Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth. Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring. Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.

1. Regulatory Affairs Excellence:
Staffing & Performance in Medical Device Companies
Best Practices, LLC Strategic Benchmarking Research
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2. TABLE OF CONTENTS
I. Executive Summary
 Research Objective & Methodology
 Key Findings
 Participating Companies Demographics
II. Respondent Background
 Respondent Demographics
 Regulatory Affairs Reporting Relationship
III. Regulatory Affairs Structure
 Functional Structure
 Corporate Regulatory Affairs FTEs
 Span of Control
IV. Regulatory Function Activities
 Active Regulatory Submissions
 2010 Filings
 Filing Trends
V. Regulatory Function Roles & Responsibilities
 Leading & Supporting Roles
 Corporate Regulatory Affairs Roles
 Storage, Publishing & Translation Solutions
VI. Regulatory Function Investment and Staffing
 2010 Spend & Staffing
 Future Resource Trends
VII. Regulatory Function Outsourcing and Offshoring Trends
 Regulatory Affairs Growth through Resource Efficiencies
VIII. Impact of 510(k) Reform
 Impact of Reform on Resources
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3. 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 Regulatory Affairs
function for medical device companies.
Background:
With the monumental task of ensuring that companies comply with the plethora of global regulations
and laws pertaining to developing and marketing medical device products, Regulatory Affairs groups
must rely on their own internal effectiveness and efficiencies to remain productive. Optimal resourcing
and staffing, including a balance of outsourcing and off-shoring, will help Regulatory Affairs in the
Medical Technology industry prioritize roles and responsibilities that will be most beneficial to growth.
Field Research & Insight Development: Objective:
 Surveyed eight leaders at eight medical device To uncover resource and activity
INFORM
companies. benchmarks as well as forward-
 Conducted three deep-dive executive interviews to looking insights about the
collect qualitative insights from selected survey Regulatory Affairs function at
participants. medical device companies.
Deep Dive Interview Questions:
1. What process improvement initiatives are you working on in the Regulatory Affairs function?
2. In what areas do lean processes already exist?
3. Which structure best supports Regulatory Affairs activities?
4. How do you approach outsourcing and off-shoring of Regulatory Affairs activities?
5. How do you expect Regulatory Affairs resources to change in response to reform?
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4. Universe of Learning: Eight Companies Engaged
Research participants included eight executives from eight medical device companies.
Three executives participated in deep-dive interviews. The key findings and insights are
based on qualitative and quantitative data from their knowledge and experiences.
Participating Companies: Bausch & Lomb; Becton Dickinson; Boston Scientific;
Edwards Lifesciences; Ethicon; Medtronic; Roche Diagnostics; Zimmer
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5. Key Findings & Insights – 1/3
The following key findings and insights emerged from the data.
Medical Device Revenue: The average medical device revenue is $7B for the benchmark
Medical Device Revenue: The average medical device revenue is $7B for the benchmark
class. Half of the medical device revenue comes from U.S. sales.
class. Half of the medical device revenue comes from U.S. sales.
Regulatory Affairs Reporting Relationship: For 38% of companies, the Regulatory Affairs
Regulatory Affairs Reporting Relationship: For 38% of companies, the Regulatory Affairs
function reports to C-level management, or the highest level of senior management. For more
function reports to C-level management, or the highest level of senior management. For more
than one-third of companies, the Regulatory Affairs function reports into aacombined Quality
than one-third of companies, the Regulatory Affairs function reports into combined Quality
and Regulatory Affairs executive.
and Regulatory Affairs executive.
Functional Structure: Most Regulatory Affairs functions are business unit centric with RA
Functional Structure: Most Regulatory Affairs functions are business unit centric with RA
employees reporting directly to the business unit they support. A hybrid approach - -one that
employees reporting directly to the business unit they support. A hybrid approach one that
centralizes planning, information, and coordination, but not staff - -may help increase
centralizes planning, information, and coordination, but not staff may help increase
efficiency.
efficiency.
Corporate Regulatory Affairs Groups: Corporate Regulatory Affairs groups average seven
Corporate Regulatory Affairs Groups: Corporate Regulatory Affairs groups average seven
FTEs. The groups primarily promote standards, monitor the worldwide regulatory environment,
FTEs. The groups primarily promote standards, monitor the worldwide regulatory environment,
coordinate internal and external policy advocacy efforts, and advise business unit Regulatory
coordinate internal and external policy advocacy efforts, and advise business unit Regulatory
Affairs staff.
Affairs staff.
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6. Medical Device Revenue Ranges from $1B to $16B
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 $7B.
Q2. Please estimate your company's 2010 annual revenue from medical device sales and related
services. (Provide all cost figures in U.S. dollars. Use data from most recently completed fiscal year.)
Estimated Medical Device
Revenue ($USD):
Max $16,000,000,000
75th Percentile $9,100,000,000
Mean $6,995,875,000
Median $5,950,000,000
25th Percentile $3,565,000,000
Min $1,447,000,000
(n = 8)
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7. Most RA Groups Support Corporate Headquarters
Given the importance of Regulatory Affairs to the overall success of a medical device
company, most Regulatory Affairs executives in the benchmark class support efforts at
corporate headquarters. Only 25% primarily support a specific business or operating unit,
which can be attributed to the existing corporate structures at those companies.
