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Materials Looking ahead


Nitinol’s ability to change shape in response to temperature has transformed the design of stents, fi lters and surgical instruments.


in medical manufacturing. For now, most commercial hydrogel devices are designed for single use or environments where sterilisation demands are minimal. Evidently, the possibilities are endless, with smart materials evolving at a rapid pace, as echoed by Roy: “There are many developments in this area, so it is difficult to point out which are most promising.” However, promising examples of stimuli-responsive materials being developed also include “materials like azobenzene-based polymers and spiropyrans, mixed polymer brushes and liquid crystal elastomers”.


Across these material classes, a pattern emerges. Laboratory prototypes perform impressively under controlled conditions but translating them into viable products means aligning their unique behaviours with the rigorous, standardised processes of medical device production. High-throughput moulding, extrusion and assembly lines are optimised for traditional materials whose properties remain stable under heat, pressure and sterilisation. Smart materials, by definition, are designed to change – an attribute that complicates manufacturing. Regulatory requirements amplify this challenge. Approval agencies require extensive data showing that a device will perform safely and predictably after sterilisation, during storage and throughout its intended lifespan in the body. For materials designed to respond dynamically to their environment, this means long-term studies to confirm that responsiveness is maintained, degradation products are benign, and so unintended changes occur under physiological conditions. Such studies can span years, demanding significant investment before a product reaches market.


The cultural conservatism of the medical device industry adds a further layer of inertia. Manufacturers operate in a high-stakes environment where reliability and compliance take precedence over novelty. Even a


Medical-grade collagens and gelatins for your in-body applications


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Radiological imaging/Shutterstock.com


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