Medical Device Scientific Affairs

$9,995.00

This six-report collection offers detailed metrics for medical device scientific affairs.  Findings show how companies allocate budgets, staffing and activity timelines for 11 scientific affairs subfunctions, with a focus on these areas:

  • Medical Science Liaisons (scientific/medical field force)
  • Medical Communications
  • Thought Leader Development
  • Medical Device Speaker Programs and Continuing Medical Education
  • Medical Device Regulatory Affairs and Compliance

The best practice discussions included in each report examine how medical device companies organize their scientific affairs teams and position them for maximum strategic impact. The reports also explore internal and external trends affecting medical device scientific affairs functions.

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Report Details

Publication Date: April 2016
Pages: 440
Chapters: 25
Metrics: 500+
Charts/Graphics: 200+

Top Reasons to Buy these Medical Device Scientific Affairs Reports

Benchmark resources for 11 vital subfunctions of scientific affairs: Launching new medical devices requires a skill set specific to scientific affairs groups. To maximize impact during new product launches, effective medical device companies align their scientific affairs teams’ structures and resources under a dedicated organization. Device companies seeking to grow their scientific affairs budgets and staffing will benefit from these reports’ insights on product support throughout the brand’s lifecycle — from early-stage development to more than five years post-launch. Use the data in these studies to right-size medical affairs subfunctions’ resources and evaluate the pros and cons of scientific affairs teams’ structures.

Establish and track scientific affairs performance metrics: Measuring the scientific affairs team’s value is a common challenge for life science companies. Medical Device Scientific Affairs: Combining Strategy with Technologydetails how top companies use multiple performance metrics and key performance indicators (KPIs) to demonstrate the value of scientific affairs teams and their subfunctions. Use these reports to determine what performance measures are most appropriate for your scientific affairs teams and how to implement them to have maximum impact.

Develop and resource dedicated scientific affairs teams with high-level visibility within the organization: Learn how medical device companies elevate the strategic value of scientific affairs teams. These studies evaluate the benefits of hiring a chief medical officer (CMO), as well as how they disseminate global resources to markets of different size. Through these practices — and others — scientific affairs teams position themselves to demonstrate greater strategic impact to the organization. These reports are a valuable tool for any scientific affairs group that wants to elevate its visibility within the larger organization.

You may also like CEIConnect: The Lifesciences Industry’s On-Demand Research Resource

Excerpt from Medical Affairs for Medical Device Manufacturers

Throughout the life sciences industry, medical affairs has become an increasingly visible function. After more than a decade of structural reorganizations — from a function tied closely to commercial operations to a purely scientific department — medical affairs has taken on more internal responsibilities than ever before. Medical affairs teams are ultimately responsible for generating and disseminating medical and clinical information throughout the community. However, they are also called upon to act as internal product experts and to contribute their expertise to clinical, sales and market access teams.

Because of their elevated role within device manufacturers, medical affairs teams are able to impact product development and performance throughout the lifecycle. Often, departments begin working with medical devices during the pre-clinical stage — building relationships with key opinion leaders (KOLs) and contributing to strategic go/no-go decisions. This support continues as subfunctional teams prepare medical publications, organize educational speaking events and deploy medical science liaisons (MSLs) to meet with thought leaders. Medical information teams, which are tasked with answering unsolicited medical inquiries, typically support products well after they enter the market. Some teams continue product support until patent loss.

Table of Contents

PH231 Medical Affairs for Medical Device Manufacturers: Aligning Structure and Resources to Impact Emerging Products and the Scientific Community

