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Products & Services New Product Development New Product Development: Structure and Functions

Leading in the Combination Product Space: Insights for Improving External Engagement, and Internal Development and Management

ID: POP-298


15 Info Graphics

19 Data Graphics

130+ Metrics

6 Narratives

Pages: 44

Published: Pre-2019

Delivery Format: Shipped


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In the highly competitive and complex healthcare marketplace, effective timely launch of new combination products can provide strategic advantage to organizations in better meeting patient needs and driving overall growth.

However, complexities of the product development cycle and stringent regulatory requirements have made it challenging for organizations to successfully develop and launch new combination products. Consequently, organizations need to adopt an effective approach toward external engagement and internal development and management to address these key challenges.

Best Practices, LLC undertook this benchmarking research to help pharmaceutical, biotechnology and other healthcare companies improve the way they develop, manage and commercialize new combination products. In particular, this report will inform product and leadership teams about key external engagement approaches, development phases and decision points, timing, staffing and investment, partner management, and IP protection needed to successfully develop and launch combination product assets.

Kindly note that “external engagement” in this report refers to the activities and collaborations undertaken to help shape future combination-product standards and regulations. Examples include peer-to-peer interactions with other firms, attendance at industry events, and active membership on standing ISO committees for combination products.

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Manufacturing; Consumer Products; Medical Device

Companies Profiled:
Abbott; AbbVie; Allergan; AstraZeneca; Bayer; Boehringer Ingelheim; Kimberly-Clark; Merck; Mallinckrodt; Nevakar; Novartis; Novo Nordisk; Pfizer; UCB Pharma

Study Snapshot

In this research, Best Practices, LLC engaged 17 executives involved in the development and launch of combination products at 14 leading pharmaceutical, biotechnology and other healthcare companies through a benchmarking survey.

Key topics covered in this report include:

  • Key external engagement approaches
  • External engagement program staffing and investment
  • Industry leaders in external engagement
  • Challenges in post-marketing safety reporting
  • Combination product development timeline
  • Development phases and decision points
  • Partner management
  • IP protection

Key Findings

Sample key insights uncovered from this report are noted below. Detailed findings are available in the full report.
  • Firms more likely to locate external engagement personnel in small, standalone group rather than within any single larger function: About half of companies (47%) have created an independent group to assess and drive external engagement within the combination product space. Some companies install their external engagement employees within Regulatory Affairs (13%), R&D (7%), Clinical Program Development (7%), Lifecycle Management (7%) or elsewhere.

  • Companies spend an average of 5 years between demonstrated feasibility and launch: According to respondents, the combination product development cycle - starting with demonstrated feasibility and ending with market entry - can take between 2-10 years, depending on the product. The average development life cycle time is nearly 5 years.

  • Analyze complaint data & market research to fuel continuous improvement: The top-rated sources for gaining critical feedback for continuous improvement are product complaint data and patient market research (rated “highly valuable” by 73% of companies), followed by physician market research (64%). Field sales and medical feedback is seen as only marginally helpful, while social media insights are not seen as reliable.

Table of Contents

Executive Summary: Overview and Insightsp. 3
Summary of key findingsp. 4
Benchmark classp. 5
Insights and recommendationspp. 6-10
Participant backgroundp. 11
External Engagement in the Combination Product Spacep. 14
Group organizationp. 15
Strategy and tacticsp. 16
Staffing and budgetp. 18
Industry leaders – and whyp. 20
Post-marketing safety reportingp. 22
Effective Combination Product Development and Managementp. 24
Development phase gates and timelinesp. 25
Effective management approachesp. 33
Demo device managementp. 38
Feedback for continuous improvementp. 39
IP protectionp. 40
Appendixp. 42
About Best Practices, LLCp. 44

    List of Charts & Exhibits

    I. External Engagement in the Combination Product Space
    • Group / internal function to which external engagement employees belong
    • External engagement approach maturity curve
    • Key external engagement strategies and tactics along the maturity curve
    • Full-time staff members allocated to all external engagement policy activities
    • Approximate total budget allocation to external engagement program for the combination product space
    • Pharma or biotech companies considered to be the industry leaders for shaping combination product regulatory requirements and reasons for the same
    • Biggest challenges for the industry in implementing the 2016 US FDA Final Rule on Post-marketing Safety Reporting for Combination Products

    II. Combination Product Development Timeline
    • Length of the entire combination product development process, beginning with demonstrated feasibility and ending with launch into the market
    • Representative case studies: Company by company readouts of combination product development phase gates
    • Drug/device co-development: Company A case study
    • Long design, short verification and validation: Company B case study
    • Long design, short verification and validation: Company C case study
    • Protracted verification and validation: Company E case study
    • Protracted verification and validation: Company F case study

    III. Insights for Strong Combination Product Development, Management & Commercialization
    • Managing the development of delivery devices in conjunction with development of own drug substance and drug product
    • Executive insights on managing the development of delivery devices in conjunction with development of own drug substance and drug product
    • Responsibility for managing the supply chain process for each kind of supplier
    • Successful tactics in customizing management approach across different suppliers
    • Group responsibility for the initial development of demo devices and for rolling up-to-date versions out to the field
    • Valuable sources for obtaining feedback for drug delivery device improvements
    • Biggest IP concerns relative to developing combination products in partnerships with other organizations
    • Successful steps taken by benchmark partners to protect IP

    IV. Appendix: Additional Combination Product Development Phase Gates and Timelines from Benchmark Companies
    • Drug-device co-development: Company X case study
      Drug-device co-development: Company Y case study