2021 BENCHMARK REPORT

STATE OF MEDICAL
DEVICE QUALITY
MANAGEMENT AND
PRODUCT DEVELOPMENT
CHARTING A PATH FOR HIGH PERFORMANCE IN A POST-COVID ENVIRONMENT
 REPORT
2021

CHARTING A Last year we published our first annual Medical Device Product
Development and Quality Management benchmark report
PATH FOR HIGH to help organizations understand the strategies, tactics, and
technologies that differentiate market-leading companies.
PERFORMANCE This year’s report continues in this same direction while
IN A POST-COVID also exploring the growing market demands, operational

ENVIRONMENT challenges, and the weight of a global health crisis that is

pressuring medical device companies to rethink strategies
and solutions moving into 2021.

We surveyed hundreds of professionals working in the

medical device industry — in both quality management and
product development — to understand their approach to
technology, risk management, process improvement, and
even how they are weathering the pandemic.

Our goal is to give you a clear understanding of the critical

industry benchmarks, technological shifts, and overcoming
internal divides within organizations that will help you navigate
through uncertainty and maintain a competitive advantage in
the new year.

We hope this report enlightens and supports you in finding

further success in the coming year.
 3 TABLE OF CONTENTS
REPORT
2021

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TABLE OF 04 CRITICAL BENCHMARKS IN THE MEDICAL

DEVICE INDUSTRY.
19 THE LEADERSHIP MISALIGNMENT.
The research shows that executives, managers, and
CONTENTS A look at key findings related to tech adoption, individual contributors evaluate company challenges
efficiency, and process and risk controls in the and performance very differently, which can fuel
industry. misunderstanding and friction.

11 WHAT DO MARKET-LEADING COMPANIES DO 22 PRESCRIPTION FOR 2021.

DIFFERENTLY? 4 things to focus on in the new year. How you can
What sets high-performers apart from peers, and join the ranks of high-performing companies in the
what can organizations do to elevate market medical device industry.
competitiveness?

13 THE TECH ADVANTAGE. 25 METHODOLOGY

Organizations using medical-device-specific quality
management systems (MDQMS) outperform
organizations that opt for general-purpose tools

15 QUALITY CULTURE: A BAROMETER OF

COMPETITIVE SUCCESS.
When a company culture is rooted in quality — and
specifically quality as a strategic asset — it drives
performance and efficiency.

W W W. G R E EN L I G H T. GURU
CRITICAL
BENCHMAR
CRITICAL INDUSTRY
BENCHMARKS
What can industry leaders learn about competitors’ achievements in risk
management, quality and efficiency? And how are companies faring in the
face of pandemic pressures?

CRITICAL
 5 CRITICAL INDUSTRY BENCHMARKS
REPORT
2021

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2021 OUTLOOK
Though the COVID-19 pandemic has buoyed the Overall, survey respondents took a negative view something the pandemic has disrupted. As well,

fortunes of some medical device companies due to about how the pandemic is affecting their company’s many companies are facing significant cash-flow

spikes in demand, the crisis has largely wreaked havoc prospects and financial viability. Some 63% report pressures due to deferred demand and/or shrinking

on supply chains and revenue projections. Earlier in the the pandemic is negatively affecting funding at their orders from existing suppliers/customers.

year, McKinsey was predicting a 40% to 50% decline in companies, a turnabout with critical implications,

third-quarter demand for elective procedures in the US particularly for smaller companies with little excess Yet looking ahead, the picture appears to be more

and Europe, a historic drop in revenue for the industry. 1 capital or high leverage. And 59% say COVID-19 is favorable. About 38% say they expect strong
negatively affecting time to market. revenue growth in 2021, and 41% expect modest

Greenlight Guru surveyed hundreds of professionals revenue growth. Just 5% project revenues will shrink

working in the medical device industry — in both More than one-third of respondents (39%) report next year.

