Avoid equipment graveyards: rigorous process to improve identification and procurement of effective, affordable, and usable newborn devices in low-resource hospital settings
BMC Pediatrics volume 23, Article number: 569 (2023)
Millions of newborns die annually from preventable causes, with the highest rates occurring in Africa. Reducing neonatal mortality requires investment to scale hospital care, which includes providing hospitals with appropriate technology to care for small and sick newborns. Expensive medical devices designed for high-resource settings often fail to withstand conditions in low-resource hospitals, including humidity, dust, frequent user turnover, complex maintenance, lack of stable power, or difficulty sourcing expensive consumables. Rigorous evaluation protocols are needed to identify effective, affordable, rugged, and easy-to-use medical devices appropriate for quality hospital-based newborn care in low-resource hospitals.
We developed an evidence-based technology review process to identify medical devices suitable for small and sick newborn care in low-resource hospitals. The eight-step process consists of: identifying devices needed for effective newborn care; defining Target Product Profiles (TPPs); identifying commercially-available products that may meet TPPs; conducting desk research to evaluate technologies against TPPs; performing technical performance verification testing under laboratory conditions; verifying technical performance after exposure to heat, humidity, dust, and power loss; performing usability evaluations with nurses, and qualifying devices that pass all steps. Devices were purchased, installed, and monitored in newborn wards across Kenya, Malawi, Nigeria, and Tanzania.
Of 271 devices considered, only 45 (16.6%) met corresponding TPPs based on desk research. Thirty-nine were purchased and evaluated in the laboratory; five (12.8%) failed to meet TPPs. Thirty-four products passing laboratory evaluation underwent short-term environmental testing; only one (2.9%) device failed. Thirty-seven products underwent usability testing with 127 clinicians; surprisingly, 14 (37.8%) failed to meet TPPs. Twenty-three products passed all evaluations, and 2457 devices were installed across 65 newborn wards in Kenya, Malawi, Nigeria, and Tanzania. Continuous device monitoring reported minimal device failures, with failed devices typically returned to service within two days, resulting in an average uptime (service days divided by days installed) of 99%.
An evidence-based device selection process can improve procurement of effective, affordable, rugged, usable newborn care devices for low-resource hospitals, and feedback to manufacturers can improve device quality. Similar processes could be adapted beyond newborn care to identify medical devices suitable for implementation in any low-resource setting.
1. WHAT WAS KNOWN?
• Reducing neonatal mortality requires medical technology; devices designed for high-resource settings frequently fail in low-resource hospital environments. The aim of this study was to develop rigorous evaluation protocols to identify effective, affordable, rugged, and easy-to-use medical devices appropriate for low-resource settings
2. WHAT WAS DONE THAT IS NEW?
• Hundreds of medical devices underwent our evidence-based technology review process, including technical testing, short-term environmental testing, and comparative usability assessments with nurses. Devices were purchased, installed, and monitored in newborn wards across Kenya, Malawi, Nigeria, and Tanzania
3. WHAT WAS FOUND?
• Of 271 devices considered, only 45 (17%) met corresponding TPPs based on desk research. Fourteen of 37 devices (38%) failed usability evaluations conducted by 127 clinicians. Twenty-three devices passed all evaluations, and 2457 devices were installed across 65 newborn wards in four sub-Saharan African countries. Ongoing device monitoring reported failed devices typically returned to service within two days
4. WHAT DOES THIS MEAN?
• Research and development of newborn devices continues to be urgently needed to meet TPPs. Ensuring medical devices are easy to use is a key area where device developers can make improvements. Engaging global agencies is critical to guarantee appropriate technologies are on national procurement lists. Similar processes could be adapted beyond newborn care to identify medical devices suitable for implementation in any low-resource setting
Every year worldwide, over 2.3 million newborns die, and 30 million small and sick newborns require hospital care . Indeed, neonatal conditions are a leading cause of death in low-income countries . The highest rates of newborn death are in Africa , where the rate of progress to improve newborn survival is slowest. More than one million African newborns die annually, the majority from preventable causes . In the face of this challenge, the world has pledged, for the first time, to end preventable newborn deaths. Sustainable Development Goal (SDG) 3.2 aims for all countries to reduce neonatal mortality rates below 12 per 1000 livebirths by 2030 . However, only one country in sub-Saharan Africa is on track to achieve the SDG for newborn survival. At current rates of progress, sub-Saharan Africa will be the last global region to achieve this goal. Some African countries will meet SDG 3.2 more than 100 years too late .
Historically, reducing neonatal mortality below the SDG target requires investment to scale hospital care during labour, delivery, and the first week of life, especially for small and sick babies [5,6,7,8]. In the 1970s, the US and UK scaled national programs of hospital-based small and sick newborn care (SSNC) [9, 10]; neonatal mortality rates dropped below 15/1000 for the first time . To help achieve SDG 3.2 for newborns, the Every Newborn Action Plan (ENAP) lays out coverage targets for achieving high-quality antenatal care, essential childbirth care, postnatal care, and in-patient care for small and sick newborns, with equity in all countries . ENAP coverage target 4 specifically calls for 80% of districts to have at least one unit equipped to provide WHO level-2 in-patient SSNC, including provision of respiratory support with continuous positive airway pressure (CPAP) .
