On August 28, 2018, Michele Van Patten Frank and Alper Ertas published "Protecting and Enforcing the Intellectual Property Behind Medical Diagnostics" in Medical Device and Diagnostic Industry. Here is an excerpt:
Medical diagnostic devices detect and measure biological events and structures in the human body. This specific class of medical device derives value from the prevention, diagnosis, monitoring, treatment, and alleviation of human disease and other conditions. The commercialization of a diagnostic device is often a lengthy, multi-step process that requires significant investment in research, design, manufacturing, clinical trials, and regulatory approval. In each stage of the product life-cycle, a company can protect and enforce intellectual property flowing from technical and functional attributes of the medical diagnostic device. Determining the appropriate form of intellectual property protection and implementing an internal IP assessment policy will help corporations maximize the competitive advantage of the innovation and return on investment.