Worldwide, 60% of newborns experience infant jaundice. Of those, one in ten will require treatment with phototherapy to prevent the possibility of serious complications, including kernicterus, a severe form of brain damage. Yet each year, 5.7 million jaundiced newborns in South Asia and Africa receive no phototherapy. In Myanmar alone, approximately half of all neonatal hospital admissions are for hyperbilirubinemia, an outcome of untreated jaundice with potentially devastating long-term health effects.

Lasting negative health effects (morbidity) and death from untreated or poorly treated newborn jaundice is not a technology problem. The physiology of the condition is well understood, and the technology for treatment has existed for decades. This is primarily a design problem: existing medical devices for jaundice treatment are poorly adapted to the context of rural hospitals in poor countries like Myanmar.

Our Firefly phototherapy device is an intuitive, cost-effective tool for reducing unnecessary suffering caused by untreated newborn jaundice in developing countries. The key benefits for Firefly are as follows:

Hard to use wrong. Firefly is designed with intuitive controls and fixed treatment lights that make it hard to use incorrectly. The device has only one treatment setting, and does not contain adjustable parts, eliminating the most common user errors with conventional overhead phototherapy devices. Firefly administers high-intensity phototherapy from both above and below the newborn, reducing treatment time by at least 40% compared to single-sided LED phototherapy. The small bassinet accommodates only one newborn, eliminating bed-sharing during treatment and reducing newborn cross-infection.

Cost effective. In global health, the key metric for assessing program cost-effectiveness is dollars per DALY (death- or disability-affected life-year). For the Firefly devices manufactured and currently treating newborns, we project that the Firefly program costs $8 per DALY. For comparison, the World Bank estimates that the EPI vaccine, which is considered a cost-effective health intervention, is $7/DALY. Furthermore, Firefly pays for itself in health care system savings within the first two years of use, by reducing treatment times and in some cases averting the need for expensive and risky exchange blood transfusions.

Durable. Firefly is designed for 5 years of night and day performance: Firefly's LEDs are rated to last up to 44,000 hours before requiring replacement. The design eliminates all moving parts, including fans and adjustable components, that can easily be broken. In order to prevent insects, dust, and other foreign bodies from entering and damaging the device or dimming the lights, the outer casings have tight seams and no holes.

Progress

As of April 2016, DtM partners Thrive Health and Vietnamese manufacturing firm MTTS have installed Firefly in twenty developing countries across Asia (Cambodia, East Timor, Laos, Malaysia, Myanmar, Nepal, Philippines, Singapore, Thailand, Vietnam), Sub-Saharan Africa (Benin, Burundi, Ghana, Nigeria, Somaliland, Tanzania, Uganda), and the Caribbean (Haiti). These devices have already treated over 40,000 newborns and will treat 220,000 newborns over their expected useful lifetime. DtM and our partners expect to distribute at least 1,000 Firefly devices, reaching over 500,000 newborns.

Firefly Point-of-View

For global health NGOs focused on infant health who want to treat patients at the point of diagnosis rather than risk transporting them to crowded central facilities, Firefly is a newborn phototherapy device designed specifically to allow rural hospitals with limited resources and inexperienced staff to successfully treat otherwise healthy newborns for jaundice.

Unlike the conventional overhead phototherapy devices they might receive through international donations or a government purchase, Firefly provides high-intensity phototherapy that is "easy to use right and hard to use wrong"-- in other words, the device is designed to eliminate the most common sources of product failure and user error.

KEY BENEFIT: treat otherwise healthy jaundiced newborns at rural hospitals

KEY DIFFERENTIATION: "hard to use wrong", eliminates the most common sources of product failure

Firefly Design Principles and Assumptions

With Firefly, we designed a device that is better suited to the context of a low-resource hospital in a poor country and leads to better newborn health outcomes. The Firefly design is based on the following principles and key design features:

EFFECTIVE

-establishing a fixed distance between the phototherapy lights and the newborn will reduce opportunities for user setup errors ensuring effective treatment and yielding more predictable clinical results

- top-and-bottom phototherapy lights will lead to more predictable clinical results despite users putting blankets on top of or underneath the infant, and in cases where blankets are not used, a level of phototherapy unmatched by most devices on the market.

- internal lifetime hours used counter will indicate then the LEDs are likely to have degraded to the point where they no longer deliver light at therapeutic intensity, leading to more predictable clinical results

- high-tech medical aesthetic will convey that device is a trusted, effective phototherapy tool leading to more staff using it, and using it more often, leading to a higher number of infants treated per unit and overall

table-top form factor fits in mom's room allowing for more effective overall jaundice treatment including both feeding and phototherapy

MAINTAINABLE

- no moving parts, meaning an absence of mechanical failure points (i.e. adjustable top light, rotating top light, wheels--often the first aspects of a device to break in this context)

- external power supply includes surge-suppression and voltage regulation, which will eliminate another principal failure mode of medical devices in developing countries, and will extend the overall product lifetime

- the rugged, low-maintenance Firefly design will last longer than OTS phototherapy in the harsh environment of a district hospital

- LED light source lasts for 5 years of continuous use with little degradation and no need to replace bulbs

- eliminating seams and sharp corners and allowing it to be removable makes the Firefly bassinet easy to wash and thereby improve infection control as compared to the standard district hospital bedding (or a common alternative, the interior of a broken incubator)

- majority of electronics are housed in rugged base which can be opened easily by service technicians for repairs if needed

USER-FRIENDLY

- a slim overhead phototherapy light source reduces patient handling and parental anxiety, while improving clinical adoption and patient outcomes

