2023

MedTech Industry
Benchmark Report
Results from a survey of over 600 leaders in the global medical device industry. Understanding
statistics, trends, and opportunities on medical device product lifecycle development, quality
management, and commercialization.
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TABLE OF CONTENTS

03 Methodology

06 Key benchmarks for the medical A glimpse of the key issues affecting the industry, including the 2023 revenue outlook
device industry and technology investments.

17 Headwinds and opportunities What do companies struggle with in the early days of product development?
for pre-market companies We take a look at the numbers.

25 Pre-market aspirations not When medical device leaders misunderstand development timelines and priorities, they
aligned with reality jeopardize their companies’ competitive position. We explore the disconnects.

29 Critical milestones and challenges What are the most significant headwinds facing companies with a product on the market,
of commercialization and where are the opportunities for them to stand out from the competition?

37 Software investments: the value Too few companies use solutions purpose-built for the medical device industry.
multiplier We look at the knock-on effects.

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Methodology
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G reenlight Guru surveyed 613 professionals working in quality, product

development, and executive management positions. We fielded the survey
to Greenlight Guru customers and community, plus partnered with Reed Tech
SURVEYED

to distribute the survey to medical device professionals worldwide.

Area of responsibility Quality / Regulatory / Clinical 59%

Product Development / Engineering / R&D 22%

Corporate Executive Office 10%

Manufacturing / Operations 7%

Other 2%

Role within organization Senior Executive 27%

Management 43%

Individual Contributor 30%

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Number of full-time <10 19%

employees
10–49 28%

50–249 31%

250–999 9%

1,000+ 13%

Does your company have Yes 73%

products for sale on
the market? No 27%

What primary type of medical Mechanical only 21%

device classification does
your company design/ Mechanical + electromechanical 13%
manufacture?
Mechanical + electromechanical + software 35%

IVD 11%

SaMD 8%

Other 12%

Which class(es) of medical Class I 39%

devices does your company
produce? Class II 69%

Class III 26%

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Key Benchmarks
in the Medical Device
Industry
2023 revenue
revenue outlook
outlook lower,
lower, but
but only
only moderately.
moderately.
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A fter a period of unprecedented volatility, the medical device

industry can expect continued headwinds in 2023. Revenue
forecasts among companies we surveyed are slowing compared
Revenue outlook for the medical device industry is slipping
Q What is your company’s revenue outlook for 2023?
Q:
to 2022; fewer companies (26%) are predicting strong revenue
growth, but the vast majority still say they expect growth this year, Expect strong Expect modest Expect to maintain Expect revenue
revenue growth revenue growth current level to shrink
even if modest.
2022

This finding aligns with what others are saying. Research 34% 46% 16% 4%
consultancy Frost & Sullivan estimates that medical-device
2023
industry revenues will rise 7.8% in 2022, compared to an 8.1% rise
in 2021 — both significantly better than the declines witnessed 26% 50% 22% 2%

during the 2020 pandemic year.1

0% 20% 40% 60% 80% 100%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

1
The Wall Street Journal: “Inflation, Supply-Chain Woes Hit Medical-Device Makers,” Nov. 2022

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Dealmaking also slowed in the second half of 2022 — and this trend is
expected to continue into 2023. Among companies we surveyed, just 42% were
focused on gaining market approval in the upcoming year, compared to 60%
one year ago. This drop is likely a reaction to a more challenging fundraising
environment. EY Life Sciences Partner John Babitt explains how this trend is
Just 42%
of companies are focused on gaining
playing out among life science and MedTech companies: “Continued uncertainty
market approval
in the overall financial markets continues to weigh on the M&A appetite; the
overall MedTech M&A and innovation ecosystem continues to remain intact, but
near-term storm clouds are likely to pause transactions volumes into 2023.”2

Fewer prioritizing market approval 75 Fewer prioritizing market approval 75

as 2023 objective 70
as 2023 objective 70
Q % who chose "gaining market approval" Q % who chose "gaining market approval"
when asked top objectives for 2023. 65 when asked top objectives for 2023. 65
is your company’s revenue outlook for 2023? 60% is your company’s revenue outlook for 2023?
60 60

