Features

Medtech Materials Experts Discuss the Root of the Matter

Simplified device designs, improved efficiency, and demand for minimally invasive surgery is shaping medtech material innovation.

By: Michael Barbella

Managing Editor

Superheroes lead complicated existences. 

A perpetual target of vengeful villains, these superhuman saviors are constantly on high alert for danger and expected to single-handedly save the world from tyrannical rule or its premature demise. 

Talk about high expectations.

Many superheroes fulfill this gargantuan obligation while leading double lives (masking their true identities through full-time work) and simultaneously battling inner demons. Such a high moral code induces widespread adoration but also unrealistic expectations and intense public scrutiny, the latter of which can prompt vicious backlash depending on the outcome of a planet- or city-saving showdown against evil. 

Surely, the superhero lifestyle has its downsides. But it has some perks, too—fame, altruism, glorification (a double-edged sword), brawn, and—obviously—super human powers.

There is no limit to the otherworldly prowess possible in the superhero universe. From the eccentric—technopathy (controlling technological hardware), density manipulation, and reality-changing muscle—to the extraordinary—weather control, time pause, teleportation, shape-shifting, and invisibility—super humans are basically invincible.

And virtually indestructible, thanks to abilities like exceptional speed or strength, self-sustenance, regeneration, enhanced senses, and resurrection. Such incredible facilities are purely fictional of course, but recent advancements in healthcare could one day turn ordinary humans into super special specimens.

A shot developed by Nationwide Children’s Hospital Research Institute (Columbus, Ohio), for example, can increase muscle mass through gene manipulation. Proven safe and effective in animal testing, the shot targets myostatin, a gene that stops muscle growth by using a protein called follistatin; bits of DNA containing the protein’s manufacturing instructions are put inside hollowed-out viruses and injected into muscle. The shot is not as quick-acting as the serum Steve Rogers (Captain America) received, but results are nevertheless fast from a clinical perspective: researchers reported a noticeable difference in muscle size within six weeks. The advancement is unlikely to spawn any super soldiers anytime soon though, as its intended target is degenerative muscle disease patients, and maximum growth size is limited. 

For now, anyway.

Likewise, the incredible regenerative abilities of Wolverine, Thor, and Wonder Woman are within (albeit, far off) sight through gene engineering and material advancements. The genetic modification breakthrough occurred at Harvard University, courtesy of a cancer research scientist who accidentally discovered a gene that renews stem cells. Mice engineered with the gene regrew toes and missing portions of their ears. 

 Northwestern University scientists can take credit for the material advancement. A research team there has created a new bioactive substance that regenerated high-quality cartilage in animal knee joints. Described as a “rubbery goo,” the material is actually a complex network of molecular components that work together to imitate the natural physiological environment of cartilage, according to the university.

Northwestern researchers applied the material to damaged animal knee joints. Within six months, the affected joints showed visible signs of repair, with new cartilage growth containing the natural biopolymers (collagen II and proteoglycans) that provide for pain-free mechanical resilience in joints. The new biomaterial combines a bioactive peptide with hyaluronic acid, a natural polysaccharide found in cartilage and joint synovial fluid. The bioactive peptide binds to a protein called transforming growth factor beta-I, which is responsible for cartilage growth and maintenance.

Northwestern researchers are hopeful the new material can someday be used to prevent knee replacement procedures, treat degenerative diseases such as osteoarthritis, and repair sports-related injuries like ACL tears. 

“Cartilage is a critical component in our joints,” said Northwestern’s Samuel I. Stupp, Ph.D., director of the Center for Regenerative Medicine, and study leader. “When cartilage becomes damaged or breaks down over time, it can have a great impact on people’s overall health and mobility. The problem is that, in adult humans, cartilage does not have an inherent ability to heal. Our new therapy can induce repair in a tissue that does not naturally regenerate. We think our treatment could help address a serious, unmet clinical need.”

Synchron and Elon Musk’s Neuralink are doing the same with nitinol and flexible polymers to create real-life cyborgs who can control computers with their thoughts.

Synchron’s brain-computer interface (BCI) device is designed to help severely paralyzed people mentally control personal electronic devices. The paper clip-sized BCI is implanted in the brain’s motor cortex through the jugular vein in a 20-minute, minimally invasive procedure. Delivered through a catheter, the self-expanding implant is made from Nitinol, a biocompatible, erosion-resistant nickel-titanium alloy commonly used to widen arteries in surgical procedures.

