Tag Archives: start-up

Is Launching A “Me Too” Medical Device Within A Year Realistic?

If you ask an engineer whether or not something can be done, I've found that most will provide you with an optimistic response. You usually get an unequivocal "yes, that seems feasible". And what the engineer fails to provide and you fail to hear is that there is not an infinite amount of money and resources at your disposal to make it happen. But you trek on anyway, believing, or probably better stated wanting to believe what you want to have happen (and likely what your boss expects). When I was approached by a startup medical device client last winter, I was asked if it would be possible to launch a "me too" medical device within a year. Before answering the question (yes, I've been that optimistic engineer), I did give the suggestion...

8 Lessons Learned from Current Medical Device Product Development Project

The current medical device startup product development project is still in process. However, there have been several lessons learned already with this project. Here are 8:
  1. Finalizing Design Control documentation may lag a little (and it’s okay).
  2. A good project manager maybe should be a control freak.
  3. Trust project team members. Don’t trust project team members.
  4. Go to my network. Expand my network.
  5. A task is not completed until there is clear objective evidence to support it.
  6. Delivering bad news never gets easier but should not be avoided.
  7. When I’m comfortable, I’m being too complacent.
  8. Communicate, communicate, communicate.

On Budget. On Task. On Time.

The other night, I was watching a home improvement show Rehab Addict, when the host, Nicole Curtis, stated: ". . . On budget. On task. On time. . ." I realize home improvements and do it yourself projects have zero to do with medical device product development. However, project management is remarkably similar across industries, genres, project types, etc. As Nicole made the statement, my attention drifted away from her latest remodel to thoughts about current and past medical device projects. I remember once very early in my career touting that my projects were always on time. And at that time, my employer didn't really track budgets, so I guess that metric doesn't really count. But I remember being very proud of being on time with projects. I remember...

Medical Device Product Development Is Like Going to the Eye Doctor

Have you ever been to the optometrist for an eye exam and been posed with the question which is better? Then the optometrist flips a lens or two while you stare at an eye chart. Sometimes the letters get clearer, other times blurrier. My latest medical device product development adventure feels sort of like an eye exam. For a few weeks, we have been back and forth and up and down on the design of a medical device. Do you like this one? How about this one? Some days, it feels like we are getting a step or two closer to ironing out the design. Other days, further away. While I so wish we would be able to narrow in and define the industrial design of the device, we are making progress on the electronics design...