5             Executive Summary

8              Study Definitions

9              Structuring Medical Affairs Departments to Support Growing Responsibilities

10           Elevating the Role of Medical Affairs in Device Organizations

16           Expanding Medical Affairs Capabilities to Manage Key Territories and Subfunctions

22           Balancing Financial and Human Resources to Drive Medical Affairs Efforts

23           Growing Medical Affairs Budgets to Match Increasing Team Responsibilities

35           Maximizing Human Resources to Drive Medical Affairs Initiatives

40           Combining Medical Affairs Expertise and Technology to Support Products

41           Supporting Medical Device Products and Overcoming Industry Challenges

46           Leveraging Databases and Digital Communication to Manage Thought Leader Interaction

52           Medical Affairs Team Profile: Maximizing Functional Impact Through Structure and Resources

CHARTS AND GRAPHICS

5             Executive Summary

9              Structuring Medical Affairs Departments to Support Growing Responsibilities

10           Elevating the Role of Medical Affairs In Device Organizations

11           Figure 1.1: Percentage of Companies with Dedicated Medical Affairs Teams

12           Figure 1.2: Operational Unit Overseeing Medical Affairs: All Companies

12           Figure 1.3: Level of Executive Leading Medical Affairs: All Companies

14           Figure 1.4: Percentage of Companies with Centralized v. Decentralized Medical Affairs Teams

16           Expanding Medical Affairs Capabilities to Manage Key Territories and Subfunctions

17           Figure 1.5: Percentage of Medical Affairs Teams with Specific Regions of Responsibility

18           Figure 1.6: Percentage of Medical Affairs Teams Housing Specific Subfunctions: All Companies

19           Figure 1.7: Percentage of Medical Affairs Teams Housing Specific Subfunctions: Large and Mid-Size Companies

19           Figure 1.8: Percentage of Medical Affairs Teams Housing Specific Subfunctions: Small Companies

20           Figure 1.9: Percentage of Companies Outsourcing Medical Affairs Tasks

21           Figure 1.10: Percentage of Companies Outsourcing Specific Medical Affairs Activities

22           Balancing Financial and Human Resources to Drive Medical Affairs Efforts

23           Medical Affairs Budgets Match Increasing Team Responsibilities

23           Figure 2.1: Annual Medical Affairs Budget, by Company

24           Figure 2.2: Percentage of Medical Affairs Teams Dedicating Budget to Specific Subfunctions: All Companies

25           Figure 2.3: Percentage of Medical Affairs Teams Dedicating Budget to Specific Subfunctions: Large and Mid-Size Companies

26           Figure 2.4: Percentage of Medical Affairs Teams Dedicating Budget to Specific Subfunctions: Small Companies

27           Figure 2.5: Average Percentage of Budget Dedicated to Specific Subfunctions: All Companies

28           Figure 2.6: Average Percentage of Budget Dedicated to Specific Subfunctions: Large/Mid-Size Companies

29           Figure 2.7: Average Percentage of Budget Dedicated to Specific Subfunctions: Small Companies

30           Figure 2.8: Percentage of Global Medical Affairs Budget Allocated to Specific Regions, by Company

31           Figure 2.9: Percentage of Global Medical Affairs Budget Allocated to Canada and the US, by Company

32           Figure 2.10: Percentage of Global Medical Affairs Budget Allocated to European Countries, by Company

32           Figure 2.11: Percentage of Global Medical Affairs Budget Allocated to Asia, Latin America and the Rest of the World, by Company

33           Maximizing Human Resources to Drive Medical Affairs Initiatives

34           Figure 2.12: Medical Affairs FTEs Supporting Specific Subfunctions, by Company

35           Figure 2.13: Percentage of Global Medical Affairs FTEs Allocated to Specific Regions, by Company

37           Figure 2.14: Percentage of Global Medical Affairs FTEs Allocated to Canada and the US, by Company

37           Figure 2.15: Percentage of Global Medical Affairs FTEs Allocated to European Countries, by Company

38           Figure 2.16: Percentage of Global Medical Affairs FTEs Allocated to Asia, Latin America and the Rest of the World, by Company

39           Combining Medical Affairs Expertise and Technology to Support Products

40           Supporting Medical Device Products and Overcoming Industry Challenges

41           Figure 3.1: Earliest Lifecycle Stage Medical Affairs Teams Support Products

42           Figure 3.2: Latest Lifecycle Stage Medical Affairs Teams Support Products

44           Figure 3.3: Challenges Facing Medical Affairs Teams

45           Leveraging Databases and Digital Communication to Manage thought Leader Interaction

46           Figure 3.4: Percentage of Companies Using a Physician-Interaction CRM

47           Figure 3.5: Age of Current Physician-Interaction CRMs

49           Figure 3.6: Access Levels Afforded to Specific Employment Levels: All Companies

50           Figure 3.7: Usage of Digital Technology by Medical Affairs Groups

51           Medical Affairs Team Profile: Maximizing Functional Impact through Structure and Resources

53           Figure 4.1: Company 2 Medical Affairs Background and Structure

54           Figure 4.2: Company 2 Medical Affairs Budget

55           Figure 4.3: Company 2 Medical Affairs Technology

PH232 Medical Science Liaison Teams for Device Manufacturers: Supporting Medical Affairs Strategy Through a Robust MSL Program

