Funding Forward: The Work Between First Proof and First Belief
The pilot worked. A clinician champion signed the letter. The method held outside the lab. Families finally have something to point to that isn’t a press release.
And then the questions begin—not about hope, but about confidence.
“Will a second site see the same signal with different staff and workflows?”
“Is the manufacturing process locked enough to trust batch-to-batch?”
“Are the endpoints the ones a regulator or payer will accept?”
“Can we run a pragmatic study without breaking the clinic’s day?”
This is the layer where most health innovations wobble: early translation—after first proof, before the wider ecosystem believes. It’s quiet work, unglamorous, and essential. It’s also the work traditional capital underfunds. That’s the gap we built Funding Forward to illuminate.
Where teams actually get stuck (it’s not “deployment”)
Pre-IND / pre-submission reality. The science is strong, but the endpoint plan isn’t. When populations are small or workflows are novel, the very first conversation with regulators hinges on whether your measures are credible in real use. Miss here, and you relive the year.
Second-site readiness (the invisible month). A new site isn’t copy-paste. EHR build, SOPs, training, and data capture eat calendar and cash. Without this, “multi-site” is just a slide.
CMC/QMS for first real use. For devices and therapies, manufacturing and quality aren’t back-office—they are the product at this stage. Lock them now or pay later.
Evidence that travels. A gorgeous forest plot won’t sell itself. You need pragmatic outcomes and basic HEOR that a payer or hospital finance lead recognizes—even in small-n settings.
Data rights & reuse. If you don’t define data ownership and sharing up front, the study you run can’t power the study you need next.
None of this is “go-to-market.” It’s the scaffolding that lets belief accumulate.
What money is for at this stage (and what it isn’t)
Early translation capital should retire named risks, not inflate headcount or chase headlines:
Align endpoints & protocol for tiny populations / novel settings.
Stand up site #2 (EHR build, SOPs, consent, training).
Finish CMC/QMS to enable first-in-human / first-in-child.
Run a pragmatic add-on (utilization, time, dropout) alongside primary outcomes.
Prepare a minimal payer packet (comparators, cost signal, coding path) without pretending you’re at coverage.
Make the next ask land (without sounding like everyone else)
Anchor your request to one translation job, two irreversible milestones, and one decision date:
One job: “We’re funding site-2 readiness + pragmatic outcomes to convert signal into credible proof.”
Two milestones: “Go-live at week 10; 3-metric outcomes readout at month 9.”
One decision date (clear and literal):
{Example: Decision Date — Month 10
If data ≥ threshold Y → file regulatory pre-submission or reimbursement code request.
If data < threshold Y → pivot to Plan X (e.g., refine protocol, adjust endpoint, or sequence a smaller study).
Plain language beats poetry. “Risk retired” beats round size.}
The founder self-audit (five fast truths)
One sentence, one risk. If you can’t name the single risk this money retires, you’re not ready to fund it.
Irreversible milestones only. Busywork milestones burn trust; irreversible ones create momentum.
Three outcomes that matter: one clinical, one workflow, one cost/utilization. (If you can’t measure them, you can’t scale them.)
Named site #2. With a signed letter and a concrete EHR plan. No “TBD networks.”
Write toward a reviewer. Every table, figure, and metric should be legible to the specific regulator or payer you’ll face next.
Funding Forward highlights non-competitive pathways that underwrite this layer—endpoints, sites, manufacturing readiness, and pragmatic outcomes—so founders can move from first proof to first belief without losing momentum in the middle. We’re not the biggest check in the story; we’re the reason the next check is straightforward. The next decade in health innovation won’t be defined by what we discover. It will be defined by what we can carry—from first proof to first belief—without stalling in the translation layer no one sees and almost no one funds.
Build the scaffolding. Make the decision date real. Retire one risk at a time.
That’s how ideas cross from “it works” to “it reaches people.”
