Original Article
Developing sustainable global health technologies: Insight from an initiative to address neonatal hypothermia Rajesh Guptaa,*, Rajan Patelb, Naganand Murtyc, Rahul Panickerd, and Jane Chend a Freeman Spogli Institute for International Studies, Center for Health Policy/Center for Primary Care and Outcomes Research, Stanford University, 616 Serra Street, Stanford, USA. E-mail: [email protected] b c
John F. Kennedy School of Government, Cambridge, Massachusetts, USA.
West Health Institute, Washington DC, USA.
d
Embrace Innovations, Bangalore, Karnataka, India.
*Corresponding author.
Abstract
Relative to drugs, diagnostics, and vaccines, efforts to develop other global health technologies, such as medical devices, are limited and often focus on the short-term goal of prototype development instead of the long-term goal of a sustainable business model. To develop a medical device to address neonatal hypothermia for use in resource-limited settings, we turned to principles of design theory: (1) define the problem with consideration of appropriate integration into relevant health policies, (2) identify the users of the technology and the scenarios in which the technology would be used, and (3) use a highly iterative product design and development process that incorporates the perspective of the user of the technology at the outset and addresses scalability. In contrast to our initial idea, to create a single device, the process guided us to create two separate devices, both strikingly different from current solutions. We offer insights from our initial experience that may be helpful to others engaging in global health technology development. Journal of Public Health Policy (2015) 36, 24–40. doi:10.1057/jphp.2014.44; published online 13 November 2014 Keywords: innovation; technology; global health; neonatal hypothermia
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40 www.palgrave-journals.com/jphp/
Insight from an initiative to address neonatal hypothermia
Background Innovation in global health technologies is often focused on creating drugs, diagnostics, and vaccines.1 Several product development initiatives focus on developing these technologies for resource-limited settings.2,3 Comparatively, other global health technologies, such as medical devices, may have an equal impact on global health.4 Yet, the process for developing and introducing such technologies is not as well understood. Best practices remain ill-defined, and development efforts in resource-limited settings remain relatively limited.2,5–7 Historically, efforts in this area have focused on the rapid development of prototypes, often neglecting issues related to design, commercialization, scalability, and, ultimately, sustainability. 8,9 This can lead to substandard products that lack local relevance, undergo longer development times, have higher development and product costs, and lack endorsement from policymakers.10,11 As a result, even when such types of global health technologies have been developed, few have proceeded beyond the pilot stage to large-scale implementation.12 To overcome this trend, we looked to the field of design. Known as ‘design theory’, design-based approaches to innovation emphasize using the perspective of the user to define every aspect of the problem and the proposed technological solution.13,14 This ‘human-centric’ approach (as it is often referred to) contrasts with a traditional needsfinding approach, where the designer of a product may attempt to understand the problem in a limited encounter with the user of the solution and then creates the product largely without further consultation of the intended user. Design theory uses continuous feedback from a sample of the individuals in the settings who will regularly use the product (i.e. the end user). It identifies the real-world scenarios in which the product will be used by those individuals (i.e. use cases).15–17 The approach incorporates a rigorous ‘empathize-defineideate-prototype-test’ methodology (see Table 1) to accurately define the problem, the end-user, and use cases, and to design the product using iterative prototyping. By taking a design theory approach to innovation, we created, manufactured, commercialized, and are scaling up a medical device for resource-limited settings to address neonatal hypothermia. In presenting our initial experience, we hope to offer a case study that outlines the advantages and pitfalls of our approach.
