Dr. Rohan Lall: Innovation, Clinical Evidence, and Compliance in Electrifying Spine Surgery

About this episode

Dr. Rohan Lall discusses innovation in spine surgery and the compliance infrastructure needed to support it.

Innovation occurs across many areas, and compliance professionals need not only to be ready for it but also to embrace it. Join Tom Fox, the Voice of Compliance, as he visits with top innovative minds, thinkers, and creators in the award-winning Innovation in Compliance podcast. In this episode, host Tom Fox visits with Dr. Rohan Lall, a clinically trained Neurological Surgeon and Chief Medical Officer of SynerFuse, about innovation in spine surgery and the compliance infrastructure needed to support it. Dr. Lall Law explains TLIF (transforaminal lumbar interbody fusion) and ETLIF, which integrates direct nerve root stimulation into reconstructive spine surgery to address persistent pain from chronically injured nerves even after decompression and fusion. Dr. Lall describes the innovation as team-driven, highlighting collaboration and detailing the regulatory path for a novel Class III device, including a feasibility proof-of-concept study, third-party data management, and an independent data and safety monitoring board. Dr. Lall outlines how compliance leaders should align with business speed while managing FDA requirements, data integrity, ethics, and risk, and he notes future…

People in this episode

Host: Tom Fox

Guest: Dr. Rohan Lall

Topics covered

• spine surgery
• innovation
• compliance
• regulatory path
• clinical trials
• neuromodulation

Keywords

• TLIF
• ETLIF
• nerve root stimulation
• data integrity
• FDA requirements
• robotics
• image guidance

Mentioned in this episode

Organizations: SynerFuse

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