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David Sable: More From ASRM – The Elusive But Real Charms of FDA Oversight of IVF Innovation

David Sable/LinkedIn

Oct 28, 2026, 13:34

David Sable: More From ASRM – The Elusive But Real Charms of FDA Oversight of IVF Innovation

David Sable, Director of Celmatix and AutoIVF and Advisory Board Member at Conceivable Life Sciences, shared on LinkedIn:

“More From ASRM: The Elusive But Real Charms of FDA Oversight of IVF Innovation

Q: You mentioned the FDA. Are you suggesting (horrors) that we should want more regulation?

A: Two parts to that. The first is that if we want to attract more venture money to finance pre-revenue innovation, then a uniformly-applied FDA regulatory system would give our sector a scorecard that makes venture investing easier.

Second: Say what you want to about the FDA, but it does protect the integrity of the most disciplined, academic, and data-driven innovators, and since it puts a good housekeeping seal of approval on the relative truth behind outcome claims, justifies the high prices of “healthcare” margins versus, say, consumer discretionary or commodity profit margins.

Margins (ie profits) are a function of where what you are selling falls on the monopoly to commodity marketplace continuum. Monopolies control the market price (in the absence of explicit regulation as in the utilities industries); in commodity markets the marketplace sets the price through a silent implicit auction process.

Every business wants to control its price. What is the promotion side of marketing other than a means of differentiating your product so it is closer to the monopoly side of the continuum than the commodity side?

What does that have to do with the FDA? I noted biotech industry, the 90%+ gross margins are a function of 1) patents on extremely specific and chemically well defined entities (ie n of 1 cannot be replicated for 20+ years) and 2) the barriers to competitive entry imposed by the FDA’s rigorous approval process for the companies/products/drugs that came first.

This exclusivity and the implied quality standards that go with it are the building blocks for a “pharmaceutical margin” pricing.

And that high pricing gets built into the financial models that investors use to triage their capital.

So lets leave it for the moment that the FDA can be a burdensome but ultimately helpful partner in entrepreneurship.

What happens when you set a pharma margins price without having undergone an FDA pharmaceuticals type approval process?

No one pays it? Or competitors open up next door and undercut your price? Or investors don’t believe your model and the project never gets off the ground?

The FDA comes knocking eventually with ‘false claims’ accusations?

More to come. Back to the meeting.”

David Sable: More From ASRM – The Elusive But Real Charms of FDA Oversight of IVF Innovation