D-Rev, a non-profit based in the United States’ Silicon Valley, designs and delivers products to improve the lives of people living on less than US$4 a day.

We believe that affordable medical devices can give even the most marginalized children a chance at healthier, more empowered lives. Our efforts to produce and promote Brilliance, a medical device that provides effective phototherapy treatment of newborn jaundice at a fraction of the cost of comparable commercial units, highlight the importance of understanding local context, delivering sustainable solutions – and shifting focus from innovation to impact.

Understanding the local context

Understanding the local context in which a solution will be rolled out is essential to identifying unmet needs and designing high-quality products that will meet those needs. Often, this involves challenging early assumptions in a new market. For example, in Kenya, we saw that babies with jaundice born in a small clinic were usually referred for treatment to a large hospital that could be hours away. We hypothesized that if small clinics could access an affordable, context-appropriate phototherapy device, more of them would treat jaundice – thereby sending fewer children to over-crowded referral facilities and minimizing the health risks of delayed treatment. It turned out our hypothesis about the market and infrastructure was not quite correct.

A baby in a phototherapy unit.
A baby is treated with a Brilliance unit in a neonatal intensive care unit in Kerala, India. | PHOTO COURTESY OF THE AUTHORS

After interviewing practitioners at more than 65 facilities, D-Rev staff learned that, for a host of reasons, most small clinics would not treat jaundice even with an affordable phototherapy device. These clinics lacked relevant diagnostic tools and could not retain infants as inpatients; moreover, severely jaundiced infants often presented with other complications requiring referral to higher levels of care anyway. Instead of designing a treatment device specific to low-level clinics – a market that did not yet exist – D-Rev focused on making phototherapy more affordable and versatile for referral hospitals where we knew there was a need, while keeping an eye on future innovations (such as low-cost diagnostics) that could remove pertinent barriers for smaller clinics.

The design process draws on knowledge of the local context. In our field research, we observed hundreds of phototherapy devices with missing or burned-out bulbs – resulting in ineffective treatment. Based on input from medical personnel working in low-resource hospitals, we designed Brilliance to run on long-lasting LEDs instead of the fluorescent bulbs typically used in low-quality devices. An understanding of details ranging from core machine functionality to simple design aspects, such as how sturdy the device looks, or how easily the height can be adjusted, ultimately decides whether a technology is used to treat children, or left to gather dust in a storage closet.

Delivering sustainable solutions

Creating distribution strategies requires intimate knowledge of user needs and market constraints. For Brilliance, D-Rev staff work closely with distribution partners to ensure units are being installed and used properly. Staff also spend time on the ground in new markets building partnerships to support sales. D-Rev staff have met countless hospital administrators, procurement staff and regulatory officials to better understand the requirements in different markets. For example, we considered shipping devices directly to purchasers at hospitals, cutting out the ‘middleman’ (distributors who import and resell medical devices at a markup) to increase affordability. But many low-resource hospitals prefer to have a local supplier provide installation, maintenance and complaint resolution, and some public hospitals would not procure devices without a local distributor. Understanding these parameters helps us focus on realistic strategies to meet customer requirements while keeping costs low.

“We designed Brilliance to run on long-lasting LEDs instead of the fluorescent bulbs typically used in low-quality devices.”

Although D-Rev is a non-profit, we work with for-profit partners on production and sales. For Brilliance, we have partnered with Phoenix Medical Systems, a private-sector leader in the manufacturing and distribution of newborn medical devices in India (D-Rev licenses the Brilliance technology to Phoenix and both organizations work together to make and sell it). We believe that leveraging the market for product delivery is the most effective and sustainable means to scale. Being market-driven also creates accountability: if the product does not meet user needs, they will not purchase it.

Of course, not all markets or market actors are perfect: D-Rev has encountered occasional price gouging and ineffective or inappropriate sales behaviour (though on the whole, these instances have been few). We try to overcome these challenges and keep the final price affordable for customers by investing time up-front in selecting high-performing partners who share our values, and by laying out clear expectations for distribution partners. In the case of D-Rev’s relationship with Phoenix Medical Systems, engineering and business staff from the two organizations work together regularly by phone and in-person to improve product quality and enhance sales training.

Measuring impact

We measure success by the number of newborn patients receiving effective care. D-Rev staff developed an algorithm based on inputs from published medical literature and fieldwork to estimate how children’s lives are impacted by the use of Brilliance phototherapy device. This algorithm uses average treatment times, usage rates and the presence of comparably effective devices at hospitals with a similar profile and income level, to ask: How many babies treated with Brilliance would not have received effective treatment otherwise? We estimate that as of September 2014, 633 Brilliance devices installed in hospitals from India to sub-Saharan Africa have treated more than 26,000 jaundiced infants who otherwise would not have received effective phototherapy.

Transparency is a core value of our impact work: community input and review increase our accountability to customers and funders. To that end, we publish our impact data via dashboards on the D-Rev website, and utilize the D-Rev blog to detail how those figures are calculated, revised and updated based on new information.

Remaining challenges

Innovative, user-centric technologies are gaining increased attention as tools to improve children’s health. But challenges remain in building a supportive ecosystem to help innovations reach scale.

One key step in building an effective ecosystem is to shift the focus from innovation to impact. Creative designs or breakthrough research alone does not improve the health of children in low-income communities. The biggest successes come from developing innovations into thoughtful, quality products based on user needs and supported by realistic supply chains. At D-Rev, we are very clear that innovative design is one step in a process to improve equity in children’s health. Equally important are the less-obvious aspects of bringing a new technology to market: engineering for manufacturability; implementing quality control systems; executing distribution and sales strategies; and measuring impact.

While the funding sector has long supported early-stage prototyping, in D-Rev’s experience, donors are just beginning to finance the full range of engineering and business development activities required to bring products like Brilliance to commercial – and economically sustainable – scale. Bringing an innovation to scale can be resource-intensive, and certainly requires patience and flexibility from funders. But ultimately, helping global health innovations become viable products transforms their ‘potential impact’ into ‘real impact’. We hope that donors increasingly assume this vital role to ensure that innovative, affordable products help children worldwide stay healthy.