Understanding the Impact of Regulatory Policy on Medical Technology Innovation and Translation

Interdisciplinary Areas: Engineering-Medicine, Innovation and Making

Project Description

Rigorous review of drug and medical device safety and effectiveness is a critical step to protect public health, but the rapid pace of scientific discovery outpaces the ability to efficiently translate innovative products to clinical practice. Current United States Food and Drug Administration initiatives promote innovation through programs that encourage the development of breakthrough technologies and early clinical studies of new products. However, the impact of these programs to effectively accelerate product discovery and development across the medical products industry remains unknown. Therefore, we propose to study the interaction of regulatory processes, programs, and the innovation ecosystem to identify the regulatory programs’ impact on product development across different organization types.

The results of this project will provide a better understanding of how innovation initiative programs and regulatory procedures impact engineering practice in the healthcare industry. This will inform regulatory policy-making to support innovative and ethical engineering practice in the healthcare industry, as well as the improvement of regulatory training and education, which would address the expanding need for regulatory professionals who are essential to successfully develop new medical products. This effort will have a synergetic effect with our ongoing effort to establish a consortium on regulatory education at Purdue University.

Start Date

Spring 2022

Postdoctoral Qualifications

- Mixed methods research and modeling expertise demonstrated through publications
- Engineering education background
- Experience translating research into education
- Socio-technical science integration interest
- Experience with health products industry
- Awareness of US regulatory policy for medical products
- Desire to identify opportunities for overcoming challenges in medical product innovation

Co-Advisors

Aaron Lottes
lottes@purdue.edu
Associate Professor of Engineering Practice
Weldon School of Biomedical Engineering
https://indianactsi.org/news_/attendance-record-shattered-during-virtual-indiana-ctsi-retreat-hosted-by-purdue-university/

Matthew Lynall
mlynall@purdue.edu
Clinical Professor of Management
Strategic Management and Management Education, Krannert School of Management
Avrum and Joyce Gray Director of the Burton D. Morgan Center for Entrepreneurship
Director of Purdue’s National Science Foundation (NSF) I-Corps Site
https://www.purdue.edu/newsroom/releases/2020/Q4/lynall-named-avrum-and-joyce-gray-director-of-the-burton-d.-morgan-center-for-entrepreneurship-at-purdue.html

Bibliography

Hamburg MA. Innovation, Regulation, and the FDA. N Engl J Med. 2010;363(23):2228-2232.
Webster A. Accelerating Innovation: Complexity, Regulation, and Temporality. Front Sociol. 2019;4:1-6.
Richmond FJ, Church TD. Graduate Training Capacity for Regulatory Professionals at US Universities: Are We Facing a Talent Crisis? Ther Innov Regul Sci. 2020;54(4):947-952.