Design, testing, and scale-up of medical devices for global health: negative pressure wound therapy and non-surgical male circumcision in Rwanda

Mody, Gita N.; Mutabazi, Vincent; Zurovcik, Danielle R.; Bitega, Jean Paul; Nsanzimana, Sabin; Harward, Sardis; Wagner, Claire; Nutt, Cameron T; Binagwaho, Agnès

doi:10.1186/s12992-015-0101-4

Cited by 8 publications

(6 citation statements)

References 32 publications

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“…It required significant time and resource to implement effectively, with activities spanning identification of stakeholders prior to starting the project through to regular interaction to maintain engagement throughout the project. However, this investment proved invaluable in achieving these ambitions and ensuring longer-term viability for the system, resonating with similar findings in the literature [40] , [41] . From the outset, it underpinned an ethos of embedding stakeholders within the team, such that it was a case of ‘designing with’, rather than ‘designing for’ this group.…”

Section: Discussionsupporting

confidence: 74%

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

Webb

Bridges²,

Aruparayil

et al. 2022

IEEE J. Transl. Eng. Health Med.

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Background: Over 5 billion people worldwide have no access to surgery worldwide, typically in low-resource settings, despite it being a primary life-saving treatment. Gas Insufflation-Less Laparoscopic Surgery (GILLS) can address this inequity, by improving current GILLS instrumentation to modern surgical standards. Objective: to develop and translate a new Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical use and thus provide a context-appropriate system to advance GILLS surgery. Methods: A collaborative multidisciplinary team from the UK and India was formed, embedding local clinical stakeholders and an industry partner in defining user and contextual needs. System development was based on a phased roadmap for ‘surgical device design in low resource settings’ and embedded participatory and frugal design principles in an iterative process supported by traditional medical device design methodologies. Each phase of development was evaluated by the stakeholder team through interactive workshops using cadaveric surgical simulations. A Commercialisation phase undertook Design to Manufacture and regulatory approval activities. Clinical validation was then conducted with rural surgeons performing GILLS procedures using the RAIS system. Semi-structured questionnaires and interviews were used to evaluate device performance. Results: A set of user needs and contextual requirements were defined and formalised. System development occurred across five iterations. Stakeholder participation was instrumental in converging on a design which met user requirements. A commercial RAIS system was then produced by an industry partner under Indian regulatory approval. This was successfully used in clinical validation to conduct 12 surgical procedures at two locations in rural India. Surgical feedback showed that the RAIS system provided a valuable and usable surgical instrument which was appropriate for use in low-resource contexts. Conclusions: Using a context-specific development approach with close engagement of stakeholders was crucial to develop the RAIS system for low-resource regions. The outcome is translation from global health need into a fully realized commercial instrument which can be used by surgeons in low-resource regions across India.

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Section: Discussionsupporting

confidence: 74%

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

Webb

Bridges²,

Aruparayil

et al. 2022

IEEE J. Transl. Eng. Health Med.

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“…There are several benefits to PrePex including the ability to shift the MC procedures to less-trained staff, which makes the procedure cost-effective and scalable[ 15 ], even in high resource settings[ 16 ].Further, the minimal invasiveness and risk make the procedure acceptable to beneficiaries[ 17 ]. However, there is little research describing the implementation of PrePex in a real world setting, outside of a research study environment.…”

Section: Introductionmentioning

confidence: 99%

PrePex Male Circumcision: Follow-Up and Outcomes during the First Two Years of Implementation at the Rwanda Military Hospital

et al. 2015

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BackgroundPrePex Male Circumcision (MC) has been demonstrated as an effective and scalable strategy to prevent HIV infection in low- and middle-income countries. This study describes the follow-up and outcomes of clients who underwent PrePex MC between January 2011 and December 2012 with weekly follow-up at the Rwanda Military Hospital, the first national hospital in Rwanda to adopt PrePex.MethodsData on570 clients age 21 to 54 were extracted from patient records. We compared socio-demographic and clinical characteristics, the operator's qualification, HIV status, pain before and after device removal, urological status, device size and follow-up time between clients who were formally discharged and those who defaulted. We reported bivariate associations between each covariate and discharge status, number of people with adverse events by discharge status, and time to formal discharge or defaulting using life table methods. Data were entered into Epidata and analyzed with Stata v13.ResultsAmong study participants, 96.5% were circumcised by non-physician operators, 85.4%were under 30years, 98.9% were HIV-negative and 97.9% were without any urological problems that could delay the healing time. Most (70.7%) defaulted before formal discharge. Pain before (p<0.001) and after PrePex device removal (p = 0.001) were associated with discharge status, although very few cases were reported, and pain was more commonly missing among defaulters. Twenty-seven adverse events were reported (7 formally discharged, 20 defaulters). Median follow-up time was seven weeks among formally discharged and six weeks among defaulters (p<0.001).ConclusionGiven that all socio-demographic and most clinical characteristics were not associated with defaulting, we hypothesize that clients stopped returning once they determined they were healed. We recommend less frequent follow-up protocols to encourage clinical visits until formal discharge. Based on these results and recommendations, we believe PrePex MC is a practical circumcision strategy in Rwanda and in sub-Saharan Africa.

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“…52 These systems can be improvised and made low-cost. 53 Thus, they are essential at the referral hospital level, though could readily be made essential at the first-level hospital if resources allowed.…”

Section: Resultsmentioning

confidence: 99%

Consensus recommendations for essential vascular care in low- and middle-income countries

Stewart¹,

Gyedu

Giannou

et al. 2016

Journal of Vascular Surgery

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Introduction Many low- and middle-income countries (LMICs) are ill equipped to care for the large and growing burden of vascular conditions. We aimed to develop essential vascular care recommendations that would be feasible for implementation at nearly every setting worldwide, regardless of national income. Methods The normative Delphi method was used to achieve consensus on essential vascular care resources among 27 experts in multiple areas of vascular care and public health, as well as with experience in LMIC healthcare. Five anonymous, iterative rounds of survey with controlled feedback and a statistical response were used to reach consensus on essential vascular care resources. Results The matrices provide recommendations for 92 vascular care resources at each of the four levels of care in most LMICs (i.e. primary health centers, and first-level, referral, and tertiary hospitals). The recommendations include both essential and desirable resources and encompass the following categories: screening, counseling, and evaluation; diagnostics; medical care; surgical care; equipment and supplies; and medications. Conclusion The resources recommended have the potential to improve LMIC healthcare systems’ ability to respond to the large and growing burden of vascular conditions. Many of these resources can be provided with thoughtful planning and organization without significant increases in cost. However, the resources must be incorporated into a framework that includes surveillance of vascular conditions, monitoring and evaluation of vascular capacity and care, a well functioning pre- and inter-hospital transport system, and vascular training for both existing and future healthcare providers.

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Design, testing, and scale-up of medical devices for global health: negative pressure wound therapy and non-surgical male circumcision in Rwanda

Cited by 8 publications

References 32 publications

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use

PrePex Male Circumcision: Follow-Up and Outcomes during the First Two Years of Implementation at the Rwanda Military Hospital

Consensus recommendations for essential vascular care in low- and middle-income countries

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