Understanding the Many Connotations of Risk in Medical Device Development and the Consequences of Getting them Wrong

The Many Connotations of Risk
and the Consequences of
Getting Them Wrong™
Presented by:
Michael Drues, Ph.D.
President, Vascular Sciences
Grafton, Massachusetts
and
Adjunct Professor of Regulatory Science, Medicine,
Biomedical Engineering and Biotechnology
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
GreenLight.Guru Webinar (March 23, 2017)
http://blog.greenlight.guru/topic/mike-drues
Taken from: Designing Medical Products Seminar Series
For additional information, call (508) 887-9486 or e-mail mdrues@vascularsci.com
© Copyright 2017 by Vascular Sciences and Michael Drues, Ph.D. All rights reserved.

For additional information, contact Dr. Drues at (508) 887-9486, e-mail mdrues@vascularsci.com or via LinkedIn.
© Copyright 2017 by Vascular Sciences. All rights reserved.
The Many Connotations of Risk in Medical Device Development
and the Consequences of Getting Them Wrong™
presented by: Michael Drues, Ph.D.
Risk mitigation in the medical device industry typically starts with a brainstorming session: the product development team
randomly rattles off risks and writes them down. This “cherry-picking” approach is a haphazard process because whether
you spend an hour or a year, you can never be certain you have captured all the important risks. Suffice it to say, this
webinar is not the typical ISO14971, QMS or Design Control approach which although commonly followed, all take a very
limited view of risk and are simply not adequate for regulatory submissions.
During this interactive webinar, a more systematic, engineering-minded approach to risk is presented. Multiple examples
of actual medical devices are used to demonstrate:
 What are the three buckets of risk and how to apply them?
 What’s the difference between a risk mitigation strategy and a risk management plan?
 How to deemphasize or not draw attention to certain risks?
 What’s the relationship between risk mitigation and product liability?
 How to handle risks in off-label uses without creating product liability nightmares?
 How to factor regulatory risk into the equation?
Ultimately risk is not a simple matter. There are many different connotations of risk. Medical device manufacturers need
to understand the impact of risk mitigation strategy on a regulatory submission as it can make or break a submission,
especially if it’s a 510(k) or de novo. Your risk management plan is also very important, not just to meet the design control
requirements, but in terms of product liability, as well. A successful medical device manufacturer must carefully consider
not only what you say regarding risk and how you say it, but also what you don’t say and how you don’t say it!
What to know more? See:
Column: The Many Connotations of Risk in Device Development and the Consequences Of Getting Them Wrong here.
Podcast: Using the Bucket Method for Medical Device Risk Management (Dec. 6, 2016) here.
Podcast: Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? (Feb. 14, 2017) here.
Webinar: Identifying Risk In Device Development – Uncovering Risk In Innovative Ways (Sept., 2016) here.
For more, visit my Guerilla Regulatory Strategy editorial homepage and my Medical Device Blog.
Speaker Biography
Michael Drues, Ph.D., is President of Vascular Sciences, a consulting and training
company offering a broad range of services to medical device, pharmaceutical &
biotechnology companies including creative regulatory strategy & competitive
regulatory intelligence, regulatory submission design, FDA presentation preparation
& defense.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from
Iowa State University in Ames, Iowa. He has worked for and consulted 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 (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and
Medicaid Services (CMS) 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 U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US
Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses
in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development,
Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools on-
ground & on-line.

The Many Connotations of Risk and the
Consequences of Getting Them Wrong™
1
For additional information, www.linkedin.com/in/michaeldrues,
call (508) 887-9486 or e-mail mdrues@vascularsci.com
Copyright 2017, Michael Drues, Ph.D.
presented by:
Michael Drues, Ph.D.
President, Vascular Sciences, Grafton, Massachusetts
and
Adjunct Professor of Regulatory Science, Medicine, and Biomedical Engineering
For questions or more information, contact me at or
(508) 887 – 9486 or mdrues@vascularsci.com
Join me on LinkedIn at www.linkedin.com/in/michaeldrues
Here’s what we’ll talk about…
 What are three ‘buckets’ of risk and how do we apply them?
 What’s the difference between risk mitigation strategy and risk
management plan?
 How to deemphasize – or not draw attention to – certain risks?
 What’s the relationship between risk mitigation and product
liability?
 How to handle risks of off-label uses without creating product
liability nightmares?
 How to factor regulatory risk into the equation?
 Case Studies
 Final Thoughts
March, 2017

2
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!

