow”: 3D Printed Skull

Last week I saw several articles published about a new device that is going to shake up the Craniomaxillofacial device market, and the Orthopedic market is next on the list. 3D Printing – chances are you’ve just started hearing about it, mostly concerning gun controls laws for assault rifle cartridges. The other week in Milan the first 3D Printed dress was worn by a model on the fashion runway. 3D printing has the capabilities to change hundreds of industries in my opinion – it’s cheap, relatively easy, and I believe it will be the next revolution in manufacturing. So let’s talk about how the big “wow” in medical devices that occurred last week. Last month the FDA cleared the 510(k) for a 3D printer that prints a human skull. That’s right – and on March 4th, the first one was implanted in a patient who was missing 75% of his skull! The company that developed this technology, Oxford Performance Materials – developed the Class 2 OsteoFab Patient Specific Cranial Device with a digital Computer Assisted Design (CAD) file, by matching the symmetry of the patient’s existing skull, so that the implant is a near-perfect anatomic fit for that particular patient. The skull itself is made of a material called polyetherketoneketone (PeKK) which is radiolucent and demonstrates a modulus of Elasticity similar to bone. The plastic also has key holes through it, which encourage natural bone growth to fill the voids. The company is already working on Orthopedic implants using 3D printing technology for other applications. As I said at the beginning – the implications of 3D printing for medical devices is massive! I can’t wait to see how this will impact the medical device industry. Also, the relatively low cost will allow for more start-up sized companies to utilize the technology, so the door is wide open for innovation that will improve the lives of countless patients. -SJG 3/27/13
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Medical Devices | medical device development | March Madness | medical device industry | Innovation

March Madness

The season is upon us. Unfortunately, the season is not spring…winter still seems to be lingering. However, the season of March Madness is in full swing! Everyone’s bracket selections are in, and we wait to find out who is the National Champion.
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correction | Medical Devices | warning letter | fda inspection | immediate action | FDA | 483 | medical device | corrective action

RQS Feature Article - Successfully Addressing Warning Letters

Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA warning letters are not to be taken lightly, and the careful handling of them is critical to ensuring your business can move foward to produce safe and effective product. The article provides five great bullet-points of advice on putting your company on the right track with the FDA
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Medical Devices | ergonomics society | medical device industry | human factors standards | human error | fda perspectives | industry guidance | regulatory submissions | usability engineering | CDRH | human factors group

HFES Health Care Symposium – What’s New in Human Factors and Usability?

Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote speaker, Dr. Ross Ungerleider, talked about practices that foster an environment (particularly in an operating room) conducive to innovative thinking and learning from human error. There were a number of presenters from the medical device industry who shared case studies, lessons learned, and various models for applying usability in their individual companies and departments. We were also fortunate to learn about some changes coming for human factors standards and the latest FDA perspectives on best practices, which I thought I’d share with you this week.
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quality agreement | 21 cfr | supplier selection | medical device industry | FDA | supplier management | supplier quality

Getting Control of Supplier Controls

It seems that for one reason or another supplier controls are a requirement that slips through the cracks of even some of the largest medical device organizations. Those of us in the medical device field should know better since 21 CFR Part 820 clearly includes requirements that medical device manufacturers shall have controls over purchased products or services related to medical device being manufactured.
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pittsburgh tech | RQS | teq | quality solutions

RQS appears in TEQ Magazine

In the March 2013 edition of the Pittsburgh Tech Council's TEQ Magazine, Jonathan Kersting highlights Regulatory and Quality Solutions' growth over the past 5 years. See here for the blog post that recounts the article. The "e-zine" can be found here.
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alternative materials | 21 cfr | Leachables | human exposure | DEHP | natural rubber latex | Latex | medical device industry | exposure levels | Allergy | Materials | BPA | phthalate | polyvinyl chloride pvc | ethylene vinyl acetate | Phthalates

Latex and DEHP and BPA, Oh my!

They’re just as frightening as Lions and Tigers and Bears, but how much do you know about them? Are they in your medical devices?
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language development | Medical Devices | cochlear implant | medical technology | cochlear implants | FDA | bionic eye | implant device

Make Sense

My son has a friend that was born deaf. When he was a small child, he had surgery to get cochlear implants. With the implants, he is able to hear. When his younger brother was also born deaf, his parents found that they carried a recessive gene that causes deafness. Both boys were able to receive the cochlear implants. They have developed normal language skills and are able to lead normal lives. Their only restriction is that they cannot play contact sports. I was talking to their mother, and I expressed my awe of medical technology - that deaf people can really hear when wearing the cochlear implant device. She told me that what surprised her most about the Deaf community was that most people who are deaf do not choose to get cochlear implants for their deaf children. There is a pride with being Deaf, and there is a whole close knit Deaf community. They do not see deafness as a handicap, but as uniqueness. Most deaf people are happy in their Deaf community so they want to share it with their children. They do not see deafness as something to be fixed so they usually do not elect to have the surgery. Adults would not benefit as much as children from the implants due to the critical periods for language development being passed. However, some adults have been thankful for the ability to experience hearing with the implants. Therefore, after much resistance, the Deaf community is slowly beginning to accept cochlear implants as a personal choice. I thought that was fascinating.
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synthetic rubbers | latex allergy | health care industry | natural rubber latex | food and drug administration | draft guidance document | food and drug administration fda

FDA issues draft guidance for accurate labeling on medical products that are not made with natural rubber latex

What do adhesive bandages, blood-pressure monitoring cuffs, sanitary napkins, ventilator bellows, wheel chair cushions, and dental dams all have in common?
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standards | european commission | IEEE | MDD | Medical Devices | BSI | medical device field | medical device manufacturer | country code | FDA | ASTM | RTCA

Keeping Up With Regulations

In the medical device field the name of the game is Compliance. The reason for V&V testing is compliance. Prior to distribution you need to provide evidence of compliance. Everywhere you turn there are rules where the medical device manufacturer or distributor must provide evidence of compliance.
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best practices | Quality System | autonomy | Guidance Document | Innovation | regulatory | improvements | quality

Autonomy with Boundaries

I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a good kid, full of promise…..and he knows the boundaries. No phone while driving, no friends in the car, follow the law and safety first.
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tax payer dollars | medical device manufacturers | fda budget | new medical devices | FDA | advamed | improved products

FDA Budget Cuts This Week

This week, the FDA faces between 5.1 to 5.3% of their budget being cut this week ($210 million of a $4.1 billion budget). I’ll be interested to see what areas of the FDA are impacted by these budget cuts, and what that means for medical device manufacturers. Proposed to be included in those cuts are the user fees medical device & pharmaceutical companies pay the FDA for timely reviews of new medical devices & drugs. Zimmer’s CEO and AdvaMed chairman David Dvorak announced during a conference “The fees voluntarily paid by industry in exchange for meeting certain performance goals are not tax payer dollars and should not be considered in the same light as appropriation funding”. March 1st marks the deadline for when or if these budget cuts will be passed.
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quality management | quality control methods | statistical quality control methods | customers needs | statistical process control | management philosophy | quality improvement system | Joseph Juran | six sigma | quality improvement techniques | juran quality | sigma six | statistical quality control

Architect of Quality – Part 4: The Juran Quality Trilogy

Today we are continuing our blog series on Joseph Juran, “Architect of Quality,” by looking at a trio of concepts he was famous for incorporating into quality management. Quality planning, quality control, and quality improvement are three central tenets to his management philosophy and became widely known as the Juran Quality Trilogy.1
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device submissions | medical device | american medical association | pubmed | Guidance Document | pma supplement | medical product | draft guidance | journal of the american medical association

Open Comments are Not Left Unheard!

Some may think the FDA does not take what industry has to say to heart or feel that there is no point in commenting on a proposed rule, because their feedback is left unread.
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Medical Devices | collaboration | medical device companies | partnership | regulatory science | regulatory pathway | nih | FDA | MDIC | medical device | Innovation | fda regulated products | medical device innovation | governing bodies | innovations

Regulatory Science

I heard an interesting new term today (new to me at least!) that I thought greatly impacts the line of work I am in. Regulatory science is "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products". This involves not only developing devices and getting them approved by governing bodies but reducing the time and cost it takes to get the device to market.
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Da Vinci | medical device industry | technology | medical device | technology advancements | surgery system | Robot-assisted | Intuitive

Technology Overkill?

