Features

Controlled Substance for Medical Device Materials

AI-driven modeling, device miniaturization, and personalized implants are driving medtech materials science innovation.

By: Michael Barbella

Managing Editor

The elastomers used by Apple Rubber feature improved chemical resistance, excellent heat resistance, and are compatible with different sterilization techniques. Photo: Apple Rubber

It took nearly 130 years for the life-bestowing technology in Mary Shelley’s gothic novel “Frankenstein” to make the leap from page to polyclinic.

In the 1818 classic, the main character—Victor Frankenstein—assembles a giant creature from stolen fragments of the dead and summons it to life. Shelley, however, is vague about the resurrection method, referencing only “instruments of life” that might “infuse a spark of being into the lifeless thing” at Frankenstein’s feet.

Hollywood, ever drawn to spectacle, pumped up the drama for the silver screen by staging the creature’s awakening during a raging electrical storm and lightning strikes to prompt its “birth” (the two representing the “spark of being” that Shelley mentioned in the novel, perhaps?).

Rather than seek Mother Nature’s help, Shelley most likely sought inspiration for the creature’s conjuring from contemporary experiments (at the time) in galvanism, or the use of electricity to move muscles.

About 15 years before Shelley’s novel, Italian physicist Giovanni Aldini experimented with a fresh human corpse, attempting to revive the man—a convicted murderer—with electric shocks directly to the heart. 

Sound familiar? 

Indeed, Aldini’s crude attempt at resuscitation echoes the work of Claude Beck, a Pennsylvania cardiac surgeon who designed the first defibrillator—a tool used to apply an electric shock directly to the heart to restore a normal rhythm. The device’s initial deployment in 1947 was successful, as it saved the life of a 14-year-old boy with a congenital heart defect.

Shelley’s famous novel and Aldini’s primitive rejuvenation attempts are indicative of the powerful interplay between fictional science and real-life science. Numerous imaginary inventions conceived on the page or the projector have made their way into the clinic, advancing diagnostics and treatments for conditions ranging from diabetes, hypertension, and arrhythmias to cancer and paralysis.

These once-fantastical visions, now realized, have pushed the boundaries of material innovation. Spider silk, for example, is being harnessed for its healing powers, while collagen and fibrin microfibers are the favored ingredients for spray-on artificial skin (first proposed by science fiction author Philip K. Dick in 1960).

Shape memory polymers such as nitinol are becoming the preferred standard in arterial and venous embolization treatment, whereas polymers like chitosan and synthetic substances akin to PEG are being targeted for self-healing biomedical applications. 

Metamaterials, meanwhile, are gaining popularity for their defiance of natural physics laws. These engineered composites obtain their unique properties from artificially designed microstructures rather than chemical composition, enabling them to manipulate light, acoustic waves, and electromagnetic fields beyond that of conventional materials. 

Such sci-fi-sounding machinations are producing some mind-bending results. MIT engineers, for instance, have created a strong, stretchy material that could be used for tissue repair scaffolds, and Rice University researchers are fine-tuning a soft but tough substance that can be controlled remotely to rapidly transform its size and shape. 

The Rice University researchers’ material is extraordinarily strong, capable of sustaining compressive loads more than 10 times its weight and withstanding temperatures that far exceed physiological conditions as well as harsh chemical environments.

“We programmed multistability, i.e., the ability to exist in multiple stable states, into the soft structure by incorporating geometric features such as trapezoidal supporting segments and reinforced beams,” said Yong Lin Kong, assistant professor of mechanical engineering at Rice’s George R. Brown School of Engineering and Computing. “These elements create an energy barrier that locks the structure into its new shape even after the external actuation force is removed. The metamaterial makes it possible to remotely control the size and shape of devices inside the body. This could enable lifesaving capabilities such as precisely controlling where a device stays, delivering medication where it’s needed or applying targeted mechanical forces deep inside the body.”

A true futuristic material.