3
Do you want
more?
MEDDevice Online (August, 2015) available here.
Do you want more?
September, 2015 available here.

4
Polling Question
Who has considered some form of “risk” in medical
device development?
Who has attended some form of training on risk?
Who is familiar with some form of standardized
approach to risk, i.e., ISO14971 or whatever?
For those who have…
Forget everything you thought you knew about risk! 
Before we begin…
What are three ‘buckets’
of risk and how do we
apply them?
Short answer:
There are many connotations of risk…
we will focus on the ‘big 3 plus one’

5
What is risk
Three buckets of risk:
1. Probability of direct harm (usually to patient, sometimes to caregiver)
a. Most obvious form of risk
b. Only form considered in risk management plans (i.e., design controls)
2. Probably of harm of not using
a. 510k vs. PMA
3. Probability of providing the wrong information
a. Endemic in all diagnostics, i.e., false (+) / false (-)
Bonus Bucket:
4. Regulatory risk
a. Probability of getting smacked, i.e., saying something, changing something…
b. Probability of being unsuccessful selling your regulatory strategy to FDA
Many other forms of risk… not included here.
What’s the difference
between risk mitigation
strategy and risk
management plan?
Short answer:
Risk Mitigation Strategy ≠ Risk Management Plan
Remember,
Risk Mitigation Strategy is key…
especially in certain regulatory submissions!

6
How do we deemphasize
– or not draw attention
to – certain risks
Notice any irony?
Short answer:
Regulatory Submission Writing vs. Regulatory
Submission Design
What’s the relationship
between risk mitigation
and product liability
Recommendation:
Limit your discussion and don’t write it down !!!

7
How should you communicate?
“Never write if you can speak…
never speak if you can nod…
and never nod if you can wink!”
Martin Lomasney (1859–1933), Massachusetts politician
best remembered for being the ward boss of Boston's Ward Eight
Or put another way…
“Never talk when you can nod…
never nod when you can wink…
and never write an e-mail because it's death.
You're giving prosecutors all the evidence we need!”
Eliot Spitzer (1959–) is a lawyer and former New York Governor (2007–2008)
How do we handle risks
of off-label uses without
creating product liability
nightmares
Note:
‘Anticipated Misuse’ ≠ Off-Label Use !!!

8
How to factor regulatory
risk into the equation
Remember,
Every regulatory strategy has regulatory risk!
Case Studies

9
Where to begin?
CDRH Website (April, 2014) [here]
Classification depends on 3 things:
• intended use & indications for use
• risk [many connotations!]
• to patient & to user
• using device
• not using device
• wrong information
• regulatory risk
• many others…
Not nearly so simple!
Example: What class is a scalpel?
Short answer: it depends!
intended use  cut tissue  class I
intended use  corneal incision  class III
indications for use found in labeling but…
may also be conveyed orally during sale of
product so…
Should you put this ‘use’ on your label?
How does classification
vary around the globe?

10
EU Classification System
Are all non-invasive devices ‘low risk’?
Examples: AED? IVD for cancer? ColoGuard?
Is it really so simple?
Absolutely not – this is why the ‘regulatory logic’ is most important!
Is this a ‘regulated’ medical device?
If so, what class? what pathway? why?
Substantial Equivalence vs. Risk
‘Buckets’ of Risk:
• Probability of direct harm
• Probability of harm from not using
• Probability of providing wrong
information
Most important,
Must mitigate all forms to mitigate
regulatory risk!
PMA P130017 (8/14) available here.