Unfortunately, most African hospitals do not have the resources to provide level-2 care plus CPAP for small and sick newborns . Many units lack functional equipment needed to provide level-2 care, including medical devices that monitor, prevent, and treat respiratory distress, infection, hypothermia, neonatal jaundice, and other neonatal conditions. Additionally, many commercially available medical devices to support level-2 neonatal care were designed for use in high-resource settings; they are too costly for low-resource settings and are not designed to withstand the harsh environmental conditions in low-resource hospitals, such as dust, humidity, heat, and electrical power fluctuations [14, 15]. Equipping hospitals in low-resource settings with devices designed for high-resource settings often results in equipment graveyards (Fig. 1), stockpiles of expensive technologies that quickly fail due to harsh environmental conditions, frequent user turnover, complex maintenance requirements, or lack of stable infrastructure, such as line voltage fluctuations [16,17,18]. Moreover, it can be difficult to source expensive consumables or spare parts needed to sustain the use of such devices.
To meet and sustain ENAP coverage target 4 , there is an important need to equip hospitals in low-resource settings with newborn technologies that are effective, affordable, rugged, and easy to use by nurses and maintain by engineers. Target Product Profiles (TPPs) have recently been established to define the setting, target user, and range of performance characteristics for 15 types of newborn care devices for use in low- and middle-income country settings . However, procurement officers in low-resource settings need publicly available information about which commercially available devices meet these TPPs. Similarly, product developers need information about remaining market gaps as well as areas where new devices are needed to meet the TPPs [20,21,22,23,24].
This paper aims to describe the development and implementation of a process to evaluate and qualify whether commercially available medical technologies for SSNC settings meet TPPs for low-resource hospitals. This information can help procurement officers ensure they obtain newborn care equipment that is effective, affordable, usable, and will last. It can help device manufacturers understand points of failure and how devices designed for use in high-resource settings can be adapted and improved to serve broader global needs. Without efforts to identify, source, and sustain qualified technologies for SSNC in hospitals, one million African newborns will continue to die from preventable causes each year.
Described here is an evidence-based technology review process designed to identify and qualify medical devices suitable for use in low-resource hospitals. A step-by-step overview of the device qualification process is shown in Fig. 2.
Briefly, the eight-step process consists of: (1) Identifying types of medical devices needed for care in a particular setting; (2) Defining TPPs for each device product category; (3) Identifying commercially available products that may meet the TPPs; (4) Conducting desk research to evaluate candidate technologies against the TPPs; (5) Performing laboratory testing to verify technical performance under laboratory conditions; (6) Performing testing to verify technical performance after exposure to harsh environmental conditions; (7) Performing usability evaluations with target users, and (8) Qualifying devices that pass all evaluation process steps. A standardised report card summarises the evaluation results for candidate technologies within each product category.
Below, we describe the process used to evaluate and qualify medical technologies for level-2 SSNC, including respiratory support with CPAP in low-resource hospitals.
Step 1: Identify medical devices needed for level-2 newborn care plus CPAP
WHO guidelines for improving the quality of care for small and sick newborns in health facilities [25, 26] and national guidelines for care of small and sick newborns in Kenya, Malawi, Nigeria , and Tanzania were reviewed to identify the types of medical devices commonly recommended to provide hospital-based level-2 care for small and sick newborns including respiratory support with CPAP. The types of devices identified include 14 product categories for level-2 newborn care plus respiratory support: syringe pump, bilirubinometer, phototherapy, glucometer, haemoglobinometer, CPAP, flow splitter, oxygen concentrator, continuous pulse oximeter, suction pump, radiant warmer, continuous temperature monitor, conductive warmer, and respiratory rate/apnoea monitor.
Step 2: Define Target Product Profiles (TPPs)
Global stakeholders were consulted to develop a TPP that defines optimal and minimal performance characteristics for each type of medical device for small and sick newborn care . The TPP development process is documented in a separate publication . The characteristics include target operator, target population, target setting, regulatory approval, relevant technical characteristics (e.g., for diagnostic devices: accuracy, range, precision, response time, type, and required volume of sample), consumable storage requirements, frequency of calibration, therapeutic dose delivered for therapeutic devices (including range and accuracy), size, mobility, inclusion of warning alarms, requirements for proprietary or non-proprietary accessories or consumables, cost (including ex-works equipment and consumable costs), power requirements (including line voltage requirements, inclusion of battery backup, battery life), maintenance requirements, and availability of user instructions/training.
Step 3: Identify candidate technologies
A comprehensive search was conducted to identify commercially available medical devices within each product category. Candidate technologies were identified by consulting international device resources, including a publicly available landscape of newborn care devices updated every six months , recommendations from newborn care experts, consultations with leading manufacturers and distributors of newborn care devices, and WHO Compendia of Innovative Technologies for Low-Resource Settings .
Step 4: Evaluate candidate technologies against TPP
Desk research was performed for each candidate technology to compare its operational and performance characteristics as described in manufacturer package inserts and publicly available materials to the minimal and optimal values outlined in the TPPs.
A product report card was developed to summarise and compare evaluation results of candidate technologies within each product category. Each row of the report card corresponds to a TPP characteristic, and each column of the report card corresponds to a candidate technology. As shown in Fig. 3, cells in the report card were coloured green if the candidate technology met the optimal TPP specification, yellow if the technology met the minimal TPP specification, and red if it did not meet either. The most promising candidate technologies were identified based on the product report card. Two units of each promising candidate technology were purchased for further testing and evaluation.
