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  • Writer's pictureShannon Lantzy

RegTech's Law (an extension of Martec's Law)

Technology changes fast (exponential), organizations change slowly (logarithmically), regulated industries are marked by inflection points

A friend recently showed me Martec's Law, which immediately felt like a breath of fresh air. Martec uses pseudo-math concepts to illustrate that technology changes faster than organizations, and that basic concept creates important downstream effects (like company failure, inefficiency).

RegTech's Law

I played around extending this to Medtech as a regulated industry. I'm curious what people think. The regulated industry changes in a dance of inflection points with its regulator. A safety signal arises (e.g., biocompatibility with mesh, cobalt, cybersecurity), the regulator changes, and medtech follows. A innovation occurs in medtech (e.g., AI as a medical device), and the regulator follows.

These inflection points are periods of turnbulance, because they represent a decrease in regulatory certainty and predictability. These points of turbulance are important and unavoidable. But, they are less painful when regulators and industry collaborate. This law gave rise to the Medical Device Innovation Consoritum (MDIC), the International Medical Device Regulators Forum (IMDRF), and especially the Medical Device User Fee Act (MDUFA). In my humble opinion, each of these mechanisms of regulator-industry is a win for all sides, especially the patients.

Hat tip to Lane Desborough who shared this (and many other) great concepts with me.

~Shannon, the Optimistic Optimizer

Ps. This bears more exposition. My readers deserve context. But it's Friday, I like to ship early, and it is time to have fun with the kids. 'Til next week my Regulatory Innovator friends!


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