4 Innovation Introduction

Accurate and representative baseline data on women’s health conditions, including data disaggregated by sex and gender, are needed to develop products that best meet women’s health needs. For example, innovators must be able to diagnose current market shortcomings—including affordability, availability, quality, suitable design, and demand—when designing scalable innovations that provide clinical, economic, and end-user value. This requires sufficient data on disease burden, sex and gender influences on health, and the social determinants of health for different populations of women. Collaborative platforms are needed to fill these data blind spots and improve the availability and collection of data on user needs, product requirements, and effective delivery approaches, which will catalyze more targeted product development and successful introduction. This data will also help demonstrate to governments, investors, and other stakeholders that women’s healthcare is not a niche market and that the business case for women’s health innovation is strong.

To strengthen the innovation ecosystem for women’s health and introduce affordable, accessible solutions to women and their healthcare providers, resources must be made available to innovators earlier in the product development process. Innovation and commercialization hubs are not a new concept, but few focus specifically on accelerating solutions for women’s health—particularly for affordable solutions that meet women’s needs in LMICs. Drawing on successful practices developed for such hubs across other disciplines, a network of women’s health innovation hubs should be designed to:

• Connect innovators with key stakeholders to improve understanding of unmet women’s health needs—including patients and their advocacy groups, healthcare professionals, academic researchers, angel and institutional investors, donors, commercial partners, and policymakers.
• Provide incubation, acceleration, mentorship, knowledge-sharing, and dedicated funding to support product development, from product design to distribution, marketing, and scaling.
• Startups in the program should receive early-stage funding, resources, and guidance along the product development continuum.
• Immersive, entrepreneurial training programs should be developed that focus on aiding academic researchers and small companies developing affordable women’s health technologies in navigating the business world, including how to seek capital, plan for market introduction, and understand market forces and challenges in LMICs.
• Industry-partnered research labs should be established to provide incubator space with mentoring and product development support for startups that develop women’s health products aligned with industry needs.
• Similar paths should be created for government partnerships, with pathways for government grant funding.
• Provide education on sex- and gender-informed product design, including the use of participatory approaches.

This level of targeted support will better equip innovators to iterate toward scalable solutions that improve women’s health. Recognizing that expertise for women’s health innovation comes from all over the world, these supports—and learnings from their implementation—should be shared across regions to ensure that solutions developed anywhere have adequate support to reach the populations that stand to benefit.

The payment and reimbursement ecosystem for women’s health including private, commercial, and government payors is complex and varies across geographic regions. At the same time, innovative therapies and diagnostics often are introduced with high costs, sometimes limited information on long-term outcomes, and slow provider adoption, all of which reduce the incentive for payors to reimburse for or cover the payment of such innovations. This can lead to less engagement and overall success for critical emerging technologies. Changing the incentive structure for payors and other supply chain stakeholders will strengthen the development of and access to key innovations.

Resource availability is often a limiting factor in developing and scaling innovation. Despite limited funding, innovators across multiple sectors are trying new approaches to overcome market challenges and deliver resources at high-leverage points in a product’s development. For example, “fast grant” programs in the women’s health space, such as Repro Grants, provide rapid funding decisions for short-term funding to incentivize scientists to focus on the basic research that drives innovation. Other sectors have pooled resources and capacities to foster collaboration between academia, industry, government, and the public with the objective of promoting economic development (e.g. the European Market for Climate Services). Such innovative pathways, including from less traditional bodies, hold promise to accelerate the development of women’s health innovation.

To enhance innovation in basic, translational, and clinical research and to increase access and equity in healthcare globally, a new funding approach should center underserved women and girls throughout the R&D continuum, from discovery and development to validation and healthcare integration. By coordinating disparate efforts and addressing key bottlenecks in both HIC and LMIC settings, funders for women’s health can establish an innovation pipeline that spans every stage in the cycle of innovation, yielding products tailored for use among specific underserved populations from the outset.

Market shaping represents a significant opportunity to advance women’s health innovation by addressing market shortcomings and optimizing market dynamics. Common issues including fragmented services, lack of access, and funding constraints in many LMICs have continually hampered the introduction and scaling of women’s health products that are routinely available in high-income settings. These products often fall into a “market trap,” characterized by a cycle of low demand, limited competition, and supply shortages. This cycle often leads to higher prices for end buyers, well above the production and shipping costs.

Successful market-shaping initiatives in global health have focused on aligning stakeholders on the most critical objectives, allowing them to navigate competing priorities and make collective tradeoffs to build a stronger market with a sustainable set of market characteristics, in terms of affordability, availability, assured quality, appropriate design, and awareness by end users (USAID, 2014). Market-shaping initiatives can encourage suppliers to develop innovations that are accessible and scalable in LMIC settings by reducing transaction costs, increasing market information, and balancing the risks for suppliers and buyers. Successful strategies in other health product markets may hold lessons for further application to women’s health, including:

• Advance market commitments (AMC): Funders agree to buy a product at established pricing identified through market analysis. This mechanism motivates suppliers without undue risk to donors or other buyers.
• Volume guarantees: Buyers explicitly agree to purchase a minimum quantity of an existing product, usually paired with a long-term supply contract that sets pricing for several years. A volume guarantee purchase agreement offsets some supplier risk and allows buyers to negotiate lower prices and better terms, as well as invest more confidently in demand generation with communities.
• Coordinated ordering: Negotiations are streamlined to lower transaction costs, enabling manufacturers to respond efficiently and reduce lead times.
• Variant Optimization: Guidelines or arrangements are designed to steer demand toward a specific, optimized set of products. This approach aggregates fragmented demand into larger orders, which encourages new suppliers to enter markets and allows existing suppliers to achieve economies of scale.