Bridging User Needs & Design Requirements: Answers are Only as Good as the Questions We Ask!

Bridging User Needs & Design Requirements:
Answers are only as good as the questions we ask!™
Greenlight.Guru Webinar Series (June 14, 2018) here.
presented by:
Michael Drues, Ph.D.
President, Vascular Sciences
Grafton, Massachusetts
and
Adjunct Professor of Regulatory Science, Medicine and
Biomedical Engineering
George Washington Univ. Graduate Dept. of Regulatory Science
Cornell University Graduate Dept. of Biomedical Engineering
For questions or more information, contact me at
(508) 887 – 9486 or mdrues@vascularsci.com or
join me on LinkedIn at www.linkedin.com/in/michaeldrues
June, 2018
Taken from: Designing Medical Products Seminar Series
For additional information, call (508) 887-9486 or e-mail mdrues@vascularsci.com
© Copyright 2018 by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.

© Copyright 2018 by Vascular Sciences and Michael Drues, Ph.D. All rights reserved.
presented by: Michael Drues, Ph.D.
Description:
We did the surgery perfectly, yet the patient died anyway… we designed the medical device perfectly, yet the patient died
anyway… we followed the regulation perfectly, yet the patient died anyway. All are iterations on the same theme, i.e., all have
the same root cause: answers are only as good as the questions we ask! Or put another way: what good is designing the right
medical device if we are solving the wrong problem? Is regulatory and quality simply about making sure your design inputs
match your user needs, i.e., ticking the boxes? What if your user needs are wrong? Do we need regulation to require us to
make sure we are solving the right problems? asking the right questions?
Regulation is all about the interpretation of words and your ability to defend your interpretation. This presentation will use the
case study approach to the relationship between user needs and design requirements in an interactive fashion including:
• What is a design input and how do we make sure we have the right ones?
• What's the relationship between design inputs and user needs?
• How do we turn “user inputs” into a viable product and more importantly the right product!
• How do we “translate” user needs to design requirements? Can regs helps?
• How to read between the lines of user feedback, i.e., wants vs. needs?
• How do we sync design requirements and user needs?
• What are the challenges for the future?
In other words, answers are only as good as the questions we ask! i.e., what good is getting the “right” answer if we’re asking
the wrong question? In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative
ways to use the regulation to their advantage! For additional information, check out:
Podcast: When Design Inputs Go Wrong + Design your label like you design your device (GreenLight.Guru, May 17, 2017) here.
Column: Design Controls: Following The Regulation Vs. Understanding Its Intent (Med Dev Online, Jan 13, 2015) here.
Additional columns, articles, podcasts and webinars can be found:
Global Medical Device Podcast (GreenLight.Guru) here, Mike on MedTech (Medical Product Outsourcing) here, Medical Design
and Outsourcing here, Guerilla Regulatory Strategy (MED Device Online) here and Healthcare Packaging here or LinkedIn here.
Presenter Bio
Michael Drues, Ph.D., is a regulatory strategy consultant specializing in designing novel
regulatory strategies to bring new and innovative medical products to market and in developing
effective communication strategies between companies and regulatory agencies to minimize time
to market and avoid delays.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State
University. He works with leading medical device, pharmaceutical and biotechnology companies
ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the
U.S. Food and Drug Administration, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid
Services and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and
regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies,
the FDA, Health Canada, the US and European Patent Offices, CMS and other regulatory and governmental agencies around the
world.
Finally, Dr. Drues is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several universities and
medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Medical Device Regulatory
Affairs and Product Development, Combination Products and Pathophysiology.

