Archives: Speakers

Al is the Vice President of Quality Assurance and Regulatory Affairs at CVRx.  He developed and implemented the quality system and was a key participant in all clinical and commercial regulatory submission work at CVRx for more than 19 years leading to European, FDA and Australian approvals for the quality system and devices.  In addition, Al has participated in the MDIC and AdvaMed Case for Quality efforts for many years.  Through this, CVRx has volunteered to pioneer new Case for Quality programs developed in conjunction with FDA to improve the quality of medical devices in general and the CVRx product line specifically, including pilots of FDA Critical to Quality assessments, maturity model assessments for the FDA Voluntary Improvement Program (VIP) and the Medical Device Information and Analysis Sharing (MDIAS) program as a co-chair of the Governing Committee.  Prior to CVRx, Al worked for Medtronic for more than 16 years in various divisions and management roles primarily in the areas of quality and reliability.  Al has a Bachelor of Science degree in Electrical Engineering from Iowa State University and a Master of Business Administration degree from the University of Colorado.

Mac McKeen has 35 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.  Recently retired Mac served as a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. In these roles Mac has prepared and submitted well over 500 submissions to FDA and global regulatory agencies.  For the last 16 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.  Throughout his career Mac has been and continues to be actively engaged in a wide range of industry and patient advocacy initiatives working directly with FDA, AdvaMed, RAPS, Medical Alley, MDIC, and the Smithsonian Institute.  Mac holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified and has been recognized as a Fellow by the Regulatory Affairs Professional Society (F.R.A.P.S) and is currently serving on the RAPS RAC Board.

Jason Neff has over 14 years of experience in the medical device and biotechnology spaces, and has worked with AtriCure, Johnson and Johnson, Boston Scientific, and the Broad Institute of MIT. He has authored numerous clinical evaluations for EUMDR and class III cardiac devices. Jason graduated from the University of Minnesota and lives in the Twin Cities area with his family.

Divya Raman, JD, MS, PMP, is the Sr Director of Quality and Regulatory Policy, Intelligence, and Strategy at Teleflex Inc. In this role Divya leads the regulations and standards management program, advocacy and policy program, and projects to support compliance to new regulations. Divya is well-versed in the area of program management and regulatory affairs and is passionate about how those two functions effectively support medical device lifecycle management. Divya has over 12 years of experience in the medical device field in multiple functional areas, such as technical communication, regulatory affairs, and medical affairs, and 6 years of experience in the legal field.

Tarek Haddad is a Technical Fellow and Sr. Director of the AI Research Group at Medtronic, where he leads the development of AI/ML algorithms to improve patient outcomes and clinical efficiency. His team’s work on AccuRhythm AI has enhanced diagnostic accuracy for heart rhythm abnormalities in Medtronic’s implantable cardiac monitors, resulting in a 91% reduction in false alerts and 42% reduction in manual ECG review workload for clinics worldwide. This innovation has earned prestigious awards, including the Minnesota Tekne Award and MedTech Breakthrough Award in AI. Tarek has pioneered advancements in device reliability methods that have become standards for the Association for the Advancement of Medical Instrumentation (AAMI). He has also created Bayesian models used in major clinical trials, such as LEADR and Symplicity Spyral renal denervation (RDN), achieving combined cost reductions of millions of dollars. He spearheads regulatory innovations, including the Predetermined Change Control Plan, which facilitates continuous AI model updates, and Medtronic’s AI Compass program, which sets ethical standards for AI in healthcare. Tarek holds an MS in Biostatistics and a BA in Mathematics from the University of Minnesota, is a Master Black Belt in Design for Six Sigma, and holds numerous patents and publications in AI, reliability, and medical technology

Is the co-founder and CEO of HabitAware. HabitAware created its Keen2 smart bracelet to help individuals like his wife and co-founder, Aneela, “retrain their brain” away from detrimental behaviors including hair pulling, skin picking and nail biting, to positive ones. HabitAware has received research grants from the NIH and NSF for research and to validate Keen2 as a treatment for these disorders. HabitAware was the Grand Prize winner of the Minnesota Cup and is a TIME Magazine Best Invention. Prior to founding HabitAware, Sameer was a professional investor at The Blackstone Group and worked in corporate strategy at Bain and Company and Ameriprise Financial.