quality management and product development — the crisis is threatening the financial viability of their

to understand their approach to technology, risk organizations — not surprising given the findings

management, process improvement, and even how 63

noted above. Medical device %
companies rely on
1 Healthcare innovation: Building on gains made through the crisis.
they are weathering the pandemic. the free flow of capital through financial markets, McKinsey (11/2020)
negatively
affecting funding

63% 59%
negatively negatively affecting
affecting funding time to market
EFFECTS OF THE GLOBAL PANDEMIC

63% 59% 39% Respondents say the pandemic has had serious
repercussions on their organizations’ financial health.
not a strategic imperative.
negatively negatively affecting threatening financial
affecting funding time to market viability of organization

Source: Greenlight Guru | 2020

59 %
39 %
Share (%) that agree the pandemic is affecting funding, time-to-market and financial viability.

negatively affecting threatening financial

time to market viability of organization

39%
W W W. G R E EN L I G H T. GURU
threatening financial
 6 CRITICAL INDUSTRY BENCHMARKS
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2021

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TECH ADOPTION TECH MATURITY IN THE MEDICAL

Similar to last year’s findings, tech maturity remains DEVICE INDUSTRY
Source: Greenlight Guru | 2020
stubbornly low in the industry. Roughly half of all
respondents say they use general-purpose tools
Tools used for design controls & risk management
to support design control and risk management ? What solution(s) does your company use to support design controls & risk management processes.

processes (53%) and for quality management We use general purpose tools We use tools designed for product We use tools designed for
(e.g. paper, Excel, Word). development in general. the medical device industry.
processes (49%). Only 23% use design control and
risk management software designed specifically 53%

for the industry and just 20% use a QMS specifically 23%
designed for the medical device industry. One survey
23%
taker explained, “[Our systems] are too manual;
higher-ups do not appreciate the value of automation.” 0% 20% 40% 60%

In practice, this means the majority of those not Q: What solution(s) does your company use to support design controls & risk management processes?
using purpose-built tools still rely heavily on storing
and accessing documents on a shared network (3
in 4 report doing this) or accessing files under some Tools used for quality management systems
? What solution(s) does your company use to support quality management processes.
type of document control (59%). Consider also:
We use general purpose tools (e.g. We use general purpose QMS or document We use QMS software designed
these document-sharing solutions can introduce paper, Excel, Word, Sharepoint). control software tools (e.g. multiple industries). for the medical device industry.
significant risks for organizations that now have
49%
teams working from home; even for those who can
access documents remotely, there are security 31%

challenges to contend with. Many document 20%

storage and sharing solutions not purpose-built for
0% 20% 40% 60%
the medical device industry lack sufficient access
controls, application controls, event logs, and end-to-
end data encryption for sensitive files. Q: What solution(s) does your company use to support quality management processes?

W W W. G R E EN L I G H T. GURU
 7 CRITICAL INDUSTRY BENCHMARKS
REPORT
2021

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RISK MANAGEMENT QUALITY METRICS

Survey takers report a variety of challenges related Given that just 2 in 10 say they use a QMS designed effort of validating new tools or processes, and
to risk management, but the most common is a lack for the medical device industry, it’s surprising that resistance to change efforts. This suggests that
of clear ownership of risk throughout the product nearly 7 in 10 agree that “quality is woven into my some who recognize that their organizations’ tools
life cycle (35%) and not having access to the right company’s culture”— a sign that some organizations and processes are inefficient are trapped by that
information during design and development (34%). are aspiring to a quality-first culture even when they inefficiency — unable to set aside time and resources
may not have the best mix of tools to achieve it. A to select and deploy better tools.
Those who use design control and risk management smaller share (45%) report that senior leadership
software created for the medical device industry at their organization sees quality management
(versus those who use general-purpose tools) are as a strategic asset rather than an area of control/
much less likely to report a missing “feedback loop” compliance. As one survey taker shared,
of post-market processes and product risk. Nearly
one-third of those who use general-purpose tools
report there isn’t a strong feedback loop of post-
market processes into product risk, versus just 11%
“ OUR COMPANY LEADERS DON’T
APPRECIATE THAT QUALITY ISN’T
JUST A BOX-TICKING EXERCISE.”
of those who use specialized design control and risk
management software specific to the industry.
Another explained, “QMS [at my company] is just
Overall, more than half say they cannot currently a hunt for signatures, even when they are aware
document closed-loop traceability and a surprising that what has to be signed is not true. ‘It’s just for
14% say they have no plans to resolve this over the compliance and nobody will notice.’ QMS is a circus
next 24 months — a troublesome finding given that to make the auditor happy. Of course, I have quit.”
closed-loop traceability is a regulatory requirement
and regulatory bodies are placing a significant What are the biggest challenges in the area of
emphasis on it. quality management? Insufficient budget, the cost/