11
How do I
determine
classification
in the EU?
available here.
Is this what we really want?
What does final
classification
estimate mean?
510k vs.
PMA
How was this brought to market? 510k? PMA?
Approved as PMA… why?
Hint: lack of precedent?
Not necessarily… think risk!
www.fda.gov
Feb. 8, 2103
Case Study:
MelaFind

12
Who has had a
colonoscopy
Was it a pleasant experience?
Case Study: PillCam
Given Imaging’s PillCam COLON Approved Via De Novo Pathway
 Indication: incomplete colonoscopy for reasons other than inadequate preparation
 Cleared via de novo pathway for low-risk devices with no [direct] predecessor on the market
 Clinical trial of 884 patients, PillCam identified 69% of patients with ≥ 1 polyp measuring
≥6mm and 65% with ≥ 1 polyp ≥ 10mm [Why a clinical trial?]
 Device has video camera at either end and transmits 4-35 frames per second over a 10-hour
period to a recording device worn by patient  computer compiles video footage [video (10 sec)]
FDANews, Feb. 3, 2014
Why (how) was this de novo-able? Hint: risk mitigation is key!
Many connotations of risk:
• Probability of direct harm to the patient / Risk to user/operator
• Probability of not using the device/drug (other options?)
• Probability of providing the “wrong” information (all diagnostics!)
• Many other types of risk
Bottom line: must acknowledge and mitigate all to maximize probability of success!
How was this brought to market? More importantly… why?
Hint: Think “regulatory logic”

13
Colon Capsule Imaging System Risks and Mitigation Measures
Identified risk Mitigation measure
Adverse tissue reaction Biocompatibility.
Equipment, malfunction leading to injury
Electrical safety, thermal and mechanical safety.
Software validation, verification, and hazard
analysis. Non-clinical testing. Labeling.
Interference with other devices and with this
device (e.g., interference with image
acquisition, patient information compromised)
Electromagnetic compatibility testing. Software
validation, verification, and hazard analysis.
Non-clinical testing.
Poor image acquisitions
Optical imaging performance testing Non-
clinical testing. Labeling.
Failure to excrete Labeling.
Misinterpretation of the captured images
Clinical performance data. Non-clinical testing.
Labeling.
Possibility of missing a polyp, or falsely
identifying a polyp
Clinical performance data. Software validation,
verification, and hazard analysis. Labeling.
Abdominal pain, nausea, vomiting, choking Clinical performance data. Labeling.
Federal Register (May 16, 2014)
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

14
Where are you aiming?
The greatest danger for most of us is not that
our aim is too high and we miss it…
but that it is too low and we reach it.
Michelangelo Buonarroti (1475–1564) was an Italian architect, painter, poet and sculptor.
Taking inspiration from one of best…
“Here's to the crazy ones. The misfits. The rebels. The
troublemakers. The round pegs in the square holes. The ones
who see things differently. They're not fond of rules. And they
have no respect for the status quo. You can quote them, disagree
with them, glorify or vilify them. About the only thing you can't do
is ignore them. Because they change things. They push the
human race forward. And while some may see them as the crazy
ones, we see genius. Because the people who are crazy enough
to think they can change the world, are the ones who do.”
Steve Jobs (1955 – 2011), entrepreneur, marketer and inventor, the co-founder of Apple Inc. and widely recognized as a pioneer
of the personal computer revolution.
More importantly…
“Imagine where we could be if discontent for the
status quo was the norm rather than the exception.”
Can you guess who said this?

