Computational design uses artificial intelligence (AI) to optimise designs towards user-determined goals. When combined with 3D printing, it is possible to develop and construct physical products in a wide range of geometries and materials and encapsulating a range of functionality, with minimal input from human designers. One potential application is the development of bespoke surgical tools, whereby computational design optimises a tool’s morphology for a specific patient’s anatomy and the requirements of the surgical procedure to improve surgical outcomes. This emerging (...) application of AI and 3D printing provides an opportunity to examine whether new technologies affect the ethical responsibilities of those operating in high-consequence domains such as healthcare. This research draws on stakeholder interviews to identify how a range of different professions involved in the design, production, and adoption of computationally designed surgical tools, identify and attribute responsibility within the different stages of a computationally designed tool’s development and deployment. Those interviewed included surgeons and radiologists, fabricators experienced with 3D printing, computational designers, healthcare regulators, bioethicists, and patient advocates. Based on our findings, we identify additional responsibilities that surround the process of creating and using these tools. Additionally, the responsibilities of most professional stakeholders are not limited to individual stages of the tool design and deployment process, and the close collaboration between stakeholders at various stages of the process suggests that collective ethical responsibility may be appropriate in these cases. The role responsibilities of the stakeholders involved in developing the process to create computationally designed tools also change as the technology moves from research and development (R&D) to approved use. (shrink)