Third Medical Innovation Impact Index Issued by Fairleigh Dickinson University’s Initiative for Patient-Centered Innovation (iPCI)

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MI3 Alert for Combination Products Review Process from Initiative for Patient Centered Innovation (iPCI)

One of the most fertile areas of medical innovation today is the combination of devices and drugs.

The third Medical Innovation Impact Index (MI3) Alert considers FDA processes for the review and approval of combination products, in particular, drug/device combinations. The current system received a score of 0 (range -10 to +10) for its impact on medical innovation by the Initiative for Patient Centered Innovation (iPCI) of Fairleigh Dickinson University’s (FDU) Rothman Institute of Innovation and Entrepreneurship. Several changes to the policy could render a substantially positive score.

One of the most fertile areas of medical innovation today is the combination of devices and drugs. The goals of drug/device regulations are laudable – (1) simplify and expedite the review of combination products that qualify as devices; and (2) to reduce the number of combination products that would be considered drugs to include only those which rely on chemical action to achieve their primary intended purposes. In practice, however, standards that differ from the statute are being applied, shunting reviews of combination products having a chemical action “even in part” or “that meaningfully contributes” to the primary intended purpose to the FDA drugs center, as opposed to the devices center, as intended in the law. This adds to the cost, time, and uncertainty in the development of these innovative products, thereby stifling their advancement.

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.

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Dina Schipper
Fairleigh Dickinson University
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