Why medical device managers should involve materials experts

^{Josh Blackmore of M Holland believes that medical device managers should involve materials experts early on to capitalise on globalisation and improve functionality.}

Medical device development may feel like you’re racing against the clock. Delays negatively impact patients, budget and a company’s competitive advantage. From selecting medical-grade materials and confirming their availability, to meeting regulatory testing requirements, the development process is complex. Integrating a medical materials expert early on streamlines the process and helps push your product across the finish line faster. Along with speeding up the development process, a medical materials expert also provides visibility into regulatory testing and creative solutions, mitigates supply chain risks, demystifies material solution sets, and identifies cost-effective mechanical properties. With market trends accelerating and further convoluting the development process, having a materials expert on your team is important.

^{Why do you need a materials expert?}   

Yesterday’s materials won’t build the medical devices of tomorrow. Emerging trends like miniaturisation, sophisticated Point of Care (POC) diagnostics, multi-purpose packaging, and globalisation are increasing the complexity of parts and functional geometry. This forces design engineers to make different material selections that enable their devices to do more. As users demand more from medical devices, the plastic resins used to create them must also meet and exceed expectations. A materials expert can help your team meet these demands by using less material to produce devices that have smaller physical footprints, are ergonomic and aesthetically pleasing, and yield accurate results.

^{Smart plastic solutions also require human ingenuity.}

Plastics are instrumental in device innovation and serve multiple purposes. For example, controlled discreet 3D conductive pathways, created from resin compounds, power wifi and electro-mechanical test procedures using laser direct structuring. Other plastics can manage surface energy and allow microfluidic channels to improve conduction of liquids or repel water-based fluids for high release. A materials expert combined with a collaborative approach enhances the development process and improves your team’s overall medical-grade material selection and understanding.  

^{Device safety begins with materials}

Medical device packaging is also crucial to ensuring accuracy and patient safety. Along with being identifiable, trackable, and traceable, packaging must withstand external factors like sterilisation, as well as defend patients against adverse effects, like hospital-acquired infections. A materials expert can help select modern medical-grade plastics that, when combined with laser engraving, can improve tracking, accelerate identification, and balance cost and supply chain risk screenings.

When selecting materials for medical device development, teams need to address several criteria. For example, is the device at risk from harsh chemical disinfectants? Or, is it possible to develop a needle shield for less than 50 pence? What about reducing or eliminating spring force for auto-injectors? Or, can you displace metal with plastic to make a reusable, durable device? How many autoclave cycles can a specific plastic material withstand? A materials expert can answer these questions, ensuring patient safety and saving you time and money by avoiding costly mistakes early on in the process.

^{Challenging the status quo}

It is time to challenge the status quo of developing products with conventional materials that only satisfy mechanical and functional requirements. A materials professional is an expert in determining specific resin(s), enabling desired technical features, and helping everyone navigate the changing regulatory landscape and regional supply chain availability. Risk-averse medical device teams often revert to materials used in previous designs because they are confident they will pass regulatory testing. Taking this approach, a materials expert is typically only brought in when problems arise, when is often too late to make changes. Instead, a medical materials professionals should participate from the start so they can help the team find new solutions and impart expertise on considerations for regulatory testing and global supply chain security.

Plastics will continue to be used to bring unique and complex technical aspects to life because they are suited to serve a range of needs while keeping up with regulations. However, for plastics to provide maximum value to the medical field, product designers, engineers, manufacturers, and materials professionals need to forge deeper partnerships.

^Conclusion

There is an opportunity for companies in the medical device space that recognise emerging trends and bring products with critical new features to life. Companies that work together, engage a materials professional early, and take a collaborative approach from product design through development and manufacturing will create products that meet demands and cut development time. These companies will shape product development standards and identify new solutions that result in high-quality devices trusted by patients and healthcare providers.