In most of the world, regulatory bodies approve medical devices based on safety. Seems like common sense. But, in the U.S., the FDA approves medical devices based on both safety and effectiveness. It’s the “E” word that is largely responsible for the long and protracted clinical trials that delay approval of novel medical devices.The solution [...]

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.Although medical device companies spend large sums of money [...]

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.Although the title of the [...]

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 [...]

Anyone been following the Value-driven Engineering movement (VdE)? In response to President Obama’s “Winning the Future” initiative, the Austin BioInnovation Institute in Akron(ABIA,) has launched a national effort in VdE.According to ABIA’s website, “VdE Incorporates product design with targeted content,” which ABIA suggests will safeguard the U.S.’s leadership position in medical device innovation and improve [...]

No physician inventor should apologize for making money off an innovation that improves medicine. Certain orthopedic surgeons, however, have pushed a tenuous ethical line in how they distribute their own devices.Entrepreneurial surgeons have formed medical device companies to develop, manufacture and distribute implantable plates, rods and screws used to fix [...]

The title of Scott Gottlieb’s Wall Street Journal article “How the FDA could cost you your life” is not only sensational, but misguided. I am no apologist for the FDA’s poor execution, weak resources and lack of transparency; however, the agency’s existence and culture are a direct response to what American [...]

Nurjana Bachman, PhD, from Boston Children’s Hospital, has made the case that pharmaceutical companies are changing their approach to partnering with academic medicine and working as a team. How about medical device companies?Dr. Bachman explains that the academic community provides long-term commitment to specific disease processes, which allows them to [...]

All participants in medical device product development understand that physician involvement in the process leads to better healthcare. I have argued in the past for an even more active physician role in the early stages of medical device concept development. Patient rights groups, however, worry about conflicts of interest. The conflicts [...]

Researchers at universities, similar to employees of medical device companies, are accustomed to assigning patent rights to their institution in an employment agreement signed during the hiring process. What may not be as obvious is that many non-academic hospitals are now including intellectual property (IP) rights in their physician employment [...]