But some of the most innovative new medical devices are actually very simple — and often, very small. In fact, that’s what’s exciting about them. Because small, simple devices are portable and easy to use, they have the capacity to spread access to high-quality medical care to some of the poorest areas in the world.
Take the AtomoRapid HIV test, which recently won the Best in Show prize at the 2014 Medical Design Excellence Awards. Not much bigger than a thumb, the device contains a sterile pad, pinprick lance and collection tube that — with a swipe of a clinician’s thumb — transfers blood safely to a testing strip. The company launched the product in Africa at the beginning of the year, selling to NGOs, doctors, pharmacies and even mining companies. Recently, the Desmond Tutu HIV Foundation started using the test kit.
Atomo Diagnostics CEO John Kelly explains that the company wanted to create a rapid response test kit that delivered fewer false negatives. “We were trying to develop something specifically for a user that typically doesn’t factor much in design thinking,” he says. “A lot of the current diagnostic products are developed by guys with PhDs in microbiology — and in the lab it works really well, because you’ve got perfect equipment and highly trained users. The problem is, the product doesn’t work quite as well when it’s taken into the field or in a consumer setting.”
That’s because medical facilities in the developing world are separated from their wealthier Western counterparts by more than just geography. A recent study by a team made up in part by World Health Organization researchers showed that only 28 percent of medical facilities and 34 percent of hospitals surveyed in Sub-Saharan Africa have reliable access to electricity, making it difficult to use high-tech machines even when they are available. Worker training can also be a major barrier to using complex equipment and techniques. In fact, the WHO estimates that 70 percent of medical equipment in Sub-Saharan Africa goes unused.
Hallie Sue Cho was thinking of exactly that problem when she created the Ottoclave, a portable medical instrumentsterilization tool that could serve as an alternative to the large, complicated autoclaves Western hospitals rely on. In developing countries, Cho “found perfectly good autoclaves sitting around — they were functioning, but they weren’t being used,” says Eric Reynolds, the fellowship administrator at MIT’s D-Lab, which works with entrepreneurs like Cho to bring to market medical devices and other products aimed at the developing world. “Autoclaves are designed for places that have electricity and people who are trained to use them.”
Cho’s Ottoclave is designed to work in the 400,000 primary health care facilities around the world that lack proper sterilization equipment. The device is essentially a pressure cooker outfitted with a sensor that tracks the pressure inside the device and announces when sterilization is complete. Even better, it can run from a variety of power sources, including wood, kerosene or solar. Compared to industrial autoclaves, the device is small and easy to transport — and based on a technology that is familiar to many people all over the world.
Entrepreneurs developing small, simple devices stress it’s important to spend a great deal of time with end users to ensure products are actually solving problems. Kelly, for example, said his company made a mistake by numbering the components of the AtomoRapid HIV kit — something it thought would help testers use the device properly. “We thought it was brilliant and that we were geniuses,” Kelly says. “But everyone looked at it and said, ‘We have no idea what those are.’”
Yet design is only one of the major challenges when it comes to small devices. Another is achieving sufficient scale to earn a return on what are often low-cost products. Reynolds points out that margins are much thinner in the developing world, which can make it difficult to fund the clinical trials that can be necessary for regulatory approval — never mind expand operations.
Zubaida Bai, founder of a company called Ayzh, has sold about 60,000 clean birth kits, which cost between $2 and $5, in India and Africa. The Janma kits are designed to be portable and ensure a sterile birth environment in any setting. The kit contains a sterile mat as a clean delivery surface, sterile instruments and sanitary wipes for the hands of the person doing the delivery — all in a biodegradable purse. Yet even though her sales have grown steadily, Bai says achieving scale is the hardest part of introducing a breakthrough product.
Healthcare professionals are sometimes reluctant to try something new, and may not even acknowledge that their current methods and equipment are problematic. “There’s no such thing in the medical world as a no-brainer,” says Bai.
Despite all the challenges, small and simple devices have the potential to revolutionize medicine. That’s because their appeal carries far beyond developing countries that can’t afford big, fancy stuff. Kelly, for one, hopes to introduce his HIV test kit for consumer use in the United States and Europe.
In a world that is increasingly mobile, small and simple isn’t a second-best solution — it’s just smart design.
Top image: Courtesy of Atomo Diagnostics