With the evolving healthcare landscape and influence of AI and other technological innovations, Medical Affairs finds itself at a crucial juncture. It is swiftly adapting and rightfully earning its place alongside Commercial and R&D as a vital ally. Looking forward, it is evident that the conventional role of Medical Affairs is undergoing transformation.
Recently, Putnam had the privilege of hosting a Medical Affairs Leadership Council Meeting engaging Medical Affairs leaders from some of the world’s leading pharmaceutical companies, as well as mid-sized players in the industry. We had candid conversations with these experts to uncover the key challenges they face and what they perceive are the most critical areas for change and evolution in the coming years.
This blog post encapsulates the unique perspectives we gathered from these industry visionaries. Their wisdom and foresight will not only shed light on the current state of Medical Affairs but also serve as a compass to navigate the path forward.
Navigating complex waters: A Medical Affairs journey through challenges
As Medical Affairs leaders navigate the constantly evolving industry, they underscore the most urgent obstacles they encounter.
1. Navigating AI, omnichannel, and digital health: Several technological innovations in Medical Affairs are bringing their own set of challenges.
- Lack of in-house expertise: A shortage of expertise in emerging technologies like AI, omnichannel strategies, and digital health presents challenges for Medical Affairs
- Unclear ownership: Determining who should own these areas – Medical, Commercial, or a collaborative effort, remains undecided
- Data privacy concerns: Collaborating with external partners who possess the expertise raises concerns about data privacy. However, building in-house expertise is resource-intensive and time-consuming
- Unclear regulatory guidance: The roles of regulators in GenAI-generated/supported use cases, such as clinical trial protocols and publications, remain ambiguous
- Lack of focus and actionability: The buzz surrounding AI often overshadows the need for identifying specific use cases and crafting actionable goals
2. Collaborating with cross-functional teams: Influencing strategy early often depends on relationships with other functional groups such as commercial, R&D, and digital. Breaking down silos and fostering co-creation is seen as a limitation.
3. Quantifying value of Medical Affairs: Mere interaction counts fall short in assessing the true effectiveness of Medical Affairs activities. There’s a pressing challenge in Medical Affairs to develop robust methodologies for quantifying the real impact these activities have on various stakeholders and the broader healthcare ecosystem.
4. Tailoring engagement for an expanding audience base: Adapting to an increasingly diverse group of stakeholders poses a significant engagement challenge.
5. Functioning in a resource-limiting environment: With budget and resource constraints, Medical Affairs is being forced to do more with less.
Charting the path forward: Keys to Medical Affairs success
In the pursuit of excellence, Medical Affairs leaders rise to the occasion by discerning five critical areas for development to surmount the challenges they face (Figure 1).
1. Master engagement strategies to connect with an expanding external audience
Engaging external stakeholders in Medical Affairs has evolved significantly. Traditionally focused on physicians, it now encompasses a broader spectrum, including payers, policymakers, organized customers, and patient advocacy groups. Even among physicians, diverse profiles exist, from tech-savvy younger generations to seasoned practitioners with different expectations. Medical Affairs must adapt its strategies for this changing landscape.
- Tailor engagement strategies: A one-size-fits-all approach no longer suffices. Different stakeholders have unique needs and backgrounds. It is important to craft omnichannel strategies that align with their specific requirements within a cohesive scientific narrative. The same data source can be tailored to suit different audiences. Moreover, any complex data should be translated into easily understandable formats for these stakeholders.
- Measure the impact of engagement approaches: To evaluate the effectiveness of engagement approaches, metrics are crucial. Medical Affairs teams must be prepared to measure the impact of their communication strategies and use data to make informed decisions about the most effective approaches for each stakeholder type.
In this era of expanding external audiences, Medical Affairs leaders should view stakeholder engagement as evolving and multifaceted. The ability to understand, adapt, and communicate effectively with diverse stakeholders is pivotal to the success of Medical Affairs teams.
2. Foster cross-functional partnerships
Within a diverse pharmaceutical organization, the significance of cross-functional partnerships cannot be emphasized enough. Not everyone within the organization may have prior experience collaborating with Medical Affairs, and measuring impact in this field can be complex. Consequently, building robust relationships is pivotal to Medical Affairs’ ability to influence strategic decisions. Additionally, effective collaborations will require clearly defined roles for Medical Affairs and other functional teams and true teamwork.
- Expand engagement with cross-functional colleagues: Medical Affairs should adopt a phased approach to gradually expand its network of cross-functional colleagues. Many departments may not be accustomed to the idea of “co-creating” solutions, making Medical Affairs a key driver of collaboration that transcends beyond traditional silos of commercial, medical, and R&D.
- Collaborate with digital and analytics teams: In the age of digital health and advanced technology, the distinction between medical and technical realms is blurring. While Medical Affairs professionals may not need to master every technical detail, they should grasp how new technologies can be applied within the larger organizational context. Medical Affairs professionals will increasingly find themselves engaging with analytics and IT experts within their organization. They must learn to effectively work together to approach digital health and AI appropriately.
- Facilitate interactive workshops for co-creation: Interactive workshops are a versatile strategy for both maintaining existing collaborations and establishing new ones. These workshops can provide a platform for Medical Affairs, IT, and Analytics teams to come together, share their perspectives, and collectively design innovative solutions. By facilitating interactive workshops, Medical Affairs can foster a culture of collaboration and innovation that is essential in the rapidly changing healthcare landscape.