Neuralink’s BCI chip contains 64 flexible polymer threads that produce 1,024 brain activity recording sites. The threads are stitched into the brain using a surgical robot. 

Three people have thus far received a Neuralink BCI, and the company—according to Musk—is hoping to implant the experimental devices in 20 to 30 more individuals this year. The first two patients, both of whom sustained spinal cord injuries, have used their newfound telepathy to multitask, play video games or chess, and create 3D objects.

“We’re just now scratching the surface of the capabilities and possibilities of this thing…” Nolan Arbaugh, who received his BCI last January, told a Neuralink website blog. “I think down the road, it’s going to make a lot of people’s lives a lot better and make people much more independent and much more capable of doing a lot of things.”

The same can be said of most medical devices and their material constructs. Advancements in medtech materials over the last several decades have led to breakthrough products such as bioresorbable stents, tissue-engineered scaffolds, bioactive hydrogel-based implants, 3D-printed prosthetics, and biodegradable health sensors. 

To gain a better understanding of the promise and pitfalls posed by modern medtech materials, Medical Product Outsourcing spoke to nearly a dozen experts over the last several weeks. Commentary came from:

Allison Clark, vice president; Mart Eenink, senior advisor; and Chris Thatcher, president/CEO at TESco
Larry Johnson, president of Supply Chain Solutions at Foster LLC
Kevin Jones, chief technology officer; Dinesh Lolla, senior materials innovation manager; and Aflal Rahmathullah, vice president of Product Development & Engineering at Porex
Brittany Mai, marketing manager at Confluent Medical Technologies
Stephen Smith, director of Market Development at Edge International
Scott Taylor, chief technology officer at Poly-Med Inc.
Romteen Youssefi, president of West-Tech Materials

Allison Clark: In sports medicine, we are seeing a shift in focus towards regenerative material solutions. Companies are investing in systems that support the body’s ability to generate new tissue with the hopes of creating more positive clinical outcomes. In spine, the balance has always teetered between titanium and PEEK, but there is continued interest in surface modification techniques—either physical or chemical—to increase bioactivity and improve clinical outcomes.

Chris Thatcher: We are seeing a drive for a next-generation material, specifically materials that are capable of self-tapping. There is a desire to be able to switch surgeons over from metals to absorbables. But there is more to it than just a “new material.” We see a desire for a distinctive material which is not just another material that is a variation of a current material.

Larry Johnson: Fundamental trends include an aging population, the continued rise of chronic diseases, along with emerging nations increasing growth in the medical device marketplace. Minimally invasive surgeries will continue to grow, as will the need for implantable devices. After COVID-19, sourcing groups at device manufacturers have gained knowledge and strength as they have become more resilient in their approach to buying, thus reducing risk within the supply chain. 

Kevin Jones, Dinesh Lolla, Aflal Rahmathullah: A major trend is the move toward materials that simplify device design, improve efficiency, and enhance sample integrity while reducing waste. The industry is increasingly focused on minimizing material loss, preventing contamination, and optimizing user experience, particularly in diagnostics, drug delivery, and patient management. 

Another key shift is integrating materials directly into device structures rather than relying on separate components. This is driving demand for engineered 3D porous materials, which enable precise control of porosity, flow, and mechanical strength in a single structure. Additionally, regulatory and environmental concerns are prompting greater exploration of PFAS-free alternatives to PTFE, a material valued for its hydrophobic and venting properties. While PTFE remains a high-performance option, manufacturers are seeking sustainable solutions that deliver similar benefits. 

The rise of self-compounding in pharmacies, particularly due to GLP-1 drugs, is also influencing material innovation. There is a growing demand for materials that ensure sterility and product integrity in compounding environments, with venting systems and filters playing a crucial role in maintaining safety and reducing errors.

Brittany Mai: Some of the major trends across the medtech material industry are around advanced material innovation and securing the supply chain. In the polymer market, we are starting to see material that pushes the boundaries of traditional polymer limitations like larger diameter Filmcast PTFE and REACH Compliant Polyimide. When it comes to alloys, the demand for higher-purity Nitinol is increasing to provide fatigue resistance in complex stent designs. Overall medical devices are getting smaller, and more procedures are going toward minimally invasive delivery devices, so manufacturers need to adapt accordingly. With all these changes, none of it would be possible if you don’t prioritize a secure supply chain. If the last few years have taught us anything, it is that it is paramount to work with a supplier with direct control over a vertically integrated supply chain and be able to respond quickly to demand changes.

