I can hardly count all those times I’ve seen some of the most promising data-driven biomedical research results that could have been incredible tools to improve patient care in one or the other way.

But when somebody actually suggested to make them available to the public there was always that other person countering this idea saying “Oh no, that would be a regulated medical device, we can’t do that”.

Discussion closed. And drawer closed after publication as well.

After spending the major part of a decade in biomedical data research I finally got frustrated enough from constantly hitting that “Medical Device Barrier”.

What’s so dreadful about medical device regulatory?

Some two years ago I sought to face the daunting enemy. Was it really so dreadful to bring a medical device to market? I had to learn all about it. And so I did.

Getting a grip of medical device regulatory was one of the most amazing things I could have ever done. The way it literally bridges all those little gaps between a medical idea, the patient benefit and a sound technical implementation is incredible.

The missing puzzle piece

To me, as someone who has both a medical and an IT background, adding regulatory to the game felt like finding that missing puzzle piece that helps put the whole picture together:

• from a patient need
• to a medical idea
• to a research finding and prototype
• to an actual device implementation
• that improves lives
• and meets the patient’s need!

I’m very grateful for having found this puzzle piece and I’m equally grateful for having had the chance to help various companies and research institutions in bringing their ideas to life. Not only by making the best use of their data in the interest of the patient. But also in taking great data-driven products to market as a medical device – and making an even more direct impact.

What’s your experience?

• Have you had moments when you seemed to hit that “Medical Device Barrier”?
• Have you found yourself wanting to turn that research finding into a patient benefit right now?
• Have you found yourself wondering whether it’s really that hard to create a medical device?

Very interested to hear your story.

My advice for when you’re in a situation where you seem to be hitting the Medical Device Barrier and feel like you really should be taking things forward: Don’t shy away. It’s much less dreadful than you would think. Dare to pass.