Energy independent appropriate medical devices – winding up social innovations for newborn health
The following post is part of our series, Technology and Innovation for Maternal and Newborn Health. Join the global conversation as we explore the potential for delivering innovative technologies to save the lives of newborns around the world.
In 2010, the World Health Organization published a report by the Priority Medical Devices project entitled, “Medical Devices – Managing the Mismatch” that applied the questions of availability, accessibility, appropriateness, and affordability of health technologies to the 15 global high-burden diseases, the first of which was perinatal conditions.
The report highlights what we have already seen to be true in the case of pharmaceuticals, human resources for health, and health systems infrastructure –technologies for health are least available in the regions with the highest burden of disease and mortality. When such medical technologies are available, they are often not designed with the low-resource setting in mind; are often not effective to meet clinical needs of patients and healthcare workers; and are difficult to maintain or use in training. In 2012, the WHO is again calling for innovative health technologies for low-resource settings.
The global medical device industry is vast – in 2011, the market is predicted to be over US$312 billion, and most of which in highly developed nations, with the USA alone accounting for 40%. Just 30 companies will account for almost 90% of these sales, with an industry average profit margin of 16.3% – making it the world’s top four most lucrative industries with communications (mobile phones), internet services and pharmaceutical industries. In 2011, in the middle of difficult economic times, just the top 10 of these medical equipment companies paid out over $6.5bn in dividends to shareholders, equivalent to the combined annual expenditure on health of the poorest 29 of the 48 countries in sub-Sahara Africa.
For major medical device companies that need to deliver returns to shareholders, there are few economic incentives to develop low-cost, appropriate, durable medical technologies. The barriers are not only in the innovation and design, but also in the “diffusion” of technologies to the global marketplace and into the hands of healthcare workers and users. These are market failures – where the “free” market mechanisms have not delivered benefits to the majority of the world. The Grand Challenges for global health was established precisely to counter these distortive market forces, and create a “pull strategy” for innovations in priority global health areas and accelerate development and diffusion.
The wind-up medical devices of Powerfree Education and Technology were developed with the same principles as the MANDATE approach – data driven by clinical need for the major causes of newborn deaths, with a real understanding of the context within which devices in low-resource settings are used. Two critical decision making tools have been developed in South Africa by a team of paediatricians (Professor John Wyatt from the University of London and Professor David Woods from the University of Cape Town) and an engineer (John Hutchinson): a fetal heart rate monitor and a pulse oximeter (oxygen monitor) to contribute to efforts on prevention of birth asphyxia and respiratory diseases of the newborn.
Certain conditions need to be kept in mind, while designing for the delivery of appropriate and affordable health technologies in low-resource settings. Such innovations in design and their respective no-frills business models have been described as “frugal innovations” or taking place in the “innovation sandbox”, especially in emerging economies like India. By intimately understanding the context of where newborn care takes place, PET’s wind-up devices have been developed along following “social innovation” design principles:
Safe and effective. Where possible devices will meet the highest quality and international regulatory standards for medical devices. The fetal heart rate monitor meets European regulatory standards already with the CE mark.
Capable of functioning independently of mains electricity and replaceable batteries, and capable of being powered by a range of options including human-powered hand crank, solar panel, car battery and generic mains adaptors. The device is capable of accepting the widely fluctuating AC parameters often experienced in Africa.
Robust, “ruggedized” and maintenance-free where possible, with a minimum lifespan of 3–5 years with intensive daily use.
Capable of operating without the need for proprietary replacement consumables wherever possible.
Simple in operation for users and acceptable to patients.
Affordable. The target price for devices in developing world markets is under $200 per device, without compromising on quality.
Provided with specially written self-help distance learning materials for use by health staff.
The fetal heart rate monitor won the INDEX: Award in Copenhagen in the Body category - the award is the largest and most celebrated global award that recognizes high-quality designs that improve life, and was demonstrated at TEDx in South Africa. In partnership with Save the Children, the fetal heart rate monitor was more recently awarded the Saving Lives at Birth Grand Challenge award to test its use in field trials in Uganda.
It is true that many innovations do create value for society – the internet, mobile phones, pharmaceuticals and health technologies. Doppler ultrasound and accurate fetal monitoring have been saving babies’ lives for decades – but only for a minority of births. When traditional markets fail to deliver these tools and their benefits to everyone, as is often the case with public goods like health, social innovations become critical to extend these benefits justly, effectively and affordably to those who need it most.
Following the development, research and testing of devices, the delivery of these tools into the hands of users becomes the next big challenge, where partnerships and multi-sector collaborations between civil society, private sector and government are the only options to integrate health technologies into programmes and health systems, as these are being strengthened.