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.
Last week’s news that J&J is abandoning their coronary stent business was sad, but provided several lessons about poor product development execution and the need for constant innovation. J&J created the coronary stent market, managing the first training and certification programs, paving the regulatory path for those that followed, and launching the first successful device. […]
We have all heard stories from doctors about some medical device company stealing their idea for a new product. Perhaps, there are real medtech bandits on the prowl, but in the vast majority of cases, it’s more a matter of misconceptions and miscommunication. Critics will point to Dr. Gary Michelson who settled a patent suit […]
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.
Despite the many challenges that larger companies have in developing new products, to their credit, most medical device companies have mastered the process of Stage-gate portfolio management. Startups and single product development efforts don’t typically manage a portfolio of projects, and hence have not paid as close attention to following a stage-gated approach. According to […]
An Investigational Device Exemption (IDE) approval is necessary before conducting FDA sanctioned medical device clinical trials. Companies often (around 200 times per year) utilize an informal pre-IDE process as a pre-cursor to the IDE application for the purpose of gaining insight from their FDA review team and presenting their product and testing or clinical plan. […]
Companies typically pursue open innovation programs with the goal of collecting new ideas more quickly than internal resources can accommodate. Medical device companies share this same goal, but due to fears of intellectual property issues, they too often shy away from open innovation. If medical device companies want to do more than solely incremental device […]
Many, if not most, medical device companies perform pilot clinical studies outside of the U.S. Cost reductions, avoiding a protracted FDA Investigational Device Exemption (IDE) approval process, and the ability to make design changes during the study without continual IDE amendments are the leading reasons to perform early studies outside the U.S (OUS). A company […]
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.
If you haven’t heard, the FDA has been publicizing their newly launched Medical Device Innovation Pathway. Besides the standard press releases, FDA’s Center for Devices and Radiological Health (CDRH) has created a 53-minute video starring Dr. Jeffrey Shuren, director of CDRH (see below) to spread the word. But, is the FDA really capable of fostering […]
Incorporating clinical studies prior to design “freeze” into a medical device product development plan is foreign to some organizations, including supposedly nimble start-ups. Changing a company’s clinical research philosophy requires well-defined goals, proactive collaboration between functional areas and discipline.
Medical device design can benefit greatly from clinical research done during development. Especially when developing a novel product, the sooner an experimental device can be studied in the clinical environment, the greater the opportunity to impact the product design, features, and procedure.
Medical device innovation has to start somewhere. Here's a list of resolutions to help clinicians who want to advance medical science.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Creating new innovative medical devices won't always come from a doctor. Medical device innovation is about combining knowledge with a thirst for problem solving and capitalizing on the opportunity to test ideas in the clinical environment. Clinicians in general, and not just doctors have the potential to add value by developing medical device solutions.