Key Considerations for Lithium-Ion Batteries in Medical Devices

In the world of medical technology, the power source isn’t just a component—it’s a critical element of patient safety and device reliability. For Class II and III devices, such as portable diagnostic equipment, infusion pumps, and surgical tools, the requirements for lithium-ion batteries are exceptionally stringent.

So, what do medical device manufacturers need from their battery partners?

1. Uncompromising Safety & Compliance: Batteries must be designed to mitigate risks like thermal runaway and must adhere to rigorous international standards (IEC 62133, UN 38.3) and regional regulations (FDA, MDR).
2. High Energy Density & Long Cycle Life: Devices need to run longer between charges and operate reliably over many years, often requiring batteries that can withstand thousands of charge cycles with minimal capacity fade.
3. Custom Form Factors: Medical devices have unique shapes and sizes. Off-the-shelf batteries rarely fit perfectly, leading to compromises in design and efficiency.
4. Robust Battery Management Systems (BMS): A sophisticated BMS is crucial for precise monitoring of voltage, current, and temperature, ensuring safe operation within strict parameters.
5. Traceability & Documentation: Full traceability of cells and components, along with comprehensive documentation, is essential for quality control and regulatory audits.

At Creup Technologies, we understand these challenges deeply. Our approach is to collaborate closely with engineering teams to develop custom lithium-ion battery solutions that are integral to the device’s success, not just an afterthought. Our advantage lies in translating these requirements into reality:

• We design with medically certified, high-quality cells from tier-one suppliers.
• Our proprietary BMS algorithms are fine-tuned for the specific discharge profiles and safety thresholds of your device.
• We specialize in creating compact, high-density packs in custom shapes, freeing your industrial designers from the constraints of standard batteries.
• Most importantly, we provide the full design history file (DHF) and traceability documentation required for your regulatory submissions.

By partnering with a specialist, you integrate a power system designed for performance, safety, and compliance from the ground up.