Tag Archives: startup

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...

Startup Medical Device Project Lessons Learned

From time to time, I like to share some lessons learned from current projects. We are in the middle of product development for a medical device startup project and have plenty of recent lessons learned to share. In no particular order--- Dates Are Wrong We all know this. Yet there is also a compelling need to drive towards completion of tasks. Does having a due date help or hurt? I can find plenty of people to support either argument. I don't like dates anymore than the next person. But at the same time, my opinion is that without a target date for completing a task, a task could linger. Of course if you are surrounding with people who are checklist oriented, accountable, and driven towards getting things done, dates probably don't matter all that...

Project Schedules Are Wrong

As a project manager, I have a love / hate relationship with project schedules. Yes, it's true that nearly every project I've ever worked on had a due date assigned to me before we even started the project. And as a project manager, I hate this. Because in those circumstances, I have to craft a project schedule that gives the assigned due date as a feasible option. You could argue that I'm doing myself a disservice and setting false expectations by taking this approach. This practice could give the stakeholder an incorrect assumption about the ability to actually achieve the due date assigned. Perhaps. And at the same time, not providing a project schedule with this approach also gives the impression that the due date assigned is not a possibility. Let me expand...

Medical Device Perfection – Is It Possible?

Medical device perfection is a matter of perspective. And ensuring your product development team has similar point of view and perspective for your medical device is very important. I think it starts with the vision of the device. It also pertains to what you are trying to achieve and when you are trying to achieve it. Perfection. Probably not a good choice of words. I'll try to explain through a short story based on a current medical device product development project. We are in the midst of a electronic medical device. Without getting into too many specifics, the device is class II. It has a custom designed PCB with embedded firmware (along with a few other electronic components). The electronics are contained within a custom designed enclosure. The device mates with single-use disposable components....