7 min reading time

“Engineers who design and develop new devices are always telling me they hate design controls,” Greenlight Guru co-founder Jon Speer tells me.

“They say, ‘Why are you talking to me about design controls?’

Because without tight design controls, how do you prove you designed a safe and effective device that meets the indications for use?”

On Wed, May 23 at noon EST, join us at https://medgroup.biz/design-control where Jon talks intended use, user needs, design inputs, reviews, history files (dhf), and risk management; specifically,

• The importance of getting your intended use right up front

• The difference between user needs and verifiable design inputs

• Which stakeholders need to be involved and why

• How many design reviews you should hold

• Why an FMEA alone for risk management doesn’t cut it (you need an ISO 14971 approach)

I asked Jon, “Isn’t everyone doing 14971 now?”

He replied, “No, not everyone. 14971 is THE medical device industry standard for risk management and yet today companies are doing an overly burdensome approach called an FMEA.

FMEAs have their place but FMEA misses the mark because it looks at single fault failures. 14971 is holistic. It looks at what can happen to patients, end users, and the environment if something happens during product use.”

That link again, https://medgroup.biz/design-control for anyone in design, development, and documentation (at a minimum).

And as always, the replay link and slides for all who register whether you can attend live or not.

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SPEAKING OF FREE WEBINARS…

This one’s for anyone concerned with commercializing or getting your product reimbursed.

Clinical Evidence Generation Strategy
https://medgroup.biz/evidence
Live presentation followed by Q+A
Speaker: MDG Advisory Board member Elizabeth Brooks
Tuesday, May 15 at noon EST

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Wow, two great webinars in one announcement?

Make it a great week.

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
My friend Michelle Lott , RAC says on her https://leanRAQA.com website that part of her job is that of “Grief Counselor.” 🙁

Julie Omohundro
Principal Consultant at Class Three, LLC
Came back around to this discussion today after concluding that an early phase startup had most likely destroyed its own product by ignoring design controls and other regulations. I doubt the principals did their reputations any good either.

This is the sad part of my work, seeing efforts to develop a device that might have helped patients fail for no good reason…

Julie Omohundro
Principal Consultant at Class Three, LLC
Cushing Hamlen, you echo my first reaction to this question, which is that design controls are too often implemented as “document controls,” so that engineers (particularly those less experienced/trained in medical devices) see them as a paperwork burden, without understanding how they relate (are important) to design engineering.

Julie Omohundro
Principal Consultant at Class Three, LLC
Tan Truyen Tran, MBA, PMP and Nick Shelley
Is it possible they had to do it twice because they didn’t take the time to do it “right” the first time? I agree that “right” is in the eye of the beholder, and that engineers, RA, and QA people look at these things with different eyes. At the same time, why would an engineer want to produce a well-designed device without also producing the documentation needed to convince investors, regulators, and customers that it is, in fact, well-designed? Because it makes a cool paperweight?

Jeremy Slate
Regional Director at BiomericsATL a joint venture of Biomerics and ATL Technology
I look at design controls this way….It is how you control the design, not how the design gets controlled. It is a tool, not a burden.

Victoria Zande
Owner/President/Creator – Alberta~Rose Incorporated
How much impact and requirement vs “design control” does psi make in some of the newer designs in oxygen concentrators on the market, and what affect will this have on current patients who use oxygen concentrators with a more substantial psi with the same LPM… While manufacturers are now engineering oxygen concentrator with more “design control” and marketing ability, is this with the best interest of the “end-user” or patient in mind??? Is smaller better??? Or – not???

Jon Speer
Founder of Greenlight Guru – Helping medical devices get to market faster with less risk
Love all the comments! From a Design Control nerd!

Del Fredricks
R&D Systems Engineer at Smiths Medical
Without Design Control you have Design out of control.

Kiran Jose
Experienced Medical device Regulatory, Quality and Compliance professional.
Do you have the same analysis for 2017

Nick Shelley
Managing Director at OpenWater International Ltd. Manufacturing, R&D, Company Direction for Start-ups.
Tan, I totally agree with you. Duplication is the bane of a professional engineer’s working life and, in the worst case, stifles creativity.

Rik Warren
Director of Business Development at VitalTech Innovations
Hi Joe, Increasingly there is growing demarcation between medical and wellness devices. The real world is experiencing a BYOD revolution. How does this medical device standard apply to non-diagnostic devices (data gatherers/ monitors)? Rik

Benjamin Ghanoongooi
Senior Quality Assurance Consultant at GIL Intl CSvs Inc
Rik Warren an excellent observation on your part. I suppose the design control must be very critical in the industry ,which one do you see the issue with? Controlling the design documentation and regulatory requirements or application or the actual product / device performance in reference to compliance and quality?

Janine Jamieson
IPQ Publications EU Editor and freelance consultant J Combinations AB
Fantastic discussion! If you’d like to learn about the added challenge of trying to meld design controls and Quality by Design approaches for medicinal products, check-out the dialogue on drug-device combination products. We are also trying to share learnings about design controls for device components.

