Experiences of medical device innovators as they navigate the regulatory system in Uganda

ObjectiveA medical device must undergo rigorous regulatory processes to verify its safety and effectiveness while in use. In low-and middle-income countries like Uganda however, medical device innovators and designers face challenges around bringing a device from ideation to being market-ready. This is mainly attributed to a lack of clear regulatory procedures among other factors. In this paper, we illustrate the current landscape of investigational medical devices regulation in Uganda.MethodsInformation about the different bodies involved in regulation of medical devices in Uganda was obtained online. Nine medical device teams whose devices have gone through the Ugandan regulatory system were interviewed to gain insights into their experiences with the regulatory system. Interviews focused on the challenges they faced, how they navigated them, and factors that supported their progress towards putting their devices on the market.ResultsWe identified different bodies that are part of the stepwise regulatory pathway of investigational medical devices in Uganda and roles played by each in the regulatory process. Experiences of the medical device teams collected showed that navigation through the regulatory system was different for each team and progress towards market readiness was fuelled by funding, simplicity of device, and mentorship.ConclusionMedical devices regulation exists in Uganda but is characterised by a landscape that is still in development which thereby affects the progress of investigational medical devices

Systems and processes for regulation of investigational medical devices in Uganda

BackgroundIn many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant barriers to innovation, clinical evaluation, and translation of medical devices.AimTo evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda.MethodsA mixed methods study design using the methods triangulation strategy was employed in this study. Data of equal weight were collected sequentially. First, a digital structured questionnaire was sent out to innovators to establish individual knowledge and experience with medical device innovation and regulation. Then, a single focus group discussion involving both medical device innovators and regulators to collect data about the current regulatory practices for medical devices in Uganda. Univariate and bivariate analysis was done for the quantitative data to summarize results in graphs and tables. Qualitative data was analyzed using thematic analysis. Ethical review and approval were obtained from the Makerere University School of Biomedical Sciences, Research and Ethics Committee, and the Uganda National Council for Science and Technology.ResultsA total of 47 innovators responded to the questionnaire. 14 respondents were excluded since they were not medical device innovators. Majority (76%) of individuals had been innovators for more than a year, held a bachelor's degree with a background in Engineering and applied sciences, and worked in an academic research institute. 22 of the 33 medical device innovators had stopped working on their innovations and had stalled at the proof-of-concept stage. Insufficient funding, inadequate technical expertise and confusing regulatory landscape were major challenges to innovation. The two themes that emerged from the discussion were “developing standards for medical devices regulation” and “implementation of regulations in practical processes”. Legal limitations, lengthy processes, and low demand were identified as challenges to developing medical device regulations.ConclusionsEfforts have been taken by government to create a pathway for medical device innovations to be translated to the market. More work needs to be done to coordinate efforts among stakeholders to build effective medical device regulations in Uganda

The lived experience of people with upper limb absence living in Uganda: a qualitative study

Background: The impact of upper limb absence on people’s lived experiences remains severely under-explored, particularly in African countries, with implications for policy and service design. Objectives: explore the lived experiences of people with upper limb absence (PWULA) living in Uganda. Method: informed by preliminary work, we designed a qualitative study employing semi-structured interviews to understand the experience of living with upper limb absence in Uganda. Seventeen adults with upper limb absence were individually interviewed and their interviews analysed utilizing thematic analysis. Results: seven themes illustrating the impact on the individual’s life after amputation were identified and categorized into (1) living and adapting to life, (2) productivity and participation and (3) living within the wider environment. This paper presents three main findings: 1) PWULA need psychological and occupational support services which are not available in Uganda, 2) PWULA want to work but face multiple barriers to employment and limited support, this is combined with complex parenting and caring responsibilities, 3) the local Ugandan culture and social structures affect in both positive and negative ways the everyday life of PWULA. Conclusion: This paper contributes the lived experiences of PWULA in Uganda which are lacking in the literature. PWULA face ableism and hardship underpinned by a lack of formal support structures and policies, which may in turn exacerbate the impact of upper limb absence on multiple facets of life