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R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.

In his new role at R&Q, Jake will provide technical leadership and support to R&Q's clients in all areas of compliance and remediation. His addition to the team enhances and expands R&Q's capabilities and positions the company to make an even greater impact on our medical device clients and the industry as a whole.

Jake's primary duty as CSO with the FDA was performing quality system audits of medical device manufacturers and contract sterilizers to access conformance with FDA's Quality System Regulation and other applicable regulations. He also conducted user facility and/or consumer investigations relating to device performance issues, and frequently developed and delivered device-related training to FDA employees and industry.

Prior to his work with the FDA, Jake was an Aerospace Engineer at the Naval Air Warfare Center for 13 years. He offered full spectrum engineering support including component technology development, component and system level T&E, and fleet support. His technical specialty was RDT&E for power drive, rotor support, and gas path sealing systems in turbine engines and gearboxes for fixed and rotary wing naval aviation platforms.

R&Q asked Jake a few questions to learn more about his FDA experience, better understand the FDA's latest thinking in 2016 and beyond, get his take on a few hot topics in the medical device industry, and why he's excited to join R&Q.

Jake O'Donnell Medical Device Consulting Firm

R&Q: Welcome to the team! Your extensive FDA experience is a welcomed addition to R&Q and we're excited to have you on board for the benefit of our clients. What can you tell us about your accomplishments in the medical device industry?

Jake: I'm thrilled and honored to be joining R&Q, thank you. One of the things I am most proud of about my time with FDA is what I hope has been the ability to bring a balanced approach to applying regulations to medical device life cycle management. I spent my formative professional years tasked with helping bring complex systems to operational status from applied research through FSD, and into fleet support. I understand the real world challenges associated with delivering a functional, producible, and affordable system. FDA’s mission statement includes language addressing assuring the safety and efficacy of regulated products, but also includes language relating to speeding innovation and improvement (facilitating availability of improved therapies). And none of us need to be reminded of the cost challenges of medical care here and globally. Arbitrary requirements that don’t add value help no one, but do add cost. I like to think that I did enough technical preparation going into audits (on the operational/physical principles and the application risks) for the products I reviewed to be in a good position to judge the relative significance of various control issues – and not have to arbitrarily fall back to the most restrictive possible interpretation of the QSR, which is of course intended to be flexible in its application.

R&Q: How can medical device companies align themselves with the FDA's latest thinking and prepare for 2016 and beyond?

Jake: Yes... well that’s the million dollar questions, isn’t it? While the agency has improved dramatically with provision of informational resources via fda.gov and other sources, challenges remain. The sheer volume of information, proposed rules, and draft guidance, and relevant cases creates challenges. As is the case with any large organization there is always some potential for variation in interpretation either regionally, or even amongst individual CSOs. It has frequently surprised me that two groups of good people (agency/industry) with nominally the same goals, can end up disagreeing so often. I think in many cases it comes from communication issues during and after inspections, or with firms not having what is probably a defensible basis for a control decision documented adequately. I do think ORA’s transition to a functionally-aligned organization will help with these legacy issues over time.

Those potential issues are not new. There is also plenty of new change taking place in FDA, both in the field organization and the center. FDA’s field organization is being functionally aligned (as opposed to historic geographic alignment), and will stand up in the new structure in about nine months. While I think this is great news for regulated industry (due to the benefits of specialization), manufacturers are very likely to see new CSOs and new review chains (different compliance officers, District Directors). Risk based prioritization of field activities is likely to grow. Technical baselining during audits will be more common, as Case for Quality and targeting of problematic market niches (e.g. – batteries) continues. CSOs are likely to receive more specific technical guidance going into audits (regarding design adequacy and best practice) than they have historically -- and for this trend firms can react/prepare by doing their own baselining with respect to function, margins, fail-safes, etc. … which shouldn’t be an issue if design history file is solid. Firms should expect increased post-market scrutiny by the agency (staffing of those functions has been growing for some time) which means you better be doing your own monitoring as well, as it is far better to know of any performance issues before FDA does so you can initiate CAPA prior to getting pre-announcement of audit.

In other areas, the drive toward harmonization of requirements for different markets / governments appears to me to be (finally) gaining some real momentum, which is probably in the ‘all good’ category for domestic firms.

R&Q: What do you think are the hot-button topics for the device industry today, and do you have any particular experience or opinions in these areas related to FDA regulation?

Jake: Well, there are always specific regulatory issues where subjective determinations are part of the formulae - resulting in much discussion, occasional disagreement, and sometimes contentiousness. Sometimes the hot topic of the day depends on the latest draft guidance release. Commonly debated issues include: - when does a design change require a supplement or new PMN (although it seems this one should be simpler); - when is a complaint or service event reportable under part 803, - part 806 issues. In other instances the language of the regulation may just be vague. These types of issues are generally manageable given adequate communication.

In some ways I am more interested in what I have observed as recurring themes that can create big problems for regulated industry. And these issues are as variable as the firms in the business are. For example, I have observed that the success of a venture firm transitioning to a producing firm is often inversely proportional to how much of the development effort had been farmed-out initially, especially if software intensive. I have seen what rapid globalization of a supply base can mean both in terms of effective sourcing and ability to react if/when issues arise. I have seen how rapid sales growth coupled with underestimating the sustaining engineering burden of life cycle management can create crisis. It is my sincere hope that a combination of proper technical preparation, regulatory experience, and my exposure to the aforementioned types recurring themes can be of some benefit to R&Q’s clientele.

R&Q: What excites you most about joining the R&Q team?

Jake: First and foremost it's the wonderful people who work here. I have interacted with many of the team members over the years, and I know it is a talented and energetic group. The team is just as interested in the success of the medical device industry as I am. I have loved having a job that involves a combination of the physical and life sciences, the law, and business management; all while supporting the medical arts and ultimately helping people. I look forward to continuing to do so with R&Q, where I believe the team feels exactly the same way. It’s amazing to love what you are doing, and I am feeling pretty lucky these days. And - if I spend any time supporting audits in the new position, I just might enjoy sitting on the crowded side of the conference room table for a change as well!

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