7             Executive Summary

11           Study Methodology

12           Study Definitions

13           Structuring and Resourcing MSL Programs to Drive Internal and External Education

14           Optimizing MSLs’ Internal and External Impact Through Team Structure

21           Drive Efficient MSL Programs with Adequate Staffing Resources

33           Dedicating Sufficient Funds to Support a Broad Range of MSL Activities

38           Managing Medical Initiatives Throughout the Product Lifecycle

39           Leverage MSLs’ Expertise to Aid Companywide Initiatives

41           Vary Medical Science Liaison Team Efforts to Best-Fit a Product’s Current Development Phase

52           Considering Company Needs to Select Key Opinion Leaders

61           Measuring and Documenting MSL Team Performance

62           Combining Multiple Performance Metrics to Showcase MSL Team Success

67           Implementing Centralized IT Systems to Track Valuable Data

70           MSL Team Profile: Bridging Resources and Talent to Drive Medical initiatives

76           Implement Health Outcomes Liaisons to Deliver Clinical Data to Payers

77           Position Health Outcomes Liaisons Under Medical Affairs to Emphasize Clinical Knowledge

79           Vary Target Interaction to Support Product Needs Based on Brand Lifecycle and Payer Tier

82           HOL Team Profile: Employing Health Outcomes Experts to Deliver Value to Reimbursement Initiatives

CHARTS AND GRAPHICS

7             Executive Summary

13           Structuring and Resourcing MSL Programs to Drive Internal and External Education

14           Optimizing MSLs’ Internal and External Impact Through Team Structure

15           Figure 1.1: Percentage of Companies with a Dedicated MSL Team

15           Figure 1.2: Age of Dedicated MSL Teams

17           Figure 1.3: Function Overseeing MSL Programs

18           Figure 1.4: Executive Overseeing MSL Programs

19           Figure 1.5: Therapeutic Areas that MSL Teams Support

20           Figure 1.6: Percentage of Companies Outsourcing MSL Operations

21           Figure 1.7: Number of MSL Teams Supported

21           Drive Efficient MSL Programs with Adequate Staffing Resources

22           Figure 1.8: Number of US-Based MSLs

23           Figure 1.9: Number of MSLs per Supported Therapeutic Area, by Company

24           Figure 1.10: Criteria Used to Determine MSL Staffing Levels

25           Figure 1.11: Factors Leading to a Decrease of MSLs or MSL Teams

27           Figure 1.12: Education Level of MSLs Working with Specialist Opinion Leaders

28           Figure 1.13: Education Level of MSLs Working with Primary Care Physicians

29           Figure 1.14: Years of Experience for MSLs Working with Specialist Opinion Leaders and Primary Care Physicians

30           Figure 1.15: Average MSL Compensation, by Company

32           Figure 1.16: Frequency of Ongoing MSL Training

32           Figure 1.17: Perceived Relationship Between MSL Training and KOL Relationships

33           Dedicating Sufficient Funds to Support a Broad Range of MSL Activities

34           Figure 1.18: Factors Used to Establish Annual MSL Program Budget

35           Figure 1.19: Estimated Annual US Budgets

36           Figure 1.20: Average Percentage of MSL Budget Contributed By Specific Functions

37           Figure 1.21: Average MSL Budget Allocation

38           Managing Medical Initiatives Throughout the Product Lifecycle

41           Vary Medical Science Liaison Team Efforts to Best-Fit a Product’s Current Development Phase

42           Figure 2.1: Earliest Development Phase That MSL Teams Work with Products

43           Figure 2.2: Allocation of Time Across MSL Initiative Categories: Pre-Launch

45           Figure 2.3: Average Allocation of MSLs’ Time Across Specific Activities: Pre-Launch

46           Figure 2.4: Latest Development Phase During MSL Teams Work with Products

47           Figure 2.5: Allocation of Time Across MSL Initiative Categories: Post-Launch

49           Figure 2.6: Average Allocation of MSLs’ Time Across Specific Activities: Post-Launch

50           Figure 2.7: Percentage of MSL Teams Facilitating IITs Pre- and Post-Launch

51           Figure 2.8: Percentage of Approved IITs that Enter the Company via the MSL Team, by Company

52           Figure 2.9: Number of KOLs per Supported Therapeutic Area, by Company

52           Considering Company Needs to Select Key Opinion Leaders

53           Figure 2.10: Factors Determining Top-Tier KOL Selection

54           Figure 2.11: Average Number of New KOL Relationships per MSL per Year

55           Figure 2.12: Average Percentage of KOL Relationships Composed of Specific Professional Backgrounds

56           Figure 2.13: KOLs’ Spheres of Influence, by Company

57           Figure 2.14: Percentage of Companies Working with KOLs on Reimbursement Panels

59           Figure 2.15: Average Number of KOL Interactions via Specific Channels per Quarter, by Company

60           Figure 2.16: Average Duration of Face-to-Face Thought Leader Visits, by Company

61           Measuring and Documenting MSL Team Performance

62           Figure 3.1: Number of Performance Metrics Measured, by Company

62           Combining Multiple Performance Metrics to Showcase MSL Team Success

64           Figure 3.2: Percentage of Companies Measuring Specific Internal Performance Metrics

65           Figure 3.3: Percentage of Companies Measuring Specific External MSL Performance Metrics

67           Figure 3.4: Percentage of Companies Using a Centralized Information System to Track and Manage MSL Activities

70           MSL Team Profile: Bridging Resources and Talent to Drive Medical Initiatives

73           Figure 4.1: Company 3 MSL Team Structure and Budgets

74           Figure 4.2: Company 3 MSL Staffing, Compensation and Performance Measurement

75           Figure 4.3: Company 3 Product Support and Time Allocation

76           Implement Health Outcomes Liaisons to Deliver Clinical Data to Payers

82           HOL Team Profile: Employing Health Outcomes Experts to Deliver Value to Reimbursement Initiatives

84           Figure 5.1: Company 10 HOL Team Structure and Budgets

85           Figure 5.2: Company 10 Staffing and Compensation

86           Figure 5.3: Company 10 Product Support

 

PH233 Medical Communication Strategies for Medical Device Companies: Driving Product Knowledge Via Medical Publications and Information Teams

