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.

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Discussions

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. We park the good stuff at http://medgroup.biz/MDG-SITE Register there now to stay up to date.

Julie Omohundro
Principal Consultant at Class Three, LLC
Jean, I find myself once again in danger of hijacking a thread, so I for now I will simply thank you for your response and leave this for another discussion on another day.

Jean Bigoney
Regulatory Affairs Specialist.
Julie, in general regulatory is different from quality in that many manufacturing sectors are unregulated. .I think I could come up with examples where you can satisfy one but not the other. The medical device industry in the US is regulated and most devices are classified such that the manufacturer has to be in compliance with 21 CFR 820, however there are also GMP-exempt devices. So maybe I’m nitpicking, but I see a distinction. They are close and they are related. And it makes sense to have QA and RA working together if the activities aren’t being carried out by the same people

Mary Parrish
Having Fun Helping Others Have Fun in Their Own Backyard!
Identifying Key Performance Metrics up front and gaining agreement to those metrics. Composing a glossary to have a common language set allows you to be clear on “definitions” . Often times miscommunication or Lack of Clear Definitions is the source of inadequate deliverables or missed deadlines. Make sure that Documentation is part of the delivered product.

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.

Julie Omohundro
Principal Consultant at Class Three, LLC
IMO, regulatory compliance *is* Quality. How would you satisfy the one without satisfying the other?

Mark Kesti
President & Chief Revenue Officer
A broad based med device industry survey asked departments heads of Manufacturing, QA/RA, Purchasing, R&D and Marketing at both large and small med device companies to identify, in order of importance, what the most important needs a contract development, design and manufacturing company should satisfy.
1. Quality. In the end, patients’ health and lives may literally depend on the quality of the med device(s) being used. Shortcuts on quality are non-negotiable.
2. Regulatory Compliance. Your contract development and manufacturing partner may be providing a $1.50 component that is used to make a $300/unit finished disposable device. Regulatory non-compliance of the $1.50/unit component could shut down your ability to sell the $300/unit disposable.
3. Time to Market. Hey, time is money and the sooner the finished med device can be sold, the sooner your required ROI can be realized, if not exceeded.
4. Price. Let’s be real, price or cost is a key element of any business decision. Please note however, that our colleagues who responded to the survey listed “price” as the 4th most important criteria for selection and use of med device contract design, development and manufacturing firms.

David H.
Helping companies develop medical devices
Having worked in both corporate & Start-up R&D and recently started a Med tech development consultancy i would echo Bruce’s points above.

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.

Mateusz Pawelec
Creator / Project Manager
I think the most important (it was allready mentioned) is the effectiveness of implementation. And fortunately it is a measurable parameter – portfolio, references market research.
But I would like notice one more thing (from the other side)- always, very important thing is the design assumptions. Even the best external company will not be able to meet our expectations if we have a bad project brief / specific and weak project manager.

Tom Ackrill
Business Development Manager at ITL Group (a Gooch & Housego Company)
Completely agree with Mark O’Donoghue – ITL are often called upon in a similar capacity to pick something up that has been designed, but not necessarily made manufacturable, and then have to perform additional R&D work to get it to the point where the big button can be pushed and product can start appearing!

I can never stress enough the importance of a clear route to successful manufacturing even from Day 1!

Mark O’Donoghue
Global Marketing & Communications Leader
Slight bias here…yes quality/speed/good pricing but..also consider how well the company can produce compelling user experiences – e.g. how strong is their Human Factors team? Critically, and it has been mentioned, but I can’t stress it enough – the connectivity to manufacturing for effective commercialization. We call it the avoiding the, “Oops we should have thought about that earlier” manufacturing scenario. We get a lot of clean-up projects due to clients who have gone to design/development firms without that manufacturing experience.

Cristina Lourenço
Personal Assistant na AUTOSTAR COMERCIO DE VEICULOS LTDA
Ailton Caglione

Jörg Lorscheider
Director Of Sales & Marketing at Omnica Corporation – Product Development
Its actually a complicated question. Service providers come in various flavors and the flavor you need is dependent on what you have in terms of human capital and of course real capital. Your requirements need to match. For example, smaller service providers may rely completely on subcontractors to accomplish the work. This might be less expensive but requires more care and oversight; especially documentation. Larger service providers require less oversight but might use full-time employees which has higher overhead costs and thus higher prices. This is an oversimplification as there are many other issues related to IP, Technical Experience, reputation etc as mentioned by the group previously.

Ee Bin Liew
Access-2-Healthcare’s Owner and Consultant
in design & development for medical technology, available paperwork is really critical. it’s officially in design control so for all its design wizardry if it aint documented it didn’t happen. 13485 certification, though in theory says that this company should have all the paperwork, it is not always the case. Ask thoroughly how the team will communicate with the client verbally and in documents, their traceability processes, as well as the delivered documentation..

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.

Cheers,
Ee Bin

Santiago Ruiz-Valdepeñas
Ingeniero | Cofundador de Up Devices
Great responses so far, my two cents:

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.

Tom Ackrill
Business Development Manager at ITL Group (a Gooch & Housego Company)
I’d have to disagree with Bruce re: the ISO certification – there’s definitely a difference between certified and compliant – being a certified company we have working knowledge of the regulations and not just “book smarts” when it comes to how they have to be applied. Also not every client will have a 13485 QMS system, so they would look to rely on their design partner to help guide them through that minefield.

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.

Bruce Ackman
Industry and Energy Commercial Lead at Cambridge Consultants
So…I work at a product development consultancy. My list of the top five criteria to look for:
1) Reputation for ethical conduct and transparency (via references)
2) Reputation for quality, creative, leading work (via case studies, awards, references)
3) Value. Demand proposals that are detailed and transparent with unambiguous timelines and deliverables. Note this is not just cost alone
4) Interpersonal fit. Has the selection process fostered a good working relationship that will strengthen during the project.
5)Direct involvement of firm principals (not juniors) on your project.

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.

Bruce

Julie Omohundro
Principal Consultant at Class Three, LLC
To expand on John and Tom’s comments, I don’t work with design firms much, but I do work with startups. When looking at any service provider, I look closely at the background of the principals. I have concluded that some number of firms that present themselves as service providers to the medical device industry are as much in the business of identifying opportunities for investors as they are in the business of offering services.

Adam Bilney
Medical Device Designer / Mechanical Engineer / Project Manager
If you’re after creative input and new ideas initially, look to companies who have diverse experience across multiple industries. The best solutions to your problem usually come from other industries. If the design firm you are talking to only does medical, this is a warning sign!

Tom Ackrill
Business Development Manager at ITL Group (a Gooch & Housego Company)
Completely agree with Brad Walker re: the IP – that’s another thing that has to be taken into consideration – whilst ITL for example doesn’t retain any IP developed as part of an R&D project, there are plenty of companies out there who will seek to retain said IP. For a startup company or a spinout, that can be corporate suicide for them.

John Muri
Mechanical Engineering Consultant
Do they have the expertise for that specific project or maybe just part of the project? Experience is a great deal, because many times just as important to know how not to do something as to know how to do it. Look at references in similar projects and see how creative the solutions were. How well the design inputs can be defined based on the clients description.
Reasonable Creativity on a design stage is very important, since that can set the rest of project steps up, regarding manufacturability, cost, serviceability not promising the Moon.

Brad Walker
General Manager, Home & Business at O’Brien Glass Industries
What was the cleverest solution that they every came up? what is their approach to understanding the ‘end user’s’ problem, that the device will solve? what do they know about manufacturability? what is their experience with the regulatory challenges? who will own any IP?