Step 5: Technical testing
Technical testing protocols were developed for each product category to measure whether a candidate technology met the minimal or optimal TPP characteristics. Table 1 summarises the major components of each test protocol for every product category, and full testing protocols are available (see Additional file 1).
Three testers independently evaluated the technical performance of two units of each candidate technology. Technical results from each evaluation were recorded by device serial number. Testing was performed under ambient environmental conditions in a research laboratory. Results were compared to TPP specifications; to pass, each device had to meet or exceed the minimal TPP performance characteristic when evaluated by each tester. Results of laboratory testing were documented in product report cards.
Step 6: Environmental testing
The suitability of candidate devices for the operating environments of low-resource hospital settings was established by evaluating technical performance following exposure to harsh environmental conditions during testing. Environmental exposure protocols were developed to mimic sustained exposure of devices to conditions of high heat, humidity, dust, and line voltage fluctuations; Table 2 summarises exposure protocols. Detailed environmental testing protocols and technical performance metrics by product category are available (see Additional file 2).
Technologies were powered on throughout the duration of exposure to harsh environmental conditions, but power was cycled between environmental exposures. One tester repeated technical testing of one unit of each candidate technology after exposure to harsh environmental conditions; to pass, the device had to meet or exceed the minimal TPP performance characteristic following exposure.
Candidate technologies were first exposed to heat in an environmental test chamber in accordance with International Electrotechnical Commission (IEC) 60068–2-2. The temperature was held at 50 °C and relative humidity < 50% for 16 hours (h). This exceeds the maximum value observed at the intended hospital sites, where temperature monitoring indicated that neonatal ward temperatures frequently reached temperatures exceeding 40 °C. After being returned to ambient temperature, technical performance metrics were measured and documented in product category report cards.
Candidate technologies were then exposed to high humidity in an environmental test chamber in accordance with IEC 60068–2-30. Relative humidity was held at 95% while the temperature was cycled between 25 °C and 40 °C for 48 h; each temperature cycle was 12 h in duration. These conditions mimic those at the intended hospitals where constant humidity and temperature monitors documented relative humidity values ranging from 35 to 100%, while ambient temperature values in the ward cycled between values corresponding to daily outdoor high and overnight low temperatures. After being returned to ambient conditions, technical performance metrics were measured and documented in product category report cards.
Candidate technologies were then exposed to dusty conditions in a dust chamber in accordance with IEC 60069–2-68, which recirculated 400 g/m2 fine dust particles < 75 μm (Arizona test dust A3 medium) for 4 h. Dust particle size analysis was performed on dust collected from a ward in Malawi to determine a representative dust particle profile. The total volume of devices took up < 25% of the test chamber volume, and the total base area remained < 50% horizontal working surface. Devices were placed within the chamber in a manner that ensured they did not shield each other from dust. Relative humidity inside the chamber was kept at 35–40%, and dust was allowed to settle for two hours prior to opening the chamber. Dust was lightly wiped off devices to make them accessible to operate, and then technical performance metrics were measured and documented in product category report cards. This dust exposure protocol was designed to simulate over 1.5 years of dust exposure measured without preventative maintenance or cleaning based on volume of dust collected over time in a central hospital in Malawi. Bilirubinometers, glucometers, haemoglobinometers, and pulse oximeters were excluded from dust testing since they are small, portable devices that are frequently cleaned between use.
Candidate technologies that require mains power or have an alternating current (AC) wall adapter for charging were exposed to line voltage fluctuations and conditions simulating total power failure. These three power failure conditions represent power scenarios commonly observed at various hospital sites, mild fluctuations to line voltage (8%), extreme fluctuations to line voltage (12%) and complete power failure. A programmable AC power source (BK Precision Model 9805) was used to create line voltage sags and surges of ± 8% and ± 12% voltage in accordance with IEC 61000–4-14 Class 2 and Class 3 with nominal voltage 220 V. To simulate total power failure, line voltage was cycled between 220 and 0 V in accordance with IEC 61000–4-14 Class X. After being returned to nominal line voltage conditions of 220 V, technical performance metrics were measured and documented in product category report cards.
Step 7: Usability evaluation
Domain-specific heuristics allow evaluators to capture usability issues specific to the intended use environment . Three evaluators assessed candidate technologies and identified potential usability concerns using domain-specific heuristics, which accounted for usability needs specific to low-resource settings, including cleanability, maintainability, ease of repair, low workload, minimising discomfort, and access to baby .
Heuristic results were used to eliminate candidate technologies with potentially catastrophic usability concerns. Candidate technologies with more than one identified heuristic violation of severity rating 4 per Nielsen’s heuristic severity ratings  were eliminated and marked red in the heuristic evaluation section of the report card. All candidate technologies with one or less heuristic violation of severity rating 4 advanced to usability testing with clinicians and were marked as green in the heuristic evaluation section of report cards. Heuristic severity ratings of candidate technologies are documented in product report cards, and detailed methods are available (see Additional file 3) adapted from heuristic applications on medical devices . Streamlined cognitive walkthroughs were conducted together by evaluators after documenting heuristics to identify or clarify any deviations from a typical device procedure .
