About Us

The Office of Commercialization helps to translate scientific and technological breakthroughs into real-world products and services. We deliver impact through a suite of services provided to Program Managers and ARPA-H funded performers.

What does success look like? For us, success is when ARPA-H-funded technology graduates from the agency, survives in the wild, and accelerates better health outcomes for all Americans.

Office of Commercialization Services

Our services span the lifecycle of ARPA-H projects and programs, from concept development to graduation. ARPA-H encourages a sense of urgency, from term limits on Program Managers to time-bound, aggressive technical milestones on our R&D efforts. This urgency means we have to start paving the path to success at the same time as we are developing the science.

Program Design

Identify opportunities and gaps
Market/IP assessment
Regulatory assessment

Solicitation Deployment

Who are possible performers?
Develop technical areas
Validate transition potential

Early Program Performance

De-risk for investors
Demystify regulatory process

Mature Projects

Safeguard IP
Help company formation
Business strategy, legal and marketing services

Transition and Commercialize

SBIR/STTR
Transition partner/third-party investment
Ongoing mentorship
Access to key customers and investors

Regulatory Support

The mission of the Food & Drug Administration (FDA) is to ensure the safety, efficacy, and security of health innovations. ARPA-H builds unprecedented technologies that nobody else can, which may not fit into traditional FDA approval pathways. Without a strategy, the regulatory process quickly becomes unclear and prohibitively expensive to navigate, especially for a small lab, business, or non-traditional performer. The Office of Commercialization works closely with the FDA and external regulatory experts to demystify the process, provide consultation directly to performers and programs, and coordinate with regulators. We also provide similar services to help performers navigate CMS and get reimbursement approval for their new technologies.

Customer Discovery

ARPA-H is a solution-based organization; it does not conduct basic or incremental research. To have a solution means solving a well-defined problem. Customer discovery is the process of understanding the person or people for whom you are solving the problem. For example, if an innovation helps a surgeon, the Office of Commercialization will help ensure that performers understand the hospital workflow, payment considerations, and user experience of a surgeon.

Mentors and Coaches

We are invested in the long-term success of performers, so we provide expert guidance on areas like business models and intellectual property. We recognize that this support is especially important for young and newly formed companies.

Ecosystem Engagement

Program Managers are central nodes in their networks and possess the domain expertise and credibility to influence the dialogue. The best programs cross disciplines, and the Office of Commercialization serves as a personal network – available on demand – connecting them with other domains, including top investors, entrepreneurs, stakeholders, and technical experts.

Market Assessments

To help with program formation, the Office of Commercialization conducts rigorous assessments to measure the potential impact of the technologies being developed, avoid duplication with other federal agencies and the private sector, and to determine the program’s transition potential.

Office of Commercialization Voices

The Entrepreneurs-in-Residence support has been helpful to us in developing our commercial strategy and answering questions around market adoption, reimbursement, and business development. Additionally, we have kicked off GMP manufacturing of a new agent and are moving towards IND approval.

Trace Biosciences

The Entrepreneur-in-Residence provided continuous and thorough feedback on our pitch deck. We also invested substantial time and effort developing different elements of the pro forma financials.

AusculTech Dx

The OC team has been an invaluable partner in the successful construction, launch, and execution of our first ARPA-H programs. The team actively engages with Program Managers, listening to and anticipating our needs.

Given that successful commercialization of cutting-edge biotechnology requires more than superior science, these services will likely be the difference between success and failure for ARPA-H.

Ross Uhrich, DMD, MBA

We gained significant insights... including a Presub application submission to the FDA. We are looking forward to the FDA Presub meeting preparation sessions, especially now that we have removed the possibility of the 510k pathway.

Yaya Scientific

The OC helped me identify blind spots that could keep my performers from bringing their developments to market.

Ileana Hancu, Ph.D.

How We Define Success

We measure our success by producing technologies that grow beyond ARPA-H and survive without perpetual ARPA-H funding. These are the most common transition pathways for ARPA-H program performers:

Large, established companies with existing infrastructure for development and sales & distribution.
Venture capital-backed emerging companies with demonstrated commitment to a technology’s domain area.
De novo startups capable of attracting venture capital or other funding.
Health care systems or other provider networks that can deploy the licensed technology directly through their care network.
Government health care systems such as the VA that can deploy the licensed technology directly through their care network.
Existing large-scale NGOs or other non-profit entities that commit to making the technology broadly available as a public good.
Startup NGOs or non-profit entities capable of attracting funding to make the technology broadly available as a public good.