Key Impact
- Scalable manufacturing framework for ~500 devices annually
- XEL-STIM accelerator reduced development timelines
Client Overview
- Geography: USA
- Market Segment: Neuromodulation / Rehabilitation Devices
- Engagement Model: End-to-End Design & Manufacturing Partnership
Business Objective
A U.S based innovator in neuromodulation and rehabilitation technologies aimed to transform traditional therapy approaches through advanced electrotherapy platforms by developing a portable neuromuscular stimulation device. The objective was to deliver a system capable of controlled, dual-wave electrical stimulation for targeted rehabilitation, while accelerating commercialization for the U.S. market. This required a strategic partner to ensure clinical performance, regulatory compliance, and a scalable manufacturing model that could support both initial market entry and long-term growth.
Our Approach
Accelerated Development with Stimulation Platform
- Leveraged SJML’s proprietary Stimulation technology platform to reduce development timelines and technical risk.
- Utilized pre-validated hardware, firmware, and system architecture to bypass extended validation cycles.
Advanced Neuromuscular Stimulation Architecture
- Designed a dual-wave stimulation system replicating physiological signaling patterns.
- Implemented FPGA-based architecture for real-time modulation and targeted therapy delivery.
- Enabled a cloud-connected therapy platform supporting usage tracking and digital care models.
DFM & Engineering
- Applied DFM principles to optimize manufacturability, assembly, and test readiness.
- Engineered a portable, durable, and user-friendly device architecture.
- Optimized component selection and cost structure for long-term scalability.
Global Supply Chain & Manufacturing Readiness
- Established multi-region supply chain with alternate sourcing strategies.
- Enables scalable production through validated processes.
- Leveraged global manufacturing footprint for flexibility and continuity.
Verification, Validation & Regulatory Compliance
Executed end-to-end V&V aligned with ISO 14971 risk management framework.
Ensured compliance with:
- FDA 510(k) pathway (Class II device)
- IEC 60601, IEC 62304, IEC 62366
- Cybersecurity (IEC 81001-5-1)
- Biocompatibility (ISO 10993)
Results & Business Impact
- Achieved concept-to-commercialization within 2 years.
- Enabled scalable manufacturing readiness for ~500 devices annually with validated production processes.
- Established FDA 510(k)-aligned development with complete V&V, documentation, and audit readiness.
