Background/Objectives:
The use of in-silico technologies in the development of implantable medical devices has gained importance in the last decade, but impacts on the economy and society have been hardly investigated. As part of the EU-funded project SIMCOR, we therefore developed a conceptual framework to describe the impact channels from primal effects along the product development cycle to numerous socioeconomic endpoints.

Methods:
We applied an iterative process to build concepts from data and set them in relation to each other using the method described in Jabareen (2009). Information from a scoping review of the literature were complemented with expert interviews from academia, companies and regulatory bodies. Repeated steps of literature work, exploratory interviews and frequent discussion sessions among the research team led to the presented framework. The resulting framework was validated through feedback from experts.

Results:
The conceptual framework describes the whole chain of impacts from the technical changes brought about by the use of in-silico technologies along the product development cycle up until the socio-economic endpoints. These are allocated to four different levels, namely ‘Firm’, ‘Market’, ‘Health System’ and ‘Society’. The conceptual framework indicates that in-silico methods could not only accelerate product development and reduce costs, but also patient safety is expected to be improved, innovations are supported and the price for a medical treatment might decrease. Underrepresented patient groups may also benefit from the use of the technology, as it expands the possibilities to augment the number of individuals in clinical trials and model rarer anatomical configurations.

Conclusions:
The conceptual framework serves as a basis for the quantification of the impacts of in-silico technologies on firm, market, health system, and society and, consequently, the potential benefits as well as disadvantages can be estimated and better classified from different perspectives.