Use of Engineering Analysis and Simulation to Guide and De-Risk Medical Device Development

Chris Hurlstone1, Charlie Lowndes1, Stuart Abercrombie1

1Team Consulting Limited, Abbey Barns, Duxford Road, Ickleton, Cambridgeshire, CB10 1SX, UK


Recent advances in computing technology and analysis software have had significant impact on how quickly and efficiently performance simulation can be carried out. This paper describes three examples where the application of simulation tools has helped guide and de-risk device development programmes.

On the rapid development of an emergency use ventilator, computational fluid dynamics (CFD) was used to assess risks relating to oxygen concentrations inside the device casework. In another example, the impact on key performance characteristics of an inhaler from small changes in geometry arising from manufacturing variability was modelled, also using CFD, to assist the setting of design specifications. In the third example, FEA was employed to ensure that deformation during manufacture of a custom foil blister pack did not exceed recommended limits, so as to minimise the risk of imperfections in finished parts. The case studies illustrate methods by which simulation and modelling can inform design decisions, in ways which do not necessarily require major commitments of time and resources.

Key Message

Complex engineering analysis and simulations which previously required significant resources can now be carried out more efficiently and effectively. Coupled with supporting empirical work, these tools can offer significant benefits to device development programmes, particularly to assist with design optimisation and de-risking.