{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"The Medtech Innovation Podcast","title":"His Reg-Tech Tool Automates Market Expansion For Medical Devices","html":"","width":"100%","height":180,"duration":3344,"description":"I'm joined by Rhys Williams, CEO at Orchestrate, as we explore how AI-powered regulatory technology is breaking down the barriers to medtech commercialization and why the infrastructure gap — not the science — is what's really holding the industry back.The $50K Barrier Nobody Questions→ Medtech companies are told to budget $20,000-$50,000 minimum just for regulatory clarity — Rhys challenges this accepted cost as a solvable infrastructure problem, not a necessary expense→ The real cost isn't government fees — it's labor hours, quarterly billing cycles, and documentation overhead that compound into six-figure regulatory bills before a single submission is filed→ Companies that delay regulatory work until post-development discover expensive gaps in clinical data demographics that force costly retreats to data collectionWhy Paper-Based Systems Aren't Actually the Problem→ Regulatory affairs professionals don't love paper-based processes — they use them because they're robust, auditable, and proven to maintain safety standards across decades of use→ Intentional friction in the product development process serves a purpose — the goal isn't zero friction, it's eliminating the friction that doesn't serve safety or quality→ The real breakdown happens when formal processes force people out of their natural workflow, creating workarounds and local version deviations that actually undermine complianceOrchestrate: RegTech That Lives in Your Existing Tools→ Deep integration with Microsoft Office and Google Workspace means regulatory workflows live inside Word, Teams, and Google Docs — not another dedicated platform that requires a learning curve→ The platform analyzes existing certifications and documentation to show exactly what can be reused for new market expansion, generating 16+ page submission documents in clicks→ What would have taken hours of manual document prep can now be done in seconds by parsing, chunking, and reusing your existing regulatory documentationBuilding...","thumbnail_url":"https://img.transistorcdn.com/SKJTlzh1Dih_UjWAMpaf9asEOJluhYL_CM3FATuVvVc/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS8yM2U1/NjA3NjAzY2M1NDA0/ZDZkYTRiY2Y3Mjky/MTRmNi5wbmc.webp","thumbnail_width":300,"thumbnail_height":300}