Women Empowering Women: Preterm Babies and the Story of Medolac How one entrepreneur was moved by the plight of premature infants to develop a new company and a new business model.

Many businesses are finding success by focusing on the social issues impacting society today. And, in that context, the lack of nutritional assistance for preterm infants is one area that entrepreneur Elena Tagger Medo has selected as her area of focus.

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The reason is the significant need that an estimated 15 million pre-term infants around the world (preterm, or premature, meaning born before 37 weeks' gestation) have because they lack access to nutritious human breast milk.

Hospitals have been struggling to help these babies but have had to ration donor milk, providing it only to the smallest, sickest babies. Such rationing has meant a shortage of what infants in neonatal invensive care need most: mother's milk.

This is why entrepreneur Elena Tagger Medo not only founded Medolac Laboratories but founded it as a public benefit corporation, which fits with her philosophy of how a social impact company should look. Medolac "banks" donor milk, which can be stored at room temperature and shipped in 4-ounce sterile packets to locations around the world.

A public-benefit corporation, created by the state of Delaware, views profits as a means to fuel growth in social impact, as well as to generate attractive returns for stockholders.

As Medo told me during a recent interview: "We couldn't work this hard just for money; we really want to change things for the better. When Delaware made it possible to convert to a public benefit corporation, we jumped at the chance and got a unanimous vote from our shareholders to do so."

She explained that her company is still a for-profit, C-corporation but with one important difference: "Our board of directors and management are able to consider the social impact of our decisions and act accordingly," she said. "It was also a really great way to communicate our commitment to doing the right thing and making the world better for the tiny babies we serve."

Babies in need

Medo told me about the emotional impact she felt the first time she saw a pre-term infant, after raising four full-term healthy babies herself. She told me she'd attended funerals for preterm infants who may have died needlessly.

She also told me about the motivation she'd received from the parents of these babies, who, she said, have had the courage to stay optimistic, visit the hospital daily or even several times a day and learn everything they can about the complex world of neonatal intensive care.

Infant formula was the standard nutrition source in hospital neonatal units for many years, Medo explained. But, starting in 1990, research increasingly connected infant formula with the increased incidence of infection and death in preterm infants.

In fact, the second leading killer of preterm infants is the intestinal infection, necrotizing enterocolitis, or NEC. Given NEC's high fatality rate, babies who survive this infection often retain only a fraction of their digestive tract, making their lives difficult and expensive. The average cost of one NEC death is $3.5 million (Published data AAP).

The earlier babies are born, the more fragile they are and the more at risk they are for NEC.

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A story from the neonatal battlefront

Medo described the start of her commitment, in the form of a letter from a neonatologist telling her how a preterm baby in her hospital had died that morning. The doctor wrote that the baby's mother's own milk supply had faltered and that the infant no longer qualified for donor milk because she weighed more than the allowable maximum to qualify.

"She was expected to go home the next week as a success story," Medo said. "Instead, she developed a fatal infection of her gastrointestinal system [NEC], associated with the lack of human milk feeding, and increasingly considered a preventable disease."

She continued: "Babies who survive the infection often need surgery to remove the infected intestinal tissue, and, if they survive, they have sometimes lost over half of their digestive tract." The reason for the high cost of a NEC death, Medo said, is because death sometimes doesn't occur until the baby is a 5- or 6-year-old child.

"Every day, I think of the babies who are still being deprived of donor milk and the parents who bury them. It's a pretty compelling motivation. It's a job we can't quit."

Female entrepreneurship at work

To address this problem, Medo started an earlier company, Prolacta Bioscience, in 1999 with the goal of developing the first protein fortifier to add to mother's milk for preterm infants. At the time, Medo had a small medical device company that sold breast pumps to neonatal intensive care units.

She began to attend conferences where neonatal nutrition was discussed, along with the outcomes of studies; she wanted to learn more about how she could help. At that time, mother's milk was fortified with cow's milk protein, which put pre-term infants at risk of contracting illnesses from the protein. In some cases, this "solution" even led to their deaths. Medo knew there had to be a better way.

That better way began with her efforts to raise $24 million in venture capital to develop and commercialize the first human milk fortifier. She initiated a large randomized clinical trial to compare outcomes for preterm infants given an exclusive human milk diet versus infants receiving a mix of human milk and cow's milk protein.

The results of the study were stunning; as a result, most hospitals set a goal to feed their preterm patients only human milk. After launching and growing her company, Medo left in 2008 in pursuit of a way to further improve outcomes for pre-term infants. Plus, she had the idea that mothers who produced breast milk might also benefit from donating the extra milk they had.

"Milk money" fills a social need.

Medo's goal evolved into increasing hospitals' access to donor milk by developing a commercial, sterile product with a long shelf life that would maximize safety, compared to what was possible with pasteurization, which does not destroy all potentially lethal spores.

Her business model not only included nursing mothers but assured them ownership and democratic control over what happened to their milk. This led to Medo's development of a cooperative business model and a federal grant: The result was the Mother's Milk Cooperative, now the supply partner to Medolac.

In order to meet the demand and make it more affordable to hospitals, Medolac's task was to rapidly increase the volume of available breast milk. This led to a program Medo established, called "Milk Money," which compensates qualified donors for pumping milk several times a day. The program has since gained traction, with thousands of donors eager to monetize their ability to produce the high-quality milk hospitals so desperately need for their pre-term infant patients.

Empowering women and advancing an industry

With a safer product, a better supply chain that the milk donors own and control, and no shortage of qualified raw milk, Medolac was in business. Although a few bumps in the road the first year slowed the company's launch, the company is now experiencing solid growth, with more hospital accounts and thousands of babies fed, Medo said.

The company's first product was named Co-op Donor Milk, so hospitals would know that their purchase was supporting nursing mothers in the United States. In fact, many of the milk donors have been able to delay their return to work simply by participating in the Mother's Milk Cooperative.

This new availability of commercially sterile human donor milk has made a big impact with hospitals. There had been a widespread but mistaken belief that pasteurized donor milk was commercially sterile; it isn't. Now, hospitals better understand and appreciate the sterilization process that Medolac provides. By making donor milk as easy to use as infant formula in the hospital, these hospitals are benefiting from reduced shipping costs and from the shortened time nurses have to spend to handle the process.

There are also further opportunities to improve the outcome for hospitalized babies: Medolac has introduced a new lactose-free donor milk. Preterm infants born before 34 weeks gestation lack the ability to effectively break down lactose. Medolac's product does it for them, sparing them from bloating, inflammation and nausea.

Today, it's become a global initiative, and one supported by data, for neonatal units to feed, or aspire to feed, only human milk.

And, not just preterm babies are benefiting from the milk collective. Adopted babies, surrogate families and working mothers all have the ability to purchase donor milk for use at home. Often, the simplest solutions truly address some of the world's complex problems, Medo pointed out.

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Additionally, she said she's proud to have helped empower a whole new group of female entrepreneurs. "I think many women have terrific ideas and creative solutions to vexing problems," she said. "It's a bold decision to take the first step, but it is so worthwhile. I would recommend that no one should let fear get in the way of starting a company . . . Now that I'm on my sixth startup, I realize that it's most rewarding when you can come up with a solution that is great for everyone involved."