7             Executive Summary

10           Study Methodology

11           Study Definitions

13           Structuring and Resourcing Medical Publications Groups Effectively to Support Communication Strategy

14           Consider Organizational Needs to Structure and Resource Medical Publications Teams

30           Outsource Workloads to Drive Cost-Efficient Medical Publications Strategies

33           Supporting New Medical Devices Through Publications Strategies

34           Implement Cohesive Medical Publications Strategies to Drive Product Performance

46           Overcome Obstacles Facing Medical Publications Teams

50           Selecting Best-Fit Journals for Medical Publications

56           Medical Publications Team Profile: Combining Resources and Strategy to Reach the Scientific Community

63           Supporting the Vast Communications Network Through Dedicated Medical Information Teams

64           Structure and Resource Medical Information Teams to Support a Wide Variety of Responsibilities

67           Coordinate Medical Information Activities by Monitoring All Communication Channels

80           Call Centers Facilitate Rapid Medical Information Delivery

81           Support Medical Information Call Centers Through Sufficient Staffing and Technology

87           Use Performance Metrics to Gauge Existing Medical Information Procedures

90           Medical Information Call Center Profile: Distributing Information Quickly and Accurately

CHARTS AND GRAPHICS

7             Executive Summary

13           Structuring and Resourcing Medical Publications Groups Effectively to Support Communication Strategy

14           Consider Organizational Needs to Structure and Resource Medical Publications Teams

15           Figure 1.1: Percentage of Companies with Dedicated Medical Publications Groups

16           Figure 1.2: Percentage of Companies with Centralized v. Decentralized Medical Publication Structures

16           Figure 1.3: Medical Publications Group Structure

17           Figure 1.4: Functional Department Housing Medical Publications

18           Figure 1.5: Level of Executive Leading Medical Publications Groups

19           Figure 1.6: Percentage of Companies with High-Output v. Low-Output Medical Publications Groups

20           Figure 1.7: Number of Abstracts Developed Annually, by Company

22           Figure 1.8: Number of Manuscripts Developed and Published Annually, by Company

24           Figure 1.9: Number of Dedicated Medical Publications FTEs, by Company

25           Figure 1.10: Percentage of Companies Offering Compliance Training to Medical Writers

26           Figure 1.11: Number of Standards Employed to Guide Publications

27           Figure 1.12: Percentage of Companies’ Teams Following Specific Publication Standards

28           Figure 1.13: Annual Medical Publications Budgets, by Company Size

29           Figure 1.14: Percentage of Medical Publications Funding Contributed by Specific Functions, by Company

30           Outsource Workloads to Drive Cost-Efficient Medical Publications Strategies

31           Figure 1.15: Percentage of Annual Medical Publications Budgets Outsourced, by Company

31           Figure 1.16: Percentage of Companies Outsourcing Specific Medical Publications Activities

33           Supporting New Medical Devices Through Publications Strategies

34           Figure 2.1: Self-Assessment for Medical Publications Efforts, by Company

34           Implement Cohesive Medical Publications Strategies to Drive Product Performance

36           Figure 2.2: Relevancy of Specific Objectives to Average Medical Publications Strategies

40           Figure 2.3: Lifecycle Stage When Companies First Develop a Device’s Publications Strategy

41           Figure 2.4: Lifecycle Stage When Companies First Publish a Manuscript for the Average Brand

42           Figure 2.5: Latest Stage During Which Medical Publications Departments Support a Brand

44           Figure 2.6: Functions Contributing to Medical Publications Efforts

46           Overcome Obstacles Facing Medical Publications Teams

47           Figure 2.7: Top Challenges Facing Medical Publications Teams

48           Figure 2.8: Percentage of Medical Publications Teams Measuring ROI

49           Figure 2.9: Percentage of Medical Information Teams with Established Safeguards Against Ghostwriting

50           Figure 2.10: Percentage of Groups Leveraging Specific Publications Channels

50           Selecting Best-Fit Journals for Medical Publications

52           Figure 2.11: Factors that Most Influence Medical Publications Groups’ Journal Selection

56           Medical Publications Team Profile: Combining Resources and Strategy to Reach the Scientific Community

59           Figure 3.1: Company 6 Medical Publications Team Structure, Staffing and Performance

60           Figure 3.2: Company 6 Medical Publications Team Budget and Outsourcing

61           Figure 3.3: Company 6 Medical Publications Strategy and Challenges

62           Figure 3.4: Company 6 Medical Publications Journal Selection

63           Supporting the Vast Communications Network Through Dedicated Medical Information Teams

64           Structure and Resource Medical Information Teams to Support a Wide Variety of Responsibilities

65           Figure 4.1: Medical Information Structure, Alignment and Staffing, by Company

66           Figure 4.2: Annual Medical Information Budgets and Outsourcing Levels, by Company

66           Figure 4.3: Medical Information Team Funding Sources, by Company

67           Figure 4.4: Percentage of Medical Information Inquiries Originating from Specific Healthcare Providers, by Company