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
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Table 1: Translating design theory to developing global health technologies Steps
Definition
Impact on Embrace development process
Lessons for resource-limited settings
Empathize Understand, at a granular Elucidated that making a Active dialog with the end traditional incubator user helps the device level, who the end users are, their specific more affordable would designer abandon problems, and their not solve the fundamental assumptions about endenvironment problems for the end user user needs Sustainability and Define Outline the specific endIntegrated affordability, scalability require clinical performance, user requirements and understanding and manufacturing scalability, production requirements addressing regulatory and regulatory issues, safety, for the product production issues in the technical performance, and initial product usability as an early part of development phase the innovation process Ideate Without restriction, list all Allowed ‘out of the box’ Frugal innovation is not potential engineering designs to emerge limited to making existing solutions to meet the end products affordable or user and production using only the available requirements technologies and materials in a target setting Non-functioning protoypes Prototype Build a testable model Demonstrated that initial offer an inexpensive and from the designs design parameters faster alternative for early emerging in the ideation identified in questionnaires input from the end user step to determine can change in the presence whether the of a prototype, the requirements are met defining/ideating steps undergo multiple iterations, and the need for two separate products Regulations for nonHighlighted the need for a Test Assess the working invasive devices and other hybrid of varying prototype in the context technologies are unclear regulatory standards; of regulatory standards, or non-existant in many revealed that valuable safety and efficacy, countries; responding to product modification effectiveness, and realthe needs of the end user data can be gathered in world usage requires consistent the distribution and scaleassessment and potential up phases continuing modification of the device (even in post-production stages)
Defining the Problem Neonatal hypothermia, defined as body temperature below 36.5°C, is a major contributor to the 3.6 million neonatal deaths that occur each year primarily in resource-limited settings.18,19 Hypothermic neonates are at
26
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
Insight from an initiative to address neonatal hypothermia
2–30 times greater risk for mortality than their normothermic counterparts.20 Estimates of hypothermia prevalence among all neonates range from 32 to 85 per cent in hospital-based settings and up to 92 per cent in selected community settings, with low birth weight (LBW) infants at particular risk.18,19,21 Preventing and managing neonatal hypothermia could reduce neonatal mortality significantly, helping reach UN Millennium Development Goal 4.19 Many environmental, physiological, behavioral, and socio-economic factors place neonates at risk for hypothermia, and thus the World Health Organization (WHO) endorses comprehensive approaches to prevention and management of neonatal hypothermia, including a strategy known as Kangaroo Mother Care (KMC). 20,22,23 KMC is a three-component strategy: skin-to-skin care between the newborn and mother; frequent or exclusive breastfeeding; and early discharge from a hospital setting. KMC has reduced neonatal morbidity in certain neonates (i.e. LBW ones) and settings (i.e. hospitals) but suffers from lack of consistent and widespread uptake, failing to reach all neonates in a diverse range of settings.24–27 Many technology- and non-technology-based interventions are available and used to prevent or manage neonatal hypothermia, including TransWarmer® mattresses, radiant warmers, polyethylene wraps, bags and caps, incubators, skin-to-skin care, light bulbs, reconfigured traditional incubators, and hot water bottles. These may or may not be aligned with KMC, and each has serious limitations such as (but not limited to) cost, lack of safety and efficacy, and minimal acceptance and uptake.28–35 Given the needs of the mother, neonate, and community at large, a range of innovative approaches may be necessary to properly address neonatal hypothermia and mitigate its impact.36 Thus, we formulated our problem statement as follows: ‘Can a technological device improve prevention and management of neonatal hypothermia in resource-limited settings and, ideally, support KMC?’
Identifying the End Users and Use Cases We selected India because of the burden of neonatal hypothermia, high proportion of home deliveries, resource constraints, and feasibility for controlled testing. To define the end user, we conducted focus groups and key informant interviews among: health-care workers in public and private health-care centers; local and national health-care administrators;
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
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Gupta et al
and community health workers, mothers, and birthing attendants from urban and rural settings. Two main categories of end users were identified: physicians and nurses at hospitals or clinics where births take place (‘health center end users’); and mothers, midwives, and community health workers in urban and rural settings where births take place in the community or home or where neonates are discharged to the community or home (‘community end users’). After defining the end users, our team conducted a second series of focus groups and key informant interviews to identify the use cases and the end users’ perceptions of current devices. ●
●
Health center end users described four use cases: (1) transport of unstable neonates from a primary/secondary health-care facility to a secondary/tertiary facility; (2) in-clinic use for LBW neonates for the immediate post-birth period, up to one hour; (3) in-clinic use for all LBW neonates for longer periods, from one hour to several days; and (4) intra-hospital transport for any stable neonate. Community end users identified two use cases: (1) LBW neonates discharged from a facility to home care; and (2) LBW neonates delivered in the community or at home. In addition, community end users would only accept a device endorsed by health center end users, and small health center end users would only accept a device endorsed by large health center end users.
