Today I attended the MD&M East Conference programme which included presentations on the FDA 510(k) process by Marjorie Shulman and Semih Oktay, a presentation of product development by Carrolyn Rice from Johnson & Johnson, and Intellectual Property by Andrew Kimmel from Knobbe Martens.

There were some fantastic insights to be had about the FDA 510(k) process and the subtle differences in IP law in the US. Some of the take-away points includes:

•  The average start-up company in America owns 25.2 patents (study by UC Berkeley). This is phenomenal when you consider that the average start up company in New Zealand may have 0.5 - 1 patents;

• The US provides a one year grace period of disclosure, meaning that you can publically disclose your idea as long as you file a provisional patent application with 12 months of first disclosure. Obviously this has limitations outside of the US;

• The FDA substantially equivalent framework has been used to overturn infringement litigation, deeming devices to lack novelty with the IP office if they have in fact been granted substantial equivalence with the FDA. So its important that your IP lawyer reviews your FDA application for consistency;

• The goal of the FDA is to establish reasonable assurance for medical devices;

• 45% of all FDA applications go into the general controls classifications and only 10-15% of all 510(k) applications need clinical data.

Designer Blythe Rees-Jones of Locus Research visited New York recently to attend the Medical Design and Manufacturing MD&M East tradeshow and the Medical Design Excellence Awards MDEA. Encircle Compression Therapy, a new medical devices developed by Blythe Rees-Jones and the Locus and TMC team was awarded a winner of the 2011 Medical Design Excellence awards – so Blythe went to the East coast of America to see what impact this new medical technology could have in the country of the stars & stripes. This is the forth of a series of posts about his experiences on the trip.

Acknowledgements: We would like to thank  The Merino Company, Andy Wynne,  Delloch, Terry Vickers & Sean O'connor for supporting this trip.