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September 15, 2017
What to Do When FDA Approval Doesn’t Mean a Medical Device Is Safe
contributor: Elizabeth Johansen
Does United States FDA regulatory approval mean a medical device is safe and effective in low-resource settings? The short answer is no. In developing countries, up to 95% of western medical equipment is broken within 5 years. In fact, only 10-30% of this donated equipment ever becomes operational. To make a medical device suitable for a low-resource community, manufacturers must go above and beyond.
As a former IDEO design engineer, I started my career working on medical devices and consumer products for Fortune 500 companies. For the last 7 years, I have had the pleasure to work with Design that Matters (DtM), Diagnostics for All, and Jana Care creating medical and diagnostic devices to improve health in developing countries. These are just some of the companies leading the charge to create more affordable and appropriate tools. Each of these organizations has had to push themselves beyond the classic regulatory standards to fulfill requirements unique to hospitals, clinics, and homes in low-resource communities.
We knew early in the design process that just meeting the standards would not yield a device appropriate for low-resource settings.
One of the common questions I am asked when I tell someone I am helping design medical devices for the developing world is whether we will be seeking FDA approval. The United States Food and Drug Administration (FDA) regulates medical devices ranging from complicated, high-risk medical devices, like artificial hearts, to simple, low-risk devices, like tongue depressors, as well as devices that fall somewhere in between, like sutures.
Europe requires medical devices to achieve UL approval and CE Mark certification. These requirements mainly focus on quality manufacturing processes and design practices like choosing safe materials and minimizing radiation coming from a device. In contrast, gaining FDA approval is known to be the most expensive and time-intensive medical device regulatory process in the world because of the unique requirement to evaluate efficacy.
When people ask me whether we are pursuing FDA approval, the subtext is whether we are building a safe device, and how we are balancing affordability, time until product launch, and safety for those we serve. My answer usually surprises them: CE Marking or FDA approval don’t guarantee safe medical devices for low-resource contexts. The best way I can explain this is through the example of Design that Matters’ Firefly phototherapy.
Firefly Phototherapy & Regulatory Approval
Firefly is a double-sided phototherapy device currently treating jaundiced newborns in hospitals in 23 developing countries. Around 10% of all newborns require treatment for jaundice in order to avoid permanent brain damage or death. Treatment is deceptively simple; shine as much blue light on the skin as possible. However, most existing solutions were not performing well in low-resource hospitals.
Design that Matters took two important steps that led to Firefly’s success. First, we pored over the international phototherapy standards that FDA and CE Mark use to validate a medical device for use in high resource hospitals with climate control, filtered air, and smooth floors. Then, we used Human-Centered Design methods to gain insights from experienced local partners, and we directly observed the intended context of use early and often in the design process. These observations led to product requirements that went above and beyond what is required in the international phototherapy standards.
Western devices fail due to poor training as well as environmental factors including heat, dust, and irregular electrical power.
Beginning with the international phototherapy standards was helpful in that they lay out how bright and uniform the light must be in order to provide clinically effective phototherapy. Other relevant standards include the general IEC/ISO for medical devices and the specific infant phototherapy standard used to design and evaluate medical electrical equipment for CE Mark and FDA Approvals. DtM designed with these standards in mind and then found where we needed to go above and beyond. We knew early in the process that just meeting the standards would not yield a device appropriate for low-resource settings.
DtM’s partnership with East Meets West Foundation and Vietnamese manufacturer MTTS was essential to developing a device that works in low-resource settings. Together, East Meets West Foundation (an affiliate of Thrive Networks) and MTTS have over a decade of experience designing and manufacturing successful newborn health technologies for the poor. In close partnership with hundreds of hospitals in Vietnam, they discovered early on that Western devices fail due to poor training as well as environmental factors including heat, dust, and irregular electrical power. Our manufacturing and implementation partners are continually learning from hospitals, designing and releasing equipment, visiting to learn from any failures, fixing the equipment, and then redesigning the next generation of equipment to even better meet the challenges. Every piece of equipment they build also goes through a functionality test before it leaves MTTS. These tests have been custom designed to predict whether equipment will endure in the low-resource environment. MTTS and DtM collaborated to recreate this same process for Firefly.
Many of these burned-out devices had passed FDA approval. They would be considered safe in the right context, but there are so many ways a device can fail in a low-resource setting.
DtM used human-centered design techniques to interview MTTS staff in-depth about their experiences in these environments. We invited MTTS to tell us stories of equipment failures and successes, encouraged them to dig up old photos to jog the memory, brought MTTS staff with us on hospital visits, and created a steady line of communication through a series of regular Skype calls to pass on new stories.
In one hospital visit in Vietnam, we encountered a bank of broken, high-tech newborn incubators. That room was used to observe all newborns shortly after birth and treat their minor health issues. I noticed many newborns in the room lying inside incubators, traditionally used to provide enclosed, warm environments for critical care. It was at odds with the low-intensity care needed for the room’s newborns. I asked a nurse why some babies were in incubators and others in open beds. She said the incubators were broken and used simply as additional beds and storage space. Some incubators had blown fuses due to power spikes, while others had undiagnosed failures that rendered them useless as anything but spare bedding. Many of these burned-out devices had passed FDA approval. They would be considered safe in the right context, but there are so many ways a device can fail in a low-resource setting. These incubators had become no more than fancy and cumbersome beds.
