Medical Innovation Impact Index

What is the Medical Innovation Impact Index (MI3TM)?

The Medical Innovation Impact Index (MI3TM) is a scoring system for important new proposed regulations (laws, rules, guidance documents), as well as for existing policies. It will mirror the “Environmental Impact” assessment that all new projects must include by Federal Law. The goal is to analyze the consequences (unintended and intended) of new and existing policies (FDA, SEC, patent law, healthcare delivery).

The Medical Innovation Impact Index (MI3) is a succinct, real-world based analysis and scoring system. On the positive side, 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. On the negative side, 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 offered.

  1. Purports to do – likelihood of achieving objectives (0 to +5)
  2. Potential Positive Impact on Innovation – likelihood of achieving (0 to +5)
  3. Unintended Consequences – likelihood of consequences occurring (0 to -5)
  4. Potential Negative Impact on Innovation  - likelihood of negative impact (0 to -5)

Regular MI3 Alerts highlighting existing as well as proposed new laws, rules, guidance documents, and policies that have an impact on medical innovation will be issued. The goal is to advance medical innovation by identifying policies that enable and hinder the development of meaningful patient-centered innovations.

The analyses are driven from “in-the-trenches” experiences of our staff and advisors who are in the front lines of the development and dissemination of medical innovations to patients. This unprecedented approach, based on real-world and practical, experiential considerations is sorely needed and in sharp contrast to the theoretical and detached evaluations performed by the government agencies (FDA, CMS, SEC, etc.). Most important, it is concerned solely with the impact on medical innovation.

Why is the Medical Innovation Impact Index (MI3) Needed?

While a great deal has been written about the negative effects of regulation on innovation in all sectors, and surveys have been conducted regarding the stifling effects of regulation on medical innovation, there is no independent analysis and scoring of policies, rules, guidance documents, and proposals relative to their likely impact on medical innovation.

During the rule-making process for regulations that are economically significant (having a likely impact of at least $100MM), a Regulatory Impact Analysis ("RIA") is required, which includes evaluations stipulated by Executive Orders 12866 and 13563. But, no such analysis exists to evaluate rules solely relative to their impact on the advancement of medical innovation. Moreover, the RIA is not mandated for guidance documents, which are the methods by which the FDA publishes detailed interpretations of its rules, truly where the rubber meets the road.

Medical innovation is too important to be neglected or left to regulators to weigh. Our understanding of fundamental biology is progressing at a lightning pace and providing tremendous medical discoveries and insights. Patients are demanding more immediate access to cutting edge therapies as evidenced by the Right to Try Law movement. Investors have increased the pace at which they have been allocating capital to the sector broadly. However, over-regulation and the inconsistent application of laws and rules continues to handicap the timely development and approval of new medicines and devices.

Nothing transformative is being done to address the problem principally because it is hard to do. For government agencies like the FDA, it is easier to propose rules and guidance documents with great sounding titles in order to deflect criticism of inadequate performance. For elected officials who need to show activity within their term periods, it is easier to mollify constituents with proposals and laws that give some acknowledgement of their pain, but accomplish little. For drug developers, it is easier to target diseases for which the greatest regulatory incentives exist because this provides the quickest way to maximize shareholder value.

Seemingly, no one wants to perform the hard work of analyzing the implications of the system of laws, rules, guidance documents, policies, and resultant modus operandi relative to their collective impact on medical innovation.

We do. And, it is critically important to patients and society that we perform this difficult work.