University of Twente Student Theses


Designing a Regulatory Implementation Strategy for Developing Affordable Medical Devices for Low-Resource Settings

Ordonez Gonzalez, Yeiny Karina (2023) Designing a Regulatory Implementation Strategy for Developing Affordable Medical Devices for Low-Resource Settings.

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Embargo date:31 January 2028
Abstract:The medical device industry has experienced significant growth in recent decades, driven by advances in technology and an increase in the need for healthcare. However, regulatory compliance can be a significant challenge for small groups in academia with limited resources and expertise, which can limit innovation and access to new technologies. To overcome these challenges, a well-designed regulatory implementation strategy is essential to ensure the safety and efficacy of medical devices while accelerating their market entry. This project aimed to design a regulatory implementation strategy for developing medical devices for low-resource settings. To this end, the breathe project was analysed and used as a starting point to design and test the regulatory implementation strategy. The master’s project began by conducting a systematic review of relevant regulatory frameworks, approaches to regulatory implementation, and regulatory pathways relevant to medical device development in low-resource settings. Based on this review, a preliminary regulatory implementation strategy was developed. In this project, a regulatory implementation strategy was proposed, which includes a concise overview of relevant regulatory systems, essential guidance documents, task organisation and prioritisation, time estimates, and identification of the need for additional certified professionals. The strategy was tested by representative users and resulted in positive feedback, with four of the five design requirements being verified. The results of this project facilitate achieving regulatory compliance, which ensures patient access to safe and effective medical devices. This project aims to accelerate the development and market entry of medical devices that can improve healthcare outcomes for under-resourced populations. The report concludes by highlighting the need for ongoing collaborative efforts between countries, regulatory agencies, healthcare providers, and medical device manufacturers to address the regulatory challenges small groups face in developing affordable medical devices for all settings.
Item Type:Essay (Master)
ETH Zürich, Zürich, Switzerland
Faculty:TNW: Science and Technology
Subject:02 science and culture in general, 44 medicine, 50 technical science in general
Programme:Biomedical Engineering MSc (66226)
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