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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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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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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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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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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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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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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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