Med-Ex The Medical Extrusion Podcast

Steve sits with Tyler Ware, Owner and President, of GenX Medical to discuss some of the unique challenges and opportunities associated with medical extrusion.GenX Medical is a custom medical tubing supplier specializing in micro-bore tubing, bioresorbable extrusions, multi-lumen tubing, and more. They are dedicated to quick delivery of prototype quantities of custom medical extrusions, but can also handle production quantity orders.For more information, visit www.genxmeds.comHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Tyler Ware | Owner and President | GenX MedicalAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtruderFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson talks with Nate Doyle, VP of Sales and Marketing, at Compounding Solutions to get an update on the current supply chain of medical plastics.Compounding Solutions LLC is a global leader in the manufacturing of custom medical polymer compounds, color concentrates, and additive concentrates for extrusion and injection molding to be used in Class I, II, and III medical devices. Our custom formulation capabilities include radiopaque, pre-colored, heat & UV stabilized, and low friction.To learn more, visit www.compoundingsolutions.netHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Nate Doyle | VP Sales and Marketing | Compounding SolutionsAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtruderFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses applying hydrophilic lubricious coatings to the inner lumens of catheter tubing with Dr. Bob Hergenrother, VP of Research at Biocoat. Bob gives a high level overview of hydrophilic coatings and discusses coating the inner lumens of silicone and thermoplastics tubing as well as aspiration lumens to aid in the removal or capture of emboli, particles, or clots.Biocoat is a full-service hydrophilic coatings provider specializing in supplying lubricious coatings, custom coating services, and coating equipment for medical devices. Biocoat is the only hydrophilic coatings provider to offer best-in-class performance in Thermal and UV (ultraviolet) coatings, as well as industry-leading customer service and coating equipment. For more information, visit www.biocoat.com Host: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Dr. Bob Hergenrother | Vice President of Research | BiocoatAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US Extruder For video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses medical extrusion for medical devices with Patrick Daly, Director of Extrusion at Biomerics. They discuss multi-lumen extrusions, elongation values of balloon tubing, polyurethane tubing, outer jacket extrusions for hypotube-based shafts, and more.Biomerics is a vertically integrated medical device contract manufacturer serving the interventional device market. Over nearly three decades, they’ve grown from one location to a vertically integrated medical device contract manufacturing partner with nine facilities. What makes them unique is their engineering depth. Through investment and acquisition, they’ve strategically added all the core technologies—both materials and processes—to meet the needs of the interventional marketplace.For more information, visit www.biomerics.comHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Patrick Daly | Director of Extrusion | BiomericsAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtruderFor video episodes visit www.us-extruders.com/podcasts

