Message from the President

Thanks to all who made it to the “Medical Device Commercialization Playbook” event in Vancouver last week.

We were delighted to be the title sponsor for such a star-studded lineup and hope to bring similar events to more cities in the next year or so.

There were a number of entrepreneurial highlights for me from Steve Arless’ swashbuckling decisions to Michael Baker’s creative repurposing of technologies, Paul Geyer’s rules for entrepreneurship (see article in this issue), Ram Rao’s ambitious ophthalmic device plays and Awni Ayoubi’s tips for operationalizing.

I also loved Larry Spears’ refreshing and useful insider’s perspective on the FDA and how to work with it. Vesna Janic speaks with Larry in our lead article.

Our post-event survey indicates I wasn't the only one who was impressed.  98% thought that overall it was Very Good or Excellent, and 92% would very or extremely likely recommend the event to friends and colleagues.  Stay tuned for more articles and interviews from speakers and attendees over the coming weeks.

As always, thanks for reading.
 

Scott Phillips, President

A view from the other side: Larry Spears, former Deputy Director FDA/CDRH Office of Compliance

By Vesna Janic

StarFish Medical recently worked with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations, as part of our ongoing efforts to improve and train our quality practices.

During our breaks, I spoke with Larry about life after the FDA, how firms can best prepare for regulatory submissions, and the new open nature of the FDA. I found his answers candid, thoughtful and useful, so I'm sharing them with StarFish readers.
 

- READ MORE ->

Rules for Entrepreneurs from 2015 Medical Device Playbook

I chaired a panel discussion on the success secrets of medical device executives  at the Medical Device Commercialization Playbook 2015.   Over 200 Vancouver BC medical device professionals attended the event.  

A highlight for many was  Paul Geyer’s (Uncensored) Rules for Entrepreneurs during the panel discussion.     His 15 rules were to the point, memorable, and I'm happy to pass them along.