Olympus Corporation [TYO: 7733]

John B. Pracyk

In my eight years as a Medical Affairs professional, I have witnessed the ascension of the medical affairs function within MedTech companies. Medical Affairs is rising from a cross-functional support role largely tied to regulatory clearances and post-market activities into being a strategic partner alongside R&D, Quality, Regulatory, and Commercial.

Bringing a balanced clinical perspective to the executive suite, Medical Affairs teams focus decision making on the unmet needs, clinical insights, the patient journey, and scientific evidence relevant to the disease states for which the company’s products and technologies are used. In other words, Medical Affairs translates the science of clinical practice into value for the company. In this way, we ensure that strategic decisions are medically informed, procedurally literate, clinically relevant, safety focused, and, most importantly, patient inclusive.

An increasingly complex health care environment is fueling the rise of the Medical Affairs function. MedTech companies require more robust Medical Affairs teams to manage the many and varied requirements of the external stakeholders who influence clinical decision-making. Medical Affairs develops and communicates unbiased, evidenced-based scientific and medical information to health care providers, patients, hospitals and health systems, payers, and policymakers at relevant stages throughout the product lifecycle.

With the proliferation of digital platforms and data greatly accelerating the rate of information sharing, decision making in healthcare is changing. The role of the individual health care provider as influencer and the key opinion leader in setting the health care agenda is being supplanted by a shared decision-making model among HCPs, patients, patient advocacy groups, value analysis committees, and payers.

“MedTech companies require more robust Medical Affairs teams to manage the many and varied requirements of the external stakeholders who influence clinical decision-making.”

Medical Affairs figures prominently into this new decision-making model by staying in regular communication with external stakeholders, generating and sharing scientific/medical communications to optimize patient care while simultaneously gathering actionable insights to identify gaps in care where new opportunities might exist. As an example, we oversee industry clinical investigations as well as facilitate compliant research collaborations and investigator-initiated studies that support the safety and performance of our products. Similarly, in some companies, Medical Affairs leads external education of HCPs and allied healthcare professionals. Internally, we work with R&D, Quality, Regulatory, Global and Regional Marketing in helping our colleagues understand the clinical context.

Looking ahead to 2030, as I recently did with the Medical Affairs Professional Society (MAPS) for which I am President (Americas Region) and Board Director, Medical Affairs teams will undergo further significant evolution along with health care systems. Part of that evolution will involve adding new levels of sophistication and specificity to areas of expertise within Medical Affairs. As we are called to provide data beyond the clinical context, such as health economics, we must build new teams whose members speak the language of external stakeholders, such as providers, payers and policy makers, and can communicate both the clinical value and cost-effectiveness of our therapies.

Further, Medical Affairs will need to engage even more stakeholders in their scientific data exchange and dialogue. These include academia, patient advocacy groups, and Big Tech. The greatest challenge to this evolution may be figuring out how to best integrate the insights gained from external stakeholders into the company vision and strategy conversations, with the goal of going beyond simply identifying gaps in patient care to aligning MedTech companies more closely with the regularly changing health care needs of patients and society.

Now that we’ve grown beyond the cross-functional support and executional role to that of a strategic partner, we can see there is so much more work to do to instantiate the clinical perspective and be an independent and trusted voice for patients and practitioners. Ours is a critical partnership that will help focus, shape, and enable MedTech companies.