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, a...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-01-01
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| Series: | Frontiers in Medical Technology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmedt.2022.1054120/full |
| _version_ | 1828056430806040576 |
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| author | Charles Norman Mpaata Brian Matovu Mercy Takuwa Noah Kiwanuka Steff Lewis John Norrie Sam Ononge Sharon Tuck Maria Wolters Marc Demulliez Robert T. Ssekitoleko |
| author_facet | Charles Norman Mpaata Brian Matovu Mercy Takuwa Noah Kiwanuka Steff Lewis John Norrie Sam Ononge Sharon Tuck Maria Wolters Marc Demulliez Robert T. Ssekitoleko |
| author_sort | Charles Norman Mpaata |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T20:55:12Z |
| format | Article |
| id | doaj.art-11e3a99b9a8549468896dff61d39566c |
| institution | Directory Open Access Journal |
| issn | 2673-3129 |
| language | English |
| last_indexed | 2024-04-10T20:55:12Z |
| publishDate | 2023-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medical Technology |
| spelling | doaj.art-11e3a99b9a8549468896dff61d39566c2023-01-23T05:56:24ZengFrontiers Media S.A.Frontiers in Medical Technology2673-31292023-01-01410.3389/fmedt.2022.10541201054120Systems and processes for regulation of investigational medical devices in UgandaCharles Norman Mpaata0Brian Matovu1Mercy Takuwa2Noah Kiwanuka3Steff Lewis4John Norrie5Sam Ononge6Sharon Tuck7Maria Wolters8Marc Demulliez9Robert T. Ssekitoleko10Biomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences College of Health Sciences, Makerere University, Kampala, UgandaBiomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences College of Health Sciences, Makerere University, Kampala, UgandaBiomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences College of Health Sciences, Makerere University, Kampala, UgandaClinical Trials Unit, School of Public Health, College of Health Sciences, Makerere University, Kampala, UgandaUsher Institute, Edinburgh Medical School, University of Edinburgh, Edinburgh, United KingdomUsher Institute, Edinburgh Medical School, University of Edinburgh, Edinburgh, United KingdomDepartment of Obstetrics and Gynecology, School of Medicine, College of Health Sciences, Makerere University, Kampala, UgandaUsher Institute, Edinburgh Medical School, University of Edinburgh, Edinburgh, United KingdomInformatics Forum, School of Informatics, College of Science and Engineering, University of Edinburgh, Edinburgh, United KingdomSchool of Engineering & Physical Sciences, Heriot-Watt University, Edinburgh, United KingdomBiomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences College of Health Sciences, Makerere University, Kampala, UgandaBackgroundIn 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.https://www.frontiersin.org/articles/10.3389/fmedt.2022.1054120/fullmedical devicesmedical innovationmedical devices regulationsclinical evaluationmedical device standardsregulatory pathway |
| spellingShingle | Charles Norman Mpaata Brian Matovu Mercy Takuwa Noah Kiwanuka Steff Lewis John Norrie Sam Ononge Sharon Tuck Maria Wolters Marc Demulliez Robert T. Ssekitoleko Systems and processes for regulation of investigational medical devices in Uganda Frontiers in Medical Technology medical devices medical innovation medical devices regulations clinical evaluation medical device standards regulatory pathway |
| title | Systems and processes for regulation of investigational medical devices in Uganda |
| title_full | Systems and processes for regulation of investigational medical devices in Uganda |
| title_fullStr | Systems and processes for regulation of investigational medical devices in Uganda |
| title_full_unstemmed | Systems and processes for regulation of investigational medical devices in Uganda |
| title_short | Systems and processes for regulation of investigational medical devices in Uganda |
| title_sort | systems and processes for regulation of investigational medical devices in uganda |
| topic | medical devices medical innovation medical devices regulations clinical evaluation medical device standards regulatory pathway |
| url | https://www.frontiersin.org/articles/10.3389/fmedt.2022.1054120/full |
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