Transition between fields?

Hi all…it’s been awhile since I’ve posted but I am always snooping around to read posts. :wink:

Recent career dilemma: I came upon an online class offered at University of Washington (state school), titled “Medical Device Design” Now, this class is under Bioengineering Department’s Continuing Education program, offered at night for working professions. I’ve looked through last year’s course syllabus, talked with the design director and even the professor about what this class is about…it basically covers general product development processes, keeping it pretty broad and relevant for other people with diverse background. This class is not specifically designed to build a platform for ID, or even designers. It does seem more or less flexible for students to cater their final outcome projects to supplement their career, so my master plan is to carry a design project as if it was a ID studio class.

I’ve been working in kitchenware ID field for 3.5 yrs now straight out of school, and have developed this yearning to be working in the medical device industry. Not to say I am actively looking, but I’m looking out 2 years or so ahead. With my portfolio FULL of kitchenware products (and very few projects from school that are worthy to present), won’t prospective medical design firms consider me as an unqualified candidate off the bat? To showcase my interest in the field, the course mentioned above might be a great way to get my foot in the door, or at least an interview?

I would love some feedback & my ultimate question to you…How did you transitioned between design fields? As a rookie just starting out her career, this is still a very big mystery. Worked on various projects outside the full-time gig? Took night classes? Contract/freelanced on weekends?

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?

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.