What kinds of medical products lend themselves best to outsourcing?
Noninvasive products are easier for an outsider to design and build than invasive ones. Theres a world of difference between a heart valve and a hearing aid. Quality should be an equal consideration across all products, but it isnt. If a hearing aid doesnt work one day, it can get fixed and nobody dies. The same is not true for an implantable device. Q: How should a device company communicate with a contractor about regulatory issues? A: It should become a performance metric. A firm should send a team to the contract manufacturer on a periodic basis to review the areas where they need to be compliant, and to verify that they continue to be. And before the contractor is hired, you need to look at their records to see if theyve been cited for anything, as thats an indicator of whether they know what theyre doing. Q: What is upper managements role, if any? A: The project managers of both companies have the overall responsibility to make sure the relationship stays healthy, but the buck st