67           Coordinate Medical Information Activities by Monitoring All Communication Channels

68           Figure 4.5: Percentage of Medical Information Requests Entering the Company from Specific Stakeholders, by Company

69           Figure 4.6: Percentage of Companies Receiving Medical Inquiries from Specific Channels

70           Figure 4.7: Percentage of Medical Inquiries Related to Specific Topics: Company 2

71           Figure 4.8: Distribution of Verbal v. Written Responses, by Company

72           Figure 4.9: Delivery of Medical Inquiry Responses, by Company

73           Figure 4.10: Written Responses/Journal Article Reprints per Month, by Company

74           Figure 4.11: Target v. Actual Turnaround Time for Medical Inquiries, by Company

76           Figure 4.12: Medical Information Team Responsibilities for Specific Activities, by Company

77           Figure 4.13: Frequency of Review and Available Web Access for Frequently Asked Questions (FAQs) and Standard Response Documents, by Company

78           Figure 4.14: Percentage of Medical Information Teams Providing Written Information for Investigational Products

80           Call Centers Facilitate Rapid Medical Information Delivery

81           Support Medical Information Call Centers Through Sufficient Staffing and Technology

82           Figure 5.1: Percentage of Companies Maintaining In-House Call Centers

82           Figure 5.2: Percentage of Companies Maintaining Outsourced Call Centers

83           Figure 5.3: Call Center Operations Hours, by Company

84           Figure 5.4: Educational Background for Call Center Staff

85           Figure 5.5: Percentage of Companies with Medical Information Specialists on Call

86           Figure 5.6: Percentage of Companies Implementing an Interactive Voice Response (IVR) System

87           Use Performance Metrics to Gauge Existing Medical Information Procedures

87           Figure 5.7: Number of Performance Metrics Used to Evaluate Call Centers, by Company

89           Figure 5.8: Percentage of Companies Using Specific Performance Metrics to Evaluate Call Centers

90           Medical Information Call Center Profile: Distributing Information Quickly and Accurately

91           Figure 5.9: Company 3 Call Center Overview and Staffing

 

PH234 Thought Leaders Development for Medical Device Firms Building Effective Relationships with Industry Leaders

5             Executive Summary

8             Study Methodology

9              Study Definitions

10           Building Relationships with Thought Leaders to Gain Deeper Product Understanding

11           Positioning and Resourcing Thought Leader Development Teams

18           Staffing Thought Leader Development Teams

22           Identifying Thought Leader Qualifications

23           Considering Physicians’ Qualifications to Match Thought Leaders to Products

38           Thought Leader Management Profiles: Implementing Effective Strategy to Partner with Key Opinion Leaders

CHARTS AND GRAPHICS

5             Executive Summary

10           Building Relationships with Thought Leaders to Gain Deeper Product Understanding

11           Positioning and Resourcing Thought Leader Development Teams

12           Figure 1.1: Preferred Thought Leader Development Organization

14           Figure 1.2: Thought Leader Development Budget

15           Figure 1.3: Average Percentage of Thought Leader Management Budget Dedicated to Activities

16           Figure 1.4: Average Annual Compensation for Advising Services

17           Figure 1.5: Average Annual Grant Funding

18           Staffing Thought Leader Development Teams

19           Figure 1.6: Number of Brands Supported by Thought Leader Development Organization, by Company

20           Figure 1.7: Number of Full-Time and Contract Employees Responsible for Thought Leader Development

21           Figure 1.8: Average Number of Interactions Between MSL and Thought Leader per Month, by Activity

22           Identifying Thought Leader Qualifications

23           Considering Physicians’ Qualifications to Match Thought Leaders to Products

24           Figure 2.1: Thought Leader Categories Targeted for Building Relationships

26           Figure 2.2: Preferred Years of Clinical Experience for Opinion Leaders, by Company

26           Figure 2.3: Preferred Years of Clinical Experience for Opinion Leaders, by Therapeutic Area

28           Figure 2.4: Preferred Number of Publications for Opinion Leaders, by Company

28           Figure 2.5: Preferred Number of Publications for Opinion Leaders, by Therapeutic Area

30           Figure 2.6: Preferred Number of Speeches for Opinion Leaders, by Company

30           Figure 2.7: Preferred Number of Speeches for Opinion Leaders, by Therapeutic Area

31           Figure 2.8: Preferred Number of Advisory Boards for Opinion Leaders

32           Figure 2.9: Perceived Importance of Factors Raising a Thought Leaders Segmenting

34           Figure 2.10: Length of Time Thought Leaders Are Expected to Spend Delivering a Promotional Speech

34           Figure 2.11: Length of Time Thought Leaders Are Expected to Spend Leading an Advisory Panel (Chair)

35           Figure 2.12: Length of Time Thought Leaders Are Expected to Spend Moderating an Advisory Panel

35           Figure 2.13: Length of Time Thought Leaders Are Expected to Spend Participating in an Advisory Panel

36           Figure 2.14: Length of Time Thought Leaders Are Expected to Spend Authoring an Abstract

36           Figure 2.15: Length of Time Thought Leaders Are Expected to Spend on General Training

37           Figure 2.16: Length of Time Thought Leaders Are Expected to Spend Authoring a Manuscript

37           Figure 2.17: Average Length of Time for Thought Leader Activities

38           Thought Leader Management Profiles: Implementing Effective Strategy to Partner with Key Opinion Leaders

39           Figure 3.1: Company 1 Profile

40           Figure 3.2: Company 2 Profile

41           Figure 3.3: Company 4 Profile

42           Figure 3.4: Company 5 Profile

43           Figure 3.5: Company 6 Profile

44           Figure 3.6: Company 7 Profile

45           Figure 3.7: Company 8 Profile

46           Figure 3.8: Company 9 Profile

 

