Partner profile: Crux Product Design
With the experience of delivering product innovations in the medical, consumer and performance goods sectors, we have the expertise to adapt and apply our methods to each client’s specific project needs.
Who are Crux and how do you typically work with Pharmaceutical clients?In many ways Crux are a traditional design & engineering consultancy, we have a cross-functional team (mechanical and electronic engineers, software developers, industrial designers and Human Factors specialists) and we work with a wealth of global pharma clients. Where we ‘break the mold’ is with our bias to action; as the industry is ever-changing, we’ve been reactive in growing new capabilities to continue to offer evidence-led design solutions rather than relying on experience and intuition alone.
How has your ‘evidence-led’ approach been beneficial on drug-delivery device projects?As speed-to-market is often a priority, getting to the ‘right answer’ quickly is vital. Late-stage changes are costly and time-consuming so we’ve seen ‘big wins’ from using science-led approaches to understand device performance at the prototype stage when committed costs are low. Be it early-stage Human Factors studies, instrumented test rigs or detailed device simulations, everything we do centres on growing confidence in the devices we design, ensuring they’re safe and effective for the end-user.
Will advanced simulations ever replace the need for physical testing?Currently extensive physical testing of medical devices is necessary with significant drawbacks as it’s time-consuming and often expensive, especially at clinical trial stages. Simulations enable a significant reduction in physical testing whilst allowing us to investigate a wide design space quickly.
Building simulations during the design and development stage allows us to test hundreds of permutations, evaluating tolerance extremes, failure modes and drug-device interactions to accurately predict the performance you’ll see at mass volume, helping us to mitigate failures. We’re presenting at DDF alongside Gilead sharing an FEA model we built that analyses subcutaneous injection behaviour including tissue backpressure, bolus formation, leakage and even pain.