Stephen Smith: There does seem to be a concern for the effect of certain metals like cobalt and chromium on a relatively small percentage of the population. Over time, minute amounts of the metal implant may leach into the body and for some people, this may cause metallosis, which can be fatal. As a result, the OEMs and government agencies are looking to limit the exposure to these materials. For example, recent European Union (EU) mandates now require that medical devices containing a greater than 0.1% cobalt content be labeled as such. For many grades of stainless steel, including implantable grades, this level of cobalt was normally considered a non-reportable residual but now we are specifying to the manufacturing mills that (a) the level of cobalt must be reported on the mill certification and that (b) the level has to be under 0.1%. Note: There are other medical implantable grades that contain much higher levels of cobalt (up to 64%), which are commonly used because of their superior strength, corrosion resistance, wear resistance, and biocompatibility. If a patient has cobalt allergies or sensitivity, the surgeon can substitute a titanium implant.

Scott Taylor: Medtech material development is at a crossroads. On the one hand, using already existing materials is perceived to support expedited regulatory path. At the same time, materials science is pushing the boundaries of what is possible, particularly with rational material design and bioinspired/biomimetic surfaces. Bridging this gap are classes of materials that are evolutions of existing materials but at the same time overcome historical challenges; for example, PLLA sutures were introduced in 1999 but were pulled from market via voluntary recall in 2001 due to crystalline structure and material persistence, as well as migration of degradation byproducts. Recent advances in material design result in lactide copolymers with improved biocompatibility throughout the degradation cycle that are capable in a variety of textile forms, including sutures and mesh. For example, Lactoprene 8411 has been used clinically in a braided form in Europe for more than 15 years and Lactoprene 8812 has clinical use in both braided and knitted form with no related safety issues. Advances in tissue engineering require these materials to approximate performance of multi-scale tissue in a dynamic way throughout the healing process.

Romteen Youssefi: Most trends in materials are being driven by EU Regulations such as RoHS and REACH that are impacting the acceptability of ingredients in materials used in the manufacture of medical device components. 

Barbella: Please discuss how existing materials are being used in different ways to meet customers’ and or market needs/demands.

Mart Eenink: Bioabsorbable polymers, which were mainly used in surgical sutures, now are used in various other applications such as orthopedic sports medicine implants and fixation devices, cardiovascular stents, vascular closure devices, hernia meshes, and many others.

Johnson: Microfluidics, 3D printing, and nylon 11 are good examples of existing materials used in different ways because their properties meet the specific requirements of the devices they are being used in. The trend of “permanent implantable” devices is enabling manufacturers and practitioners to have options beyond what has been available in the past. This means the options available allow device manufacturers to better match materials available with properties needed for an application.

Jones, Lolla, Rahmathullah: Traditional flat-sheet materials are increasingly being replaced with engineered 3D porous structures to improve functionality. In diagnostics, wicking materials are now integrated into structured sample collection devices that enhance fluid flow consistency and efficiency. In bioprocessing and drug delivery, venting materials are being adapted for sterile sample handling and contamination control, especially with the growth of self-injection and personalized medicine. In medical filtration, hydrophobic porous structures are evolving to provide greater control over fluid and gas exchange, ensuring sterility while enhancing performance. 

Additionally, materials are being leveraged to enrich diagnostic samples through surface energy and surface charge modifications, such as cation exchange mechanisms used in nucleic acid isolation and antigen removal from blood, expanding beyond traditional filtration applications. One notable example is the use of DEAE (diethylaminoethyl) functionalized materials, which serve as cation exchangers in diagnostic assays to remove highly charged contaminants. This approach enhances sample purification and improves assay sensitivity, demonstrating how advanced material modifications can significantly impact diagnostic performance.

Taylor: The ability to apply existing materials in new applications and new processes is critical for medical devices to borrow from the history and known safety profile of these existing materials and is a major reason that this is the starting point for designing new products. Even with regulatory shifts, both in the U.S. and internationally, we’ve found reference materials are useful and important for regulatory discussions and product adoption. However, new products have to differentiate in some way to justify adoption, which is very often a result of new form factors, adoption of new processes, and/or performance characteristics that are meaningful to a user. An example of this is introduction of textile-based orthopedic anchors for some indications as opposed to injection molded screw-style anchors. These may be based on the same material but are presented as very different designs to achieve fixation. This same material/new form factor approach can be translated into myriad products with the potential to unlock a range of performance features not previously available. Even more powerful is the development of new materials suited for particular processes or feature sets, including mass reduction, mechanical performance, degradation profile, and tissue and cell response, among others.

