One Device for Depression, Anxiety & Insomnia: Fisher Wallace Labs

This one is a deep dive into the unglamorous reality of building a prescription medical device. Kelly Roman, co-founder and CEO of Fisher Wallace, flew in from New York to sit down with Grant Chapman and Drew Westrick (Glassboard's CTO is back in the co-host seat) to talk about brain stimulation for depression, anxiety, and insomnia, and the nearly 17-year road to getting it through the FDA.
Kelly's path is anything but typical: a Harvard English major who worked in early social media, adapted Sun Tzu's "The Art of War" into a graphic novel for HarperCollins, and then took over a crude brain-stimulation prototype in 2009 because, antidepressant side effects aside, the thing actually worked on him. What follows is a masterclass in the parts of hardware most founders never see: how you design a placebo ("sham") for a device people can feel, why depression is regulated as a Class III device, and why getting through the FDA is only half the battle.
What we get into:

Kelly's unlikely route into med tech, from Harvard English and early social media to a graphic-novel "Art of War"
How Fisher Wallace sold a research device for 14 years (2009 to 2023) under a quirk of FDA regulation, while running trials on it the whole time
The 165-first-responder anxiety study that came back a "home run," and the pivot to a Beats-inspired, wire-free form factor
Device classes 101: why anxiety and insomnia are Class II but depression is Class III, and the difference between "cleared" and "approved"
The placebo problem in mental-health trials, why it's even bigger in at-home studies, and how SSRIs separate from placebo by only about two points
The hardest design challenge of all: a sham device you genuinely can't feel, made possible by a high-frequency carrier waveform and a successful blinding assessment
How the FDA weighs efficacy against severity, the suicide-risk calculus, and the "wellness paradox" where any risk outweighs benefit for a healthy person
A category essentially frozen since 1976, brass-bulb devices from the turn of the century, and Fisher Wallace's multi-year fight to create a Class II path
Why FDA clearance is not reimbursement, and the real-world-evidence game (IQVIA, healthcare-utilization data, employer pilots) that actually gets a device paid for
Pricing and distribution: DME, upfront fee vs monthly billing, the VA and Medicaid, and recurring revenue from software rather than hardware
The IP moat: a prescribable waveform, electric-field modeling, and one device for the three most common conditions

A few lines that stuck with us:

"It's never going to happen again in our space."

"You have to strategically bake in a very high placebo effect in any mental health trial."

"Just because you prove it's safe and effective doesn't mean the insurance carriers are going to cover it."

About the guest: Kelly Roman is the co-founder and CEO of Fisher Wallace, which develops wearable brain-stimulation devices for depression, anxiety, and insomnia. He's based in New York.
The Hardtech Podcast is hosted by Grant Chapman and Drew Westrick of Glassboard.