# Decisions That Don't Wait for the CEO: How a Medtech Startup Turned Speed Into a System > Personal reflections after listening to Medsider's interview with Cala Health CEO Deanna Harshbarger. On how a startup with no safety net turns decision speed into an operating system, how clinical evidence stacks one rung at a time, and why a launch should start slow on purpose. Educational content, not investment advice, no stock recommendations. Published: 2026-09-01 Locale: en Tags: medical devices, startup operations, clinical evidence, product design, decision making ![An early-morning workbench where a few people gather around a wrist-worn device and an opened shipping box, the long table receding toward a window](/covers/medsider-2026-08-31-building-an-operating-system-for-faster-decisions--cover.png) > Speed is the essence of war: take advantage of the enemy's unreadiness, travel by unexpected routes, strike where he has taken no precautions. > > —— Sun Tzu, *The Art of War*, "The Nine Situations" (Spring and Autumn period; translation mine) ## What this episode is about This is a Medsider interview released on 31 August 2026. Host Scott Nelson sat down with Deanna Harshbarger, CEO of Cala Health — a company making a wrist-worn device that looks a lot like a watch and uses non-invasive nerve stimulation to reduce hand tremor. It's indicated today for essential tremor and for action tremor in Parkinson's disease. Her background is worth a minute. She trained as a chemical engineer and actually practised, doing R&D and process engineering. She says that shaped how she thinks about money, because in that world the margins are pennies on the dollar. Twenty-two years in medical devices followed — interventional cardiology at Johnson and Johnson, deep brain stimulation at Boston Scientific, diabetes care at Medtronic — and she joined Cala in 2021, first as chief product officer, later as CEO. Listening to it, the real subject isn't the device. It's a much more general question: how does a small company with no safety net make good decisions without routing every one of them through the boss? Her answer isn't a leadership philosophy. It reads more like system design. Here are the points I found most informative, plus some things I found myself thinking about afterwards. ## The main points **One. The difference between a large strategic and a startup isn't discipline — it's the second chance.** She put it in a way I liked: at a startup it's one equation, x plus y equals z, and if you miss one term there's nothing on the other end to make it up. A large company is a portfolio; one division ebbs, another flows, the whole still stands. That's why startup decisions have to be fast. But she was careful here — fast doesn't mean abandoning science or data. It means you don't have time to run down every single number before you act. **Two. The precondition for deciding fast is getting the information out first.** This she took from Johnson and Johnson, where every unit was expected to stand alone, and where everyone — from an operator on the line to the person running the sales team — understood the company's financials. She brought that straight into Cala: everybody should understand our high-level financials, because that's how we make decisions, down to the individual level. Her line was blunt: how can they make the right decisions if they don't have full information? **Three. So they hold an all-hands every single week, still, at their current size.** The habit is inherited from years and years ago. It's short. Business status, celebrations, what's coming. What strikes me is that most companies hit some scale and say this doesn't work anymore, move to monthly or quarterly, and transparency quietly steps down a notch each time. Her logic runs the other way: precisely because you can't stay in every detail once you move up, the people who *are* in the details need the same information you have. **Four. The product design section is the most vivid part of the episode.** They ran unboxing interviews — ship the box to a patient, then get on a video call and watch them open it. One patient with a first-generation box had so much trouble that he tore the seal open with his teeth. She called it eye opening, and I get it completely. You're treating people whose hands shake, and your packaging needs steady hands to open. No slide deck tells you that. They eventually took the design down to the studs; every single person on the engineering team met patients. Even "the band has to be changed every ninety days — can they change it?" got asked as its own question. **Five. Clinical evidence stacks one rung at a time, and the order matters.** Her ladder: feasibility (does this even work) → confirm the mechanism of action → a randomised controlled trial in a truly controlled environment → real-world evidence for how it actually behaves out there. One line I wrote down: you should know the answer to what outcome you're going to get before you run the RCT. More than 2,000 patients have been through their clinical studies, which she says is unusual in this space. **Six. Reimbursement is harder than regulatory, and the bar only rises.** She was emphatic about this. Because the therapy was genuinely new, no codes existed for it — Cala had to create them and prove it was different from what was already out there. She said Cala got told no every time, went back, gathered the clinical and technical evidence, and came again. And before a broad coverage determination, you're fighting patient by patient, single battles. That, she said, is the hardest stretch. **Seven. They launched slowly on purpose, and squared it with the board in advance.** Everything about the therapy was new, so they knew they were learning as they went. Her words: it's hard to hold back, but it's really important to hold back, because you never want to alienate your customer at the first go around. What made it possible is that their board and investors are in it for the marathon. She added a very practical piece: lay out ahead of time which signals mean gas and which mean brake, and set yourself up financially and structurally to survive going slow — otherwise you've hired a whole commercial team and then announce a limited launch, and all those people sit on your payroll. **Eight. On fundraising she used two words: sprint and marathon.