Q9. Which entity do you primarily support? (Choose one.)
A specific
business/
operating unit,
25%
The corporate
headquarters,
(n = 8) 75%
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8. Most Regulatory Affairs Structures Are BU-Centric
Nearly two-thirds of companies employ a business-unit-centric Regulatory Affairs
structure where RA employees report directly to the business unit or manufacturing site
they support, but also have informal reporting relationships ("dashed line reporting") to a
separate Regulatory hierarchy that ultimately reports to a senior Regulatory Affairs leader.
Q12. How is Regulatory Affairs structured in your company? (Choose one.)
Distributed
Other, 13% Regulatory-
centric
Function: RA is
a separate
function
Business-unit- closely aligned
Centric with or
Regulatory distributed into
Function: RA BUs and/or
employees sites, 25%
report directly
to the BU or
manufacturing
site they
support, 63% Other:
•In transition from business centric
(n = 8) to distributed RA centric
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9. Most File Regulatory Submissions in >50 Countries
In addition to U.S., EU, Japan and Canada, benchmarked companies file regulatory
submissions in 56 other countries on average. A seamless global IT solution for document
storage is critical to avoid reinventing the wheel for every submission.
Q18. Outside the US, EU, Japan and Canada, in how many additional countries does your company file
regulatory submissions for medical devices?
Number of Additional
Countries where Filing
Regulatory Submissions:
Max 100
75th Percentile 60
Mean 56
Median 56
25th Percentile 45
Min 24
(n = 7)
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10. As with EU, Canadian Submissions are Less Taxing on RA
Resources
Canadian licensing costs are much lower per submission than for the U.S. or Japan,
although cost per submission is slightly higher than for the EU.
Q17. Approximately how much is your Regulatory spend and how many Regulatory FTEs and
Consultants do you have per each of the following active regulatory submissions?
Global RA Spend/ Global RA FTEs/ Global RA Consultants/
Active Submission Active Submission Active Submission
Canadian Canadian Canadian Canadian
Canadian Canadian
licenses - licenses - licenses - licenses -
licenses - Class III licenses - Class II
Class III & Class II Class III & Class II
& IV devices: devices:
IV devices: devices: IV devices: devices:
Max $1,800,000 $340,000 17.50 2.70 2.00 0.50
75th Percentile $249,251 $229,091 1.67 1.73 0.21 0.15
Mean $411,342 $162,966 3.58 1.20 0.37 0.12
Median $213,333 $163,102 1.49 0.93 0.06 0.02
25th Percentile $170,383 $84,457 1.10 0.57 0.04 0.02
Min $26,793 $10,563 0.55 0.18 0.00 0.00
(n = 7 7 7 7 7 7)
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11. PMAs and IDEs Received Consultant Focus
PMAs (see previous slide) and IDEs had the highest Regulatory Consultant FTE levels.
Submission Consultant FTE levels are total RA Consultant FTEs divided by total number of
submissions for each category.
Approximately how many Consultant FTEs were involved in each of the following submissions in 2010?
Canadian
Canadian Investiga-
Japan Japan Shonin licenses - licenses - tional Device Design Technical
Todokede (approval Class III &
applications):
Class II Exemptions dossiers: files:
(notifications): Class IV
devices: (IDEs):
devices:
Max 2.00 5.00 0.40 4.00 4.00 2.00 2.00
75th Percentile 0.82 0.42 0.19 0.16 1.54 1.50 0.53
Mean 0.57 1.01 0.15 0.73 1.13 0.86 0.51
Median 0.15 0.23 0.12 0.10 0.40 0.40 0.27
25th Percentile 0.10 0.14 0.02 0.04 0.22 0.30 0.11
Min 0.00 0.00 0.00 0.00 0.00 0.00 0.00
(n = 6 6 5 6 7 7 7)
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12. RA Leads Submissions, Labeling, FDA Correspondence, and
Registrations
At all organizations, regulatory takes a lead role for filing submissions. Meanwhile, 75
percent of companies have regulatory leading interactions with the FDA on official
correspondence and listings/registrations.
Q22. For the following responsibilities, does the Regulatory Affairs function lead, support, or play no
role? (Choose one role per responsibility.)
No Role Supporting Role Leading Role
Regulatory submissions to gain and/or
100%
market authorization
Labeling/publishing 25% 75%
FDA Official Correspondent 13% 13% 75%
FDA Listings and Registration 13% 13% 75%
Field corrective actions: notification to
13% 50% 38%
regulatory agencies; and follow up reporting
Responses to Notified Body Observations 75% 25%
Responses to FDA warning letters 88% 13%
Responses to FDA 483 observations 88% 13%
Audit support (FDA, Notified Bodies, all other
100%
agencies)
(n = 8) Complaint handling and MDR reporting 38% 63%
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13. 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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