Youssefi: The list of biocompatible materials is relatively short. However, customers seek more effective and efficient processing of such materials to improve output and reduce manufacturing costs. 

Barbella: Please share an instance of an innovative material solution your company devised to solve an existing problem or meet a customer’s need. 

Clark: One particular company we have worked with developed technologies that help detect problems in patients that undergo a variety of vascular surgeries. A key component of their device system is an absorbable soft tissue marker that has echogenic properties. This marker works in conjunction with a proprietary, AI-enabled ultrasound device to provide quantitative flow measurements to the patient’s care team. TESco partnered closely with this company to select the appropriate material and manufacturing process to achieve the desired clinical performance characteristics in an injection molded device.

Johnson: One of Foster’s key technology platforms is imaging technology. A core competency of Foster has been the addition of radiopaque fillers to materials so they show up on a fluoroscope in minimally invasive interventional catheter procedures. Fluoroscopy is a radiation-based imaging technique hospitals would rather avoid in preference for non-radiation imaging techniques, if possible. Two non-radiation imaging techniques that are coming into vogue for medical procedures are MRI and ultrasound. 

Foster has developed and continues to improve the functionalizing additive technology that is added to polymers so that practitioners have options for visibility into MRI and ultrasound imaging techniques. These imaging techniques have not replaced fluoroscopy yet; however, progress is being made with current applications for the technology.  

Jones, Lolla, Rahmathullah: A recent example is our work in midstream urine collection, where we developed a sintered porous polymer wick to improve fluid handling and sample flow. Previous materials failed to provide consistent fluid transfer between the collection pad and diagnostic membrane, leading to inaccuracies. We created a more reliable and efficient urine collection wick by optimizing our sintered material’s surface energy and porosity. This innovation is critical as home testing and self-administered diagnostics become more common. Engineering microstructural flow properties ensure better sample collection, reducing user errors and enhancing diagnostic accuracy. In addition, our materials have been applied to support self-compounding in pharmacies, particularly for injectable drugs like GLP-1s. By designing venting systems and filters that maintain sterility and simplify the compounding process, we’ve helped reduce errors and improve safety in these critical applications.

Mai: A recent innovative materials solution Confluent recently accomplished concerned substances in the Polyimide manufacturing process. Polyimide suppliers have historically used NMP (n-Methyl-2-pyrrolidone) as a solvent in the manufacturing process. In a recent finding that could have ramifications in the industry, the EPA has found that NMP, as a whole chemical substance, presents “an unreasonable risk of injury to human health when evaluated under its conditions of use.” This finding determined that NMP posed an unreasonable risk to health in 29 of 37 use cases, which include domestic manufacturing, import, processing in plastics manufacturing, various other industrial uses, as well as disposal. To mitigate this risk to the medical industry’s supply chain, Confluent has developed an NMP-Free option with equivalent performance to historical polyimide along with a stable supply chain available in three weeks or less. This material meets Europe’s REACH compliance requirements, avoids the impending EPA findings against NMP, and provides improved safety for our employees, vendors, and patients.

Taylor: Two examples come to mind.

Example 1: Light curable resins for 3D printing. Identified needs: 3D printable with high resolution using standard DLP- and SLA-style printers; absorbable; mechanically competent (improved over PEGDA and GELMA-type materials); biocompatible throughout degradation cycle; dimensionally stable throughout degradation cycle; and compatible with bioprinting.

Solution: A series of photoreactive, polyester-based liquid polymers (Photoset) that link together through chain extension and crosslinking to form highly toleranced scaffolds for tissue engineering. This material has been printed using a wide variety of light-based 3D printing, for example FormLabs SLA and DLP printers, without modification. This material has been shown to be biocompatible throughout the degradation cycle.

Example 2: Absorbable elastomers as highly compliant coating. Identified needs: Non-crosslinked; solution and/or thermal processing; and well-known components.

Solution: A high molecular weight, low crystallinity copolymer containing lactide, glycolide, trimethylene carbonate, and caprolactone (Strataprene) produce a highly compliant material that can be processed through melt extrusion or through solvent-mediated processes using acetone, chloroform, dichloromethane, and other standard organic solvents. This material exhibits mechanical performance similar to TPU and has been applied as coatings for textile structures (e.g. the Uriprene stent), and as an occlusive barrier to knitted textiles and metallic stents with good base material adhesion and more than 500% elongation to break. Other processes such as electrospinning and FDM printing have also been explored.

Youssefi: We have been able to identify alternative manufacturing processes to meet the existing specifications and requirements and improve cost efficiency for our customers. 

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