Steve discusses additive manufacturing for medical devices with Drew Richardson, Director of Additive and Component Development at Resolution Medical. Drew discusses their partnership with Carbon3D, the benefits of CLIP printing over conventional FDM printing, some of the interesting projects they’ve worked on, and more.Resolution Medical is a medical device manufacturer located in Minneapolis, MN. They are FDA registered in vitro diagnostic and in compliance with all applicable regulations, including the Quality System Regulation 21 CFR Part 820 and ISO 13485:2016.For more information, visit www.resolutionmedical.com Host: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Drew Richardson | Director of Additive and Component Development | Resolution MedicalAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US Extruder For video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses silicone extrusion for medical devices with Paul Mazelin, CEO of Simedex. Paul dives into some of the differences between silicone extrusions for class II vs class III devices, Mico extrusions, ShapeShift Technology and more.SiMEDEx Inc. is an ISO 13485 certified company based in Paso Robles, CA. SiMEDEx that extrudes precision silicone tubing for medical device applications. The company has a robust quality system supporting the medical device community in both implantable and non-implantable applications.For mor information, visit www.simedex.comHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Paul Mazelin | CEO | SimedexAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtruderFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses early-stage medical device development with Jordan Mykleby, Vice President of Merge Medical.Merge is a medical device studio that pairs engineering and business strategy services to advance clinically relevant technology toward commercialization. We prepare early med device technology for funding and advanced development. For more information, visit www.mergemed.com Host: Steve Maxson | Innovation & Business Development Manager | US Extruders Guest : Jordan Mykleby | Vice President | Merge Medical Announcer: Bill Kramer | President | US Extruders Producer/ Editor/ Original Music: Eric Adair | Marketing Manager | US Extruder For video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses deflectable and steerable catheters with Ross Paulson, VP Engineering and Design Services at Midwest Interventional Systems. They focus on deflectable and steerable catheters for modern interventions that require transeptal access to the left side of the heart. They take a deep dive into some of the design inputs for deflectable and steerable catheter shafts and discuss applications for bi-directional and 4-way deflectable catheters. Midwest Interventional Systems is a contract design, development, and manufacturer for minimally invasive delivery systems based in Maple Grove, MN. They are a dedicated and multidisciplinary group of problem solvers with decades of engineering expertise. As a leader in complex catheter development, they have assembled a team of world class engineers that don't shy away from challenges. For more information visit www.midwestint.com Host: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Ross Paulson | VP Engineering and Design Services | Midwest Interventional SystemsAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US Extruder For video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses polymers and compounds for medical devices with Amar Nilajkar, VP of Business Development at Foster. Amar goes into detail on their new fluoropolymer-based solutions, including their PureFluon FEP, Porex Virtek® sintered PTFE membrane technology, and compares some of the differences in regulatory and manufacturing environment that are required for implantable polymers and compounds.For over thirty years Foster Corporation has been serving medical device manufacturers with industry leading technology and service in biomedical materials. These include custom medical compounds, implantable materials, and polymer distribution. Within ISO 13485:2016 facilities, Foster offers comprehensive support to customers from formulation development through production.For more information visit www.fostercomp.comHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Amar Nilajkar | VP of Business Development | FosterAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtruderFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson interviews Ido Sadan, R&D Manager at Coramaze Technologies base in Petach Tikva, Israelabout the online collaboration community, Medtech-Secrets, the idea of heuristics in device development, and a new medical implant device developed by Coramaze Technologies.Medtech-Secrets is on online community that promotes collaboration between innovators in the industry.For more information visit www.medtech-secrets.comwww.facebook.com/groups/medtech.secretswww.linkedin.com/company/medtech-secretsCoramaze Technologies is medical device company that develops minimally invasive technologies to treat structural heart valve diseases.For more information visit www.coramaze.com Host: Steve Maxson | Innovation & Business Development Manager | US Extruders Guest : Ido Sadan | R&D Manager | Coramaze Technologies Announcer: Bill Kramer | President | US Extruders Producer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtruderFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses medical balloons with Teddy Mudge, Founder and Managing Director of Hoop Medical.Hoop Medical specializes in the development and manufacture of advance medical balloons for the global medical device industry.For more information, visit www.hoopmedical.comHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Teddy Mudge| Founder & Managing Director | Hoop MedicalAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtrudersFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses medical balloons with Teddy Mudge, Founder and Managing Director of Hoop Medical.Hoop Medical specializes in the development and manufacture of advance medical balloons for the global medical device industry.For more information, visit www.hoopmedical.comHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Teddy Mudge| Founder & Managing Director | Hoop MedicalAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtrudersFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses the supply chain of PTFE Liners and FEP heat shrink tubing and expansion activities with Junkosha USA’s President and CEO, Joe RowanJunkosha are pioneers of fluoropolymer-based technologies across many sectors including microwave interconnect and medical devices. This includes thin wall etched PTFE liners and peelable FEP heat shrink tubing for medical devices. Junkosha has three operations in Japan, including their headquarters as well as sites in the US, UK and China.For more information, visit https://www.junkosha.com/enHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Joe Rowan | President & CEO | Junkosha USAAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtrudersFor video episodes visit www.us-extruders.com/podcasts

Steve Maxson discusses transforming extrusion from an art to a science with Systematic Extrusion’s CEO, Braulio Polanco.Systematic Extrusion is the pioneer in hands-on extrusion training. They have developed a data-driven systematic approach based on scientific principles that enable extrusion manufactures to produce high quality product consistently and effectively every time. For more information, visit www.systematicextrusion.comHost: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest : Braulio Polanco | Founder & CEO | Systematic ExtrusionAnnouncer: Bill Kramer | President | US ExtrudersProducer/ Editor/ Original Music: Eric Adair | Marketing Manager | US ExtrudersFor video episodes visit www.us-extruders.com/podcasts