55 55
55% 5
50 50

45 45
42%
40 40

35 35
2021 2022 2023 202

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

2
MedTech Dive: “MedTech M&A decline poised to continue in 2023 amid ‘bumpy’ market: report,” Oct. 2022

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Will the financial slowdown

Development of in-device technologies slows in 2023
trigger a cooldown in innovation and
Q Which of the following technologies are included in your products?
breakthrough technologies?
2022 2023

According to our research, fewer companies are investing in Bluetooth-enabled devices 26% 22% ↓
newer technologies like bluetooth-enabled devices, AI, and 3D
Remote monitoring —* 20%
printing. Downturns — even modest downturns as we may see in
2023 — spark cost-cutting pressures. This means novel ideas and Artificial intelligence / machine learning 25% 19% ↓
products are harder to bring to market in slowing economies.
3D printing 19% 15% ↓
Hanson Gifford, CEO and managing partner at investment firm Telemedicine integrations 16% 10% ↓
The Foundry and partner at Lightstone Ventures, advises that the
types of products that get pickup in this kind of environment need
Robotics 10% 11% ↑
to be compelling. At the 2022 Medical Device Summit, Gifford Digital therapeutics —* 8%
offered this advice for entrepreneurs: “[The product] has to be a
dramatic improvement, because the whole healthcare industry
5G-enabled devices 9% 7% ↓
has gotten more and more rigid and fixated on a specific pathway Neurotechnology —* 6%
of wringing the costs out of whatever is the best treatment. You *Answer choice not available in 2022 survey
have to give them real incentive to change.”3
Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

3
GeekWire: “Advice for entrepreneurs in the medical device industry on raising cash and growing startups,” Nov. 2022

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Medical device companies are Given the economic climate, what’s top of mind for medical device companies?
First and foremost: compliance. One survey taker explained his mindset:
doubling down on compliance “It would make my job much easier if everyone inside my company would
readiness acknowledge that compliance is critical to what we do every day.”

To stay in compliance, many companies tell us they are implementing or upgrading their
quality system processes. (This is a top priority for those on the quality team, but less so
for other professionals we surveyed; just 1 in 3 corporate executives see it as a priority).

Quality/ Product Development/ Corporate

Regulatory/ Clinical Engineering/ R&D Executive
Compliance a top priority
Gaining market approval for a new product 45% 38% 40%
for quality professionals –
by a large margin Gathering required documentation & executing on training 26% 18% 15%

Q What are your top objectives Conducting market research & building robust product plan 19% 20% 30%
for 2023?
Ensuring compliance to a regulatory body 62% 40% 47%

Determining product specifications 19% 26% 22%

Verification and validation testing 40% 36% 45%

Clinical testing or evaluations 37% 35% 35%

Implementing or upgrading the quality system processes 50% 28% 33%

Implementing or upgrading product development processes 39% 36% 23%

Improving customer satisfaction and/or brand equity 27% 25% 30%

Scaling to manufacturing 23% 16% 27%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Well equipped to
65% 65% meet quality
Fully 1 in 3 objectives
medical device industry professionals say
they are not well equipped to meet quality
and product development objectives in 2023.
Well equipped to meet quality objectives

How well equipped are companies to meet their objectives?

Fully 1 in 3 professionals we surveyed say they are not well
equipped to meet quality and product development objectives in Well equipped
2023. “What we find through our survey each year is that a large to meet product 61% 61%
share of medical device companies are struggling under the development
weight of regulatory demands, highly complex tech stacks, and objectives
fundraising challenges” says MedTech Community Leader and
Guru, Etienne Nichols “This year, economic uncertainty is adding
to the burden — meaning those companies that are less agile
and less quality-focused will face serious headwinds.” Well equipped to meet product development objectives

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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To spark innovation, rethink regulatory regimes

Yet again, professionals in the industry say simplifying and harmonizing
regulations is the single biggest driver of innovation. This point of view is
particularly true for those who work in quality and clinical roles, but even
engineering, R&D, and C-level executives vouch for its importance.

