By: Lisa Peng, Director, Chemicals and Materials

With MD&M West behind us, Kline + Company Director Lisa Peng covers what the talk on the trade show floor means for the medical device industry. 

Revolution in Biomaterials  

Biomaterials are revolutionizing medical devices, emphasizing biocompatibility, functionality, and sustainability. We are seeing new products being developed and positioned to perform equally or better than incumbents in an environmentally friendly and sustainable way. 

“The industry is gradually shifting away from the mentality that certain PFAS are irreplaceable in critical healthcare applications and embracing innovation to develop alternative solutions.” 

With concerns over PFAS persistence and potential health risks, medical device manufacturers are developing alternative materials that maintain performance while reducing environmental impact. 

The industry is gradually shifting away from the mentality that certain PFAS are irreplaceable in critical healthcare applications and embracing innovation to develop alternative solutions. In fact, many compounders have moved to adopt PFAS-free formulations for suitable and less risky applications. 

Advances in biodegradable polymers, bio-based resins, and recyclable composites are helping to create safer and more eco-friendly medical devices. 

Regulatory pressures are also pushing for improved material sourcing, waste reduction, and life-cycle assessments to ensure compliance while promoting greener healthcare solutions. 

Advancements in Additive Manufacturing Technologies 

Additive manufacturing technologies continue to mature across many industrial verticals. 3D-printed medical devices have the potential to transform healthcare by enabling customized, cost-effective, and rapidly produced solutions. This technology allows for patient-specific designs, improving personalization and function while reducing waste. 

With the proliferation of AI tools, designing and optimizing designs can be done much faster, improving precision and accelerating innovation. The industry is now challenged not only by regulation but also by potential grey areas involving intellectual property created by designs optimized through the use of AI. 

“3D-printed plastic, primarily PEEK, made a significant leap recently, gaining FDA approval for several critical implant applications.” 

Metallic 3D printing is generally more mature in medical applications compared to plastic 3D printing. Metal additive manufacturing has been adopted in high-value, regulated fields such as orthopedics, dental implants, and surgical instruments, where precision, strength, and biocompatibility are critical. 

3D-printed plastic, primarily PEEK, made a significant leap recently, gaining FDA approval for several critical implant applications such as spinal interbody fusion cages, cranial and maxillofacial implants, and orthopedic implants. 

Polymer implants have the advantages of biocompatibility, radiolucency (meaning they do not interfere with imaging), and mechanical properties that are similar to bone. 

Evolution of Sterilization Methods  

The landscape of sterilization continues to evolve with advancements in technology, materials, and regulatory requirements. 

While EtO remains a widely used method for sterilizing heat- and moisture-sensitive devices, regulatory scrutiny over its environmental and carcinogenicity risks has led to stricter emissions controls and efforts to reduce its usage. Shifting to other sterilization methods, such as radiation (Gamma, E-beam, and X-ray), is necessary as EtO capacities reduce due to shutdowns. 

A range of other sterilization techniques, such as Vaporized Hydrogen Peroxide, Nitrogen Dioxide, Chlorine Dioxide, and Supercritical CO2, are being developed. The shift in sterilization can be challenging for various plastics used in devices and packaging. 

For example, we know that polymers have low radiation stability. This is also an opportunity for innovation for supply chain players, from biomedical materials used in actual devices to final packaging that uses various types of materials such as plastics, adhesives, and paper. 

As biomaterials, additive manufacturing, and sterilization methods evolve, staying ahead in the medical device industry requires strategic insight. Kline’s advisory services provide the market intelligence and expert guidance needed to adapt and thrive. Find out more about our medical devices advisory services.