As medical devices become smaller, more intelligent, and less intrusive, their composition will require more advanced substances. To discover the kind of material enhancements that may be in store for the medtech industry, as well as the challenges in bringing them to market, MPO spoke to a handful of experts over the last several weeks. The group included:

  • Bing J. Carbone, president of Modern Plastics, a Shelton, Conn.-based provider of high-performance, medical-grade polymer stock shapes for the medical device industry.
  • Ryan Heniford, director of Global Sales & Business Development for Medical Devices at Evonik Health Care.
  • John Tranquilli, materials manager at Apple Rubber, a Lancaster, N.Y.-headquartered, ISO 9001 designer and manufacturer of standard AS568 and ISO 3601 O-rings, rubber seals, molded shapes, and custom seals.
  • John Zawacki, senior director of Strategic Marketing, Healthcare at TekniPlex, a Wayne, Pa.-based provider of medical device components and materials science solutions.

Michael Barbella: What forces are driving innovation in medtech materials?

Bing J. Carbone: Three forces drive most of it: Clinical performance targets keep moving, regulatory expectations keep tightening, and manufacturing keeps getting more advanced, especially around complex geometries, tighter tolerances, and more demanding sterilization environments.

On the materials side, the big push is for polymers that hold properties through sterilization, offer predictable biocompatibility, and deliver repeatable, lot-traceable performance at scale. That is why the market keeps leaning into higher-performance families like PPSU, PEI, PAEKs, and “medical-grade versions” of familiar materials that come with tighter controls, traceability, and documentation.

Ryan Heniford: Across medtech applications, the demand for cutting-edge materials is accelerating due to several factors:

Clinical performance and patient outcomes—Aging populations and rising chronic disease rates require biocompatible, fatigue-resistant, and application-specific materials that promote faster healing and reduce complications.

Technological advancements—Digital design workflows, AI-driven modeling, and additive manufacturing are enabling miniaturization, imaging compatibility, integrated sensing, and personalized implants. Materials must support these advancements while maintaining precise structure-function relationships.

Surgical innovation—Robotic surgery and 3D printing are redefining implant architectures, driving the need for materials that support anatomical customization, lightweight structures, and next-generation surgical guides.

Evonik’s RESOMER bioresorbables and VESTAKEEP PEEK polymers are addressing these challenges through their unique properties, enabling device manufacturers to create innovative solutions for demanding applications.

John Tranquilli: I believe there are three main forces at play. 1.) Rubber materials with lower friction. Many assemblies need to minimize the force required for users, and rubber friction can significantly impact this. Currently, coatings or lubricants are used to reduce force, but they can lead to additional regulatory testing or contamination issues. 2.) PFAS regulations are restricting the use of fluorinated compounds, which are widely used in medtech applications due to their versatility. 3.) The need for higher levels of testing to meet regulatory standards. Additional biocompatibility tests are required before starting the approval process.

John Zawacki: Three macro forces are driving medical device materials innovation: clinical demand for less invasive therapies, economic pressure for value-based outcomes, and industry desire for efficient regulatory approvals. As devices grow smaller, smarter, and more personalized, the materials that comprise them must simultaneously satisfy contradictory demands: greater strength in thinner profiles, enhanced biocompatibility with extended contact duration, improved sustainability alongside stringent performance standards, and lower costs despite supply chain complexity. These forces drive material selection, sustainability considerations in healthcare manufacturing, and technologies that enable minimally invasive device innovations.

The drive toward minimally invasive procedures continues to intensify across every therapeutic segment. For example, in structural heart interventions, transcatheter technologies continue to replace open surgery. Peripheral vascular procedures increasingly require ultra-flexible, high-strength catheter systems that can navigate tortuous anatomy. Neurovascular applications demand even smaller profiles: clinicians at a recent medical conference specifically noted their inability to advance catheters to critical locations because they are too large reach some target areas. These clinical realities require complex procedural navigation, which drives the need for materials that are flexible enough to navigate anatomy without vessel trauma, yet rigid enough to maintain column strength for device delivery. Imaging requirements often require radiopaque formulations that provide fluoroscopic visibility without compromising mechanical performance. Material needs drive innovation requirements for distinct material specifications that in turn drive compound development. Material innovation must anticipate clinical failure modes, not merely replicate existing materials in alternative chemistries. For CDMOs, this demands deep collaboration at the design phase to identify material requirements and constraints before they become manufacturability problems or, worse, clinical complications.