Because syringe pumps are known to have major usability concerns , the heuristics and cognitive walkthrough portion of Step 7 was performed prior to Steps 5 and 6 for devices in the syringe pump category to save time and resources that might be devoted to evaluating technical performance of candidate technologies likely to be eliminated by usability concerns.
For all devices within a product category, comparative usability testing was then performed with two groups of end-users. Detailed usability evaluation protocols (see Additional file 4) were developed following best practices in the field of usability . Usability testing was first performed with representative users in Houston, Texas, including medical students, nurses, and physicians. Usability testing was then performed with users in Blantyre, Malawi, including nurses and physicians working at both central and district hospitals in Malawi. All participants were recruited as part of protocols approved by the Rice University Institutional Review Board and the University of Malawi College of Medicine Research Ethics Committee. All surveys and interviews were completed in English, a language spoken by participants across both countries. After watching a brief instructional video, users were asked to complete a small series of typical and/or critical tasks for each candidate technology within a product category (Table 3).
A total of 127 users completed usability evaluations across 11 product categories, including 51 participants from Houston and 76 participants in Malawi. Demographics of participants are summarised in Table 4.
Products in each category were evaluated by an average of six users, with some users evaluating more than one product category as time allowed. In Houston, 18 users evaluated products in more than one product category. In Malawi, 14 users evaluated products in more than one product category. The order of candidate technologies was randomised among participants to account for ordering bias.
Usability assessment results were documented using the International Organization for Standardization (ISO) 9241–11 suggested metrics: efficiency (the time required to complete a task), effectiveness (the percentage of users able to complete each task successfully), and user satisfaction . A modified system usability survey (SUS)  was used to capture user satisfaction. The SUS is a validated survey to capture subjective user satisfaction with a device . Users were also asked to identify their preferred device within each product category. Exit interviews were conducted with users to understand challenges or concerns about clinical use of the evaluated technologies, including the potential for alarm fatigue, concerns about consumables, or the ability to clean a device properly. Results of usability testing were documented in product report cards, with SUS scores identified as ≥ 70 optimal (green), < 70 and ≥ 50 minimal (yellow), and < 50 below minimal (red) to align with adjective ratings that describe SUS scores .
Step 8: Qualify technologies
Product report cards were used to assess and document the suitability of each candidate technology for use within a low-resource hospital. Candidate technologies that met all minimal TPP requirements and additionally passed technical, environmental and usability evaluations were identified as qualified to provide effective newborn care in low-resource settings.
Feedback and test results were provided to manufacturers of devices that were evaluated but did not pass the qualification process; in some cases, this led to collaborative discussions that resulted in efforts to improve product performance.
Field evaluation of qualified technologies
Qualified technologies from eight product categories (phototherapy lights, glucometer, CPAP, flow splitter, oxygen concentrator, pulse oximeter, suction pump, radiant warmer) were purchased and installed in 65 newborn wards across Kenya, Malawi, Nigeria, and Tanzania, starting in October 2019. Equipment was installed by local equipment dealers in Tanzania, Kenya, and Nigeria and by Newborn Essential Solutions and Technologies (NEST360) staff in Malawi. Device up-time, defined as the number of days the device is functional compared to the number of days the device is installed and available for use, device failures, and time to respond to failures, were monitored by local equipment dealers or program staff. Feedback regarding the performance history of qualified technologies implemented in hospitals in low-resource settings was provided to manufacturers where relatively minor changes could significantly improve device performance.
Fourteen types of medical devices commonly used in level-2 newborn care, plus respiratory support with the provision of CPAP, were identified based on WHO and national guidelines. Product categories included syringe pump, bilirubinometer, phototherapy, glucometer, haemoglobinometer, CPAP, flow splitter, oxygen concentrator, continuous pulse oximeter, suction pump, radiant warmer, continuous temperature monitor, conductive warmer, and respiratory rate/apnoea monitor. TPPs for each of these product categories are publicly available, hosted by UNICEF .
We evaluated a total of 271 medical devices across 14 product categories. All 14 product category report cards are available (see Additional file 5). Table 5 summarises the number of candidate technologies identified and evaluated at each step of the process.
Of the 271 devices considered, only 45 (16.6%) met the corresponding TPPs based on desk research. Common reasons devices did not meet TPPs include high cost, the required use of proprietary consumables, lack of regulatory approval, or lack of regulatory approval for use with newborns. We did not identify any qualified devices for three product categories (continuous temperature monitor, conductive warmer, and respiratory rate/apnoea monitor) because no commercially available candidate technologies met the TPP in those three product categories. We purchased 39 of these products and evaluated their performance in the laboratory; five (12.8%) failed to meet the TPPs. Thirty-four products passing laboratory evaluation were subject to short-term environmental testing; only one (2.9%) device failed. Thirty-seven products underwent usability testing; of these, 14 (37.8%) failed to meet the TPP. Notably, five of the six syringe pumps evaluated did not meet the TPP for usability. A total of 23 technologies in 11 of 14 product categories passed all evaluation stages and were qualified for newborn care in low-resource settings. Figure 4 shows the report card for the product category of phototherapy lights.
