Developing medical devices for pediatrics brings both engineering and business challenges. The medical device industry is beginning to understand that kids are not simply smaller adults, but have unique design requirements. Unfortunately, major medtech companies just don’t know what to do about it. Read More
The recent VdE debate on the Healing Innovation blog forced me to reconsider what drives innovation in medical devices. A reduced pool of money clearly hurts innovation, which is our current situation due to the lack of regulatory visibility and healthcare reimbursement concerns. But, under the same financial constraints, what has a greater impact on innovation, the process or the people?
Last week the Healing Innovation website posted a blog asking whether Value-driven Engineering (VdE) is the solution to the recent challenges to innovation in the medical device industry and whether the PR on the initiative overstates the impact relative to the content of the movement. And, fundamentally is the process in itself actually innovative? The leadership at the Austen BioInnovation Institute in Akron (ABIA), after reading the post, felt that a few of the assertions are flawed and requested an opportunity to respond. The following is that response: Read More
Anyone been following the Value-driven Engineering movement (VdE)? In response to President Obama’s “Winning the Future” initiative, the Austen BioInnovation Institute in Akron (ABIA,) has launched a national effort in VdE. Read More
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. Read More
How do you build a community of clinicians looking to solve medical challenges with improved devices, diagnostics, equipment, or implants? Why not via the Internet? www.scrubstorm.com launched on April 26th at the annual conference, SAS11, of the International Society for the Advancement of Spine Surgery (ISASS) in Las Vegas, Nevada.
Mike Sinsheimer (MedTech Catalyst) and Ken Solovay (ScrubStorm) Beta-launching the ScrubStorm platform at the ISASS Annual Meeting
How does a medical device company improve R&D productivity when most of the industry is in decline due to regulatory and reimbursement pressures? According to Ray Swanson (partner at TCG, LLC), the best performing companies place the customer at the helm of a market-driven innovation process. Read More
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 improvements, however, open innovation provides an invaluable opportunity to discover breakthrough products.
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 innovation outside a token project each year?
A little over 1 year ago the medical device start-up company I was managing was in a holding pattern due to funding constraints. Perhaps out of boredom, and in some respects to have a Plan-B, I started to brainstorm new ideas for a start-up business. Read More