W W W. G R E EN L I G H T. GURU
 8 CRITICAL INDUSTRY BENCHMARKS
REPORT
2021

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? What are your biggest challenges when it comes to improving quality management processes?

Insufficient budget 41%

Cost/effort of validating new

35%
tools/processes
IMPROVING QUALITY MANAGEMENT
Resistance to change effort 34%
Cost, lack of time, and resistance to change
all cited as top barriers to improving quality Underinvestment in
29%
management. education/training

Underinvestment in 28%
tools/ solutions

Lack of management buy-in 28%

Confusion about 25%

compliance guidelines
Source: Greenlight Guru | 2020
Siloed quality 22%
systems/data sources

20% 25% 30% 35% 40% 45%

Q: What are your biggest challenges when it comes to improving quality management processes?

W W W. G R E EN L I G H T. GURU
 9 CRITICAL INDUSTRY BENCHMARKS
REPORT
2021

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MARKERS OF EFFICIENCY STRATEGIC INDICATORS

This year, Greenlight Guru’s survey focused According to a large-scale study by McKinsey about
specifically on markers of efficiency. Regardless the effects of the pandemic on business leadership
of quality or total risk, how efficient are internal and innovation, the pharma and medical products
processes that oversee these? sector was the only one surveyed that increased its
focus on innovation in 2020 compared to 2019 2 — a
The majority (59%) report their companies’ processes sign that some companies view the pandemic as an
are “efficient” or “very efficient” in bringing new opportunity to eliminate complacency and focus on 2 in 3 s
devices to market. (Not surprisingly, investment in those factors that will drive growth and differentiation. into their c
industry-specialized tools correlates with greater
efficiency.) Greenlight Guru’s survey looked at how companies
2 in 3 say quality is woven
into their company culture.
view quality — whether as a requirement for compliance
or a strategic asset that lends insights and improvements
across the product development continuum. Roughly

“
Among the specific findings:
1 in 3 respondents work for a company
■ On average, it takes 144 hours to compile a
that values quality as a strategic asset,
design history file.
meaning quality is supported at every
■ Approximately 1 in 4 respondents say that level of the organization and viewed SENIOR LEADERSHIP DOES NOT
documenting closed-loop traceability (CLT)
as a competitive strength. An equal UNDERSTAND THEIR ROLE IN BRINGING
requires “substantial effort.” Just 28% say
share (34%) say their organizations
IN A QMS. THEY DO NOT UNDERSTAND
they can document CLT in real-time.
either value quality purely as a
THAT THEY NEED TO OWN IT. THEY ONLY
31% say it takes 2 days or more to update a WANT TO BE TOLD WHAT TO DO TO BE
■
compliance activity or don’t value
traceability matrix; only 13% can do so in BLACK-AND-WHITE TO A STANDARD.
quality at all. When asked whether

”
less than one hour.
quality data is used to make business – survey respondent
decisions, just 1 in 4 said this is true.

2
“Innovation in a crisis: Why it is more critical than ever.” McKinsey (June 2020)

W W W. G R E EN L I G H T. GURU
 10 CRITICAL INDUSTRY BENCHMARKS
REPORT
2021

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QUALITY AS A STRATEGIC ASSET

Most still view quality as a compliance issue,
45
45 % %
55
55 % %

not a strategic imperative.

