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 t...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-07-01
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| Series: | Frontiers in Medical Technology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmedt.2022.952767/full |
| _version_ | 1828396593194205184 |
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| author | Brian Matovu Mercy Takuwa Charles Norman Mpaata Fiona Denison Noah Kiwanuka Steff Lewis John Norrie Sam Ononge Owen Muhimbise Sharon Tuck Maureen Dimitri Etuket Robert T. Ssekitoleko |
| author_facet | Brian Matovu Mercy Takuwa Charles Norman Mpaata Fiona Denison Noah Kiwanuka Steff Lewis John Norrie Sam Ononge Owen Muhimbise Sharon Tuck Maureen Dimitri Etuket Robert T. Ssekitoleko |
| author_sort | Brian Matovu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T08:32:46Z |
| format | Article |
| id | doaj.art-b3d32d19a7d34804a4e92e3229d7a449 |
| institution | Directory Open Access Journal |
| issn | 2673-3129 |
| language | English |
| last_indexed | 2024-12-10T08:32:46Z |
| publishDate | 2022-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medical Technology |
| spelling | doaj.art-b3d32d19a7d34804a4e92e3229d7a4492022-12-22T01:56:03ZengFrontiers Media S.A.Frontiers in Medical Technology2673-31292022-07-01410.3389/fmedt.2022.952767952767Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovationsBrian Matovu0Mercy Takuwa1Charles Norman Mpaata2Fiona Denison3Noah Kiwanuka4Steff Lewis5John Norrie6Sam Ononge7Owen Muhimbise8Sharon Tuck9Maureen Dimitri Etuket10Robert T. Ssekitoleko11Biomedical 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, UgandaDepartment of Epidemiology and Biostatistics, The Queen's Medical Research Institute, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, United KingdomEdinburgh Medical School, Clinical 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 Gynaecology, School of Medicine, College of Health Sciences, Makerere University, Kampala, UgandaBiomedical Engineering Unit, Department of Physiology, School of Biomedical Sciences College of Health Sciences, Makerere University, Kampala, UgandaUsher Institute, Edinburgh Medical School, University of Edinburgh, Edinburgh, United KingdomBiomedical 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, UgandaMedical 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.https://www.frontiersin.org/articles/10.3389/fmedt.2022.952767/fullmedical devicesclinical trialsmedical innovationsmedical device regulationsinvestigational medical deviceshealth technical assessment |
| spellingShingle | Brian Matovu Mercy Takuwa Charles Norman Mpaata Fiona Denison Noah Kiwanuka Steff Lewis John Norrie Sam Ononge Owen Muhimbise Sharon Tuck Maureen Dimitri Etuket Robert T. Ssekitoleko Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations Frontiers in Medical Technology medical devices clinical trials medical innovations medical device regulations investigational medical devices health technical assessment |
| title | Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations |
| title_full | Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations |
| title_fullStr | Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations |
| title_full_unstemmed | Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations |
| title_short | Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations |
| title_sort | review of investigational medical devices clinical trials and regulations in africa as a benchmark for new innovations |
| topic | medical devices clinical trials medical innovations medical device regulations investigational medical devices health technical assessment |
| url | https://www.frontiersin.org/articles/10.3389/fmedt.2022.952767/full |
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