Over the past few years, there have been some really great technologies that have changed the way we live our lives. Smartphones are the easiest example. Life would be a lot different if I didn’t have instant access to my e-mail, the weather, the spinning schedule at my gym, or Fruit Ninja. While many technology advancements have certainly improved the way we live our lives, there are some that may be technology overkill. Like a washing machine or dryer that you can remotely monitor and control from your PC, or a Mercedes Benz that can shift the direction of your headlights away from the oncoming traffic. A washing machine that you turn on yourself, or headlights that point straight ahead are alternative options that accomplish the same end goal, they just do it much more cost-effectively than the high-tech ways. Don’t get me wrong, the development and engineering that went behind these things is super impressive, but sometimes, the bang is just not worth the buck.
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risk analyses | probability | residual risk | risk analysis | severity

Go Ahead, Take a Chance

Throughout our daily lives, we assess risk. At the grocery store, driving to work, giving advice to our kids and buying a car are all examples of internal risk analyses. How can we be sure that we’ve considered everything? Do we know that we’ve given every aspect the proper weight? Do we truly know the effect of every situation?
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adverse events | Medical Devices | quality engineering | Regulatory Affairs | design quality | mhra | risk management | medical device | maude database | design dossier

Regulatory Thoughts

Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality engineering and risk management. My exposure to regulatory affairs was at an arms length. I was always the person on the other end of a conversation where I was the one being told that I need to do something in a particular way because the regulations said so.
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new medical devices | medical device industry | medical device | regulation | sensors | innovations | medical breakthroughs

New Medical Devices Coming Soon to a Hospital Near You

Recently I came across a FoxNews article (‘Medical breakthroughs on the horizon for 2013’ by Dr. David Samadi) that got me excited. The reason why I pursued the medical device industry was to be in a field that impacted people; a field that matters. I don’t care who you are – anyone with a loved one who has ever been sick, or needed surgery, etc. has been impacted by medical devices in some way. What impresses me is how medical devices are always pushing the boundaries.
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quality management | safety hazards | pareto principle | quality control | pareto chart | Joseph Juran | six sigma | healthcare reform

Architect of Quality – Part 3: The Pareto Principle

Today’s post is a continuation of our blog series on Joseph Juran, “Architect of Quality.”1 We’re going to take a look at the Pareto principle, which is one of Juran’s most widely used contributions to quality management.
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medcity | technology hub | research triangle park | innovation center | life science industry

Cleveland Rocks… its way to the top five growing life science hubs

After many years of adamantly claiming not to have a “hometown,” hating the 100% humidity-filled summers (that I still despise), and trying to be indifferent about anything “Southern,” I have finally come to peace with my Southern roots and my “Southernisms.” It wasn’t until I re-located to Cleveland, Ohio this past summer that I realized how much I miss the down home cooking, Southern hospitality (including the “Sirs” and “Ma’ams”), and of course 75% of the year being flip-flop wearing weather; I never thought that these things influenced my life so much, until I realized how much I miss these things.
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NBC | Universal Sports | curling

Curling Nationals!

Something very exciting is happening this week in Green Bay, Wisconsin. The 2013 Men's and Women's Curling Nationals are taking place all week. What's even more exciting is that this year the semi-final and final games will be on national television. In the past there has only be online web-streaming of the event. The link to follow along can be found here. Curling zone also has great coverage of the event. In addition live coverage of featured games are playing all day at this link.
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QMS | MDD | EU | Canada | Medical Devices | FDA | health canada | 21 cfr 820 | Preventive Action | iso 13485

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange nightmare with future Broadway stars re-enacting a root cause analysis!).
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standards | MDD | iso 14971 | medical device | Medical Device Directive | ISO | iso 13485

Making Sense of Standards

You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming. After a little digging into the changes to EN ISO 14971 and EN ISO 13485, hopefully I can provide you with a little clarity.
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medical device industry | taxes | FDA | medical device | public health | govenment | regulatory | 510(k) | CDRH

Headaches

The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My colleagues and I were very excited to hear about it. These changes will make things better for the public and smoother for us, especially after these new employees are fully trained. Good news, right?
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Medical Devices | visual signal | risk level | alarm systems | safety feature | compliance

Auto Compliance

Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium - the automated compliance robot!
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internal auditor | auditee | external auditor | compliance | observation | Preventive Action | internal audits | corrective action

Thoughts About Auditing

'Tis the season for auditing. The beginning of this year, just like years in the past, seems to have brought the New Year's Resolution that audits will be scheduled and conducted to correct the sins of the previous year and take a fresh look at the upcoming year. To this point I've conducted three audits and after this week I'll have been the auditee twice (essentially an audit per week to start the year).
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quality systems | submissions | guidance documents | good manufacturing practices | FDA | biological product | current good manufacturing practices | combination product | Combination Products

Would you like fries with your Combo meal?

On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product. First off, what are Combination products you may ask? It is any combination of a drug, a device, or a biological product. As defined in 21 CFR 3.2, this may refer to two or more regulated components that are physically or chemically combined into a “single” entity, or even a “kit” combination where the before-mentioned are packaged together in a single package. The Combination Products Coalition (CPC) sees this as an excellent move by the FDA, and hopes it will reduce the amount of duplicated work for drug, device, and biological product requirements. But with the new Combination policies, how will this affect current manufacturers? A big long term “pro” might lead to a short term “con” as companies will need to modify their current Quality Systems to accommodate this new rule. Also, what will this do to the number of combination product filings? Will companies take this as a positive, or see it as an additional hurdle? -SJG
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gmp | final rule | FDA | medical device | Pharma | Biologics | Combination Products

Final Rule - Combination Products

Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four sections comprise the final rule(1-2); §4.1 - Scope, §4.2 - Definitions, §4.3 - Applicable CGMPs, and §4.4 - Single-entity or co-packaged combination products compliance with these requirements.
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13485 | MDD | EU | Quality Management System | Quality System | Product Quality | FDA | medical device | 21 cfr 820 | Joseph Juran | quality

Architect of Quality – Part 2: The Human Dimension

Welcome to the second installment in our blog series featuring Joseph Juran, “Architect of Quality.”1 Today, we’re going to take a deeper look at one of his major contributions – the addition of the “human dimension” to management theory.
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medical device review | FDA | Guidance Document | PMA

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I discussed in my previous post, the FDA also issued a guidance titled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) at the same time.
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iPhone | mHealth | mobile medical applications | healthspot | Android | FDA | medical device | Apps | health spot | 510(k) | retinal exam

Mobile Medical Applications - Where do we go from here?

With the recent announcement of 510(k) clearance of a retinal examining attachment and companion app can we now declare the outcry against the FDA finished?
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Value Chain | Medical Devices | x-ray | healthcare | Insurance | customer

Who is your customer?

My mom works as an x-ray technician at a small orthopedic office in Chicago-land. Recently, the office ordered a new x-ray machine to replace their old and outdated equipment. My mom was very eager to use the new equipment, and was very happy to have an upgrade. However, after a few days of shuffling patients in and out of the room, she already had some complaints: the lever for the film was difficult to operate, there was not enough clearance between the machine and the door to get a stretcher in the room, the surface of the table was too slippery. One thing she said that really stuck with me was that no one ever asked her for her opinion when buying the equipment, even though she was going to be the one using it every day. She said she would have picked a different machine, if she had the choice.
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requirements | argentina | brazil | international | China | labeling | registrations | venezuela | mexico

Small Label, Big Impact

There have been a bunch of countries recently that have changed their regulations to require a native language registration label on medical devices. These labels must call out a specific set of information including manufacturing location and address, and the Registration Number of the device. The label doesn’t need much information on it – these labels are usually very small. Countries like China and Brazil have had this requirement for quite some time, and recently countries such as Argentina, Venezuela and Mexico are following suit. I can truly understand why these countries are making this labeling requirement, as it makes it easy to check if a medical device is registered. However, these requirements are causing logistical problems for manufacturers which make the cost of registration in these countries prohibitive.
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quality product | Quality System | customer feedback | supplier evaluations

Some Things Never Change....

There are some things in life that never change. So, if they never change, let’s learn the rules. A teacher once told me “once you know the rules, embrace them.”
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Medical Devices | Regulatory Affairs | medical device manufacturers | maude database

Medical Devices and Fantasy Football, More in Common Than You Think

I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the Championship round for the NFL I began some reflection. I found myself realizing that fantasy football has similarities to writing a technical file for a medical device.
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listing | MDD | EU | Medical Devices | us | gmp | mdufa III | FDA | FDASIA | enforcement actions | registration

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:
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adverse events | hip replacement | surgery | safety communication | FDA | medical device | implantables

Hitting Home

One of the more personal aspects of why I work in regulatory and quality is because of my dad. As a youth, he experienced a hip injury. Combine that with a condition (don't ask - I never remember its fancy medical name) that causes weak capillaries, and that resulted in a "busted hip". Specifically, one that had become so painful in his late 30's he needed a hip replacement.
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quality management | FDA | medical device | 21 cfr 820 | Joseph Juran | quality | iso 13485

Architect of Quality - Part 1

Have you ever wondered where quality management systems came from, or why these infrastructures are designed the way they are? In an effort to explore our roots at RQS, this post is the first in a series about Joseph M. Juran who was a dominant figure in the development and dissemination of quality related concepts that we use in manufacturing today. His autobiography is entitled Architect of Quality1, and his design influence can be seen in many aspects of current quality systems. Let’s take a look at Mr. Juran’s life and contributions to this field.
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proposed rule | Unique Device Identification System | Unique Device Identification | UDI

Identification... Unique Device Identification.