** The core is that every assumption in your financial model needs a proof point behind it, and you have to show both the here and now of the company and what it becomes. One level up, work out your own objective first and then match investors to it — if their incentive is short-term gain and your path is long, the misalignment was there from day one. She noted that having sat on the other side of the table at three large strategics, she knows what gets asked. ## Going further ### "The news says it got cleared — should I take a look?" When I first started following medical companies, my most reliable mistake was treating regulatory clearance as the end of the story. A headline says a device was cleared, and it looks like a door swinging open. This episode lays out the doors queued up behind it: is there a payment code, is there a payment determination, and how fast does the company itself choose to roll out. She says reimbursement only gets harder and the bar keeps rising — and before a broad coverage determination, it's won one patient at a time. That's a three-year stretch that never appears in a headline. So now, when I read that kind of news, I ask one more question: which box did this move the company into? The "we proved it works" box, or the "someone is willing to pay" box? The distance between those two is often longer than the distance from lab to clearance. And the second one usually has no press release — it changes quietly inside some payer's internal policy document. The deliberate slow start belongs in the same reading. If a company sells more slowly than expected in year one, the numbers alone say weak momentum. If that slowness was planned, with gas-and-brake conditions agreed with the board beforehand, it means the opposite. I'm not saying slow should make you optimistic. I'm saying when you see slow, it's worth looking for whether anyone described it in advance. Slowness explained beforehand and slowness explained afterwards are two entirely different objects. ### "Where's the moat? I can't read the technology" This is where I get stuck. I can't evaluate the technology and I can't get through the patents, so what's left? The episode gave me an angle: look at what's accumulating. The host said something I thought was exactly right — the moat gets deeper and wider with every single study you run, even a post-market one. That works because of the ladder underneath it. Feasibility gives you a trend. The randomised trial gives you causation under control. Real-world evidence tells you what happens when people actually use it. None of the three substitutes for the others, and you can't buy the set at once — they're gated by time, and whoever comes later has to run the same clock no matter how well funded they are. That accumulation also converts into other things. She said the reimbursement was won on evidence laid down years earlier; the same body of evidence is what convinces physicians and patient advocacy groups. One asset collecting rent in three places is a different kind of moat from "we have technology nobody can replicate" — the latter can be routed around by something better, the first has to be outlasted. My own crude method now: look at how many of a company's studies started *after* commercialisation. Nobody makes you run those. Running them raises the bar for whoever comes next. It's a signal about management's time horizon, and it's much harder to fake than any paragraph about being long-term oriented. That's an angle, not a test. Heavy accumulation can also mean the thing isn't good enough and keeps needing defence — so the follow-up question is whether each study pushes into a new question, or re-proves the same one. ### "My decisions are either too slow or too fast" This was the part that landed hardest for me, and it has almost nothing to do with investing. The way she talks about speed is counterintuitive. Most discussions of decision speed are about the decider — be decisive, have judgement, it's all about that person. Hers is entirely about everyone else: everybody understands the financials, weekly all-hands, lean toward transparency. Speed is the output. Information distribution is the input. Looking at my own investing notes with that lens, a lot of what I'd been calling hesitation wasn't psychological at all. At the moment of deciding I simply didn't have the numbers in front of me — they lived in three different places, I couldn't be bothered to assemble them, so I stalled. By the time I had to decide, I was going on impressions. That's not the same as her "you don't have time to run down every number." I hadn't even worked out which numbers mattered. There's one more contrast worth keeping. She said if you're still down in all the details after moving up, you're probably not doing your actual job. Her fix is the buck-stops-here mindset — because you'll be the one asked why this happened, you know where to dive in and where to stay high. That mindset isn't for pressuring anyone. It's a navigation aid: accountability tells you where attention belongs. Here's what I tried, and I'm not sure it's right for everyone: write down the three decisions from the past year you most regret, then ask one question about each — was my judgement wrong, or was I forced to decide without the information? If two of the three are the second kind, judgement isn't the thing that needs work. ## Worth a look - The episode itself: Scott Nelson interviewing Cala Health CEO Deanna Harshbarger, Medsider, 31 August 2026. The Medsider site carries a full written version with links - Cala Health's site at calahealth.com, where you can see what the device actually looks like and read the indications - For the difference between essential tremor and action tremor in Parkinson's, national neurology society patient pages tend to be clearer than news coverage - If the reimbursement path interests you, search around how a new technology obtains its own procedure code — you'll find that the "told no every time" in this episode is the norm, not the exception - Medsider has a long run of interviews with device founders; going through several is a faster education in the industry's structure than an industry report ## The one thing to take away If I could keep one sentence from the whole hour, it's this: decision speed isn't a property of the decider, it's a result of how information is distributed. A team is usually slow not because the people in it are indecisive, but because the information needed to decide lives in one person's head, so everything has to queue behind that person. Her whole approach — everyone understands the financials, weekly all-hands, lean toward transparency — is the same move seen from different sides: push the information outward, and decisions start happening in the right places on their own. The reverse holds too. If you find that everything waits on your nod, it's probably not that nobody dares to decide. It's that they don't have the three numbers you have. Something I tried that worked better than I expected, in case you want to borrow it: this week, pick one judgement you're carrying alone. It doesn't have to be work — whether to replace the car, whether to move your parents to a different hospital, whether to stop your kid's tutoring all count. Write the three concrete facts you're actually weighing (not feelings — numbers or facts) into five sentences, and send or say them to the people that decision will affect. Not to make them decide for you. Just so they can see what you're looking at. The first time I did it I felt exposed, like I was showing how roughly I'd been thinking. What I found afterwards was that the next time the same kind of question came round, the other person arrived with a judgement instead of a question.