PFAS – Impact on Ireland’s Medical Device Industry

“Safety, reliability, functionality, and efficacy” are some of the fundamental characteristics required for devices designed to diagnose, prevent, monitor, and treat medical conditions. In an ever-increasing and complex regulatory landscape, ensuring device performance, patient safety, and environmental protection is now more important than ever and is proving to be a significant technological challenge across the medical device industry.

Medical devices are typified by reliability, safe and consistent performance, governed by device design and the materials of construction. For manufacturers, it is critically important to use materials with known physical, chemical, and biological properties and that the material performance is consistent during production and during clinical use.

We have seen the sweeping impact of MDR, especially around challenges in the re-qualification of complex devices, and now we are seeing more fundamental challenges being introduced as a result of the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation specifically relating to the use of per- and polyfluoroalkyl substances (PFAS).

The EU has proposed comprehensive restrictions on PFAS, aiming to phase out their use in most applications due to their persistence, bioaccumulation, and toxicity. The controlled use of PFAS is very important from this perspective, but limiting or removing their use could have a major impact on the performance of a vast number of critical materials across industries whose properties depend on the use of PFAS chemistries.

The PFAS group of synthetic chemicals are known for their useful properties such as surface lubricity, durability, resistance to heat and water, and biocompatibility. Due to these attractive properties, PFAS have been used in a wide range of MedTech applications in both finished products and across material supply chains. The introduction of restrictions on the use of PFAS is particularly concerning for the medical device industry, as the combination of material properties provided by PFAS chemistries is so useful.

This concern is compounded by the fact that, in general, no direct alternatives are available for use in many MedTech applications. Often, the only potential alternative is another type of PFAS. One thing is for sure: addressing these challenges will require significant research and development engagement across the industry, from raw materials supply through manufacturing to sterilisation and ultimate device performance.

The Impact on Ireland’s Medical Device Industry

Ireland has a thriving medical device industry, and we are globally regarded as a leader in the sector. Indeed, we host 18 of the top 25 MedTech companies, and are home to over 450 MedTech companies,. Moreover, we have established a diverse ecosystem of medical technologies production, from coronary stents to contact lenses. It is known that PFAS restrictions will impact a huge number of MedTech companies in Ireland, and we have seen real examples of significant R&D projects to address PFAS restrictions in practice. The tightening of PFAS regulations presents several challenges:

Product Reformulation: 

Medical device manufacturers must reformulate products to reduce or eliminate PFAS content. This process involves extensive research and testing to ensure that alternative materials meet the stringent performance and safety standards required. These could include biocompatibility, mechanical performance, and even processibility within existing manufacturing lines.

Process Optimisation: 

Manufacturing processes will need to be redesigned to minimise or eliminate PFAS usage. This will involve modifying or improving production techniques, optimising raw material use, and implementing advanced technologies such as advanced filtration to capture or scavenge PFAS particles.

Materials Substitution: 

The transition to PFAS-free materials can disrupt supply chains, as manufacturers need to source new materials and establish new suppliers. Not only can this lead to increased costs and potential delays in product availability, but new materials will need to be requalified and critically evaluated against the device performance requirements.

There may be design improvements required to accommodate the use of new materials in achieving process yields and device performance. PFAS are valued for their durability, chemical resistance, and thermal stability. Identifying direct alternative materials that match these properties without compromising the performance and safety of medical devices is a significant challenge.

The Irish MedTech industry crosscuts all aspects of medical device development, from concept to production, and we expect PFAS restrictions to cause considerable challenges across all stage gates of development and potentially drive marketed devices back into the development and revalidation cycles.

We recently hosted Dr Robert Cooper, the inventor of the stage gate system, who spoke about managing these types of technological challenges through stage gating. This is particularly relevant as the PFAS restrictions could impact a large number of material supply chains, often resulting in multifaceted R&D projects.

This will come at a significant cost to the sector. However, companies are not alone in this and should seek to maximise research, development and innovation support available.

Opportunities to support the transition

As our industry faces into the challenges and uncertainty arising from PFAS restrictions, there are significant supports available to fund RD&I projects. Indeed, supporting industry is a central theme to our national RD&I policy. We expect to see R&D in across the TRL scales, and Innovation in the realisation of potential new value chains arising from the move away from PFAS, underpinned by investing in technical expertise, creating new technologies and developing new materials.

The soundings are clear that this will require R&D projects across the product life cycle, and proactive investment in R&D can help mitigate the impact. Companies should consider how to support their RD&I effort, and Ireland is well-positioned in this regard.

We have established robust mechanisms to fund the change, such as the R&D tax credit, RD&I grants and the KDB. In addition, the European Commission provides several funding programs to support research and innovation related to PFAS regulations, such as the LIFE programme, Horizon Europe, and the European Regional Development Fund (ERDF).

PFAS regulations are critical for protecting human health and the environment from the harmful effects of these persistent chemicals. The medical device industry faces significant challenges in adapting to these regulations, but proactive investment in R&D can help mitigate these impacts. Ireland is making strides in addressing the PFAS restrictions through targeted R&D. Government funding programs play a vital role in supporting these efforts.

Learn more

In KPMG’s R&D Incentives Practice, we have significant experience in identifying the right approach across the varied funding mechanisms and can add value to your RD&I. Go to kpmg.ie/RandD to find out more.

Guest post by Dr Eoin McCarthy, Associate Director, KPMG R&D Incentives Practice.