The regulatory system was built for products that already exist. Yours doesn't fit the mold — and that's the problem.

Novel devices face a paradox. The more innovative the technology, the more compelling the science — and the less the existing regulatory framework knows what to do with it. There's no predicate to reference. No established endpoint to measure against. No performance goal derived from decades of prior submissions. No clear pathway that anyone has walked before.

Standard statistical approaches were designed for standard problems. When your device is genuinely new, standard approaches can leave you exposed.

We've built regulatory pathways where none existed.

BSC specializes in the statistical and regulatory challenges that arise when innovation outpaces precedent. We've developed novel endpoints from scratch, constructed performance goals from literature and real-world data, designed studies for technologies FDA had never reviewed, and built analytical frameworks that became the template for submissions that followed.

This work requires more than statistical expertise. It requires regulatory imagination — the ability to anticipate what a reviewer will ask about a method they've never seen, justify an approach that has no direct precedent, and build confidence in a pathway before anyone has walked it.

Common scenarios we navigate

• Novel device with no predicate — We help define what evidence FDA needs, build the analytical framework to generate it, and construct the statistical justification that supports a first-of-kind submission

• No established endpoint or performance goal — We develop defensible endpoints grounded in clinical literature, expert consensus, and historical data, and work with sponsors to gain FDA alignment before pivotal studies begin

• Unprecedented regulatory pathway — We map the statistical strategy to the regulatory landscape, engage with FDA through Pre-Sub meetings, and build the evidentiary case for a pathway that doesn't yet have a roadmap

• Real-world evidence integration — We design RWE strategies that meet FDA's evolving expectations, integrating observational data with clinical evidence in ways that are methodologically sound and regulatorily defensible

• Propensity score matching and causal inference — When randomization isn't possible or ethical, we design and implement propensity-based analyses that rigorously control for confounding, support causal claims, and satisfy regulatory expectations for non-randomized comparisons

• Adaptive trial designs — We design trials that can learn and adjust as data accumulates — modifying sample size, allocation ratios, or stopping rules at pre-specified interim points — while preserving Type I error control and maintaining regulatory defensibility throughout

What we do in these engagements

Drawing on our Advance services, we support:

• Novel endpoint development and validation

• Performance goal development from literature and RWE

• Regulatory pathway mapping and Pre-Sub strategy

• Bayesian and adaptive design for unprecedented scenarios

• Real-world evidence study design and integration

• Scientific justification documentation

• FDA engagement strategy and meeting support

• Precedent research and cross-industry benchmarking

Innovation deserves a statistical partner who can keep up

The risk with a novel device isn't just regulatory uncertainty — it's bringing the wrong statistical team to a problem they've never seen. Generic methods applied to unprecedented challenges produce generic outcomes. At best, delays. At worst, rejection of science that deserved approval.

BSC has built its reputation on exactly these situations. We don't default to the textbook when the textbook doesn't apply. We build the framework your program needs — methodologically rigorous, regulatorily defensible, and designed to give your innovation the best possible path forward.

Your device is new. Your statistical strategy should be too.