We identified 17 candidate phototherapy devices. Of these, desk research indicated that four appeared to meet the TPP characteristics. The manufacturer discontinued one of the four, and the remaining three were purchased for testing. Common reasons the other 14 phototherapy devices did not meet the TPP include high cost, difficulty replacing lightbulbs, and lack of regulatory approvals. All three candidate phototherapy devices passed technical, environmental, and usability testing and were designated as qualified for newborn care in low-resource settings. Figure 5 shows the report card for the product category of syringe pump.
We identified 21 candidate syringe pumps. Of these, desk research indicated six appeared to meet the TPP characteristics; these were purchased for testing. The other 15 syringe pumps did not meet the TPP, most commonly due to the requirement of proprietary syringes and instrument pricing. Of the six purchased syringe pumps, only three passed the heuristic usability evaluation, and these were subject to technical, environmental, and usability testing. Two passed technical testing, but only one passed usability testing and was identified as qualified for newborn care in low-resource settings. Major usability concerns identified during usability testing included that a significant fraction of users could not correctly start an infusion with the desired volume and/or flow rate.
Field evaluation of qualified technologies
From October 2019 until December 2022, 2457 devices from eleven product categories were procured by a global equipment dealer and installed in 65 newborn wards at tertiary and secondary hospitals in Kenya, Malawi, Nigeria, and Tanzania covering a variety of staffing levels, power quality and environmental conditions. This included 53 syringe pumps, 32 bilirubinometer, 288 phototherapy lights, 22 glucometers, three haemoglobinometers, 416 CPAP machines, 234 flow splitters, 502 oxygen concentrators, 443 pulse oximeters, 237 suction pumps, and 227 radiant warmers. Devices in Kenya, Nigeria, and Tanzania were installed by a local equipment dealer and maintained by project and local biomedical staff. Devices in Malawi were installed by project staff and maintained by project and local biomedical staff. A health technology management system was used by local dealers and local biomedical engineering technicians to report the functionality of devices. The number of device failures reported to the global equipment dealer was 337, and local equipment dealers, on average, were able to return failed devices into service within two days. From installation to December 2022, the average up time of equipment, defined as days in service divided by days since installation, is 99%.
Table 6 summarises field evaluation data by product category.
We developed a rigorous, eight-step process to identify medical devices that are effective, affordable, rugged, and easy to use in low-resource settings and followed this process to select and implement a bundle of technologies in 65 newborn wards across Kenya, Malawi, Nigeria, and Tanzania. Of the 271 devices considered, only 45 (17%) met the TPPs based on desk research. Fourteen of 37 devices (40%) failed usability testing from evaluations with 127 clinicians. Thirty-four products passed technical laboratory evaluations and then underwent short-term environmental testing, where only one device (3%) failed. Twenty-three devices passed all evaluations, and 2197 devices were installed and continue to undergo device monitoring and quality improvement across 65 newborn wards in Kenya, Malawi, Nigeria and Tanzania.
Our findings emphasised that continued investment in research and development, commercialisation, and regulatory approval is urgently needed for devices to meet TPPs. We subjected hundreds of devices to the same rigorous evaluation process; however, only a small number (less than 30) met all performance metrics. In three of the 14 device categories recommended by the WHO as necessary for newborn care (continuous temperature monitor, conductive warmer, respiratory rate/apnoea monitor), there were no commercially available products that met TPPs. While many devices in these categories are currently under development, most remain years away from the necessary regulatory approvals for safe use in hospitals. Finding ways to accelerate the development cycle timeline while meeting all internationally recognised standards without sacrificing safety is critical.
The study revealed interesting trends in common reasons devices failed to meet TPPs, which included high initial and recurring costs, difficulty replacing or sourcing consumables, lack of appropriate regulatory approvals, and that devices were difficult for nurses to use effectively. Medical device manufacturers have an opportunity to improve current solutions or develop new devices to address these gaps. Manufacturers interested in low-resource markets could save research and development time by assessing usability of physical prototypes by a wide range of stakeholders .
Nearly half (40%) of evaluated devices did not pass usability testing. This finding highlights the critical need for device manufacturers to invest in user centred design (UCD). Poor usability can lead to deadly errors, longer task times, and system use avoidance. Unfortunately, usability in medical device design remains underdeveloped, with most countries engaged in design evaluations from high-resource settings . Focusing usability research on high-resource countries can fail to consider the types of device errors that pose challenges in LMICs, such as critical understaffing and frequent nurse rotation between wards. WHO estimates a projected shortfall of 10 million health workers by 2030, mostly in LMIC  further increasing the importance and need for easy-to-use medical devices with the growth of task-shifting amidst limited human resources . Therefore, to use devices quickly and effectively, implementation of user centred design for medical devices will remain essential.
One important step in ensuring the usability of medical devices in low-resource settings is to conduct significant portions of usability evaluations in the settings in which the technology will be deployed . Although there may be cost and time advantages to conducting preliminary testing where the device is being designed , the advantages of testing in environments where the device will be used are significant. More importantly, the testing methodologies that are widely used in usability must themselves undergo a cross-cultural evaluation to determine how to best modify them to be effective in low-resource settings. This means understanding how researchers interact with users, what measures they use, and understanding cultural norms users employ when participating [46, 48]. One usability tool that is likely stable across cultures and socio-economic factors is the heuristic evaluation. Fundamental heuristics represent basic elements of product use, which do not drastically change by setting.
