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A World-Class Standard of Care, Anywhere in the World<\/h2>\n
Brezinski got involved with this issue when she led the neonatal ICU at a community hospital, where she wanted to procure a second phototherapy device so the facility could treat a pair of jaundiced twins. Although she landed a donation to cover the high cost of the device, she wondered about areas of the world where it wouldn\u2019t work to ask for such a donation.<\/p>\n
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At the same time, she was serving as a research affiliate at MIT, working to improve medical care while patients were in transit from community hospitals to urban centers by maintaining constant communication with paramedics. The point was \u201cto raise the level of care to meet the needs of the patient, regardless of where the patient is.\u201d<\/p>\n
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The doctor has pursued that same philosophy ever since she founded Little Sparrows<\/a> \u2014 \u201cto meet or exceed the level of care that patients get in the United States.\u201d<\/p>\n <\/p>\n \u201cJaundice is one of the most preventable causes of neonatal death in the developing world,\u201d Brezinski explains. The condition arises from a buildup of bilirubin<\/a>, a substance that occurs naturally in all of our bodies. For most people, ordinary liver functions prevent such a buildup, but the livers of newborn infants \u2014 especially premature ones \u2014 can\u2019t always cope.<\/p>\n <\/p>\n A small excess of bilirubin causes yellowing of the skin, which affects about 60% of full-term and 80% of pre-term newborns. In severe cases, the substance acts as a neurotoxin that can cause deafness, vision impairment, cerebral palsy, or death. About 10% of all newborns are at high risk \u2014 yet jaundice can be cured in almost all cases by blue-light phototherapy. <\/p>\n In the developing world, babies often receive limited skilled medical care during pregnancy, delivery, and the first week of life. In the U.S., Brezinski explains, screening for jaundice is \u201cpart of routine care of the newborn,\u201d but in places like Burundi, where Little Sparrows has a pilot program, screening is often \u201cinadequate or absent, for any number of reasons.\u201d<\/p>\n <\/p>\n As the doctor puts it, \u201cEven though we could cure it, we can\u2019t treat it [in those places] \u2014 and that is the tragedy.\u201d<\/p>\n <\/p>\n <\/p>\n Brezinski tackled this challenge by getting her hands dirty. \u201cI actually started by building prototypes at my kitchen table,\u201d she says, working to construct an inexpensive phototherapy device as good or better than traditional ones using nothing but parts she could order online.<\/p>\n <\/p>\n Through several generations of design prototypes, she kept in mind not only the clinical requirements for treating neonatal jaundice, but also practical constraints \u201cto be sure this was going to be usable and deployable in a low-resource area.\u201d<\/p>\n <\/p>\n \u201cAll of your user and context restraints have to inform what your final outcome will be,\u201d she adds. She has developed the device first on her own, then with the help of her physician husband,\u00a0Gary Gilbert, and ultimately with the broader Little Sparrows team. Throughout that process, Brezinski has kept the unit lightweight and easy to use even for caregivers with limited medical training or in facilities where electricity may be available for only part of the day.<\/p>\n <\/p>\n Throughout the process, the design team keeps in mind that \u201cthe user is the baby,\u201d not the person who turns the machine on.<\/p>\n <\/p>\n <\/p>\n Having attended Autodesk University<\/a> to sharpen her design and CAD modeling skills, Kontson is now using Fusion 360 to refine the therapy unit\u2019s design. The software\u2019s sculpting environment helps with the shape of the enclosure, and the rendering space allows Kontson to simulate LEDs within the model to see exactly where the light falls. She says that they can also simulate stresses and fatigue on the product, which is especially useful because it keeps them from doing that manually \u201cwith the few [physical] prototypes we have.\u201d<\/p>\n <\/p>\n Brezinski notes that \u201cWe know the product works, and we could just make a bunch of these right now.\u201d However, the team continues to learn from it <\/p>\n The doctor points out the \u201ceasy pitfall for a lot of people\u201d to ignore economic realities or market constraints. Even when you want to have a global impact, she says, \u201cYou still operate in the real world.\u201d<\/p>\n <\/p>\n The transition from the doctor\u2019s kitchen table to the real world started in 2012, when an early prototype of the device was a finalist in the Saving Lives at Birth competition<\/a>. Realizing that she needed to leverage the business community, Brezinski founded Little Sparrows early in 2013. Since then, she has secured support from the National Institutes of Health and the Autodesk Entrepreneur Impact Program<\/a>.<\/p>\n <\/p>\n Now Kontson is working through the regulatory requirements to gain FDA approval. This will allow the company to sell the device in the United States, which will expand the company\u2019s market presence while meeting a need for phototherapy in rural areas of the country such as Indian reservations. Beyond that, FDA approval will demonstrate that the product does indeed meet the highest standard of care.<\/p>\n <\/p>\nJaundice Doesn\u2019t Have to Be a Problem<\/h2>\n
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<\/p>\nPortable, Affordable Treatment for Neonatal Jaundice<\/h2>\n
Building a Better Phototherapy Device<\/h2>\n
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Brezinski and her product engineer, Erica Kontson\u00a0and biomedical engineer Shreyas Renganathan, are now working with a design that has two components: a \u201cnest\u201d to cradle the baby, and an enclosing light array. Brezinski says that \u201cthe Fusion 360 software really lets us see how those two components interact with each other,\u201d and to iterate rapidly through multiple designs between fabrication of physical prototypes.<\/p>\nBringing a New Medical Device to Market<\/h2>\n
![\"1](\"http:\/\/www.autodesk.com\/products\/fusion-360\/blog\/wp-content\/uploads\/2016\/03\/1-LS-225x300.jpg\")
s ongoing field tests in Africa, which will soon expand to a second site in Burundi and a site in Tanzania. As new field data is folded back into the design of the unit, it also informs the company\u2019s market approach.<\/p>\nA Vision for the Future<\/h2>\n