Medical device development from ideation to regulation and technology transfer in low- and middle-income countries
doi.org/10.47895/amp.vi0.5134
- Author:
Roxanne P. De Leon
1
;
Lourdes Marie S. Tejero
2
,
3
Author Information
1. Electrical and Electronics Engineering Institute, University of the Philippines Diliman, Quezon City, Philippines
2. Technology Transfer and Business Development Office, University of the Philippines Manila
3. College of Nursing, University of the Philippines Manila
- Publication Type:Journal Article
- Keywords:
innovation;
ASEAN
- MeSH:
medical device;
health technology;
technology transfer
- From:
Acta Medica Philippina
2023;57(6):70-76
- CountryPhilippines
- Language:English
-
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.
- Full text:5134-Article Text-111922-2-10-20230814.pdf