The New MEDDEV CER Guidance You're gonna need a bigger boat

The new revision of the EC guidance on Clinical Evaluations (i.e, CERs), was issued in June of this year.  MEDDEV 2.7.1 Rev 3 is now Rev 4.  The industry has provided many ways to learn about the new document via white papers, webinars and conferences (thanks!).  The education has been great, but what’s it like for someone who is used to writing CERs to the […]

Innovation and the 2016 MN Cup

If you’re worried about the state of innovation in the Minnesota medical device community, you only need to look to the MN Cup competition to be reassured. I was privileged to be one of about 20 judges in the Life Science/Health IT division of the MN Cup this year and was struck by the number of competitors who had all the right stuff. […]

The Fatal Tesla Crash and Medical Device Risk

There was a tragic car crash two months ago involving a Tesla Model S while the driver had the car in its “Autopilot” mode. The driver of the car lost his life after hitting a tractor trailer making a turn in front of him; Tesla stated that neither the driver nor the car recognized the looming hazard and did not apply the brakes. […]

Product Testing – It Can Really Hurt

Imagine a pioneering surgeon inventor and entrepreneur dedicated to proving that his latest medical device is safe by implanting it within the muscle of his own rib cage… by himself.  Then, months later, removing it… again, by himself.  The surgeon told me that it was a lot more difficult taking the device out than it was putting it in!  While the ethics and safety of […]

Can You Reduce Device Risk Just By Informing the User?

Over 20 years ago, a doctor phones a medical device company’s technical service group from nearly half a world away, and is in a panic. He’s performing his first implant of the newly available AICD technology, and his patient is sedated, on the table and there is a problem. “I’ve implanted the defibrillator, programmed it, turned it on, and now it’s […]

Risk, FMECA and an Engineer’s Creativity

My wife walked in the door with a big sigh years ago after taking our young son to Toys ‘R Us. She realized he was going to take after his engineer father when, after picking an interesting toy off the shelf, he turned it over to see how it worked instead of just playing with it. Apparently, she thought one engineer in the […]

Provisional Patent Applications: An Important Tool for the Inventor/Entrepreneur

There are many good reasons to consider filing a provisional patent application on your new idea. Of course, a patent attorney will be able to explain the benefits and issues of a provisional application and to help in putting it together. Although I’m not an attorney, I have filed quite a few applications on my own inventive ideas, and have worked with many start-up clients […]