Designing Medical Devices for Predictably Unpredictable Environments

An operating theater at Connaught Hospital in Freetown, Sierra Leone (photo: Steve Rudy)

An operating theater at Connaught Hospital in Freetown, Sierra Leone (photo: Steve Rudy)

Via The Lancet Global Health Blog

(Full Disclosure: I work here, so am obviously an interested party)

Many remote hospitals in sub-Saharan Africa lack basic medical devices, like infant incubators, radiant warmers, and anaesthesia machines. Recognizing this, well-meaning individuals and organizations from high-income countries donate medical equipment – sometimes new, but mostly used – to these hospitals. Despite the best of intentions, this equipment often fails. Fortunately, social entrepreneurs and engineers are re-thinking medical device development in ways that could lead to real, sustainable improvements in health systems around the world.

There is no question that donated, used medical equipment has a role to play in strengthening low-resource health systems; it can better allow clinicians to provide life-altering, life-saving care to their communities. But, as Jane Cockerell, Chief Executive of the Tropical Health and Education Trust (THET), pointed out recently on this blog, the system must do better. (Her organization also helpfully produced a how-to guide for medical device donations). Roughly halfof medical equipment in developing countries – much of it donated – is inoperable or otherwise out of service. This is simply not good enough.

Medical device donations fail for a lot of reasons, but the main one is that medical equipment functions most effectively when it is designed for the environments it will be used in, and most medical devices used in sub-Saharan Africa don’t meet this modest bar. So they break – and often stay broken. Even when used medical device donations are thoughtfully executed, there’s a limit to how effective they can be. A MRI machine designed for an American hospital simply isn’t fit to adapt to the most common difficulties faced by remote, under-resourced hospitals in Malawi or Nepal. A power outage in America is a national newsworthy event; in much of Malawi, it’s a daily occurrence. An American hospital running out of compressed oxygen would be vilified, scandalized, and sued; a low-resource Nepali hospital running out of compressed oxygen is the status quo. When an X-ray machine needs maintenance or a spare part in America, a trained expert with a spare part is readily available; in remote, under-supported Malawian hospitals it’s difficult to find either.

And so, as painful as it is to see life-saving medical equipment sit broken, idle, or otherwise inoperable in hospitals’ “medical device graveyards,” it isn’t remarkable or even all that surprising. It’s actually kind of obvious: the equipment isn’t designed for that environment, so why would we expect it to work there?

Designing devices to meet the needs in which they’ll be used – call it “context-aware design” – isn’t new. It’s perhaps the central tenet of medical device design: Know Thy Hospital. In hospitals and health systems in low-resource settings, the customer needs flexible technology fit for predictable unpredictability. Sometimes the electricity is available; sometimes it’s not. The shipment of oxygen canisters may have arrived on time; it may be 2 months late.

My organization, Gradian Health Systems, manufactures and sells the Universal Anaesthesia Machine (UAM), a device designed to function continuously in any environment. It’s made to thrive in predictably unpredictable environments. When electricity is available, the UAM’s in-built oxygen concentrator supplies ample oxygen to the patient. When the electricity cuts out, the system uses cylinder/tank or pipeline oxygen; if that isn’t available, it seamlessly converts to room air (known as draw-over anaesthesia). The oxygen monitor will last up to 10 hours on rechargeable battery backup, providing integrated safety in a potentially unsafe environment.

Training on the Universal Anaesthesia Machine at Connaught Hospital in Freetown, Sierra Leone (photo: Steve Rudy)

Training on the Universal Anaesthesia Machine at Connaught Hospital in Freetown, Sierra Leone (photo: Steve Rudy)

Crucially, the UAM is built for easy maintenance and repair, because that’s what the customer needs. With nothing more than a hex wrench, a screwdriver, and basic training provided during installation, the hospital’s in-house technician is able to diagnose most issues with the machine and locally source the necessary spare part. If he or she is unable to fix it, there will always be an in-country biomedical engineer who knows the UAM well – because we trained him or her.

My organization is only one of many to focus on context-aware design for difficult environments; to name just two others:

  • D-Rev created the Brilliance phototherapy unit, which uses LED bulbs that can last 25 times as long as a typical compact fluorescent bulb
  • Daktari designed a rugged, ultra-portable CD4 counter that can be used just about anywhere, allowing physicians to safely bring it to remote areas

Universities are helping to develop the context-aware design mindset in students, too.Rice University and Stanford University both have well-regarded programmes that have spun off a number of highly disruptive technologies that were designed with the end user in mind, including:

It is crucial to design medical equipment that meets stringent safety and regulatory standards set by national and international bodies, like FDA and CE-mark approval. Without adhering to these high standards, device designers run the risk of creating technologies that are “good enough for them” but not “good enough for us.”

Organizations like THET have done an invaluable service by documenting how to appropriately donate used medical equipment. But we must recognize that used equipment is, at best, a partial solution. It isn’t designed for use in predictably unpredictable environments, and for that reason it often fails. Proper design focuses on the needs of the customer – not the needs of the donor.

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