Barbella: What role do cost pressures and supply chain resilience play in materials decisions?

Carbone: Cost pressure is real, but in medtech it is not “cheapest resin wins.” In regulated devices, a material switch can trigger revalidation, documentation updates, and risk reviews. That makes continuity and documentation part of the cost equation. Supply chain resilience increasingly means dual sourcing, predictable lead times, and confidence in lot control and traceability. Customers want partners who can help them avoid line-down events, expedite correctly, and ship with the right cert package the first time. At Modern Plastics, we built our quality system to support that expectation, including ISO 13485 certification for medical device distribution and robust certification support.

Heniford: Medical device manufacturers are under increasing pressure to balance cost efficiency with performance and reliability. Evonik supports OEMs and procurement teams with:

Multi-regional production capabilities—Ensuring consistent supply across global markets.

Redundant qualified sites—Mitigating risks associated with supply chain disruptions.

Long-term supply assurance frameworks—Supporting business continuity and scalability.

Evonik’s materials are engineered for stable processing windows, predictable degradation behavior, and high batch-to-batch reproducibility. These attributes reduce validation costs, streamline scale-up, and enable rapid commercialization without compromising innovation.

Tranquilli: I don’t believe material costs largely influence material decisions. Usually for medtech applications, customers prefer high-quality, robust materials. Since many parts consume little material, high-cost materials have less impact. One factor often overlooked is the need to qualify multiple materials to mitigate supply chain issues. With material consolidations, suppliers may discontinue materials, and it can take years to get new materials approved for end users. Testing and certifying multiple materials can reduce the risk of supply disruptions during the prototype stage.

Zawacki: Materials innovation used to primarily emerge from understanding both polymer chemistry and clinical workflow. Now the supply chain workflow is just as important a consideration, but economic realities also constrain material choices. For example, in the U.S., Medicare reimbursement rates continue declining through annual conversion factor cuts, forcing hospitals to prioritize devices that reduce procedure time, material waste, and complications. Similarly, the shift from volume-based to value-based care models ties payments directly to outcomes, so devices must be shown to improve patient results, not simply complete procedures. Furthermore, geopolitical tensions, tariff uncertainty, and pandemic lessons have accelerated the demand for supply chain regionalization. Medical device manufacturers increasingly prioritize suppliers with geographically distributed manufacturing to mitigate single-source risk. For materials suppliers, this creates both challenges and opportunities.

Barbella: How are materials enabling less invasive and/or more personalized therapies?

Carbone: Less invasive care needs smaller profiles, more flexibility, and higher strength-to-weight performance. Materials make this possible by enabling thinner walls, improved fatigue resistance, and compatibility with sterilization and imaging requirements. Personalization is accelerating through patient-specific devices and more complex components. High-performance polymers and implant-grade materials support those designs while keeping weight down and, in some cases, providing radiolucency compared with metals. We are seeing this clearly in the continued adoption of implant-grade PEEK and related stock-shape demand.

Heniford: Evonik’s advanced material solutions empower medical device manufacturers to develop less invasive and personalized therapies. Key innovations include:

Cardiovascular and soft tissue repair—RESOMER bioresorbable polymers enable thinner, more flexible components for stents, scaffolds, and delivery systems. Their tunable degradation profiles match healing timelines, eliminating the need for removal surgeries and supporting targeted therapeutic delivery.

Orthopedics and facial aesthetics—VESTAKEEP PEEK provides metal-like mechanical properties with radiolucency, improving post-operative imaging, reducing stress shielding, and enabling patient-specific 3D-printed geometries. Applications include surgical guides, craniofacial implants, and porous lattice structures for enhanced integration and recovery.

Evonik’s materials are at the heart of innovations that improve patient outcomes and reduce surgical complexity.

Tranquilli: More robust materials, with greater chemical resistance, can enable end users to provide a wider range of therapies in a single device.

