NB Health Care

Thursday
March 13
2014

Mike Miesen

Know Thy Hospital: Engineers and entrepreneurs are rethinking medical device design, and the world could be healthier as a result

Many remote hospitals in sub-Saharan Africa lack basic medical devices, like infant incubators, radiant warmers and anesthesia 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, as Jane Cockerell, the chief executive of the Tropical Health and Education Trust, recently outlined at the Lancet Global Health Blog. (Her organization also produced a how-to guide for medical device donations; read it here.)

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 it breaks – and often stays broken.

Fortunately, social entrepreneurs and engineers are rethinking 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, lifesaving care to their communities.

But, as Cockerell points out, the system must do better. Roughly half of medical equipment in developing countries – much of it donated – is inoperable or otherwise out of service. This is simply not good enough.

Even when used medical device donations are thoughtfully executed, there’s a limit to how effective they can be. An 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 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 usually readily available; in remote, under-supported Malawian hospitals it’s difficult to find either.

(A Universal Anaesthesia Machine, left.)

And so, as painful as it is to see lifesaving 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 two months late.

The organization I work for, Gradian Health Systems, is a nonprofit social enterprise that manufactures and sells the Universal Anaesthesia Machine, 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 oxygen to the patient. When the electricity cuts out, the system uses cylinder/tank or pipeline oxygen; if that isn’t available, it converts to room air (known as draw-over anesthesia). The oxygen monitor will last up to 10 hours on rechargeable battery backup.

The UAM is built for easy maintenance and repair. With nothing more than a hex wrench, a screwdriver and basic training provided during installation, the hospital’s in-house technician should be 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’s an in-country biomedical engineer who knows the UAM; Gradian has trained about 100 technicians and engineers on the device.

Gradian 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 LEDs that can last 25 times longer than typical, difficult-to-source compact fluorescent bulbs.

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-dependent design mindset in students, too. Rice University and Stanford University both have well-regarded programs that have spun off a number of highly disruptive technologies that were designed with the end user in mind, including:

• The Bubble Continuous Positive Airway Pressure, or bCPAP, device for newborns, which showed positive results in a recent study conducted in Malawi.

• The Embrace BabyWrap, a low-cost newborn incubator, was designed for use in hospitals and health centers with intermittent access to electricity, keeping newborns warm when the power cuts out.

It is critical 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 the Tropical Health and Education Trust 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.

A version of this post originally appeared at the Lancet Global Health Blog.

Mike Miesen is a business strategy analyst at Gradian Health Systems.

Categories
Entrepreneurship, Environment, Health Care
Tags
consumer products, global health, health care, medical devices, product design, social enterprise, sustainability