How Medical Affairs Can Drive a Successful 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

• 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.

I.	Executive Summary	p. 3-10
	Research Overview	p. 4
	Key Recommendations	p. 7
	Detailed Study Findings	p. 8
II.	High-Impact Launch Activities & Operations	p. 11
III.	Effective Education & Training Programs	p. 20
IV.	Launch Team Alignment & Successful Cross-Functional Collaboration	p. 29
V.	Role & Value of Clinical Specialists	p. 42
VI.	Strong Medical Information & Call Center Support	p. 54
VII.	Staffing & Investment Trends	p. 62
VIII.	APPENDIX A: Profile of Study Participants	p. 67
IX.	APPENDIX B: Additional Field Quotes & Benchmark Data	p. 70
X.	About Best Practices, LLC	p. 80

• 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

• 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

• 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

• 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

• 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

• 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

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

• 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