Steve Jwanouskos (Vice President – Regulatory, Clinical and Quality Assurance; Allux Medical) is a graduate of the University of Minnesota with a Bachelor of Science in Rhetoric (scientific and technical writing and editing). He has held increasingly more responsible positions in 17 years in the medical device industry, has garnered new product approvals for both PMA and 510(k)-regulated devices, which include permanent implants (magnetic transponders, cardiac stents), electrophysiology ablation systems, Doppler guidewires, ultrasound imaging catheter systems and phototherapy systems.
The talk will examine the systemic issues that have led to medical device failures. The goal of the talk is not to describe that “The tire is flat.” Instead, it would be “The tire will go flat unless we do ‘X’”. It will be based on the publicly available information on well-known medical device disasters (Therac 25 radiation therapy software, Bjork-Shiley heart valve, etc.). I will then go into detail about what to do about a product malfunction with regard to failure investigations, reports, removals and corrections.