PH235 Medical Device Speaker Programs and Continuing Medical Education Reaching the Community Through Educational and Promotional Events

Executive Summary

9             Study Methodology

10           Study Definitions

11           Building the Ideal Speaker Program Through Team Structure and Speaker Recruitment

12           Structuring Speaker Program Teams to Manage High Volumes of Activities

17           Enlisting Key Physicians as Promotional and Educational Speakers

22           Conducting Speaking Events and Measuring Program Effectiveness to Mitigate Challenges

23           Ensuring Ground-Level Speaker Program Activities Are Strategically Planned to Bring Success

37           Assessing Speaker Program Effectiveness to Overcome Industry Challenges

42           Partnering with Top-Tier Thought Leaders Through Competitive Compensation

43           Considering Engagement Requirements and Company Policies to Compensate Speakers

53           Equipping Speaker Programs with Adequate Financial and Staffing Resources

54           Dedicating Substantial Funding to Drive Speaker Programs

60           Filling Varying Roles to Support Speaker Program Teams

63           Continuing Medical Education: Contributing to the Medical Community’s Growing Knowledge Base

CHARTS AND GRAPHICS

9             Study Methodology

10           Study Definitions

11           Building the Ideal Speaker Program Through Team Structure and Speaker Recruitment

12           Figure 1.1: Percentage of Company’s Total Speaker Programs

12           Structuring Speaker Program Teams to Manage High Volumes of Activities

13           Figure 1.2: Structure of Speaker Program Teams

14           Figure 1.3: Functions Involved in Speaker Program Activities

14           Figure 1.4: Activities the Speaker Program Team Oversees

15           Figure 1.5: Total Speaker Events Conducted Annually

16           Figure 1.6: Percentage of Speaker Programs Conducted, by Format: US

17           Enlisting Key Physicians as Promotional and Educational Speakers

18           Figure 1.7: Number of Speakers within Speaker Bureau

18           Figure 1.8: Credentials of Speakers Hired

19           Figure 1.9: Preferred Speaker Background

19           Figure 1.10: Impression of Speakers Speaking for More Than One Company

20           Figure 1.11: Average Perceived Effectiveness of Speaker Recruitment Tools

21           Figure 1.12: Hours of Training Provided to Speakers Before They Are Allowed to Present

21           Figure 1.13: Speaker Compensation for Training

22           Conducting Speaking Events and Measuring Program Effectiveness to Mitigate Challenges

23           Ensuring Ground-Level Speaker Program Activities Are Strategically Planned to Bring Success

24           Figure 2.1: Percentage of Companies Utilizing Specific Types of Speaker Program

25           Figure 2.2: Typical Attendance of Speaker Programs

26           Figure 2.3: Typical Attendance of Speaker Programs: Urban Setting

27           Figure 2.4: Typical Attendance of Speaker Programs: Suburban Setting

27           Figure 2.5: Typical Attendance of Speaker Programs: Rural Setting

28           Figure 2.6: Average Cost per Speaker Program Attendee

29           Figure 2.7: Upper Limit of Company Cost per Attendee

30           Figure 2.8: Average Cost of Speaker Programs: Urban Setting

31           Figure 2.9: Average Cost of Speaker Programs: Suburban Setting

31           Figure 2.10: Average Cost of Speaker Programs: Rural Setting

32           Figure 2.11: Typical Duration of Speaker Programs, by Type

33           Figure 2.12: Best Time of Day to Conduct Speaker Programs, by Type

33           Figure 2.13: Worst Time of Day to Conduct Speaker Programs, by Type

34           Figure 2.14: Typical Preparation Time for Speaker Programs, in Hours

35           Figure 2.15: Lifecycle Stage when Speaker Programs Begin to Support Product

36           Figure 2.16: Lifecycle Stage when Speaker Programs Are Most Effective

37           Assessing Speaker Program Effectiveness to Overcome Industry Challenges

38           Figure 2.17: Rating of Effectiveness and Satisfaction with Company’s Overall Speaker Program Initiative

38           Figure 2.18: Average Perceived Effectiveness of Speaker Programs at Companies 9 Through 15

39           Figure 2.19: Perceived Effectiveness of Speaker Programs Now as Compared to Five Years Ago

41           Figure 2.20: Ratings of Speaker Program Challenges: Companies 1 Through 7

41           Figure 2.21: Ratings of Speaker Program Challenges: Companies 8 Through 14

42           Partnering with Top-Tier Thought Leaders Through Competitive Compensation

43           Considering Engagement Requirements and Company Policies to Compensate Speakers

43           Figure 3.1: Means of Compensating Speakers

44           Figure 3.2: Minimum and Maximum Allowed Compensation for Speakers Paid a Flat Fee

46           Figure 3.3: Typical Flat Fee for Speaker Compensation

47           Figure 3.4: Compensation for Speakers Paid an Hourly Rate

48           Figure 3.5: Percentage of Companies that Include Travel Costs in Speaker Compensation

49           Figure 3.6: Typical Compensation for Travel

51           Figure 3.7: Percentage of Companies with an Annual Cap for Compensation to an Individual Speaker

51           Figure 3.8: Maximum Annual Payment Allowed for a Single Speaker

52           Figure 3.9: Functions to Which the Annual Cap Applies

53           Equipping Speaker Programs with Adequate Financial and Staffing Resources

54           Figure 4.1: Overall Speaker Program Budget, by Company

54           Dedicating Substantial Funding to Drive Speaker Programs

56           Figure 4.2: Regional Allocation of Speaker Program Budget

57           Figure 4.3: Percentage of Budget Outsourced

58           Figure 4.4: Functions that Contribute to Speaker Programs

59           Figure 4.5: Percentage of Speaker Program Budget Accounted for by Each Function

60           Filling Varying Roles to Support Speaker Program Teams

61           Figure 4.6: Placement of Speaker Program FTEs on Team

62           Figure 4.7: Number of FTEs Involved with Speaker Programs at Different Levels

63           Continuing Medical Education: Contributing to the Medical Community’s Growing Knowledge Base

65           Figure 5.1: Company 15: Structure and Organization

66           Figure 5.2: Company 15: Resources and Activities

PH236 Regulatory Affairs and Compliance for Medical Device Manufacturers: Maintaining Industry Standards to Ensure Product Success

