The Hardtech Podcast

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Aug 2026

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The Hardtech Podcast pulls back the curtain on the bold ideas, design challenges, and engineering breakthroughs behind today’s most innovative hardware products — and the people who make them happen. From first sketch to final build, we dive deep into the minds shaping the future of physical tech.

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September 11, 202648 min

ClearObject - Turning Vision AI Into a Wearable

A vision system can see a car enter a work zone in milliseconds. Getting that warning to a worker standing two miles down the highway, wearing a helmet and running a jackhammer, is a completely different problem. Derek Bleyle, VP of Product at ClearObject, and Tim Hagan, Principal Data Scientist at ClearObject, join host Grant Chapman and guest host Elijah Clarke, hardware engineer at Glassboard, to tell the story of Clear Work Zone, from a design thinking workshop with the New York State Thruway Authority to a production system protecting crews today. ClearObject spent eight years building software for connected products before this, and the episode is an unusually honest look at what that team had to learn. They started with commercial off the shelf everything, discovered that phones and smartwatches could not deliver the range, battery life, or control they needed, and ran a six week proof of concept that ended with one of their developers soldering a wearable together in a hotel room the night before the demo. That demo was enough to earn buy in from the customer and from their own leadership, which is the real lesson for anyone trying to get a hardware idea moving. From there the conversation gets into the engineering. Why they alert when a vehicle actually enters the zone rather than trying to predict it, because alert fatigue kills a safety product on day one. Why Wi-Fi HaLow was the only wireless option that could cover a two and a half mile closure with low latency when Bluetooth is too short and cell service does not exist. How they budgeted two and a half seconds from event to a worker getting clear, and drove the end to end system down to four tenths of a second. What it takes to build a device that survives sunlight, dust, rain, vibration, and being thrown in the back of a truck with a helmet on top of it. Derek and Tim also talk about the shift in mindset that happens when a product moves from convenience to safety critical, the difference between the buyers who run safety organizations and the workers actually wearing the device, and the value of building in the hundreds instead of the thousands so real users can live with a product long enough to tell you what is actually wrong with it. If you are building a connected hardware product, this is a clear look at the path from idea to something people trust with their lives, and a reminder that the last 20% of the functionality is where 90% of the effort lives. Special Guest: Derek Bleyle.

August 31, 202647 min

Babba - Heating and Cooling Baby Bottles at Scale

Some founders chase a new idea every few years. Dan Evans did the opposite: he got world-class at one genuinely hard technology and rode it across an entire career. In this episode, Dan, the CEO and founder of Babba, joins DeAndre Harakas and Grant Chapman for a conversation that is equal parts engineering deep dive and founder's playbook. Babba makes a portable baby bottle cooler and warmer built on thermoelectric (Peltier) cooling, the same notoriously nonlinear, power-hungry technology Dan first mastered at his previous startup, RecoverX, in the sports and wellness recovery space. RecoverX was acquired by Hyperice just months after launch, and Dan turned that hard-won expertise toward a new problem: warming and cooling breast milk safely, quickly, and on the go. The engineering half of the conversation is a genuine masterclass. Dan and the Glassboard team get into why thermoelectric cooling is so hard to control that being off by an inch means being off by a mile, how he whiteboarded the physics during the pandemic and proved the doubters wrong, and why balancing mechanical engineering, electrical engineering, fluid dynamics, and food science (you cannot cook or denature the milk) made this one of the hardest products any of them has worked on. The other half is about everything that happens after the engineering works. Dan talks through hearing past the noise of a rough prototype to what customers actually care about, why hardware's go-to-market is as brutal as the build, and why the capital moat around hardware survives even as AI speeds up design. Then he gets refreshingly honest about fundraising: 700 personalized investor outreaches, the second and third-order networks that actually lead to a check, building to be acquired, and the strange transition from venture-startup craziness to running a healthy small business. What we get into: Getting great at a "party trick" almost nobody can do, then finding every nail that needs the hammer The RecoverX story: four years of R&D, a launch, and an acquisition by Hyperice just months later Why thermoelectric cooling is so nonlinear that you have to nail the math and the engineering together The ugly alpha prototype vs the pretty 3D print, and why bridging the two is the hard part Not cooking the milk: balancing mechanical, electrical, and fluid engineering with food science The six-month roadblock, and selling into high-consideration baby purchases vs the athletic market Hearing through the noise of a prototype to what customers truly care about, and asking for the brutal feedback Why hardware's go-to-market is as hard as the build, and why the capital moat stays even as AI accelerates design The three pillars of fundraising and sales, 700 personalized outreaches, and second and third-order networks Building to be acquired, and the leadership shift from startup to small business A few lines that stuck with us: "Get really good at a party trick that almost nobody else knows, then find all the nails that need the hammer." "With thermoelectric cooling, when you're off by an inch, you're off by a mile." "The people you message might not be the people who invest in you. They might be the bridge to the person who does." "If you can find joy in the journey and not just the destination, you'll make a really good entrepreneur." About the guest: Dan Evans is the CEO and founder of Babba, which makes a portable baby bottle cooler and warmer built on thermoelectric cooling. He previously founded RecoverX, a thermal-control company in the sports and wellness recovery space that was acquired by Hyperice, and he has built his career around mastering one hard technology and applying it across multiple products. The Hardtech Podcast is hosted by DeAndre Harakas and Grant Chapman of Glassboard. Special Guest: Dan Evans.