Published in MED Device Online available here.
The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong
by Michael Drues, Ph.D., author of Guerilla Regulatory Strategy
Publication Date: August 6, 2015 Page 1 Copyright 2015 by Michael Drues, Ph.D. All rights reserved.
Risk assessment and risk management in the medical device industry
typically start with a brainstorming session. Members of the product
development team sit down together, start randomly rattling off risks
as they come to mind, and write them all down on a piece of paper. I
call this the ‘cherry-picking’ approach to risk, because it is an almost
haphazard process. Regardless of whether you spend an hour or a year
brainstorming on risk, in the end you can never be certain you have
captured all the potential risks.
To help offset the inherent shortcomings of brainstorming sessions, I
recommend a more systematic, engineering-minded approach. Start by
breaking risk down into three main types —or buckets — similar to the
medical device classification system, where we have Class I, II, and III.
The first category of risk is what I call the “probability of direct harm.” This is the most obvious connotation of risk and
the one most people think of first. What is the likelihood that somebody — usually the patient, although sometimes it is a
caregiver — experiences harm caused directly by the use of your medical device?
Bucket number two is the “probability of harm caused by not using your device.” In other words, what other options does
the patient have if they don’t use your device? Are there other devices that could be used instead? Are there drugs or
surgical procedures that could be used? Or perhaps there are no alternatives at all.
Evaluating the probability of harm caused by not using the device is actually a requirement of FDA’s premarket approval
(PMA) process, but not the premarket notification, or 510(k), process – although there has been some discussion about
adding it to the 510(k) pathway, as well. In the PMA world, this form of risk is what the regulation calls “alternative
practices or procedures.” Since PMA devices are, by their nature, more complicated — often life-sustaining or life-
supporting kinds of devices — it makes sense to take into account other options the patient might have.
From the manufacturer’s perspective, the least burdensome path is if you are working in an area where the patient is in
eminent danger of demise and there are no other options. At that point, you can argue that your device is better than
nothing. In this case, the bar for safety is set at its lowest level – as it should be in these types of situations – but this is
not usually the case in the 510(k) world.
The third risk bucket is the “probability of providing the wrong information.” This type of risk is endemic in all diagnostic
devices (i.e., patient monitors, imaging systems, and in vitro diagnostics, including companion diagnostics, just to name a
few). Any time your device is providing actionable information, especially diagnostic or treatment information, to either
the physician or the patient, you must consider ‘what is the probability that your device is providing inaccurate or wrong
information?’
For example, in an in vitro diagnostic (IVD) device for cancer, what is the likelihood that your device says the patient has
cancer when, in fact, they do not (i.e., a false positive)? Alternatively, what is the likelihood that your device says the
patient does not have cancer when, in fact, they do (i.e., a false negative)? Of course, in this example, the risk of a false
negative is much more problematic than a false positive. Nonetheless, there are ways to mitigate both of these risks –
something that a savvy regulatory professional should always do.
These three types of risks are important in a regulatory sense, because you have to mitigate all of them in your
submission, regardless of your regulatory pathway (i.e., 510(k), PMA, de novo). However, risk is also important from a
design control perspective.
Regulatory Risk vs. Design Control Risk
While there is certainly some overlap between risk presented in a regulatory submission and risk in the context of design
controls, these risks are not carbon copies of one another. Unfortunately, I have seen companies literally copy and paste
the risk management plan from their design controls into their regulatory submission.
Such submissions are destined to fail, because the design control connotation of risk is narrower than the regulatory
connotation of risk. In a design control context, the risk management plan is pretty much limited to the first bucket of
risk, the probability of direct harm. However, on the regulatory side, the risk mitigation strategy is a vital component of all
regulatory submissions, especially 510(k) and de novo.

