#97 Beyond Ablation For Pain Management: Diagnostic-First FDA Strategy, Dual-Use Electrodes and the The Next Wave of Neurotechnology with Dave Rosa

Dave Rosa, CEO and President of NeuroOne, medtech entrepreneur, board member and former executive at St. Jude Medical, Boston Scientific and C.R. Bard. With three decades in medical devices and more than $200 million raised, Dave brings a rare mix of operator, inventor and capital markets experience to the future of neurotechnology and pain care.In this episode, we unpack one of the biggest mistakes medtech companies make: building technology without enough real-world user feedback. Dave explains why innovation for the sake of innovation often fails, especially in larger companies, and why the best products are shaped by how physicians and patients actually use them. We also explore NeuroOne’s unique approach of combining diagnostics and therapeutics through the same electrode, and why that kind of multifunctional platform thinking can be both clinically powerful and commercially strategic.A major theme in this conversation is regulatory strategy. Dave walks through NeuroOne’s deliberate “diagnostic first, therapeutic second” FDA pathway, explaining why starting with an easier regulatory indication can de-risk the technology, shorten timelines and create a stronger platform for later therapeutic claims. We also discuss the value of reusing the same generator across multiple indications, how founders often wait too long to engage with FDA, and why platform leverage matters from both a business and development perspective.We also go deep on chronic pain and lower back pain. Dave shares why today’s pain solutions often fall short, how different triggers require different treatment approaches, and where technologies like ablation, stimulation and smarter electrode design could shift outcomes. He also highlights how seemingly small user-experience issues, like frequent recharging, can destroy patient adherence and wipe out billions in company value.Timestamps[00:00:08] Why MedTech Companies Fail When They Ignore Real User Feedback[00:02:04] Innovation vs Iteration: When “New” Adds No Real Value[00:02:22] Combining Diagnostics and Therapeutics With the Same Electrode[00:03:52] Why NeuroOne Chose a Diagnostic-First FDA Strategy[00:05:21] Pain Management Today: Ablation, Stimulation and Complex Back Pain[00:08:21] What Is Fundamentally Broken in Lower Back Pain Solutions[00:09:26] How Small Patient Frictions Can Destroy Adoption and Valuation[00:11:11] The Power of Reusing the Same Generator Across Multiple Indications[00:13:00] The FDA Mistake Many Founders Still Make[00:21:15] Where Neurotechnology and Pain Management Are Heading NextConnect with Dave - https://www.linkedin.com/in/daverosa/Learn more about NeuroOne - ⁠https://nmtc1.com/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠Subscribe to the Podcast