The medical device development landscape in South Africa: Institutions, sectors and collaboration

A characterisation of the medical device development landscape in South Africa would be beneficial for future policy developments that encourage locally developed devices to address local healthcare needs. The landscape was explored through a bibliometric analysis (2000–2013) of relevant scientific papers using co-authorship as an indicator of collaboration. Collaborating institutions thus found were divided into four sectors: academia (A); healthcare (H); industry (I); and science and support (S). A collaboration network was drawn to show the links between the institutions and analysed using network analysis metrics. Centrality measures identified seven dominant local institutions from three sectors. Group densities were used to quantify the extent of collaboration: the A sector collaborated the most extensively both within and between sectors; local collaborations were more prevalent than international collaborations. Translational collaborations (AHI, HIS or AHIS) are considered to be pivotal in fostering medical device innovation that is both relevant and likely to be commercialised. Few such collaborations were found, suggesting room for increased collaboration of these types in South Africa

Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

Background: Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. Methods: We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to <18 years) with HIV-associated TB who were receiving rifampicin and twice-daily dolutegravir were eligible for inclusion. We did a 12-h pharmacokinetic profile on rifampicin and twice-daily dolutegravir and a 24-h profile on once-daily dolutegravir. Geometric mean ratios for trough plasma concentration (Ctrough), area under the plasma concentration time curve from 0 h to 24 h after dosing (AUC0–24 h), and maximum plasma concentration (Cmax) were used to compare dolutegravir concentrations between substudy days. We assessed rifampicin Cmax on the first substudy day. All children within ODYSSEY with HIV-associated TB who received rifampicin and twice-daily dolutegravir were included in the safety analysis. We described adverse events reported from starting twice-daily dolutegravir to 30 days after returning to once-daily dolutegravir. This trial is registered with ClinicalTrials.gov (NCT02259127), EudraCT (2014–002632-14), and the ISRCTN registry (ISRCTN91737921). Findings: Between Sept 20, 2016, and June 28, 2021, 37 children with HIV-associated TB (median age 11·9 years [range 0·4–17·6], 19 [51%] were female and 18 [49%] were male, 36 [97%] in Africa and one [3%] in Thailand) received rifampicin with twice-daily dolutegravir and were included in the safety analysis. 20 (54%) of 37 children enrolled in the pharmacokinetic substudy, 14 of whom contributed at least one evaluable pharmacokinetic curve for dolutegravir, including 12 who had within-participant comparisons. Geometric mean ratios for rifampicin and twice-daily dolutegravir versus once-daily dolutegravir were 1·51 (90% CI 1·08–2·11) for Ctrough, 1·23 (0·99–1·53) for AUC0–24 h, and 0·94 (0·76–1·16) for Cmax. Individual dolutegravir Ctrough concentrations were higher than the 90% effective concentration (ie, 0·32 mg/L) in all children receiving rifampicin and twice-daily dolutegravir. Of 18 children with evaluable rifampicin concentrations, 15 (83%) had a Cmax of less than the optimal target concentration of 8 mg/L. Rifampicin geometric mean Cmax was 5·1 mg/L (coefficient of variation 71%). During a median follow-up of 31 weeks (IQR 30–40), 15 grade 3 or higher adverse events occurred among 11 (30%) of 37 children, ten serious adverse events occurred among eight (22%) children, including two deaths (one tuberculosis-related death, one death due to traumatic injury); no adverse events, including deaths, were considered related to dolutegravir. Interpretation: Twice-daily dolutegravir was shown to be safe and sufficient to overcome the rifampicin enzyme-inducing effect in children, and could provide a practical ART option for children with HIV-associated TB

Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

BACKGROUND: Cohort studies in adults with HIV showed that dolutegravir was associated with neuropsychiatric adverse events and sleep problems, yet data are scarce in children and adolescents. We aimed to evaluate neuropsychiatric manifestations in children and adolescents treated with dolutegravir-based treatment versus alternative antiretroviral therapy. METHODS: This is a secondary analysis of ODYSSEY, an open-label, multicentre, randomised, non-inferiority trial, in which adolescents and children initiating first-line or second-line antiretroviral therapy were randomly assigned 1:1 to dolutegravir-based treatment or standard-of-care treatment. We assessed neuropsychiatric adverse events (reported by clinicians) and responses to the mood and sleep questionnaires (reported by the participant or their carer) in both groups. We compared the proportions of patients with neuropsychiatric adverse events (neurological, psychiatric, and total), time to first neuropsychiatric adverse event, and participant-reported responses to questionnaires capturing issues with mood, suicidal thoughts, and sleep problems. FINDINGS: Between Sept 20, 2016, and June 22, 2018, 707 participants were enrolled, of whom 345 (49%) were female and 362 (51%) were male, and 623 (88%) were Black-African. Of 707 participants, 350 (50%) were randomly assigned to dolutegravir-based antiretroviral therapy and 357 (50%) to non-dolutegravir-based standard-of-care. 311 (44%) of 707 participants started first-line antiretroviral therapy (ODYSSEY-A; 145 [92%] of 157 participants had efavirenz-based therapy in the standard-of-care group), and 396 (56%) of 707 started second-line therapy (ODYSSEY-B; 195 [98%] of 200 had protease inhibitor-based therapy in the standard-of-care group). During follow-up (median 142 weeks, IQR 124–159), 23 participants had 31 neuropsychiatric adverse events (15 in the dolutegravir group and eight in the standard-of-care group; difference in proportion of participants with ≥1 event p=0·13). 11 participants had one or more neurological events (six and five; p=0·74) and 14 participants had one or more psychiatric events (ten and four; p=0·097). Among 14 participants with psychiatric events, eight participants in the dolutegravir group and four in standard-of-care group had suicidal ideation or behaviour. More participants in the dolutegravir group than the standard-of-care group reported symptoms of self-harm (eight vs one; p=0·025), life not worth living (17 vs five; p=0·0091), or suicidal thoughts (13 vs none; p=0·0006) at one or more follow-up visits. Most reports were transient. There were no differences by treatment group in low mood or feeling sad, problems concentrating, feeling worried or feeling angry or aggressive, sleep problems, or sleep quality. INTERPRETATION: The numbers of neuropsychiatric adverse events and reported neuropsychiatric symptoms were low. However, numerically more participants had psychiatric events and reported suicidality ideation in the dolutegravir group than the standard-of-care group. These differences should be interpreted with caution in an open-label trial. Clinicians and policy makers should consider including suicidality screening of children or adolescents receiving dolutegravir

Investigating promises of nanotechnology for development: A case study of the travelling of smart nano water filter in Zimbabwe.

Using the case of a smart nano water filter that was developed to treat water in Zimbabwe, this article investigates how the filter developed and travelled within a development context and how this relates to promises of nanotechnology for development. The case study is set in a low-resource environment to demonstrate empirically that how and whether or not nanotechnology products are solutions to problems in developing contexts is not a feature of the technology itself, but depends on the social and cultural contexts in which the developers and users live and work. The paper draws on the Social Construction of Technology approach as developed by Pinch and Bijker [1] to show that the processes of technological development involve considerable openness and social contestation over the design, character and meaning of the technology. The case highlights that the filter, in its local contexts of use, constitutes, for different people a solution to the problem of lack of access to clean water or a source of conflict. As the filter's design and context of use changed in unexpected ways even within a national context, we assert that that the situation is even more complicated when technologies travel internationally, such as from the global North to the global South. Although nanotechnology is often capital intensive, this case illustrates that potentially promising nanotechnology products can be developed within a national context in a developing country in a low-cost manner with help of local knowledge and in the absence or outside of large regulatory schemes. We argue that portraying nanotechnology as a solution for development issues without considering the context of use may be helpful for the development of nanotechnology, but does not guarantee the use of nanotechnology for development issues

Nanotechnology in South Africa – Challenges in evaluating the impact on development

International audienc

Critical elements in the design, development and use of medical devices. A systemic perspective of orthopedic devices landscape in low- and middle-income countries

Objectives The paper reviews the critical elements in the design and development of medical devices in general and orthopedic devices in particular as well as illustrates by means of examples the initiatives that have been put in place to incorporate contextual factors in low resource settings. Methods Data was collected by means of a targeted literature review from different databases using key terms. The search was done using combinations of key terms namely ‘medical devices’, ‘low- and middle-income countries’, ‘high income countries, drivers of innovation’, ‘technology transfer’ and ‘local production’. Results The study yielded five critical elements which are indispensable in the development of medical devices. It emerged that the context of use, by virtue of encompassing the stakeholders, geographical space and medical devices provides a vantage point for addressing the complexities in the development of medical devices in low resource countries. The paper argues that approaching the critical elements from a contextual standpoint provides a systematic perspective for developing medical devices that are customised to the prevailing environments in low- to middle- income countries. Conclusion With the growing markets for medical devices, the review highlights the importance of forging strategic alliances between high income and low- to middle- income countries in developing appropriate medical devices for the users. The paper contributes to the policy discourse targeting both local and foreign manufacturers of medical devices as well as stakeholders from the public sector, industry and not for profit organisations on the importance of contextual awareness in the development of technologies

Towards understanding the drivers of policy change: a case study of infection control policies for multi-drug resistant tuberculosis in South Africa

BACKGROUND: Explaining policy change is one of the central tasks of contemporary policy analysis. In this article, we examine the changes in infection control policies for multi-drug resistant tuberculosis (MDR-TB) in South Africa from the time the country made the transition to democracy in 1994, until 2015. We focus on MDR-TB infection control and refer to decentralised management as a form of infection control. Using Kingdon's theoretical framework of policy streams, we explore the temporal ordering of policy framework changes. We also consider the role of research in motivating policy changes. METHODS: Policy documents addressing MDR-TB in South Africa over the period 1994 to 2014 were extracted. Literature on MDR-TB infection control in South Africa was extracted from PubMed using key search terms. The documents were analysed to identify the changes that occurred and the factors driving them. RESULTS: During the period under study, five different policy frameworks were implemented. The policies were meant to address the overwhelming challenge of MDR-TB in South Africa, contextualised by high prevalence of HIV infection, that threatened to undermine public health programmes and the success of antiretroviral therapy rollouts. Policy changes in MDR-TB infection control were supported by research evidence and driven by the high incidence and complexity of the disease, increasing levels of dissatisfaction among patients, challenges of physical, human and financial resources in public hospitals, and the ideologies of the political leadership. Activists and people living with HIV played an important role in highlighting the importance of MDR-TB as well as exerting pressure on policymakers, while the mass media drew public attention to infection control as both a cause of and a solution to MDR-TB. CONCLUSION: The critical factors for policy change for infection control of MDR-TB in South Africa were rooted in the socioeconomic and political environment, were supported by extensive research, and can be framed using Kingdon's policy streams approach as an interplay of the problem of the disease, political forces that prevailed and alternative proposals

Crossing boundaries in the delivery of healthcare – a qualitative study of an eHealth intervention in relation to boundary object theory

With the increasing trend of digitalisation in the health sector, eHealth is being deployed to facilitate interaction between health professionals and service users without physical contact or close proximity. It became prominent during the COVID-19 era when mobility for physical meetings was restricted. Focusing on a video-supported digital toolkit, REACT-NOR, this study explored the experiences of caregivers and supporters in relation to the notion of boundary object. In-depth semi-structured interviews were conducted with 10 supporters and 11 caregivers to gather first-hand experience on the use of the digital tool. It emerged from the study that the use of REACT-NOR made a huge difference for the involved parties by bridging the knowledge gap between supporters and caregivers. The use of the video in particular was useful in engaging and emotionally connecting the supporters and caregivers, resulting in an exciting digital experience. The effectiveness of the digital tool can be explained in the context of a boundary object in that it facilitated the processes of transferring, translating and transforming knowledge. The tool exhibited the attributes of dynamism, flexibility, standardisation and shared structure, which resonates with the notion of a boundary object. An understanding of how boundary objects work is crucial especially with remote care, as depicted in this study, due to the fact that the transfer of knowledge involves multiple processes such as sharing of new and existing knowledge, translation to make it accessible to others and transformation to render it usable across different boundaries.</p

Crossing boundaries in the delivery of healthcare – a qualitative study of an eHealth intervention in relation to boundary object theory

With the increasing trend of digitalisation in the health sector, eHealth is being deployed to facilitate interaction between health professionals and service users without physical contact or close proximity. It became prominent during the COVID-19 era when mobility for physical meetings was restricted. Focusing on a video-supported digital toolkit, REACT-NOR, this study explored the experiences of caregivers and supporters in relation to the notion of boundary object. In-depth semi-structured interviews were conducted with 10 supporters and 11 caregivers to gather first-hand experience on the use of the digital tool. It emerged from the study that the use of REACT-NOR made a huge difference for the involved parties by bridging the knowledge gap between supporters and caregivers. The use of the video in particular was useful in engaging and emotionally connecting the supporters and caregivers, resulting in an exciting digital experience. The effectiveness of the digital tool can be explained in the context of a boundary object in that it facilitated the processes of transferring, translating and transforming knowledge. The tool exhibited the attributes of dynamism, flexibility, standardisation and shared structure, which resonates with the notion of a boundary object. An understanding of how boundary objects work is crucial especially with remote care, as depicted in this study, due to the fact that the transfer of knowledge involves multiple processes such as sharing of new and existing knowledge, translation to make it accessible to others and transformation to render it usable across different boundaries