Client Background & Product Requirements

A renowned medical technology brand planned to develop a "Clinical-grade Remote Physiological Monitoring Wristband." The product is designed for long-term wear on patients' wrists to monitor heart rate, blood oxygen levels, and body temperature 24/7. The client set extremely rigorous specifications, including material biocompatibility, miniaturization precision of internal components, and IP68-rated protection.

Due to the critical nature of medical data accuracy, the client sought an integrated manufacturing partner with ISO 13485 certification. The partner needed to simultaneously handle silicone straps, precision plastic structural parts, and SMT electronic assembly to ensure consistent product quality.

Manufacturing Challenges

• Biocompatibility and Comfort: The wristband had to meet medical-grade standards. The molded surfaces required a flash-free, perfectly rounded finish to prevent friction and discomfort during long-term wear.
• Stability of Ultra-Small Components: The internal sensor bracket weighed only 0.008g. Traditional injection molding processes struggled to control precision at this scale, which could lead to sensor misalignment.
• Multi-material Bonding & Protection: The junction between the rigid housing and soft silicone had to withstand high-pressure disinfection and daily waterproofing. This presented a high level of difficulty in structural encapsulation.
• Precision Electronic Integration: PCBA assembly and waterproof dispensing had to be completed within an extremely confined space. Any tolerance stack-up could result in signal interference or water leakage.

Foreshot’s Solutions

1. LSR / LSM (Liquid Silicone Rubber) Injection Molding

We utilized LSR technology to manufacture the medical-grade wristbands. The excellent flow properties of liquid silicone allow for fine anti-slip textures while passing biocompatibility tests (such as skin irritation tests). Through an automated precision de-molding process, we ensured edges remained free of parting lines, significantly enhancing the wearing experience.

2. Specialized Micro-Injection Molding Technology

For the micro-brackets weighing less than 0.01g, Foreshot deployed specialized micro-injection machines, locking molding tolerances within +/- 0.01mm. This ensures the physiological sensors maintain the optimal contact angle with the skin, improving the accuracy of monitored data.

3. Insert Molding and ISO 13485 Assembly Services

By using insert molding to integrate metal contacts with the plastic housing into a single piece, we strengthened the structural waterproofing. All SMT electronic assembly and full-device testing were conducted in ISO 13485 certified medical-grade cleanrooms. We also introduced automated air-tightness testing and vision inspection systems to guarantee zero-defect quality.

Project Results & Value

• Significant Yield Improvement: By integrating micro-injection and LSR technologies, the overall mass production yield was increased from the client's expected 85% to 98.5%.
• Product Miniaturization: We helped the client reduce internal structural space by 30%, making the wristband thinner, lighter, and more competitive in the market.
• Rapid Mass Production Cycle: The transition from mold development to trial production took only 8 weeks, helping the client successfully launch the product before major medical trade shows.
• Quality Compliance: The product passed 100% of biocompatibility and high-pressure waterproof tests, smoothly securing international medical device certifications.

Market Feedback: Through Foreshot’s technical integration, the client successfully reduced product weight by 15%. The device received significant attention at medical technology exhibitions for its "clinical-grade precision" and "wearing comfort," and has now successfully entered the global remote healthcare supply chain.