Respiratory & Sleep Medicine
BSC's published research in sleep medicine reflects deep domain knowledge in polysomnography endpoints and respiratory assessments. We translate this expertise into regulatory strategies that anticipate FDA expectations and accelerate your path to approval for ventilators, sleep apnea devices, and respiratory diagnostics.
Overview
BSC provides statistical expertise for respiratory devices and sleep medicine technologies, including ventilators, respiratory monitoring systems, sleep apnea treatment devices, and pulmonary diagnostics. Our experience spans both acute respiratory conditions and chronic sleep disorders. Multiple team members have decades of experience at University of Pennsylvania Sleep Center as directors of the biostatistics core.
Specialized Capabilities
Apnea-hypopnea index (AHI) analysis and responder definitions. Sleep stage analysis and architecture assessments. Polysomnography endpoint design. Respiratory function testing (spirometry, gas exchange). Long-term adherence modeling for sleep therapy devices.
Regulatory Experience
We understand FDA expectations for sleep disorder treatment devices, including appropriate sham controls, objective outcome measurement, and long-term effectiveness assessment. Our team has experience with both home sleep testing and laboratory polysomnography endpoints.
Representative Studies
- Oral appliances for sleep-disordered breathing
- Home sleep testing devices
- CPAP and BiPAP devices for sleep apnea
- Respiratory monitoring and diagnostic systems
- Pulmonary function testing equipment
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
WHAT CLIENTS SAY
“They listen the first time. I’ve never had to go back and respell out what I needed."
”They work to understand the problem and leverage the information that is already there.”
Former FDA Regulator
WHAT CLIENTS SAY
"Battle ground tested."
"There is nothing that David and team haven’t seen over the years – the good, bad, and ugly.”
Vice President, Clinical Operations
WHAT CLIENTS SAY
"Get stuff done when you have to do something no one else has done before."
"They aren’t afraid to tackle difficult scenarios in compressed timelines."
CEO, Medical Device Company
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