By the Rothman Institute, Special for USDR.
The Medical Innovation Impact Index (MI3), a new method for evaluating the impact of regulation on medical innovation, has been developed at the Initiative for Patient Centered Innovation (iPCI) of Fairleigh Dickinson University’s (FDU) Rothman Institute of Innovation and Entrepreneurship. The inaugural MI3 Alert pertains to new FDA (Food & Drug Administration) draft guidance documents and a Senate proposal for accelerating the approval of certain medical devices.
“The main impediment to innovation in general, and medical innovation in particular, is not scientific discovery, entrepreneurial fervor, or investment, rather, it is regulation,” said Joseph V. Gulfo, MD, MBA, Executive Director of the Rothman Institute. “The purpose of the MI3 Alerts is to score regulations on their intended and unintended impacts on medical innovation and to create a dialog to advance policies that will promote the development of patient-centered breakthroughs.”
The Medical Innovation Impact Index (MI3) is a succinct, real world analysis and scoring system based on interviews with legal and medical experts who interact with government agencies regularly in the review of new products in development. The purported benefits and potential positive impacts on medical innovation are listed and scored zero to +5, based on the likelihood of achieving these objectives; the unintended consequences and potential negative impacts on medical innovation are listed and scored 0 to -5, based on the likelihood of these untoward effects happening. A final composite score (ranging from -10 to +10) is calculated and a recommendation is provided.
Currently, no analysis exists to evaluate rules solely with respect to their impact on the advancement of medical innovation, which is the purpose of the Medical Innovation Impact Index. MI3 alerts will be issued monthly.
About Fairleigh Dickinson University
Devoted to the preparation of world citizens through global education, Fairleigh Dickinson is New Jersey’s largest private university and features more than 100 liberal arts and professional degree programs, two international campuses, dozens of partnerships with internationally renowned institutions and special programs and status within the United Nations.