Cushing Hamlen
Design Quality Assurance Engineer (Contract – Principal Level) at Teleflex Medical Vascular Solution
To echo another comment below: if people complain about design controls, then they do not understand engineering. The basics of design controls are defined non only in FDA regs, but also in project management, systems engineering,and Six Sigma best practices. Do not confuse “document controls” with “design control” – they are two very different things. Design control is NOT a paperwork exercise – it is basic good engineering practice.

Claus Rømer Andersen
EMC & Radio Consultant for Medical Devices
Kiran, it’s available from FDA https://www.fda.gov/ICECI/Inspections/ucm589892.htm#Devices

Beluh Mabasa Ginting
Section Head of Standardisation at Directorate of Supervision of Medical Devices and Household Health Ministry of Health
The proper of concept and design of a medical device is highly dependent on the design control that is the responsibility of the R & D department. Risk management files should contain all the data related to this design control because these data very helpful for post market control and post vigilance especially when adverse events occur. Base on my experience The FMEA is not restricted to a failure of a component’s design but can also include failures in the certificate of analysis (COA) of the raw material (is it medical grade or not).

Rik Warren
Director of Business Development at VitalTech Innovations
Benjamin Ghanoongooi I am not opposed to any of them. The difficulty as I see it is BYOD relies upon consumer goods manufactured by hundreds (of more) separate companies. A standard is hard to implement and harder to enforce. EG- Apps monitoring various conditions using only the native capabilities of the smart phone. I believe that devices used for diagnostic decision-making are easier to control because of the FDA certification process. Standards are necessary. But even that is eroding because of the onslaught of wearables et al into the marketplace. My note was not in opposition but to illustrate the difficulty in broad implementation. Rik

Richard Abbott
Director Special projects at Abbott MDA Ltd (Currently contracting as MDR project manager with DePuy Synthes)
I’m my experience many of the MEDDEV company’s still using single failure FMEA processes are from the long term product use category, such as Orthopaedic implant manufacturers. In many, getting senior management and senior engineers to change from what has been done for years and been good enough in the past to new standards is always challenging, more so when the company’s are remediating product ranges that require a paradigm shift away from single failure process focussed on the product only, to possible multi failure processes that encompass all aspects of the products use including the human interaction factor.

Laleh Jalali
Director of Systems Engineering at Amgen
Design controls are the culmination of best engineering practices, lessons learned from all the product development failures over the years and across the industries, and they should be followed not because regulation “forces” us to do it but because it’s the fastest and most guaranteed way to deliver what the customer needs. The same is true for ISO 14971, it’s holistic approach to risk management is not “burdensome”, you’ll pay later if you don’t follow its principles, it focuses all your separate risk control efforts to “harm to end user”.

Norm Crawford
GDTP-S, Model Based Definition Specialist
I am completely in favor of design controls. However, being reasonably well experienced with the design controls in the medical industry, why is it that the FDA continues to permit spectacular mis-use of geometric tolerances ultimately defining part definitions. If the drawings or models say interpret the document per an ASME standard, ISO standard, or whatever standard, then said documents should be per the standard. And if the suppliers in the medical industry simply don’t like it, too bad. Perhaps people like me can be part of the solution by becoming FDA inspectors.

Caetano Lobo
Medical Devices R&D / Industrial Design / Usability Engineering
Miguel Grissai Santos

Tomasz Taubert
Senior Mechanical Engineer at Tomar Electronics
Design controls are blessing. Even while working at a medical device development company, I’ve heard some other engineers calling DC a “paperwork”. That’s unfair. Design controls speed up the development process and reduce its cost. Any non-medical company that musters enough discipline, would benefit from effective implementation.

Julie Wei
Orthopedic braces Manufacturer@Rison Orthotics Limited
Design and Design Control similarly as the relationship between Products and Quality Control, Without the later, the former can not go far.

Tan Truyen Tran, MBA, PMP
Industrialization Program Manager at Voluntis
Hi ! Engineers want good designed devices (and most of time would do over-engineering for that). What they don’t like are rather documenting and formalizing the activities, the need to follow work instructions and procedures, and all the gating approvals that frustrate them by delaying their ability to design the device efficiently (from their perspective).
Everyone want the same thing : well designed devices, controlled changes, but QARA people and Engineering people do not understand each others.
I am almost sure that at your company, there are informal test to lower the risk of rising an issue during the formal testing phase. That make sense, but why do you perform the task twice ? because formal activities that include design process cost much more effort than “informal” activities that performing a second time the activity is less costly.
Don’t you see something illogic ? Does it really follow the intentions behind the words?

Tan Truyen Tran, MBA, PMP
Industrialization Program Manager at Voluntis
Doing right the first time is not always easy, that’s why there are so much thing to catch the issues (bugs, non conformances, not foreseen hazards).
I think there are two things : doing things, and documenting them. Even outside of medical device fields, veteran engineers perform impact and risk analysis prior to implementing them. What they don’t is documenting them. Formalizing help to do it right, especially less less experimented people, and provide the related evidences, but require more paper works.
Why don’t they like paperwork ? I think most of us don’t like it, but we understand it’s a necessary tasks to be done.
Engineers are Technical Design focus, RA peoples are Regulatory focused, QA people are quality/process focused. The same that RA people care less on technical implementation and investors stuffs than Regulatory compliance, Engineers care less on Regulatory and investors stuffs than an effective technical design. It’s a matter of focus and specialization.