Medical device development has been burdened lately by a high regulatory burden and an increasing uncertainty around reimbursement [1, 2]. In reaction to this, consumer medical devices with minimal regulatory burden that are mostly self-pay and self-treat, have garnered significant interest from the medical device community.
In a panel discussion moderated by Josh Makower, MD (Co-founder of Stanford Biodesign Innovation Program, Founder of ExploraMed incubator, and General Partner at New Enterprise Associates) and hosted by Wilson Sonsini Goodrich and Rosati (WSGR) and Silicon Valley Bank (SVB), the question of whether the grass is really greener was posed to a panel of four guests with diverse backgrounds that brought multiple perspectives to this question. Comprising the panel were Asha Nayak, MD (Global Medical Director at Intel Corp), Charles Wang, MD (Co-founder and COO of Lumo Bodytech), Karl Ronn (Co-founder and Board of Directors Member at Butterfly Health), and Karen Long (President and CEO at Nuelle).
Exploring Asian Medical Device Markets: An International Conversation with Anurag Mairal and Karl Im
Anurag Mairal and Karl Im, two contributors to the international medical device community, recently joined our Biodesign Alumni Group for its first International Tableside Chat in which over 40 participants from the US, India, and Singapore were connected by a video link to provide a truly interactive forum for discussion of the opportunities and challenges with device development in Asia. Read more
Recently, Josh Makower MD, Aabed Meer, an MD-MBA Candidate at Stanford, and Lyn Denend, a Research Associate also at Stanford published results of a survey that sought out to (1) investigate problems with medical device company interactions with the FDA and compare these interactions with those necessary for clearance in Europe, (2) assess perception of FDA versus European regulatory pathways from these companies, and (3) provide a quantitative measure of the time and cost to navigate the current FDA system.
The survey gathered data from 203 companies with 213 unique product submissions. The participating companies represent approximately 20% of medical device companies in the US. Read more
J. Johnson & K. Wu
Earlier this year, J&J announced its intention to acquire Acclarent, Inc. for $785 million, making it perhaps the biggest exit of the year in med devices and definitely creating a buzz among fellow entrepreneurs. Perhaps you, like many others, are thinking to yourself, “How can I do that?” and “What are they doing that I should be doing?”
So, how did Acclarent become a success? How did they avoid pitfalls that might have led them to becoming one of the often-quoted 9-out-of-10 startups that fail?
At this year’s NFL Biodesign Alumni Annual Event, we had the opportunity to explore these questions and get insights from those in the trenches at Acclarent since its inception 6 years earlier in 2004. Read more