The resulting Firefly Design
Building on the best practices for phototherapy design in the first world, plus what we learned through interviews and field research at hospitals throughout Southeast Asia, DtM created a unique design that prevents bugs, dust, and liquids from entering and enables Firefly to keep operating during broad power fluctuations.
1. Keeping Cool and Free of Bugs
Typically, devices with electronics have holes. You may never have noticed, but if you look at your computer, most will have a series of perforations. Most devices with electronics also make a purring sound. For many electronic devices, both of these features are due to the need to keep the electronics cool. The purring sound is usually a fan, and the holes enable it to blow hot air out and bring cool air in. These features keep the device from becoming dangerously hot to touch, and also to ensure the electronic components can perform optimally.
In a US hospital, electro-mechanical medical devices share these same cooling solutions. However, when these devices are taken to low-resource contexts, they run into trouble. The interior fills with dust and insects. The fans are often the first thing to break, causing the electronics to overheat and burn out in the warm environment. A DtM friend in India quipped, “You haven’t really tested a piece of electronic technology for distribution in Asia until you’ve trained a cockroach to climb in and pee on every single little component on the inside.”
Instead of fans, another way to keep electronics cool is by exposing a large surface area of high thermal conductivity to the air. You may have noticed cooling fins on other home electronics like your refrigerator. Metal cooling fins increase the amount of area exposed to the air on the bottom of Firefly and increase conduction compared to a flat, plastic outer surface. In order to completely seal Firefly, DtM designed a novel passive cooling system for the top and the bottom.
The top light was easier to design because heat rises: we manufacture the top light from an aluminum extrusion that has sufficient surface area on top to enable heat from the top lights to rise upward and away from the device. The bottom light was more difficult because any rising heat could directly contribute to overheating the newborn in the bassinet. For this issue, we designed a tilted bottom surface and installed cooling fins. Because hot air rises, air from the lowest part of the device rises up along the fins, cooling the base electronics and enabling the majority of the heat to rise off the rear.
2. Riding power fluctuations
Earlier I mentioned the Duke University study found that up to 95% of medical equipment sent to developing countries is broken within five years. There are many causes, but one of the major issues is fluctuating power sources. Electrical power in Myanmar is 220v at 50Hz. Brownouts, blackouts, and voltage fluctuations are common, especially in the dry season. The typical Nigerian building experiences power failure or voltage fluctuations about seven times per week, each lasting for about two hours and without the benefit of prior warning. To enable Firefly to ride the waves, we knew we needed a serious power supply. However, the power supply is one of the main components generating heat in a device. Could we point to any existing examples of technology that were already good at working through power fluctuations and could solve the heat problem?
“You haven’t really tested a piece of electronic technology for distribution in Asia until you’ve trained a cockroach to climb in and pee on every single little component on the inside.”
The answer? Laptops! During field research in hospitals in eight countries throughout Southeast Asia, we were always able to use our laptops! Most laptop power cords include a “brick” – that is the power supply. Reading the numbers on the brick, most of these power supplies accommodate a range of voltages for input. In the end, we were able to find an existing off-the-shelf power supply integrated with a power cable that is CE Mark certified for medical use, can accommodate 100-240 Volts AC, and keeps the hot power supply outside of our sealed device and away from the baby, just like a laptop power cord. This power supply doesn’t keep Firefly going during every power surge or dip, but it will dramatically increase the ability to use it in many countries through many electrical fluctuations, and it’s much easier to replace if it breaks.
In the end, MTTS obtained CE Mark certification for Firefly to help it be more easily approved for use in new countries. However, the evidence was laid out in front of us; the phototherapy standards used in FDA approval and CE Mark certification focus on hospitals with big resources. To design Firefly to work well in low-resource contexts, DtM leveraged partner and field experience to go beyond known phototherapy standards in order to deliver a device that meets a higher standard of care. DtM is proud to partner with East Meets West Foundation and manufacturer MTTS and their joint vision of designing devices that really work in hospitals with few resources. The work continues today; I am currently Senior Advisor to DtM using the same human-centered design methods to usher the design of a newborn warmer with help from MTTS and a new partner; the Affordable Design and Entrepreneurship Program at Olin and Babson College.
What Can You Do?
So, what can you do when FDA approval doesn’t mean equipment is safe or effective?
First, inform yourself about what it means to bring appropriate medical devices to low-resource contexts. Just because a device has regulatory approval, does not mean it was designed for every context. One resource is the WHO Medical Device Technical Series to help those designing, procuring, or writing regulations and policies related to equipment for low-resource contexts. Produced under the guidance of the indomitable Adriana Velzquez-Berumen, this includes advice spanning R&D, regulatory, assessment, and management. Another resource is IDEO.org’s free Design Kit and Acumen’s free online course Introduction to Human-Centered Design. The kit and course have helped many organizations better understand their target communities and beneficiaries leading to better programs and technology.
Second, find medical devices that have been deemed appropriate for the intended context. The WHO Compendium of Innovative Health Technologies for Low Resource Settings is a good place to start. Keep a special eye out for devices from companies that have made it their mission to create context-appropriate solutions.
Finally, help identify gaps that haven’t been met and support organizations that are developing more appropriate technology to fill those gaps. These products-in-progress are often found among networks and accelerators like the Pneumonia Innovations Team, MGH Center for Global Health’s CAMTech, and Villgro, just to name a few.