Misalignment about sources Quality/ Regulatory/ Clinical Product Development/ Engineering/ R&D Corporate Executive
of innovation 80%
Q Which of the following
do you feel strongly contributes
to product innovation in the 60%
medical device industry?
40%

20%

0%
Streamlined, Harmonized More investment More funding More open dialogue
simplified international standards in R&D options within the industry
regulations & regulations

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Though the pandemic in the short term shortened regulatory

pathways and boosted collaboration, many believe that over the
Fewer than 1 in 3
long term these efficiencies won’t hold up. Nicole Mantini, counsel pre-market medical device professionals are
at Torys LL, explains, “From a regulatory perspective, increased “very knowledgeable” about industry and
flexibility and collaboration are great because they get needed regulatory compliance information.
products to the market faster. But the trade-off could be that these
processes, which may be perceived to streamline or shorten
regulatory review, are going to be subject to greater scrutiny from
the public or from potential plaintiffs. And so the same degree of
Knowledge about regulatory compliance low for
vigilance in terms of regulatory compliance, processes and record
pre-market companies
keeping is still warranted for manufacturers.”4
Q How knowledgeable do you personally feel on industry and regulatory
compliance information?
Most professionals we surveyed say they are not very
knowledgeable about industry and regulatory compliance
N ot a t
all 2% at all 6%
information. For pre-market startups, just 29% say they are “very N ot

knowledgeable” — a point of serious concern. On the topic of

Ve
Ve

r
y2
new EU Medical Device Regulation, for example, researchers

ry
%

9%
Somewhat 65
Somewhat 59

40%
Elisabetta Bianchini and Christopher Clemens Mayer explain
how essential regulatory knowledge is not just to compliance, Post-market Pre-market
but to innovation: “It should not just be seen as an obstacle
for new innovations in the medical domain, but as a chance.
The whole process aims to ensure quality and efficacy of new
devices, and thus help companies to enter the market and to be
distinguishable from non-medical or non-certified devices.”5
Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

4
Lexology: “Lessons learned from COVID-era medical device regulation,” Nov. 2022
5
Artery Research: “Medical Device Regulation: Should We Care About It?” March 2022

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1 in 3
say they hire consultants to fill in the gaps

To keep staff informed and trained on these issues, the majority rely
on in-house training programs. And 1 in 3 say they hire consultants
to fill in the gaps.

In-house training is the top In-house training program(s)

56% Post-market
source of regulatory knowledge 55%
Pre-market
Q How does your company keep Leveraging consultants
staff trained on the latest 36%
37%
regulatory changes and
requirements? Accredited industry courses/ training
42%
32%

Unaccredited industry courses

14%
14%

Other
5%
2%

0% 20% 40% 60%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Unpacking the specific challenges

of compliance
The majority of medical device company professionals say they
struggle to meet certain regulatory requirements, like maintaining
design master records (DMR) and documenting procedures
for CAPA. These challenges are evident both in pre-market
companies and those that already have product(s) launched.

Ronny Bracken, Principal at Paladin Biomedical Consultants,

says it’s important for companies to get a handle on the high
(and often onerous) level of documentation required to meet
“ Small companies [...] complain about
the regulations, and they complain about the
paperwork. What I try to tell people is that it's a
regulatory requirements. He explains, “Small companies [...] way of life. If you embrace it and try to figure out
complain about the regulations, and they complain about the the most efficient way to satisfy regulations — but
paperwork. What I try to tell people is that it’s a way of life. If at the same time, do good product development —
you embrace it and try to figure out the most efficient way to
it'll make all the difference in the world.
satisfy regulations — but at the same time, do good product
development — it’ll make all the difference in the world.”6 Ronny Bracken, principal at Paladin Biomedical Consultants

6
Greenlight Guru: “Raising Capital for Medical Device Startups,” March 2022

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Switzerland’s move to potentially allow US FDA-approved devices in that

country — effectively bypassing EU regulations — is a positive sign that countries
are taking seriously the high cost of regulation, both for manufacturers
and the public.7

More than 1 in 4 lack competence Documented Design Risk Device Master

procedures controls management Record (DMR)
in key compliance areas for CAPA 6%
5% 5% 7%
4% 2%
Q Consider the following procedures 3% 4%
required by regulatory bodies. Rate your Pre-market Excellent
22% 26% 26% 24% 26% 22%
company’s level of competency 15% 16%
Post-market Good
maintaining clearly documented
versions of each.
31% 35%
43% 46% 46% 42% 45%
49%

