About

About Us

Diagonal Health is a woman-owned consultancy with 25 years of experience enabling life sciences and healthcare organizations to demystify, map, and influence the federal government. We facilitate the translation of research and development into accessible diagnostics and therapies.

We work with life sciences and healthcare companies and their investors, nonprofit associations and venture philanthropists, and anyone with a great idea that solves a problem in the healthcare system.

Our track record of success in advancing medical technologies from the bench to the bedside includes:

Consulting with research-based biopharmaceutical companies on how re-orient their research and development plans in response to significant market, policy, and legislative changes such as the Inflation Reduction Act.
Advising companies applying for federal funding to develop applications that are compelling and comprehensive.
Strategizing with early-stage researchers and their investors to identify policy, regulatory, reimbursement, and legislative pathway(s) for innovative technologies to reach the market.
Lobbying Congress for appropriations funding directed to the research priorities of patient advocates, health systems, and nonprofit foundations.
Educating early-stage researchers and their investors on the pathway(s) for their technology to reach the market.
Building coalitions to engage policymakers, regulators, and legislators to advocate for research and health outcome priorities.

Our Mission: Innovation to Approval to Market

Diagonal Health advises clients on how to engage the new Advanced Research Projects Agency for Health (ARPA-H) to shape its research priorities, obtain funding, and bring innovations to market. ARPA-H has received and is now investing $4.0 billion in appropriations (available through September 2026) and is seeking an additional $1.5 billion in FY 2025.

Diagonal Health’s strategy and advisory services help clients to position their funding proposals to align with ARPA-H’s priorities and navigate the complex policy, regulatory, and payment processes for new medical technologies.

ARPA-H was proposed by President Biden in 2021 and authorized by Congress in 2022 to “pursue ideas that break the mold on how we normally support fundamental research and commercial projects in this country.” APRA-H is investing in high-risk, high-reward healthcare innovations. It operates using the same model as the Defense Advanced Research Projects Agency (DARPA), which brought us the Internet, GPS, and similar game changers.

Why You Need Us

Diagonal Health believes that companies that receive ARPA-H funding will require additional help influencing policies across HHS, like at the Food and Drug Administration (FDA) and Centers for Medicare and Medicate Services (CMS), to transition their solutions to market. These agencies face expanding missions and shrinking resources. We also anticipate that the approval of, or payment for, some innovations will stretch the limits of these agencies’ existing authorities and reources, potentially requiring help from Congress to bring them over the finish line.

Diagonal Health guides its clients on partnering with ARPA-H and provides advisory services that build on ARPA-H’s innovation ecosystem, including how to advocate for their innovations in the health policy and legislative communities, obtain regulatory approval, and gain market access.

Importantly, while ARPA-H welcomes interaction with researchers and potential partners, they can’t write a proposal for you. We know whom to engage, when, and how to package your funding proposals.

Once you receive funding, ARPA-H can get you consulting help through their Investor Catalyst Hub and their Customer Experience Hub. But those entities can’t use federal funds for certain key purposes, such as engaging policymakers to design new regulatory pathways and payment models. We know how to navigate the regulatory and payment landscape to bring innovations to market.

Finally, ARPA-H does not view engaging in the public policy process as part of its mission. That’s completely fine – health policy is a complicated field. We’ve spent entire careers building mastery of policy and legislative stakeholders and processes.

Biography

Diagonal Health LLC is owned and operated by Jen Madsen, MPH. Jen is a senior life sciences and healthcare industry strategic advisor, impact investor, and consulting executive. Her passion is improving health outcomes and patients’ experience with the healthcare system. She has expertise in accelerating biomedical innovation, regulatory modernization, and payment system redesign. Jen has a 25-year track record of impactful engagements with government, nonprofit and industry leaders in Washington, DC. Her key skills span strategic planning, portfolio management, policy development, philanthropic strategy, coalition building and impact measurement.

Jen has served as a strategy consultant to ARPA-H, CMS, FDA, and NIH; advocated for policy changes as a government affairs and policy representative for patient advocacy organizations, industry trade associations, coalitions, and companies; and held senior business development roles in several strategy consulting firms.

Jen has consulted to the new federal Advanced Research Projects Agency for Health (ARPA-H) within the past six months and has deep understanding of the agency’s mission, people, and culture.