The two most important parts of a 510(k) are the substantial equivalence argument and the risk mitigation strategy.
Quite frankly, it doesn’t matter if you fill out all the forms properly: Without a rock-solid substantial equivalent argument
and a bulletproof risk mitigation strategy, you probably will not be successful with your 510(k), and certainly not your first
attempt.
The de novo is even more straightforward than the 510(k) because, in the de novo, there is no substantial equivalence
argument – if there were, you would not be in the de novo pathway. So, a successful de novo submission comes down to
only one thing: risk mitigation strategy. You have to mitigate all three categories of risk in order to be successful with the
de novo.
How To Address Risks You’d Rather Not Draw Attention To (In Your Submission)
In my opinion, there is a big difference between writing a regulatory submission and designing a submission. As an
engineer, it doesn’t matter if I’m designing a medical device, designing a clinical trial, or designing a regulatory
submission — design is design. But, when it comes to regulatory submission design, the way you present your
information — not just what you say and how you say it, but what you don’t say and how you don’t say it — is critically
important.
This is especially true of risks to which you might not want to draw attention. Take, for example, a very simple medical
device, like a hypodermic syringe. This device can be very useful for injecting drugs, taking blood samples, etc. But,
without much imagination, you can imagine it causing a lot of harm, as well.
Which begs the question: hypodermic syringes have been around for a long time but, if you were developing the first
hypodermic syringe today, would it get on the market? This is the medical device equivalent of asking “if Aspirin was new
today, would it get on the market?” This is not a simple question!
Most people present risks in some sort of order in a submission, either by frequency (from most frequent to least
frequent) or severity (from most severe to least severe). But presenting risks in this manner draws attention to them —
something you may not wish to do.
So, take a different approach. The regulation does not tell you how to present risks in a submission. It doesn’t stipulate
that you list them in any particular order. It doesn’t specify how many risks to include. That’s up to you.
Why not present the risks in random order, rather than by frequency or severity? And why not include a lot more risks
than you otherwise might, so as to not draw attention to certain other risks? This approach dilutes the pool, so to speak.
It is not dishonest, as the information is in the submission — you just aren’t drawing attention to it. This is just one way
regulatory professionals can design a regulatory submission, rather than merely write one.
Conflicting Positions On Risk
Often, what we want to accomplish from a regulatory perspective is diametrically opposed to what we want to achieve
from another perspective. For example, consider the tension between risk mitigation and product liability. The underlying
assumption, in both regulatory submissions and design controls, is that the scope of the conversation is limited to risks
associated with on-label use of the product.
Not long ago, a large medical device company invited me to help facilitate a brainstorming session to develop a risk
management plan, as required by the design controls for their new device. We were going through the different buckets
of risk, and people were coming up with all the different risks they could imagine associated with the on-label use of this
device. Then, the topic of risk associated with off-label use came up. As soon as that happened, the ranking person in the
room, a senior VP at this medical device company, said “this meeting is over.” Why? Because of product liability.
If a device causes harm to a patient, the manufacturer will undoubtedly get sued (I’ve been involved in several of these
kinds of cases). And, if opposing counsel can show that the company knew, should have known, or even was thinking
about risks associated with off-label use of its device that were not sufficiently mitigated, the company can be held to a
higher level of liability.
Massachusetts politician Martin Lomasney famously said, “Never write when you can speak; never speak when you can
nod; never nod when you can wink.” A more modern twist on this saying came from Elliot Spitzer, the former governor of
New York, when he said, “Never talk when you can nod, never nod when you can wink, and never write an email,

