Med Device Forward

Most process development in medical device manufacturing starts one of two ways: a blank page, or copy-paste-and-edit. Steve Parmelee — a 25-year veteran of nitinol implant fabrication — says both waste your time and your budget.Steve has scaled manufacturing operations from a one-person startup to 2,500 employees, worked inside blue-chip OEMs and boutique contract manufacturers, and co-founded Emerging Components to do process development differently: deep fundamental understanding of the process itself, with data and guardrails in place of tribal knowledge.In this conversation with co-host Mike Sanchez, Steve gets specific about what medical device OEMs and startups should demand from a manufacturing partner:Why “starting with a blank page” and “copy-paste” are both the wrong way to develop a manufacturing processHow to scale beyond tribal knowledge — so your process doesn’t depend on one irreplaceable expertThe electropolishing trap: how a too-tight operating window boxes you in at validation and kills scalabilityWhen a contract manufacturer should bring in outside partners — and how to vet themIf you lead operations, quality, regulatory, or business development at a medical device company — or you’re a startup heading toward submission — this episode is a 20-minute masterclass in choosing and working with a nitinol manufacturing partner.Timestamps00:00 — Welcome and introducing Steve Parmelee01:40 — From 100,000 parts a day to a handful: Steve’s path from high-volume manufacturing to medical device startups03:24 — What OEM customers actually want: expertise, transparency, execution04:40 — Founding Emerging Components and the process-first philosophy05:19 — “No blank pages”: what differentiates Emerging Components07:12 — Handling complexity and scaling beyond tribal knowledge08:49 — Electropolishing deep dive: chemistries, stable regimes, and the validation operating window11:13 — Partnering strategy: covering 85–90% in-house and choosing trusted experts for the rest14:38 — Being a solution-based provider: communication as an extension of the customer’s teamGuest BioSteve Parmelee is President and Co-Founder of Emerging Components, a process-development-driven contract manufacturer specializing in complex nitinol and metal components for medical device OEMs and startups.Links & CreditsConnect with Steve Parmelee on LinkedInEmail: [email protected] Components: emergingcomponents.comFollow Med Device Forward wherever you listen to podcastsApple Podcasts: https://podcasts.apple.com/us/podcast/beyond-tribal-knowledge-how-nitinol-manufacturing-scales/id1892446514?i=1000772377681Spotify: https://open.spotify.com/show/2CyUafSlpfhwg0DZa4ELFQProduced by Anthrolux Media

In this episode of The Med Device Forward, we talk with Jody Scrivner, VP of Operations at MB&A — Monica Burt & Associates — a medical device quality, regulatory, and operations consulting firm based in Memphis, Tennessee. Jody helps medical device manufactures navigate the new QMSR requirements, quality management systems, and product life cycle processes. She brings 26 years of experience in this industry, spanning everything from hearing aids to extremities and spine products. She spent two decades on the OEM side before joining MB&A, where she now leads growth initiatives and stays deeply connected to the trends and challenges facing manufacturers today. Find Jody on LinkedIn: https://www.linkedin.com/in/jody-scrivner-mba-32a2a914/Mike Sanchez, co-host of the Med Device Forward, is our guide to the commercial side of the medical device contract manufacturing industry with 28 years in sales and marketing in this industry, working in and with the companies and the teams who drive this space forward. Find Mike on LinkedIn: https://www.linkedin.com/in/mike-sanchez-13044214/Dewey Forbes, producer and co-host of the Med Device Forward, runs Anthrolux, a web development and video production company that helps medical device companies get found in today's search engines. Find Dewey on LinkedIn: https://www.linkedin.com/in/deweyforbes/