24% 17%
Fair
22% 21% 20% 23% 18%
30%
Poor

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

7
Regulatory Focus: “Switzerland eyes allowing FDA-approved medical devices onto its market,” Dec. 2022

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Headwinds and
opportunities for
pre-market companies
Analysts largely agree that 2023 will be a tough environment
environment forfor medical
medical device
device
commercialize and
companies hoping to commercialize and cash
cash out.
out. In
In 2021,
2021, 403
403 healthcare
healthcare
companies went public, compared to to just
just 20
20 in
in 2022
2022 — — and
and many
many expect
expect at
at least
least the
the
first half of 2023 to be at least as challenging
challenging asas 2022.
2022. HowHow prepared
prepared are
are medical
medical
device startups to weather a challenging year?
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For pre-market device startups,

ineffective systems pose a serious threat
Among pre-market device companies, only 30% say they are “very
confident” their current quality system can handle projected growth
over the next 12 months — a stunningly low number. And just 1 in Top three quality challenges for pre-market companies
4 say they are “very confident” they can demonstrate total lifecycle
traceability if a government agency or other notified body showed
up for an unannounced audit. These figures underscore the critical
role that technology plays in accelerating quality and patient safety. 01 Insufficient
01 Insufficient budget
budget

Keep in mind, the upside of tech-powered quality management

is not simply efficiency or speed; AI-powered systems can help 02
02 Cost/ effort of validating
Cost/ effort of validating new tools or processes
new tools or processes
companies establish a foundation of quality — ensuring quality
priorities are met at each stage of the product development and
commercialization lifecycle. With purpose-built tools, quality can 03
03 Confusion about regulatory
Confusion about regulatory
compliance guidelines
compliance guidelines
more easily become a part of the company culture rather than a
series of steps necessary for compliance.

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When early-stage companies adopt tools that are purpose-built

for the medical device industry, the onerous tasks of Fewer than 1 in 3 "very confident" about quality systems'
documenting, tracing, auditing, optimizing, etc. are all largely ability to handle growth
automated. In our study, for example, the number who say that Q How confident are you that your current quality system can handle your company's
projected growth over the next 12 months?
demonstrating closed-loop traceability is “high effort” is cut
in half when the company uses software designed for
Very confident Somewhat confident Not at all confident Unsure
the medical device industry rather than industry-agnostic
30% 49% 14% 7%
solutions.

Budget (or lack thereof) is one of the bigger stumbling blocks

to improving quality management processes, along with the cost/ 0% 20% 60% 80%
effort of validating tools and confusion about regulatory regimes.
Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Survey takers shared their frustrations about budget, tech

and regulatory complexity; one explained, “We need a single
source of truth rather than the many unconnected tools we
use today. Our current systems don’t allow for traceability over
processes and departments. We need a true QMS.”
Mostly only "somewhat confident" about demonstrating total
lifecycle traceability
Q If a government agency or notified body showed up for an unannounced audit
tomorrow, how confident are you that you could demonstrate total product
lifecycle traceability?

Another reported, “[We need] simplified, standardized Very confident Somewhat confident Not at all confident
regulations. Currently, multiple regulatory bodies we report to all
26% 53% 21%
have different requirements, which adds significantly to the cost
of fees, testing and effort required.”

0% 25% 50% 75%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Lack of collaboration / ownership are Pre-market companies tell us that a lack of clear ownership for risk throughout the
entire product life cycle poses a threat to effective risk management — it’s the most
top product development obstacles cited challenge related to managing risk.

And 1 in 3 companies report their level of cross-functional collaboration is “fair” or

“poor.” Many survey takers report the lack of effective collaboration is related to
subpar technology investments. One person explained, “In order for cross-functional
teams to work well, we need an eQMS that can support end-to-end collaborations.
We desperately need full utilization of an automated and closed-loop QMS, meaning
transitioning our ‘hybrid paper’ approach to fully electronic processes.”

Lack of clear ownership a top Lack of clear ownership for risk throughout product life cycle
30%
factor when managing risk
Insufficient design & development information to assess product risk
Q What are your biggest challenges
27%
in managing risk for your
device(s)? Visibility and traceability of the risk management files
22%

Keeping up with ISO 14971 regulatory changes

19%

Lack of post-market feedback

16%

Overuse or over-reliance on FMEAs and other tools

12%

Showing pre-market responses only 0% 10% 20% 30%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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When managing design controls, pre-market companies

struggle most with documenting work throughout the product
Top 5 Most Painful Tasks in Design Controls
development lifecycle (30% chose it — the top-cited task).
Q What are your most painful tasks related to managing design controls?
This, too, is effectively a technology problem, not a people or
management problem.