Qualit y management is seen as a Qualit y management is seen as a
strategic asset, critica l to our necessar y activity in order to be
competitiv e position . complian t.

Source: Greenlight Guru | 2020 Q: Does senior leadership within your company see quality management as a strategic asset or a necessary area of control/ compliance?

W W W. G R E EN L I G H T. GURU
SIGNALS FR
MARKET LE
SIGNALS FROM
MARKET LEADERS
In what ways do highly competitive companies outperform their peers?
The research uncovers what these best-in-class organizations do differently.

SIGNALS FR
 12 SIGNALS FROM MARKET LEADERS
REPORT
2021

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O f those surveyed, 40% report their organizations are

highly competitive relative to market peers.
So, what separates these high-flyers from all the
3
likely to leverage traceability for impact analysis.
When asked whether “engineers at my company
spend more time on compliance paperwork than
HIGHLY COMPETITIVE COMPANIES
OUTPERFORM IN KEY AREAS
others? engineering,” just 21% of high performers agreed with
this statement, versus 50% of lower performers.
t r o n g r e ve n u e g r o
Highly competitive companies are 4x more ec t s w th
E xp 60 %
likely to forecast strong revenue growth in 2021 Perhaps not surprisingly, job satisfaction among
when compared to less competitive peers — professionals at high-performing companies is

ta

In
da

te
40 %
though that level of out-performance is mostly

gr
le
significantly higher: 81% of people working in high-

a te
ab
re l i
expected. What else sets them apart?

r i sk
performing companies report being “satisfied”

A cc e s s c o n s i s t e n t l y
20 %

t h ro u
or “very satisfied,” versus 42% of those at lower-

g h p ro d u c t l i fe c
Market-leading companies take a holistic approach performing companies. 0%
to documenting design controls and risk. For
example, 40% of high performers begin Finally, high-performing organizations view quality
documenting design controls in a traceability

yc l e
as a strategic asset; it’s not a “checkbox” activity,
matrix during concept and feasibility, compared to

Va
but a key engine of competitive strength. Or, as one

lu eq
just 8% of lower performers, and 36% begin respondent phrased it,

n
ua

io
it y

ct
fa

l
documenting risk during concept and feasibility, as
as tis
sa

“
tra b
compared to just 14% of lower performers. QUALITY MANAGEMENT IS THE GLUE te g h jo
ic as
set Hig
FOR THE COMPANY; IT IS THE BUSINESS
Half of high-performing companies say they MANAGEMENT SYSTEM. WHEN VARIOUS
Highly competitive relative to market peers
PROCESSES ARE NOT IMPLEMENTED
fully integrate risk management into the QMS Highly competiti ve relative to market peers
EFFECTIVELY, DEPARTMENTS WORK Not very competitive relative to market peers
throughout the product life cycle, compared to IN SILOS, AND IT RESULTS IN POOR Not very competiti ve relative to market peers
29% of lower performers. OUTCOMES AND PERFORMANCE.”
Source: Greenlight Guru | 2020
High performing organizations are also 2x more

3
Survey-takers self-evaluated how competitive their organizations are relative to their peer group. They chose from the following answer choices: “highly competitive,”
“moderately competitive,” and “not very competitive. This section compares “highly competitive” to “not very competitive” responses.

W W W. G R E EN L I G H T. GURU
THE TECH
ADVANTAG
THE TECH
ADVANTAGE
While technology is never curative, the right tools do give companies a significant
advantage. The research points out the specific benefits that specialized
technology for the medical device industry offers the companies that deploy it.

