The Freeplay Fetal Heart Rate Monitor is a human powered device that monitors an unborn child’s heart rate during labor. A large proportion of stillbirths are due to hypoxia (limited oxygen intake) during labor but traditional Doppler ultrasounds are too costly and need power and batteries. The $300 FHRM device is powered through a crank allowing healthcare workers to make life-saving decisions while off the electrical grid in developing countries.  The team won the INDEX award for this idea.

 INDEX AWARD NOTES:

The optimal technology in primary care settings is a Doppler ultrasound fetal heart rate monitor--but these are expensive, break easily and rely on replaceable batteries--wholly unsuitable in under-resourced settings.

The design includes an obstetrics ultrasound device connected to the main unit by a cord. That main unit processes the signal and displays it. It also contains a power-management electronic module, a sound amplifier and a crank for winding up the device.

Credit also goes to Freeplay Energy for its focus over the years on a series of Design to Improve Life solutions that address the needs of many people who have no access – or only irregular or scarce access - to electricity.

In the developing world, price is one of the most important parameters affecting the potential impact of any life-saving design. The Freeplay Fetal Heart Rate Monitor costs $ 300, which is lower than the price of competitors’ products, which often sell at a prize of up to $ 1.000. The low price strengthens the potential for the design to have a significant impact.

The Freeplay Fetal Heart Rate Monitor has just ended the first major field tests performed by Doctors without Borders (Medicins sans frontiers), who are enthusiastic about the product. The challenge in the coming years is to gain widespread distribution to clinics and hospitals in need of the design. In this connection, it is reassuring that the company behind the Freeplay Fetal Heart Rate Monitor is a pioneer in impact-by-distribution, having grown a global network of distributers, helping to expand the reach of the Freeplay series in the developed and developing worlds.

The fact that the Freeplay Fetal Heart Rate Monitor also arose from Freeplay Energy’s philosophy of making products free of electrical-power restrictions also argues for the potential impact of the design: Human power does the work.

The severe problem addressed, the solution chosen, the price and the potential for distribution all amount to an anticipated bright future of wide impact for this off-the-grid design.

Context:

Nearly 2 billion people in the world, approximately 25 percent of the global population, still do not have access to electricity, according to Global Issues. Sub-Saharan Africa, has the lowest levels of electrification in the world, with nine in 10 people living without access to power.

Over 99 percent of the world’s 4 million yearly deaths of newborns -- and half-a-million maternal deaths, according to the figures of UN occur in the developing world. These deaths are deemed preventable by UN if a basic program of trained personnel, reliable equipment and adequate facilities are provided. Developing nations are establishing such programs, but the cost of medical devices remains extremely high with designs tailored to hightech first-world environments. As a result, less than 1 percent of such life-saving devices are present in low-income countries - a mismatch of tragic proportions.

The Freeplay Fetal Heart Rate Monitor is the first in a range of fit-for-purpose, low-cost, appropriate medical devices to combat this problem and make available such technology in affected low-resource settings. It is rugged in design and materials, and brings the benefit of electronic and accurate measuring of the fetal heart rate to healthcare workers, thus empowering them to make timely and life-saving decisions during childbirth.

The design team has focused on minimizing cost and boosting the robust character of the unit, while providing state-of-the-art electronics functionality with power provision in a design that elegantly fits the context.

Designed by: Philip Goodwin (industrial designer); Stefan Zwahlen (electronics designer); John Hutchinson; (project leader). Cape Town, South Africa.
Additional credits: Professor John Wyatt, University College London, United Kingdom; Dr Joy Lawn (medical research council, South Africa); Professor David Woods, University of Cape Town, South Africa.
Produced by: Ultrasound Technologies Ltd Wales UK.

What is being awarded?

The Freeplay Fetal Heart Rate Monitor is a human powered device that monitors an unborn child’s heart rate during labor and thus can help healthcare workers to make life-saving decisions while off the electrical grid in developing countries.

The design includes an obstetrics ultrasound device connected to the main unit by a cord. That main unit processes the signal and displays it. It also contains a power-management electronic module, a sound amplifier and a crank for winding up the device.