Through our discussions with end users, each technology- and nontechnology-based intervention previously mentioned presented at least one major flaw and no one solution appeared to offer benefit to the degree that it was a preferred solution by the majority (Tables 2 and 3).
Designing the Product Our initial design target was a single device whose core function was ‘to create a thermal environment to achieve and maintain a newborn temperature range of 36.5–37.5°C’. The main design-based challenge was to construct a device that did not require continuous electricity, would provide a constant temperature over time, was low-cost, and did not require written instructions or detailed training to use. We decided to build a functioning prototype to capture further end-user input on all parameters simultaneously, and then we revised the prototype based on
28
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
Insight from an initiative to address neonatal hypothermia
Table 2: In-clinic/transport setting Efficacy in thermoregulation
Cost effectiveness
Portability
Safety
Mother-child interaction
Ability to work without electricity
Ease of use
Low cost innovations (light bulbs, hot water bottles, thermocol boxes, etc.)
1
3
2
1
1
2
3
Kanmed (heated water mattress)
3
2
1
3
1
1
2
Transwarmer (sodium acetate gel pack)
2
2
3
2
2
3
3
Radiant warmers/ Incubators
3
1
1
3
1
1
2
Transport incubators
3
1
2
3
1
1
2
Skin to skin care
3
3
3
3
3
3
2
Table 3: Rural/at-home setting Efficacy in thermoregulation
Cost effectiveness
Portability
Safety
Mother-child interaction
Ability to work without electricity
Ease of use
Ease of integration into daily activities
Light bulbs
1
3
2
1
1
1
3
3
Blankets
1
3
3
2
3
3
3
3
Hot coals
1
3
1
1
2
3
2
2
Sari hammock
1
3
1
2
1
3
3
3
Hot water bottles
1
3
2
2
1
3
2
2
Thermocol boxes
1
3
3
2
2
3
3
3
Room warmers
2
2
1
3
3
1
2
3
Skin to skin care
3
3
3
3
3
3
2
1
the feedback received. We constructed the first working prototype using a flexible pouch of material to be heated over boiling water to supply heat and then to be stored in a sleeping bag to maintain heat.
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
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Gupta et al
Notably, feedback from end users shifted dramatically in the presence of the prototype. Community end users had initially rated portability of high importance, but this diminished and, instead, was replaced with the perceived ability of the device to safely hold the baby. Health center end users, who had initially indicated high preference for a non-electricitybased solution, indicated that complete independence from electricity was, in the end, not a requirement given that many clinics (even in rural parts of India) had at least intermittent electricity. When compared to the proposed solution that required the burden and risk of boiling water in a health center, an electricity-requiring device provided greater ease of use. With starkly different end users and use cases, requirements appeared to vary greatly. Accordingly, we abandoned the idea of developing a single device to meet the needs of both end-user types. Rather, we decided to create two separate devices (incorporating the same basic technology) to cater to the two end-user groups. Given our limited staff capacity, we decided to develop fully and test the health center device first, and then to develop the community-based device. For health centers, we designed a precision electric heater to ensure that the pouch heated to the correct temperature while minimizing risk of overheating. The heater had an intuitive single-button user interface without control knobs or settings. We maintained the portability of the heater to allow within-facility transport. For the community, we modified the sleeping bag to lie flat to allow the baby to sleep safely, and eliminated portability from the design. We also modified the original non-electric prototype to maintain heat consistently for a longer duration. With both devices, we prioritized several targets: potential for manufacturability (materials and molds translatable to large-scale manufacturing); production affordability (1 per cent of the India market cost, US$20 000, of traditional incubators); regulatory requirements (Indian and European Union standards); durability (rugged and reusable materials); and intuitive use (eliminating any text on the device itself and using culturally appropriate symbols and colors). For each product, the team created and revised hundreds of prototypes before coming to the final design. Initially, we made several non-functioning prototypes at once, so that we could collect user feedback, plus filter and iterate. Later, as the design became more solidified, we built prototypes to test functionality and to be manufacturing-appropriate.
