This study provides insights into how medical device companies are mobilizing resources to support meeting quality standards and regulations throughout the product life cycle. This research establishes meaningful metrics around Quality cost and staffing as well as organizational structure for the function in the U.S. and globally.

1. Benchmarking Quality Staffing & Performance:
How Medical Device & Technology Companies Ensure
Quality & Safety While Managing Cost Effectiveness
Best Practices, LLC Strategic Benchmarking Research
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2. TABLE OF CONTENTS
I. Research Objective & Methodology p. 3-15
II. Quality Organization Cost & Staffing p. 16-24
III. Quality Organization Structure p. 25-37
IV. IT Solutions for Quality Activities p. 38-46
V. Managing Document Control p. 47-56
VI. Employing Quality Audits & Management Reviews p. 57-67
VII. Deploying Quality Training p. 68-72
VIII. Managing Software Quality p. 73-79
IX. Managing Supplier Quality & Incoming/Receiving Inspections p. 80-87
X. Managing Manufacturing/Outgoing Inspections p. 88-95
XI. Managing Laboratory Testing & Scientific Quality Processes p. 96-103
XII. Complaint Management & Resolution Activities p. 104-118
XIII. Managing NCE Activity p. 119-124
XIV. Managing Corrections & Removals p. 125-127
XV. Supporting R&D Clinical Trials p. 128-131
XVI. Quality System p. 132-135
XVII. Future Directions for Quality Organization p. 136-143
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3. Research Objective &
Methodology
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4. Research Background and Methodology
Best Practices, LLC conducted this benchmarking study to establish meaningful
benchmarks for the resource levels and the activities scope of the Quality function for
medical device companies.
Background:
Medical Device and Technology companies devote significant resources to ensure their products meet
quality standards and regulations at every stage of the product life cycle, from R&D and product
development through manufacturing, sale, and post-market activity. Increasingly, companies are
challenged to ensure quality and safety while managing costs and assessing risk. This survey benchmarks
how companies are addressing these critical quality, safety, regulatory and business requirements.
Field Research & Insight Development: Objective:
 Surveyed 11 leaders at 11 medical device To uncover resource and activity
INFORM
companies. benchmarks as well as forward-
 Conducted five deep-dive executive interviews to looking insights about the
collect qualitative insights from selected survey Quality function at medical
participants. device companies.
Deep Dive Interview Questions:
1. What improvement initiatives are you working on in the Quality function?
2. Where are you taking out headcount – why is this an area for cuts?
3. How are you approaching risk with fewer resources - fewer inspections, etc.?
4. What are the primary drivers of outsourcing or off shoring Quality activities?
5. What are your systems for effectively and efficiently managing complaints?
6. Does sustaining engineering include production line support and product design?
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5. Universe of Learning: 11 Companies Engaged
Research participants included 11 executives from 11 medical device companies. Five
executives participated in interviews.
Nitinol Devices & Components
Participating Companies: Bausch & Lomb; Boston Scientific; Covidien; Edwards Lifesciences; Ethicon;
Medrad; Medtronic; Nitinol Devices & Components; Roche Diagnostics; Terumo Medical; Zimmer
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6. Medical Device Revenue Averages $5.6B
Medical device and technology companies of all sizes face regulatory changes and must
adapt resources to meet demand. Medical device revenue in the benchmark class averages
approximately $5.6B.
Q. Please estimate your company's 2010 annual revenue from medical device sales and related
services. (Provide figures in U.S. dollars, using data from 2010 or most recently completed fiscal year.)
Estimated Medical Device
Revenue ($USD):
Max $16,000,000,000
75th Percentile $9,903,000,000
Mean $5,551,636,364
Median $4,300,000,000
25th Percentile $1,075,000,000
Min $62,000,000
(n = 11)
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7. Nearly 2/3 Increased Quality’s Staffing during Past 3 Years
Almost two-thirds of the benchmark class indicated growth in quality function staffing
and only 18% of companies indicated a decrease in the number of FTEs over the past
three years. The average percent change of total FTEs was positive 8%. The range of
percent changes for staffing was -7 to 13%.
Q. Staffing Change Trend: How has the total numbers of FTEs of your company's medical device
Quality function changed during the past three years? (Choose direction, then fill in the % change.)
Decreased, Increased, % Change of Quality
18% 64% FTEs in Medical Devices
and Related Services:
Max 13%
75th Percentile 12%
Mean 8%
Median 10%
25th Percentile 9%
Remained the
same Min -7%
18%
(n = 11) (n = 7)
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8. Quality Span of Control Ranges from 5 to 12 Direct Reports
Some companies provide a robust span of control for managers and senior managers.
Managers oversee twice as many direct reports as Vice Presidents, and more than five
more direct reports than their counterparts. Directors in quality have the smallest span
of control, averaging around five direct reports.
Q. Quality Span of Control: What is the average number of direct reports for a dedicated Quality
employee at each of the following levels?
Vice
Director Senior Manager Manager
President
Max 8 8 20 60
75th Percentile 7 6 7 8
Mean 6 5 7 12
Median 6 5 5 6
25th Percentile 5 4 3 4
Min 1 1 2 3
(n = 9 9 7 10)
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9. Compliance/Document Control is Automated with Some
Centralization
All medical device companies indicated some level of automation, with nearly half
responding that they highly automate in order to achieve high performance. In contrast,
centralization of this function is not as prevalent, as the benchmark class demonstrated
varying levels of centralization.
Q. Organizational Approach For Achieving High Q. Organizational Approach For Achieving High
Performance in Compliance/Document Control: Performance in Compliance/Document Control:
How centralized is this function? (Choose one) How automated is this function? (Choose one)
Highly
9% Completely
centralized 0%
automated
Mostly
27% Highly
centralized 45%
automated
Some activities Some
36% 55%
centralized automation
Mostly
9% Mostly manual 0%
decentralized
Completely Completely
18% 0%
decentralized manual
(n = 11) (n = 11)
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10. Corporate Level Quality Management Reviews are Completely
Standardized for 55%
Over 90% of corporate quality management reviews are mostly standardized, with 55% of
these reviews being completely standardized. More importantly, almost two-thirds of
business unit and manufacturing sites have mostly standardized quality management
reviews as well.
Q. Standardization of Quality Management Reviews: Please indicate the standardization of your Quality
Management Reviews at each level. (Choose one per level.)
N/A No standardization Some standardization Mostly standardization Complete Standardization
n=
Corporate 9% 36% 55% 11
Business 11
9% 27% 45% 18%
units/divisions
Manufacturing sites 18% 18% 45% 18% 11
Other 50% 50% 2
Other:
• Operations Quality Management Review
• Regions that don't have a manufacturing site
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11. About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts
work based on the simple yet profound principle that organizations
can chart a course to superior economic performance by studying
the best business practices, operating tactics and winning
strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
919-403-0251
bestpractices@best-in-class.com
www.best-in-class.com
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