August 24, 202655 min

Nuvio - Putting a PT in Your Walker

The walker is one of the most common and least reimagined products in healthcare. Matt Cumella set out to change that. A doctor of physical therapy with a board certification in geriatrics, Matt spent years in post-acute and aging care, and in this episode he joins Grant Chapman and Drew Westrick to trace the whole arc, from a formative burn-trauma ICU rotation to building Nuvio. He makes a simple but overlooked point: for the people he treated, the hardest moment often was not walking, it was standing up. Nuvio's first walker was reengineered around that, with an H-frame you step inside of (rather than shuffling behind), and ergonomic handles set at the right height to help someone rise out of a deep couch or chair. From there, Matt and the team pushed further, adding sensors to put a physical therapist's eye into the device and turn every session into meaningful, reimbursable data. What we get into: Matt's path from sports-med dreams to a burn-trauma ICU rotation that reset his whole view of the field Why daily independence, not peak performance, became the goal, and why a small loss of mobility can cascade into a house of cards in older age The walker everyone settles for, four posts and tennis balls, and why the real problem is sit-to-stand, not walking The H-frame design: stepping inside a ring of stability, the kitchen-sink demo, and a walker that folds and stands on its own Designing for three stakeholders at once: the patient, the home environment, and the caregiver who loads it into the car The pivot from the analog "acoustic" walker to a smart one, and the goal of putting a physical therapist in your walker Why the data matters: reimbursement, evidence, and moving from "how far did you walk" to the next 10 to 20 metrics The art of a properly constrained product, working through prototype to production, and continuity of care from hospital to home A few lines that stuck with us: "It's less about the top 5% of performance. It's getting 85% of your points back." "How do we put a physical therapist in your walker?" "We built a device that, even if you didn't know it was smart, would still win." "Product can be for anybody." About the guest: Matt Cumella is the founder and CEO of Nuvio and a doctor of physical therapy with a board certification in geriatrics. He spent years in post-acute and aging care before building Nuvio, a reimagined walker and, increasingly, a sensor-driven care platform for people working to regain their mobility and independence. This episode of The Hardtech Podcast was hosted by Grant Chapman and Drew Westrick of Glassboard. Special Guest: Matt Cumella.