30
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
Insight from an initiative to address neonatal hypothermia
Figure 1: Embrace Nest.
Preliminary Outcomes Compared to traditional incubators, the new devices differ considerably with respect to: size (smaller), mechanism of thermoregulation (heat transfer and heat maintenance), cost (less expensive), durability/ portability (more rugged/portable), infrastructure requirements (minimal), ease of use (no literacy requirement), need for regular maintenance (only cleaning of the sleeping bag component), training requirements (single training session, with one follow-up session), risk of harm (none observed), and ability to integrate with KMC (feasible). The health center device is shown in Figure 1 and comprises precision electric heater (single temperature with no ability to change the temperature) that warms a phase change material-enclosed pouch. The pouch itself has a color indicator to show when the appropriate temperature is achieved – in approximately 30 min. The pouch is then placed in the back of a cocoon-shaped miniature sleeping bag with a hood and the neonate is placed in the secured bag. The phase change pouch does not touch the infant and the bag is designed such that the heat from the pouch is evenly distributed throughout the bag for up to 6 hours.
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
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Gupta et al
Embrace Nest has undergone evaluation in two studies in India, randomized to standard of care. The initial study with 20 LBW infants and their mothers demonstrated non-inferiority in reaching target temperature and thermostability over a 4-hour period, plus feasibility in the use of the device.37 The second study of 160 stable LBW neonates demonstrated non-inferiority (P
Developing sustainable global health technologies: Insight from an initiative to address neonatal hypothermia Rajesh Guptaa,*, Rajan Patelb, Naganand Murtyc, Rahul Panickerd, and Jane Chend a Freeman Spogli Institute for International Studies, Center for Health Policy/Center for Primary Care and Outcomes Research, Stanford University, 616 Serra Street, Stanford, USA. E-mail: [email protected] b c
John F. Kennedy School of Government, Cambridge, Massachusetts, USA.
West Health Institute, Washington DC, USA.
d
Embrace Innovations, Bangalore, Karnataka, India.
*Corresponding author.
Abstract
Relative to drugs, diagnostics, and vaccines, efforts to develop other global health technologies, such as medical devices, are limited and often focus on the short-term goal of prototype development instead of the long-term goal of a sustainable business model. To develop a medical device to address neonatal hypothermia for use in resource-limited settings, we turned to principles of design theory: (1) define the problem with consideration of appropriate integration into relevant health policies, (2) identify the users of the technology and the scenarios in which the technology would be used, and (3) use a highly iterative product design and development process that incorporates the perspective of the user of the technology at the outset and addresses scalability. In contrast to our initial idea, to create a single device, the process guided us to create two separate devices, both strikingly different from current solutions. We offer insights from our initial experience that may be helpful to others engaging in global health technology development. Journal of Public Health Policy (2015) 36, 24–40. doi:10.1057/jphp.2014.44; published online 13 November 2014 Keywords: innovation; technology; global health; neonatal hypothermia
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40 www.palgrave-journals.com/jphp/
Insight from an initiative to address neonatal hypothermia
Background Innovation in global health technologies is often focused on creating drugs, diagnostics, and vaccines.1 Several product development initiatives focus on developing these technologies for resource-limited settings.2,3 Comparatively, other global health technologies, such as medical devices, may have an equal impact on global health.4 Yet, the process for developing and introducing such technologies is not as well understood. Best practices remain ill-defined, and development efforts in resource-limited settings remain relatively limited.2,5–7 Historically, efforts in this area have focused on the rapid development of prototypes, often neglecting issues related to design, commercialization, scalability, and, ultimately, sustainability. 8,9 This can lead to substandard products that lack local relevance, undergo longer development times, have higher development and product costs, and lack endorsement from policymakers.10,11 As a result, even when such types of global health technologies have been developed, few have proceeded beyond the pilot stage to large-scale implementation.12 To overcome this trend, we looked to the field of design. Known as ‘design theory’, design-based approaches to innovation emphasize using the perspective of the user to define every aspect of the problem and the proposed technological solution.13,14 This ‘human-centric’ approach (as it is often referred to) contrasts with a traditional needsfinding approach, where the designer of a product may attempt to understand the problem in a limited encounter with the user of the solution and then creates the product largely without further consultation of the intended user. Design theory uses continuous feedback from a sample of the individuals in the settings who will regularly use the product (i.e. the end user). It identifies the real-world scenarios in which the product will be used by those individuals (i.e. use cases).15–17 The approach incorporates a rigorous ‘empathize-defineideate-prototype-test’ methodology (see Table 1) to accurately define the problem, the end-user, and use cases, and to design the product using iterative prototyping. By taking a design theory approach to innovation, we created, manufactured, commercialized, and are scaling up a medical device for resource-limited settings to address neonatal hypothermia. In presenting our initial experience, we hope to offer a case study that outlines the advantages and pitfalls of our approach.