because it’s death. You're giving prosecutors all the evidence they need!” The same discretion is necessary in medical
device product liability.
Documenting risks associated with the off-label use of your device — which is basic engineering (common sense, one
might say) — can be the kiss of death if your device causes harm and you get sued. Opposing counsel simply will
subpoena the email or meeting notes and say, “Back in August 2015, you had this brainstorming meeting and talked
about this particular form of risk….”
From a regulatory perspective, you want to document everything but, from a product liability perspective, you want to
document nothing! My advice to you, tongue in cheek, is to document everything and then, as soon as you do, shred
everything. Pragmatically speaking, though, after years of playing this game, here is my advice: At the beginning of your
risk brainstorming meeting, agree to limit the discussion to risks associated with the on-label use of the device — but that
should never go into your meeting notes!
In a related example, the CEO of a company I recently worked with was presenting at a medical conference. He started
going a little bit off-script, discussing off-label uses for the company’s new medical device. To make a long story short,
there were a couple of FDA staffers sitting in the audience. Talk about getting your hand caught in the cookie jar.
But here’s the thing: Every single person in the room, including the folks from FDA, knew that, in reality, the device was
going to be used in the off-label ways described. Unfortunately, this tension between regulatory and other priorities is
incentivizing medical device companies to avoid asking important questions and addressing important issues. We have
become like ostriches sticking their heads in the sand, pretending these things don’t happen. From a humanitarian
perspective, how does this make the world a better place?
Including Off-Label Uses In Risk Management — Without The Product Liability Headaches
Avoid creating product liability issues when developing your risk management plan by following this simple advice: Don’t
design your regulatory strategy in isolation. You need to design your regulatory strategy in conjunction with your product
liability strategy, your reimbursement strategy, your intellectual property strategy, and everything else. Just like the
human body, nothing in regulatory strategy exists in isolation — every part is in constant communication with everything
other part.
In addition, I would recommend designing your labeling, especially the high-level labeling — which includes label claims
and indications for use — just like you would design your physical device. Again, to me, design is design.
For example, during a recent project, we designed the product labeling at the same time we designed the device. We
designed them to be in sync with one another. Just like in product development, where we may come up with five or six
different prototype designs and evaluate the merits of each, we came up with five or six potential indication-for-use
statements for the same device, and we did a regulatory burden assessment on each one. In other words, if we say this,
we must prove that; if we say that, we must prove this, and so on.
We presented the different indication-for-use statements to the senior management team, along with the regulatory
burden assessment. Representatives from regulatory, reimbursement, marketing, legal, and other departments
participated in the discussion. We were able to decide, as a company, where the labelling “sweet spot” was for that
particular company and that particular device. This process formed what the company would say from a regulatory
perspective, from a marketing perspective, from a product liability perspective, etc.
That sweet spot — that fulcrum, or balance point, or whatever you want to call it — will be different for every company.
They key to finding it is getting context and input from all the different functional groups within the organization.
Another Form Of Risk To Consider
There is one more form of risk I would like to briefly touch upon: regulatory risk.
Unlike the three buckets of risk we discussed previously, regulatory risk is something I never talk about at FDA or any
other regulatory agency because, frankly, it’s not their concern. It is, however, something I talk about a lot with the
medical device companies I work with.
Regulatory risk has two connotations. The first is the probability of being unsuccessful when trying to “sell” your
regulatory strategy to a particular regulatory agency. Every regulatory strategy holds a certain degree of regulatory risk.
You can mitigate it, you can minimize it, but you cannot eliminate it.