The other night, while I was drinking a refreshing beverage (neither shaken, nor stirred) and completely engulfed in an iconic (British) action-espionage movie, I began thinking of fingerprints (thanks to the movie's protagonist using spiffy spy gear to trick the baddies!) and how they are unique to the individual who possesses them, and in theory sort of like snowflakes and kind of like Unique Device Identification (UDI).
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preparing for FDA visit | regulatory harmonization | remediation | Australia | FDA | New Zealand | medical device | regulatory news | white paper

Regulatory Intel - Jan. 14, 2013 Quick-Hits

A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:
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wellness products | watch sensors | mobile medical applications | FDA | medical device | wearable tech

Mobile Medical Applications - Healthcare at CES

So I wasn't kidding last week about wearable tech, which made the biggest splash at CES 2013, an annual consumer electronics expo. Coverage thanks to CNET.com.
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RTA | submission | FDA | medical device | 510(k) submission | 510(k) review | Guidance Document | Refuse to Accept | 510(k)

New "Refuse to Accept" Guidance Document for 510(k)s

There has been much controversy about the new RTA FDA Guidance document titled "Refuse to Accept Policy for 510(k)s". The draft of this guidance was issued for review in August of 2012 and was recently released at the end of that year. However companies are still talking about the changes to the policy and the issues they have with them. As always, the draft guidance document went through the review process where companies could read through the document and provide comments. 
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Regions | Orthopedic Capital of the World | Medical Devices | biomedical | Pittsburgh | Catheter Valley | Ohio | Biomedical Industry

Location, Location, Location

January is usually that time of year where I start day dreaming about a vacation somewhere warm and sunny. California is always on the list. California has a lot more to offer than just its beautiful beaches and amazing sights. A recent article on the biomedical industry had some amazing statistics about California.
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fashion | consulting

Be Smart: Look Smart

I wanted to write about an interesting event that a group of us at RQS had this weekend. One of our employees, Kathy Callan, is a professionally trained Fashion Consultant. Kathy is one of those people that always looks put together. She is walking evidence of her talent and knowledge.
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The Promise

Training is an integral part of what we do at RQS, whether it’s one on one or in a more formal setting. Recently, as I talked with staff members at one organization, I realized that we needed to do a basic class on documents that make up the Quality Management System. As process owners, these folks know the most about what they do every day and the way things should work. Technically, they knew more about the process than I did, that’s the way it is in every organization. A procedure or process map can’t be written in a vacuum. The real people must be involved to represent “what really happens.” How else will the document be practical? I can facilitate the format and ensure that requirements are met, but the real folks provide the content. In the Quality Manual, the commitments to quality are outlined per the requirements. The broad commitment should be endorsed by management and maps out the processes by which the company ensures quality. The Quality Manual is a Level I document, the “parent” of all of the other documents. The Quality Procedures are the methods used to ensure that quality commitments are fulfilled. These Level II documents promise certain outcomes, further demonstrating that the quality thread permeates the organization and that there is a plan to ensure quality. Examples may be a Service Procedure, Complaint Handling Procedure, Purchasing Procedure, etc. Work Instructions are the Level III documents used to tell staff members the actions that are taken for a specific task. Work instructions or standard operating procedures outline the day to day tasks that ensure that the promises are kept. If tasks are carried out with consistency, the outcome is more likely. (notice, I didn’t say guaranteed!) Examples of work instructions are: PM tasks, how to upload an electronic file, or how to run the dishwasher. These instructions ensure that we have clean dishes! Records are proof that you have kept the promises that were made. Along the process, there is a record of what has taken place - a great tool for proving reliability or problem solving. If the promises couldn’t be kept for some reason, the company has taken the proper actions to realign the process – and there is a record of the steps that were taken. That’s Documents 101.
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Quality Lessons of a New Parent

2012 brought many new challenges to my life. Some dealt with changes in my professional career, some dealt with personal losses of friends and family, but none were greater than becoming a parent for the first time. Being in Quality I'm accustomed to having some semblance of control over the inputs and outputs related to a project. Being in Quality and/or Regulatory empowers someone to protect the customer by ensuring they are receiving what they anticipate and that it is safe. I figured being in Quality and Regulatory would give me a leg-up on fellow new parents since I was already used to ensuring that a product complies to regulations, determined and graded the risks, developed control measures for said risks, and validating the effectiveness of the control measures. Wow, was I wrong.
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Mobile Medical Applications - Only a Bandage?

Often enough, I'll hear or say, "It's just a bandage" (to avoid the popular brand-name bandage) in response to a solution that won't truly fix a problem or is just a temporary measure or bridge to the better solution. I had a thought today that it might apply to our current use of mobile medical applications. Is this how our smartphones and their glorious mobile medical applications will be viewed in retrospect? A temporary fix to the next real-deal technology? Will they really be the Beta, American reception of the MiniDisc, or HD DVD of healthcare?
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eCopy | Federal Register | RTA | proposed rules | mdufa III | Food and Drug Administration Safety and Innovation | Medical Device Excise Tax | medical device industry | mdufa | Medical Device Establishment Registration and List | comparative effectiveness research | 2013 | CER | public comments | FDASIA | eCopy Program for Medical Device Submissions | petition

New Year, New Resolutions

Happy New Year - I hope that all of our blog readers had a wonderful holiday and brought in 2013 with warm and welcoming arms!
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A Fresh Start

Every New Year, many of us take stock of our lives and make resolutions to live differently. We see January 1st as an opportunity for a fresh start. Whether it’s the chance to renew a friendship, correct a mistake, or take an opportunity that we may have previously missed, sometimes the second chances we’re given can make an incredible difference in our lives. So in honor of the New Year and all the promise it holds, I decided to make this post a highlight of some fresh starts made possible through medical device innovations.
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Holiday Anecdotes

Quick thoughts from my holiday time with my family:
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Regulatory Intel - Alerts, Updates, Newsletters

Quite appropriate for the season, I found a little "gift" in my documents folder - a list of Regulatory Intelligence Sources! If I'm remembering correctly, these links may have come from the RAPS Online University program. This week's post: Alerts, Updates, and Newsletter sources.
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Medical Devices | Holidays | Christmas | labeling | Intended Use | Stents | Risk | Hazards

Unwanted Gifts

Have you ever received a gift that you didn’t really want? Was it an ugly sweater from Great Aunt Margie, or a holiday pillow that didn’t quite match with your décor? People always say, it’s the thought that counts… but if that was the case, gift receipts would not be so important, and return lines at Kohl’s would not be so long the day after Christmas. A bad gift is not the end of the world; we just grin and bear it, and learn to craft a more detailed wish list the next year to avoid any room for ‘interpretation’.
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Mobile Medical Applications - Progress?

I'll admit, I'm a sucker for the "Best of " everything for whatever reason. Why do I need to watch a mash-up of Gangam Style, Walk Off the Earth, and "Call Me Maybe"? The answer is "I don't", but I love it all. Sports stories, worst media sensationalist stories (such as today's end-times farce), best quotes, worst quotes - give it to me!
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Heart to Heart

Seven years ago today, I waited by the phone. Waiting for the news that my niece had been born. This wait was much different for me than previous births. This was a nervous and unsure wait.
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MDD | EU | FDA | health canada | medical device | cleveland

Mistake, I Think Not!

As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I have heard my fair share of “Mistake on the Lake (Erie)” jokes. Yes, it’s true the Cuyahoga River caught fire in 1969, the city has suffered from loss of jobs due to de-industrialization, there have been numerous failed redevelopment efforts, and as far as sports teams go; well, I have yet to see a championship winning team. Jokes aside, I don’t think anyone can argue that the Northeast Ohio region has evolved into a world class leader in medical treatment, education and innovation in the health care industry.
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biodegradable circuits | ingesting medical device | medical device | biodegradable | circuits

Biodegradable Circuits

When I first heard the words “biodegradable” and “electronic devices” together, especially in the context of nanotechnology and the medical field, the idea smacked ever so slightly of science fiction. You know, the sort of advancement that belongs in an era of teleportation and colonies on other planets. Apparently, the science is real and also really cool. A team of researchers from the University of Illinois, Tufts University, and Northwestern University have developed a family of biodegradable electronics that dissolve completely in water and other similar fluids. Silicon, magnesium, and magnesium oxide are the standard ingredients for the circuitry, and an engineered silk barrier protects the materials from water so they don’t begin breaking down right away. The circuits are ultrathin, only a few nanometers thick, and the engineers can control how quickly the device breaks down by changing the thickness of the materials. They can also control the length of time before the device begins to biodegrade by modifying the structure of the protective silk layer. (For more on cool new uses for silk in nanotechnology, check out Rebecca’s earlier article.)
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Medical Devices | NASA

Astronaut Icecream and Medical Devices

In recent years, my father has picked up a new hobby of star-gazing. What started out, as I believe, as an excuse to get out of the house and away from the mother-in-law, has slowly turned into a full-fledged astronomical geekfest (no pun intended). So, for Christmas this year, I thought it would be pretty awesome to buy the old man a star – a physical star in space. Yes, I know… no one can own a star, or a planet, or even Space itself, but the theory is amusing. Upon purchasing a star, its coordinates are issued, registered in the company’s database of stars, and the “owner” of the star is given the super-hero or super-villain ability to name it (now, I think a hilariously clichéd, yet appropriate name for my Dad’s star would be “Death Star”, but I am leaving the naming up to him).
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MDD | EU | label | Regulatory Affairs | RQS | labeling | ifu | FDA | health canada | medical device | user guide | instructions for use | manual

Labels impact the device

During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
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FDA | medical device | regulatory

Call me a (Juris) Doctor!?

