Trade Secrets in the Medical Device Industry: The Role of Company Documentation

To understand how trade secrets operate in the medical device industry, it is important to get a perspective on how this industry operates, how it is regulated, and who are the stakeholders. As explained below, there is a tension between the need for manufacturers to maintain the secrecy of their device developments, improvements, and processes, while also satisfying regulatory disclosure requirements, and the need to market the device and its attributes robustly. Navigating these competing demands requires a careful but practical approach to maintaining confidentiality at all levels of development.