In user centred design, similar considerations also need to be made. Understanding how to better employ ethnographic methods effectively , how to use prototypes appropriately , how to appropriately incorporate gender, education, and cultural issues into user selection , simplifying UCD practices where appropriate , and understanding how to collect the right contextual information  are all important elements in ensuring that UCD is effectively used in low-resource settings.
Almost all evaluated devices passed short-term environmental testing. This unexpected result leads us to believe longer-term environmental exposure under actual, clinical-use conditions is required to surface potential failures. Furthermore, learnings from usability evaluations with nurses led us to believe that harsh environmental conditions should be evaluated in combination with the impacts of high turnover of users. Device failures seen during field evaluations were often the results of environmental factors combined with user errors (misplaced accessories, repeated device misuse causing physical damage, infrequent device cleaning and preventive maintenance, inappropriate device or consumable storage, incorrect electricity, inadequate access to spare parts or battery charging) and, in some instances, they were related to manufacturing (low durability of component parts). We predict accounting for high user turnover during short-term or long-term environmental testing would produce a higher rate of device failure.
Supporting the entire ecosystem surrounding device implementation is critically important. Procurement of devices can be difficult if local distributors do not support a particular geography; therefore, we created a distributor network that supports device installation, device monitoring, and clinical and technical trainings on proper device use and maintenance. It is critical to ensure devices are on national procurement lists to ensure they get into hospitals and additionally essential to strengthen the supply chain to ensure provision of required consumables and spare parts. Our team implemented device monitoring as well as quality improvement processes to understand device and user failures that may lead to poor device uptake during implementation.
Strengths and limitations
Strength of our approach is that we subjected a large number of medical devices to the same rigorous evaluation process, using consensus-driven TPPs as a benchmark for performance. Limitations of our process include usability evaluations were conducted with a representative sample of clinicians from Malawi, which may not capture user needs in all low-resource settings. Nevertheless, selecting and designing medical devices specifically for the constraints of low-resource settings can help to prevent many unnecessary deaths.
An evidence-based device selection process can help improve procurement of effective, affordable, rugged, and usable newborn care devices for low-resource hospitals, and feedback to manufacturers can improve device quality. Results have been shared with national and global procurement agencies to ensure qualified technologies for hospital-based care of small and sick newborns are on national procurement lists. A similar process could be adapted for use beyond newborn care to identify medical devices suitable for implementation in any low-resource setting.
Availability of data and materials
All data generated or analysed during this study are included in the article or uploaded as supplementary information.
Continuous Positive Airway Pressure
Every Newborn Action Plan
International Electrotechnical Commission
International Organization for Standardization
low- and middle-income countries
Litres per minute
Newborn Essential Solutions and Technologies
Sustainable Development Goal
Small and sick newborn care
System Usability Survey
Target Product Profile
User centred design
World Health Organization
UN Interagency Group for Child Mortality Estimation (UN IGME). Levels and trends in child mortality: Report 2022. New York: 2023.
The Lancet. Global Burden of Disease. Lancet. 2020. https://www.thelancet.com/gbd.
United Nations. Transforming Our World: The 2030 agenda for sustainable development. New York: United Nations; 2015.
Lawn JE, World Health Organization (WHO). Survive and thrive: transforming care for every small and sick newborn. Chapter 2. Geneva: WHO; 2018.
Kinney MV, Cocoman O, Dickson KE, et al. Implementation of the every newborn action plan: progress and lessons learned. Semin Perinatol. 2015;39(5):326–37.
Lawn JE, Davidge R, Paul VK, et al. Born too soon: care for the preterm baby. Reprod Health. 2013;10(Suppl 1):S5.
Bhutta ZA, Das JK, Bahl R, et al. Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost? Lancet. 2014;384(9940):347–70.
Lawn JE. The child survival revolution: what next? Lancet. 2014;384(9947):931–3.
Richards-Kortum R. Ending preventable newborn death in Africa. American Academy of Arts & Sciences; 2017. Accessed 12 Oct 2022. https://www.amacad.org/news/ending-preventable-newborn-death-africa.
World Health Organization (WHO). Standards for improving quality of maternal and newborn care in health facilities. Geneva: WHO; 2016.
March of Dimes, PMNHC, Save the children, WHO. Born Too Soon: the Global action report on preterm birth. Eds CP Howson, MV Kinney, JE Lawn. Geneva: World Health Organization; 2012.
UNICEF, World Health Organization (WHO). Ending preventable newborn deaths and stillbirths by 2030. Geneva: World Health Organization; 2020.
World Health Organization (WHO). Every newborn: an action plan to end preventable deaths. Geneva: WHO; 2014.
Di Pietro L, Piaggio D, Oronti I, et al. A framework for assessing healthcare facilities in low-resource settings: field studies in Benin and Uganda. J Med Biol Eng. 2020;40:526–34.
Piaggio D, Medenou D, Houessouvo RC, Pecchia L. Donation of medical devices in low-income countries: preliminary results from field studies. In: CMBEBIH 2019: Proceedings of the International Conference on Medical and Biological Engineering, 16 -- 18 May 2019. Banja Luka: Springer International Publishing; 2020. p. 423–7.
Perry L, Malkin R. Effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? Med Biol Eng Comput. 2011;49(7):719–22.
