Category Archives: start-up

Medical device product development – take action!

Product development of any kind is definitely challenging and full of all kinds of unknowns, obstacles, and pivots. Medical device product development is certainly no different. To complicate matters with med device, throw in regulatory, such as FDA, to complicate matters. If you ask entrepreneurs and startups in the medical device space to define their single biggest challenge, the response will overwhelmingly be clear. Money. Not enough funding to get to market. money   Which kind of stinks. Especially if you have a fantastic idea for a medical device technology that can improve the quality of life. Seldom is having the idea good enough to secure all the funding necessary. So what do you do? I mean every thing ¬†you need to do requires funding. Right? Well yes. And...

Medical Device Startup – 3 Things To Do

Imagine for a moment that you are a medical device startup. There are probably thousands of things you are concerned about and have to do before you can go to market. Where do you begin? It's easy to get bogged down realizing all the stuff you have to do. But you have to make progress. And in order to do so, you need some structure. You need to focus. It requires discipline. Before you start every day, you need to ask yourself this simple question: What do I need to accomplish for my medical device startup today? If "today" is too big, break it up into smaller chunks. Yes, you need to have some idea of where you are going--the end goal. So figuring out the smaller chunks should be based on that. Once you...

Medical Device Startups Serving OR & Critical Care

This post comes from David Gomez, CEO and Founder of Infinitus Medical Technologies. David actually posted this on LinkedIn, where I asked if I could post it here.

Attention to all medical device start-ups serving the operating room and critical care markets:

  • Are you seeking funding to get your approved products into the market?
  • Are you having a hard time finding investors because you are considered a product and not a company?
  • Has the chaos of the Affordable Care Act destroyed investment opportunities?
  • Does your product(s) have value propositions that align with current changes demanded by this legislation?
  • Does your product or service come from a clinical perspective or have...

Joy of 510(k) Clearance

Cinco de Mayo was a good day--for many reasons! One of the reasons is that I received notification from FDA that a 510(k) we submitted for our startup medical device client received clearance. Did I mention "5" is my number? 510(k) clearance on 5/5--pretty sweet! The project has been rewarding and challenging, as with most medical device product development projects. I especially found the FDA 510(k) review process to be a bit more challenging than I had expected. A few rounds of "refuse to accept" followed by a reviewer who seemed to challenge just about everything we provided as supporting evidence. Having gone through this experience with a tough and difficult reviewer is something I do appreciate. Working with him actually made the second submission much more complete and smoother (so far) with FDA. Receiving...