Medical Device Development from Ideation to Regulation and Technology Transfer in Low- and Middle-income Countries

Abstract

Necessity motivates innovators in low- to middle-income countries (LMICs) to develop medical devices that solve
unmet local health needs. At the start of each process, multidisciplinary teams incubate ideas. Design planning
and validation require funding, infrastructure, procurement, and testing. Ultimately, the regulatory and technology transfer processes usher the technology to market. These stages are standard procedures in developed nations; in an LMIC, these present a new set of hurdles to overcome. To assist innovators, this paper describes the hurdles from ideation to regulation and technology transfer and delineates mechanisms to address them.