Velazquez-Berumen A, Manimaran M. Driving innovation in low resource settings. World Hosp Health Serv. 2016;52(3):7–11.
Howitt P, Darzi A, Yang GZ, et al. Technologies for global health. Lancet. 2012;380(9840):507–35.
Kirby R, Molyneux E, Dube Q, McWhorter C, Bradley B, Gartley M, et al. BMC Paediatrics. Target product profiles for neonatal care devices: systematic development and results with NEST360 and UNICEF. BMC Pediatr. 2023.
Niemeier D, Gombachika H, Richards-Kortum R. How to transform the practice of engineering to meet global health needs. Science. 2014;345(6202):1287–90.
Ayah R, Ong’ech J, Mbugua EM, Kosgei RC, Waller K, Gathara D. Responding to maternal, neonatal and child health equipment needs in Kenya: a model for an innovation ecosystem leveraging on collaborations and partnerships. BMJ Innov. 2020;6(3):85–91.
Sinha SR, Barry M. Health technologies and innovation in the global health arena. N Engl J Med. 2011;365(9):779–82.
Ploss B, Douglas TS, Glucksberg M, et al. Part II: U.S.-Sub-Saharan Africa educational partnerships for medical device design. Ann Biomed Eng. 2017;45(11):2489–93.
Malkin R, von Oldenburg BK. Diffusion of novel healthcare technologies to resource poor settings. Ann Biomed Eng. 2013;41(9):1841–50.
World Health Organization (WHO). Human resource strategies to improve newborn care in health facilities in low-and middle-income Countries. Geneva: WHO; 2020.
World Health Organization (WHO). Standards for improving the quality of care for small and sick newborns in health facilities. Geneva: WHO; 2020.
Federal Ministry of Health Nigeria. National guidelines for comprehensive newborn care. Federal Ministry of Health Nigeria; 2021. https://www.frieslandcampinainstitute.com/ng/news/national-guidelines-for-nigeria-to-reduce-neonatal-mortality/.
Kirby R, Palamountain K. Target product profiles for newborn care in low-resource settings (v1.2). Copenhagen; UNICEF; 2020.
Kirby R, Molyneux E, Langton J, Werdenberg J, Palamountain K. Newborn technology landscape: technologies for newborn care in low-resource settings: 7th Edition technical report. NEST360. 2022.
World Health Organization (WHO). WHO compendium of innovative health technologies for low-resource settings 2022. Geneva: WHO; 2022.
Shanklin R, Kortum P, Acemyan CZ. Adaptation of heuristic evaluations for the physical environment. Proc Hum Factors Ergon Soc Annu Meet. 2020;64(1):1135–9.
Johnston J, Asma E, Ziegler Acemyan C, Oden M, Richards-Kortum R, Kortum P. Development and use of heuristics to evaluate neonatal medical devices for use in low-resource settings. J User Exp. 2021;17(1):12–20.
Nielsen J. Usability inspection methods. Conference companion on Human factors in computing systems. 1994. p. 413–4.
Zhang J, Johnson TR, Patel VL, Paige DL, Kubose T. Using usability heuristics to evaluate patient safety of medical devices. J Biomed Inform. 2003;36(1–2):23–30.
Spencer R. The streamlined cognitive walkthrough method, working around social constraints encountered in a software development company. Proceedings of the SIGCHI on Human Factors in Computing Systems. 2000. p. 353–359.
FDA. Infusion Pump Improvement Initiative. Published 2017. Accessed October 12, 2022. https://www.fda.gov/medical-devices/infusion-pumps/infusion-pump-improvement-initiative.
Kortum P. Usability assessment: how to measure the usability of products, services, and systems. Santa Monica: The Human Factors And Ergonomics Society; 2016.
International Organization for Standardization. ISO 9241–11:2018. Ergonomics of human-system interaction - Part 11: Usability: Definitions and concepts. Geneva: ISO; 2018.
Bangor A, Kortum PT, Miller JT. An empirical evaluation of the system usability scale. Int J Hum Comput Interact. 2008;24(6):574–94.
Brooke J. SUS: a quick and dirty usability scale. Usability Evaluation in Industry. 1996.
Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: adding an adjective rating scale. J User Exp. 2009;4(1):114–23.
Coulentianos MJ, Rodriguez-Calero I, Daly SR, Sienko KH. Global health front-end medical device design: the use of prototypes to engage stakeholders. Dev Eng. 2020;5:100055.
Bitkina OVI, Kim HK, Park J. Usability and user experience of medical devices: An overview of the current state, analysis methodologies, and future challenges. Int J Indfy Ergon. 2020;76:102932.
Liu JX, Goryakin Y, Maeda A, et al. Global health workforce labor market projections for 2030. Hum Resour Health. 2017;15:11.
Sabet Sarvestani A, Coulentianos M, Sienko KH. Defining and characterizing task-shifting medical devices. Glob Health. 2021;17(1):60. https://doi.org/10.1186/s12992-021-00684-6. PMID:34022920;PMCID:PMC8140413.
Smith A. Issues in adapting usability testing for global usability. In: Global usability. London: Springer London; 2011. p. 23–38.
