In silico testing in healthcare is becoming increasingly cost-effective and time saving to understand the behavior of medical devices before conducting clinical trials. It also enables regulatory approval while prioritizing patient safety. Our proposition is the development of an innovative modelling framework based on the coupling of analytical material selection methodology with a simulation driven design approach, that supports material and geometry optimisation for new medical devices development [1]. The first part of this work is to identify the best material candidates that have met design constraints and objectives of a total hip joint replacement, using advanced bio-engineering materials databases. In the second part, a computer-aided design (CAD) model of a hip implant is simulated using finite-element analysis (FEA). The model is subjected to multiple structural forces that mimic a real-life scenario of a hip implant. The software facilitates meshing of the model and delivers instant multiphysics simulation. An instantaneous visualization of stress and strain fields into the hip joint led to an optimized combination of material and geometry, resulting in relevant new designs of a common hip joint. Our numerical outcomes were finally compared to reference data from literature [2]. Lastly, when it comes to producing the implants and in order to reduce post-operative problems and provide precision-fitting, additive manufacturing of patient-specific hip replacement implants is suggested. For this, we propose modelling of the AM process and its resulting stresses and strains [3], as this can identify potential part failure and hence improve the chances of manufacturing the custom implant defect-free first time.

[1] Fleischmann C. et al., A new approach to quickly edit geometries and estimate stresses and displacements of implants in real-time, Current Directions in Biomedical Engineering 5(1):553-556 (2019). https://doi.org/10.1515/cdbme-2019-0139

[2] Şensoy, A.T. et al. Optimal Material Selection for Total Hip Implant: A Finite Element Case Study. Arab J Sci Eng 44, 10293–10301 (2019). https://doi.org/10.1007/s13369-019-04088-y

[3] Pant P. et al., A Simplified Layer-by-Layer Model for Prediction of Residual Stress Distribution in Additively Manufactured Parts. Metals. 11(6):861 (2021). https://doi.org/10.3390/met11060861

Keywords: biomaterials, medical devices, healthcare, material selection, optimization process, simulation driven design, innovative modelling framework, additive manufacturing, topology optimization