Polymer Material and Process Selection Criteria for Medical Devices

Steve Maxson and William Cohn, MD

In this episode, Steve Maxson sits with Anant Hegde, CTO of Medeologix, to discuss his expertise in balloon tubing and complex extrusions. Medeologix is a contract development and manufacturing partner for minimally invasive devices, they empower MedTech companies globally to transform visionary concepts into mass-produced realities. Their unparalleled engineering expertise and seamless design-for-manufacturing integration accelerate their clients’ product time to market, ensuring the swift delivery of innovative, high-quality medical devices that set new industry standards and ultimately enhance patient well-being. To learn more, go to www.medeologix.com.Host/ Producer: Steve Maxson | Innovation & Business Development | US ExtrudersGuest: Anant Hegde| CTO | MedeologixAnnouncer: Bill Kramer | President | US ExtrudersEditor/ Original Music: Eric Adair | Director of Communications & Digital Strategy| US Extruders

A new MedTech Unboxed episode is out now with Christopher Haig, President of Efemoral Medical, a company developing bioresorbable scaffolds for treating peripheral arterial disease (PAD), affecting over 200 million globally. Here’s a snapshot of our discussion: FlexStep Technology: A balloon-expandable, drug-eluting bioresorbable scaffold with inter-scaffold spaces for flexibility, made of PLLA with a co-polymer for ductility and rapid resorption (1-2 years), eluting sirolimus to prevent restenosis. Clinical Progress: The EFEMORAL I trial (33 patients enrolled across 4 sites in New Zealand/Australia) shows promise, with 20-patient results to be presented by Dr. Andrew Holden at @CXSymposium in London, April 23, 2025. Funding Update: Raised $10M+ in equity through angel investors and $2M+ in SBIR grants; targeting $20M Series B for IDE submission, including GLP animal studies and randomized trials for US PMA approval.

Steve sits down with Brian Gordon, President of Micro-Tek Corporation to discuss their role in medical wire and tubing innovationHost/ Producer: Steve Maxson | Innovation & Business Development | US Extruders Guest: Brian Gordon | President | Micro-Tek Corporation Announcer: Bill Kramer | President | US Extruders Editor/ Original Music: Eric Adair | Marketing/ Business Development | US Extruders For video episodes visit www.us-extruders.com/podcasts

Steve chats with Matt Bills, President of Renegade Medical Extrusion, about his entrepreneurial journey in MedTech, innovative extrusion technologies, unique programs like the Outlaw Experience, and market trends shaping the future of medical tubing.For more information on Renegade Medical Extrusion, visit www. renegadeextrusion.com.Host/ Producer: Steve Maxson | Innovation & Business Development | US ExtrudersGuest: Matt Bills | President | Renegade Medical ExtrusionAnnouncer: Bill Kramer | President | US ExtrudersEditor/ Original Music: Eric Adair | Marketing/ Business Development | US ExtrudersFor video episodes visit www.us-extruders.com/podcasts

In this episode, Steve sits with Tilak M. Shah to explore the fascinating world of polymer chemistry and its impact on medical device performance and manufacturing. From the classifications of polymers—like hard Shore D plastics and soft Shore A materials—to the critical differences between thermoplastics and thermosets, we break down complex topics into practical insights. We also dive into liquid polymer processing methods, including dip molding and polymer dispersions, and explore their applications in creating compliant balloons and stent coatings.Host/ Producer: Steve Maxson | Innovation & Business Development | US ExtrudersGuest: Tilak M Shah | Biomaterial Consultant | TS PolymersAnnouncer: Bill Kramer | President | US ExtrudersEditor/ Original Music: Eric Adair | Marketing/ Business Development | US ExtrudersFor video episodes visit www.us-extruders.com/podcasts