THE TECH
 14 THE TECH ADVANTAGE
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R oughly half of all respondents say their organizations

still use general-purpose tools, both to support
design control and risk management processes
can demonstrate product lifecycle traceability in the
event of an unannounced audit.
UPSIDE OF PURPOSE-BUILT
QMS TOOLS
Companies that use an MDQMS significantly
(53%) and quality management processes (49%). Those using general-purpose tools may end up with outperform their peers in these key areas.
good results, but they suffer due to the inefficiency of
We wondered: What advantages do companies that
use technology specifically designed for the medical
using tools not purpose-built. As one survey-taker noted,
95% Feel confident they could pass
an unannounced audit

device industry have compared to those using general-

“ THE LEVEL OF DOCUMENTATION
SUPPORT MY ROLE PROVIDES TO
purpose tools, in particular, a quality management
system designed specifically for the medical device
OPERATIONS AND DEVELOPMENT
IS SIGNIFICANT AND NOT UNDERSTOOD
50% Expect strong revenue growth
in 2021 despite pandemic
industry (MDQMS)? BY SENIOR LEADERSHIP.”

MDQMS users are significantly more likely to project

strong revenue growth in 2021 (50% say this, versus Finally, those using purpose-built tools for the medical
70% Can currently demonstrate
closed loop traceability

31% of those using general-purpose tools). About device industry are much more likely to say their
60% say the data generated by their quality system is MDQMS had a positive impact on securing funding —
consistently reliable, compared to 36% of those who
use general-purpose tools. And those who use a
a finding that’s particularly interesting given current 60% Have access to consistently
reliable data
conditions in capital markets. Some 69% of those
specialized MDQMS are 1.7x more likely to be able to using an MDQMS say their quality management Q: What solution(s) does your company use to support
quality management processes? [Answer choices: (a)
demonstrate closed-loop traceability and 1.7x more system had a positive impact on securing funding, general purpose tools (e.g. paper, Excel, Word, Sharepoint);
(b) general purpose QMS or document control software
likely to say they are “very confident” the company versus 40% of those using general-purpose tools.
tools (e.g. software that can be used for multiple industries);
(c) QMS software designed for the medical device industry.]

Source: Greenlight Guru | 2020

W W W. G R E EN L I G H T. GURU
BUILDING A
A QUALITY
BUILDING A QUALITY
CULTURE
For organizations that aim to be top competitors in their niche, quality is seen
as much more than a tactical advantage; quality is a mindset that influences
best-in-class product development and product improvement.

BUILDING A
 16 BUILDING A QUALITY CULTURE
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G reenlight Guru asked respondents several

questions about quality, including to what
extent senior leaders see quality as an asset, versus
Market strength: Companies that see quality as an
asset are 2x more likely to say their organizations
are “very competitive” relative to market peers than
do not view quality as an asset. One survey taker
explained the risk his/her company takes when it
views compliance as a necessity, cut off from the
seeing quality as a necessary aspect of compliance. those that don’t value quality the same way; they are overall health of the business: “The most influential
What are the specific benefits that correlate to also less likely to report experiencing the negative members of senior leadership are not aware of the
organizational leadership that values quality beyond effects of the pandemic, such as loss of funding or disparity between our current level of compliance
a compliance requirement? slowed time to market. and what is expected by many auditors. Maintaining
the quality system does not always show immediate
Efficiency: Three in four (76%) quality-as-an asset value, but when it becomes critical (audits, recalls,
companies say they are efficient in bringing new etc.) it is too late to fix things. Not prioritizing quality
products to market, compared to 45% of all others. is a gamble.”
Quality companies are also 1.6x more likely to be able
to demonstrate closed-loop traceability compared Strategic point of view: Quality-focused companies
to those that don’t prioritize quality, and they spend are twice as likely to say the data from their quality

“
less time achieving traceability. Half management system is consistently reliable and
of the companies that view quality as twice as likely to report they often use quality system
an asset can update their traceability data to make business decisions. One survey taker
[MY COMPANY] DOESN’T UNDERSTAND matrix in four hours or less. explained that their company doesn’t see the strategic
THE CONCEPT OF CONTINUAL value of quality, saying, “[My company] doesn’t
IMPROVEMENT APPLIED TO QMS
Risk management: Companies that understand that quality is not about documentation
PROCESSES. COMPLIANCE IS NOT THE
treat quality as an asset are much more for compliance, but how it contributes to the overall
END GOAL, IT SHOULD BE A MINIMUM
likely to integrate risk management benefit for the company.” Another complained,
EXPECTATION.
throughout the product life cycle; 57% “Company leaders do not fully grasp the strength of
– survey respondent say they integrate risk throughout the a good interwoven quality system that feeds/covers
life cycle, versus 34% of those that every aspect of the firm.”

