Consulting
BioSense Review offers technical consulting for organizations developing, evaluating, or commercializing biosensor and wearable health technology.
The work is grounded in hands-on research experience with biomedical signal acquisition, processing, and clinical validation. We have worked in academic medical settings where the rigor of measurement methodology was not optional. That standard carries over into every consulting engagement.
Who We Work With
- Medtech companies developing wearable health monitoring products
- Device manufacturers seeking independent signal validation
- Clinical research teams designing wearable-based study protocols
- Investors conducting technical due diligence on biosensor companies
- Regulatory teams preparing FDA submissions
What We Offer
Signal Validation and Algorithm Review
Independent assessment of signal acquisition pipelines, preprocessing methods, and feature extraction approaches. We evaluate noise handling, artifact rejection, and algorithm performance against appropriate reference standards.
Regulatory Technical Support
Technical writing and scientific substantiation for FDA 510(k) submissions, De Novo requests, and predicate device comparisons. We understand what reviewers look for and how to present validation evidence clearly.
Study Design and Protocol Review
For clinical validation studies, we advise on reference standard selection, data collection protocols, statistical analysis plans, and subject population criteria. The goal is validation data that holds up under scrutiny.
Signal Processing Development
Custom signal processing pipelines for cardiac, respiratory, electrophysiology, and EMG applications. Deliverables can include production-ready code, technical documentation, or white-label analysis tools.
Technical Due Diligence
For investors evaluating biosensor companies, we provide independent assessments of product claims, algorithm robustness, regulatory exposure, and the credibility of published validation studies.
How It Works
We start with a short introductory call to understand your project and determine whether we are a good fit. If we move forward, you receive a written proposal with defined deliverables, timeline, and fees. All engagements are subject to NDA upon request.
Get in Touch
Use the Contact page to start a conversation.