Medical Device Development

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This report serves as a guide to medical device manufacturers that are undertaking new product planning and early commercialization initiatives for US-based launches. Because each product is different, the study profiles 11 devices, including product support and investments, unique approaches to product development and commercialization, and the human and financial resources needed to support these processes.

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Report Details

Publication Date: April 2015
Pages: 120
Chapters: 3
Metrics: 400+
Charts/Graphics: 95

Top Reasons to Buy This Medical Device Development Report

Leverage clinical trials to supplement FDA submissions and to enhance marketing messages: Although the FDA only requires clinical trials to support Pre-Market Approval (PMA) submissions, both PMA and pre-510(k) submissions can benefit from clinical data by earning more extensive claims than those submissions without clinical trials. Clinical trials may also satisfy anticipated questions from the FDA, thereby expediting regulatory clearance. This report includes medical device companies’ strategies for successful early commercialization for products launching in the US market, including the percentage of companies using specific regulatory pathways.

Manage commercial board size and responsibility to limit delays and keep communication open: Resourcing commercial boards appropriately, both in terms of adequate numbers as well as the right mix of functions, is crucial for product success. It is necessary to have several groups providing input and sharing information while maintaining the appropriate lines of communication. This report examines commercial board staffing and spending in detail. It also includes data on how different functions can most effectively contribute their expertise and experience to commercial teams.

Look to partnerships and acquisitions to maximize resources during product development and commercialization: Because medical device development and commercialization consume a lot of resources, many device manufacturers look to partnerships and acquisitions to aid a number of processes. Medical device companies can use acquisitions to gain businesses, intellectual property and technology, or any combination thereof. Medical Device Development features data that highlight the prevalence of partnerships and acquisitions for surveyed companies supporting Class 2 and Class 3 products.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual medical device & diagnostics research reports.

Excerpt from Medical Device Development

Medical device manufacturers face a number of challenges — from growing numbers of competitors to attaining the resources needed to support development — moving their products through development and into today’s saturated market. Because the commercial landscape is so competitive, organizations must begin commercialization processes early in the product lifecycle — sometimes as early as concept and prototype development. However, commercialization teams need the human and financial resources — either internal or through partnerships — to support emerging products throughout development.

This report serves as a guide to medical device manufacturers that are undertaking new product planning and early commercialization initiatives for US-based launches. Because each medical device product is different, this study profiles 11 companies’ devices, product support and investments. After presenting these unique approaches to product development and commercialization, this study examines the human and financial resources needed to support these processes. Appropriately resourcing commercialization boards allows teams to better support product launches.

Table of Contents

7             Executive Summary

8             Early Device Commercialization: Key Recommendations for Success

16           Profiling Successful Medical Device Commercialization Efforts and Resources

17           Surveying the Medical Device Commercial Landscape

27           Medical Device Commercialization Profiles

72           Organizing Commercial Staff and Spending During Product Development

101        Development and Commercialization Strategies for Product Launch Success

102        Choosing the Best-Fit Regulatory Pathways and Supporting Data

111        Looking to Collaboration and Acquisitions to Drive Development and Commercialization

119        Navigating Commercial Strategy and Potential Challenges

CHARTS AND GRAPHICS

7             Executive Summary

8             Early Device Commercialization: Key Recommendations for Success

9             Figure E.1: Percentage of Companies Using Specific Regulatory Pathways, by Medical Device Product Novelty and Classification

10           Figure E.2: Percentage of Products Developed Organically versus Acquisitions and Collaboration, by Company Size

