Case Study: Becoming a Medical Device Software Supplier

摘要

Today many software development companies are restructuring their business model to enter the medical device domain. The reason for this change is that significant opportunities exist within the healthcare industry and particularly in relation to the usage of software within this domain. However, in order to become either a medical device software supplier or manufacturer there are challenges to overcome. This paper describes a case study of an Irish software development company that in 2014 decided to change their business model to enable them to become a medical device software supplier. The paper provides an account of their journey from being an plan-driven automotive software supplier to securing software development contracts from leading medical device manufacturers. This involved them having to re-design and re-structure their software development approach to meet both the demands of medical device standards and medical device multinational third party software selection criteria.