GOOD STORIES

Solving Complex PFAS Substitution Challenges in Medical Devices

For MedTech companies, PFAS substitution is becoming a strategic priority, not just a compliance exercise. The EU's PFAS restriction is still being finalized, but as proposed, many device categories are expected to receive some of the longest derogation periods of any sector. That won't fully insulate MedTech as this sector only accounts for around 7% of total EU PFAS consumption. Hence, the sector depends on suppliers serving far larger industries that face shorter deadlines. The availability of PFAS could therefore tighten and costs could rise before MedTech's own regulatory timeline.

Industry:MedTech / Medical Devices

“PFAS substitution is not just a matter of compliance, it is also a matter of resilience and, in some cases, cost savings.”

Waiting for regulatory clarity is therefore a risky strategy. One international MedTech company recognized this early and wanted to accelerate its transition toward PFAS-free medical devices. Emendo was brought in to support the harder substitution cases, where no direct replacement could be identified.

Pixel-style icon of a pair of binoculars, symbolizing observation or monitoring.

Observe

  • Specifications built around PTFE’s full property profile
  • Failure modes were poorly understood
  • No PFAS-free alternatives could be identified
Pixel-style icon of a stylized human head with visible brain and radiating lines, symbolizing thinking, innovation, or ideation.

Think

  • Assessment of functional requirement and failure modes
  • Scouting of material candidates and suppliers
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Improve

  • Scouting of material candidates and suppliers
  • Viable PFAS-free candidates and suppliers identified
  • Viable PFAS-free candidates and suppliers identified

THE CHALLENGE

Moving Beyond One-to-One Material Replacements

The customer had already identified PFAS-containing components across several products and started substitution activities internally, but quickly found that no material offered a direct one-to-one replacement.

The remaining cases included coatings, tubing and bearing elements, primarily based on fluoropolymers such as PTFE.
A key challenge for finding alternative materials was that the material requirements of the PFAS-containing components reflected the full property profile of the original PFAS material, rather than the actual functional requirements of the component.

As no PFAS-free alternative material can match the same combination of properties as PFAS, the project required a reassessment of which requirements were truly essential, including parameters such as biocompatibility, low-friction performance, temperature resistance and flexibility.

OUR APPROACH

A Structured Path to PFAS-Free Alternatives

Using Emendo’s established PFAS substitution playbook, adapted to the customer’s needs, we combined material science, market screening and supplier engagement.

Our work included:

  • Identifying gaps between existing specifications and available materials.
  • Re-evaluating failure modes based on customer-generated data.
  • Re-assessing material requirements together with the customer’s engineers to distinguish essential requirements from properties inherited from the PFAS material.
  • Mapping relevant suppliers and commercially available PFAS-free alternatives.
combination devices lab creation

THE RESULTS

A Stronger Foundation for PFAS-Free Development

The customer came away with revised material requirements that opened the field to alternative materials, without compromising the functional needs of the components. 

Together with the revised requirements the customer received a detailed overview of available PFAS-free materials and relevant suppliers. Furthermore, several candidate materials were sourced for testing on the customer’s side. 

Beyond the individual substitution cases, the customer walked away with a structured, repeatable methodology for evaluating and selecting PFAS-free alternatives.  One the internal team can now apply to the remaining components without starting from scratch each time.

Facing a Difficult PFAS Substitution?

Get in Touch

PFAS substitution is rarely a simple material swap. Emendo supports the full journey, from identifying PFAS-containing components and screening alternatives to requirement definition, supplier sourcing, testing strategy and redesign where needed. With broad material science expertise, an extensive supplier network and an established substitution playbook, we help companies build a structured path toward PFAS-free products.

Thore Bach Thomsen

Thore Bach Thomsen

Scientific Lead Consultant

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Moving beyond PFAS

In collaboration with IDA Polymer