Health technology assessment of medical devices during development

摘要

This thesis was written under the assumption that the implementation and adoption of new medical devices can be supported by an early assessment of economic and clinical perspectives. The early stages of the medical device development are found crucial, as early in the lifecycle the device development process can either emerge or conclude without major financial drawbacks for the company. An assessment of medical devices starting at the early stages could result in a decrease of the failure rate at each stage of further medical device development, and thus in an increased Research and Development (R&D) efficiency. This, on the other hand, could lead to more successful reimbursement of new medical innovations and better prioritization of devices that are most likely to succeed.However, as the iterative use of medical device assessment alongside their development is relatively new and unknown, many questions remain. To answer some of those questions, this thesis particularly addressed the:1.clinical need and methods to engage various stakeholders within the medical device development,2.the evaluation of the commercial viability of medical devices early in the lifecycle to prioritize development of the most “beneficial” technologies using potential added value to society and, hence, economic returns,3.the adaptation of a decision support tool for the manufacturers to be used alongside the medical device development process.