Section 03
Good Health & Wellbeing
Ensure healthy lives and promote well-being for all at all ages.
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Community Health Outcomes

Our efforts regarding the research and development of new products are driven by our mission and values. We aim to provide quality, lifesaving products to patients in need and to remove barriers to accessing quality care. In order to do this, we intentionally manage our portfolio of products to fill unique niches in the market in order to sustain our priority work of serving small patient populations.

In the coming years, we aim to develop more products designated with the Humanitarian Device Exemption. An example of our commitment to HDEs is the Flourish Pediatric Esophageal Atresia Device. Flourish was created to give doctors a minimally invasive alternative to surgery when treating esophageal atresia – a congenital birth defect which occurs in about 1 in every 2,500 newborns¹. Esophageal atresia is a birth defect of the esophagus – the tubular structure that connects the mouth to the stomach. In babies born with this condition, the upper part of the esophagus does not connect to the lower part of the esophagus and the stomach, making it impossible for them to eat normally. Using rare earth magnets, Flourish gradually stretches both ends of the infant’s esophageal pouches together to form a fully functioning esophagus. This is a life-changing procedure that provides an alternative to an invasive procedure with an extended recovery period.

Humanitarian Device Exemption (HDE) 

A pathway to provide a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.
¹ .Mahoney L, Rosen R. Feeding difficulties in children with esophageal atresia. Paediatr Respir Rev.2016;19:21-27.)

Social Determinants of Health

Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. The SDOH include Economic Stability, Education Access & Quality, Healthcare Access & Quality, Neighborhood & Built Environment, as well as Social & Community Context.

When we think about our mission to serve patients, we consider our patients holistically and in their unique contexts. One way to think about the social determinants of health is to look around you and consider the aspects of your life that impact how healthy you are. These include your access to healthy foods, safe spaces to enjoy the outdoors and breathe clean air, the ability to seek quality medical care when you need it, and so on. For instance, living in a food desert without access to a grocery store with healthy foods might result in reliance on processed or fast foods. This lack of nutrition could cause individuals in this situation to experience such health challenges as diabetes, obesity, or heart disease.