12           Figure E.3: Breakdown of Medical Device Acquisitions

16           Profiling Successful Medical Device Commercialization Efforts and Resources

17           Surveying the Medical Device Commercial Landscape

18           Figure 1.1: Percentage of Device Companies Marketing Products, by Novelty and Company Size

19           Figure 1.2: Expected Commercial Competition, by Medical Device Product Novelty

20           Figure 1.3: Total Market Size versus Peak Annual Sales: Top 10 and Top 50 Device Companies

21           Figure 1.4: Total Market Size versus Peak Annual Sales: Small Companies’ Class 3 Devices

22           Figure 1.5: Total Market Size versus Peak Annual Sales: Small Companies’ Class 2 Devices

23           Figure 1.6: Expected US Market Share, by Company Size and Device Class

24           Figure 1.7: Expected US Market Share, by Competition Level

26           Figure 1.8: Sources of Underlying Device Technology, by Device Class

26           Figure 1.9: Sources of Underlying Device Technology, by Company Size

27           Medical Device Commercialization Profiles

29           Figure 1.10: Top 10 Company 2: Product Background and Level of Competition

30           Figure 1.11: Top 10 Company 2: Product Technology and Development

31           Figure 1.12: Top 10 Company 2: Development and Commercialization Spending

32           Figure 1.13: Top 10 Company 2: Commercialization Staffing

33           Figure 1.14: Small Company 15: Product Background and Level of Competition

34           Figure 1.15: Small Company 15: Product Technology and Development

35           Figure 1.16: Small Company 15: Development and Commercialization Spending

36           Figure 1.17: Small Company 15: Commercialization Staffing

37           Figure 1.18: Small Company 20: Product Background and Level of Competition

38           Figure 1.19: Small Company 20: Product Technology and Development

39           Figure 1.20: Small Company 20: Development and Commercialization Spending

40           Figure 1.21: Small Company 20: Development and Commercialization Spending

41           Figure 1.22: Small Company 19: Product Background and Level of Competition

42           Figure 1.23: Small Company 19: Product Technology and Development

43           Figure 1.24: Small Company 19: Development and Commercialization Spending

44           Figure 1.25: Small Company 19: Commercialization Staffing

45           Figure 1.26: Small Company 22: Product Background and Level of Competition

46           Figure 1.27: Small Company 22: Product Technology and Development

47           Figure 1.28: Small Company 22: Development and Commercialization Spending

48           Figure 1.29: Small Company 22: Commercialization Staffing

49           Figure 1.30: Small Company 23: Product Background and Level of Competition

50           Figure 1.31: Small Company 23: Product Technology and Development

51           Figure 1.32: Small Company 23: Development and Commercialization Spending

52           Figure 1.33: Small Company 23: Commercialization Staffing

53           Figure 1.34.: Small Company 28: Product Background and Level of Competition

54           Figure 1.35: Small Company 28: Product Technology and Development

55           Figure 1.36: Small Company 28: Development and Commercialization Spending

56           Figure 1.37: Small Company 28: Commercialization Staffing

57           Figure 1.38: Top 50 Company 7: Product Background and Level of Competition

58           Figure 1.39: Top 50 Company 7: Product Technology and Development

59           Figure 1.40: Top 50 Company 7: Development and Commercialization Spending

60           Figure 1.41: Top 50 Company 7: Commercialization Staffing

61           Figure 1.42: Small Company 16: Product Background and Level of Competition

62           Figure 1.43: Small Company 16: Product Technology and Development

63           Figure 1.44: Small Company 16: Development and Commercialization Spending

64           Figure 1.45: Small Company 16: Commercialization Staffing

65           Figure 1.46: Small Company 17: Product Background and Level of Competition

66           Figure 1.47: Small Company 17: Product Technology and Development

67           Figure 1.48: Small Company 17: Development and Commercialization Spending

68           Figure 1.49: Small Company 17: Commercialization Staffing

69           Figure 1.50: Small Company 18: Product Background and Level of Competition

70           Figure 1.51: Small Company 18: Product Technology and Development

71           Figure 1.52: Small Company 18: Commercialization Staffing

72           Organizing Commercial Staff and Spending During Product Development

73           Figure 2.1: Total Commercial Board Staffing During Concept and Prototype Development: Class 3 Devices

74           Figure 2.2: Total Commercial Board Staffing During Concept and Prototype Development: Class 2 Devices

75           Figure 2.3: Commercial Board Staffing During Concept and Prototype Development, by Function: Class 3 Devices

75           Figure 2.4: Commercial Board Staffing During Concept and Prototype Development, by Function: Class 2 Devices

