Medical Devices - DFM

#1
Hi

I currently work for a Medical Device contract Manufacturer and the intention is to provide a DFM and a DFM & Prototyping service to our Customers. Can i ask, what factors and considerations we need to take into account when offering the aforementioned services to our customers ?

Thank you in advance
 
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Tidge

Trusted Information Resource
#4
Without trying to get too deep into the realm of "Design Controls for Medical Devices", there are a few areas where I have seen a misalignment of expectations between a "DHF owner" and (something like a) "prototype/contract manufacturer":

1) Medical Device companies are obligated to make safe medical devices, where safety is defined as the absence of unacceptable risks. You will need to have a firm understanding of how your company is going to be expected to work in that context. From your POV, you don't want to be surprised if your partner all-of-a-sudden starts asking for all sorts of risk management documents specific to your process(es)... typically these are manufacturing processes, but could also be design processes.

2) Prototyping can be tricky, depending on how on-the-ball the partner is with design controls. You will need to have an understanding of the formalities and expectations of your partner. "Simple" things like revision control can quickly spiral. Establish contracts such that you can deliver what is precisely asked of you.

3) You ought to be blunt about the issues around and differences between prototyping and scale-up. Problems can manifest themselves in all sorts of ways. A classic example is (for injected molded components) when tools used to make the prototypes become the production tools... this has consequences for both parties.
 

Bev D

Heretical Statistician
Leader
Super Moderator
#5
Thre are entire books and days of training and several excellent software programs that deal with Design for Manufacturing. We cannot hope to cover it all in this forum. Specific question yes.

Suffice it to say that DFM is all about making it simple and easy to manufacture. fewer different parts, easy access, ‘obvious’ ways to assemble or fabricate something, error roofing.

As for DFM’s integration with medical device manufacture: DFM should make products safer as it makes the wrong things harder to do…
 

Junn1992

Quite Involved in Discussions
#6
To echo Tidge's comments, with the release of MDR, your clients would be asking and requesting for extensive documentation. So you yourself should be ISO 13485 certified to meet their requirements. In addition, supplier control on your side is very important as Notified Bodies might come down to your site and check documents.
 
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