When considering different regulatory strategy options, it is important to assess regulatory risk. Potential regulatory
strategy one might carry a relatively low regulatory risk. Strategy two might be moderately risky, while strategy three is
high-risk. Although regulatory risk is nearly impossible to quantify precisely, you can assign an approximate value (low,
medium, or high, in this example).
The second connotation of regulatory risk is what I call “the probability of getting smacked.” For example, what is the
likelihood that you make a marketing claim and somebody (FDA or otherwise) comes back to you and says, “Hey, you’re
saying this about your product. How do we know that’s true? Prove it.”?
You need to consider both the probability that someone will call you out on a claim and the likelihood you will be able to
defend it. This is more than a regulatory decision — it’s a business decision.
Some companies tend to be a little more aggressive. They push the envelope a little more, and make pretty bold claims
(Sometimes, you see these claims being advertised on TV!). On the other end of the spectrum, some companies are very,
very conservative.
It’s important to understand the different options and their potential ramifications. If you make one claim, your risk of
getting smacked may be pretty high, but it may also be easy to defend. With another claim, your risk may be low, but it
may be harder to defend.
To illustrate, consider a binky, also known as an infant pacifier. One manufacturer makes the label claim, displayed
prominently on its package, “promotes healthy oral development”’ This is a very nebulous label claim but, in the
regulatory world, the more vague or non-specific the claim, the better. Why? Such a claim is very difficult to define (what
does “promotes healthy oral development” mean?), and therefore the “probably of getting smacked” is low.
Furthermore, if you do get smacked, it is easy to defend yourself. If the manufacturer made a more specific medical
claim (i.e., use our binky and reduce the likelihood of gingivitis), that would be a completely different story and its
regulatory risk would be much higher.
While publically, FDA is not fond of nebulous label claims, there are many examples of devices that have them. On the
flipside, the Centers for Medicare and Medicaid Services (CMS) is not at all fond of nebulous label claims and typically will
not reimburse for them. This is another example of how regulatory strategy and reimbursement strategy can sometimes
be diametrically opposed, and it’s up to the manufacturer to find a “sweet spot” in between the two.
As an aside, some chuckle when I use very simple examples like pacifiers, but consider this: Albert Einstein said, “if you
can’t explain something simply, you don’t understand it well enough.” If we can’t explain the regulatory logic using a
pacifier — something that everyone can understand — how can we apply the same logic to a much more complicated
medical device, like a vena cava filter?
Consider this: Recently, a manufacturer received an FDA warning letter because it claimed its wheel chair cushion would
“reduce causes of skin tissue trauma.” This is a relatively strong claim for a product that was never cleared or approved
by FDA and, as a result, the manufacturer got ‘smacked’ with an FDA warning letter.
Like many such manufacturer problems, this situation was totally avoidable! How? There are two choices: Make a more
nebulous claim (i.e., “Our cushion makes your rear-end feel better,”), or go through the clearance or approval process
and prove the claim so you can use it to your competitive advantage.
Of course, there are advantages and disadvantages to both approaches but the lesson to be learned is this: It is not
enough to be careful with what you say – you must also be careful with how you say it!
Key Takeaways
The most important thing to remember regarding risk is that it is not a simple matter. There are many different
connotations of risk: We talked about several important ones in regulatory submissions and design controls, but obviously
there are other forms — financial risk, for example.
In addition, medical device manufacturers need to understand the impact of risk mitigation strategy on a regulatory
submission. As I said before, that can make or break your regulatory submission, especially if it’s a 510(k) or a de novo.
Your risk management plan is also very important, not just to meet the design control requirements, but in terms of
product liability, as well.

Finally, I would urge you to carefully consider not only what you say regarding risk, but also what you don’t say. There
are many shades of grey. Some people don’t like shades of grey, but I personally love them in regulations. The
ambiguities, the vagueness gives you the wiggle room to do what you think is necessary, as opposed to having regulation
that is very specific. Unambiguous regulation makes it more of a challenge (but not impossible) to argue the value of
doing something in a new or different way.
About the Author
Michael Drues, Ph.D., is President of Vascular Sciences, an education,
training, & consulting company offering a broad range of services to
medical device, pharmaceutical & biotechnology companies including
(but not limited to): stimulating & innovative educational programing,
brain-storming sessions, prototype design, product development,
benchtop & animal testing, regulatory strategy, intelligence & clinical
trial design, FDA presentation preparation & defense, reimbursement,
clinical acceptance, business development & technology assessment.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical
Engineering from Iowa State University in Ames, Iowa. He has worked
for and consulted 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 (FDA), Health Canada, the US
and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) 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 U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US
Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
Finally, Dr. Drues is an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology at several universities and
medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical Trial Design,
Medical Device Regulatory Affairs and Product Development, Combination Products, Pathophysiology, Medical
Technology, Translational Medicine and Biotechnology.
To learn more about the author, including his upcoming presentations and list of columns, podcasts and webinars, visit
his LinkedIn page here or contact him directly at::
Vascular Sciences
246 Magill Drive
Grafton, MA 01519
Phone: (508) 887-9486 / Fax: (508) 861-0205
E-mail: mdrues@vascularsci.com
URL: www.vascularsci.com
LinkedIn: www.linkedin.com/in/michaeldrues

Understanding the Many Connotations of Risk in Medical Device Development and the Consequences of Getting them Wrong

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