The Regulatory System Was Built for Products That Already Exist

If your device is genuinely novel — no predicate, no established endpoint, no clear pathway — you already know that standard statistical approaches weren't designed for your situation. The guidance documents point in directions that don't quite apply. The methods sections of other submissions don't map to what you're trying to measure. And the risk of investing in a clinical program built on the wrong framework is real.

That worry is legitimate. But it isn't the end of the story.

BSC has spent nearly four decades helping sponsors navigate the edges of what FDA has seen before. We've developed novel endpoints, built first-of-kind statistical frameworks, and worked directly with agency staff to establish the methodological ground rules for programs that didn't fit neatly into existing categories. We know what it takes to move a novel device from scientific uncertainty to regulatory acceptance.

What We Do

Novel Methodology Development

When no established endpoint exists, we build one — working from the clinical evidence base, patient outcome literature, and direct FDA engagement to define what success looks like and how to measure it. This includes endpoint development, threshold justification, psychometric validation support, and the statistical rationale FDA will need to evaluate your approach.

Regulatory Pathway Mapping

We help sponsors identify the most credible path forward: De Novo, PMA, 510(k) with a performance goal, or a hybrid approach. We support Pre-Sub preparation, help frame statistical questions for agency feedback, and translate FDA responses into actionable study design decisions.

Advanced Statistical Methods

For programs that require methods beyond standard frequentist testing, we bring deep applied expertise: Bayesian evidence synthesis, adaptive designs, propensity-based methods for non-randomized comparisons, real-world evidence integration, and simulation modeling to validate design operating characteristics. Every method we propose is built for regulatory defensibility, not just analytical elegance.

Stakeholder Alignment

Novel programs require internal alignment as much as regulatory strategy. We support sponsor teams in building a shared scientific rationale — across clinical, regulatory, and executive stakeholders — so that the statistical approach is understood, owned, and consistently communicated throughout the program.

What Makes This Different

Working at the edge of FDA's experience requires a different kind of statistical partner. Not just technical competence — though that's necessary — but the regulatory instinct to know what an agency reviewer will accept, what they'll push back on, and how to build the scientific case that earns their confidence.

BSC brings that instinct from nearly 40 years of work across medical device submissions, including programs where the path had to be created, not just followed.

Working on something FDA hasn't seen before? [Talk to us.]