When teams use disjointed tools that don’t communicate 01 Documenting work throughout new product development
with one another, maintaining a traceability matrix is painfully
inefficient — requiring hundreds of hours to search, connect, 02 Implementing risk control measures

and update. That said, the majority (61%) say they continuously
update design controls and DHFs throughout the device 03 Ensuring traceability throughout Total Product Lifecycle

lifecycle.
04 Managing the Design History File

05 Managing information in multiple systems

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How do pre-market companies handle DHFs?

Q What is your organization’s approach to managing Design Controls
and Design History Files (DHFs)?

Continuously updated Updated throughout the design Created for device

throughout device lifecycle and development phase only submission only

61% 23% 16%

0% 20% 50% 75%

Series Showing pre-market responses only

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

% Excelle
nt 1
o r 13 0%
Po
Cross-functional collaboration

Ve
Q Rate your team’s ability to

ry
view/ access real-time

good 24%
Fair 20%
data for cross-functional
collaboration.

Showing
pre-market responses only G ood 33%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Underinvesting in technology poses
a significant challenge for pre-market
companies
34%
are using a purpose-built solution for
continuous product development
24
2023
For pre-market companies, documenting every detail of the product
development process (and managing all that documentation so that it can
be consulted at a moment’s notice) is among the company’s most important
efforts … even if it’s not the most exciting. Yet our research shows that
pre-market companies underinvest in technology — viewing it as a nice to
have rather than a need to have.
Our research shows that only one in three companies (34%) is using a
purpose-built solution for continuous product development in the medical
device industry. Slightly more (35%–38%) are using tools specific to the
industry for risk management and audit management.
Documentation is more straightforward when you set up the optimal systems
on day one, rather than discovering one or two years in that your approach
won’t pass regulatory scrutiny (and requires costly back-pedaling). As
economic conditions become more challenging — and budgets leaner —
device companies must be proactive about designing robust processes and
rigorous documentation that will satisfy regulators and investors alike.
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Pre-market
company aspirationsnot
aspirations
not aligned with reality
For pre-market companies, it can be difficult to predict what challenges they’ll face
during product development and commercialization
commercialization — — and
and how
how long
long the
the whole
whole
process will take. Many teams find themselves
themselves working
working toto maintain
maintain aggressive
aggressive
timelines with little room for snags, blockers, or delays.

We looked at pre-market startups’ estimates of challenges and timelines compared

We looked at pre-market startups’ estimates of challenges and timelines compared
to the experience of those who have gone through the process to tease out the
to the experience of those who have gone through the process to tease out the
gaps and help companies plan.
gaps and help companies plan.
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Pre-market companies misjudge

Development timelines
time-to-market by more than 50%
Q How long do you think new product development processes take on
average — from design planning to design transfer (NPDI)?
The comparisons are arresting. Pre-market companies tend
to underestimate the product development lifecycle for Pre-market (Expectation–Yrs) Post-market (Reality–Yrs)
Class I devices, but seriously overestimate what’s required
for Class II and Class III. CLASS I 1.5 2

CLASS II 2.6 3.3

CLASS III 3.7 5.6

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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These overestimates expose a problem as well. Sharing inaccurate timelines —

or overly conservative ones — with investors can be just as damaging as
sharing those that are too aggressive. Overestimates can signal any number
of issues to investors: hidden operational challenges; an unclear vision;
misalignment between departments, priorities, and necessary resources;
or tension between development goals and quality goals. All of these can
raise red flags for investors.

New product <1 year 1-2 years 3-5 years 6-8 years >8 years
timelines by class
Class III
Q How long did your new product
development process take — from 5% 34% 43% 12% 6%
design planning to design transfer
(NPDI) — for your most recent Class II
product? Please answer by device 11% 49% 34% 5% 1%
classification.
Class I
24% 55% 16% 5%

0% 20% 40% 60% 80% 100%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Early-stage companies are overly optimistic about scaling

operations
Expectations about scaling manufacturing
Pre-market companies tend to focus on specific aspects of Q What are/will be the biggest challenges scaling manufacturing as you
manufacturing they think will present challenges (such as logistics launch your product in the market?
and manufacturing quality), but underestimate the challenges
Post-market Pre-market
posed by many others. On the other hand, companies that have
released products to the market report more challenges across Supply chain logistics
34%
the board — from managing timelines to supporting a strong 30%

feedback loop between quality and development teams. Project management timelines and targets
31%
36%