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
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Gupta et al
Table 1: Translating design theory to developing global health technologies Steps
Definition
Impact on Embrace development process
Lessons for resource-limited settings
Empathize Understand, at a granular Elucidated that making a Active dialog with the end traditional incubator user helps the device level, who the end users are, their specific more affordable would designer abandon problems, and their not solve the fundamental assumptions about endenvironment problems for the end user user needs Sustainability and Define Outline the specific endIntegrated affordability, scalability require clinical performance, user requirements and understanding and manufacturing scalability, production requirements addressing regulatory and regulatory issues, safety, for the product production issues in the technical performance, and initial product usability as an early part of development phase the innovation process Ideate Without restriction, list all Allowed ‘out of the box’ Frugal innovation is not potential engineering designs to emerge limited to making existing solutions to meet the end products affordable or user and production using only the available requirements technologies and materials in a target setting Non-functioning protoypes Prototype Build a testable model Demonstrated that initial offer an inexpensive and from the designs design parameters faster alternative for early emerging in the ideation identified in questionnaires input from the end user step to determine can change in the presence whether the of a prototype, the requirements are met defining/ideating steps undergo multiple iterations, and the need for two separate products Regulations for nonHighlighted the need for a Test Assess the working invasive devices and other hybrid of varying prototype in the context technologies are unclear regulatory standards; of regulatory standards, or non-existant in many revealed that valuable safety and efficacy, countries; responding to product modification effectiveness, and realthe needs of the end user data can be gathered in world usage requires consistent the distribution and scaleassessment and potential up phases continuing modification of the device (even in post-production stages)
Defining the Problem Neonatal hypothermia, defined as body temperature below 36.5°C, is a major contributor to the 3.6 million neonatal deaths that occur each year primarily in resource-limited settings.18,19 Hypothermic neonates are at
26
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
Insight from an initiative to address neonatal hypothermia
2–30 times greater risk for mortality than their normothermic counterparts.20 Estimates of hypothermia prevalence among all neonates range from 32 to 85 per cent in hospital-based settings and up to 92 per cent in selected community settings, with low birth weight (LBW) infants at particular risk.18,19,21 Preventing and managing neonatal hypothermia could reduce neonatal mortality significantly, helping reach UN Millennium Development Goal 4.19 Many environmental, physiological, behavioral, and socio-economic factors place neonates at risk for hypothermia, and thus the World Health Organization (WHO) endorses comprehensive approaches to prevention and management of neonatal hypothermia, including a strategy known as Kangaroo Mother Care (KMC). 20,22,23 KMC is a three-component strategy: skin-to-skin care between the newborn and mother; frequent or exclusive breastfeeding; and early discharge from a hospital setting. KMC has reduced neonatal morbidity in certain neonates (i.e. LBW ones) and settings (i.e. hospitals) but suffers from lack of consistent and widespread uptake, failing to reach all neonates in a diverse range of settings.24–27 Many technology- and non-technology-based interventions are available and used to prevent or manage neonatal hypothermia, including TransWarmer® mattresses, radiant warmers, polyethylene wraps, bags and caps, incubators, skin-to-skin care, light bulbs, reconfigured traditional incubators, and hot water bottles. These may or may not be aligned with KMC, and each has serious limitations such as (but not limited to) cost, lack of safety and efficacy, and minimal acceptance and uptake.28–35 Given the needs of the mother, neonate, and community at large, a range of innovative approaches may be necessary to properly address neonatal hypothermia and mitigate its impact.36 Thus, we formulated our problem statement as follows: ‘Can a technological device improve prevention and management of neonatal hypothermia in resource-limited settings and, ideally, support KMC?’
