3 Important Trends for Medical Device OEMs in 2024
The medical device industry never stands still as patient and clinician expectations evolve, new technologies are developed, and regulations change. As a result, continuous improvement and adapting to change are essential to stay competitive, profitable, and compliant.
In this blog, we will look at three of the key trends that will impact medical device OEMs in 2024 and the coming years.
Maintaining Compliance in a Changing Regulatory Landscape
The regulatory landscape for medical devices is constantly shifting as regulators refine rules, get to grips with new technologies, and react to new information and data. The need for medical device OEMs to stay on top of developments is more important than ever. We can use two examples to demonstrate this point.
The first example is the use of PFAS (per- and poly-fluoroalkyl substances) such as PTFE in medical device products. PFAS is a topic that will remain on the agenda over the coming year and beyond as the amount of evidence (and concern) grows about the impact that PFAS has on the environment. There are also concerns about the effect of PFAS on human health.
Regulators in the EU have published proposals to restrict the use of PFAS by banning certain types. There is also growing unease in the US, although PFAS are considered essential in many medical devices because of the critical role they play and the fact there are currently no recognized alternatives. One thing that is for certain though, is the debate will continue.
The second example is the publication of the FDA’s long-trailed revision to 21 C.F.R. Part 820. The revision, known as the Quality Management System Regulation (QSMR), amends current good manufacturing practice (CGMP) in relation to quality system requirements. The changes bring 21 C.F.R. Part 820 into greater alignment with international standards.
With QSMR, there is now a greater focus on risk management, so manufacturers need to update their QMS and device documentation. There is a two-year transition period to implement the changes and move to a risk-based approach.
Both of these examples demonstrate the importance of staying on top of not just regulatory changes that have taken effect (such as in the second example), but also potential changes that could be coming down the track.
Mitigating Supply Chain Risks
Supply chain considerations have been high on the agenda of many medical device OEMs over the past few years, and this is set to continue in 2024:
- The trend of reshoring is expected to continue as OEMs establish partnerships with suppliers closer to home.
- Multi-sourcing is also likely to continue as a mitigation to supply chain shortages and disruptions.
- Product development processes now often take into account design-for-supply-chain considerations.
The above trends (and the drivers for them) are well-established, but there will also be unique supply chain challenges that medical device OEMs will need to overcome. We highlighted one in a previous point – the growing concern around PFAS. While PFAS issues haven’t reached a stage of forced regulatory changes, some experts predict that other drivers, such as legal challenges, might accelerate a more rapid move to alternative materials.
In fact, some companies involved in medical device supply chains have already committed to moving away from PFAS use. One of the most prominent examples is 3M. It has said it will stop manufacturing PFAS by 2025 and it is working to discontinue its use of PFAS over the same period. This will impact the supply chains of medical device products that contain PFAS-containing 3M components, with that impact increasing if other companies follow 3M’s lead.
Manufacturing Process Innovation to Facilitate Device Innovations
Product development in the medical device industry has always been at the cutting edge, but the levels of innovation and technical development that we are currently seeing are beyond anything that has gone before. These innovations have the potential to transform health outcomes, but they also present challenges. This includes challenges for regulators as mentioned earlier in this blog, but manufacturing challenges also exist.
To keep up with innovations in product design, there must also be innovation in manufacturing processes. Innovation not just to produce new and novel medical devices, but to produce them safely, profitably, and at scale.
The growing number of combination products, the further miniaturization of medical devices and components, and the increasing use of sensors, fiber optics, and other advanced technologies are all examples of the need for continuous development, improvement, and innovation in manufacturing techniques.
The Importance of Strong, Reliable Partners
Each of the three trends covered in this blog demonstrates the importance of working with strong and reliable partners. In other words, partners who invest in manufacturing process improvement, who can provide compliance support, and who will enhance the resilience of your supply chain rather than increasing risks. In 2024, working with the best suppliers and partners has never been more important.
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