W W W. G R E EN L I G H T. GURU
 17 BUILDING A QUALITY CULTURE
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LEADERSHIP BUY-IN TO QUALITY CULTURE:

Organizations that prioritize quality tend to have leaders that support their
efforts. For example, among companies that DO NOT prioritize quality,
50% of employees say a lack of management buy-in is an obstacle to
improving the product development process, compared to just 7% of
those who work for companies that view quality as a strategic asset.

Perhaps not surprising, people working at companies that prioritize

quality are 4x more likely to report feeling satisfied with their jobs. One
survey taker shared what it feels like to work in an organization that
doesn’t value quality; he explained, “Quality is often painted as the bad
guy who is forcing us to slow down to do work that doesn’t matter.”

W W W. G R E EN L I G H T. GURU
 18 BUILDING A QUALITY CULTURE
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2021

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QUALITY AS A STRATEGIC ASSET

When companies view quality as an asset rather than a compliance requirement,
they tend to outperform in key areas.

Quality as strategic Quality as required Gap (percentage points)

Highly competitive relative to 46%

market peers
34% 12%

Efficient when bringing new 76%

device to market
45% 31%

Begin documenting risk during 42%

concept/feasibility
27% 15%

Use traceability for more than 77%

compliance
46% 31%

60% 20% 40% 60% 80%

Q: Does senior leadership within your company see quality management as a strategic asset or a necessary area of control/
Source: Greenlight Guru | 2020 compliance?

W W W. G R E EN L I G H T. GURU
LEADERSHI
MISALIGNM
LEADERSHIP
MISALIGNMENT
Company leadership often has different focus and expectations vs. managers and
individual contributors — and these differences can lead to additional risk, as well
as affect job satisfaction.

LEADERSHI
 20 LEADERSHIP MISALIGNMENT
REPORT
2021

2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T
EXECUTIVES
Ensuring traceability throughout
EXECUTIVES
PRIMARY BARRIERS INproduct
PRODUCT DEVELOPMENT
2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T

the life cycle

Ensuring traceability throughout
the product life cycle
EXECUTIVES
Ensuring traceability throughout
the product life cycle
EXECUTIVES

T he research shows that the way company leaders

view opportunities and challenges differs greatly
between management and what we call “contributors,”
managers point to “lack of clear ownership for risk
throughout the product life cycle” (40%).
Ensuring traceability throughout
the product life cycle

or those on the ground completing the tactical work. One survey taker described the way risk is treated at his/
This misalignment can not only lead to problems her company, and how little the function is appreciated:
MANAGERS
understanding and working toward shared goals; it Documenting work throughout

“ [COMPANY LEADERS] DON’T UNDERSTAND MANAGERS

can also breed resentment and job dissatisfaction. product development
THAT RISK MANAGEMENT IS WOVEN Documenting work throughout
product development
MANAGERS
THROUGHOUT THE ENTIRE LIFECYCLE
What does each group view as the most painful tasks Documenting work throughout
OF THE PRODUCT AND THAT RISK-BASED product development
MANAGERS
related to managing design controls? Executives APPROACH MUST BE PART OF OUR
Documenting work throughout
are most concerned with ensuring traceability PROCESSES FROM START TO FINISH.” product development
throughout the product life cycle, managers say
documenting work throughout product development,
and individual contributors are most focused on Even more interesting, when asked whether their
managing a “pile” of documents. Yet when it comes organization values quality as an asset, executives CONTRIBUTORS
are much more likely to believe this is true. Some Managing a "pile" of
to the primary barriers in product development, all CONTRIBUTORS
documents
three groups agree: A shortage of resources. 46% of executives claim the company views quality as Managing a "pile" of
documents
CONTRIBUTORS
a strategic asset, versus 31% of managers and 34% of
Managing a "pile" of
When it comes to the biggest risk management individual contributors. One survey taker explained: documents
CONTRIBUTORS
challenges, there’s a big divide between what Managing a "pile" of

