I am starting a new job in an agency who specialized in medical device. I am a straight outta school industrial design graduate and I would like to know where to get some extra knowledge about Medical design.
Congrats on your job! The medical sector is very cool to design for. A good designer with a heavy focus on usability can really help people and potentially save lives.
What kind of things will you be designing?
In the medical sector standards play a big part. There are a lot of guidelines in place to help you and make sure the design is safe. Basically a whole library of do’s and don’ts
Looking at the medical device directive (europe) gives a good insight into this:
As you can see some are super specific. Such as those for very specific devices. Where things such as frequency and harmonies of beeps of alarms and icons to use are defined. There are also standards on usability (EN 60601-1-6:2010) which has gotten much stricter the last few year. Good news for an industrial designer!
My examples are for europe, but in the US it isn’t much different.
I also like looking at medgadget, you can see many new products and developments on there.
Really understanding your stakeholders and who actually makes the decisions for the products is extremely important. Is it the surgeon? or the patient, or maybe the purchaser in the hospital?
Depends on which devices you do. Diagnostics are not the same as the surgical suite which in turn is not the same as the equipment on the medsurg floors, which in turn is not the same as radiology, and so on and so on.
Wait until you actually get a project to provide the direction you will need to narrow down the hundreds of potential sites.
I also don’t know if you will strictly be on the front end conceptualization or on the back end documentation, or both. Do you need to worry about credentialing so you can walk through the door to observe users or do you need to worry about the quality system.
I’ve been doing this for 20 years and still don’t know much when compared to what’s out there.
The company specializes in drug delivery injection product.
For what I know, I need to worry about mostly everything (haha…). We do product strategy, on field observation, front end conceptualization, prototyping (in-house and external manufacturer), quality test, documentations (FDA approval).
I think it’s gonna be a very good formation for me.
Good, it is great that you have other designers to learn from. I suggest that in addition to your other research, the=at you take advantage of the team by setting up a regular series of coffee sessions where you can ask them to go through past projects, learnings, successes, failures. Also, don’t be afraid to invite another designer to a review meeting.
It is amazing to me a simple piston syringe, with or without a needle requires a 510K. And if you are a unit dose device, an NDA will be required. All pertinent information on submissions will be on fda.gov.
If you are going into the field, you’ll need credentialing through VendorMate, MedReps and a third one that escapes me. You have to update once a year for all three with shots and documentation of shots.
For any 510K or NDA most of the 1-5 years it will take to launch a product will be used on testing and trials. I would highly suggest speaking with your regulatory group on finding a way to say yes (they typically say no) to trying product on people in the field. I can’t tell how many bad ideas come out of the lab, untested on actual users, that get rammed through because of the high cost of investment only to miserably fail in sales. That company will quickly become a follower.
What typically happens in the medical field, you’ll have the leaders, with a good innovation system, and the followers who knock-off the innovators. There are only a few innovators and being in the NPD group of a follower sucks.
Med Device is such a broad field so its hard to answer your question (surgical, orthopedic, neuromuscular stimulus, transcute drug delivery, glucose monitor, bone fusion, sport med, and so on). I don’t know where you’re located but attending MD&M West is a good start to see what’s out there. Its like the CES for med devices. Also talk to some people in Regulatory Affairs, Quality Systems- Medical Devices and Insurance reimbursements. That’s the landscape R&D have to navigate through for PD.