The Regulatory System Was Built for Products That Already Exist

If your device is novel, you already know that standard statistical approaches weren’t designed for your situation.

The risk of investing in a clinical program built on the wrong framework is real.

What We Do

Novel Methodology Development

When no established endpoint exists, we build and justify them, 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 credible paths forward: De Novo, PMA, 510(k), randomized or with performance goal (PG), 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 methods, 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 us Different

Working at the edge of FDA’s experience requires a different kind of statistical partner. At BSC®, we have 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 over 40 years of work across medical device submissions, including programs where the path had to be created.

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