Industries

Medical Affairs

Identifying and assessing medical affairs’ value is hard, but not impossible.

As your medical affairs department takes on a broader and more critical role, how do you manage the growing pains?

Medical affairs personnel, primarily medical science liaisons (MSLs) in-field or medical information call-center specialists, engage with healthcare providers and appropriate key opinion leaders (KOLs) in scientific, information-based and non-promotional dialogs. Medical affairs is a trusted resource for unbiased, non-promotional information about a company’s products unavailable elsewhere. In markets where off-label use is commonplace, such as oncology and specialty therapeutics, the need for this information is even greater. MSLs also bring critical information back in-house to help with clinical trial design and strategy.

During the past five to 10 years, medical affairs departments in the United States, and globally, have grown in size and scope, becoming largely independent of commercial organizations. Pharma, biotech and medical device companies have made these changes in response to recent shifts in the industry landscape, including:

  • The rising cost of drug development. The average cost to develop a new medicine (including the cost of failures) has more than doubled in the past decade, according to PhRMA, and is estimated to be $2.6 billion today.1
  • Regulators’ heightened scrutiny of marketing practices. In the United States, fines for improper marketing have amounted to more than $20 billion since 2004, according to ZS research.

Across the industry, there is a growing recognition that medical affairs departments can also create value by more effectively addressing customer needs throughout the product life cycle. However, they face big challenges in demonstrating their value and determining how best to grow, organize and operate:

  • Given the non-promotional nature of medical affairs’ work, it is not easy for the department to demonstrate its value to the company. Unlike the commercial organization, medical affairs cannot point to commonly accepted ROI metrics.
  • The recent trend of erecting increasingly strong firewalls between medical affairs and the commercial organization in response to compliance concerns has created the new challenge of finding innovative ways to appropriately address strategic and operational issues across these groups.

The challenges in designing an appropriate and effective medical affairs organization typically boil down to three fundamental problems:

  • Applying insights on customer needs to help define its strategic goals and improve performance
  • Determining the right size, structure and geographic alignment of the in-field MSL teams
  • Understanding and articulating the value that medical affairs brings to the broader organization (for example, setting KPIs)

1 Source: PhRMA 2015 Biopharmaceutical Research Industry Profile, phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf

Enable medical affairs to deliver maximum value.

ZS can help you build a medical affairs department with the right size and structure to meet your strategic goals, as well as demonstrate the department’s value to internal stakeholders:

  • Set strategic goals based on customer (and internal) needs. ZS works with medical affairs leaders to define strategic goals for their groups. Taking a coordinated approach to define strategies across medical affairs, commercial, development, compliance and HR departments helps to ensure that teams are pursuing an aligned set of strategic goals. In addition, using Voice of the Customer market research to gather feedback from customers about their own needs and MSLs’ effectiveness is essential for gaining insights that prepare you to set strategic goals and build the right capabilities for achieving them.
  • Grow and scale wisely. We can help you take the guesswork out of determining the right size, structure and geographic alignment of your medical affairs organization. We appropriately tailor our time-tested methodologies and tools for designing field forces to work for medical affairs groups. We work extensively with field medical management to determine the optimal size of MSL teams and to geographically map MSLs to territories based on appropriate business criteria and workload metrics.
  • Articulate value. ZS can help you identify, understand and articulate the value created by medical affairs and devise appropriate KPIs that work for your company. We apply our wealth of experience in designing reporting templates to support you in effectively communicating KPIs and other value-related information to key stakeholders using simple and consistent terminology.  

Why partner with ZS to improve your medical affairs organization?

ZS is uniquely qualified to support your efforts to create a world-class medical affairs organization. Drawing upon methodologies, frameworks and tool kits developed during our more than 30 years of supporting commercial organizations, we work closely with the leaders of medical affairs departments to design strategies and processes tailored appropriately to their department’s distinctive needs. We also help medical affairs teams apply the deep analytics and reporting capabilities that their commercial colleagues have come to see as indispensable to their daily roles.

Our holistic perspective on actions along the continuum from strategy to implementation ensures that downstream choices are linked to the overarching strategy. This approach includes helping you improve resource planning, tackle tough strategic issues within and across departments, and introduce new feedback mechanisms and reporting capabilities that build internal support for medical affairs’ value.

We have supported more than 25 medical affairs clients during the past year. These projects have included:

  • Working with a large biotechnology company to establish and evaluate KPIs for its global medical affairs organization and develop standardized dashboards and reports   
  • Developing Voice of the Customer studies for medical affairs departments with the specific goal of assessing the effectiveness of MSL teams. To go beyond “satisfaction” metrics, we identified opportunities for improvement in-field and translated those into granular value KPIs that the broader internal organization could understand and respect.
  • Helping a medical affairs management team overcome limited data and high levels of uncertainty to determine the optimal size and structure for an MSL team
  • Supporting a global specialty-driven pharmaceutical company in developing actionable and effective performance metrics specific to MSL roles