NH MedTech Lightning Showcase

SBIR / STTR is back.

Emily Caporello opened the substantive discussion with a status update on the federal funding mechanism many smaller companies in the room rely on. The program lapsed in October and went unauthorized until April; reauthorization is now in place, and NINDS is clearing the backlog. New SBIR / STTR funding opportunities publish June 1. Next NIH receipt date: September 5. The path from application to award typically runs about nine months for those who succeed on their first try.

The funding ladder: Phase 1 (proof of concept) runs $300k to $700k depending on institute; Phase 2 (companies that have demonstrated proof of concept) lands in the $2M to $3M range. Across all 27 NIH institutes and centers, the agency moves about $1.4 billion a year through this program; required by statute, since federal funding agencies must direct 3.5 percent of their budgets to small businesses.

Reach out. Send a one-pager. NIH program staff have a mandate to respond.

NIH has moved away from evaluating applications strictly on pay lines toward institute-level priorities, which makes a pre-application conversation with a program contact significantly more valuable than it used to be. NINDS in particular has prioritized funding companies that are new to the program.

What strategics actually look for.

Skander Limem delivered the night's most reusable segment: five filters BD uses when evaluating early-stage companies for collaboration.

1. A clearly stated value proposition for the patient. Too many startups, especially those coming out of academia, lead with the technology and a product. The shift strategics want to see is from product to solution; understanding the full clinical workflow, the pain points, the actual unmet need.
2. Health economics fluency. Who pays, and how? Is this reimbursement based, or a cash-pay market like a cosmetic procedure where the patient is the payer and pricing is sensitive? If a new code is required, how long is the path to coverage?
3. Technical feasibility and scalability. Most startups can show feasibility. The harder question is whether the technology scales, both in volume and as a fit with a strategic's supply chain and inventory model.
4. Funding strategy and openness to partnership. The era of "give me $50,000 and acquire me" is over. Strategics expect a startup to validate, launch, and demonstrate sustainable revenue against a clear market dynamic.
5. The team, and the advisory bench. Coachability. A good board and advisors who push the company past "just go fast" is genuinely differentiating.

Policy: RAPID, and the window to move it.

Clayton Hall opened with a reframe of how small companies should think about Washington: politics is the business of earning and spending political capital, and medtech still wears a white hat. US manufacturing, US jobs, patient outcomes. Policymakers are mostly inclined to be helpful when companies engage early, not when companies arrive in crisis mode.

On reimbursement, Hall walked through the fourth acronym in fifteen years for the same goal; closing the valley of death between FDA approval and full Medicare coverage. CASER became NSIT, NSIT became TSET, and TSET is now RAPID. The version under discussion would allow early CMS engagement, pre-IDE, for breakthrough Class 2 and Class 3 devices, so trial design can be aligned with what CMS actually needs in order to issue coverage at the time of regulatory approval.

The magic will be in the details. If FDA wants 200 patients with 18-month follow-up and CMS still wants 2,000 patients with 5-year follow-up, nothing has actually changed.

The political appetite is there: the underlying legislation cleared House Ways and Means Committee 41-3 last year. The broader environment is volatile (Republican Senate majority, a House that's fragile vote-to-vote, primaries in play), so Hall's expectation is that the window to move RAPID elements through Congress is now, not later.

AI moves from feature to core workflow.

Nate Doemling told two stories that connect the work back to patients. The first was COVID. HiArc designed a large molecular diagnostics instrument for Abbott Molecular in 2017-2018, ready for production with a build plan of about 40 units for its first full year. When COVID hit, Abbott pushed an EUA-approved assay in three weeks and instrument demand went from zero to 2,000 units overnight; in a global environment where components, circuit boards, and plastics were nearly impossible to source. By Doemling's estimate, the work that came out of Merrimack during that period touched more than 300 million lives through LabCorp and Quest core lab networks.

The second story was about AI. HiArc is using it internally to write and debug code; more importantly, customers are using it inside the products themselves. Mammography is the example that hits closest to home: historical false positive rate was about 40 percent. AI-assisted analysis, trained on millions of scans and able to distinguish dense breast tissue from a tumor more accurately than the human eye alone, has brought that figure down to around 10 percent.

In the next 10 years, we're going to have 100 years of innovation in medtech.