Donna-Bea Tillman, PhD, MPA, FRAPS

Senior Consultant, Medical Devices, Biologics Consulting Group
Former Director of Regulations & Policy, HSG, Microsoft Corporation
Former Director, Office of Device Evaluation, US Food & Drug Administration


Dr.Tillman, PhD, is a Senior Consultant with Biologics Consulting Group, where she helps clients navigate the FDA regulatory pathways, regulatory requirements, short and long term regulatory strategies, and assists clients with FDA interactions to increase the availability of safe and effective medical devices and combination products. Dr. Tillman is a biomedical engineer with more than 20 years of medical device regulatory experience, including 17 years at the FDA. Dr. Tillman is a former director of the FDA CDRH Office of Device Evaluation, and has broad expertise in medical device regulatory affairs. At the FDA she led a team of 375 scientists and clinicians responsible for the premarket review of medical devices in the US, planned, implemented, and monitored programs to achieve center and agency strategic initiatives, and provided executive leadership for the development of a regulatory framework addressing health information systems. Prior to this position, Dr. Tillman served as Deputy Director for the Office of Device Evaluation, Deputy Division Director for the Division of Cardiovascular Devices, and Chief of the Branch of Pacing and Electrophysiology Devices at the FDA, where she developed programs for the implementation of the Medical Device Modernization and User Fee Act, managed the medical device regulatory review program, and provided scientific and regulatory oversight of the review work of DCD branches, particularly with regard to novel, complex, and problematic issues. Dr. Tillman is also recognized as a thought-leader in the area of medical device regulatory requirements for software, and spent 2 years as the Director of Regulations and Policy at Microsoft establishing a medical device regulatory and quality program, managing premarket submissions and product registrations in the US and internationally, and overseeing the post-market safety program. Dr. Tillman became a Fellow of the Regulatory Affairs Professional Society in 2012, one of 12 highly accomplished professionals working in the healthcare product regulatory field honored that year. Dr. Tillman received a BS in bioengineering from Tulane University, a MPA in public administration from American University, and a PhD in biomedical engineering from Johns Hopkins University.

Interview with Donna-Bea Tillman

“I’m really encouraged by the holistic approach that the CDI is taking to transform the entire experience and not just fix just one little piece of it … I’m the most excited about how we can really make a difference in people’s lives. Dialysis patients have to give up an awful lot in order to receive their therapy. Providing a solution that would enable them to reclaim part of their lives so they could do the things they want to do is really a very worthwhile goal.”

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Kassandra Thomson (KT): Thank you again for your time today. I want to start by having you tell us a little about your background and what your role is in your current position.

Donna-Bea Tillman (DBT): I am a biomedical engineer by training. I started my career at the FDA as a medical device reviewer in the branch that reviews obstetrics and gynecology medical devices, and I spent a couple of years there as a reviewer learning the FDA’s way of doing things. Eventually I worked my way into management in cardiovascular devices, and eventually was the Director of the Office of Device Evaluation at FDA where I was responsible for the premarket medical device review program. Along the way I got very interested in medical device software. Software and computers have always been one of my passions, and I was involved in developing a lot of FDA guidance and policy on what I’m going to call ‘traditional software’, some of the really early stuff on how FDA would regulate things like stand-alone software and mobile medical apps. In fact, when I ended up leaving FDA I went to work for Microsoft, and I was out in Seattle part time for [2] years helping Microsoft [set up] a medical device quality program. After that I left Microsoft and I started consulting, and I have been consulting for the past [8] years. I am the Medical Device team leader here at Biologics Consulting, and I do a lot of work in the software and cardiovascular device spaces, as well as combination products like drug and device combinations.

KT: How would you describe your area of expertise that you bring to the table as a member of the CDI Scientific Advisory Board?

DBT: My role is to support the FDA regulatory review process for the CDI, and in particular trying to help the groups and organization think about what are FDA’s regulatory requirements going to be and how can we start thinking about them sooner rather than later. I find a lot of times that people who are developing new technology wait until they’ve gotten further along than they should to start thinking about regulatory requirements. My role is to be a constant nudge to the team to be thinking about what the impacts of decisions might be on the future FDA regulatory process.
KT: Your input has been invaluable on our board the last 2 years, so we’re very glad to have you.

DBT: I’m glad to participate! As a consultant a lot of times, you’re never really part of the team in the same way you are when you work for a company or when you work for the FDA. Being a board member makes me feel like I’m part of a team trying to do something that I think is worthwhile, so I’m really very happy to be involved.

KT: You’re definitely part of the team. I wanted to get your thoughts on the CDI’s goal of transforming dialysis, and in particular the goal of developing a new wearable dialysis device.

DBT: I think this is super exciting. As a biomedical engineer I’m very intrigued by the technological challenges that are being faced, so I think that’s a really interesting problem from an academic perspective. But it’s also a really important public health challenge. Kidney disease is a significant public health problem in this country, and I’m really encouraged by the holistic approach that the CDI is taking to transform the entire experience and not just fix just one little piece of it. I’m also really excited about the idea that some of the technology that’s being developed for this particular problem could also be leveraged in other device and medical areas as well.

KT: Do you see any other challenges that would need to be overcome in order to transform patient care in dialysis in particular?

DBT: As I mentioned there are obviously some pretty significant technical challenges, but there are some really bright scientists that are working on the CDI team, so I am optimistic they’re going to be able to come up with a way to overcome those challenges. The other challenge that I see, which is really a little bit outside of my area, is how we’re going to provide access to this technology, and how in particular we’re going to address reimbursement. There are a lot of people that could use this technology and I suspect that the solution is not going to be an inexpensive one. I believe it’s going to be important to think about how we can not only solve this problem, but how can we solve it in a way that will provide access to as many people as possible who could benefit from it.

KT: That’s definitely one of the principles we’ve focused our goals on is to try and make sure whatever we develop is accessible for patients. That leads nicely into the next question, which is that we truly believe the patient voice is critical to success, and so we have embedded patients on our development and leadership teams, and also put together a Patient Advisory Board. Do you see this level of patient engagement in other areas of healthcare technology development, and do you think it will lead to improved treatment options?

DBT: In answer to the first question, no I don’t see this level of engagement in many of the other device areas I work in. In fact, it is something that tends to frustrate me, because I feel like often it’s the technology that’s being focused on first and the patients second, and that often times we have technology in search of a solution. I can’t tell you how many times I say to potential clients, “What exactly is the clinical problem you’re trying to solve with this technology?”, or “How will the doctors use that information in a patient care decision?” So I think this is a really important thing that is not always thought about early enough in a lot of the medical device areas that I work in, and I really applaud the approach the CDI is taking. I think this is a really important aspect of this problem and it’s important that it be considered as much as the technological problems that we’re trying to solve.

KT: What are you most excited about as a member of our scientific board?
DBT: I think I’m the most excited about how we can really make a difference in people’s lives. Dialysis patients have to give up an awful lot in order to receive their therapy. Providing a solution that would enable them to reclaim part of their lives so they could do the things they want to do is really a very worthwhile goal.

KT: Excellent. Well, thank you again very much for your time.