Medical Affairs: Ready to See (and Hear) the Patient

How do you define medical affairs? It’s complicated. By today’s standards, medical affairs is the noncommercial, medical/scientific engagement, insights, and communications arm of a biopharmaceutical or medtech company. As President (Americas Region) and Board Director of the , John B. Pracyk, MD, PhD, MBA, Chief Medical Safety Officer, Senior Vice President, Medical & Scientific Affairs, at Olympus, provides context for how medical affairs creates and delivers value among healthcare stakeholders including physicians, providers (hospitals and health systems), payers, policymakers, and ultimately patients. Dr. Pracyk was tapped to be a contributing author of a recent visionary published by the society, which articulates medical affairs’ evolving role in the ecosystem of patient-centric healthcare. Here he provides perspective on the roles and value of medical affairs specifically within medtech.

Medical affairs’ big bang

“Medical affairs has been around for about 35 years. It started in pharma and subsequently has expanded to support biotech and medtech companies as well,” explained Dr. Pracyk. “When you think of medtech it could be in vitro diagnostics, laboratory test and imaging capital equipment, surgical energy devices, implants, high-resolution imaging, or any number of emerging categories of diagnostics or devices. Each of these products requires the input of medical and scientific experts across the lifecycle.”

An evolution of the medical affairs concept

According to Dr. Pracyk, the role of medical affairs has evolved to encompass five core responsibilities, making sure that a company’s decisions are:

medically literate
clinically relevant
procedurally safe
financially sustainable
patient inclusive

“Medical science liaisons—also called field medical—are just one of the many subdisciplines of medical affairs that are now filled by surgeons” often on the medtech/device side, and “physicians, nurses, pharmacists, PhD scientists” and “other degreed medical and/or science professionals,” Dr. Pracyk explained. These are professionals who “provide insights for what’s going on in the disease/therapeutic area, as well as identify and solve for critical unmet patient needs, and other challenges within the healthcare ecosystem,” he added.

MAPS to give direction

“T�� started in 2016 as an organization for those of us serving patients from within industry,” said Dr. Pracyk. “MAPS is just shy of 10,000 members, from across 260 pharmaceutical and medtech companies.” MAPS is a nonprofit that comprises nearly 30 large industry partners, (Industry Partnership Program) as well as what Dr. Pracyk describes as “solution providers—specialized firms that provide a wide range of services to the industry,” to which MAPs offers membership through its “Partner Circle Program.”*

The organization is multitiered, with 16 working groups outlined on , including compliance, external education, medical communication, digital strategy, medical informatics, patient centricity, and . (For more information on how medtech fits into the picture, see sidebar: Martians and Venusians, Different by Degree)

A strategy for the future: the patient

“Traditionally, in pharma and medtech, there’s two large verticals within an organization: commercial and R&D. There’s a third pillar emerging, and that is medical and scientific affairs,” explained Dr. Pracyk. “In the past, [medical affairs] was very much a cross-functional support role.” “”¹ white paper emphasizes a strategy for the field’s future challenges. “T�� idea is that we’ve ascended from that cross-functional support and executional role to that of a strategic partner to instantiate the clinical perspective, as well as be an independent voice for the patients and practitioners in that disease state or therapeutic area.”

In addition to helping HCPs make the best use of drugs, diagnostics, and devices, “now we’re taking patient-centricity to the next level by helping industry focus on what outcomes are most important to the patient,” said Dr. Pracyk. Thus, “if it’s a hip implant, maybe it’s all about ambulatory distance enabling a father to walk his daughter down the aisle at her wedding.” And on the evidence dissemination front, “now it’s moving towards patient inclusivity where patients are invited as co-authors in clinical trials. Disease groups and patient advocacy organizations now have a voice because of social media’s impact.”

One of MAPS’ 2030 goals is broadening stakeholder engagement to include patient associations and incorporating real-world evidence from patient populations in research. “We want to make sure the patient’s perspective is represented,” explained Dr. Pracyk. “We not only want to influence strategy—but shape the scientific and the patient-care narrative from the perspective of the patient.”

John B. Pracyk, MD, PhD, MBA
Diplomate, American Board of Neurological Surgery | Dipl. ABNS
Fellow, American Association of Neurological Surgeons | FAANS
Fellow, American College of Surgeons | FACS

Chief Medical Safety Officer
Senior Vice President, Medical & Scientific Affairs
��ߺ��Corporation

New partners, big data, and antennas

The MAPS white paper envisions partnerships between medical affairs and government and private payers, regulators, policy makers and even “’Big Tech,’” which is an emerging collaborator, and sometimes competitor, especially in the space of healthcare data,” according to Garth Sundem, Director of Communications and Marketing, MAPS.