3. Establish the value of Medical Affairs using impact metrics
Medical Affairs serves as a crucial link between pharmaceutical companies, healthcare providers, and patients within the healthcare ecosystem. However, quantifying its impact and value has been a historical challenge. Metrics often centered on easily quantifiable aspects, like the number of field staff interactions, which, while informative, do not always reflect meaningful impact. Moreover, the growing presence of headquarter-based Medical Affairs staff adds complexity to the measurement process.
- Identify meaningful impact metrics: To establish value, Medical Affairs leaders must identify metrics that genuinely measure impact. These metrics should align with the overarching goals of Medical Affairs, such as improving patient outcomes, contributing to product development, and supporting informed decision-making among healthcare providers. Examples of impact metrics include changing HCP practice behaviors, KOL feedback/satisfaction, advancing HCP understanding on disease and treatments, improvement in product access, and demonstrating medical actions change conversations over time. Ultimately, impact measures must represent tangible changes in the clinical management of patients.
- Prioritize patient-centric metrics: How does the work of Medical Affairs impact patient well-being? Metrics should encompass patient outcomes, adherence to treatment regimens, and the overall patient experience. By demonstrating improvements in these areas, Medical Affairs can showcase its commitment to patient-centric care.
- Emphasize on both quick wins and long-term gains: The value of Medical Affairs should be demonstrated through ‘quick wins’ and long-term achievements. Early successes can secure the necessary resources for long-term initiatives, such as investment in building AI and analytics tools and capabilities. Metrics demonstrating short-term wins should therefore be included to enable securing resources for larger, more strategic endeavors.
4. Harness the promise of generative AI in Medical Affairs
Artificial Intelligence (AI), including Generative AI, has undergone rapid advancements and is poised to revolutionize various facets of Medical Affairs. It holds immense promise, offering numerous identified use cases, such as patient engagement, real-world evidence analysis, and insight generation. However, effective adoption of this technology presents challenges for Medical Affairs leaders.
- Identify key use cases: One of the primary challenges is determining which specific use cases to focus on when resources and time are limited. AI has the potential to impact almost every facet of Medical Affairs, from optimizing clinical trial designs to enhancing healthcare-provider interactions. A recent publication by MAPS highlights specific use cases for Generative AI as it relates to the pillars of Medical Affairs . Medical Affairs leaders must carefully evaluate their organization’s needs and priorities to identify the most promising AI applications. Consideration should be given to areas where AI can streamline processes, improve decision-making, or enhance patient care.
- Navigate regulatory guidance through collaboration: Generative AI lacks established regulatory precedents, requiring Medical Affairs leaders to adapt to evolving regulations. Collaboration with regulatory agencies is essential to ensure AI technologies comply with ethical standards, particularly as it relates to clinical trials and publications. Staying informed about emerging regulatory trends and fostering a culture of compliance within the team is crucial.
- Assess internal development vs. outsourcing: Another critical consideration is developing AI capabilities in-house or outsourcing to vendors. Both options have merits and challenges. In-house development offers control, customization, and data privacy advantages but is slower and demands significant investments in talent and infrastructure. Outsourcing to specialized vendors can expedite AI implementation but may entail relinquishing some control and potential proprietary data. Medical Affairs leaders should assess their organization’s technical capabilities, budget, and timeline to make informed decisions. Ensuring outsourcing vendors are working in secure GenAI sandboxes can alleviate concerns about proprietary data.
5. Invest in new talent beyond clinical to diversify expertise
Medical Affairs leaders are facing a significant shift in the skill sets required to excel in their roles. The advent of cutting-edge technologies and innovations like Generative AI, digital health, and omnichannel has ushered in a new era, demanding expertise that extends beyond the traditional boundaries of medical and clinical knowledge.
- Recruit specialists in AI and data analytics to adapt to the digital era: As the healthcare industry embraces new technologies, Medical Affairs leaders acknowledge the need to diversify their talent pool. They are investing in roles that go beyond the clinical realm. These include positions in Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR). Moreover, hires with experience and exposure to AI, data analytics, and related fields are becoming increasingly common.
- Integrate individuals with AI and data capabilities into traditional roles to elevate team expertise: While it is not essential for everyone within Medical Affairs teams to have in-depth technical expertise in data analytics and AI, there is a fundamental need within the team to understand how these technologies work conceptually. This knowledge will enable Medical Affairs professionals to apply their strategic thinking in the broader context of the organization. The successful integration of individuals with AI and data capabilities into traditional roles isn’t just a choice; it’s a necessity for Medical Affairs teams to stay ahead, enhance their decision-making, and deliver more impactful results.
Medical Affairs leaders must acknowledge the significance of technological advancements in healthcare. It is not just about adopting new tools but redefining the role of Medical Affairs. By investing in talent with expertise beyond the clinical, organizations can harness diversity and innovation, staying competitive and leading the way in healthcare advancement.
In conclusion, Medical Affairs stands at a critical juncture, shaped by technological innovation, cross-functional collaboration, the quest for quantifiable value, and the promise of AI. The insights shared by industry leaders provide a compass for navigating the complexities of this dynamic field. As we embrace tailored engagement strategies, forge cross-functional partnerships, establish meaningful metrics, and invest in diverse expertise, Medical Affairs is poised to drive healthcare excellence in an era of unprecedented change.
1. Vision for Generative Artificial Intelligence in Medical Affairs (MAPS). [Online]. Available from: https://medicalaffairs.org/vision-gen-ai/. [Accessed 28 September 2023].