Stranger in a strange land
How MedTech startups lose the future
Lost in the Mekong
After school, Jon backpacked in Laos and worked for food in a small village by the Mekong river.
It was late August in the high 30s C and humid. They would get up at 4:30 to prune the banana trees with machetes. By 8:30 they were done and stopped for breakfast. In the afternoon, the wife, Thrang, would teach them Khmu but it was like Klingon as far as Jon was concerned.
That afternoon, Jon asked Thrang for the day off to travel to the big city. It was 3 buses and 4 hours.
He left early, arrived at the big city by noon and picked up some things he needed and walked back to the Central Bus station.
Jon went to the cashier and asked for a ticket to the village.
Jon, “I need a one-way ticket to Hong Kiew”
Cashier: “wa’maH vagh tup ‘etlh SIQpu’ tu’lu’. cha’ rep ‘etlh nom tu’lu’ je. nuq DaneH?”
Jon heard direct bus in 15’ and express bus in 3 hours.
Jon, “I don’t speak Khmu, direct bus?”.
Cashier: “HIja’! - bIjaHnIS net nID. QaQ.” wa’maH vagh tup Duj SIQpu’ tu’lu’.
Jon heard Yes, bought the direct bus ticket and boarded.
4 hours later, the bus is flying past the junction instead of turning west towards the river and the village.
Jon goes to the driver, “Hong Kiew?” Driver, “No no go Hong Kiew, this direct bus to Muang Pek. I let you off here and you can take another bus”.
No bus stops in sight. He starts walking west and after 2 hours of walking North up the river, realizes that he is lost.
He walks South down the river and night falls.
No one in sight.
No cell coverage.
He’s f-ked.
But there is a road.
Maybe to the village.
Lost on the regulatory pathway
Jon eventually made it back to the village and after returning home to San Diego started working in tech.
He started a home networking device company and raised seed and a Series A and B with some Silicon Valley investors. 3 years into the company - he got an offer from Fortinet and they made a nice exit. A year later he left Fortinet with a sizable sum and started thinking about his next rodeo.
Jon didn’t start out trying to fix the healthcare system. But he remembered his experiences in Laos and he wanted to make a difference for patients.
Thinking about an indication that affects 24% of the world population and 55% of the population over 60 - he started looking for IP.
In 2007, he spun up a company with strong academic IP. The science was real. The unmet need was obvious. The device worked—at least in the lab.
At that point, everything felt open.
What Jon didn’t realize was that the most important constraints hadn’t shown up yet — but they were already being set.
He went back to his first Silicon Valley investor. The one with the name of a tree. They loved the idea and put in $5M.
By 2014, Jon launched clinical trials to generate evidence. It was a bet, because a home device in the space was new but Jon was confident with his experience in the Fortinet exit and took a bet that a 510(K) would unlock the market
There was a flood of patients who needed this.
Between 2015 and 2019, they got readouts from the first clinical trials with 287 patients. They didn’t show statistically significant clinical benefit.
Not failure exactly. But not success either.
This was the first real warning sign—though it didn’t feel like one at the time.
Investors wanted answers. Advisors wanted momentum. Jon was still in the game, but his range of movement was getting worse.
In 2019, they tuned the device configuration and went for a pivotal trial with 900 patients and a De Novo submission.
By December 2021, it worked. Statistically significant. Clinically meaningful.
In August 2022, the FDA granted clearance.
From the outside, this looked like victory.
Inside the system, something else was happening.
In October 2023, CMS declined to issue a reimbursement code. “Not suitable for inclusion,” they said. Without a code, patients wouldn’t buy a new device and disposables that cost over $2k for a 3 month course of treatment.
FDA clearance didn’t open the market. It closed the conversation.
FDA and CMS operate under different systems of reasoning.
Years earlier, no one had seen this coming. Not his regulatory consultants. Not the partners at the tree-name VC.
By January 2025, Jon finally secured FEHB reimbursement through Blue Cross / Blue Shield. It was a big win that unlocked revenue.
But the path there had been narrow, exhausting, and far more constrained than it ever needed to be.
Looking back, Jon could see it clearly. The biggest risks weren’t technical. They weren’t even regulatory. They were structural assumptions that went unexamined at the moments when optionality was highest—when the system was still flexible enough to absorb different futures.
The irony was brutal: by the time the threat was visible, the decision had already been made.
Jon didn’t fail. He survived.
And in MedTech, that distinction matters more than most people admit.
We love the start and the end
We love the romance of the start, when people quit their jobs and start something and launch a new idea or raise some funding..
We love interesting stories, exceptional achievement and beautiful people.
Look at AI and Mira Murati.
We love the finish, whether it’s an acquisition or an IPO, or a bankruptcy. Or investors suing the founders. Like the guy who raised $80M and used it for a private jet and sponsoring golf tournaments.
We ignore the 10 year path of MedTech losing their options somewhere on the banks of the Mekong.
Outro
MedTech doesn’t fail because of a particular regulatory pathway.
You fail because you didn’t make the threats explicit to yourself, your employees and investors at the beginning of the path.
You commit assets
You choose vendors and consultants
You choose strategies for clinical evidence.
You freeze architectures
All before anyone asks:
“What must be true for this not to blow up later?”
With 5-10 year paths to market in MedTech, threats aren’t discovered late — they’re decided early and named late.
This week on Life Sciences Today
If this story resonated, this week’s Life Sciences Today episode digs into another place where optionality quietly collapses: clinical trials.
This week I hosted Denali Rose, Veeva VP and co-host of the Note To File podcast and we had a free-wheeling no holds barred talk about clinical trials.
One of the most fun shows I did - tune in!
Her parents are outdoors people and named her after the national park in Alaska. One of the most fun shows we’ve ever done. Denali is Vice President Sales & Strategy, Site Solutions at Veeva. That’s her day job - she’s also the co-host and producer of the Note To File podcast.
She’s super smart and extremely experienced in the patterns and anti-patterns in the clinical trial industry.
Visit Note to File here
You can see the episode here
About me
I’m a writer, host of Life Sciences Today podcast, ex-pharmatech founder, father of 4.
I’ve been building in tech, cyber, privacy, and clinical data for 25+ years across Israeli medical device startups, Verily, Amgen, and the Fortune 1 company. I work at the intersection of business, engineering, AI and clinical data.
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Brilliant use of the Lost in Laos narrative to frame the MedTech regulatory misalignment problem. The point about FDA clearance closing the conversation rather than opening it is something I wish more founders understood before committing capital. I've seen this pattern repeatedly where technical validation creates false confidence while the real lock-in happens at the reimbursment layer. The observation that threats aren't discovered late but decided early and named late should be printed on every term sheet in this space.