77           Figure 2.5: Total Commercial Board Staffing During Development and Final Design: Class 3 Devices

77           Figure 2.6: Total Commercial Board Staffing During Development and Final Design: Class 2 Devices

78           Figure 2.7: Commercial Board Staffing During Development and Final Design, by Function: Class 3 Devices

78           Figure 2.8: Commercial Board Staffing During Development and Final Design, by Function: Class 2 Devices

79           Figure 2.9: Total Commercial Board Staffing During Clinical Studies

80           Figure 2.10: Commercial Board Staffing During Clinical Studies, by Function: Class 3 Devices

80           Figure 2.11: Commercial Board Staffing During Clinical Studies, by Function: Class 2 Devices

82           Figure 2.12: Total Commercial Board Staffing During Market Approval and Manufacturing Ramp-Up: Class 3 Devices

82           Figure 2.13: Total Commercial Board Staffing During Market Approval and Manufacturing Ramp-Up: Class 2 Devices

83           Figure 2.14: Commercial Board Staffing During Market Approval and Manufacturing Ramp-Up, by Function: Class 3 Devices

83           Figure 2.15: Commercial Board Staffing During Market Approval and Manufacturing Ramp-Up, by Function: Class 2 Devices

85           Figure 2.16: Average Number of FTEs Serving on Commercial Boards Throughout Product Development, by Function: Class 3 Devices

85           Figure 2.17: Average Number of FTEs Serving on Commercial Boards Throughout Product Development, by Function: Class 2 Devices

87           Figure 2.18: Development Phase During Which Dedicated Marketing Groups Were Created, by Company Size: All Devices

87           Figure 2.19: Development Phase During Which Dedicated Marketing Groups Were Created, by Company Size: Class 3 Devices

88           Figure 2.20: Development Phase During Which Dedicated Marketing Groups Were Created, by Company Size: Class 2 Devices

90           Figure 2.21: Average Duration of Development Phases, by Company Size: All Devices

90           Figure 2.22: Duration of Development Phases, by Company: Class 3 Devices

91           Figure 2.23: Duration of Development Phases, by Company: Class 2 Devices

92           Figure 2.24: Average Commercial Investment During Concept and Prototype Development, by Phase Duration: All Devices

93           Figure 2.25: Average Commercial Investment During Development and Final Design, by Phase Duration: All Devices

93           Figure 2.26: Average Commercial Investment During Clinical Studies, by Phase Duration: All Devices

94           Figure 2.27: Average Commercial Investment During Approval and Manufacturing Ramp-Up, by Duration: All Devices

94           Figure 2.28: Average Total Commercial Investment, by Total Duration: All Devices

95           Figure 2.29: Average Commercial Investment per Phase, by Approval Pathway

96           Figure 2.30: Total Commercial Investment: Top 10 and Top 50 Device Companies

97           Figure 2.31: Total Commercial Investment: Small Companies

98           Figure 2.32: Total Commercial Investment: Class 3 Devices

98           Figure 2.33: Total Commercial Expenditures per Phase: Class 3 Devices

99           Figure 2.34: Total Commercial Investment: Class 2 Devices

100        Figure 2.35: Total Commercial Expenditures per Phase: Class 2 Devices

101        Development and Commercialization Strategies for Product Launch Success

102        Choosing the Best-Fit Regulatory Pathways and Supporting Data

105         Figure 3.1: Percentage of Companies Using Specific Regulatory Pathways, by Company Size and Medical Device Product Class

106         Figure 3.2: Percentage of Companies Using Specific Regulatory Pathways, by Medical Device Product Novelty and Classification

107         Figure 3.3: Percentage of Companies Using Specific Regulatory Pathways, by Therapeutic Area: Class 2 Devices

107         Figure 3.4: Percentage of Companies Using Specific Regulatory Pathways, by Therapeutic Area: Class 3 Devices

111        Looking to Collaboration and Acquisitions to Drive Development and Commercialization

112         Figure 3.5: Percentage of Products Developed Organically versus Acquisitions and Collaboration, by Company Size

112         Figure 3.6: Percentage of Products Developed Organically versus Acquisitions and Collaboration, by Device Classification

115        Figure 3.7: Breakdown of Medical Device Acquisitions