Did you know that currently 29% of the AACC's membership comes from industry, including those members who work in Medical and Scientific Affairs (MSA)3 (1)? We work in the MSA departments of our respective companies and are often asked what we do and why we chose this career option. The answers to these questions vary, but here are some of our insights into this career path.
Working in MSA affords us the opportunity to work collaboratively with members of the laboratory medicine community to improve the practice of laboratory medicine through sponsored research, education, key opinion leader development, and scientific exchange. MSA personnel serve as an important communication channel between the community and a company's research and development team and sales and marketing functions. We are called upon to provide input into new product requirements, and this knowledge is built from the interactions with our academic and clinical colleagues. We are also part of teams that collaborate with key opinion leaders on improving existing assay performance, the understanding of new roles for existing assays, and the discovery of new biomarkers. In the aggregate, we work to advance the field.
However, there are some differences between us and our academic and clinical colleagues. While we may not be directly involved in patient care, we are still focused on providing the best care to patients through the products our companies sell. Sometimes the standard of care involves the “off-label” use of legally marketed in vitro diagnostics tests. Regulatory agencies, including the US Food and Drug Administration (FDA), recognize this fact and require that manufacturers instruct certain scientific personnel (who frequently have titles like Scientific Affairs, Medical Affairs, and Medical Science Liaisons) to engage in scientific exchange that is fair, balanced, and grounded when it comes to such situations. Under almost all circumstances, such exchange must be initiated by our customers. Proactive dissemination of off-label use materials may be viewed as promotional. While we can present the results from interesting studies and discoveries to our customers that have been published in the peer-reviewed literature, we cannot discuss how these discoveries may apply to the products our companies sell, if these products have not been cleared by the FDA for the intended use described in the research. We can discuss any claims that have been cleared or approved by the FDA, but discussions that deviate from the intended use of a product must be initiated by the customer. This is often a limitation that our clinical and academic colleagues do not appreciate.
It is perhaps worth noting that industry scientists may freely discuss “research use only” products so long as such discussions are in an appropriate research (i.e., not diagnostic) context. Such products are likely to be novel or new to market, may have unknown or unproven clinical utility, and must be used in a research setting (2).
We work in a regulated environment. While clinical laboratories are regulated by, e.g., CLIA, the College of American Pathology, and the Joint Commission, the medical device industry in the US is regulated by the FDA. The Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act of 1938 require that medical device manufacturers seek premarket notification or premarket approval from the FDA before a new device enters interstate commerce to ensure its safety and efficacy. Medical device manufacturers must ensure that all device promotion, including speech, is consistent with their products' labeling, thus restricting off-label use discussions to the aforementioned scientific exchange. Interestingly, however, recent court cases (and a letter from Congress to the Secretary of the Department of Health and Human Services) have begun to challenge this requirement, and truthful and nonmisleading discussions about off-label use are being protected by the First Amendment (3).
In closing, we would like to provide some tips on how to work with members of corporate MSA teams. When engaging with us on topics that are off-label, formulate direct and probing questions, so we can share what we know. Share your study ideas with us; we are happy to see if our companies can support investigator-initiated scientific studies. Come to us with concerns you have with our products, we will try to get you answers. Members of MSA work for diagnostic companies and instrument manufacturers, and scientific exchange, good science, and patient care are points of focus.
A career in MSA is a rewarding one. We have the opportunity to interact with a diverse customer base. We are involved in the science (and the business) of medical devices. Collectively, we will continue to advance the practice of laboratory medicine.
3 Nonstandard abbreviations:
- Medical and Scientific Affairs
- Food and Drug Administration.
Authors' Disclosures or Potential Conflicts of Interest: Upon manuscript submission, all authors completed the author disclosure form.
Employment or Leadership: C.L. Wiley, AACC; D.S. Mason, Waters Corporation.
Consultant or Advisory Role: None declared.
Stock Ownership: D.S. Mason, Waters Corporation.
Honoraria: None declared.
Research Funding: None declared.
Expert Testimony: None declared.
Patents: None declared.
- Received June 23, 2016.
- Accepted June 29, 2016.
- © 2016 American Association for Clinical Chemistry