Funny. In the IDSA conference thread, I brought up this very topic.
At the conference in Chicago this year, one of the talks will be, SHOULD ONLY EXPERTS DESIGN MEDICAL PRODUCTS?
http://www.idsaconference.org/index.php/speakers/item/270-bob-schwartz-ge-healthcare
atmo, the difference between medical and any other design is that we are beholding to the FDA and what we call the quality system. In a nutshell, if we make a claim, we have to prove it. Not only do we have to prove a benefit - “this will grow hair”, we have to prove everything about the product. Made out of ABS? Great. Prove it.
So we have a long paper trail. There is a lot of standardization. Meaning, for certain types of medical devices, we know what battery of tests need to be done in order for the FDA to approve the product.
As to the debate at the IDSA conference, those who are pro-specialist will claim there is an advantage to know and have experience with the quality system. And I would agree. But I see it as only an advantage, not a necessity, and it is something that certainly can be learned.
It is not up to the designer to determine and implement the quality system at a manufacturer. That is the job of QA. Our job is only to follow the system. And quite frankly, a monkey can do it. But again, without that experience, you can very easily add time and cost to a project.
For example, let’s say you have some liquid formulation as a part of your product. You need to prove that its efficacy will stay there over time. That is the purpose of expiration dates. As time goes on, the active ingredient will deteriorate. 2 years is a good amount of time. My introduction came from a client where we also changed their corporate ID. Their main color went from blue to green. They had a bottle with a liquid reagent in it. The cap color was blue. We recommended they change it to green. They have to prove that changing the pigment in the plastic cap does not change the stability of the liquid reagent. Even with an accelerated method, you still need 6 months to prove nothing will happen. And you also still need the 2 years of non-accelerated data to prove nothing will happen.
And the testing can be expensive. I am working on getting $400K approval from our board for testing a product on people.
So yes, having knowledge of what needs to be done and when it needs to be done is vital. But product development is product development. And I think there is no reason someone with kitchenware experience cannot design medical devices. You are solving a problem and it doesn’t matter if the problem is in the kitchen or in surgical suite #3. You have been trained to solve that problem.
Good luck. I have been doing medical device design for 20+ years. I think it is great fun.