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alexandrabuga replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development 7 years, 3 months ago
I work at a non-profit hospital so for our more robust medical devices that we are unable to develop in-house, we use outside contractors to develop the devices. So the company will come and meet with surgeon that invented the device and work closely with the surgeon to understand the problem its solving and how best to improve the original prototype. Usually for medical devices coming out the surgery department, this even involves the contracted engineers viewing an actually surgery to see the current medical instruments the surgeon is using and how he/she uses it during surgery. It’s actually a pretty fascinating process because the surgeon earlier on thinks he/she knows what they want and the engineers come in and have a different perspective and can provide creative solutions the surgeons didn’t initially consider. The company will usually come up with 6-10 different designs and we will pick one to move forward with to build a functional prototype. During the development, they will require the surgeon’s input to make sure it’s in line with the capabilities the surgeon will require to perform the surgery and not only the look but the feel so the type of material/size etc. All key stakeholders are included in the Design Review. For this particular example this would include at MSK; MSK inventor, contracted company (business people and engineers), MSK engineers, MSK business stakeholders (me).