When Medicines360 CEO Dr. Andrea Olariu reflects on her organization’s journey, she sees more than just the success of a single product. The hormonal IUD Liletta, which has reached 1.8 million women and saved the US healthcare system over $120 million, represents something bigger: Proof that innovation and access can be designed together from day one.
Founded in 2009 by MacArthur Fellow Victoria Hale, Medicines360 is a women’s health innovation organization that made history in 2015 as the first nonprofit to launch a drug-device combination product in the United States. Unlike most traditional pharmaceutical or medical device companies, they prioritize access and affordability from the outset, enabling them to distribute products at low cost to safety-net clinics while expanding globally through subsidiaries.
Now, with the launch of their 360 Innovation Hub, Medicines360 is systematically applying this proven model to tackle broader challenges in women’s health.
“We really look at women’s health as a challenge, but also a huge opportunity, both in mission and revenue,” explains Dr. Olariu, who joined Medicines360 in 2010 and has led the organization as CEO since 2023. “Our model is to bridge the two worlds of public sector and private sector and bring them together in a successful model.”
A Unique Business Model
Medicines360’s approach represents a fundamental shift from traditional pharmaceutical or medical device development. As a nonprofit, they can prioritize access and partner with for-profit companies for distribution and sales of their products, leveraging already existing infrastructures. The organization distributes its hormonal IUD, Liletta, at low cost to over 4,000 safety-net clinics in the US, while offering the same product globally under the brand name Avibela in low- and middle-income countries.
Medicines360’s model emerged from a fundamental insight: Brilliant products often fail to reach their intended users due to barriers that could have been addressed during development, not after market launch.
“Even when you look at innovations that have been happening, it takes a very long time for that innovation to have broad access,” Dr. Olariu explains. “It can take up to two decades for a new innovation to have broad reach, and that’s just not acceptable.”
Medicines360’s solution was to incorporate what they call “access endpoints” directly into clinical trials alongside traditional safety and efficacy measures. This generates data about real-world barriers during the research phase, when addressing them is still feasible and cost-effective.
The IUD experience provided a compelling case study. Beyond developing the product itself, Medicines360 tackled systemic barriers preventing women from accessing existing IUDs. One major issue was the requirement for STI testing before insertion, which created a multi-visit process.
“Most women would be lost in this process,” Dr. Olariu explains. “What we did in our large clinical trial was allow all women to be inserted with an IUD and then test immediately after that, treat those who had asymptomatic infection, and prove through data that you don’t need to test and wait.”
Building the Innovation Hub
The success of this integrated approach led to the formalization of the 360 Innovation Hub, which operates through three pathways for bringing innovations to market.
First, they develop entirely new concepts internally. “We have products that are just our own idea, and we develop them from the “napkin” stage to go to market,” Dr. Olariu explains. One such product, focused on cancer detection, will enter clinical trials later this year.
Second, they partner with inventors who have promising ideas but lack the infrastructure to scale them. The flagship example is PeriPeach, a product developed by Dr. Tess Kim that prevents severe tears during childbirth and is based on the use of warm compresses.
“Her idea is to productize this in a way that will be cost effective, easy to implement in currently existing hospital workflows, and make it safe with temperature control,” Dr. Olariu explains. The product addresses a known solution – warm compresses work but are impractical in clinical settings – by creating a version that’s both effective and operationally feasible.
Third, they engage in co-development partnerships with other organizations, sharing both resources and risk through the development process.
Proven Impact and Scale
The numbers demonstrate the model’s effectiveness: 4,000 safety net clinics served, 1.8 million women reached in the US, 60,000 IUDs supplied globally, and over $120 million saved for the US healthcare system.
“We have proven that you can do good business by making products available not just to your highest paying, easiest to reach population, but to a broader population,” Dr. Olariu explains.
As the Innovation Hub evaluates new opportunities, they’re preparing additional collaborations for announcement later this year. Their model offers a template for systematically bridging breakthrough research and real-world implementation.
“To be successful at a bigger stage in women’s health, partnerships are extremely important,” Dr. Olariu concludes. “We need to get together and leap forward in women’s health, not just take small steps.”