1
For additional information, www.VascularSci.com,
call (508) 887-9486 or e-mail mdrues@vascularsci.com
© Copyright 2018 by Michael Drues, Ph.D. and
Vascular Sciences. All rights reserved.
Greenlight.Guru Webinar Series (June 14, 2018)
https://www.greenlight.guru/webinar/bridging-user-needs-design-requirements
Answers are only as good as the questions we ask!™ 1
© Copyright 20178 by Michael Drues, Ph.D.
and Vascular Sciences. All rights reserved.
presented by:
Michael Drues, Ph.D.
President, Vascular Sciences, Grafton, Massachusetts
and
Adjunct Professor of Regulatory Science, Medicine and Biomedical Engineering
George Washington University Graduate Dept. of Regulatory Science
Cornell University Graduate Dept. of Biomedical Engineering
For questions or more information, contact me at
(508) 887 – 9486 or mdrues@vascularsci.com
Join me on LinkedIn at www.linkedin.com
Greenlight.Guru Webinar Series (June 14, 2018) here.
Do you want more?
For columns, articles and podcasts… visit vvv.VascularSci.com
Global Med Dev Podcast (GreenLight.Guru) here
Mike on MedTech (Medical Product Outsourcing) here
Medical Design and Outsourcing here
Guerilla Regulatory Strategy (MED Device Online) here
Healthcare Packaging here
LinkedIn here

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Here’s what we’ll talk about…
✓ What is a design input and how do we make sure we have the right ones?
✓ What's the relationship between design inputs and user needs?
✓ How do we turn “user inputs” → viable product → the right product!
✓ How do we “translate” user needs to design requirements? Can regs helps?
✓ How to read between the lines of user feedback, i.e., wants vs. needs?
✓ How do we sync design requirements and user needs?
✓ What are the challenges for the future?
✓ Anything else important?
In other words…
Answers are only as good as the questions we ask!
i.e., what good is getting the “right” answer if we’re asking the wrong question?
Polling Question
Where do your user needs originate?
Within your design team? Within your company? Outside your company?
Have you translated user needs into design inputs?
Do you measure the efficacy of your user needs/design inputs?
Before we begin…

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First, an important disclaimer...
I can’t make you an expert in a few minutes!
I’m not even going to try but…
Remember my philosophy of education:
To teach you how to think not what to think!
Is it possible to think regulatory?
“Regulatory affairs is a way of
thinking much more than it is a body
of rules and regulations – or at least
it should be!”
Michael Drues (1964–)
Regulatory Strategist and Amateur Philosopher ☺
www.meddeviceonline.com/author/michael-drues
“Science is a way of thinking much
more than it is a body of knowledge.”
Carl Sagan (1934–1996)
American astronomer, author and science journalist
So how about this?
Maybe Carl Sagan would be proud!

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What is a Design Input
“(c) Design input. Each manufacturer shall establish and maintain procedures to ensure
that the design requirements relating to a device are appropriate and address the
intended use of the device, including the needs of the user and patient. The
procedures shall include a mechanism for addressing incomplete, ambiguous, or
conflicting requirements. The design input requirements shall be documented and
shall be reviewed and approved by a designated individual(s). The approval, including
the date and signature of the individual(s) approving the requirements, shall be
documented.”
21 CFR 820.30(c) here
Much more important…
What does this mean?
Hint: Regulation is all about the interpretation of words…
and your ability to defend your interpretation!
Case Study:
Intended Use vs. Indications for Use
Are they the same?
i.e., are the substantially equivalent, are they bioequivalent?

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Intended Use vs. Indications for Use
• Many use synonymously but not the same – although there often overlap
• Both ‘high-level’ labeling
Indications for Use:
• Focus on patient, i.e., what diseases, injuries, conditions, etc. does product
diagnose, treat, etc.
• Indications for Use (IFU) ≠ Instructions for Use (IFU) = Directions for Use (DFU)
Intended Use:
• Focus on product, i.e., what does device/drug actually do (i.e., how does it work?)
Labeling Recommendations
• Start broadly – can narrow if necessary – be prepared to negotiate
• Stated vs. inferred/implied label claims
• Design high-level labeling just like design product
• Take advantage of label expansions
• Think outside the regulatory box – reimbursement, product liability, etc.
• Consider contraindications only as last resort
This is not rocket science – but it is a poker game – strategy is key!
What's the relationship
between Design Inputs
and User Needs
User need is not defined… should it be?
“Design validation shall ensure that devices conform to defined user needs and intended
uses…” and “Design validation means establishing by objective evidence that device
specifications conform with user needs and intended use(s).” (CFR: §820.30g)
What does this mean?
Recommendation: Should not be defined by regulation but by YOU!
i.e., YOU should define terms and procedures in your QMS!

