Health Technologies and Innovation in the Global Health Arena

Sidhartha R. Sinha, M.D., and Michele Barry, M.D.

N Engl J Med 2011; 365:779-782September 1, 2011

Article

In recent years, interest in both global health and health care innovation has grown tremendously, and there has been increasing recognition of the importance of medical devices and other nonpharmaceutical health-related technologies to all aspects of health care. In 2007, for example, the World Health Organization (WHO) issued the first global directive on medical devices, recognizing that, like medicines, many health technologies are indispensible. Many appropriate technologies, however, are inaccessible to the majority of people who need them, particularly in low- and middle-income countries — largely because of capacity constraints, a perception that medical devices are out of the reach of or superfluous to developing countries, and the lack of assiduous, multidisciplinary needs assessment and innovation promotion in such countries.

The recognition that the “right to health” should include access to certain devices comes more than 30 years after similar recognition for essential medicines. One reason for this delay is the common conception of medical devices as expensive, highly engineered products that are often nonessential. But this description is generally not applicable to the health-related technologies needed in low- and middle-income countries. The WHO defines medical devices as “health technologies that are not medicines, vaccines, or clinical procedures” but are used in diagnosis, prevention, or treatment,1 and the types of technologies seen as potentially appropriate for low-resource settings are quite different from the PET scans and implantables seen in wealthy countries. Low-cost infant warmers, point-of-use water purifiers, portable low-cost ventilators, self-contained parasite-detection systems, low-technology child-restraint seats, and reusable newborn suction devices are examples of health technologies that the WHO has indicated are needed for low-resource settings and are worthy of investigation.2

Health Technologies That Are Appropriate for Low-Resource Settings.

Creating appropriate products for low-resource settings requires not only a rethinking of what is considered a health technology, but also cross-disciplinary innovation and in-depth understanding of the particular needs of each country. Location-specific needs assessment will help ensure that more appropriate devices reach people in need and will support parallel efforts to deploy novel devices, processes, or information technologies to cost-effectively reduce disease incidence. It will also help to prevent the adoption of ineffective or inappropriately costly technologies that could divert resources from other critical health care areas.

The consequences of inadequately understanding a country's needs are evident. About 70% of complex medical devices sit inoperable at their destinations in developing countries,1 and most basic devices don't reach developing-country populations in adequate numbers. Costs certainly play a role in the lack of penetration, but this gap has many other causes — key among them, a lack of capacity. The capacity issues include a lack of spare parts and needed consumables (e.g., adhesive patches for electrocardiogram leads) and a lack of the basic infrastructure, distribution channels, trained personnel, and engineered systems required for utilizing devices appropriately. Of course, devices are not the answer to all medical problems — in many cases, the most cost-effective solution may be a vaccination or education, for example, but only an understanding of the needs and the inherent capacity constraints can clarify the appropriate solution.

The limitations to device development are not insurmountable. Just as many developing countries used cell phones to leapfrog conventional copper-wire landlines, innovation in medical technology offers similar promise. For example, “lab-on-a-chip” technology, which may cost less than a penny per paper-based chip, can replace many expensive diagnostic tests and be used at rural locations. Similarly, remote monitoring and diagnosis using cell-phone platforms and telemedicine kiosks may help countries avoid the high costs associated with building conventional rural health systems. Certain technologies, such as bilirubinemia monitors and point-of-care tuberculosis tests, can be used for rapid screening and detection. Such technology can allow developing countries to cost-effectively identify disease in remote areas and prioritize intervention efforts.

The urge to apply technologies without proper identification and understanding of the most compelling needs is a frequent source of failure for medical innovation. Information on the burden of disease can clarify the unmet health needs that might be addressed with technology. For example, each year almost 2 million children, disproportionately in developing countries, die from pneumonia. Although research into prevention is critical, there's also a need to better triage and monitor afflicted children. Mobile-phone–based pulse oximetry and low-cost sensors for monitoring respiratory and heart rates, which are being field-tested in Uganda, can provide community health workers with the basic information they require for those purposes.

