Breast physiology and milk biochemistry
Research into breast anatomy and physiology and human milk biochemistry at The University of Western Australia (UWA) has led to partnerships with Medela AG (Medela) resulting in innovative solutions for mothers and babies. Calmita® is an infant teat for preterm infants with an integrated vacuum-controlled valve. Calmita increases breastfeeding in preterm infants and reduces length of stay in the neonatal intensive care unit (NICU). UWA research led to the development of Medela’s breast pump: the Symphony. From 2011-2016 Medela extended that technology into four breast pumps designed for home use: offering solutions to mothers who are returning to work but wish to maintain lactation. UWA research is frequently used in Medela consumer outreach which relies on UWA’s basic research.
Impact Case Study
Human milk is a juicy, complex, dynamic live fluid full of thousands of molecules that have evolved over time to provide protection from infection and other short and long-term health benefits. Breast milk is full of nutritive components such as macronutrients, vitamins, hormones as well as protective components such as live white blood cells. Its composition is uniquely tailored for the human infant. UWA’s Human Lactation Research Group (HLRG) combines biochemistry, metabolomics, molecular biology, physiological measurements and ultrasound imaging to understand milk synthesis and milk removal from the breast as well as aims to understand how the milk assists in the development of the baby. To do this, HLRG studies the effect of milk composition, gastric emptying and breastfeeding behaviour on the development of infant appetite control and body composition. Key research developed at UWA has led to advances in knowledge about breast anatomy and physiology and for 20 years UWA has partnered with Medela AG (Medela) to co-develop specialist breast pumps and teats for preterm infants.
Products: calmita and two-phase expression breast pumps
In 2010, based upon UWA research, Medela released Calma; the first infant teat that could closely simulate the way a baby feeds from the breast. Preterm infants often experience difficulties with breastfeeding so demand from neonatologists seeking a product like Calma but redesigned for preterm babies quickly followed. Calmita was developed at UWA based on applied research of a breastfeeding infant’s suck, swallow and breathe patterns. It allows preterm infants to practise and apply natural sucking behaviour using an integrated vacuum-controlled valve. Released to market in 2013, Calmita has been shown to increase breastfeeding in preterm infants (Simmer, 2016). Use of Calmita has been shown to hasten discharge (mean 2.5 days) from neonatal intensive care. Considering that 16% of all live births in Australia are admitted to a special care nursery or neonatal intensive care unit (Australian Institute of Health and Welfare, 2015) at a costs of over AUD$1,500 per day, Calmita actively decreases expenditure on pre-term infants where independent feeding is often the last hurdle for NICU discharge.
UWA research also led to the development of Medela’s flagship hospital-grade breast pump: the Symphony. The two-phase expression technology imitates two natural sucking patterns. During breastfeeding, the baby’s sucking starts out fast yet gentle to stimulate the milk-ejection reflex. It then switches to a slower and deeper rhythm. Twophase expression became a market differentiator other manufacturers have tried to replicate. From 2011-2016 Medela released four models of patent protected breast pumps, all of which used the two-phase technology but were designed for home use.
The World Health Organisation recommends infants should be exclusively breastfed for the first six months of life but returning to work can jeopardise this gold standard. The Australian Bureau of Statistics (ABS) survey of Pregnancy and Work Transitions in 2013 found Australian women take on average 7-8 months maternity leave and during this time breastfeeding rates drop from half of all children at six months to just under a third in children nine to 12 months. One-day absences due to a sick child are twice as likely in mothers who formula-feed versus those who breastfeed (Cohen; Am J Health Promot. 1995). Medela breast pumps offer a solution to mothers who are returning to work but wish to maintain lactation.
Medela’s growth, education strategies and branding
Medela positions itself as a research-based company that invests in basic and exploratory research. Their website names UWA as a long-standing research partner and seven of the web-based research resources they provide for professionals directly cites UWA research. UWA research is frequently used in their social media outreach to customers and their mission statement of translating scientific findings into evidence-based benefits heavily relies on UWA’s basic research. The partnership with UWA has also impacted the company’s culture with their evidence-based research heavily integrated into marketing strategies even resonating into a tag line of “Research is in Medela’s DNA”. Medela also showcases the world’s top lactation scientists at an international conference each year aimed at midwives, lactation consultants, neonatal nurses, maternal child health nurses, general practitioners, paediatricians, speech therapists and dietitians. These conferences started as UWA’s HLRG team translating their basic research but by 2016 attracted over 300 delegates representing 41 countries.
The research-led business model employed by Medela has had great economic success. Revenue was estimated at $US630 million in 2014, with products being sold globally to 18 subsidiaries and upwards of 120 distributors.
Policy change and product standards
Medela has used UWA research to successfully lobby for policy change with the US government and its health insurance providers in a way that has increased revenue and also benefitted US society. Using the evidencebased research, Medela lobbied for inclusion of a breastfeeding benefit in the Affordable Care Act, which was passed in 2013. As a result, Medela estimated that in 2014, 47,000 more US infants were breastfed; with minority, less educated and unmarried mothers disproportionately helped, for an estimated cost of $US1.54 per member, per year. Medela has used UWA research to substantively provide input to the US Food and Drug Administration and the EU body (TÜV) on what standards should be required for all products classified as a breast pump. An example of this is the minimum vacuum range available on breast pumps has been predicated on UWA research.
The Human Lactation Research Group (HLRG) combines a number of modalities including biochemistry, metabolomics, molecular biology, physiological measurements and ultrasound imaging to understand milk synthesis, milk removal from the breast, the effect of milk composition on both term and preterm infant gastric emptying, breastfeeding behaviour, appetite control and body composition. The understanding of these mechanisms has facilitated successful breastfeeding by providing an evidence base for the clinical management of human lactation. Research has been ongoing since early 2000’s, however the key findings relating to this case study were published between 2005 and 2012.
UWA’s HLRG is headed by UWA Senior Research Fellow Professor Donna Geddes, with four UWA post-doctoral researchers: Dr Chinh Tai Lai, Dr Jacqueline Kent, Dr Melvin Gay, Dr Sharon Perrella. Professor Peter Hartman is a Senior Honorary Research Fellow at UWA. The head of Breastfeeding Research at Medela is Leon Mitoulas who is also an Honorary Fellow at UWA.