Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
Big medtech companies have been criticized for their diminishing innovation record, especially from this blog. One of the few innovation strengths that large companies should exhibit is manufacturing. And, I’m not referring to advanced manufacturing in itself, but the synergy between manufacturing and R&D. In the mid-nineties, I had the pleasure to experience Cordis Corporation (pre- […]
A year ago we wrote about hospital systems starting to take greater ownership of physician inventions, with intellectual property rights now defined in employment agreements, even for non-research hospitals. A recent legal case has further cemented the constraints for innovative physicians. According to the Boston Globe, a state superior court judge has thrown out a […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
I’m a born skeptic of conferences and the carousel of speakers that are on the meeting circuit, but Converge — a one-day meeting earlier this month to discuss the convergence of technology and healthcare — was a refreshing change. In addition to the obvious focus on the future of healthcare technology, attendees and speakers were […]
When selecting a lawyer to defend your patent application, consider experience drafting and a prosecuting application, defending patents after they are issued as well as general business experience.
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 […]
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 […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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 […]
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 […]
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 […]
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 maladies such as spine […]
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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 society values. Almost every […]
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 make well-educated guesses about […]
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 of interest are not […]
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 agreements. Hospitals, especially large hospital […]
I don’t want to become an FDA basher. It just seems like every year it is getting harder to push the medical device rock up the FDA hill. Speaking with peers, their perception has been similar, but last week the speculation was confirmed. I have never spent the time to actually look up FDA approval […]