Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. The future of rapid virtual prototyping, digital patients and populations, virtual clinical trials and personalized medicine is upon us, and bringing better medical devices to patients in the U.S. faster is possible with the important research and investigations made by this community. One of the crucial advancements is establishing computational modeling and simulation as valid scientific evidence which will transform the regulatory pathway for future medical products. The speakers in our symposium, representing different stake-holders, will highlight opportunities to advance regulatory science for medical devices.
Tina Morrison, PhD,
Advisor of Computational Modeling, Center for Devices and Radiological Health, Food and Drug Administration
Dr. Morrison is a mechanical engineer who studied Cardiovascular Biomechanics for two years as a post-doctoral fellow at Stanford University. During that time, she investigated the in vivo biomechanics of the aorta using gated CT imaging; those data are now used as boundary condition inputs for computational modeling and bench-testing of endovascular devices. Her research efforts continue at the Center for Devices and Radiological Health (CDRH). Currently she is the chief Advisor of Computational Modeling for the Office of Device Evaluation, and is leading the Regulatory Review of Computational Modeling working group at CDRH. She dedicates much of her energy towards advancing regulatory science through modeling and simulation because she believes the future of medical device design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization.
Additionally, she has been a scientific reviewer on a variety of medical device pre-market application, principal investigator on two projects, and a technical expert on another since 2008. She is a co-principal investigator on a Critical Path Initiative (CPI) project titled "Leveraging the Simulation-Based Engineering and Medical Imaging Technology Revolutions for Cardiovascular Devices", where she is greatly involved in an effort to enhance the use of simulation-based engineering and computational modeling in the evaluation of medical devices.
Also, she is the principal investigator on a CPI project titled “Characterization of Human Aortic Anatomy Project (CHAP)”, a multicenter study examining the biomechanical environment of diseased aortas, where aspects of this research are being funded by FDA’s Office of Women’s Health to investigate disparities in treatment outcomes between men and women for endovascular repair. Finally, she provides technical expertise regarding finite element analysis and medical imaging for a project titled
“Assessment of plaque composition, dynamic biomechanics, and therapeutic outcomes in subjects implanted with endovascular devices (ASPECT)”. She received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.
Bill Murray, President and CEO, Medical Device Innovation Consortium (MDIC)
Bill joined MDIC in August 2013. He has over 25 years of senior leadership experience spanning the range of privately financed start-up to billion dollar plus global businesses. Bill’s most recent experience was as CEO of Envoy Medical, a privately financed commercial stage medical device company. Prior to Envoy, he was Interim President and CEO of MTS Systems (MTSC), a public $500M industrial technology company. Bill’s small company experience spans 5 years as CEO and executive consultant to privately financed start-up medical device companies. His large company experience includes leadership as the Molecular Biology Division President of Applied Biosystems, and at Medtronic where he spent 18 years in various senior leadership positions, including President of the Pacemaker Business. Bill currently serves on the Board of MTS Systems and previously served on the Boards of LifeSync Holdings, and ReShape Medical. Bill has served on various industry association and community leadership boards. He earned a Bachelor of Science Degree in Electrical Engineering from The University of Florida.
Kathryn M. O'Callaghan, Senior Science Health Advisor, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration
Kathryn O'Callaghan is a Senior Science Health Advisor at the US Food and Drug Administration. At FDA's Center for Devices and Radiological Health, she leads research/analysis and policy development activities to advance 3 high priority areas: 1) To strengthen and streamline the US clinical trial enterprise; 2) To improve study diversity and availability of sex-specific information for safe and effective medical device use in women; and 3) To support more efficient device development and regulatory evaluation by leveraging advances in regulatory science research in areas such as patient reported outcomes, biomarkers, and computer models, through qualification of Medical Device Development Tools. Katie previously worked as a Lead Reviewer in the Division of Cardiovascular Devices, responsible for premarket evaluation in a variety of product areas including drug-eluting stents, mechanical circulatory support systems, prosthetic heart valves and other cardiovascular devices.
Prior to joining FDA, Katie worked as an R&D engineer for a MedTech industry start-up, with responsibilities in development and testing of design improvement prototypes including animal studies, long term reliability testing, and analysis of devices after investigational human use. She also served as a research liaison between the University of Pittsburgh Medical Center and MIT Biotech Process Engineering Center on a collaborative project to develop a viable extracorporeal bioartificial liver support system. Kathryn studied Bioengineering at the University of Pittsburgh with a dual concentration in Artificial Organs and Biosystems/Signals. She also has a BA in German Language & Literature.
“Regulatory Science Methods: The Medical Device Development Tool”
FDA’s Center for Devices and Radiological Health (CDRH) is proposing to establish a voluntary program to support the development and qualification of Medical Device Development Tools (MDDTs) – tools that manufacturers and the FDA use to assess and measure the performance, safety and effectiveness of medical devices. Examples include the use of computational modeling in place of assessments typically conducted through human, animal or bench testing; patient reported outcome rating scales, such as those for pain, symptom relief, function, improved mobility, or health status (also commonly referred to as “quality of life”); and clearly defined clinical outcomes based on subjective clinical decision-making if used as a measure of treatment benefit, such as heart-failure related hospitalization. CDRH believes this will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting the necessary information to make regulatory assessments.
In the US today, patients and their doctors have ready access to safe, effective medical devices that can save lives and improve health. This is due in large measure to advances in regulatory science, which yields tools, standards, and approaches needed to evaluate the safety, effectiveness, quality and performance of the products we regulate. The decision to qualify an MDDT will be based on an evaluation of relevant available scientific evidence (including tool validation, scientific plausibility, extent of prediction and capture), and consideration of the specified context of use along with advantages & disadvantages of relying on assessments using the MDDT within the specified context of use. Qualification reflects FDA CDRH’s determination that when a medical device developer uses an MDDT within a qualified context of use, assessments and measurements made using that MDDT will be accepted in support of device development and regulatory decision-making. The use of qualified MDDTs will improve the efficiency of the premarket regulatory evaluation process, by removing the steps needed for repeated case-by-case validation of scientific tools and methods used to obtain data in development of medical devices.
FDA CDRH intends to conduct a pilot program for new MDDTs, which will help optimize the qualification process and inform final guidance. One technical area of focus will be exploring the use of regulatory-grade computational models to generate data for use in regulatory evaluation. Interested parties should contact FDA CDRH for consideration and discussion of potential MDDT and the value they could bring to medical device development and evaluation.