Ethical risks of AI-designed products: bespoke surgical tools as a case study

An emerging use of machine learning (ML) is creating products optimised using computational design for individual users and produced using 3D printing. One potential application is bespoke surgical tools optimised for specific patients. While optimised tool designs benefit patients and surgeons, there is the risk that computational design may also create unexpected designs that are unsuitable for use with potentially harmful consequences. We interviewed potential stakeholders to identify both established and unique technical risks associated with the use of computational design for surgical tool design and applied ethical risk analysis (eRA) to identify how stakeholders might be exposed to ethical risk within this process. The main findings of this research are twofold. First, distinguishing between unique and established risks for new medical technologies helps identify where existing methods of risk mitigation may be applicable to a surgical innovation, and where new means of mitigating risks may be needed. Second, the value of distinguishing between technical and ethical risks in such a system is that it identifies the key responsibilities for managing these risks and allows for any potential interdependencies between stakeholders in managing these risks to be made explicit. The approach demonstrated in this paper may be applied to understanding the implications of new AI and ML applications in healthcare and other high consequence domains.