- single button on/off interface with only 1 level of lighting, too hot warning light, and treatment time display makes the device intuitive even to untrained staff and mothers

- small size, rugged housing, and intuitive controls make it perfect to operate in the room with mom, making it more infant-friendly with increased mother-child bonding

COMFORTING

- treating infants in Mom's room will lead to better infant monitoring and feeding, while promoting mother-child bonding

- isolating babies from each other during phototherapy will help prevent hospital-acquired infection

- an overall modern, high-tech but soft and rounded aesthetic will inspire confidence in parents and care-givers and thereby improve clinical adoption

- a small overhead phototherapy array will improve patient visibility and allow three-sided access to the infant

- rounded feet allow device to be secure even sitting on uneven surfaces like beds

Measuring Impact: Firefly is transforming newborn healthcare systems

Firefly Newborn Phototherapy transforms newborn healthcare systems and prevents disability and death due to newborn jaundice. Firefly quickly pays for itself in healthcare system savings due to significantly faster treatment times, reduced incidence of newborn cross-infection and in some cases averting the need for expensive and risky exchange blood transfusions:

Firefly treats jaundice faster: DtM's Firefly is considered the world's most effective newborn phototherapy device for low resource contexts. With double-sided phototherapy administered from above and below, it reduces treatment times by almost 50%.

Firefly's design reduces risk of newborn cross-infection: According to the WHO, more than 1 million of the estimated 3.3 neonatal deaths around the world each year are caused by severe infections, including sepsis/pneumonia, tetanus, and diarrhea. Conventional overhead phototherapy units encourage the treatment of multiple newborns in a single bed, which increases the risk of newborn infection, especially from skin-to-skin transmission of conditions like respiratory and umbilical cord infections. Firefly is designed to encourage the isolation of newborns receiving jaundice treatment which reduces the incidence of infection and therefore reduces the rate of newborn mortality and infection-related transfer for overburdened national-level hospitals.

Firefly treatment averts need for exchange blood transfusions: Untreated and incorrectly treated jaundice progresses until the condition requires a exchange blood transfusion (EBT) to be corrected. EBT is dangerous and can result in disability and death. Firefly's intensive phototherapy is designed to resolve cases of mild, moderate, and severe jaundice. By offering intensive treatment at the local and national levels, Firefly significantly reduces the incidence of cases requiring EBT.

Measuring impact: Monitoring and Evaluation

DtM tracks the beneficiaries of our products and of products our team has helped design and launch. We leverage the resources of implementation partners to conduct ongoing monitoring and evaluation. For example, Dr. Priscilla Joe, Clinical Advisor to Thrive Networks and Medical Director of the Neonatal Intensive Care Unit at UCSF Benioff Children's Hospital Oakland, oversees impact assessment. Sample program outcomes that Dr. Joe has presented [1] include:

- 68% reduction in exchange blood transfusions for severe jaundice in inborns (newborns delivered in a referral hospital), and 38% reduction for outborns (newborns transferred to referral hospital after birth) in Myanmar.

- Reduces burden for tertiary hospitals as secondary hospitals become better equipped to manage neonates.

- Strengthens health systems capacity to deliver neonatal care as train-the-trainer approach expands to additional hospitals.

Clinical results show that, compared to overhead LED phototherapy, Firefly significantly reduces phototherapy treatment times, reduces the incidence of nosocomial or hospital-acquired infection and in some cases averts the need for expensive and risky exchange blood transfusions.

In collaboration with Thrive Networks, MTTS and Dr. Steven Ringer, Chief of Newborn Medicine at Brigham and Women's Hospital in Boston MA, Design that Matters developed a rigorous model for Firefly's cost of ownership and return on investment. Our financial makes the following assumptions:

- the Firefly device is operating at capacity (treating two patients per week)

- the healthcare system incurs a cost of US$20/day for inpatient care and $200 for an exchange transfusion

- Firefly is operating in a region such as Myanmar with a high incidence of severe jaundice

- the total cost of Firefly production, delivery and installation is US$1,700, and the device has an effective operating lifespan of five years.

Given our clinical results and the assumptions in the financial model, we find that, compared to overhead LED phototherapy in terms of health-care system savings due to reduced treatment time, reduced incidence of newborn cross-infection and averting exchange blood transfusions, Firefly reaches break-even in less than one year and offers a lifetime ROI of $10K or seven times the initial cost of production, delivery and installation.

[1] http://thrivenetworks.org/impact/publications#breath-of-life-update

Presentation slides: http://thrivenetworks.org/uploads/downloads/09162014-Thrive-Networks-Breath-of-Life-Presentation-to-Pneumonia-Innovations-Team.pdf

Measuring Impact: Path to Scale

Firefly has received CE Mark certification, allowing that the device meets all applicable standards for medical devices in the European Union. This internationally recognized certification opens access for Firefly to many more countries around the world, including India, a country of 1.2 billion people and over two million babies in need of phototherapy each year.

Firefly manufacturing partner MTTS expects to receive FDA approval for Firefly in 2016. CE Mark and FDA approval create the opportunity for Firefly to scale into industrialized markets at a higher but still competitive price point. This should increase product volumes, which will allow us to more quickly amortize the cost of tooling and therefore reduce the product price point in LMICs.

FDA approval will also facilitate the transshipment of Firefly devices through the USA. This will make it easier for American NGOs like Partners in Health and US government-funded newborn health initiatives to procure Firefly to international medical device distribution programs such as capacity-building and disaster relief.