Zawacki: The demand for miniaturization, sensor integration, and personalized medicine creates new material requirements more stringent than traditional biocompatibility and mechanical specifications, driving the need for tighter tolerances, smaller wall thicknesses, and greater breadth of sizes.

 Regarding sensors, interventional catheters increasingly function as integrated diagnostic and therapeutic platforms: intravascular ultrasound (IVUS) and optical coherence tomography (OCT) require catheter materials compatible with embedded sensors while minimizing diameters and wall thicknesses. Magnetic microcatheters incorporating elastomeric matrices with programmed magnetic particles enable precise navigation through complex anatomy via external field control. Pressure and flow sensors fabricated through microelectromechanical systems (MEMS) technology demand polymers that maintain dimensional stability while transmitting physiological data in real time. These applications push the limits of material science: a catheter shaft must simultaneously provide electrical insulation for sensor leads, mechanical reinforcement for pushability, lubricious inner surfaces for device delivery, and biocompatible outer layers, in thin-walled tubing, with precise concentricity tolerances. The technical challenge lies not merely in material selection but in process control for maintaining dimensional specifications, while enabling subsequent bonding or coating operations.

As for personalized therapies, they often depend on localized drug delivery via device-integrated pharmaceutical coatings. For tubing and catheter component suppliers, drug-eluting capability requires materials engineering at the molecular level: polymer matrices that bond pharmaceutical compounds, release them at controlled rates, maintain mechanical integrity throughout degradation, and ultimately resorb without residue.

Barbella: How is your company meeting customers’ material needs or solving an unmet market need through material innovation? 

Carbone: We focus on supplying medical-grade materials that are easy to source, document correctly, and use correctly. We have lots of inventory on our floor. That is the unmet need more often than people admit. Modern Plastics supports medical device customers with ISO 13485-certified distribution, lot traceability, 20-year record retention, controlled-climate storage, and certification and testing options that meet regulatory requirements.  

We also help customers select a wide variety of proven medical-grade materials we offer from RADEL, Heat Stabilized Polypropylene, ULTEM, PMMA, gamma-stabilized polycarbonate for sterilization-sensitive applications, and implant-grade PEEK in sheet, rod, and tube stock shapes, along with 3D filament, aligned to contact duration and performance requirements.

Heniford: Evonik’s High-Performance Polymers are specifically designed to meet the unique requirements of medtech applications. Key offerings include:

RESOMER bioresorbables—Delivering tunable degradation, high purity, and multiple delivery forms (powders, granules, filaments, mono- and multi-filament) for cardiovascular scaffolds, soft tissue repair devices, orthopedic fixation, and drug delivery systems.

VESTAKEEP PEEK—A high-strength, radiolucent polymer ideal for long-term implants, personalized orthopedic solutions, and craniofacial/aesthetic reconstruction. It supports advanced 3D printing workflows to create osteoconductive, porous structures.

VECOLLAN recombinant collagen and biosynthetic cellulose—Non-animal, scalable biomaterials for soft tissue repair, wound care, orthobiologic, and aesthetic regenerative applications.

Endexo surface modification additives—Providing passive, non-eluting antithrombotic, friction-reducing, and anti-fouling properties for commonly used polymeric biomaterials.

Epicyte—A bioactive, nanostructured cellulose material designed for advanced wound care applications. epicite provides an ideal environment for moist wound healing by regulating moisture levels and offering anti-inflammatory properties. Its highly versatile structure supports wound recovery while being gentle on sensitive skin, making it suitable for burns, chronic wounds, and post-operative care.

These innovative solutions are backed by Evonik’s global expertise in polymer formulation, bioresorbable process development, additive manufacturing optimization, and regulatory documentation support.

Tranquilli: Initially, we offered only medical-grade silicone compounds for medtech applications. Due to limitations of silicone rubber, we needed to explore other polymers. We then developed EPDM and FKM compounds specifically designed for the medtech industry. Biocompatibility testing confirmed that these materials are suitable for this industry. These materials outperform silicone rubber in applications such as dynamic movement or chemical resistance.