August 18, 20261 hr 10 min

Special Episode - The AIM IN Summit 2026

This is a special one. Grant Chapman flies solo (a Hardtech Podcast "after dark" on a Friday) with Ben Wrightsman, founding board member of AMVIC, the Advanced Machine and Vehicle Innovation Center. Ben is a Hoosier lifer who has spent 30 years at the center of Indiana's hard-tech story, and he is exactly the kind of guest who can connect electric race cars, battery chemistry, contract manufacturing, and the coming wave of humanoids into one throughline. The conversation traces his arc from teenage electrician to Purdue, to Delphi's electric race car program and the EnerDel battery pedigree that quietly runs through nearly every EV today, to a decade building the Battery Innovation Center from fewer than six clients into a 600-plus-client powerhouse. That story becomes the blueprint for AMVIC: a nonprofit built to accelerate the entire machine, not just one subsystem, and the organization behind the upcoming AMVIC AIM IN Summit. What we get into: Ben's 30-year arc: electrician, Purdue, electric race cars, and the Delphi and EnerDel battery pedigree behind modern EVs How a scrappy battery lab on a landlocked naval base grew from fewer than six clients to more than 600, and pivoted from government dependence to a thriving private-market model Why hardware has to crawl, walk, run, always in that order, and why you should rent a manufacturing line before you ever build your own "Small fingerprints on very cool big things," and the quiet power of being the connective tissue in an ecosystem From the Battery Innovation Center to AMVIC: going from one subsystem to the whole machine, and why it is structured as a nonprofit Why the real AI story is a manufacturing renaissance: power, fiber, high voltage, and the data-center buildout nobody sees Humanoids, the dangerous jobs nobody wants, and why the robots are not coming for your job (with a Y2K and internet reality check) The origin of the AMVIC AIM IN Summit: how a 25-person dinner with a crazy idea became a sold-out summit built on demos, not sales pitches A few lines that stuck with us: "We have small fingerprints on very cool big things." "Hardware has to crawl, walk, run, and you have to do it in that order." "The renaissance in AI and data centers is really about manufacturing." "Compound interest is a hell of a drug." About the guest: Ben Wrightsman is a founding board member of AMVIC, the Advanced Machine and Vehicle Innovation Center, a nonprofit accelerating advanced machine and vehicle innovation. Over 30 years he has worked across electric racing, batteries (Delphi and EnerDel), contract manufacturing, and the Battery Innovation Center, and he is one of the driving forces behind the AMVIC AIM IN Summit. Join us at the event: The AMVIC AIM IN Summit is September 23rd in downtown Indianapolis, starting at 8:00 AM, with a Critical Energy panel, an OEM and innovation panel, a humanoid showcase, and Ben speaking. Register here: [event registration link] This special episode of The Hardtech Podcast was hosted solo by Grant Chapman of Glassboard. Special Guest: Ben Wrightsman.

August 17, 202644 min

Lexia Solutions - Giving Everyone a Seat at the Table

Some products are altruistic and some are shrewd. The best ones, like Uplift, are both. In this episode, Jeff Runnels, co-founder of Lexia Solutions and inventor of Uplift, joins DeAndre Harakas and Grant Chapman for a conversation that starts in a childhood classroom and ends up rewriting how venues think about accessibility. Jeff tells the story from the beginning: being pulled out of class into the "blue group" as a kid with undiagnosed dyslexia, a Quiz Bowl moment that made him question his worth, and a diagnosis in the tenth grade. Years later, a dinner with his wife Bliss and a formative friendship gave him the insight behind Uplift, a relocatable, battery-powered lift that gives a wheelchair user a real seat at the table without asking them to leave their chair or wait for a building to be remodeled. Then it turns into a masterclass in go-to-market. Jeff walks through the genuinely clever business case: how Uplift restores dozens of ground-floor seats, disperses accessible seating into every section, and uses ADA equivalent facilitation so that accessibility becomes something venues are motivated to buy, not just required to provide. What we get into: Jeff's origin: the "blue group," a Quiz Bowl gut-punch, and a dyslexia diagnosis in the tenth grade The dinner with Bliss, a friendship named Hal, and the dignity of meeting someone at eye level What Uplift actually is: the ClearSight seating system, a relocatable lift that sets up in under a minute The seat math: restoring roughly 45 ground-floor seats and dispersing accessible seats into every section The legal moat: ADA equivalent facilitation (Section 103), the swimming-pool-lift precedent, and why Uplift needs no construction Making accessibility pay: venue revenue, luxury suites, and accessibility as a sponsorship asset Building it safe: the multi-year UL and CSA certification journey, and why every test matters The unglamorous middle of hardware: a bad shop, a second mortgage, a U-Haul, and 72 hours to a patent Why fixed-bid hardware is impossible to estimate, straight from both sides of the table Assistive tech that ends up helping everyone, and why looking at the world a little differently is the whole point A few lines that stuck with us: "They don't really want to be picked up. They just want to be on your level." "You're weaponizing capitalism to make the ADA happen." "If you didn't write it down, it didn't happen." "We named it Lexia Solutions. Dyslexia." About the guest: Jeff Runnels is the co-founder of Lexia Solutions and the inventor of Uplift, a relocatable lift that brings wheelchair accessibility to bars, luxury suites, and concert floors with no construction required. The company name comes from dysLEXIA. Jeff was diagnosed with dyslexia in the tenth grade and has spent years building Uplift toward UL and CSA safety certification. The Hardtech Podcast is hosted by DeAndre Harakas and Grant Chapman of Glassboard. Special Guest: Jeff Runnels.