I was going to write about China Labeling this week, but I didn't feel like it!
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Biocompatibility | mobile medical applications | Precedence | FDA | Substantial Equivalence | regulatory | 510(k) | quality

Setting Precedence

I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something in common. It’s something that we as regulatory and quality folks struggle with and love at the same time. It’s the topic of precedence.
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Biocompatibility | MDD | EU | Medical Devices | 10993-1 | FDA | health canada | medical device | Medical Device Directive | 10993

Biocompatibility - Simple, Right?

I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.
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MDD | EU | end user | FDA | health canada | medical device | customer

In Your Face

My teenager works at a local eatery – I thoroughly believe the saying, “A good teenager is a tired teenager”. Besides, there is a lot to be learned from being in the work force.
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What is the Medical Device Excise ?

Let me start my blog off by stating that I personally love tracking politics. Presidential election years are my favorite, with all the debates, mudslinging, scandals and whatnot that comes with the elections. It's pretty much like watching your favorite reality tv show. Unfortunately, when you turn off this show you have to deal with real life repercussions from the decisions that are made. Now we all know that there is a whole lot going on in Washington, D.C. nowadays. There's the Fiscal Cliff rapidly approaching, the Affordable Care Act will be arriving in the near future, heck there's even people worried that the world is coming to an end (darn Mayan prophecy!). What I want to focus on is something that was part of the Affordable Care Act, that being the Medical Device Excise Tax.
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medical device innovation consortium | RAPS | off-label promotion | webinar | MDD | EU | mHealth | Medical Devices | mobile medical applications | Training | FDA | scanadu | Pharma | Medical Device Directive | mobile medical apps | US vs. Caronia | Caronia | United States vs. Caronia | qualcomm | x prize

Quick Hits - December 11, 2012

In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:
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mHealth | mobile medical applications | submission | FDA | devices | medical device | Apps | AliveCor | software | predicate | mobile medical apps | EKG | 510(k)

Mobile Medical Applications - Community Bull-Dozers

Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.
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New Heights in Prosthetics

About a week ago I read an article in Mechanical Engineering magazine that I found inspirational from several perspectives. Design-2-Part online magazine also covers the same story in this article.
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Medical Devices | News | FDA | marketing | off-label

United States v. Caronia

Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the applicability of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), to the Caronia case. In Sorrell, the Supreme Court ruled that a Vermont statute, which regulated certain speaker and content-based restrictions related to pharmaceutical companies was in violation the First Amendment of the U.S. Constitution.
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WIB | healthcare | health | Eliza Corporation | Women in Bio | Alexandra Drane

Women in Bio Success!

This past Thursday (11/29) several RQS employees were fortunate enough to attend the kick-off event for the Women in Bio Pittsburgh chapter which featured keynote speaker Alexandra Drane. Alexandra is the founder and Chief Visionary Officer at Eliza Corporation. The event was buzzing with excitement as women in a number of life sciences fields came together and shared a common interest of wanting to improve healthcare and wanting to improve people's lives. Alexandra's speech was humorous and powerful. She discussed her current company (Eliza Corporation) as well as her previous three start-up companies. Alexandra has no regrets from past failures and in fact went into detail on everything she learned from her previous companies. I think being able to admit a mistake is the best way to move on and learn from it.
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iPhone | mobile medical application | mHealth | x prize foundation | tricorder | mobile medical applications | Android | medical apps | FDA | medical device | scanadu | star trek | Apps | Blackberry | 510(k) | qualcomm | iOS

Mobile Medical Applications - Beam Me Up, Scanadu

In a fantastic case of science-fiction-meets-reality, Qualcomm created the X Prize Foundation to challenge developers and innovators to create a Star Trek Tricorder. The prize? $10M!
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MDUFMA | Small Business | User Fee | Pediatric | PMA | 510(k) | Discount

Deals and Steals

Thanksgiving night I was standing outside in the cold in a line that wrapped halfway around Target. My motivation for this spontaneous Black Friday door-buster shopping was peer pressure, but I was also excited to take advantage of the great prices. Even though I wasn't in the market for a new 50" HD TV for only $350, I still found good deals on some gloves and a new GPS. I took advantage of the deals and steals of the holidays. A good sale is just too hard to pass up.
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quality systems | production quality | design quality | China | FDA | medical device | regulatory | quality

International Spotlight - China

When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and wealthier. China accounts for 1/5 of the world’s population – about 1.3 billion people. Most marketing departments feel that this huge market is worth the incredible effort that it takes to register medical devices. China registration is therefore usually in the international registration strategies for most large medical device companies.
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post market surveillance

No Time for Common Sense

Last week, I had a computer issue...not a big issue, more like an annoyance. Nevertheless, I dutifully called our IT support and after a couple of hours of investigation, we determined that the problem could be solved by one of two solutions; change the battery or change the mother board. The manufacturer of my machine was notified and was sending me a battery to change. The next day, a technician contracted by the manufacturer called me to say that he needed to come to my house to change the motherboard. This didn’t make sense to me. I said that we should wait to try the battery solution first. I cited three reasons: • It was the cheapest solution. • I could do it myself. • It was the less risky option. The conversation between the technician and myself went like this: “Ma’am, I’ve got this ticket to close, I’ve got to come to change the motherboard.” Me: “Can’t we wait one more day to see if the battery change solves the problem?” “Ma’am, are you saying that you’re refusing to let me close the ticket?” Me: “No, I’m just saying that we shouldn’t waste the motherboard.” “All that I want to do is close this ticket and I’m going to close it today. If I can’t come to change the motherboard, I’m going to close the ticket anyway.” Me: (reluctantly) “I’ll be home all afternoon.” “OK, now I’m happy.” This is a prime example of the technician being so consumed with his small part of the world, that he doesn’t have the power to use common sense. He doesn’t even care to try to use common sense. He doesn’t consider the low cost solution, the risk to my computer, or even about the best way to provide customer service. He is only focused on one thing – closing his ticket. Now, I know that it’s not this guy’s fault – he’s only responding to external stimulus that provides a reward for closing tickets. That’s his job, only closing tickets. He doesn’t consider the big picture – like being involved in post market surveillance, true customer service, understanding the real problem to feed back data to the manufacturer or even the recurrence rate of this problem. He is rewarded for closing tickets – it may even be linked to his pay or a promotion. If you are in a position to provide guidance, direction or coaching to individuals or a team, make sure that you give them the tools and autonomy to look at the big picture. Allow them to make decisions and apply common sense – they will save your company money and provide true customer service.
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Can't we just all get along?

Why is it that anytime a project is underway that it seems as if quality is an afterthought? Why are Regulatory and Quality (R&Q) Engineers typically considered to only support the deliverables at the end of a projects launch? How can this be when they are working our tails off throughout the process? Is it that they’re the project team ninja, operating in the shadows outside the view of the surrounding team members?
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Balancing Act

Early in product development, it’s easy to be overly optimistic about designing a user-friendly device. The risk management process tends to be a reality check of sorts, often resulting in a tradeoff of usability for safety with the intent of mitigating risks. Design changes are usually the most effective risk mitigations, as opposed to labeling or training. However if you change the design to mitigate every risk, there’s a chance you’ll be left with a product that’s so frustrating to use that no one will buy it (I’m imagining confirmation popups after every UI keypress or multiple user actions required to activate every feature). Once you’re knee-deep in risk management, it’s hard to find the balance between safety and usability.
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Doctor Mario to Surgery, please… Doctor Mario to surgery

When you think of video gamers or computer gamers, what typically comes to mind? Out of the many images, word associations, and stereotypes that may have just gone through your head, I am confident that the words, “future robotic surgeon” were not included.
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Truth Behind Facts

My focus lately has wildly been on healthy eating, various diets and finding the true source of where our food comes from; behind the labeling/packaging, behind the marketing....what am I really eating? Prior to this new obsession food has always just been...food. Something I knew I needed, never questioning its source. However various documentaries, books and articles have slowly opened my eyes to just how misleading labeling and marketing can be. Understanding long term effects of unhealthy eating is always a big topic and even more recently understanding the long term effects of "healthy" eating is being researched more and more. What we THINK is healthy is largely based on the fact of what we are TOLD. However, who is checking and questioning the person that is telling us?
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Pittsburgh | networking | Women in Bio

Women in Bio - November 29th Kick-off Event

On November 29th the Women in Bio (WIB) Pittsburgh chapter will be having its official launch event with guest speaker Alexandra Drane. This will be an interesting informational and networking event that a number of RQS employees are planning to attend. It is encouraging to see life science focused events like this popping up in the Pittsburgh area. For more information about the event and the Pittsburgh Chapter in general please follow the link!
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Mobile Medical Applications - Call Security!