Greenlight Guru published a report for medical device Maintaining manufacturing and production quality
29%

“
company founders about the challenges of developing and 22%
The question I come back to always is: Do you
Sourcing and vetting vendors/ space
commercializing new products — and we interviewed investors
understand, realistically, the milestones 23%
23% and
about the specific mistakes they see when interviewing founders
value-creation
Communication/ episodes
feedback loop between that areteams
quality and development in front of you
and vetting investments. Many point to unrealistic timelines as the 18%
and how you’ll reach those? 24%
biggest hazard for new product development. Navigating post-market surveillance
James Eadie, managing director
18% at Santé Ventures
20%
“The question I come back to always is: Do you understand,
Meeting ROI expectations
realistically, the milestones and value-creation episodes that 15%
17%
are in front of you and how you’ll reach those?” James Eadie, Engineering support
12%
Managing Director at Santé Ventures, told us. “If you’re a 20%

preclinical stage company and pointing towards FDA approval, Training new employees
10%
that’s going to require significant clinical studies. What are the 18%

Hiring workers for the manufacturing site

interim steps before you? Five years and $40 million down the 7%
18%
road, what steps will help prove the technology?”
0% 10% 20% 30%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Critical milestones
and challenges of
commercialization
MEDICAL DEVICE
Medical device COMPANIES
companies areARE COMING
coming off a OFF A BANNER
banner YEAR —
year in 2021 INone
2021in—which
ONE
IN WHICH INVESTOR FUNDS FLOWED FREELY, AND DEMAND FOR NOVEL MEDICAL
investor funds flowed freely and demand for novel medical devices was high after
DEVICES WAS HIGH AFTER A PERIOD OF HEALTHCARE DISRUPTION. NOW
a period of healthcare
COMPANIES disruption.
FACE A PERIOD Now, companies
OF CORRECTION — ANDface a period
THOSE WITHof correction —
INEFFECTIVE
PROCESSES AND TECHNOLOGIES WILL SUFFER MOST.
and those with ineffective processes and technologies will suffer most.
2 0 2 3 M E DTEC H I NDUSTRY B E N CHMARK RE P ORT 2023

Improving quality management Medical device companies with products on the market report that resistance
to change efforts is their biggest challenge (37% cite this) — above the cost
involves a mindset shift of validating new tools, and confusion about regulatory compliance. Other
critical challenges include the cost/effort of validating new tools, as well as
confusion about regulatory compliance guidelines.

Post-market Pre-market
"Resistance to change"
Resistance to change efforts 37% 25%
is the most common obstacle
to improving quality Cost/ effort of validating new tools or processes 33% 35%
Q What are your biggest Confusion about regulatory compliance guidelines 33% 34%
challenges when it comes
to improving quality Insufficient budget 28% 35%
management processes?
Underinvestment in education/ training 27% 20%

Underinvestment in tools/ solutions 26% 15%

Lack of management buy-in 23% 18%

Not measuring results 21% 18%

Not aware of better solutions/ tools 20% 16%

None of the above 5% 10%

Not applicable 4% 7%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Tech complexity drags on efficiency

When asked to reflect on challenges, medical device
professionals invariably cite complexity. Part of the issue is the
jumble of regulations that create burdensome documentation
requirements, but many also point to tech stack complexity —
the haphazard collection of systems and tools that work in silos
and don’t support real-time collaboration and efficiency.

On average, survey takers with at least one product on the

market told us they use 9 distinct platforms and tools — solutions
for planning, quality, clinical, product development, supplier
management, batch records, etc. And few of these tools share Companies with a product on the market on
data in real time. Just 8% of post-market companies say all
average use nine distinct platforms and tools.
those technology solutions share data in real time. One survey
taker explained, “When I search for things, I can never really
be sure that what I’ve found is all there is. No one can work
independently here because of poor documentation.” Another
shared, “I wish we could use one tool interactively for several
uses. We really need the ability to share and download — all
while maintaining control documents.”