August 11, 202654 min

Eight Sleep - Building a $1.5B Sleep Company the Hard Way

Most people optimize their workouts and their meals, then spend a third of their life doing nothing intentional about sleep. Eight Sleep built a business on closing that gap, and in this episode Sam Kang, the company's Chief Product Officer, joins DeAndre Harakas and Grant Chapman to talk about what it actually takes to build the Pod, the smart mattress cover that heats and cools your bed. Eight Sleep has surpassed $500M in Pod sales, expanded to 34 countries, and been valued around $1.5B, and Sam runs product across all of it. Having come up through product-development consulting before leading hardware and then product at Eight Sleep, he is that rare guest who is deeply technical and has also been through the fire and flames of scaling a consumer-hardware company. It turns into two conversations in one: a real engineering deep dive, and a product masterclass any founder can steal from. What we get into: From a product-development consultancy to the bedroom, and why 10,000 hours at a consultancy build a problem-solving muscle rather than a single vertical Generalists vs specialists, and why shipping great hardware needs both The two dozen physics domains packed into one product: embedded software, electronics, thermals, and fluid control Why cooling a bed is dramatically harder than heating it (heating is nearly free; cooling means moving heat somewhere else) Why hardware is held to a higher bar than software: you cannot ship-and-improve your way out of a leak Appliances designed to fail, engineering to the warranty, and how better tools let teams fly closer to the sun The doorman vs the revolving door, and the cost of optimizing for the business case over the customer Ship or die: balancing customer, engineering, and shareholder value long enough to have real impact Latent demand, and how to detect it before sinking 18 months into a product The art of the MVP, the "hair on fire" test, and the crawl-walk-run of AI-generated ads, painted 3D prints, and the Wizard of Oz test Leaving your ego at the door, and why you need someone else to tell you it is ready to ship A few lines that stuck with us: "You can't software-update a leak." "At a consultancy, your 10,000 hours are all in problem-solving, not in any one vertical." "When the ego finally goes in the trash can, engineers get phenomenal at product, because they're chasing the user's happiness, not their pride." About the guest: Sam Kang is the Chief Product Officer at Eight Sleep, the sleep-technology company behind the Pod. He came up through product-development consulting (Mindtribe) before leading hardware and then product at Eight Sleep. The Hardtech Podcast is hosted by DeAndre Harakas and Grant Chapman of Glassboard. Special Guest: Sam Kang.

