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As originally asked by Devmalya Sarkar

Hi all,

We’d all agree that design is critical to the development of a safe and effective medical device. But in light of sizeable number of post-approval recalls of medical devices across multiple disease states over the years, I was thinking about how two main factors (amongst many others) influence the entire development cycle of a medical device. These are:

1. Inclusive design – designing simple, empathetic, intuitive products
2. Improvements in the process – better testing workflows, testing throughput

Would love to have your thoughts on which, do you reckon, is most important and practicable when it comes to developing new products?

Alternatively, what sort of a mix of the above two might help reduce risks of regulatory hurdles and/or post-approval failures?

Cheers,
Dev

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Jean Denis
Quality Manager at Laser Components Canada
I like Yi’s comment. I have personally redesigned products to be simpler and at the same time easier to manufacture and, more reliable and, better performing. Simplicity was, and is, one key. To attain that simplicity, the other key has always been creativity, based on knowledge gained through experience and broad exposure. Firstly, understand what the customer needs (not just what he or she says he or she wants). Secondly, understand the physics and constraints of each design proposal. Thirdly, understand what processes are required to produce a design and what these processes are realistically capable of. Many of my design decisions were born out of manufacturing limitations and ultimately drove me to the optimum solution.
To answer Dev’s question, my opinion would be that both are equally important in a regulatory environment. You may “know” that you have a good design, you must also prove it. The weaknesses that I’ve seen in design testing generally amount to a cursory approach – use of flawed statistics, either in test design or in analysis. Rarely is worst design condition and worst conditions of usage employed to configure testing. The old saying, “if you want to know a product is worthy – give it to a room full of 3 year-olds to play with” really exemplifies stress testing and (otherwise) unpredictable conditions of use. Lean product design implies getting simple prototypes out into the field early and oftern, Six-Sigma enhances that with ways to test and characterise the design space to find the optimum solution amongst the failures.

Yi Dong
Staff Scientist at Siemens Healthineers
Simplify as much as possible from the beginning all the way through product development, I think, is the the better solution.

Norm Crawford
GDTP-S, Model Based Definition Specialist
DFMA is of course a major subject in product development. Unfortunately, it seems all too often that professional training, learning, and application of geometric dimensioning and tolerancing is still considered unimportant. GD&T is often applied based on emotional understanding or purely theoretical thinking versus reality of actual parts and features. We still see so called critical features located with +/- linear dimensions because someone wants so called simple inspection. The bottom line is that when it comes to DFMA and many other quality initiatives, the dimensional management needs to be better addressed. That cannot happen if the team does not understand the language of dimensioning and tolerancing.
Simple training and willingness to listen and learn the language can resolve many issues and speed product delivery at higher quality and lower cost.

Michael Malis
Senior Consultant for Regulatory Affairs, Compliance and Quality Assurance
I would modify this a little: “Yes, it is all about the customer and their safety!”

Marie Theres Grahnert
Marketing bei Interlock Medizintechnik GmbH
Thank you all for the great discussion and useful hints!

Annika Fahlén
VP, Senior QA/RA specialist
Thanks Burell, fully agree with you that the customer focus is the back bone and the reason for why bother with development in the first place?

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Anika is right! I would like to add one more issue which has NOT been brought up.

Analyze your competitors products with feedback from their customers, so you really really know what the CUSTOMER THINKS. Dr. Druker wrote for over 50 years “It is all about the customer.”

Annika Fahlén
VP, Senior QA/RA specialist
My recommendation is to put most of the effort within the pre-study phase. Knowing customer needs and have a clear understanding of how you want to provide the solution is according to me the most efficient solution.
If you try out your concept ideas, ensure clear requirements and a good understanding on how to solve the customer needs before kick off your development project, you will most likely get the best result in the shortest time. Many companies spend too short time in the pre-study phase, eager to deliver, resulting in a complex design change loop and a costly process. 70% preparation, 30% design control is more efficient than the other way around. However, a perfect process or design can never replace a high performing team i.e. “It is all about having the right people”

Jean Denis
Quality Manager at Laser Components Canada
How useful is it to improve a process so that it capably and repeatably produces a bad product/design? Q: How do we design bad products? A: It’s easier to design a bad product than it is to design a good one, we don’t well understand the conditions of use, the needs of the user, the possible modes of failure, engineers are not driven to find the proper solution, just the convenient one. I’ve seen it happen where we keep flogging a bad design instead of acknowledging the basic problem and working to design that out. Of course manufacturability, quality, customer complaints all depend primarily on good design. But, we regularly push to get to market by compromising on design and end up paying for it 10-fold down the road in manufacturing, returns and complaints.

Niklas Dahlberg
Senior R&D Engineer på Wellspect HealthCare
“As a design engineer I can put more waste into a value stream in five minutes than a sea of lean thinkers can remove in a lifetime” (unknown design eng.). It’s of great importance to implement tools for DFx assessments into your development process and state requirements for your thought process in early development. You will also have to apply some sort of tools for identifying requirements that may be conflicting, for instance easy to open / air tight packaging. QFD may be used here. By ranking and assessing your requirements from the start the conflict of process and design is made more transparent and you are given options to address the conflicts of design vs process or marketing reqs in early development when changes still has low cost. The use of common development methods and principles works in every industry I however have a feeling that the med tech developers sometimes tend to focus on getting the paper work solid than making lean and efficient development processes and there isn’t really a conflict there.

Phil Jackson
Programme Manager at Arjo
Design for Manufacture is an integral part of the design input stage of development and must be recognised in the design process. Keeping products outwardly simple for the operator to but complex enough to allow efficient and effective system fault diagnosis for the support function is equally important. Verification and Validation should include an element of reliability testing, be it accelerated or under “normal” operating conditions.
For me the amount of time and the effort you spend capturing all the design inputs before you “cut metal” will pay for itself multiple times over the life of the product.

Michael Malis
Senior Consultant for Regulatory Affairs, Compliance and Quality Assurance
Even if you spent a lot of time and have the best product specifications, if the product is not design for manufacturability, need for “process improvements” will occur.
Design for Manufacturing, good work instructions and training of assembly group will assure that the product can be produced repeatably!

Bruce Flora
Product Engineer
Traditionally, the cost & effectiveness of a product to set by its design. Process improvements assure the product can be produced repeatably. Process improvements are indicated if quality is erratic or there is a lot of rework. The best products I worked on spent a lot of time defining the product and market before starting a design.

Kevin Rooney
Quality Director – Contract Manufacturing at Medtronic
Interesting read of you all are interested. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM388442.pdf

Michael Malis
Senior Consultant for Regulatory Affairs, Compliance and Quality Assurance
Technology became “less sophisticated” due to the NEED ti go to the market! Is this the right approach?

Karli “KC” C.
Disrupt your work life. Make progress. Find solutions. Innovate. Fully live.
Considering the entire lifecycle of the product, early and often feedback from manufacturing and early adopters, and taking time to personally observe the manufacturing of the product are all useful for designs that work well in manufacturing.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Validation will be dealt with “forever.” Can you design out complexity?

Is that “sophisticated technology” with complicated continuous validation absolutely necessary?

Are there other less complicated options or designs that simply eliminate the validation?