Masters Applied Projects

Project 8

Strategic Drivers of Medical Technology Innovation

Student:

Alison Dewald

Mentors:

Dr. David Feigal - Arizona State University, Sandra Day O’Connor School of Law
Dr. Vincent Pizziconi, PhD- Arizona State University, SBHSE
Dr. Brent Vernon, PhD - Arizona State University, SBHSE

YouTube Link:
View the video link below before joining the zoom meeting

Zoom Link:
https://asu.zoom.us/j/85010705811


Abstract:
As medical technologies continue to evolve and adapt to the dynamic needs of users, it is crucial to consider in parallel how regulations should be adjusted to avoid downstream negative impacts. The directionality of cause and effect between medical innovations and regulations remains in question as the medical device field advances. Regulatory agencies, such as the US Food and Drug Administration (FDA), are making changes to regulations to account for new breakthrough technologies and progressing demands of the global medical climate. Programs and initiatives created by the FDA have goals to reduce the cost and time of medical technology development, assessment, and review, increase collaboration amongst centers and stakeholders, and form guidances for new technologies, all while ensuring safety and efficacy. The outcomes of these programs are yet to be fully realized, specifically their impact on medical device development. Thus, the purpose of this research is to analyze the relationship between new FDA strategies/policies and medical device innovation. Various metrics were gathered through reported data by the FDA - number of submissions, approvals, clearances, recalls, warning letters, and review time - and evaluated for correlative relationships with new medical device programs, acts, regulations, and innovations. The findings from this analysis will provide an evidential starting point for potential regulatory changes to be made to shift current FDA policies from retroactive to proactive in promoting medical technology innovation.