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

Matovu, Brian; Takuwa, Mercy; Mpaata, Charles Norman; Denison, Fiona C.; Kiwanuka, Noah; Lewis, Steff; Norrie, John; Ononge, Sam; Muhimbise, Owen; Tuck, Sharon; Etuket, Maureen Dimitri; Ssekitoleko, Robert T.

doi:10.3389/fmedt.2022.952767

Cited by 5 publications

(2 citation statements)

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“…Moreover, few of these trials are locally initiated, and most are sponsored and led by foreign research organizations. The barriers to conducting clinical trials in Sub Saharan African (SSA) countries include complicated logistical systems, inadequate funding, slow regulatory and ethical approval procedures, and poor infrastructure among others ( 22 , 23 ). The existing inefficiencies in regulatory practices and policies, and lack of infrastructure and facilities lead to high costs for trials, increased participant burden, lengthy and poorly defined clinical trial timelines ( 24 ).…”

Section: Introductionmentioning

confidence: 99%

Systems and processes for regulation of investigational medical devices in Uganda

Mpaata

Matovu

Takuwa

et al. 2023

Front. Med. Technol.

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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.

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Section: Introductionmentioning

confidence: 99%

Systems and processes for regulation of investigational medical devices in Uganda

Mpaata

Matovu

Takuwa

et al. 2023

Front. Med. Technol.

Self Cite

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“…The scarcity of medical device clinical trials in Africa is indicative of the challenges in developing and regulating medical devices within the continent. This gap in clinical trials is a significant barrier to ascertaining the effectiveness and safety of medical devices in the African context (Matovu et al, 2022).…”

Section: Comparative Analysis Of Medical Device Regulations: Usa Vs A...mentioning

confidence: 99%

Nzubechukwu Chukwudum Ohalete

Oluwatoyin Ayo-Farai,

Chinyere Onwumere,

Chinedu Paschal Maduka

et al. 2024

World J. Adv. Res. Rev.

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This paper delves into the critical role of Navier-Stokes equations in biomedical engineering, with a specific focus on their application in the development of medical devices across the United States and Africa. The study aims to elucidate the integration of fluid dynamics principles in medical device innovation, assess the influence of cultural and economic factors on device design, and explore the regulatory landscape shaping this domain. Employing a methodical approach, the study analyzes Navier-Stokes applications in diverse geographical contexts, utilizing case studies to underscore the relevance and methodological rigor in biomedical engineering. The findings reveal that Navier-Stokes equations are pivotal in modeling biological fluid flows, essential for the design and analysis of cardiovascular and respiratory devices. The advancement of computational fluid dynamics (CFD) has significantly enhanced these applications, enabling more precise and patient-specific analyses. However, challenges in computational resources and simulating physiological conditions are identified as key limitations. The study highlights the profound impact of cultural and economic considerations on medical device design and functionality. It emphasizes the necessity of creating devices that are not only innovative and effective but also culturally appropriate and economically viable. Additionally, the evolving regulatory frameworks, particularly in the wake of global health crises, are examined for their impact on device safety and efficacy. In conclusion, the study recommends continued research and development to address the identified challenges and limitations, advocating for a multidisciplinary approach that integrates engineering, computational modeling, and medical expertise. It also calls for the consideration of cultural, economic, and regulatory factors in the design and development of medical devices, ensuring their global applicability and effectiveness in improving healthcare outcomes.

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Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study

Fufa,

Marew,

Ashenef

2023

Ther Innov Regul Sci

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

Cited by 5 publications

References 46 publications

Systems and processes for regulation of investigational medical devices in Uganda

Systems and processes for regulation of investigational medical devices in Uganda

Nzubechukwu Chukwudum Ohalete

Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study

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