In this episode of the Neural Implant Podcast, host Dr. Ladan Jiracek speaks with Ali Samiian, founder of Poplar Access Advisors, about one of the most overlooked challenges in neurotechnology and medical devices: reimbursement.
Ali has spent over 20 years working across pharma, medical devices, and neuromodulation, including leadership roles at Abbott, Novartis, and Cala Health, where he helped secure reimbursement for a first-in-class wearable neuromodulation therapy for essential tremor. In this conversation, Ali explains why FDA approval alone is often not enough for a company to succeed, and why coding, coverage, and payment strategy must be considered from the earliest stages of device development.
The discussion covers reimbursement strategy for neurotech startups, how clinical trial design impacts commercialization, lessons learned from Cala Health, home-use neuromodulation, CMS and Medicare pathways, and why many promising neurotechnology companies fail despite having strong science and working products.
Key Takeaways
1. FDA approval does not guarantee commercial success. Many neurotech startups mistakenly believe FDA clearance is the finish line, when reimbursement is often the real challenge. A device can be safe and effective yet still fail commercially if insurers refuse to pay for it.
2. Reimbursement strategy should shape product design early. According to Ali, critical reimbursement decisions are often locked in years before launch through choices around device form factor, clinical trial design, and regulatory pathway selection. Waiting until after FDA submission can force companies into expensive redesigns and delays. Ali recommends founders begin thinking about reimbursement during product design, regulatory pathway selection, clinical trial planning, and fundraising, before key commercialization decisions become difficult to change.
3. Neurotech companies must think beyond efficacy alone. Payers want more than proof that a therapy works. They care about long-term outcomes, comparators, durability, site-of-care economics, and whether the product delivers clear value for money.
4. Cala Health helped prove wearable neuromodulation can be reimbursable. Ali describes how Cala Health overcame major reimbursement hurdles by differentiating its tremor therapy from simple TENS devices, ultimately securing substantially higher reimbursement and validating a commercial path for wearable neuromodulation.
5. Neurotechnology may be entering a commercialization inflection point. With advances in closed-loop systems, home-use therapies, and successful acquisitions in the space, Ali believes neurotechnology and electroceuticals are approaching a "golden age" where investors and payers increasingly recognize their value.
Episode Timestamps
0:15 - Can you introduce yourself and explain what Poplar Access Advisors does?
2:30 - What exactly is "reimbursement" in healthcare?
4:40 - How do coding, coverage, and payment work together?
6:05 - What are the biggest commercialization mistakes medtech startups make?
10:20 - When should founders start thinking about reimbursement?
13:55 - How did Cala Health secure reimbursement for wearable neuromodulation?
20:10 - Is reimbursement becoming more unified or more fragmented?
22:20 - How do companies actually communicate with payers and CMS?
23:50 - What is different about reimbursement for neurotechnology and neuromodulation?
26:20 - What mistakes do neurotech founders repeatedly make?
27:35 - Are we entering a golden age for neurotechnology and electroceuticals?
