Translating medical device innovations to market - a Ugandan perspective.

There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting health care service delivery. Whereas medical technologies developed in HICs face substantial challenges in getting to the bedside, there are at least clear pathways in most of the major markets, such as the UK, the EU, and the USA. Much less is known about the challenges that innovators of medical technologies face in LMICs. The aim of this study was to map out current bottlenecks in medical device innovation in Uganda, a LMIC in Sub-Saharan East Africa.A cross-sectional survey was carried out using a digital questionnaire. Twenty-one individuals completed the questionnaire, with the majority being medical device innovators (n = 12). Only one of these had undertaken all the innovation stages, up to clinical validation. Very few innovators had established companies, and/or acquired intellectual property. It is evident from similar studies that challenges in medical device translations are multidimensional, and hence interdisciplinary collaborations are key to accelerating translation processes, especially for LMICs.

Achieving optimal heath data impact in rural African healthcare settings: measures to barriers in Bukomansimbi District, Central Uganda.

BACKGROUND: Health data is one of the most valuable assets in health service delivery yet one of the most underutilized in especially low-income countries. Health data is postulated to improve health service delivery through availing avenues for optimal patient management, facility management, and public health surveillance and management. Advancements in information technology (IT) will further increase the value of data, but will also call for capacity readiness especially in rural health facilities. We aimed to understand the current knowledge, attitudes and practices of health workers towards health data management and utilization. METHODS: We conducted key informant interviews (KII) for health workers and data staff, and focus group discussions (FGD) for the village health teams (VHTs). We used both purposive and convenience sampling to recruit key informants, and convenience sampling to recruit village health teams. Interviews and discussions were audiotaped and transcribed verbatim. We manually generated the codes and we used thematic analysis to identify the themes. We also developed a reflexivity journal. RESULTS: We conducted a total of 6 key informant interviews and 3 focus group discussions of 29 participants. Our analysis identified 7 themes: One theme underscored the health workers' enthusiasm towards an optimal health data management setting. The rest of the six themes resonated around working remedies to the systemic challenges that grapple health data management and utilization at facilities in rural areas. These include: Building human resource capacity; Equipping the facilities; Improved coordination with partners; Improved data quality assurance; Promotion of a pull supply system and Reducing information relay time. CONCLUSION: Our findings reveal a plethora of systematic challenges that have persistently undercut optimal routine health data management and utilization in rural areas and suggest possible working remedies. Health care workers express enthusiasm towards an optimal health management system but this isn't matched by their technical capacity, facility readiness, systems and policy willingness. There is an urgent need to build rural lower facilities' capacity in health data management and utilization which will also lay a foundation for exploitation of information technology in health.

Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.

Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.

Systems and processes for regulation of investigational medical devices in Uganda.

Background: In 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. Aim: To evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda. Methods: A 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. Results: A 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. Conclusions: Efforts 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.