From 2019 to 2023, Jen was a Principal, Senior Principal and Department Manager at the MITRE Corporation, a not-for-profit company that works in the public interest. MITRE operates federally funded research and development centers (FFRDCs), including the only FFRDC devoted exclusively to healthcare. As the Health FFRDC’s Department Manager for Health Policy and Operations, Jen was responsible for all aspects of business development, project leadership, and people management for a team of 17 professional staff and a $25 million book of business. Her portfolio included the Centers for Medicare and Medicaid Services (CMS) Office of the Administrator, which in 2022 requested strategic support for 10 project teams performing parallel four-month sprints to stand up new cross-cutting initiatives.

Jen’s past MITRE work with the National Institutes of Health (NIH) and Food and Drug Administration (FDA) focused on accelerating biomedical innovation. She led a MITRE technical paper with recommendations for ARPA-H that could, if implemented, accelerate biomedical innovation across the federal government, powered by an interoperable digital data infrastructure.

During the COVID-19 pandemic, she advised the NIH Rapid Acceleration of Diagnostics for COVID-19 (RADx) “Shark Tank” program and brokered a novel working relationship across NIH and FDA to prioritize and accelerate reviews for emergency use authorization. The project’s impact includes authorizing the first COVID-19 test for use at home without a prescription and shortening the timeline for developing a new diagnostic test from seven years to seven months.

Jen was MITRE’s Project Leader for a novel Innovator Support project for the NIH Office of the Director, Small business Education and Entrepreneurial Development (SEED) office, piloting entrepreneurship coaching and regulatory and reimbursement consulting services for small business and academic innovators. She was also Project Leader supporting a new alternative payment model (APM) for the Center for Medicare and Medicaid Innovation (CMMI). Both projects received MITRE’s highest honor, the Program Recognition Award, in 2022 and 2020, respectively.

Since 2021 Jen has served as a member of the Board of Directors for Mental Health America (MHA), the nation’s largest community-based nonprofit organization for mental health. MHA is focused on next generation prevention: on the health and well-being of future generations, systemic reforms, and embracing new frontiers of science. MHA’s work is guided by the voices and wisdom of lived experience. Jen co-chairs the public policy committee, which recently updated MHA’s position on reducing gun violence and is developing a new position on social determinants of mental health.

Previously Jen was chief of staff to the CEO at Food Allergy Research and Education (FARE) and advocated for people with life-threatening food allergies. She led development of the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, enacted in 2021; and raised awareness of a national shortage of epinephrine, which convinced the FDA to recognize the shortage and approve new generics, making headlines in The Washington Post and New York Times.

From 2010 to 2018, Jen was a senior leader in the advocacy community for developers of advanced diagnostic laboratory tests with algorithms, during a critical period of regulatory and reimbursement uncertainty and change.

Advised innovative diagnostic labs and makers of cell and gene therapies on market access at international law firm Arnold & Porter LLP.
As Senior Director for Economic and Regulatory Affairs at the College of American Pathologists led a 10-person team focused on FDA, Medicare, and commercial payer policy for molecular pathology and next-generation sequencing.
As vice president for policy at the American Clinical Laboratory Association, led critical negotiations with FDA and physician societies on regulation and reimbursement for molecular genetic tests.
Advised nationally known clinical laboratories and health insurers on the Affordable Care Act as a principal at the Podesta Group, a bipartisan lobbying firm.

From 2003 to 2009, Jen held progressively senior roles in a startup consulting firm, Avalere Health:

Advised biopharmaceutical companies and patient advocates on the implementation of the Medicare prescription drug benefit
As a member of the firm’s Leadership Team during a period of rapid growth, her responsibilities spanned client relationship management, business development, marketing and public affairs;
Authored peer-reviewed papers and spoke at many conferences, corporate training programs, and briefings for Members of Congress.

Jen’s first job in Washington was as a health economist with the Congressional Budget Office of the U.S. Congress, where she estimated private sector costs of federal mandates on health insurers. She earned an MPH in Health Policy with honors from Yale University, a BA in Biochemistry from Rice University and did post-baccalaureate public health research in Kenya on an endowed travel scholarship.

Jen’s husband Dana is a senior cybersecurity executive in the federal government. They live in Arlington, Virginia, with their two dogs.