Session Organizer: Ross Meisner, Basil Systems
We all know FDA clearance is a required hurdle for medical innovations. We've also all heard the vast range of experiences innovators have had going through the FDA process, from relatively smooth and speedy, to horrendously long and painful. How can innovators best plan and prepare for the smooth & speedy outcome? What do we need to know, when do we need to know it, and what actions will be most impactful to the regulatory process? Bring your regulatory questions and join our panel of hands-on experts to learn the most important tips and tricks.
510k Program and "Tips & Tricks" for Success
Jacqueline Torfin
Partner, QRx Partners
Jacqueline Torfin has over 30 years experience and deep expertise in quality, regulatory and clinical compliance. Ms. Torfin holds a Bachelor’s Degree in Medical Technology from the University of Minnesota and a Master’s Degree in Leadership from Augsburg College, and is certified as a Quality Auditor through ASQ.
She is a Partner of QRx Partners providing quality, regulatory, clinical and compliance support to pharmaceutical, biological, and medical device companies, with a focus on due diligence, post merger integration, QMS optimization, compliance leadership, mentoring/coaching and 483 and Warning Letter remediation services. Her expertise spans GMP, GLP as well as GCP compliance.
Ms. Torfin is an adjunct faculty member at St. Cloud State University’s Master of Medical Technology Quality Program. She was instrumental in the development of the curriculum for CAPA, Supplier Quality, Design Controls, and Quality System Design and Implementation courses.
She has served in Senior Global roles with companies such as Beckman Coulter, CIMA Labs Inc (Cephalon/Teva), PDL BioPharma (Genmab), Arizant Healthcare (3M), Heraeus Medical Components, NAMSA, and many others. She has also served as a Data Protection Officer, playing a key role in the implementation of processes and procedures to fullfill GDPR requirements, and has an expertise in Data Integrity processes.
PMA Program and Innovation Pathway
Mac McKeen
Fellow, Regulatory Science, Boston Scientific Corporation
Mac McKeen has over 30 years of experience in the medical device industry in regulatory and quality roles focused on the Total Product Life Cycle related to the product development, quality compliance, clinical study, and the regulatory submission and approval of cardiovascular devices and is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. Recently, Mac provides Regulatory guidance and leadership to Global Sterilization Operations and product supply chain programs and manages the FDA Master File Program for BSC. For the last 14 years Mac has served as an Adjunct Professor at the University of Minnesota instructing undergraduate and graduate level courses in the Technology Leadership Institute on medical device development. Mac holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified and elected as a Fellow by the Regulatory Affairs Professional Society (F.R.A.P.S).
Regulatory Submission Characteristics and Recalls of 510(k) Medical Devices
Pinar Karaca-Mandic, PhD
Distinguished McKnight University Professor
C. Arthur Williams Jr. Professor of Healthcare Risk Management
Founding Director, Business Advancement Center for Health (BACH)
Department of Finance | Carlson School of Management
University of Minnesota
Abstract: This work examines regulation of medical devices by the U.S. Food and Drug Administration (FDA), specifically focusing on the approval of medical devices through the 510(k) clearance pathway, and their safety. A novel database is constructed processing 48,747 medical device approval submission files to the FDA using a natural language processing based automated text extraction algorithm. The study findings identify significant associations between several regulatory submission characteristics and recalls of medical devices, suggesting ways to inform evidence-based improvements on medical device regulation.
Bio: Pinar Karaca-Mandic (she/her), PhD is a Distinguished McKnight University Professor, and the C. Arthur Williams Jr. Professor in Healthcare Risk Management in the Department of Finance, Carlson School of Management, University of Minnesota. She is the Founding Director of the Business Advancement Center for Health (BACH). Prior to that, she served as the Academic Director of the Medical Industry Leadership Institute from 2017 to 2021. She is also a Research Associate at the National Bureau of Economic Research (NBER).
As a health economist, her vision is to improve "value" and "equity" in healthcare. Her work contributes to better understanding factors that improve access to safe and effective medical technologies and treatments; identifies the roles of regulations and market-based models in the functioning of the health insurance markets; as well as addresses frictions and social determinants of health through innovations.
Her research has been published in leading economics, policy and medical journals, and funded by the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), the U.S. Department of Health and Human Services (HHS), Robert Wood Johnson Foundation and American Cancer Society.
She is the co-founder of the multiple national and international award winning University of Minnesota COVID-19 Hospitalization Tracking project which collected and disseminated daily data on COVID-19 hospitalizations across all U.S. states and sub-state geographies between March 2020 and August 2022. She is also a co-founder and CEO of XanthosHealth, a University of Minnesota start-up with a social care referral technology platform for oncology.
Prior to joining the Carlson School faculty, Karaca-Mandic was Associate Professor of Health Policy and Management at the University of Minnesota’s School of Public Health. She holds a Ph.D. in Economics from University of California at Berkeley, and BA in economics and mathematics (high honors), and a concentration in public policy from Swarthmore College.
Session Organizer Bio
Ross Meisner
Chief Commercial Officer, Basil Systems
Ross leverages 30 years in healthcare and technology management to drive growth at Basil Systems. He was a founder of Dymedex Consulting (acquired by Navigant/Guidehouse) where he developed break-through market growth strategies for medical products. Earlier Ross led Global Market Development at Medtronic and spent his early years in Silicon Valley and Tokyo. Ross holds a BSEE and an MBA.