Webinars

Enabling Medical Device Innovation with Computational Modeling & Simulation (CM&S) Webinar

Innovation in medical devices is accelerating at an unprecedented pace, yet the rate of translation to clinical adoption remains consistently below industry need. Skyrocketing development costs and escalating ethical concerns represent headwinds all medical device companies face, often beyond the resources of smaller companies. One way to overcome these challenges is through the use of modeling and simulation of device performance, but its use in the regulatory process lags its potential. In this webinar, we will present the results of an industry survey measuring progress of its adoption, as well as a comprehensive industry landscape report from MDIC, providing context and identifying a path forward. A panel representing the medical device industry, technology suppliers, and regulatory agencies will provide their expert commentary as well as answer the questions that are on the top of mind to all.

Moderator: Randall Schiestl, Vice President, Research & Development, Global Technology, Boston Scientific

Speakers:

David Flynn, PhD, Fellow, CM&S, Global Technology, Boston Scientific
Steven Levine, PhD, Senior Director, Virtual Human Modeling, Dassault Systèmes
Jeffrey E. Bischoff, PhD, Sr Director, Research, Zimmer Biomet
Brent Craven, PhD, Research Scientist & Program Manager (Acting), Credibility of Computational Modeling and Simulation Program, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Jithesh Veetil, PhD, Senior Program Director, Digital Health & Technology, Medical Device Innovation Consortium (MDIC)

Date: March 30, 2023 at 11:00 am (ET).

About the Speakers

Moderator: Randall Schiestl

Vice President, R&D Global Technology & Services Boston Scientific Corporation

Randall L. Schiestl, PMP, is Vice President, R&D, Global Technology & Services at Boston Scientific Corporation where he leads a team driving the development and sustainment of minimally invasive medical devices. He has global responsibility for building technical community, centralized R&D services, enabling technology partnerships, driving R&D globalization, leading product security and data governance, and implementing global R&D systems. Engineering teams that he directs are located across multiple facilities both US and OUS and he leads the cross-divisional Technical Executive Committee within Boston Scientific.

Mr. Schiestl (Randy) has a BSME degree from the University of Minnesota, College of Science & Engineering, high distinction. He also holds MBA and Executive MBA degrees from the University of Minnesota, Carlson School of Management. Work history includes Honeywell, Alliant Techsystems, and Boston Scientific. Randy is a certified Project Management Professional.

Jithesh Veetil, PhD

Senior Program Director, Digital Health & Technology, MDIC

Dr. Jithesh Veetil, PhD joined MDIC as a Program Director to lead Data Science and Technology initiatives. His prime focus at MDIC is to aid in the development of regulatory grade tools based on computational modeling & simulation science relevant to clinical applications, This program builds upon the success MDIC has had with the Virtual Patient model that resulted in mock submission for clinical trials augmented with virtual patient data. These exciting programs in the pre-competitive MedTech sector will be carried out in collaboration with MDIC members and their engineers, statisticians, regulatory professionals, and medical doctors. The goal is to utilize the External Evidence Methods (historical, prospective and concurrent data- including but not limited to – Digital Evidence, Clinical Trial Data, Real World Evidence-RWE, Electronic Health Records-EHR, and Patient reported Outcomes-PRO) to better understand safety, efficacy and performance of medical devices. Dr. Veetil also leads the cybersecurity projects at MDIC

Dr. Veetil has extensive experience in designing and development of programs towards modernizing scientific workforce and practices by building academic-industrial-nonprofit collaboration through his work at National Institutes of Health (NIH) campus as the Lead Scientist and Program Manager for the Foundation for Advanced Education in the Sciences (FAES). Previously, Jithesh worked with Global Biological Standards Institute (GBSI), a Washington DC based non-profit as its Scientific Program Manager, leading the development and implementation of multiple programs on science policy, communications, and advocacy, including those related to cell line authentication, antibody validation, and reproducibility in biomedical research and development. Dr. Veetil also served as the Operations Manager for Preludesys Inc., working with international clientele from medical, IT, insurance and paralegal organizations on medical/healthcare data management.

