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Products & Services Medical Affairs Launch Optimization

How Medical Affairs Can Drive a Successful Medical Device Product Launch

ID: POP-306


Features:

36 Info Graphics

31 Data Graphics

470+ Metrics

32 Narratives


Pages: 80


Published: 2019


Delivery Format: Shipped


 

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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
The gradual shift toward real world evidence in the medical device industry coupled with intense competition and a highly regulated promotional environment have pushed the Medical Affairs function into a significant launch role.

From driving prominent launch activities and training programs to managing alignment and collaboration between the various internal stakeholder functions, the Medical Affairs function needs to fulfill the growing demands brought on by the multiple facets of its launch role.

Best Practices, LLC undertook this benchmarking research to deliver insights into how Medical Affairs operations, field teams, and call centers can provide high-value support for the launch of medical device products. This research will help Medical Affairs teams identify and implement more effective practices, pinpoint organizational gaps, and inform strategic planning for new medical device product launch.

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Medical Device; Biotech; Manufacturing; Consumer Products; Biopharmaceutical; Clinical Research; Laboratories; Diversified


Companies Profiled:
Abbott; AcelRx; Alcon; Alcresta Therapeutics; Allergan; Astellas; Bausch + Lomb; Bayer; Boston Scientific; Ferring Pharmaceuticals; GE Healthcare; Gedeon Richter ; GRAIL; Innocoll; Irrimax Corporation; Medtronic; Merck; Nobel Biocare; Novartis; Nutricia; Roche Diagnostics; Sanofi; STERIS; Terumo Corporation; W.L. Gore and Associates

Study Snapshot

Best Practices, LLC engaged 32 Medical Affairs leaders from 25 leading medical device companies in this research through a benchmarking survey. Five Medical Affairs executives were engaged in deep-dive interviews to capture additional insights.

Key topics covered in this report include:

  • Most valuable Medical Affairs activities
  • Effective education and training insights
  • Approaches to achieving strong alignment and collaboration between internal stakeholder functions
  • Internal and external activities led by clinical specialists
  • Effective medical call center models and tools
  • Staffing and investment levels
  • Pitfalls and lessons learned from other medical device launches


Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • Medical Affairs Launch Support Activities: Medical Affairs can bring high value to product device launch via proven top-rated medical device support activities such as advisory board guidance, MSL field work, scientific publications, and clinical research – all of which are rated “highly effective” by 66% of competitors.

  • Education and Training Formats: Onsite training is most common (97% of organizations use it) and effective (72% call it “highly effective”) training format. Onsite training works well for medical devices support, which is often very technical and product/procedure-based.

  • The Role of Clinical Specialists: 71% of device firms have clinical specialists on staff. Clinical specialists are especially useful during the launch of a breakthrough product, where they can train therapeutic area end-users on how to properly and safely use a new treatment.

Table of Contents

I.
Executive Summaryp. 3-10
Research Overviewp. 4
Key Recommendationsp. 7
Detailed Study Findingsp. 8
II.
High-Impact Launch Activities & Operationsp. 11
III.
Effective Education & Training Programsp. 20
IV.
Launch Team Alignment & Successful Cross-Functional Collaborationp. 29
V.
Role & Value of Clinical Specialistsp. 42
VI.
Strong Medical Information & Call Center Supportp. 54
VII.
Staffing & Investment Trendsp. 62
VIII.
APPENDIX A: Profile of Study Participantsp. 67
IX.
APPENDIX B: Additional Field Quotes & Benchmark Datap. 70
X.
About Best Practices, LLCp. 80

    List of Charts & Exhibits

    I. High-Impact Launch Activities & Operations

    • Highest, medium and lowest value Medical Affairs activities in driving the success of a new medical device product launch
    • Insights emerging from deep-dive interviews with Medical Affairs executives on critical activities during each launch phase, and key takeaways for Medical Affairs organizations
    • Valuable Medical Affairs activities in driving the success of a new medical device product launch
    • Medical Affairs sub-function managing each of the listed activities at benchmarked organizations
    • Full activity management breakdown
    • Top activity areas on which Medical Affairs organizations have driven the greatest launch impact