“ COMPLIANCE IS SEEN AS A documents

executives say versus what managers say. Executives
NECESSITY/BURDEN AND IT IS
overwhelmingly choose “having enough information
HIGHLY SEPARATE FROM PRODUCT
during the design and development process to DEVELOPMENT, MY WORK IS OFTEN
All three groups agree:
assess product risk” (45% choose this), while DISREGARDED AND SELDOM VALUED.”
Primary barriers in productOF
A SHORTAGE RESOURCES.
development,
all three groups agree:
A SHORTAGE
Primary OF RESOURCES.
barriers in product development,
all three groups agree:
A SHORTAGE
Primary barriers OF RESOURCES.
in product development,
all three groups agree:
A SHORTAGE OF RESOURCES.

W W W. G R E EN L I G H T. GURU
 21 LEADERSHIP MISALIGNMENT
REPORT
2021

2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T
2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T

O verall, executives tend to be more satisfied POINT OF VIEW BY COMPANY ROLE

with the job. About 41% say they are “very What are the key differences in point of view when comparing senior executives, management and
satisfied” compared to 23% of managers and 30% of individual contributors?

individual contributors. Understanding what drives Senior Individual

Management
Executive Contributor
these numbers is important. A few clues: Managers
and contributors who work with purpose-built "Shortage of resources" is a top barrier to
tools tend to be more satisfied than those who use improving product development process 44% 52% 57%
general-purpose tools. And those who work at
organizations that view quality as an asset are 2.5x "Access to data" is a key challenge when
assessing product risk 45% 32% 29%
more likely to be “very satisfied” compared to those
who do not. One survey taker offered additional
Believe quality is woven into company
insight on this point: culture 72% 67% 60%

“ [MANAGEMENT DOESN’T UNDERSTAND]

THE HIGH-STRESS LEVELS CAUSED
BY NONCOMPLIANCE.”
Very satisfied in current role 41% 23% 30%

Source: Greenlight Guru | 2020

W W W. G R E EN L I G H T. GURU
A PRESCRIP
FOR 2021
A PRESCRIPTION
FOR 2021
What can organizations do to join the ranks of high-performing companies in the
medical device industry?

A PRESCRIP
 23 A PRESCRIPTION FOR 2021
REPORT
2021

2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T
2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T

B ased on the research, we see four key areas

for medical device companies to focus on in
2021 and beyond.
INVEST IN MOVING UP THE TECH MATURITY
CONTINUUM
The research shows that those companies that
quality systems, etc.), but quality culture also plays a
big role. The report’s author explains,

invest in technology designed for the medical

device industry gain efficiency and real-time insights,
and they also tend to be more strategic in how
“ HIGH-PERFORMING SITES DO NOT LEAVE
QUALITY TO THE QUALITY FUNCTION
ALONE; INSTEAD, THEY EMBED QUALITY-
RELATED ACTIVITIES INTO THE ROLES OF
they use risk and quality data to inform business
STAFF ACROSS THE ORGANIZATION.”
decisions. Now more than ever, these companies
are benefiting from process automation, more
reliable data, and even AI-fueled insights to target
BUILD COHESION BETWEEN LEADERS,
failures or inefficiencies in the system. For best-in- MANAGERS, AND CONTRIBUTORS
class organizations, however, technology is not a Companies should take steps to (a) diagnose
solution to all that ails, but a “partner” in the journey the areas where leaders, managers, and on-the-
to process improvement and efficiency, and quality ground contributors have differing perceptions of
management. the organization’s priorities and practices. Do these
groups have shared values? Do managers and
ADOPT A ‘QUALITY CULTURE’ APPROACH individual contributors feel understood and valued
Best-in-class organizations see quality not as a by leaders?
compliance requirement, but as a pathway to
building value and fueling growth. A report from A big step in the right direction: addressing process
McKinsey found the direct cost of quality for medical inefficiencies and dysfunction. Too often the “cost”
device manufacturers to be approximately 6.8% to of new technology, more reliable data, and improved
9.4% of industry sales — and high-quality practices quality systems are much less than the cost of not
would reverse a large portion of these costs. 4 The doing these things — punitive expenses in the form
path to high quality, says McKinsey, is in part about of wasted labor hours, noncompliance, product
operational excellence (product and process controls, development delays, and employee turnover.

