Client Overview
- Geography: USA
- Market Segment: Orthopedics | Spine Care
- Engagement Model: End-to-End Design, Manufacturing & Regulatory Support
Business Objective
A US-based medical device company focused on advancing non-invasive adjunct therapies to improve spinal fusion success rates.
Design, engineer, verify, and mass manufacture a Class III stimulation system delivering precise therapeutic dose with high usability and safety, along with CDSCO licensing and FDA 510(k) dossier support.
Our Solution
System Architecture & Device Functionality
- Clinically aligned stimulation parameters tuned for effective bone growth support
- Fixed-dose, microprocessor-controlled therapy delivery ensuring consistency
- Simplified single-button interface minimizing patient use variability
Electronics & Product Engineering
- Embedded control system for precise dose regulation and repeatability
- Safety-driven circuit design aligned to essential performance requirements
- Optimized power management for reliable long-duration therapy cycles
Mechanical & Industrial Design
- Robust enclosure design supporting daily use in home-care settings
- Human factors engineering to reduce user error and improve adherence
Design for Manufacturability (DFM) & Pilot Production
- Design optimization for scalable production and cost efficiency
- Component standardization to ensure supply chain reliability
- Pilot builds to validate assembly processes and device performance
- Documentation aligned with DMR/DHR for commercial manufacturing
Regulatory & Compliance
- Parallel regulatory pathway development for US and India markets
- CDSCO test licensing and manufacturing approval support
- Compliance aligned with Class III device safety and performance standards
Results & Business Impact
- Accelerated path to market through parallel regulatory and manufacturing readiness tracks
- Reduced transition time from engineering to commercialization
- Scalable manufacturing foundation enabling future volume ramp-up