6             Executive Summary

8             Study Methodology

9              Study Definitions

10           Building Regulatory Affairs Team Influence Through Structure and Budget

11           Structuring Centralized Regulatory Affairs Functions to Meet Internal Needs

30           Enhancing Regulatory Affairs’ Strategic Impact

31           Leveraging Cross-functional Groups to Increase Regulatory Impact

42           Navigating Different Regulatory Agencies and Timelines

52           Product Case Studies: Meeting with Agencies to Enhance Regulatory Involvement

59           Structuring Compliance Teams to Support Portfolio Demands

60           Matching Compliance Team Structure to Company Needs

65           Balancing Declining Compliance Resources with Increasing Functional Importance

69           Implementing Industry Standards with Compliance Training and SOPs

70           Ensuring Industry Standards with Compliance Training

81           Overcoming Challenges in Staffing, Communication and Regulatory Intelligence

84           Compliance Team Profiles: Focusing Team Efforts to Develop Effective SOPs

CHARTS AND GRAPHICS

8             Study Methodology

9              Study Definitions

10           Building Regulatory Affairs Team Influence Through Structure and Budget

11           Structuring Centralized Regulatory Affairs Functions to Meet Internal Needs

12           Figure 1.1: Regulatory Affairs Group Structure

12           Figure 1.2: Level of Executive Leading Regulatory Affairs

13           Figure 1.3: Countries/Regions for Which Regulatory Affairs Is Responsible

13           Figure 1.4: Therapeutic Areas for Which Regulatory Affairs Is Responsible

14           Figure 1.5: Functions that Regulatory Affairs Oversees

15           Figure 1.6: Age of Regulatory Affairs Functions

16           Figure 1.7: Age of Regulatory Affairs Functions, by Company

17           Figure 1.8: Regulatory Affairs Budgets, by Company

18           Figure 1.9: Departments that Fund Regulatory Affairs

19           Figure 1.10: Percentage of Funding from Different Departments, by Company

20           Figure 1.11: Percentage of Total Funding Spent on Regulatory Affairs Activities

21           Figure 1.12: Time and Budget Spent on Regulatory Activities for Company 3

22           Figure 1.13: Time and Budget Spent on Regulatory Activities for Company 4

22           Figure 1.14: Time and Budget Spent on Regulatory Activities for Company 5

23           Figure 1.15: Percentage of Companies that Outsource a Portion of Regulatory Affairs Responsibilities

24           Figure 1.16: Percentage of Regulatory Affairs Budget Outsourced

24           Figure 1.17: Percentage of Regulatory Budget Outsourced, by Company

25           Figure 1.18: Percentage of Regulatory Affairs Work Outsourced

26           Figure 1.19: Frequency of Contact with Outsourced Personnel

27           Figure 1.20: Number of FTEs Within Regulatory Function, by Company

28           Figure 1.21: Number of Outsourced and In-House Regulatory Affairs FTEs, by Company

29           Figure 1.22: Number of FTEs Within Regulatory Function, by Company

30           Enhancing Regulatory Affairs’ Strategic Impact

31           Leveraging Cross-Functional Groups to Increase Regulatory Impact

31           Figure 2.1: Importance of a Successful Regulatory Intelligence Function

32           Figure 2.2: Functions with Which Regulatory Affairs Often Interacts

33           Figure 2.3: Regulatory Affairs Groups’ Involvement with Marketing Activities

34           Figure 2.4: Regulatory Affairs Groups’ Involvement with Clinical Trials

35           Figure 2.5: Regulatory Affairs Groups’ Involvement in Manufacturing Activities

36           Figure 2.6: Level of Regulatory Affairs Teams’ Interaction with Marketing/Commercial

37           Figure 2.7: Level of Regulatory Affairs Teams’ Interaction with Clinical/R&D

37           Figure 2.8: Level of Regulatory Affairs Teams’ Interaction with Medical Affairs

39           Figure 2.9: Frequency of Meetings with Marketing/Commercial per Month

39           Figure 2.10: Frequency of Meetings with Clinical/R&D per Month