4
“Capturing the value of good quality in medical devices.” McKinsey (February 2017)

W W W. G R E EN L I G H T. GURU
 24 A PRESCRIPTION FOR 2021
REPORT
2021

2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T
2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T

MEASURE BASELINE PERFORMANCE WITH AN In the COVID era, agility and speed are of particular
EYE TOWARD INCREMENTAL IMPROVEMENTS concern. A McKinsey study analyzed changing
The pandemic has forced many businesses to priorities among business executives during the
rethink the pace of development, as well as the cost pandemic and “speed” was the top priority. The report
of pushing ahead with existing plans in the face of a explains, “Leaders at faster organizations — that is,
radically different market environment. A report from those who say their organizations are significantly
RBC Capital Markets explains, faster than their competitors — report significant
outperformance compared with leaders in slower

“ IN [THE HEALTHCARE] SECTOR, THE

NEXT PHASE OF COVID-19 WON’T BE
A SLOWDOWN BUT AN ACCELERATION
organizations for all of the organizational outcomes
we asked about, including profitability, operational
OF CHANGE AND INNOVATION, MANY resilience, organizational health, and growth.”
OF WHICH WERE SIMMERING IN THE
BACKGROUND BEFORE THE PANDEMIC.” 5

Companies must define the specific metrics that

will drive value, innovation, and growth even once
the pandemic has passed. For example, what can
organizations do to free engineers from “paper
pushing” and redirect them to more valuable (and
satisfying) activities? What would be the return on
investment for technology upgrades? And where can
leaders design efficiency and speed into the process?

5
“The impact of COVID-19: a catalyst for change, innovation and investment.” RBC Capital Markets

W W W. G R E EN L I G H T. GURU
METHODOL
METHODOL

METHODOL

2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T
2021
REPORT

METHODOLOGY

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25
2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T
 26 METHODOLOGY
REPORT
2021

2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T
2 0 2 1 S TAT E O F M E D I C A L D E V I C E Q UA L I T Y M A N AG E M E N T & P R O D U C T D E V E LO P M E N T | B E N C H M A R K R E P O R T

T he results in this report are from an online survey that was fielded
between October 6 and 20, 2020. It had 311 respondents, all of whom
completed the survey. Key demographic variables are included below.

YEARS OF EXPERIENCE IN INDUSTRY SIZE OF COMPANY ROLE IN COMPANY

10%% 15%% 18%%

25%% 25 %
18%% 12%%
53 %
%

10%%
30%%
16 %%than 1 year
Less 25%%
1-2 years 50%%
18 %
%
53%% 3-5 years Number ofNumber of Employees
Employees
10
%
%
Less than 1 year 6-10 years Fewer
Fewer than 10 than 10 250 to 999
250 to 999 Senior Executive Individual
Contributor
16 %
%
1-2 years More than 10 to 49 10 to 49 1,000 or 1,000 or Management
18 %
% 10 years more more
3-5 years 50 to 24950 to 249

6-10 years

16 %
% Source: Greenlight Guru | 2020
More than Source: Greenlight Guru | 2020 Source: Greenlight Guru | 2020

10 years

W W W. G R E EN L I G H T. GURU