Another challenge outlined in the paper is the need to develop new metrics to measure the value of the medical affairs function to the organization. As Dr. Pracyk explained, “medical affairs is absolutely non-commercial and should not be measured on return-on-investment nor any type of financial metric; therefore, what are the KPIs that demonstrates the value that medical affairs is providing? In medtech, often medical affairs professionals are the only clinicians within the company that are uniquely qualified to speak to the science and practice of medicine.”

Not surprisingly, the paper also emphasizes “scientific exchange” over the traditional labels like “data dissemination” or “communications.” Sundem describes this reciprocal role, where medical affairs also curates “relationships and dialogue with stakeholders that results in a two-way flow of information – expert advice flowing from the company into society and insights from external stakeholders flowing into the organization.” Dr. Pracyk says that medical affairs acts as “an antenna that both receives and broadcasts the activities out there in the real world.”

To Dr. Pracyk, the Vision 2030 white paper is a significant first in that “it was actually authored entirely by medical affairs leaders with years of industry experience, from within the profession.” Unlike other papers that seek to envision the future of medical affairs, “Everybody that was a contributing author, and a principal author, is well recognized in the specialty of medical affairs, representing a variety of different companies.”

Read the entire MAPS white paper at:.
For more information about a career in medical affairs, read “,” also published by the .

*MAPS organization details confirmed 9/29/22 by Garth Sundem, Director of Communications and Marketing, MAPS.

Reference:

1. MedicalAffairs.org. The Future of Medical Affairs 2030. Accessed September 15, 2022. .

Sidebar:

Martians and Venusians, Different by Degree

Admittedly, the recent white paper “”¹ has “a pharma focus, respectfully acknowledging its provenance and origins,” according to John B. Pracyk, MD, PhD, MBA, Chief Medical Safety Officer, Senior Vice President, Medical & Scientific Affairs, at Olympus. If a version were to focus strictly on medtech, Dr. Pracyk said it might “differ by degree, rather than kind.” The degrees of separation between pharma and medtech are outlined in “.”² In this paper, Dr. Pracyk discusses how these two industries interact as part of the same ecosystem within the medical affairs discipline.

Timelines and resources differ

In addition to a basic distinction that surgeons tend toward medtech/medical devices and physicians tend towards pharma, medical affairs professionals on the device side (Martians?) are involved in product development from the beginning, whereas professionals on the pharma side (Venusians?) are involved around the time of product launch.

In medtech, “Our timetable is much shorter. It may take us two to three years to bring something to market. In pharma it’s going to be a decade or so,” Dr. Pracyk explained. And the disparities in the respective economies of scale is also telling, whereas pharma has greater numbers and subspecialities, and medtech typically has smaller, more cross-functionally trained teams.

Medical technology needed on Venus

Looking toward the future, Dr. Pracyk anticipates the need for specialized digital expertise in medtech. Increasingly, “medical devices have digital ecosystems; hence ‘medical technology’ is the new preferred term,” he noted. “You’re going to need practitioners that are versed not only in what’s going on in the disease state and the unmet needs, but how does the technology answer those unmet needs, deliver value, and do so in a safe and effective manner. So, we in medical affairs stand squarely at the intersection of medical practice and management science. And digital will catalyze this reaction.”

The world is flat

Whether on Mars, Venus, or Earth, social media’s impact on the landscape is also evident. “In the past there’s been a big focus on key opinion leaders – really, those people publishing and presenting. But now with social media, a small hospital in rural America, a regional referral center, or a government hospital in Europe, will all have louder voices and more significant contributory roles moving forward.”

Key opinion leaders will continue to present from the podiums, but new digital opinion leaders are also rising as key influencers on social media platforms. “A pulmonologist in Boise, Idaho, on a Thursday evening could decide to have a pop-up meeting with 40 other pulmonologists online,” Dr. Pracyk says. “And all of a sudden you see an uptick in conversations across the globe in a certain therapeutic area,” traced back through social media analytics to that event. “T�� world is becoming flat with regards to scientific engagement thanks to the reach of these social media platforms.”

Sidebar References:

1. MedicalAffairs.org. The Future of Medical Affairs 2030. Accessed September 15, 2022. .
2. MedicalAffairs.org. Medical Devices are from Mars, Pharmaceuticals are from Venus. What can we learn from each other? ELEVATE. Accessed/Downloaded September 16, 2022.

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