Should Have Held a Design Review

Have you ever had one of those moments during your medical device product development efforts when you said “we should have held a design review”? Unfortunately, I’ve found myself making this exact statement a couple times during the past couple weeks.

Instead, we chose to push forward. Face to face discussions, email correspondence, and phone calls with the various team members suggested things were progressing just fine. The medical device being developed has quite a few components: mechanical, electronic hardware, firmware, disposables, etc. Our product development approach has been largely divide and conquer and working in parallel. There have been a few touch points when each of the various components needed to come together for overall review and testing. However, we have pushed and pushed each of the individual efforts assuming this would be better for the aggressive project schedule.

Then came time to merge mechanical, hardware, and firmware pieces to conduct some design verification and simulated use testing. We pushed forward with this phase without getting the entire team together for a formal Design Review. And it kind of hasn’t been working out the way I would like. In fact, it has been a little bit of a mini-disaster of sorts. The device isn’t performing exactly as we had hoped. Rather than the team figuring out how to work together to resolve the issues, there has been a lot of finger pointing.

And as project manager, like it or not, I own that. This is my responsibility to address.

The silver lining is that holding a Design Review still had merit. So I got the team together to discuss and review the important and critical issues. Surprise, it actually helped–A LOT! The value of having a team meet together face to face should not be underestimated. I know this. I know this. But damnit, the schedule…

Okay, no more excuses. Lesson learned (again). This time, I’ll err the other way. I’d rather have too many face to face discussions and Design Reviews versus not enough. This is especially important at key stages during the medical device product development process. Design Reviews should precede the start of major milestones. Design Reviews should also happen upon completion of these milestones. Include the entire core team in all Design Reviews, even if the particular topic seemingly has little to do with some of the resources. Project team members should always have the opportunity to gain knowledge about the project. Plus, the other added benefit to this in my experience generally speaking, is that the more opportunities team members have to interact with one another face to face, the greater the bonds and level of trust.

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