Another leading cause of death and disability is road-traffic injuries. Low- and middle-income countries, according to the WHO, shoulder about 90% of this burden. The problem is compounded by the extended time that may be required to transport an injured patient to a distant hospital. Preventing further injury and limiting additional pain during transport is the focus of a multidisciplinary team of students in India, who have created a versatile, low-cost, radiolucent, limb-immobilization device to help patients reach medical care more safely. Once such devices have undergone scrutiny including cost-effectiveness analysis, they could dramatically improve care for millions of people.

To create solutions for developing countries that reflect their needs and value systems requires multidisciplinary needs-finding research, as well as financial and design modeling and business-implementation plans. Several universities around the world, working on the well-founded premise that successful innovation rarely happens in isolation, are building medical-device innovation programs. These institutions have recognized that training and fostering of collaboration with engineers, health care professionals, business and design strategists, and social scientists are crucial to the development of scalable, cost-effective devices.

A climate of innovation should be promoted globally, but we must acknowledge the enormous differences among developing economies. Fostering technologies that “disrupt” or leapfrog more expensive conventional methods may be ideal for most developing countries, and incremental innovations that increase the value of current medical devices may sometimes be the most useful approach. By contrast, promoting relatively expensive “blue sky” innovation — which represents a major departure from existing solutions and generally requires substantial academic and commercial infrastructure — may work in countries such as China and India but would be quixotic in most developing countries.

Collaboration should also extend into public–private partnerships among industry, academic centers, nongovernmental organizations, and governments. Many medical technology companies produce devices in the developing world, yet many of these products are out of reach of the local population. In India, the majority of medical devices manufactured are exported, while 75% of the medical devices used in the country are imported.3 Although such an imbalance may be justified on economic grounds, when local populations cannot obtain the products they make for export, issues of distributive justice must be considered early in the process of entrepreneurship and innovation.

Finally, we must not embrace technology for its own sake. Billions of dollars are spent on technologies that don't clearly improve outcomes. Medical devices must meet real needs and provide clear value. Financing such innovation will require investment from nongovernmental organizations, governments, and global institutions promoting health but can also be supported by less-conventional sources. A microfinancing model, for example, could be used to support product distribution and promote diagnosis by local health care workers, thereby enfranchising the poor through employment while promoting health. In developing countries, universities with appropriate expertise or external collaborators can train local multidisciplinary teams to identify solutions, helping them build their own innovation programs to improve health. Regulations, including requirements for postmarketing surveillance, must be in place to ensure that health care resources are not wasted and that innovative technology is not pursued at the expense of either traditional prevention efforts or the safety of vulnerable populations.4 Substantial evidence indicates that when the value of improved quality of life and productivity are considered, investments in health technology offer great returns.5 Assessing medical needs, building capacity, and promoting cost-effective innovation will help in realizing technology's potential for achieving better health in low-resource settings.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Source Information

From the Biodesign Program (S.R.S), the Division of Gastroenterology and Hepatology (S.R.S.), Department of Medicine (S.R.S., M.B), and the Center for Innovation in Global Health (M.B.), Stanford University, Stanford, CA.

References

References

1
World Health Organization. First WHO global forum on medical devices: context, outcomes, and future actions. 2011. (http://www.who.int/medical_devices/gfmd_report_final.pdf.)

2
Idem. Compendium of new and emerging health technologies. 2011. (http://whqlibdoc.who.int/hq/2011/WHO_HSS_EHT_DIM_11.02_eng.pdf.)

3
Deloitte. Medical technology industry in India: riding the growth curve. July 2010. (http://www.deloitte.com/assets/Dcom-India/Local%20Assets/Documents/Medical_technology_Industry_in_India.pdf.)

4
Institute of Medicine. Medical devices and the public's health: the FDA 510(k) clearance process at 35 years. July 29, 2011. (http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx.)

5
Health, retirement needs challenge an aging America. Press release of the National Institute on Aging, Bethesda, MD, September 28, 2004. (http://www.nia.nih.gov/NewsAndEvents/PressReleases/PR20040928Health.htm.)

Citing Articles (2)

Citing Articles

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R. Richards-Kortum, L. V. Gray, M. Oden. (2012) Engaging Undergraduates in Global Health Technology Innovation. Science 336:6080, 430-431
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Maxime Cannesson, Joseph Rinehart. (2012) Innovative Technologies Applied to Anesthesia: How Will They Impact the Way We Practice?. Journal of Cardiothoracic and Vascular Anesthesia
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