Zawacki: TekniPlex utilizes its materials science expertise and deep understanding of the healthcare market to work in close collaboration with forward-thinking medtech companies. Through early and continuous engagement, TekniPlex helps define, refine, and translate unmet clinical and market needs into clear, measurable product requirements. These requirements are then embedded into material selection strategies or material innovation programs from the very beginning of customer partnerships, ensuring that material performance is aligned with real-world application and regulatory expectations.

Material innovation at TekniPlex spans a broad spectrum, ranging from the optimization of existing materials and manufacturing processes through to the development of entirely new material solutions. This includes working in partnership with carefully selected third-party suppliers, as well as the in-house design and engineering of novel polymer systems. Where appropriate, polymer chemistries may be selectively combined, modified, or tailored to achieve specific mechanical, chemical, and biological performance characteristics.

By integrating scientific expertise with market insight and collaborative development, TekniPlex delivers innovative materials science solutions that not only meet technical specifications but also support regulatory compliance, manufacturability, and long-term product success within the medtech sector.

Barbella: What material innovations will redefine the medtech sector over the next decade?

Carbone: A few buckets stand out. First, continued expansion of implant-grade and high-performance polymers, especially PEEK and related families, as devices push for higher strength, fatigue resistance, and imaging compatibility. Second, materials engineered for advanced manufacturing, including forms and grades that support tighter tolerances, complex geometries, and more consistent performance in small, intricate components. Third, surface- and multifunctional materials, including antimicrobial strategies, improved wear interfaces, and more application-specific formulations designed around sterilization methods, contact duration, and long-term stability. The winners will be materials that reduce total risk: predictable properties, strong documentation, stable supply, and a clear validation path.

Heniford: Evonik is actively shaping the future of medtech materials through emerging platforms such as:

Smart/stimuli-responsive biomaterials—Enabling implants that respond to physiological changes.

Osteoconductive bioresorbables—Supporting bone regeneration and integration.

4D-printed scaffolds—Combining advanced additive manufacturing with dynamic material properties.

Next-generation sustainable polymers—Aligned with circular economy principles for reduced environmental impact.

These cutting-edge innovations will drive competitive differentiation and define procurement and R&D strategies across all of Evonik’s priority segments.

Tranquilli: I could see a need for a low-friction, non-PFAS material. We are currently looking at different options for this.

Zawacki: Materials science innovation is fundamentally changing the role materials play in medtech. Materials are no longer passive or purely structural elements. They are becoming active partners in device performance, directly influencing how therapies are delivered, how devices interact with the body, and how patients heal. This shift will enable more precise targeted therapies and smart drug delivery, better biological integration with reduced immune response, and the development of durable, patient-specific implants. At the same time, advanced materials will drive miniaturization of diagnostic and therapeutic devices and enable materials that actively participate in healing, sensing, or regeneration. A major driver of this transformation is the emergence of smart and stimuli-responsive materials. These materials can change their properties in response to environmental cues such as temperature, pH, light, or mechanical stress. This will allow devices to adapt inside the body—for example, minimally invasive implants that expand only after placement, or drug delivery systems that activate exclusively at a target site. Instead of being static tools, medical devices will become adaptive systems.

Sustainability will also reshape material choices. As healthcare waste becomes a growing concern, plant-based polymers, biodegradable plastics, and recyclable components will enter mainstream medtech, particularly for single-use devices. Material lifecycle and environmental impact will become core design constraints, not afterthoughts.

Regulation will also accelerate this trend. Increasing scrutiny around biocompatibility, toxicity, and long-term safety will push material decisions into the earliest stages of product development. Material selection will become not just an engineering decision, but a clinical, regulatory, and strategic one.

Finally, advances in material formulations will encourage additive manufacturing beyond prototyping into real medical production. This will enable complex geometries, mass-customized implants, and emerging bio-printed tissues, supporting a long-term shift toward personalized medical devices at scale.

In the next decade the fundamental change is clear: Medtech will move from designing devices around materials to designing materials that define what devices can do. In the future, the intelligence, safety, and sustainability of healthcare technologies will be embedded directly in the materials themselves.

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