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Good regulation is neither specific
nor rigid… nor should it be!
Flexibility of the QS Regulation (Preamble)
“The QS regulation embraces the same "umbrella'' approach to the CGMP regulation that was the underpinning
of the original CGMP regulation. Because the regulation must apply to so many different types of
devices, the regulation does not prescribe in detail how a manufacturer must produce a specific
device. Rather, the regulation provides the framework that all manufacturers must follow by
requiring that manufacturers develop and follow procedures and fill in the details that are
appropriate to a given device according to the current state-of-the-art manufacturing for that specific
device.
Manufacturers should use good judgment when developing their quality system and apply those
sections of the QS regulation that are applicable to their specific products and operations, 21 CFR
820.5 of the QS regulation. Operating within this flexibility, it is the responsibility of each manufacturer to
establish requirements for each type or family of devices that will result in devices that are safe
and effective, and to establish methods and procedures to design, produce, distribute, etc. devices that meet
the quality system requirements. The responsibility for meeting these requirements and for having
objective evidence of meeting these requirements may not be delegated even though the actual
work may be delegated.
FDA has identified in the QS regulation the essential elements that a quality system shall embody,
without prescribing specific ways to establish these elements. Because the QS regulation covers a
broad spectrum of devices, production processes, etc., it allows some leeway in the details of
quality system elements. It is left to manufacturers to determine the necessity for, or extent of,
some quality elements and to develop and implement specific procedures tailored to their
particular processes and devices.”
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm
Rules and Exceptions
Average regulatory professionals know the rules…
better regulatory professionals know the exceptions…
the best regulatory professionals know the exceptions to the exceptions!
James Thurber (1894 – 1961) was an American cartoonist, author,
journalist and playwright known for his cartoons and short stories,
published in The New Yorker magazine.

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Don’t just follow the
rules… think!
Rules are mostly made to be broken
and are too often for the lazy to hide behind.
General Douglas MacArthur (1880 –1964) was an American general in the US Army during the
1930s and played a prominent role in the Pacific theater during World War II. He was one of only
five men ever to rise to the rank of General of the Army in the U.S.
How about a simple example
Doctor: The device needs to be portable. [User Need]
↓
Engineer: What does that mean?
Maybe the device needs to:
✓ lite weight (<5 pounds) – or – on a cart (how big?)?
✓ be smaller than a lunch-box (how small is that?)
✓ be self-contained (does it need to connect, i.e., power, wi-fi, etc.)?
✓ etc., etc., etc.…
All are design inputs
Recommendation: Confirm with other users, i.e., trust but verify!
Remember… define terms and procedures in your QMS!
Why is all this “required?” [Hint: the designer is not the user!]

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Are there other design inputs
✓ Device function
✓ Physical characteristics
✓ Performance
✓ Safety
✓ Reliability
✓ Standards
✓ Regulatory requirements
Recommendation:
1. Identify as many as possible at the beginning
2. Evaluate/reevaluate throughout design/development process
3. Test at the end of the process, i.e., trust but verify!
Do we really need regulation to tell us this?
✓ Human factors
✓ Labeling & packaging
✓ Maintenance
✓ Sterilization
✓ Compatibility (materials/devices)
✓ Environmental
✓ Anything else…
What are the challenges
for the future
Or put another way…
What's one of the most significant limitations of the Design Controls?
Fundamental tenant: meet the needs of your user! But…
Why assume the user knows what they really need?!?!?
Evolutionary vs. Revolutionary Product Development
horse → car, candle → lightbulb, etc.
How about a medical device example…

