Developing Medical Affairs Capabilities within Medical Device Companies: Global Coordination and Managing Compliance

STUDY OVERVIEW

Medical Affairs is evolving into a critical function for the medical device sector. As its importance and duties have grown, Medical Affairs within the device sector has faced many challenges in creating and maintaining the function as a global group.

Best Practices, LLC conducted this study to identify what medical device companies require in order to create effective global capabilities for the Medical Affairs function. The study also reviews how device companies are coordinating compliance standards across different geographies.


KEY TOPICS

• Coordinating the Global Medical Affairs Function
• Managing Compliance and Information Exchange
• Benchmark Participant Demographics

• Management approach for key Medical Affairs activities
• Reporting relationship between global and regional Medical Affairs groups
• How regions develop their compliance standards
• How regions identify their compliance standards
• How regions identify their compliance standards
• How organizations share compliance challenges and best practices across global and regional levels

• Global Coordination: More than 80% of the benchmark class employs a bottom-up reporting approach for the activities related to payers and providers, such as medical education, field-based medical team operations, and thought leader management. Although some of the interviewees think that developing a top-down approach is ideal to avoid compliance issues and promote better communication for payer and provider related activities, local differences such as, language, culture and regulations force companies to employ a bottom-up approach for these activities.
• Segments: Global reporting approach to Medical Affairs resources allocation is significantly different across segments. While 88% of the LCS employs a bottom-up approach, only 50% of the MCS & SCS has a similar approach for this activity.
  

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.