SBIR-STTR Award

The broader impact of this Small Business Innovation Research (SBIR) Phase I project will be significant to breastfeeding mothers who experience difficulties producing milk or knowing the volume of milk expressed during each session. While the benefits of breastfeeding throughout the first year of a baby’s life are widely accepted in the medical community, 60% of mothers do not succeed in sustained breastfeeding. The success or failure of breastfeeding is dependent upon a baby getting enough milk, and currently there is no objective method of determining the amount of milk a baby is receiving and how much residual milk remains in the breasts. The proposed device will collect objective data that will help mothers overcome challenges in breastfeeding and avoid further complications like clogged ducts and/or mastitis. Specifically, the device will help mothers track their milk output accurately, therefore reaching lactation goals, and allow mothers to ensure that babies receive the required nutrition to thrive during the early stages of life. The depersonalized data collected from the bra will enable medical professionals and researchers to gain insights about human milk production volumes and factors influencing milk production and infant health, thereby expanding horizons for further research in this field. This Small Business Innovation Research Phase I project will create a proof-of-concept prototype bra that utilizes textile-based sensors to accurately measure the volume of milk expressed during a breastfeeding/breast pumping session. This project will lay important groundwork to create the first medical device using embedded fabric sensor technology to determine three data points: breast emptiness, milk volume output per session and changes in breast milk production over time. Research will focus on the design of the sensors and the form-factor of the bra that will facilitate capturing accurate data. There will be associated data capture and analysis demonstrating both measurable metric data trends to inform breastfeeding moms and aggregate cohort-level data trends for high level data analysis in an area with a paucity of actual data. When in use, the bra will be fitted to women while breastfeeding or pumping and be able to determine both the milk depletion and residual volume in the milk ducts and the volume of milk produced. After completing additional R&D, the product will perform three different functions: 1) determine the degree of breast emptiness; 2) measure the volume of milk expressed per session; 3) detect early risk of clogged ducts to avoid mastitis. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

The broader impact/commercial impact of this Small Business Innovation Research (SBIR) Phase II project impacts mothers and babies during the breastfeeding period. Although breastfeeding benefits for the mother and the baby are recognized worldwide, many mothers are unable to attain their breastfeeding targets due to common discontinuance problems. The proposed solution may increase breastfeeding rates by supporting mothers who are breastfeeding or breast pumping, providing them with resources to sustain breastfeeding. Access to valuable information on the volume of breastmilk expressed could enable mothers to carefully monitor their milk production. At the same time, it may allow the prediction of clogged milk ducts, avoiding serious complications such as breast engorgement or lactational mastitis that can be avoided with early intervention. This intervention could prevent not only early discontinuance in breastfeeding but also promote increased health for mothers by reducing the risks of disease. The monitor may also impact babies? health since breastfeeding is recommended to achieve optimal growth and development. Further, the proposed monitor may provide the scientific community with data to enable research into different aspects of mothers? health, for example, determining the reasons for the formation of mastitis.This project may lead to a new paradigm in lactational health for the baby and the mother. There is an important need to meet breastfeeding objectives by reducing discontinuances and reducing common conditions such as lactational mastitis. The proposed solution aims to increase breastfeeding rates by providing mothers with a comfortable and effective method for measuring the milk volume expressed and for determining if milk ducts are clogged. Research objectives include: (1) sourcing and testing fabrics for the bra from multiple vendors; (2) designing and developing of the embedded system and the bra, so that will be able to accommodate a wide range of breast shapes and sizes; (3) designing and developing mobile applications and algorithms, which will include data analytics and prediction; and (4) optimizing the bra and mobile applications. The project could result in a smart, all-day wearable, comfortable garment designed for breastfeeding mothers that is paired with a mobile app to show analysis and results adapted to each mother.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.