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Case Study: Bare Metal Coronary Stent
Hint:
What's the biological problem (i.e., root cause)?
Remember…
If the only tool you have is a hammer…
all of your problems look like _____ ?
Transmyocardial
Revascularization (TMR/pTMR)
a.k.a. mechanical angiogenesis
Some reverse engineering…
What's the user need?
How does user need → design input?
Does this influence / limit / bias design?
Answers are only as good as the questions we ask!
True
Angiogenesis
How does that apply here? Hint: What solutions do we not have & why?
LOTS!
Why is this important? Can you say disruptive technology?
What’s the real sham?
‘Unbelievable’: Heart Stents Fail to Ease Chest Pain
(New York Times, Nov. 2, 2017) here.
Background:
• >500K patients/yr (WW) have stents inserted to relieve
chest pain at cost $11K – $41K (US hospitals)
Method:
• 200 patients treated 6 weeks with drugs →
• procedure: “real or fake” insertion of stent
“This is one of the few studies in cardiology in which a sham
procedure was given to controls who were then compared
to patients receiving the actual treatment.”
“In both groups, doctors threaded catheter through the
groin or wrist and, with X-ray guidance, up to the blocked
artery. Once the catheter reached the blockage, the doctor
inserted a stent or, if the patient was getting the sham
procedure, simply pulled the catheter out.”
Conclusion:
“A procedure used to relieve chest pain in hundreds of
thousands of patients/year is useless for many of them.”
Is this a sham procedure or a sham device?
What do you think?

10
Always question the status quo!
BusinessWeek, May 29, 2006
“Treatments are based largely on rules and
traditions, not scientific evidence.”
something called “evidence-based medicine”
We need more critical thinkers!
Einstein also said:
“Insanity is doing the same thing over and over again and
expecting different results.”
So
What do we get when we put both together?
Unfortunately,
The world is much more complicated than many would like to believe!
“The problems that exist in the world today
cannot be solved by the level of thinking
that created them.”
Albert Einstein (1879-1955)
German born American Physicist who developed the special and general theories of
relativity. Nobel Prize for Physics in 1921.

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Can we print a stent?
What kind of stent?
Better…
Can we print a customized bioabsorable stent?
Bare Metal Stents Stent Grafts Drug-Eluting Stents
Boring! Boring! Boring!
Can we 3DP a ‘customized’ vascular stent?

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Can we 3DP a ‘customized’ vascular stent?
What’s next?
How about a personalized (i.e., 3-D printed) DES? – wicked cool! ☺
Advantages: choose drug (drugs), dosage, release rates, location, etc.
Should FDA regulate this? If so, how?
Northwestern Engineering News (Oct, 2016) available here.
Absolutely! Watch this…
Method:
micro continuous liquid interface production
(microCLIP)
↓
liquid photo-curable resin to print objects with light
↓
fabricate stent precisely matching patient anatomy
Advantages:
• Extremely high res (print features small as 7µm)
• Print up to 100 stents at a time →
faster/cheaper than traditional manufacturing
• Speed: print 4-cm stent in minutes
Nothing is impossible…
Sir Arthur Charles Clarke, (1917 – 2008) was a British science fiction author, inventor and
futurist, famous for his short stories and novels, including 2001: A Space Odyssey.
Any sufficiently advanced technology
is indistinguishable from magic.
Arthur C. Clarke, “Profiles of The Future” 1961 (Clarke's third law)
the impossible just takes a little longer!

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How do we
view the
world?
Discovery is seeing what everyone else has seen
and thinking what no one else has thought.
– Albert Szent-Gyorgi, 1937 Nobel Prize in Physiology and Medicine
Or put another way…
It's not what you look at that matters, it's what you see.
– Henry David Thoreau (1817–1862), American author, poet and philosopher
So what do you see?
There are many regulatory consultants out there…
but there are surprisingly few good ones!
So how do you become a good one?
Learn when to follow and
more importantly…
when to lead!

Bridging User Needs & Design Requirements: Answers are Only as Good as the Questions We Ask!

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Bridging User Needs & Design Requirements: Answers are Only as Good as the Questions We Ask!