Matin S, Asma E, Mjumira R, Valle M, Acemyan C, Oden M, Kawaza K, Kortum P, Richards-Kortum R. Proxy Users for Usability Testing of Medical Devices for Use in Sub-Saharan Africa. In: Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care, 12(1). Sage CA: Los Angeles, CA: SAGE Publications; 2023. p. 208–12.
Winschiers-Theophilus H. The art of cross-cultural design for usability. In Universal Access in Human-Computer Interaction. Addressing Diversity: 5th International Conference, UAHCI 2009, Held as Part of HCI International 2009. San Diego, CA, USA, July 19-24, 2009. Proceedings, Part I 5. Springer Berlin Heidelberg. 2009. pp. 665–71.
Mohedas I, Sabet Sarvestani A, Daly SR, Sienko KH. Applying design ethnography to product evaluation: A case example of a medical device in a low-resource setting. In Proceedings of the 20th International Conference on Engineering Design ICED15; 2015.
Coulentianos MJ, Rodriguez-Calero I, Daly SR, Burridge J, Sienko KH. Medical device design practitioner strategies for prototype-centered front-end design stakeholder engagements in low-resource settings. In: Proceedings of the Design Society: International Conference on Engineering Design (1)1. Cambridge University Press. 2019. pp. 957–964.
Bekele R, Groher I, Sametinger J, Biru T, Floyd C, Pomberger G, Oppelt P. User-centered design in developing countries: a case study of a sustainable intercultural healthcare platform in Ethiopia. In 2019 IEEE/ACM symposium on software engineering in Africa (SEiA). IEEE; 2019. pp. 11–15.
Searle E. What is the best possible design for all my users?: A single question to guide user-centered design in low-resource environments. In: Proceedings of the 7th International ISCRAM Conference; 2010.
Aranda-Jan CB, Jagtap S, Moultrie J. Towards a framework for holistic contextual design for low-resource settings. Int J Des. 2016;10(3):43–63.
Most importantly, we thank the newborns and their mothers whose data are the heart of NEST360. We also thank all the neonatal nurses who provided critical usability feedback on all candidate technologies, as well as Carrie Noxon for technical writing support.
Technical Collaborative Authorship Group
3rd Stone Design—Alexsandra Brandt, Danica Kumara, Li Jin; Hatch Technologies—Ali Khalid, Cliff Osoo, Nicki Bisceglia, Vince Gate; Kamuzu University of Health Sciences—Maureen Valle, Rowland Mjumira; Rice University Rice360 Institute of Global Health Technologies—Abby Chapin, Alyssa Shapiro, Christina Samuel, David Kimmey, M. Grant Belton, Yifan Jack Wang, Jake Johnston, Jessica Anderson, Joseph Bailey, Josh Coyle, Kaede Gordon, Madeleine Tadros Weld, Meaghan Bond, Natalie Mitchell, Sara Liaghati Mobarhan, Sarah Elina Salter, Shababa B Matin, Sonia E Sosa Saenz, Sylvie Kalikoff, Taylor Boles.
About this supplement
This article has been published as part of BMC Pediatrics, Volume 23 Supplement S2, 2023: NEST360 Small and sick newborn care: learning for implementation across Africa and beyond. The full contents of the supplement are available at https://bmcpediatr.biomedcentral.com/articles/supplements/volume-23-supplement-2.
This work is funded through the NEST360 Alliance with thanks to John D. and Catherine T. MacArthur Foundation, the Bill & Melinda Gates Foundation, ELMA Philanthropies, The Children’s Investment Fund Foundation UK, The Lemelson Foundation, The Sall Family Foundation, and the Ting Tsung and Wei Fong Chao Foundation under agreements to William Marsh Rice University.
Ethics approval and consent to participate
All participants enrolled for usability evaluations provided written informed consent as part of protocols reviewed and approved by the Rice University Institutional Review Board and the University of Malawi College of Medicine Research Ethics Committee. All candidate technologies were purchased at commercial value by NEST360. Device manufacturers were made aware of the proposed evaluation process and agreed to participate with the understanding that results would be shared privately with device manufacturers and shared publicly with device make and model anonymised.
Consent for publication
I have read the Journal’s policy, and two of the authors (MO, RRK) have the following competing interests: MO, RRK are inventors of a bCPAP device (Patent US 2015/0258291 A1) and bilirubinometer device that have been licensed to 3SD; the devices are licensed at 0% royalty in GAVI-eligible countries, and the inventor’s share of all royalties have been donated to Rice University. This does not alter our adherence to BMC Pediatrics policies on sharing data and materials. All other authors (EA, MH, GB, RK, LM, CZA, KMP, PK, KK) declare they have no competing interests.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Technical testing protocols. Technical testing protocols by product category.
Environmental testing protocols. Environmental testing protocols for heat, humidity, dust, and power, performance functionality protocol by product category.
Heuristic methods protocol. Protocol for heuristic and cognitive walkthroughs.
Usability methods protocol. Protocol for usability evaluations with human subjects (end users).
Product Category Report Cards. Report cards by product category with device make and model anonymised.
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Cite this article
Asma, E., Heenan, M., Banda, G. et al. Avoid equipment graveyards: rigorous process to improve identification and procurement of effective, affordable, and usable newborn devices in low-resource hospital settings. BMC Pediatr 23 (Suppl 2), 569 (2023). https://doi.org/10.1186/s12887-023-04362-x