Getting FDA approval is base camp at Everest - getting paid is reaching the summit
Jennifer Ernst doesn't know the word impossible.
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Intro
Jennifer Ernst and I connected on LinkedIn.
The breadth of her experience and the precision of her thinking and ability to execute against all odds - this person doesn’t know the word ‘impossible’.
One of the most interesting and inspiring people I’ve ever had the privilege to meet.
From Xerox Parc to neuromodulation to treat sinus headaches, and a pivot to immunotherapeutics to protect against radiation injury and to support immune function in oncology settings.
Yes - this sounds like a career of 3 people.
Jennifer spent her career at the edge of science and market reality.
She started at Xerox PARC, helping translate breakthrough research into viable business models.
Later, she helped scale Thin Film Electronics and then co-founded Tivic Health, where she brought a non-invasive neuromodulation device from concept to FDA clearance in just three years for less than $3 million. She eventually took the company public and later helped lead a pivot into biopharma.
That story alone is compelling. But the deeper insight from our conversation was about commercialization.
FDA clearance is hard but it’s only the beginning.
In MedTech, especially in devices and neuromodulation, there is often an assumption that FDA clearance is the hardest part. It is hard. It takes years, capital, discipline, and good data. But Jennifer’s point was sharper: FDA approval is not the finish line. It is the beginning.
Her metaphor was perfect. Getting FDA approval is base camp at Everest. You are not at the summit. You are barely at the start of the real climb.
The real climb is reimbursement, adoption, and business model design.
Neuromodulation is a particularly revealing example. The field is exciting because these devices are often non-invasive, can have strong safety profiles, and may offer meaningful alternatives to drugs or surgery. But that promise creates its own trap. If a device is non-invasive, there may be no surgical procedure tied to it. If there is no procedure, there may be no billing code. And if there is no billing code, physicians may have little economic incentive to adopt it, even if the device helps patients.
That creates the commercialization bottleneck Jennifer kept returning to: how does everyone in the system get paid?
It is not enough for the product to work. The payer has to see cost avoidance. The physician has to have a viable revenue path. The company has to support education, adoption, and ongoing use. A technically elegant product can still fail if it lands in a market structure that has no way to absorb it.
Jennifer’s own experience made this concrete. Tivic’s sinus device had a strong safety profile and compelling results. But launching during COVID, dealing with shut physician offices, facing high customer acquisition costs, and lacking a recurring revenue model made the commercial path far harder than the regulatory one. That is a lesson many founders learn too late: the market does not reward clinical novelty by itself.
Jennifer identified a major anti-pattern in neuromodulation:
too many companies try to go direct-to-consumer without understanding the real cost of consumer marketing.
Direct-to-consumer without understanding what that really means
That move is seductive.
If physicians are hard to educate and reimbursement is unclear, direct to consumer sounds like freedom.
But in reality, consumer health requires enormous spending on education, trust-building, and repeat engagement.
Medical devices also carry higher manufacturing and quality costs than standard consumer electronics (because of specially-designed hardware, manufactured in very small quantities and with a specialized supply chain).
If the product is a one-time purchase with no recurring revenue, the economics can break fast.
In other words, skipping the healthcare system does not mean you escape the commercialization challenge.
It usually means you inherit a different one — and often a more expensive one.
Jennifer’s insight is one every founder in medtech should keep in mind: approval gets you to base camp. The summit is building a system where the product gets used, paid for, and sustained.
(Tivic Health rebranded as Valion Bio end of April 2026)
Visit Valion Bio here
Jennifer is now working on her next rodeo - if you want to contact her - DM me on substack and I’ll make the introduction.
She’s good people.
Watch the show here.
OpenCRO
My conversation with Jennifer reinforces a theme I think about a great deal in my own work: commercialization is not something to “add later” after you develop a device or drug.
Revenue assurance has to be designed into the company’s value proposition.
That is the premise behind OpenCRO, my latest company.
We help medtech teams build development and commercialization programs in which the revenue logic is legible early — before companies discover, too late, that regulatory progress and commercial readiness are not the same thing.
One of the most common mistakes I see is treating the product label as a regulatory output rather than a commercial input. By the time payers ask, “How do you measure benefit?”, the pivotal trial is often already enrolled and the protocol can no longer be changed. At that point, commercial failure is no longer hypothetical. It is simply delayed.
I have seen variations of this problem across more than 40 medtech commercialization programs in the US - and I hear it from leaders on Life Sciences Today
If that sounds familiar, I’m offering a free 30-minute stress test of where your next deal is most likely to break: FDA review, hospital IT, procurement — or all three.
I’d love to talk to you - grab a time here. No strings.