In an odd turn of coincidence, I have been involved in more discussions regarding mobile security this week than I have in the life of the RQS blog. I took it as a sign that I should write about it.
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Regulatory Intel - Government Databases

One challenge that many regulatory professionals face is finding applicable and relevant data to conduct their day-to-day activities. Regulatory intelligence is important in the constantly evolving healthcare industry for activities such as submissions, pre- and post-market risk assessment, design controls, continuous improvement, and compliance.
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Medical Devices | acronyms | Drugs | NDA | 510(k) | Combination Products | Pharmaceuticals

Exploding Bombs?

I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office a little bit confused, and then it dawned on me that she did not want me to cause any sort of mass destruction...just to look at the BOM (Bill of Materials). Phew! It's just part of the jargon of the industry. Everyone uses abbreviations, numbers, code names, and pneumonic devices to mean any number of very important things.
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Steven Casey | Medical Devices | usability | technology | human error | human factors | phasers

Set Phasers on Stun

Several years ago a good friend who knows my interest in human factors and engineering psychology gave me a book called Set Phasers on Stun and Other True Tales of Design, Technology, and Human Error, by Steven Casey. I started to read it again recently and wanted to share it with you because the book demonstrates, according to the message on the jacket, “how technological failures result from the incompatibilities between the way things are designed and the way people actually perceive, think, and act. New technologies will succeed or fail based on our ability to minimize these incompatibilities between the characteristics of people and the characteristics of the things we think and use.” In the book Casey relates quite a few real-life stories about the interactions of people with modern technology and discusses the what caused the resulting human error. So if you need some new reading material, I encourage you to pick up a copy – I think you’ll find it fascinating!
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me too products | FDA | medical device | success | Innovation | Innovation Pathway

Success as an innovator

How can you be successful as an innovator?
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medical device | Innovation | Cleveland Clinic

Rethinking Innovation

One of my favorite topics about the medical device industry and technology in general is innovation. Rebecca's post last week discussed the Medical Innovation Summit - "Innovative to the Bone" hosted by the Cleveland Clinic. Although I was unable to attend the event, I did find an interesting article that discussed the current status of innovation as well as what the future looks like in this area.
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magnetic resonance imaging | medical imaging | mobile medical applications | mma | MRI | medical device | computed tomography | iPad medical apps | picture archiving communication system | teleradiology | mobile medical apps | aycan mobile | PACS

Mobile Medical Applications - Aycan 510(k)

To continue our product highlights within mobile health, we turn to Aycan's "Aycan Mobile" product which received clearance on September 12, 2012. A picture of its use on an iPad is shown on their website.
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When the Lights Go Down in the City

Just the other day, I left work with high ambitions of going to the gym. However, when I walked out of the office, it was completely dark outside; it felt like the middle of the night. I instantly started second guessing my decision, I mean, it had to be almost bed time, right? No, it’s just that time of year. Despite my lack of motivation, and my sudden drowsiness, I went to the gym anyway.
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inspection | warning letter | FDA | 483 | medical device | EIR

Stay out of Frying Pans and Fires!

Quick note today as a training seminar came through my inbox.
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Innovative to the Bone | RQS | Top 10 Medical Innovations for 2013 | Medical Innovation Summit | 2012 Medical Innovation Summit | Cleveland Clinic | Top 10 Innovations

Innovative to the Bone

Last week, Regulatory and Quality Solutions participated in Cleveland Clinic’s 10th Annual Medical Innovation Summit – “Innovative to the Bone”! Each year, the Summit highlights different areas of specialization, with this year focusing on orthopaedics. It was our first year participating in the Summit, which brought together more than 1,100 executives, investors, entrepreneurs, and clinicians from around the world October 29th – October 31st.
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Lessons of a High School Speech Geek

When I was in high school, I was a speech geek. Every Saturday during the Forensics season I got up before the crack of dawn, met up with my speech and debate team, and drove to a different local school to compete in a public speaking tournament. The category I competed in primarily was Original Oratory, which required each student to write an original persuasive or informative 10-minute speech, memorize it (preferably before the tournament if you harbored any hope of escaping public humiliation), and deliver it in front of a room full of peers and judges. I know it sounds like torture, and every Saturday morning when I woke up at 5 AM, I asked myself why I couldn’t have a normal hobby like so many of my other friends. My brain doesn’t function well enough at 5 AM to have that conversation, so I ended up doing Forensics all 4 years of high school. I spent long hours doing research and crafting my speeches, but although they were coherently structured, well-substantiated, and (I thought) interesting, initially my scores were pretty disappointing. As I watched some of the more experienced students in competition though, I learned that how I presented my speech was just as important as what I was actually saying.
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FDA | medical device | comprehensive regulatory assistance | Linkedin

Searching for Medical Device Info

As a recently new professional in the medical device industry, I try to find any tips or tools I can use to gain more knowledge about the industry as a whole. Increasing my general knowledge of the field can only help me when I interact with other professionals. When thinking of what to blog about this week, I was curious how others (young professionals or not) gain more knowledge about their job roles and the industry that they are working in.
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iPhone | touchscreen | mobile medical applications | usability | buttons | medicaldevices | Android | medical device | medicaldevice

Mobile Medical Applications - Difficult Usability?

The topic of this week's post was a bit more challenging than normal. Ever since my inadvertent "reboot" of the Everyday Usability series, my brain was stuck in that frame of mind. Even today I struggled to break my mind from it.
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Medical Devices | Halloween | Courses | Training | Learning | FDA

Training and a couple jokes

Trick-or-treating in my neighborhood was moved to Saturday this year because of Hurricane Sandy...therefore I needed a few Halloween jokes to keep me going until this weekend. Here you go:
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Left Wing, Right Wing, or Somewhere in Between

In the spirit of November’s highly anticipated Presidential Election, an important and multi-faceted question was raised during a recent RQS presentation. “How will the results of this year’s 2012 Presidential Election affect the medical device industry?”
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Need a Hand?

Have you ever felt like you were trying to do too many things at once and could really use a third hand? Like trying to answer the phone while carrying the groceries in (as the bags are breaking) while keeping the dog from escaping…. As our lives get increasingly busier, our hands have more to do than they can keep up with. It’s easy to take for granted the little things in life that free up our hands so we can take on more activities, but we sure miss them when they’re not there! Today’s post was inspired by Ryan’s return to the Everyday Usability thread last week and brought to you by Hurricane Sandy.
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literature review | medical device

Conducting a Literature Review

One issue that came up last week with a client was how to conduct a literature review and how important literature reviews were. I have experienced in some cases, companies that have a lot of man power behind the reviews but these companies do not have solid criteria for focusing their searches. I have experience with other companies that do not necessarily have enough people or time to solely focus on conducting a literature review, yet they have created great search acceptance criteria. So which is better?
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MDD | EU | Europe | medicaldevices | medical device | European Union | Medical Device Directives | IVD | medicaldevice | active implantable medical device

Overview of New Medical Device Regulations in Europe

This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
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Everyday Usability | landfill | usability | medicaldevices | Starbucks | medical device | trash | green movement | medicaldevice | recycling

Blast from the Past - Everyday Usability

I couldn't resist the urge to post another picture in the Everyday Usability series after seeing this:
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mHealth | idiom | mobile medical applications | mma | medicaldevices | medical device | Apps | titanic | medicaldevice

Mobile Medical Applications: Titanic Chairs

I've often believed that the number of idioms and quirky phrases describing a particular characteristic, event, or circumstance is mostly equivalent to its frequency in everyday life.
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Clinical Studies | Stents | Guidance Document | Women in Bio | Breast Cancer

October brings awareness to women’s health issues

October is a very important month for women: It’s National Breast Cancer Awareness Month. There are many things to be proud of for how far we have come with treating breast cancer. The Susan G. Komen Foundation reports that the 5-year survival rate for female breast cancer survivors in the U.S. has improved from 63% in the early 1960’s to 90% today. Thanks to advances in technology and awareness of the disease, we have been able to make great strides.
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User Research Methods

So you’re designing a new medical device and you want to gain a better understanding of how it will fit into your intended users’ workflow. Where do you start? Some common tools for user research that are particularly useful during early stages of design are contextual inquiry, focus groups, and critical incident analysis. Let’s take a quick look at each method.
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Great Lakes Venture Fair

Last week, Regulatory and Quality Solutions, attended the first Great Lakes Venture Fair (GLVF). The fast-paced day-and-a-half event (Wednesday, October 17, 2012 and Thursday, October 18, 2012) was held in downtown Cleveland, OH and featured some of the highest potential entrepreneurs and their venture-backable companies from Ohio and the Midwest. During the event, we also saw a few of our GCIC neighbors, including Securus Medical Group, Inc. and Thermalin Diabetes, LLC.
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medical device | compliance | standard