August 3, 202651 min

ohSnap! - The Engineering Behind Invisible Design

Mobile phones are supercomputers in our pockets, yet turning them into ergonomic gaming machines or daily-use handhelds requires an extraordinary degree of mechanical precision. ohSnap has built a brand around ultra-thin, magnetic, high-utility phone accessories and controllers—products that live on your person 24/7 and must feel flawless every single time you touch them. In this episode, Head of Engineering Shafae Ali sits down with DeAndre and Grant for a deep dive into the intersection of technology, industrial design, and human experience. The first half explores Shafae's self-taught origins in engineering, the painstaking mechanics of snap fits and magnet integration, and why the last 15% of hardware refinement is where most products fail. The second half pivots into engineering leadership, the philosophy that "great design is invisible," structured brainstorming without physics constraints, and how ego-free team culture drives breakthrough innovation. What we get into: What ohSnap creates: Ultra-thin magnetic mobile grips, chargers, and the MCON magnetic gaming controller designed for seamless mobile play. The electromechanical challenge: Why designing products that live in your pocket requires far tighter tolerances than static home devices like thermostats. The 85/15 Rule in hardware: Why reaching 85% functionality happens early, while the final 15% demands ruthless obsession. Technology vs. Design: Why practical tech (like early Bluetooth headsets) eventually gives way to markets won purely by superior user experience. "Great design is invisible": How subtle tactile cues, snap tension, and weight distribution create subconscious user satisfaction. Shafae’s origin story: Watching Total Recall at age 11 or 12 and immediately trying to build sci-fi hardware in real life. The "Anti-Question" engineering framework: Asking "how do we produce less heat?" instead of "how do we cool this component?" Structured brainstorming: Creating a dedicated space where physics don't exist and "magic" is encouraged before applying math equations. AI & User Experience: Comparing today's raw AI interfaces to the first iPhone (which shipped without an App Store) and predicting the future of frictionless UX. Building an ego-less engineering culture: Why throwing individual egos in the trash leads to collective problem-solving and mutual trust. A few lines that stuck with us: "Great design is invisible." "You get 85% of the way there pretty early. That last 15% was just absolutely hard." "Brainstorming should be structured... Physics doesn't exist here. We don't believe in physics, we believe in magic." "Instead of asking 'how do we cool the product?', ask 'what if I just made less heat?' That's when you get real innovation." About the guest: Shafae Ali is the Head of Engineering at ohSnap, a hardware company dedicated to creating non-bulky, magnetic mobile grips, chargers, and gaming controllers like the MCON. Known for his self-taught velocity and deep attention to detail, Shafae leads electromechanical design with a passion for user-centered engineering. Host & Show Credits: The Hardtech Podcast is hosted by DeAndre Harakas and Grant Chapman of Glassboard. Glassboard is a hardware product development company helping founders and enterprise teams bring physical products to market. Episode Links: ohSnap Official Website ohSnap MCON Magnetic Controller Special Guest: Shafae Ali.

June 29, 202643 min

Alenthia Run - From PT Clinic to Wearable Device

What if the gait analysis that normally takes a lab full of motion-capture cameras could ride along on every run? That's the bet behind Alenthia Run. Cooper Boydston, the company's CTO, joins DeAndre and Grant to talk about turning lab-grade running science into a small wearable that sits on your sacrum, reads your biomechanics, and flags the form problems that lead to injury. It's two conversations in one: how the technology actually works, and the very real hardware-founder journey of getting a device like this out of the lab and onto real runners. What we get into: How running-form analysis used to work: locked in a lab, on a treadmill, covered in motion-capture markers, reviewed by an expert, and usually only after something already hurt How Alenthia makes it continuous and portable: data on every run, not just one visit The tech under the hood: pairing a well-placed accelerometer with lab-grade motion capture as the "true source," then using machine learning to turn noisy signal into a visual "fingerprint" of your gait DeAndre's flag-football hamstring story, and why small changes in form prevent injuries The hardware journey: shrinking a whole physical-therapy clinic into one device, and why "the first rule of hardware is to try not to do it" Why UX and industrial design have to come in early (the classic "where's the power button?" moment), instead of getting bolted on at the end The "lily pad" path of prototyping: lab accelerometers wired to a laptop, to a dev kit in a 3D-printed box, to a real wearable Being your own first customer, and the pivot from selling to clinics toward the consumer market The surprising core early adopter: people who would have visited a clinic but live where none exists, and why they happily forgive rough early hardware Product-market fit and Mike Seibel's "hair on fire" test The vision for V2 and V3: on-device compute vs the phone's "walled garden," and the resurgence of standalone, bespoke hardware Building the team as "three guys in a garage" while still running the lab, plus closing advice for hardware builders (the 90/10 rule, and the mountain you would never climb if you saw the top) A few lines that stuck with us: "A frog never jumps all the way across the pond. He goes lily pad to lily pad." "It takes 10% of your time and budget to get 90% of the way there, and 90% to get the last 10%." "You were three steps away about 300 steps ago." About the guest: Cooper Boydston is the CTO of Alenthia Run, which builds a wearable sensor that brings lab-grade running biomechanics out of the clinic and onto every run. The company grew out of a physical-therapy practice. The Hardtech Podcast is hosted by DeAndre Harakas and Grant Chapman of Glassboard. Special Guest: Cooper Boydston.

