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I was talking with a client in the medical device design & development space.
He and every one of his competitors claim they are ISO:13485 certified and have many experts. They boast their client roster, show their portfolio, and promise quality/speed/good pricing.
Have you ever shopped for product design help?
What are the top five criteria you would use to choose a design and development firm?
I’ll refrain, but I have my answer and I can’t imagine alternative answers.
So if you would kindly, let’s see if everyone comes up with similar replies.
One tip for designing a medical device (75 comments)
Implantable DBS for Parkinsons (163 likes)
Who’s checking your promotional pieces?
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Finally, in new product design, I have gone to my top 6 prospective clients, asked them to identify what would be most important to them in order to accept the product in their practice. I have been able to identify Beta Tests, Version 2 and 3 from these interactions with prospects.
Disagree slightly on point 2) – client case studies but this is more of a mark of respect of client confidentiality, we don’t publish even if the product does launch, our sector is relatively small so reputation does travel.
On the point of ISO certification, At the moment we publicize that we are internally compliant to ISO and aiming for certification in the next few months, We have been audited by clients to 13485 and encourage them to do so. With start ups we work in either creating the Client a QMS and developing the product in parallel or conduct a Robust Tech transfer at each milestone.
I can never stress enough the importance of a clear route to successful manufacturing even from Day 1!
Ee Bin Liew
all other factors, are no different from sourcing for any other biz partner of any function and of any industry for that matter., but with that many (and growing number of) players, we really tend to default to credentials, trust, referrals, references etc. However, that does drive the new (and perhaps equally competent) players out of the assessment rather too quickly. I’d prefer a more pragmatic approach and have someone who really knows design & development evaluate in detail instead.
Hope it helps.
I have worked with both big pharma and biomedical startups as an outsider. In my experience, the key difference between mediocre vs great design work in medical devices is Scientific Rigor: The ability to develop the whole product from basic science up, document progress and demonstrate performance both analytically and experimentally.
Medical Devices should offer a level of performance and reliability far beyond the average consumer product, even when the systems involved are usually more complex. Therefore the trial and error approach to design, so common in consumer products, is ill suited to medical devices.
Of course, a professional attitude, transparency, flexibility, management skills… are all essential for any organization or person that you work with, in any industry.
I’d be extremely wary of going into a medical device development without a cast-iron assurance of regulatory compliance at every stage of the game.
I’m reserved on the issue of 13485 ‘certified’ vs ‘compliant’. Most design firms will necessarily work to the client’s QMS and not lead the DHF anyhow. If there is strong evidence of being able to do this, through documentation, reputation and referral, then ISO Certification is nice but not essential.
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