Identifying the End Users and Use Cases We selected India because of the burden of neonatal hypothermia, high proportion of home deliveries, resource constraints, and feasibility for controlled testing. To define the end user, we conducted focus groups and key informant interviews among: health-care workers in public and private health-care centers; local and national health-care administrators;
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
27
Gupta et al
and community health workers, mothers, and birthing attendants from urban and rural settings. Two main categories of end users were identified: physicians and nurses at hospitals or clinics where births take place (‘health center end users’); and mothers, midwives, and community health workers in urban and rural settings where births take place in the community or home or where neonates are discharged to the community or home (‘community end users’). After defining the end users, our team conducted a second series of focus groups and key informant interviews to identify the use cases and the end users’ perceptions of current devices. ●
●
Health center end users described four use cases: (1) transport of unstable neonates from a primary/secondary health-care facility to a secondary/tertiary facility; (2) in-clinic use for LBW neonates for the immediate post-birth period, up to one hour; (3) in-clinic use for all LBW neonates for longer periods, from one hour to several days; and (4) intra-hospital transport for any stable neonate. Community end users identified two use cases: (1) LBW neonates discharged from a facility to home care; and (2) LBW neonates delivered in the community or at home. In addition, community end users would only accept a device endorsed by health center end users, and small health center end users would only accept a device endorsed by large health center end users.
Through our discussions with end users, each technology- and nontechnology-based intervention previously mentioned presented at least one major flaw and no one solution appeared to offer benefit to the degree that it was a preferred solution by the majority (Tables 2 and 3).
Designing the Product Our initial design target was a single device whose core function was ‘to create a thermal environment to achieve and maintain a newborn temperature range of 36.5–37.5°C’. The main design-based challenge was to construct a device that did not require continuous electricity, would provide a constant temperature over time, was low-cost, and did not require written instructions or detailed training to use. We decided to build a functioning prototype to capture further end-user input on all parameters simultaneously, and then we revised the prototype based on
28
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
Insight from an initiative to address neonatal hypothermia
Table 2: In-clinic/transport setting Efficacy in thermoregulation
Cost effectiveness
Portability
Safety
Mother-child interaction
Ability to work without electricity
Ease of use
Low cost innovations (light bulbs, hot water bottles, thermocol boxes, etc.)
1
3
2
1
1
2
3
Kanmed (heated water mattress)
3
2
1
3
1
1
2
Transwarmer (sodium acetate gel pack)
2
2
3
2
2
3
3
Radiant warmers/ Incubators
3
1
1
3
1
1
2
Transport incubators
3
1
2
3
1
1
2
Skin to skin care
3
3
3
3
3
3
2
Table 3: Rural/at-home setting Efficacy in thermoregulation
Cost effectiveness
Portability
Safety
Mother-child interaction
Ability to work without electricity
Ease of use
Ease of integration into daily activities
Light bulbs
1
3
2
1
1
1
3
3
Blankets
1
3
3
2
3
3
3
3
Hot coals
1
3
1
1
2
3
2
2
Sari hammock
1
3
1
2
1
3
3
3
Hot water bottles
1
3
2
2
1
3
2
2
Thermocol boxes
1
3
3
2
2
3
3
3
Room warmers
2
2
1
3
3
1
2
3
Skin to skin care
3
3
3
3
3
3
2
1
the feedback received. We constructed the first working prototype using a flexible pouch of material to be heated over boiling water to supply heat and then to be stored in a sleeping bag to maintain heat.
