Posted January 4th 2012 at 4:20 pm by
in Stories from the Field

Creating a Phototherapy Device for Babies in Vietnam

Creating a Phototherapy Device for Jaundice Babies in Vietnam

Baby Le Bao Ngan being fed by Mom, Vu Ngan Ha, 3 ½ days after birth by cesarean section. Baby Ngan was the 3rd infant to receive full treatment from Project Firefly’s infant phototherapy device. Photo by Will Harris of Design that Matters.

The world’s best design teams often create products for the world’s wealthiest people.  Medical devices are among the most important products demanding an intensive, years-long design process.  Yet they rarely reach low-income people.

At Design that Matters (DtM), a non-profit design firm in Boston, we are breaking the mold by designing products that benefit families in the developing world living on less than $2 a day. Since joining DtM as its Director of Product Development, I have learned that it takes a lot of collaboration, trust and spontaneity to create designs that fit this large and unique market.

To give a little more background: before DtM, I worked as an engineer and project leader at IDEO, a high-profile global design firm.  Part of my work involved designing products for prominent U.S. medical device and pharmaceutical corporations. My colleagues at these corporations were highly-educated engineers and business people who chose to work in the medical field because they are committed to helping people live healthier lives.

The design of the Eli Lilly Kwikpen insulin injector for diabetics was one IDEO project of which I was particularly proud. The design process started in 2003, and the device finally hit the market in 2008. During my two-year contribution, I learned how to operate in a society where lawsuits loom around every corner. Through prototype after prototype, test after engineering test, and hours of meetings to identify every potential failure point, the obsessive compulsive, engineering, perfectionist part of myself felt good about the care the team put into designing this ultra-safe device.

Now, every year, millions of quantities are distributed across countries around the world. But as the years went by, I began to wonder: Exactly who are the millions of people benefitting from designed devices like Kwikpen?

Access to quality medical care is not universal, even in a first world country. I have firsthand experience with the broken medical system in the U.S. My mother has lived in a nursing home for the past six years under the auspices of Medicare and Medicaid services. Each day, we are prevented from accessing high-quality doctors. There are a maze of exclusions from receiving well-designed medications, devices, and equipment beyond the reach of my mother’s insurance providers.

The Kwikpen I helped to design is available only by prescription. It is not covered by many health insurance plans. In fact, it is incredibly costly to pay out-of-pocket due to the painstaking Research & Development effort required to create a new medical device in a litigious society.

Now consider DtM’s Project Firefly where we ask: How might we create intuitive and affordable products that help provide accessible, quality medical care for those who have very little?

Project Firefly is a joint effort between DtM, East Meets West Foundation (EMW), and Vietnamese manufacturer Medical Technology Transfer and Services (MTTS) to design an easy-to-use infant phototherapy device to cure neonatal jaundice in rural district hospitals across Southeast Asia.

Our collaborative team of Boston-based designers and Vietnamese doctors has begun to answer these tough questions. DtM just returned from a trip to Vietnam kicking off a one-month clinical trial for Project Firefly.  For me, the experience was an eye-opening and inspiring lesson in collaboration, trust, and spontaneity given my own American, Food and Drug Administration-laden notions of risk.

We arrived at the Neonatal Intensive Care Unit of the National OBGYN Hospital in Hanoi, the morning of December 5th. It was Project Firefly’s first day of clinical trials. After a quick chat with National OBGYN’s clinical trial supervisor, Dr. Nguyen Ngoc Loi, and NICU Director, Dr. Nguyen Thanh Ha, we began the effort to implement the clinical trial. I quickly discovered the biggest challenge for this trial was collecting the information to verify that Firefly does treat jaundice, while maintaining infant safety and keeping the already overloaded doctors and nurses happy.

Creating a Phototherapy Device for Jaundice Babies in Vietnam

One of nine rooms in the busy Neonatal Intensive Care Unit at National OBGYN Hospital, Hanoi. Project Firefly phototherapy can be seen in the upper left corner in the process of clinical trial. Photo by Timothy Prestero of Design that Matters.

Firefly is designed for rural district hospital settings that have no other infant treatment equipment.  However, National OBGYN Hospital in Hanoi was chosen for the one-month clinical trial to keep Firefly filled with infants and close to MTTS during the trial. The National OBGYN Hospital has more than 150 infants, the highest baby occupancy anyone on the team had ever seen.

They were in a nine-room NICU, with over 40 incubators that were used to keep them warm. Other babies on the waiting list were on wheeled infant beds packed together – two or three to a bed.

Our first hurdle was satisfying the Vietnamese doctors’ sense of safety while keeping the babies at an appropriate temperature as prescribed by EMW’s U.S. clinical advisers. The ambient temperature in a given NICU room was 28 C (82 F), however the National OBGYN’s doctors were concerned that the babies might get cold.

MTTS engineers conducted a test running Firefly and the overhead infant warmer for one hour, and infant bed temperatures were deemed safe. Dr. Ha asked, “Why are you doing all these thermal tests? We trust Firefly! There is no need to worry!” The Vietnamese medical team verified that this setup was just right, so we cleared it for our first jaundice treatment.

Next, Dr. Loi had to identify the first baby to receive phototherapy. Based on EMW recommendations for phase one testing, Dr. Loi searched for an infant that was not premature, that did not have any medical complications other than jaundice, and was at least 4-days-old.

Initially, he chose Tran Thi Huong.  But at noontime, baby Huong was ready for lunch, so the search continued. Another prospect, wrapped tightly in blankets, was deemed too warm after a quick temperature check. Finally, a third infant was just right.

At 12:12pm on December 5, 2011 baby Nguyen Huong Giang was the first infant to receive phototherapy from Firefly. She was placed in the bassinet by Nurse Uyen and two probes were placed on her skin to closely monitor her temperature. Baby Giang looked calm and comfortable the minute she was set into the device.

Creating a Phototherapy Device for Jaundice Babies in Vietnam

Firefly phototherapy treating its first newborn, Nguyen Huong Giang at National OBGYN Hospital. Hanoi as Trang Tran of East Meets West Foundation, Elizabeth Johansen of Design that Matters, Kelley Maynard and Leon Hiemstra of Medical Technology Transfer and Services look on. By Will Harris of Design that Matters.

Cameras were clicking madly! What a huge moment for DtM and the entire team.  Change was in the air. After working together for two years, through many field studies and conference, the team was giggling with excitement.

After this firsthand experience implementing a developing world clinical trial, the DtM team feels so grateful for its experienced partners MTTS and EMW who have operated in Vietnam for upwards of 9 years painstakingly forming relationships with hundreds of hospitals. They knew how to design a test protocol that was just right, helping the project find a balance between the worlds of the overblown, litigation driven, high margin, U.S., medical device market, and “anything goes”. Firefly has gone on to cure 17 infants of jaundice since December 5th. If the final results on January 6th continue to be just half as good as they are so far, the project will be ready for a roll out in Fall 2012.

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