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A data-driven approach to optimizing

quality efforts Audit readiness is the top quality/regulatory metric
Q Which quality/regulatory metrics are most important
to company leadership?
To oversee and optimize quality efforts, professionals use a
number of metrics, with “audit readiness” above all others.
Audit readiness
51%
Measuring and optimizing quality efforts is not simply about
Process capability/ performance
compliance; these also add value to the bottom line. McKinsey: “We
44%
estimate the total direct cost of quality at 6.8 to 9.4 percent of industry
Product testing performance
sales. Good quality practices would recover a large part of these costs. 43%

Moving the industry to median or top-quartile performance in quality DHF/ DMR transfer
operation practices and reducing nonroutine external quality failures 32%

would capture savings equal to 1.6 to 3.0 percent of industry sales.”8 Training effectiveness
31%

Despite these measurement efforts, only 15% say they have a Supplier qualification
31%
high level of visibility into quality problems.
Quality cycle times
24%

Rate of change & change resolution rates

19%

Just 15% 0% 20%

Showing responses from companie with at least one product on the market
40%

have a high level of visibility into quality problems

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

8
McKinsey & Company: “Capturing the value of good quality in medical devices,” Feb. 2017

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Of those who have a product on the market, 17% report they’ve been issued
a warning letter, and on average it takes two years for device companies to
resolve issues surfaced in warning letters.

More than 1 in 3 (35%) say they are “very confident” they could demonstrate
2 Years
total product lifecycle traceability if a government agency or notified body It takes 2 years for device companies to
showed up for an unannounced audit tomorrow. resolve issues surfaced in warning letters.

Nearly double that number (62%) can demonstrate closed-loop complaint

handling. The biggest challenges to closed-loop complaint handling are a
lack of resources (27%) and weak feedback loops (27%).

68%
Showing those who say they 68

can demonstrate closed-loop 66

complaint handling
64
62%
62

60

58

56

54

53%
52
2020 2021 2022

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Quality of supplier management for on-market companies

Supplier management: Q Rate your current supplier management program. How well does your organization
A new imperative, given ongoing supply chain challenges qualify new suppliers, manage existing suppliers, and maintain a high level of
communication and transparency?
Supply chain friction is putting even more pressure on 2% 8%
6%
manufacturers as they try to compete in a tough market. Despite
this, few have achieved supply chain excellence. Only 8% say
Excellent 8% Very poor 6%
their supply chain management program is “excellent” — a few
Above average 44% Below average 2%
points lower than last year.
Average 40%
40% 44%

Showing responses from companies with

at least one product on the market

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Not surprisingly, project management timelines and targets are cited as the
biggest challenge (mentioned by 36% of on-market companies surveyed).
An article in the Wall Street Journal found supply chain woes in the medical
device industry will likely persist into 2023: “Across the industry, specialized
plastics, metals and resins needed to make devices are all in short supply,
according to the companies.”9

Headwinds when scaling Supply chain logistics

30%
manufacturing Communication/ feedback loop between quality and development teams
24%
Q What are your biggest challenges
related to scaling manufacturing Sourcing and vetting vendors/ space
23%
as you launch your product in the
market? Maintaining manufacturing and production quality
22%
Navigating post-market surveillance
20%
Engineering support
20%
Training new employees
18%
Hiring workers for the manufacturing site
18%
Meeting ROI expectations
Showing responses from companies 17%
with at least one product on the market 0% 10% 20% 30%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

9
The Wall Street Journal: “Inflation, Supply-Chain Woes Hit Medical-Device Makers,” Nov. 2022

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What’s needed? Much greater levels of collaboration between manufacturers and suppliers.
Today only 43% say they maintain transparency with partners about timelines/
status, and just 36% include partners in design change decisions. “We’re all
going through a major modernization in our supply chains,” Ashley McEvoy,
who heads Johnson & Johnson’s medical-technology unit, said at an industry
conference. “We have not been pace setters relative to other industries.
We’re going to have to get masterful at logistics.”10

Collaborating with supply Encourage partners to communicate for better decisions

chain partners 45%

Q In what ways do you collaborate Maintain transparency with partners about production/ manufacturing status
with your supply chain partners
43%
today?
Include partners in design change discussions
36%

Provide updated product build packages

20%
Showing responses from companies
with at least one product on the market 0% 10% 20% 30% 40%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

10
The Wall Street Journal: “Inflation, Supply-Chain Woes Hit Medical-Device Makers,” Nov. 2022

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Software
investments:
the value multiplier
Medical device companies are are bullish
bullish on
on software solutions —
software solutions — the
the platforms
platforms and
and
tools that make their work more
more efficient
efficient and
and effective.
effective. Approximately
Approximately half
half (49%)
(49%)
of all pre-market startups said they would be increasing investments in software
solutions in 2023, and
and 34%
34% of
of on-market
on-market companies
companies say
say the
the same.
same.
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Many companies are still stuck using Across many phases of the product development lifecycle, companies are
still using general-purpose tools like Microsoft Word or Excel, and even using
general-purpose tools paper files for documentation. By doing this, they’re missing out on data
integration, automation, dynamic searches, and scalability — all available from
a true eQMS platform.

