Partner profile: Crux Product Design

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.

How accurately do these simulations match real world scenarios?

Crux puts in significant lab and theory-based ‘ground-work’ validate the accuracy of our models. At Crux, we’ve used simulations to correctly predict how API suspension formulations can clog hypodermic needles with incredible accuracy. We’ve also predicted tissue backpressure within 5% of experimental values. That said, sometimes we only need a ‘directional steer’ to grow understanding of key performance drivers (generating Pareto plots etc.) so sometimes a less complex model will be sufficient to correctly inform of a route forward.

What’s the most exciting thing you’re currently working on?

Our work is always incredibly interesting as we get to study a mix of engineering, mathematics and natural sciences to help build groundbreaking models. Applying these techniques to the improvement of long-acting formulations by understanding how large volumes of drug interact with human tissue is exciting because it will really benefit device design and patient outcomes. There will always be new challenges posed by changing patient demographics, novel treatment modalities and new commercial constraints, but by front-loading analysis, we can de-risk early on.