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
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Gupta et al
Notably, feedback from end users shifted dramatically in the presence of the prototype. Community end users had initially rated portability of high importance, but this diminished and, instead, was replaced with the perceived ability of the device to safely hold the baby. Health center end users, who had initially indicated high preference for a non-electricitybased solution, indicated that complete independence from electricity was, in the end, not a requirement given that many clinics (even in rural parts of India) had at least intermittent electricity. When compared to the proposed solution that required the burden and risk of boiling water in a health center, an electricity-requiring device provided greater ease of use. With starkly different end users and use cases, requirements appeared to vary greatly. Accordingly, we abandoned the idea of developing a single device to meet the needs of both end-user types. Rather, we decided to create two separate devices (incorporating the same basic technology) to cater to the two end-user groups. Given our limited staff capacity, we decided to develop fully and test the health center device first, and then to develop the community-based device. For health centers, we designed a precision electric heater to ensure that the pouch heated to the correct temperature while minimizing risk of overheating. The heater had an intuitive single-button user interface without control knobs or settings. We maintained the portability of the heater to allow within-facility transport. For the community, we modified the sleeping bag to lie flat to allow the baby to sleep safely, and eliminated portability from the design. We also modified the original non-electric prototype to maintain heat consistently for a longer duration. With both devices, we prioritized several targets: potential for manufacturability (materials and molds translatable to large-scale manufacturing); production affordability (1 per cent of the India market cost, US$20 000, of traditional incubators); regulatory requirements (Indian and European Union standards); durability (rugged and reusable materials); and intuitive use (eliminating any text on the device itself and using culturally appropriate symbols and colors). For each product, the team created and revised hundreds of prototypes before coming to the final design. Initially, we made several non-functioning prototypes at once, so that we could collect user feedback, plus filter and iterate. Later, as the design became more solidified, we built prototypes to test functionality and to be manufacturing-appropriate.
30
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
Insight from an initiative to address neonatal hypothermia
Figure 1: Embrace Nest.
Preliminary Outcomes Compared to traditional incubators, the new devices differ considerably with respect to: size (smaller), mechanism of thermoregulation (heat transfer and heat maintenance), cost (less expensive), durability/ portability (more rugged/portable), infrastructure requirements (minimal), ease of use (no literacy requirement), need for regular maintenance (only cleaning of the sleeping bag component), training requirements (single training session, with one follow-up session), risk of harm (none observed), and ability to integrate with KMC (feasible). The health center device is shown in Figure 1 and comprises precision electric heater (single temperature with no ability to change the temperature) that warms a phase change material-enclosed pouch. The pouch itself has a color indicator to show when the appropriate temperature is achieved – in approximately 30 min. The pouch is then placed in the back of a cocoon-shaped miniature sleeping bag with a hood and the neonate is placed in the secured bag. The phase change pouch does not touch the infant and the bag is designed such that the heat from the pouch is evenly distributed throughout the bag for up to 6 hours.
© 2015 Macmillan Publishers Ltd. 0197-5897 Journal of Public Health Policy Vol. 36, 1, 24–40
31
Gupta et al
Embrace Nest has undergone evaluation in two studies in India, randomized to standard of care. The initial study with 20 LBW infants and their mothers demonstrated non-inferiority in reaching target temperature and thermostability over a 4-hour period, plus feasibility in the use of the device.37 The second study of 160 stable LBW neonates demonstrated non-inferiority (P
