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. We are approaching design verification and gearing up for system testing. But lately, we’ve kind of been chasing our tail (and not catching it) on the design. The device involves measuring pressures. The hardware / firmware resource provided a prototype advertised as ready for testing a few weeks ago. The prototype was delivered to the startup for testing. Within a few hours, the startup put the brakes on stating it was not ready. There was a short list of things to address, and the unit was sent back for tweaks.
A week or so later, the tweaks were made and the unit was given back to the startup. A day later, the startup said it still was not ready.
This happened another time or two until last week. The team sat down face to face to review the prototype. The prototype had all the latest tweaks and adjustments. The startup still had a few issues. The hardware / firmware resource took the device back to make the few minor adjustments. Once completed, I picked it I picked up the device. I walked through it, ensuring the features and functions were addressed. Satisfied, I delivered it to the startup. Within a couple hours, the startup called saying it still was not right. I was stumped.
I dropped everything I was doing and headed to pick it up. I walked through the device again. I felt as though it worked as intended. I decided to bring it home and test it for a few days. I confirmed the device works. Yes, I found a few bugs. But the device works. I let it run for over 2 days. I ran the battery down a couple times. I plugged it in. I changed settings. I communicated this to the project team. We had a meeting earlier today to discuss and review. Prior to the meeting, I hoped we would initiate some performance testing today.
The startup thought otherwise. They listed all the features and reasons the device is not ready. I reiterated that the device works and could be tested further–NOW–to verify performance. It was clear, though, the startup wanted a perfect device before starting testing.
I bit my tongue. During the drive back, I racked my brain. Eventually with my thoughts gathered, I had a chance to chat with the startup CEO. I shared my point of view and opinions. He then stated his: let’s continue moving forward. The near term goal is to prepare a FDA 510(k) submission. To do so we need performance testing. He continued by stating once we make the submission, we have a couple months during FDA review to fine tune and perfect the product. And perfecting the device is critical for this startup; they have no desire to launch an inferior device into the market. I agreed. We need to drive towards a viable device that is safe and effective.
The CEO indicated he relayed this to the other team members. I’m just not sure yet that everyone is on board.