The Healing Innovation (HI) blog has spent the last year making the case for greater collaboration between the medical device industry and clinicians. HI, however, has also blogged extensively about the conflicts of interests created by clinicians becoming PR mouthpieces for new products and clinical trial results. Read More
I’m not sure why it has not received more attention in the medical device start-up world, but the Entrepreneur Access to Capital Act (EACA), which recently passed in the U.S. House of Representatives, has the potential to open the door to intriguing fundraising possibilities for individual medical device innovators and start-ups. Read More
Happy New Year! Healing Innovation hopes that Santa left you a great gift under the tree that you can enjoy in 2012. Disguised as Jolly Old Nick, the FDA left Healing Innovation a present that we have been wanting for years. The promise of continuity in FDA reviews.
Although it appears to have been released sometime in November, just about Christmas day we unwrapped a standard operating procedure (SOP) from the FDA called “SOP: Management of Review Staff Changes During the Review of a Premarket Submission”.