Dr. Veetil completed his PhD in Biomedical Engineering at University of Arkansas, Fayetteville, AR, followed by postdoctoral fellowship at NIH. He has published numerous peer-reviewed manuscripts, reviews and book chapters. He also holds Masters in Biotechnology and Bachelors in Food Technology.

Jeffrey E. Bischoff, PhD

Sr Director, Research, Zimmer Biomet

Jeffrey E. Bischoff, PhD is Senior Director of Biomechanics at Zimmer Biomet, where he has been since 2006. Prior to joining the medical device industry, he completed his Ph.D. in Mechanical Engineering at the University of Michigan, served as Lecturer at the University of Auckland (New Zealand) and as Assistant Professor at the University of South Carolina, where he pursued federally funded research in various aspects of computational biomechanics and was instrumental in forming a biomedical engineering degree program.

Over the past fifteen years, Jeff has supported device development efforts using computational analysis across a wide range of orthopaedic applications, and throughout the total product life cycle from design ideation through regulatory clearance and commercialization. He has been actively involved with the ASME VVUQ40 Sub-Committee, including as chair of the orthopaedic working group and as vice-chair of the sub-committee. He is currently on his second term as chair of the sub-committee, effective 2022-2025.

Brent Craven

Research Scientist & Program Manager (Acting), Credibility of Computational Modeling and Simulation Program, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Brent Craven is a Research Scientist and Program Manager in the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA). He received his PhD in Mechanical Engineering from the Pennsylvania State University in 2008. His areas of expertise include computational fluid dynamics, fluid-structure interaction, multiphysics modeling, patient-specific modeling, and verification, validation, and uncertainty quantification (VVUQ) methods applied to medical devices such as mechanical circulatory support devices, artificial heart valves, intravascular blood clot filters, and inhalers. His research at the FDA primarily focuses on advancing computer modeling and VVUQ methods for medical devices. In addition to research, he regularly serves as a subject matter expert on medical device regulatory submissions. He has authored 55 refereed journal articles and more than 100 conference proceedings and abstracts. He is currently an Associate Editor for the Journal of Verification, Validation and Uncertainty Quantification and Frontiers in Physiology. He has received a number of awards for his research and regulatory contributions, including the 2022 FDA Scientific Achievement Award for Excellence in Analytical Science, the 2018 FDA CDRH Excellence in Scientific Research Award, and an FDA Commissioner’s Special Citation Award in 2021 for his regulatory contributions in the technical review of emergency use ventilators.

David Flynn, PhD

Fellow, CM&S, Global Technology, Boston Scientific

Dave is a Fellow in the CM&S Center of Excellence, a member of Global Technology Services, at Boston Scientific. He has over 30 years of design and simulation experience at BSC. Previously, he worked in the Rhythm Management division on the Leads Product Development and PG Hardware Engineering teams, supporting defibrillator, pacemaker and leads product design/testing. For the last 8 years he managed the global CM&S and Anatomical Modeling Teams. He recently transitioned to a new role and is now responsible for collaborating with external organizations such as Avicenna Alliance and MDIC to further the development/use of CM&S. He is also responsible for promoting the use of CM&S within Boston Scientific and for researching new simulation methods as well as mentoring others through the Center of Excellence. Dave has a PhD degree in Mechanical Engineering from Worcester Polytechnic Institute.

Steven Levine, PhD

Senior Director, Virtual Human Modeling, Dassault Systèmes

Steven Levine, PhD is the Sr. Director of Virtual Human Modeling at Dassault Systèmes. Dr. Levine has more than 30 years of experience in the development of computational science and engineering software. He is Founder and Executive Director of the Living Heart Project. Prior to his current role, he was Chief Strategy Officer for SIMULIA, the simulation brand within Dassault Systèmes. Dr. Levine was elected into the College of Fellows in the American Institute for Medical and Biological Engineering (AIMBE) in 2017 and holds a PhD in Materials Science from Rutgers University. He began his career in health tech at a startup that when public as Accelrys, where he led Corporate Development prior to its acquisition in 2014.

Current as of March 30, 2023