Keeping up with Standards

With recent clients I have been dealing more and more with new standards coming out or revisions being made to standards. This has got me thinking a lot about how to keep up with current standards. What is the best way of being notified of new releases of standards as well as interpreting and then implementing those standards?
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mHealth | Medical Devices | mobile medical applications | Windows 8 | mma | medicaldevices | Android | medical device | mobile medical apps | medicaldevice | iOS

Mobile Medical Applications: Whale Cupcake

A good friend of mine in high-school was trying to understand the definition of a "hyperbole". Now, if Google would have been sophisticated enough at the time to include the "define:" feature, it would have returned the following for hyperbole: Exaggerated statements or claims not meant to be taken literally. Instead, I got the following nugget of awesome: So it would be like saying I ate a whale, when I really ate a cupcake? I think my response was laughter and "Sure, something like that..."
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Medical Devices | Stents | Innovation | PMA | de novo | Disruptive Technology

Blockbuster is no more - A discussion on disruptive technology

Every time I go home to visit my parents, one thing that comes up more often than not, is the fact that our local Blockbuster closed. It’s been about two years now, and they still can’t get over it. Me? I’m happy to rent from a RedBox, or even better, kick my feet back on the coffee table and click the OnDemand button. Video rental stores have been completely overtaken by something much simpler and cheaper. THAT is what a disruptive technology is.
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The Change Agents

…cue Mission Impossible Theme Song…
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nano technology | Frontiers in Optics | spider silk | optics | nano | medical device industry | Omenetto | OSA | biomedical | FIO | Huby | microchip | Optical Society | implantables | Spider-Man

Spider silk isn't just for Spider-Man

The vast majority of us are familiar with Stan Lee and Steve Ditko’s Marvel comic book series, "The Amazing Spider-Man", where he would go web-slinging from here to there, in order to catch the baddies (of course, there is a lot more to this story than just that… but web-slinging is the main take-home point for now). Not only is our childhood superhero strong and just, but he is also smart.
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medical device

Medical Devices in Different Markets

I recently took a two week vacation to South Africa traveling to Cape Town, Prince Albert and various parts of the northern Western Cape. It was an absolutely amazing trip with many memories of time spent with my family. Traveling to a foreign country has shown me a lot of new things about the world and the various cultures and lifestyles that people experience from the food, music, and climate to politics, religion and available healthcare.
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Excise Tax | medical device | Tax | Affordable Care Act | Medical Device Tax

Medical Device Tax: Funding Healthcare for Millions

In the second of the two part series, we'll review support of the 2.3% tax of the medical device industry to go into effect on January 1, 2013. Earlier this week, I outlined why the industry sees this tax as an enormous burden and described actions already being taken to off-set the cost of the tax (the overwhelming sentiment toward the tax). In all fairness, we need to consider why the tax was implemented, and what greater good it is serving.
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MDD | Medical Devices | Europe | CE Mark | Pittsburgh Technology Council

Devices Regulations in Europe

On Tuesday, I attended a Pittsburgh Technology Council event downtown titled “Medical Devices and the European Union: What does the Path of Entry Look Like?” which was sponsored by RQS! (We gave out stress balls in the shape of a pill!) I’ve posted a few times before regarding some of the regulatory hurdles of entering the US market, so I was very excited to get more perspective on the European path and share that information with all of you.
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Kickstart | Veteran's Affairs | medical device | orthosis | Cleveland Clinic | Cadence Biomedical

Now that’s some real horse power

Our neighbors located up the street from our Cleveland, OH location, at the Cleveland Clinic, have recently helped develop horse power into a whole new meaning. A Cleveland Clinic researcher found that one reason horses are more efficient at walking and running than humans, is because of the extremely long tendons in their legs. The Cleveland Clinic researcher then took the horse’s anatomy and applied it to help develop an orthosis device, fittingly called Kickstart, which helps patients with impaired walking. The technology behind Kickstart was licensed to Cadence Biomedical and hit the market in September.
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Moderating Usability Testing

Since I’m in the middle of several usability testing projects right now, I thought this would be a great time to discuss some things to remember when moderating usability testing activities:
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Excise Tax | medical device | Tax | Affordable Care Act | Medical Device Tax

Medical Device Tax: Windfall or Pitfall?

Thanks to Sherri's earlier post, we've begun to explore the landscape of the medical devices industry in reaction to the 2.3% tax on revenue for medical device companies as a result of the Affordable Care Act. The tax is being implemented in part to fund the estimated 30 million additional Americans that will be provided with health coverage.
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medical device review | FDA | medical device | Emergo Group | CDRH

Creating Consistency

One major variable med tech companies are faced with today is the unknown of FDA reviewers. It seems like what works for one company doesn’t necessarily work for the rest. And why is this so?
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Mission | Medical Devices | Substantial Equivalence | Innovation | Intellectual Property | 510(k)

Navigating Substantial Equivalence

Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.
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occupational safety and health | osha guidelines | MDD | EU | Medical Devices | intuitive responses | design considerations | usability | interaction | occupational safety and health administration osha | environments | FDA | health canada | medical device | occupational safety and health administration | 510(k) | environmental conditions

Mobile Medical Applications: Mobile Medical Device Design

Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or when transported, so let’s look at some design considerations specific to this subset of devices.
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proposals | EU | FDA | CE Marking | European Union | new legislation | FDASIA | September

More changes heading our way?

After a recent statement by the EU health commissioner, it appears that FDASIA's influence may have gone abroad. As the medical device industry gears up and is adapting to the changes that FDASIA brings, it may also have to prepare itself for even more changes heading our way.
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RQS on YOUR Airwaves

Another thanks must go out to the Pittsburgh Technology Council for hosting RQS on their TechVibe Radio program. The PTC's CEO Audrey Russo and Director Visibility Initiatives Jonathan Kersting interviewed President Maria Fagan, Vice President Lisa Casavant, and Vice President Bob Marshall regarding the growth of the company.
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Medical Devices | healthcare innovation | Mobile Health | medical claims | Health IT | Small Business | FDA | algorithm | HIMTA | mobile app regulation | FDASIA | mobile apps

Mobile Medical Applications: Innovation vs. Regulation

Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a Mobile Health office within the FDA. Specifically focusing on health alone, there are thousands of mobile apps that focus on counting calories, recording miles walked, and monitoring blood sugar levels.
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Real Service

“I need a 25 foot garden hose, do you have one?”
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Medical Devices | Patents | Intellectual Property

Eureka!

Eureka! A light bulb goes off, and suddenly you’ve invented a great new medical device that will save millions of lives worldwide every year.
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Medical Device Design for Cross-Cultural Use

As if it isn’t challenging enough to design a medical device that can be used safely and effectively by a select group of individuals in a specific environment, the complexity increases when designing for international use by operators with diverse cultural backgrounds. HE75:2009 advises medical device manufacturers considering international markets to use the following approach:
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iPhone | mHealth | Diabetes | glucose measurements | Mobile Health | mobile medical applications | electronic log book | regulatory department | Android | FDA | medical device | regulatory news | Apps | design engineers | device manufacturers | Glucose Monitor | medical application | fda clearance

Mobile Medical Applications: Falling Star?

I think it's high time we start profiling a few applications that have been approved for use by the FDA, discuss their functionality, and potentially profile the impending issues they may encounter.
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Pittsburgh Social Exchange | Pittsburgh Technology Council | networking | SMaSh

Networking Success!

The Networking with Technology event hosted by the Pittsburgh Technology Council and Pittsburgh Social Exchange last Wednesday on September 19th was a success!
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Unexpected Benefits

Medical Device Companies are required to comply with various regulations, based on where products are marketed. As start-up businesses or established companies enter the medical device arena, sometimes quality systems and regulations are viewed as a painful part of doing business. Cultures, procedures, workflow and management style may be changed when implementing a Quality System – and change is always difficult. However, there may be some unexpected benefits realized by a company that embraces a Quality Management System.
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Setting Realistic Expectations of Medical Device Users

During recent usability testing of an updated medical device, I was reminded how important it is to set realistic expectations of medical device users when designing a product. Since the end users are the experts at what they do, it’s easy to think of them as having super-human abilities to foresee safety hazards or creatively troubleshoot device issues. While device users often surprise us with their perceptiveness and ingenuity, we need to remember that they have limitations like the rest of us. Designing medical devices should involve anticipation of and compensation for as many of these limitations as possible so that users can interact as safely and effectively as possible with the final devices.
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Networking with Technology

Several RQS employees will be attending the Networking with Technology event this Wednesday hosted by the Pittsburgh Technology Council and Pittsburgh Social Exchange. This event is taking place on Wednesday the 19th from 6:00-8:00 PM at the Rivers Club. The event will provide information about how technology can be used to boost networking efforts. Registration for this event is still open and those in the Pittsburgh area are encouraged to sign up!
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smartphones | iphone 5 | iPhone | Medical Devices | google | application development | dual core | lumia | Mobile Health | mobile medical applications | nexus | health applications | FDA | windows millenium | technical specifications | app development | qualcomm

Mobile Medical Applications: Five or One Galaxies in the Lumia Nexus?