Credit also goes to Freeplay Energy for its focus over the years on a series of Design to Improve Life solutions that address the needs of many people who have no access – or only irregular or scarce access - to electricity.

The challenge addressed by the design

The statistics speak for themselves: An estimated 136 million women deliver babies every year. Of these, up to 20 million women may develop complications of some sort, and an estimated average 1500 die every day, according to WHO. Maternal deaths have economic and geographic disparities: In the world’s least- developed countries, the likelihood of dying during childbirth is 300 percent higher than in industrialized nations, with 50 percent of all deaths related to pregnancy and childbirth occurring in Sub-Saharan Africa, according to UN

Summing up, 99 percent of 4 million newborn deaths occur in the developing world, according to UN amounting to a problem that UN says outnumber HIV/AIDS, from which 3 million people die every year, according to WHO.

The severity of the problem has led to it being referenced in two of eight United Nations Millennium Goals, agreed to by 190 heads of state as warranting solution by 2015. One of those Millennium Goals is Child Health the other is Maternal Health. The objective of the Maternal Health goal is to reduce threats to women in childbirth by 75 percent by 2015. Unfortunately, UN estimates that this target is least likely of the goals targets to be achieved.

Form:

In terms of Form, the Freeplay Fetal Heart Rate Monitor is a solid, robust, durable design that fits the context in which it is intended to be useful. It has few components and its operation is intuitive. First-time users seem able to grasp how to use it quickly.

The materials combined in the device are substantial. The crank delivers up to 10 minutes of use after one minute of winding. The read-out is precise and ensures the unit can be used successfully not only by professionals but also by semi-professional midwives and others.

The weight distributions in the design are right – the device feels trustworthy and robust, combined with professional and accessible instructions for use.

FROM THE COMPANY:

The Importance of Monitoring the Fetal Heart Rate During Labour

The fourth Millennium Developmental Goal is to reduce by two-thirds the number of childhood deaths below 5 years of age. (The fifth millennium goal is to reduce by thee quarters the maternal mortality ratio).

The neonatal death rate (the rate of deaths in the first month of life) forms almost a third of all under 5 deaths. Furthermore, the incidence of fetal hypoxia (lack of oxygen) during labour must be reduced substantially as this is a major cause of neonatal deaths. For example, in South Africa, 29% of neonatal deaths are due to hypoxia during labour. In addition almost a half of all fresh stillbirths are due to intrapartum hypoxia while the burden of brain damaged children following intrapartum hypoxia is uncertain but remains tragically high (A).

During labour the fetus is dependent on the placenta to provide an adequate supply of oxygen. In normal labour the uterine contractions are of limited duration with enough time between contractions for the maternal blood supply to replenish the oxygen stores in the placenta. If the uterine contractions are abnormally prolonged or occur too frequently the fetus may become distressed due to a failure of the oxygen supply line. If the fetus receives inadequate amounts of oxygen during labour, the fetal heart rate slows in order to reduce the oxygen demands. This slowing of the fetal heart (bradycardia) towards the end of a uterine contraction is the important clinical marker of fetal hypoxia. It is therefore essential for the fetal heart rate to be monitored before and after a uterine contraction at regular intervals during all labours. This method of fetal monitoring is an essential part of primary care in labour and is promoted by the World Health Organisation.

The current obstacle to counting accurately the fetal heart rate in labour in poor countries is a lack of appropriate technology. In contrast, the Pinard fetal stethoscope is cheap and widely available but is inefficient in obtaining the correct fetal heart rate. The best choice in primary care settings is a Doppler ultrasound fetal heart rate monitor. However the commercially available monitors are expensive, break easily and rely on replaceable batteries. For these reasons the present methods of fetal monitoring are unsuitable in under-resourced settings. What is needed to solve this technical problem is a cheap, robust and energy independent monitor like the FHRM.

The acclaimed Perinatal Education Programme provides cheap and appropriate self-help learning courses for nurses and doctors, and partners very well with the Freeplay monitor to provide an excellent package of suitable educational material and monitoring device (B)

A. Pattinson R. Woods D, Greenfield D, Velaphi S. Improving survival rates in newborn infants in South Africa. Reproductive Health 2005; 2:4.
B. www.EBEhealthcare.com