SPE Workshop: Implantable Polymers for Medical Devices: Materials, Processing, Applications, and Regulatory Considerations

  Workshop

Implantable Polymers for Medical Devices: Materials, Processing, Applications, and Regulatory Considerations

  October 13,15 & 16, 2026
  All workshop days are from 11:00 AM to 12:30 PM ET.
  Online

SPE Workshop: Implantable Polymers for Medical Devices:  Materials, Processing, Applications, and Regulatory Considerations

  Summary

This workshop provides plastics professionals, engineers, material scientists, and medical device developers with a comprehensive understanding of polymers used in long-term implantable applications. The course focuses on practical, industry-relevant knowledge essential for selecting, processing, and validating high-performance biomaterials that meet stringent biological and regulatory demands. Participants will explore key topics including material selection for implantable devices, synthesis and manufacturing methods, processing techniques, material properties and characterization, biological interactions and testing, real-world applications, and regulatory pathways. Special emphasis is placed on advanced biomaterials used in cardiovascular, neurologic, orthopedic, and other chronic implants. Attendees will gain actionable insights into achieving long-term biostability, mechanical durability under physiological conditions, and successful translation from concept to commercial product.

This workshop addresses current industry challenges such as enhancing device longevity, supporting minimally invasive technologies, and navigating evolving regulatory landscapes. It equips attendees with the knowledge and confidence to innovate in the rapidly growing field of implantable medical devices while ensuring safety and compliance. By the end of the program, participants will be able to critically evaluate materials, optimize processing for implantable performance, assess biological risks, and develop strategies for regulatory success. This course offers unique value through the instructor’s firsthand experience in commercializing advanced biomaterial and device technologies.

No advanced prerequisites are required beyond basic polymer knowledge, though experienced professionals will benefit greatly from the depth and real-world perspective provided.

  Agenda

(Click each session to expand)
October 13, 2026
Duration: 1.5 Hours

  Description

Overview of polymers suitable for long-term implantation (polyurethanes, silicones, fluoropolymers, and emerging materials). Critical selection criteria including mechanical performance, chemical stability, biocompatibility, and device-specific requirements. Real-world case studies highlight successes and failure modes in cardiovascular applications.

October 15, 2026
Duration: 1.5 Hours

  Description

Polymer synthesis routes, morphology control, and processing technologies (extrusion, molding, dipping, electrospinning, etc.). Rheology, phase separation, and optimization of physical, mechanical, and thermal properties. Practical troubleshooting and scale-up insights drawn from extensive industry experience.

October 16, 2026
Duration: 1.5 Hours

  Description

Polymer-biology interactions, ISO 10993 testing protocols, biostability strategies, and surface modification techniques. Current and emerging applications in cardiovascular devices, biosensors, drug delivery systems, and smart implants. Detailed review of regulatory frameworks (FDA 510(k)/PMA, EU MDR, ISO standards), risk management, and post-market surveillance.

 

If you can't attend one or several sessions live, or if you want to review some concepts, the recordings will be available after each session.

  Registration Information

SPE Premium Member$405
SPE Members$450
Nonmembers$650

  Workshop Packs

Strengthen your team’s skills and take advantage of group savings with an SPE Workshop Pack.
Go here for Workshop Pack information and registration.


 
3 Sessions
 
Level: Intermediate
 
Total Hours: 4.5 Hours
 
Streaming access on desktop and mobile browsers

  Instructor

Ajay Padsalgikar
Technical Fellow
Biolinq Inc
  LinkedIn

Dr. Ajay D. Padsalgikar

is a recognized expert in polymer science and medical device biomaterials with over 30 years of cumulative experience. He graduated with a degree in Polymer Engineering from the University of Poona, India in 1990 and earned his PhD in Polymer Science from Clemson University, USA in 1996.

