Preliminary Assessment of a New Medical Device Idea: A case study evaluation of the IP and Reimbursement options for the Intra-Cranial Pressure (ICP) device idea

Abstract

Medical devices are used extensively to provide diagnostic and treatment solutions to patients. However, sustaining and building a competitive advantage in this industry requires constant innovation. Furthermore, developing medical device is costly and involves investment of immense time and resources. Thus conducting an assessment of a medical device idea before proceeding ahead with its development is critical and essential to ensure development of a successful product. Preliminary assessment is essentially the evaluation of the commercial potential of a new product idea. Factors considered in evaluation consist of an assessment of the fit of the idea with the company strategy and capabilities, a preliminary market and competitive assessment, a preliminary technical assessment and a financial analysis. In addition to these factors, evaluation of a medical device idea also involves an assessment of the IP risks surrounding the idea, and also the reimbursement and regulatory requirements required. This thesis takes a case study approach to Telemetry Research's ICP device idea in terms of only the IP and reimbursement considerations, since Telemetry Research has already covered the other factors. To do this, an in-depth literature review was done to identify the key factors that are considered in the preliminary IP and reimbursement assessment of a new device idea. These factors were then used to evaluate the IP and Reimbursement options for the ICP device idea. The main findings of this research with regards to the preliminary IP assessment for the ICP device were that the freedom to operate (FTO) risk with proceeding ahead with the idea is minimal. With regards to the preliminary reimbursement assessment for the ICP device, the results showed that since the idea falls under the category of new devices, proceeding with this idea would involve applying for new codes, coverage and payment considerations. Overall, while the IP landscape for the ICP device idea is not laden with considerable risk, the reimbursement landscape for the ICP device idea presents some challenges. Therefore, the thesis concludes that careful reimbursement planning with regards to the reimbursement strategy for the ICP device concept will be required if Telemetry Research proceeds ahead with development of the idea.