40           Figure 2.11: Frequency of Regulatory Affairs Teams’ Meetings with Medical Affairs per Month

41           Figure 2.12: Regulatory Affairs Teams’ Perceived Success in Communicating with Different Functions

42           Figure 2.13: Which Regulatory Body Poses More Challenges?

42           Navigating Different Regulatory Agencies and Timelines

43           Figure 2.14: Countries that Present the Greatest Regulatory Hurdles

46           Figure 2.15: Perceptions on How Regulatory Times Have Changed in Recent Years

46           Figure 2.16: Perceived Factors Impacting Protraction of Regulatory Timelines

47           Figure 2.17: Duration of Regulatory Submission Timelines: Investigational Stage

47           Figure 2.18: Duration of Regulatory Submission Timelines: Pre-Market Stage

48           Figure 2.19: Duration of Regulatory Submission Timelines: Post-Market Stage

49           Figure 2.20: Frequency of Regulatory Affairs Teams’ Contact with FDA

51           Figure 2.21: Perceptions of Specific Regulatory Affairs Challenges

52           Product Case Studies: Meeting with Agencies to Enhance Regulatory Involvement

53           Figure 2.22: Company 19 Case Study 1

54           Figure 2.23: Company 19 Case Study 1, Cont.

55           Figure 2.24: Company 19 Case Study 2

56           Figure 2.25: Company 19 Case Study 2, Cont.

57           Figure 2.26: Company 20 Case Study 1

58           Figure 2.27: Company 20 Case Study 1, Cont.

59           Structuring Compliance Teams to Support Portfolio Demands

60           Matching Compliance Team Structure to Company Needs

62           Figure 3.1: Compliance Group Structure

62           Figure 3.2: Countries/Regions for Which Compliance Is Responsible

63           Figure 3.3: Level of Executive that Heads Compliance Group

64           Figure 3.4: Age of Compliance Groups

65           Figure 3.5: Departments that Fund Compliance

65           Balancing Declining Compliance Resources with Increasing Functional Importance

66           Figure 3.6: Compliance Budgets, by Company

67           Figure 3.7: Percentage of Companies that Outsource a Portion of Compliance Responsibilities

68           Figure 3.8: Percentage of Compliance Budgets Outsourced

68           Figure 3.9: Number of In-House and Outsourced FTEs, by Company

69           Implementing Industry Standards with Compliance Training and SOPs

70           Figure 4.1: Compliance Group Responsibilities

70           Ensuring Industry Standards with Compliance Training

71           Figure 4.2: Intervals at which Companies Train Internal Personnel

72           Figure 4.3: Percentage of Companies that Maintain Quotas for Internal Compliance Training

72           Figure 4.4: How Does the Company Measure Compliance Training?

73           Figure 4.5: Internal Departments that Compliance Trains

74           Figure 4.6: Number of Hours of Training an Internal FTE Receives per Year, by Function

75           Figure 4.7: Number of Hours of Training a Market Access FTE Receives per Year for Company 29

76           Figure 4.8: Number of Hours of Training a Sales FTE Receives per Year

76           Figure 4.9: Number of Hours of Training a Clinical Development FTE Receives per Year

77           Figure 4.10: Percentage of Companies that Train New Hires

78           Figure 4.11: Number of Hours of Compliance Training a New Hire Receives

79           Figure 4.12: Percentage of Companies that Train External Personnel in Compliance

80           Figure 4.13: Number of Compliance Training Hours an External FTE Receives per Year at Company 27

81           Overcoming Challenges in Staffing, Communication and Regulatory Intelligence

82           Figure 4.14: Perceived External Compliance Challenges

82           Figure 4.15: Ratings of Departmental Compliance

83           Figure 4.16: Perception of Internal Compliance Challenges

84           Compliance Team Profiles: Focusing Team Efforts to Develop Effective SOPs

85           Figure 4.17: Company 27 Profile

86           Figure 4.18: Company 27 Profile, Cont.

87           Figure 4.19: Company 29 Profile

88           Figure 4.20: Company 29 Profile, Cont.