In this episode, Steve talks with Farhad Sadeghi, the founder and lead polymer scientist at Analytical Polymers. They dive deep into the world of biomedical balloon tubing and explore the nuances of non-compliant, semi-compliant, and compliant balloons. Farhad sheds light on why precise tube sizing is essential for optimal performance and then gets in to how factors like resin selection, extrusion techniques, the balloon-forming process, and tensile specification can affect balloon tubing.Host/ Producer: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest: Farhad Sadeghi| Founder and Lead Polymer Scientist| Analytical PolymersAnnouncer: Bill Kramer | President | US ExtrudersEditor/ Original Music: Eric Adair | Marketing/ Business Development | US ExtrudersFor video episodes visitwww.us-extruders.com/podcasts

In this episode we’re joined by Scott Nelson, CEO of FastWave Medical, to dive into the next generation of Intravascular Lithotripsy (IVL) technology. FastWave is at the forefront of advancing treatments for vascular calcification, and Scott will break down how IVL is addressing critical clinical needs, particularly when it comes to modifying vascular calcium. We'll also explore how FastWave’s innovations compare to traditional devices like plain balloons and atherectomy tools, offering a more effective and synergistic approach to vessel preparation.For more information on FastWave Medical, visit www.fastwavemedical.com Host/ Producer: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest: Scott Nelson| CEO| FastWave MedicalAnnouncer: Bill Kramer | President | US ExtrudersEditor/ Original Music: Eric Adair | Marketing/ Business Development | US ExtrudersFor video episodes visitwww.us-extruders.com/podcasts

In this exciting episode of the Med-Ex Podcast, we’re joined by Jakob Dohse from MeKo Manufacturing, a global leader in high-precision laser material processing. With over 30 years of experience, MeKo has become synonymous with innovation in the medical device industry, specializing in the production of intricate components like stents and heart valve frames from both metal and bioresorbable materials. Jakob takes us on a fascinating journey through MeKo's family-owned history, their commitment to quality, and how their custom laser processing and post-processing techniques, like electropolishing, are transforming the way medical devices are manufactured and used. But that’s just the beginning! We also delve into MeKo’s cutting-edge work with Resoloy® a resorbable magnesium alloy for implants, and Vasculoy®, a nickel- and cobalt-free vascular alloy designed for patients with allergies. Jakob shares insights on everything from rapid prototyping and finite element analysis (FEA) to the use of cold ablation techniques in polymer tube manufacturing. Host/ Producer: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest: Jakob Dohse | CEO | MeKo ManufacturingAnnouncer: Bill Kramer | President | US ExtrudersEditor/ Original Music: Eric Adair | Marketing & Business Development | US Extruders

In this episode, Steve sits down with Jennifer Green, Sr. Global Technical Business Development Manager at Lubrizol Advanced Materials. Jennifer is here to unravel the mysteries of TPU (thermoplastic polyurethane) and why it’s becoming a superstar in the world of medical devices. They also explore the versatility of TPU—think customizable polymers, specialty formulations, and even how TPUs are paving the way for ultra-soft catheter tips and compliant balloons. This episode goes from the nuts and bolts of TPU chemistry to why it might just be the go-to material for your next medical innovation.The Lubrizol Corporation, a Berkshire Hathaway company, is a science-based company whose specialty chemistry delivers sustainable solutions to advance mobility, improve well-being and enhance modern life. Every day, the innovators of Lubrizol strive to create extraordinary value for customers at the intersection of science, market needs and business success, driving discovery and creating breakthrough solutions that enhance life and make the world work better. Founded in 1928, Lubrizol has global reach and local presence, with more than 100 manufacturing facilities, sales and technical offices and 8,000 employees around the world. For more information, visit www.Lubrizol.com.Host/ Producer: Steve Maxson | Innovation & Business Development Manager | US ExtrudersGuest: Jennifer Green | Sr. Global Technical Business Development Manager| LubrizolAnnouncer: Bill Kramer | President | US ExtrudersEditor/ Original Music: Eric Adair | Marketing/ Business Development | US ExtrudersFor video episodes visit www.us-extruders.com/podcasts