Case Study: Positioning for ARPA-H Funding

Diagonal Health serves clients who are interested in ARPA-H. While most of the time, clients are interested in funding for a research proposal, sometimes we consult with individuals are interested in a sounding board for their proposed application to be a Program Manager, or who are interested in work as a federal contractor to ARPA-H.

Diagonal Health understands how to collaborate with ARPA-H to secure research funding for revolutionary biomedical and digital health innovations, as well as navigate the complex regulatory and adoption pathways to get your technology into the hands of patients. ARPA-H is currently investing $4.0B in funding available through FY 2026.  They are seeking to invest in established entities, small start-ups, and non-traditional government performers, each of which can benefit from Diagonal Health’s insight into ARPA-H. 

Diagonal Health’s CEO Jen Madsen knows the elements of a good ARPA-H proposal:  having a well-curated problem, advancing the state of the science, understanding the organization’s processes and priorities, showing a pathway to regulatory approval, and demonstrating economic viability of your proposed solution. 

• ARPA-H Ecosystem:  Jen has firsthand experience navigating the network that ARPA-H is building of investors, customers, innovation hubs, incubators, and accelerators aimed at supporting funding recipients from her experience at innovation consultancy BMNT.  This ecosystem was shaped by legislation authorizing ARPA-H that adopted MITRE’s advisory recommendations included in the Congressional whitepaper that Jen drafted.
• Regulatory Pathways:  Jen understands the stakeholders, processes, and pitfalls of securing regulatory approval for biomedical innovations from her experiences as a regulatory lobbyist, industry association representative, consultant, and as one of 30 national experts advising NIH investment of $1.0 B in the RADx initiative.  As a RADx advisor, Jen recognized the need to engage FDA to ensure RADx investments were informed by regulatory approval considerations.  FDA’s actions, guided by Jen’s advice and multiple convenings, ensured that at-home COVID-19 tests gained regulatory approval in only seven months, compared to an average timeline of seven years. 
• Economics:   Jen has mastered a key determinant in the economic viability of biomedical innovations:  coding, coverage, and payment.  She understands the processes CMS uses to develop and value new CPT codes, working with insurers, physician specialty societies, and the American Medical Association. At the College of American Pathologists, she led the team of professionals who run the Molecular Pathology Advisory Group, the Pathology Coding Caucus, and valuations for the Clinical Laboratory Fee Schedule. Her advocacy influenced legislative language in the Medicare Modernization Act, the Affordable Care Act, MACRA, PAMA, and the 21^st Century Cures Act.