June 8, 20261 hr 4 min

Venture Declassified - Moats & Multiples in Hardtech

This one is a crossover. Grant sat down with the team behind Venture Declassified, a podcast about what it actually takes to invest as an angel, for a freewheeling conversation about how hard tech companies get evaluated differently from software at the earliest stages. Grant plays the founder in the room and asks three active investors, Jacob Schpok (Elevate Ventures), Mike Kelly (Start Something Ventures), and Ben Pidgeon (VisionTech), to tell him what they're really thinking. It runs from definitions to deal mechanics, with plenty of detours along the way: why your fridge is designed to die, whether subscription hardware is a fad, and a real worked example of a hard tech company that sold to John Deere. There's a companion episode on the Venture Declassified feed, so go find that one too. What we get into: Where the lines are between hard tech, deep tech, and a plain product company (and why quantum computing is "deep tech" until it ships) The business-model twist: hardware waking up to recurring revenue and lifetime value (Ozlo, Plunge, and a hypothetical kitchen subscription), and the financing gymnastics that requires Whether subscription hardware is durable or a fad, the Gen Z economics behind it, and how the speed of innovation killed the resale market Why so much modern hardware is "designed to fail" after the warranty, the uncanny valley of quality (cheap vs mid vs expensive purchases), and when to design for delight instead of indestructibility The opposite extreme: med device and oil-and-gas hardware, where the cost of a single failure is enormous The core investing question: how you underwrite a technical founder, why software is just as "diverse" as hardware, and what changed now that 3D printing and dev kits let almost anyone build a "banger" prototype Power law, and why a software company "looks better" early because going zero-to-one is so much cheaper The flip side: the hardware moat, why hardware gets acquired for the technology (not the sales engine), and why copying Uber had almost no technical risk Multiples and returns: 7x for SaaS vs 2-3x for product companies, and the angel's case for putting hard tech in a portfolio (hint: it looks a lot like life science) The Smart Apply story: a LiDAR-guided sprayer that reportedly saved a farmer about $800K in year one and sold to John Deere, and exactly how the investors underwrote it Closing wisdom: founder vs opportunity, what "coachability" really means, the danger zone of conflicting advice, and the quiet part out loud (if no one will fund you, you might be the problem) A few lines that stuck with us: "Once you graduate your product, you're hard tech. While you're still in Bell Labs, you're deep tech." "The same chasm the founder needed to cross to get from zero to one is the same chasm any competitor would also face." "If you're pitching the right market with the right numbers and no one is giving you money, you might be the problem." About the guests: Venture Declassified is a podcast about angel investing featuring Jacob Schpok (Partner and Head of Platform at Elevate Ventures), Mike Kelly (co-founder of Start Something Ventures and operating partner at Elevate Ventures), and Ben Pidgeon (Managing Director of VisionTech). This is a Hardtech Podcast crossover, hosted by Grant Chapman of Glassboard with the team from Venture Declassified. Special Guests: Ben Pidgeon, Jacob Schpok, and Mike Kelly.

June 8, 202641 min

Fisher Wallace - One Device for Depression, Anxiety & Insomnia

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. Special Guest: Kelly Roman.