Throughout his career, Dr. Padsalgikar has held key roles at leading organizations including Huntsman Polyurethanes (Belgium), AorTech Biomaterials (Australia), St. Jude Medical and Abbott (Minnesota), and DSM Biomedical (Pennsylvania). His expertise centers on chemistry, morphology, processing, and the development of high-performance polymers for long-term implantable medical devices. He has deep experience translating advanced biomaterials from synthesis through manufacturing to clinical applications, with particular focus on cardiovascular and neurological implants and device technologies. He has taken new biomaterials and devices through regulatory approvals.

In July 2022, Dr. Padsalgikar joined Biolinq Inc. as Technical Director, where he leads material solutions for next-generation biosensors and implantable devices.

He has authored more than 30 scientific papers and 10 international patents. He has also written two authoritative books published by Elsevier: Plastics in Medical Devices for Cardiovascular Applications (Feb 2017) and Applications of Polyurethanes in Medical Devices (June 2022). These publications, along with his extensive industry contributions, establish him as a leading authority in implantable polymers, making him exceptionally qualified to deliver this technical workshop.


  Questions? Contact:

For questions, contact Iván D. López.


  Who Should Attend?

This workshop is designed for professionals involved in the development, selection, processing, testing, and commercialization of implantable medical devices, including:

  • Materials scientists and polymer engineers
  • Medical device design and development engineers
  • Manufacturing and process engineers
  • R&D scientists working with biomaterials and implantable systems
  • Quality, validation, and regulatory professionals
  • Technical managers and project leaders in the medical device industry
  • Professionals seeking to understand the relationship between material selection, biological performance, and regulatory compliance

  Why Should You Attend?

Long-term implantable medical devices place unique demands on polymeric materials. Success depends on selecting materials that can maintain mechanical integrity, biostability, and biocompatibility over many years while also meeting rigorous regulatory requirements.

This workshop provides a practical understanding of implantable polymers, covering the entire development pathway from material selection and processing to biological evaluation, risk management, and regulatory approval.

  Why This Course Matters

The medical device industry faces increasing demands for longer-lasting implants, minimally invasive technologies, enhanced safety, and regulatory compliance. Material selection and processing decisions made early in development can determine long-term product success or failure.

This workshop matters because it equips professionals with the knowledge needed to evaluate implantable materials, optimize manufacturing processes, assess biological risks, and accelerate successful commercialization. Participants will leave with practical tools to improve device performance, ensure compliance, and support innovation in the rapidly growing field of implantable medical devices.

  Everyday Problems You’ll Address

  • How do I select the most appropriate polymer for a long-term implantable application?
  • What causes implantable polymers to degrade or fail in the body over time?
  • How do processing methods influence long-term device performance and reliability?
  • Which material properties are most critical for cardiovascular, neurologic, orthopedic, and other implantable applications?
  • How can biological risks be identified and mitigated early in development?
  • What testing is required to demonstrate biocompatibility and safety?
  • How can I successfully navigate FDA, EU MDR, ISO 10993, and other regulatory requirements?

  What You’ll Learn

You will gain a practical understanding of implantable polymer systems, including:

  • Selection criteria for implantable polymers, including polyurethanes, silicones, fluoropolymers, and emerging biomaterials
  • Polymer synthesis, morphology control, and manufacturing methods used in implantable devices
  • Processing technologies such as extrusion, molding, dipping, and electrospinning
  • Mechanical, thermal, rheological, and physical property characterization
  • Polymer-biological interactions and long-term biostability considerations
  • ISO 10993 biocompatibility testing and risk assessment strategies
  • Surface modification approaches for improved biological performance
  • Current and emerging applications in cardiovascular devices, biosensors, drug delivery systems, and smart implants
  • Regulatory pathways, quality considerations, and post-market surveillance requirements

This educational program is provided as a service of SPE. The views and opinions expressed on this or any SPE educational program are those of the Speaker(s) and/or the persons appearing with the Speaker(s) and do not necessarily reflect the views and opinions of the Society of Plastics Engineers, Inc. (SPE) or its officials, employees or designees. To comment or to present an opposing or supporting opinion, please contact us at info@4SPE.org.

Refund Policy

Full refund 14 days prior to the event start date. Please contact customerrelations@4spe.org for assistance with registration.

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