What???
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Standing Out vs. Fitting In

Innovators are constantly being pulled in different directions on whether they should develop a product that ‘Stands Out’ or one that ‘Fits In’. It’s like middle school all over again! I’ll go through some of the challenges with choosing to develop a new state of the art device versus a device that is an improvement on the current standard of care.
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Cleveland, We Have a Problem

Since this is my first contribution, let me give you the intro - my name is Mike Andreas and I am a Senior Quality Engineer with RQS. My background, aside from 5 years in the medical imaging industry, includes mechanical engineering, configuration management, and a lot of pizza. As much as I would love to base my posts on the latter, I fear it may not be terribly relevant to this community. Bummer...
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telemetry | MBAN | FDA | wireless medical device | FCC

Healthcare going mobile

Hospital patients (and hospital staff) no longer have to grow weary of the constant due diligence of power cord avoidance (in fear of tripping on or becoming tangled in cords from the patient monitoring devices). Now, thanks to wireless medical devices, such as portable patient monitors and infusion pumps, more attention can be centered on keeping the hospital gown closed.
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Creating Growth and Improving Performance

I recently read an article that focused on describing what it takes for a company to create growth and improve its performance. So how can companies do more with less? This article describes several areas a company can focus on in order to become more successful in their industry.
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RQS on the Airwaves!

Thanks to the Pittsburgh Technology Council and their TechVibe Radio program, Regulatory and Quality Solutions will be on the radio this Saturday at noon. Hosted by the PTC's CEO Audrey Russo and Director Visibility Initiatives Jonathan Kersting, the radio program will provide a look at the growth of RQS since its inception and the plans for growing in the future.
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Death and Taxes

We’ve heard it before: “There are two things certain in life: death and taxes.”
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Success Rates for Usability Objectives

Continuing our discussion about usability objectives from last Wednesday, a related question that comes up frequently is – What acceptance criteria should I use for my usability objectives? or Is it acceptable to have a usability objective of less than 100% success?
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nanomaterials | medical device industry | medical device | nanotechnology | FDASIA | med-tech industry

Nano-what? Nanotechnology.

Over the past 50 years, the advancement of technology has been beyond incredible. Although, we are not zipping around in flying cars, fearing the dreaded encounter with a hoverboard gang, or living amongst cyborgs, we are witnessing things never before thought possible. Such innovations include robotic performed surgeries, implantable drug-eluting stents (DES), and the ability to “print” skin grafts.
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Becoming a Successful Consultant

Since I am a recent graduate and new to the work force, I wanted to discuss what exactly it takes to become a successful regulatory affairs consultant in the life science industry. Biospace wrote an article on this subject describing the five steps to becoming a successful private consultant. These steps include:
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PTC Breakfast Briefing on EU Market

Pittsburgh Technology Council (PTC) is hosting a Breakfast Briefing on October 9th, 2012 to discuss important aspects on gaining approval and releasing medical device product in the European Union. The briefing will include a keynote by Paul Brooks of the British Standards Institute (BSI) as well as an industry panel for discussion of their experiences. Additional information, including times, registration fees, and other topics / presenters swill be announced in September.
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FDA Releases Mission, Vision, and Shared Values

The core of strong organizations can be found in its mission and its vision. The Center for Devices and Radiological Health (CDRH), the body of the FDA dedicated to medical devices, strives, just like an private company, to be a strong organization. In an attempt to meet this goal, FDA has released their Mission, Vision, and Shared Values statements.
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What's taking so long?

How long does it take to get device clearance through the 510(k) pathway? Does your 90 days seem to stretch into 160? What’s taking so long?
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FDA: Jekyll or Hyde?

Black and white. Yes and no. On and off. Absolutes. Extremes. Exactly what our sensationalist media involuntarily expects each of us to believe is absolute truth. And, thankfully, wisdom typically prevails with the ever-present maxim “The truth lies somewhere in between.”
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Defining Usability Objectives

If you ever plan usability testing activities for a medical device, you may find yourself responsible for defining usability objectives. Today’s topic is - What makes a good usability objective?
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Walking like an Egyptian

Recently, the little brother of my close childhood friend and his family experienced a dramatic, life-altering event. While serving in the US Army as a Commanding Officer of the Army Rangers, my friend’s little brother became a double amputee while on tour in Afghanistan.1,2 After a few months, many surgeries, a lot of support, and a superb medical team, he is now walking on a pair of brand new (prosthetic) legs. This is due greatly in part to his determination, optimism, and of course prosthetic limb technology, as we know it today.
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RQS Honored With Tech 50 Nomination

Yearly, the Pittsburgh Technology Council issues awards, the Tech 50 awards, for local technology companies to recognize the success and growth of the technology sector in the Pittsburgh region. RQS is pleased to announce that it has been nominated for a 2012 Tech 50 award in the Solutions Provider category. The announcement of the award winners will occur later in the fall. Additional details on the awards and other finalists can be found at the Pittsburgh Tech Council's website.
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An Idea Around Innovation

Hello and welcome! This is the kickoff blog to RQS’s new daily blogging social media initiative. The purpose of this blog is to provide current, thought-provoking content about quality and regulatory affairs, life sciences and healthcare that impacts the Pittsburgh and Cleveland communities, United States as a whole and finally the entire world! This initiative aligns with RQS’s business model to becoming a national and international regulatory and quality service company in the future. Content in this blog will be posted daily by me (Jillian Walker) as well as Rebecca Spelich, Kristen Berger, Sherri Hall and Ryan Kasun who are all part of the Regulatory and Quality Solutions team.
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RQS Rises to Top of Pittsburgh 100

As announced Thursday at a ceremony and reception hosted by Pittsburgh Business Times at the Duquesne Club, Regulatory and Quality Solutions was named the 4th fastest growing company overall in the Pittsburgh region, and 2nd fastest in the Professional Services category.
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RQS in the News - Cleveland Office Opening

Regulatory and Quality Solutions is in the news again, this time featured in the Pittsburgh Business Times. The article describes the Cleveland market and why it is an attractive location for the first branch office of RQS. The article can be found online here.
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FDA ISO 13485:2003 Pilot Program

Effective June 5, 2012, FDA will begin a voluntary pilot program to accept voluntary submissions of external audit reports compiled by one of the founding members of the Global Harmonization Task Force (GHTF). Said audit reports will be reviewed by the FDA to determine whether the nonconformances observed within its contents suggest that the establishment will produce nonconforming and/or defective devices. The FDA will then use the audit result as part of its risk assessment to determine whether the manufacturer can be removed from the FDA’s routine inspection plan for one year from the last day of the ISO 13485:2003 audit.
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Upcoming Webinar - Common Mistakes for Medical Device Startups

BSI is hosting a webinar on April 24th, 2012 at 11:00 AM on the 7 common mistakes of medical device startups. I would anticipate that their information stems from their work as a notified body for manufacturers seeking market clearance for Europe (in which case, this information will be not only very useful, but quite accurate). Attendees should expect to be presented with a lot of Euro-centric information, but most of the content should cross-over to any startup medical device manufacturers regardless of their prime target market(s).
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Kim Platt joins RQS as Principal Specialist

Good evening everyone,
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Lori Smith-Sakalousky joins RQS as Principal Specialist

Good evening everyone,
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registration database | iPhone | wellness products | jawbone | personal data | myfitnesspal | bodymedia | workouts | FDA | mobile applications | quick scan | fitness and health | barcodes | calorie burn | 510(k) | annoyance | weight watchers | mobile apps | 60 minutes | gray area | electronic logs

Mobile Medical Applications: Wellness Apps

After a small hiatus, the Mobile Medical Apps blog series is back! Today we'll take a look into wellness and weight-loss applications.
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medical images | software developers | submissions | regulatory effort | image viewing software | diagnosis | computer file | ipad | regulatory pathway | submission | FDA | medical device | image credit | barco | press release | calibration | medical applications | 510(k) | princeton | job | fda clearance

Mobile Medical Applications: Visual Calibration

Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on said iPad (both versions 1 and 2 according to the article).
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iPhone | MDD | mHealth | Medical Devices | Mobile Health | mobile medical applications | mma | FDA | medical device | mobile medical apps | 510(k)

Mobile Medical Applications: Cyber Security

As with all software and technology, security is, and will always remain, a hot-button topic. It is even a point of contention for computer consumers - Mac vs. PC debates often will focus on how Mac's don't "need" virus protection (which is somewhat of a misnomer, but certainly good marketing).
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iPhone | mobile medical application | mHealth | Mobile Health | mobile medical applications | mma | Android | FDA | Apps | Blackberry | smart phone

Mobile Medical Applications: What's App-ening?

