A Framework for Engineering Education that Reflects the Convergence of Innovation and Regulation

Introduction:: Since the end of World War II, the United States government has invested in science and engineering innovation to spur the development of new technologies and to preserve its standing as a technological superpower. Included in that investment is support for the development of an innovative technical workforce, the training of which primarily occurs in universities [1,2].


Materials and Methods:: The federal government has similarly invested in advancing and protecting its public’s health since the early 20th century. Today, the Food & Drug Administration (FDA) serves as the government body responsible for protecting public health through its regulation of the safety, efficacy, and security of drugs, biological products, and medical devices. The policies and authority of the FDA are dynamic, reflecting the current social, economic, political, and legal landscapes [3]. For example, as racial and ethnic health disparities have become more widely known, FDA policies have shifted to encourage greater racial and ethnic diversity in clinical trials [4]. The convergence of these two government activities reflects the interplay between their objectives: the initiative to spur innovation and the need to provide the bounds that ensure and/or enhance public health in the context of evolving societal and technological trends.


Results, Conclusions, and Discussions:: The field of Regulatory Affairs sits at the intersection of technological innovation and regulations at the federal, state, and local levels. Individuals working in this field are expected to demonstrate competencies that reflect their ability to both interpret regulatory statutes and to inform engineering product research and development at all stages [5]. We posit that these competencies are needed not only for the Regulatory Affairs professional, but also the 21st century biomedical engineer.

A biomedical engineering education framework that integrates core Regulatory Affairs concepts has the potential to create understanding, approaches, and technologies that improve health and healthcare as well as current sex-, gender-, and race/ethnicity-based health and healthcare disparities. In concert with fundamental knowledge regarding sex-, gender-, and race/ethnicity-based discrimination and historical marginalization and social determinants of health, including economic stability, social and community context, neighborhood and environment, and education, training in Regulatory Affairs will enable the biomedical engineers of the future to contribute to understanding, approaches, and technologies that are accessible to and effective for all Americans.


Acknowledgements (Optional): : NCC is supported by the UCI Chancellor's Inclusive Excellence Professorship and Edwards Lifesciences Foundation.

References (Optional): :

1. Bush, Vannevar. “Science: The Endless Frontier.” Transactions of the Kansas Academy of Science (1903-), vol. 48, no. 3, 1945, pp. 231–64. JSTOR, https://doi.org/10.2307/3625196. Accessed 29 Apr. 2023.


2. Slaughter, Sheila, and Gary Rhoades. Academic capitalism and the new economy: Markets, state, and higher education. Johns Hopkins University press, 2004.


3. Eisenberg, Rebecca S. "The role of the FDA in innovation policy." Mich. Telecomm. & Tech. L. Rev. 13 (2006): 345.


4. Adashi, Eli Y., and I. Glenn Cohen. "The FDA initiative to assure racial and ethnic diversity in clinical trials." The Journal of the American Board of Family Medicine 36.2 (2023): 366-368.


5. Regulatory Competency Framework.” Regulatory Affairs Professionals Society (RAPS), 2021, https://www.raps.org/resources/regulatory-competency-framework.