General purpose tools General purpose tools Tools for [blank] Tools designed for the Unsure
(e.g. paper, Excel, Word) in general medical device industry
versus purpose-built
solutions for pre-market
Design controls
companies 41% 17% 34% 8%
Q What system/tool do you use for Risk management
the following:
47% 10% 35% 8%

Audit management
45% 14% 32% 9%

Complaint handling
37% 14% 35% 14%

Continuous product development

40% 19% 31% 10%

Supplier management
49% 18% 24% 9%

Showing responses for

pre-market companies only 0% 20% 40% 60% 80% 100%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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For on-market companies, more than half use general-purpose tools for risk
management, and more than 40% use general-purpose tools for design controls,
clinical testing, continuous product development, and supplier management.
These tools may document tasks, changes, and action items, but they are
near-primitive options when it comes to searching, scaling, and collaborating.

General purpose tools General purpose tools Tools for [blank] Tools designed for the Unsure
(e.g. paper, Excel, Word) in general medical device industry
versus purpose-built
solutions for companies with
Quality management
product(s) on the market 40% 18% 40% 2%
Q What system/tool do you use for Design controls
the following:
46% 23% 27% 4%

Risk management
51% 19% 26% 4%

Complaint handling
37% 24% 34% 5%

Supplier management
48% 21% 23% 8%

Clinical testing
44% 22% 19% 15%

Continuous product development

45% 29% 16% 10%

Showing responses for

pre-market companies only 0% 20% 40% 60% 80% 100%

Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study

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Using technology to multiply value
across the product lifecycle
Comparing companies that use general purpose tools vs. those that use purpose-built solutions:
Quality management
50% more likely to say they’ll
meet their quality objectives
in 2023.
2x more likely to say
documentation of design
controls is “excellent”.
Nearly 2x more likely to say
they’ll meet their product
development objectives
in 2023.
Source: Greenlight Guru’s 2023 Medical Industry Benchmark Study
40
2023
General purpose tools — solutions like Microsoft Word/Excel, or even paper
files — are a decent solution in the early days when a startup is trying to save
money. But as time passes, files grow, and documentation requirements
become more complex, those “easy” tools quickly become a drag on
productivity and — at worst — an insurmountable barrier.
We investigated the behaviors of best-in-class companies — organizations
that use tools purpose-built for the medical device industry — to understand
how technology can be a boost (or a drag) on performance.
Product development Risk management Clinical data capture
Over 2x more likely to say they 2x more likely to say their team’s 1.8x more likely to say
include supply chain partners ability to view/ access real-time employees have “high visibility”
in design change discussions. data for cross-functional to access data and details
collaboration is “very good” about quality problems.
Almost 3x more likely to say or “excellent”.
employee training oversight is
fully automated (i.e., automated
notifications rather than
tracking via spreadsheets
and searching for people who
need additional training).
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Investing in people by investing

in technology
Most companies are not able to influence the regulatory environment, of course,
but by investing in purpose-built technologies, companies can spend less time
on managing paper and duplicating efforts, and more time on development,
innovation and improving clinical outcomes.

We asked survey-takers, “What’s the one thing that would make your job easier
or more effective?”

Responses fell into two primary categories:

Dynamic technology: Streamlined, simplified regulations:

Professionals we surveyed believe investments in the
right tech stack — including data integration, systems
automation, robust documentation and data management,
and real-time collaboration — drive company performance
as well as individual satisfaction. One person shared,
“More than anything, I’d like a system that links everything —
absolutely everything, like product documentation —
together. It would transform my job.”
Complex regulatory environments and misalignment
among key markets slows development and pushes
out smaller players. One person explained, “We need a
pragmatic, risk-based approach to the interpretation and
implementation of new regulations; EU MDR has been
inappropriately and poorly implemented / interpreted by
regulators, and it impacts everyone — from the viability of
new products to patient outcomes.”

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