    II. Effective Education & Training Programs

    • Usage vs. effectiveness of educational programs and training forums either hosted by or supported by benchmarked organizations
    • Effective educational programs and training forums either hosted by or supported by benchmarked companies
    • Insights emerging from deep-dive interviews with executives on Medical Affairs’ education and training support of medical devices, and key takeaways for Medical Affairs organizations
    • Highly effective education and training programs
    • Use of educational wet labs and effectiveness of wet labs as an educational or training program
    • Insights emerging from deep-dive interviews with Medical Affairs executives on wet lab usage, and key takeaways for Medical Affairs organizations
    • Approval of educational wet labs from compliance department
    • Insights emerging from deep-dive interviews with Medical Affairs executives on approval of educational wet labs from compliance department, and key takeaways for Medical Affairs organizations

    III. Creating Launch Team Alignment & Successful Cross-Functional Collaboration

    • Effective approaches for achieving strong alignment and collaboration between the various internal stakeholder functions supporting a medical device product launch
    • Insights emerging from deep-dive interviews with Medical Affairs executives on the importance of alignment and clear definitions of roles and responsibilities, and key takeaways for Medical Affairs organizations
    • Frequency with which launch committee typically holds full cross-functional meetings leading up to product launch
    • Insights emerging from deep-dive interviews with Medical Affairs executives on the risks involved with underestimating all that is needed to competently launch a new product, and key takeaways for Medical Affairs organizations
    • Bridging the gap between clinical development to post marketing, a steward for the “Medical Value Message”
    • Key teams on the new medical device product launch committee
    • Functions represented at the launch committee
    • Insights emerging from deep-dive interviews with Medical Affairs executives on avoiding market entry missteps, and key takeaways for Medical Affairs organizations
    • Smaller cross-functional teams with whom Medical Affairs group meet regularly to support launch apart from the full formal launch committee: Medical and clinical-focused sub-teams
    • Smaller cross-functional teams with whom Medical Affairs group meet regularly to support launch apart from the full formal launch committee: Commercial-oriented sub-teams
    • Smaller cross-functional teams with whom Medical Affairs group meet regularly to support launch apart from the full formal launch committee: Distribution and commercial excellence sub-teams
    • Top lessons learned from previous medical device product launches

    IV. The Role & Value of Clinical Specialists

    • Use of clinical specialists
    • Insights emerging from deep-dive interviews with Medical Affairs executives on the role of clinical specialists, and key takeaways for Medical Affairs organizations
    • Function to which clinical specialists belong
    • Insights emerging from deep-dive interviews with Medical Affairs executives on key differences between MSLs vs. clinical specialists, and key takeaways for Medical Affairs organizations
    • Insights emerging from deep-dive interviews with Medical Affairs executives on the clear definition of the responsibility spheres, and key takeaways for Medical Affairs organizations
    • High-value external and internal clinical specialist activities
    • Value of listed external activities led by clinical specialists to support a medical device product launch
    • Insights emerging from deep-dive interviews with Medical Affairs executives on leveraging the clinical specialist role, and key takeaways for Medical Affairs organizations
    • Value of listed internal activities led by clinical specialists to support a medical device product launch
    • Clinical specialist incentives
    • Incentive types used for clinical specialists

    V. Strong Medical Information & Call Center Support

    • Structuring call center systems to effectively triage and resolve both safety and product complaints relative to medical devices
    • Insights emerging from deep-dive interviews with Medical Affairs executives on call centers at large and small medical device companies, and key takeaways for Medical Affairs organizations
    • Effectiveness of innovative tools / systems in enabling call centers to either automate or streamline communications
    • Insights emerging from deep-dive interviews with Medical Affairs executives on outsourcing medical call center services, and key takeaways for Medical Affairs organizations
    • Use of innovative call center tools and systems
    • Highly effective innovative call center tools / systems
    • Usage vs. effectiveness of innovative call center tools and systems

    VI. Staffing & Investment Trends

    • Size of patient population served
    • Number of MSLs and clinical specialists on staff in support of medical device products
    • Investment allocation to key Medical Affairs sub-functions during launch year and the year prior to launch

    VII. APPENDIX A: Profile of Study Participants

    • Geography and job titles of benchmark partners
    • Area of geographic responsibility of benchmark partners in their current role

    VIII. APPENDIX B: Additional Field Quotes and Benchmark Data

    • Full verbatim responses: Highest Medical Affairs impact areas in support of a successful medical device product launch
    • Full verbatim responses: Top lessons learned during launch support
    • Management of various Medical Affairs work streams
    • Use of education and training programs
    • Year -1 and launch year investment to key Medical Affairs sub-functions
    • Call center structures used by benchmark companies