It has been predicted by many technology pundits that smartphones will be in everyone's hands within the next few years. Of course there will be different flavors of smartphones to adjust to different consumer ranges, but the way of the numpad flip-phones will be left to the late 90s and the 2000s.
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Everyday Usability 14

Well folks, our Everyday Usability photo series has come to an end with this final post. Today's blog post, in line with last week, is the nuance of language. For example, I "googled" the term "Usability" to be inspired by pictures of usability for the post. Alas, I needed the top 20 hits to find 5 decent examples of usability (seen below).
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RQS in Top 25 of Best Places to Work in Western Pennsylvania

As announced last Wednesday, October 19th, 2011, Regulatory and Quality Solutions LLC placed 25th of the 78 nominees for "Best Places to Work in Western Pennsylvania in 2011.
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Everyday Usability 13

For our penultimate edition of Everyday Usability, we take a look into what the future of Usability could look like. What better way to improve usability than to remove the physical interface altogether and implementing voice control of medical devices?
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Making Sense of the FDA's 510K Program

Good morning,
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Everyday Usability 12

Good morning blog folks! I greet you this morning with a familiar topic from the early part of this usability series: Colors! (or "Colours!" for those of our readers who favour the use of "u" in said words).
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"Cheap" Microscope Anyone?

Biotech's slow coup of the mobile industry never ceases to amaze me. In this latest piece of news, the addition of a simple (and cheap) ball lens to the iPhone camera creates a microscope strong enough to view details at the cellular level. It is being touted as the perfect device for roaming doctors or those in low-income areas for quick diagnosis of blood disease. With the advent of the iPhone 4S (latest version announced last Tuesday, to ship this Friday, Oct. 14th), the new 8-megapixel lens will make the iPhone an even better imaging because of the better resolution its pictures will have.
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Incentive-Based Regulation: Is it possible?

As some who know me would tell you, my mind happens to wander at times about a variety of topics. The subject of this mental galavant happened to be the current regulatory landscape in the United States - specifically the FDA's new outlook of regulation and greater enforcement.
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Everyday Usability 11

A great example of usability engineering is right in front of us every day (especially as we become a more technological society): electrical outlets!
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Improving Device Human Factors Through Focus Groups

When designing medical devices it is important to identify use-related hazards as early in development as possible so that mitigations can be developed into user interface requirements, incorporated into the design, and then tested for effectiveness. The recently released draft FDA guidance entitled Applying Human Factors and Usability Engineering to Optimize Medical Device Design describes several examples of analytical approaches to hazard identification. The use of focus groups, one of the more popular approaches, is worth a closer look. When they are conducted early in development and centered on developing use scenarios and investigating foreseeable misuse, these meetings can be a useful forum for risk identification.
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Acne Apps Dried Up by FTC

In light of the recent drafts of the FDA's regulation and guidance for controlling mobile apps, it is the Federal Trade Commission (FTC) handing down fines to app developers for false claims.
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Everyday Usability - 10

Here in our tenth edition of Everyday Usability, we'll discuss the usability of bathrooms!
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Disney's Root Cause Analysis?

My son was watching Disney's Beauty and the Beast in the car this weekend and I noticed, being the complete nerd that I am, that Belle and the Beast conducted a pretty good root cause analysis:
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EN 62304 Certification?

Last week, I guided a client and their software developer through a notified body audit. Thankfully, this particular developer was well polished (albeit not ISO 13485:2003 certified) resulting in a smooth and quite impressive audit result. The length of the audit was far shorter than any of us anticipated resulting in some dead time to simply chat.
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Everyday Usability 9

Yankees - Redsox. Democrats - Republicans. French - British. Google - Apple. They find themselves in perpetual disagreement; however, I'm sure there is one topic on which no one will disagree:
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RQS Nominated for 2011 Best Places to Work

Regulatory and Quality Solutions, LLC was recently announced as a nominee as one of the "Best Places to Work in Western Pennsylvania". The announcement of the winners will occur later in Fall 2011. The RQS blog will provide updates with any web-based news stories prior to the announcement and any news regarding the winners once they have been revealed.
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FDA Issues Draft Guidance for Clinical Investigations

On 8/29/2011, the FDA issued a Draft Guidance recommending changes to monitoring practices in clinical trials. The earlier 1988 Guidance recently was withdrawn and building on the spirit of ICH E6 (1996), the FDA recognizes the desirability of increased monitoring flexibility in a world where technological tools have become available. The Guidance suggests that a risk-based approach tailored for the specific study can best achieve protection of human subjects, maintain data integrity, and comply with regulations.
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Everyday Usability 8

I was discussing quality system documentation with a colleague yesterday when it dawned on me that usability can (and should) apply to quality systems. An example I later identified is shown below:
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FDA Regulation Goes Mobile

Mobile medical applications are revolutionizing the way that healthcare is delivered across the world. In fact, it is estimated that by 2015, 500 million smart phone users worldwide will be using a health care application (app) on their Smartphone or tablet [1]. Mobile medical applications, or mobile medical apps, can enable a mobile platform to become a heart monitor, a light for diagnosing melanoma, or even a blood glucose meter. The possibilities are endless.
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Everyday Usability 7

There must be something about the simplicity and innocence of children that is particularly inspiring when it comes to usability. Clearly, it is a frequent inspiration for this picture series and this week's post is no exception.
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PBT Article on RFID Tagging Quotes VP Casavant

In the July 29th to August 4th edition of the Pittsburgh Business Times, Kris B. Mamula writes about Ortho-Tag, Inc., a McKees Rocks company that has created an RFID (Radio Frequency Identification) tagging system for implants. The technology will revolutionize the information and monitoring behind implants, allowing a user to "[wave] a wand" past the implant to retrieve all necessary information on the implant.
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Jyothsna Nunna joins RQS as Staff Quality Engineer

Good morning everyone!
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Everyday Usability 6

Have you ever felt like an idiot for walking straight into a doo
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IOM Issues Report on the FDA's 510(k) Process

The Institute of Medicine (IOM) has released their latest report regarding their review of the 510K process as requested by the FDA. Recall the FDA requested that the IOM review the 510K process on several specific areas to assess the process with regard to protecting the public health as well as providing innovative devices.
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Everyday Usability 5

Ever attempt to open a carton of milk, but end up splitting the lip of the carton? Of course, the frustrating battle ensues as you struggle to migrate that final sliver to the other side. Clearly, our pain was heard! Companies began to sell their milk with convenient plastic twist tops to avoid the... Inconvenience... of splitting the carton open. In the end, the change to the carton may have enhanced the product twofold: the seal of the twist top may increase in-fridge longevity, as well as encourage the use of the cartons over non-compostble plastic jugs.
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Scott Wright joins RQS as Principal Regulatory and Quality Advisor

Please join me in welcoming team member Scott Wright, Principal Regulatory and Quality Advisor, to RQS!
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MDDS Regs Change, Provide Insight for Future Changes?

The United States Food and Drug Administration (FDA), in an attempt to further the safety of the nation’s medical data systems, issued the final rule for the reclassification of medical device data systems (MDDS) on February 15th, 2011 and went into effect on April 18th, 2011. MDDS products are defined by the FDA as products that transfer, store, convert from one format to another format in accordance with a preset specification, or display medical device data which may include software, electronic or electrical hardware, modems, interfaces, and communications protocol (excluding active patient monitoring).[i] Digital-to-analog converters, data systems to record and recall blood pressure, and software to display biological signals are all examples of the type of product affected by this regulation.
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Everyday Usability 4

Prior to becoming a parent, I prepared for many things - diapers, late nights, regurgitation (to be light) - and have experienced them all (plus the many wonderful moments!) in my 13 months as a dad. What I wasn't consciously thinking about were toys - loads and loads of toys from relatives that simply want to spoil my little man until he looked like an oxidized apple core. Sure, I'm quite grateful for the hours of entertainment that the toys (may) provide (because we all know that the TV remote or a cell phone are far more fun than real toys), but I hated this:
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Everyday Usability 3

Our VP, suffering from a terrible cold last winter, decided that the best remedy would be the DayQuil/NyQuil dual pack. Perfect, right?! Symptoms dealt with day and night with the added bonus of deep sleep. Alas, the development at Vicks clearly didn't realize that the NyQuil was a shade of green while their DayQuil was a shade of red. Remind you of anything?
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Everyday Usability 2

The Double Wide Grill is an eclectic eatery on Carson Street in Pittsburgh's South Side Flats. Apart from its wonderful culinary offerings, it also offers a fantastic example of usability for this week's post (and, no, not all of these posts will be inspired by restaurants, I promise!).
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VP Casavant featured in Pittsburgh Business Times

Lisa Casavant, Vice President of Regulatory & Quality Solutions, was quoted in a recent article in the Pittsburgh Business Times. In the article, Casavant spoke on the impact of usability on the medical device industry. Usability has become a focus of the FDA and Europe as it is becoming increasingly clear that usability studies aid greatly in developing safe and effective product.
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Picture Series - Everyday Usability 1

Today begins Regulatory & Quality Solutions' first picture series titled "Everyday #Usability". The intent of the series is to post images from everyday life that emphasize the importance of usability. There will be examples of both poor and great usability. This week's post? Double doors with a metal bar between them.
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Pittsburgh Business Times Featured Article

Regulatory & Quality Solutions adapts business model to economy
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