Biomedical Consortium and the University of St Thomas announce a seminar.
Topics in Medical Device Development
Five Medical Device Professionals will address different aspects of Medical Device Design, Development and Commercialization and we will end with an FDA representative giving perspective on the current process. Topics include:
- Medical Device Commercialization: The steps after a Concept Prototype
- Mobile Medical Technologies
- Cybersecurity for Medical Devices
- Risk Management for Medical Devices
- Case Study: Bring a Medical Device to Market
- FDA observations related to design development
When: March 21, 2018, 8:00 am – noon (Hot breakfast is included)
Where: University of St Thomas, Anderson Student Center, Room 340
2115 Summit Ave, St Paul, MN 55105
Andy Pfahnl, ScD. President & CEO, Kobara Medical, Inc.
Dr. Pfahnl is Founder of Kobara Medical, a startup in the cardiac rhythm and neuromodulation space. He has over 20 years of experience in commercializing technologies and leading business operations in semiconductor test, electronics components for the telecom/networking industry, and the medical device industry. Dr. Pfahnl has earned a Doctor of Science and Masters of Science in Mechanical Engineering from the Massachusetts Institute of Technology, and a Bachelors of Science in Mechanical Engineering from Rensselaer Polytechnic Institute.
Henry Pak. Principal Consultant, The Waddell Group
Henry has over 25 years of broad life sciences experience. He has managed projects (pharmaceuticals, medical devices, healthcare providers) in Product Strategy and Development, Quality/Regulatory, Sales/Marketing, Supply Chain/Operations and Technology Management for immunodiagnostics and medical devices. Henry has a Biomedical Engineering degree from Northwestern University, a Masters in Bioengineering from the University of Illinois and a Masters in Engineering Management (MEM) from Northwestern. Henry is certified as a Six Sigma Black Belt, and in Auditing, Organizational Management, Quality, Reliability, New Product Development Professional, and Project Management Professional.
Nick Wine, Sr. Systems Engineering Manager, Medtronic
Nick is responsible for a large contingent of systems engineers in Medtronic’s Cardiac Rhythm Heart Failure business. He holds a Master’s degree in Electrical Engineering Systems from the University of Michigan and a Bachelor of Science in Electrical Engineering, also from the University of Michigan.
Kiran Kuppuswamy, Sr. Engineering Manager, Medtronic
Kiran is responsible for assessing the reliability/quality of market-released Implantable Pacemakers/Defibrillators and taking appropriate actions to ensure patient safety for the Cardiac Rhythm and Heart Failure division. He is also responsible for the overall product Risk Management Process for the business units in the Cardiac Vascular Group. Prior to joining Medtronic, Kiran held reliability engineering positions in the semiconductors/consumer electronics industries, and was a Reliability Engineering Research Fellowship at the University of Arizona. Kiran has a B.S in Mechanical Engineering from Bangalore University and an M.S in Reliability Engineering from the University of Arizona.
Meghan Moore, RAC, Regulatory Affairs Specialist, Ximedica
Meghan provides regulatory input to research and product development teams that engage in the design of complex medical products. Prior to Ximedica, Meghan worked at Medtronic in Structural Heart, Extracorporeal Therapies as a Regulatory Affairs Specialist. Meghan holds a B.S. in Mortuary Science from the University of Minnesota and a M.S in Regulatory Science from the University of St. Thomas.
Susan Matthias, Consumer Safety Officer, Device Specialist, US FDA
Susan currently serves as a Consumer Safety Officer, Medical Device Specialist in the US Food and Drug Administration’s Office of Medical Device and Radiological Health Operations, Division II, Minneapolis District Office. She is responsible for conducting inspections at medical device companies and currently serves as a subject matter expert and presenter for certain FDA training courses. Prior to joining FDA, she was the manufacturing manager for a mid-sized medical device firm. She also has held various engineering and project management roles at industrial and automotive firms. She has earned a Bachelor of Science degree in Mechanical Engineering from the University of Minnesota.