A New Breakthrough for TPE Materials in the Medical Field: The Development Case of ES35A-XND Material for Medical Shoe Insoles
Time of issue:2026-01-19
I. Customer Needs and Background
The customer is a manufacturer of medical shoe insoles, and their core requirements are as follows:
- Low hardness (35A Shore A) Ensure foot comfort and reduce fatigue from prolonged wear.
- High resilience After prolonged stress (>8 hours/day), the deformation is less than 5%, and the recovery rate exceeds 90%.
- Processing adaptability Suitable for 200℃ injection molding process, with short molding cycle and high yield rate.
- Weather resistance Tolerant to changes in temperature and humidity, with stable material performance.
II. Development Process and Sample Validation
1. First-generation test material: ES35A-XND (baseline material)
- Formula Design :
- TPE matrix + silicone modifier, optimizing molecular chain flexibility.
- Add a lightweight filler to achieve a specific gravity of 0.88 g/cm³.
- Performance performance :
- Hardness: 35A, tensile strength: 3 MPa, elongation at break: 580%; overall performance meets the standards.
- The injection molding exhibits excellent flowability (melt index of 1.2 g/10 min), and the molded parts have a smooth, flawless surface.
- Test results :
- Simulated tread test (10,000 cycles): Deformation rate: 2.8%; Rebound rate: 96%.
- Conclusion Initially meets the requirements, but the customer requests further optimization of costs and process stability.
2. First optimization trial sample: ES35A-01 (Result: NG)
- Adjust direction :
- Replace some of the high-cost silicone modifiers with low-cost plasticizers, aiming to reduce costs by 10%.
- Adjust the filler ratio to reduce the target specific gravity to 0.85 g/cm³.
- Reason for failure :
- Flowability has decreased (melt index 0.8 g/10 min), resulting in insufficient injection molding fill and a yield rate dropping to 70%.
- The hardness has increased to 38A, and the customer feedback indicates reduced foot fit.
- The elongation at break has dropped to 520%, and the resilience fails to meet the standard.
- Conclusion Cost optimization comes at the expense of critical performance. NG 。
3. Second optimization test sample: ES35A-SL (Result: NG)
- Adjust direction :
- Add an anti-aging additive (UV-531) to enhance weather resistance.
- Adjust the vulcanization system with the goal of enhancing long-term stability.
- Reason for failure :
- The uneven dispersion of the additive resulted in a tensile strength dropping to 2.4 MPa and a tear strength of 8.5 kN/m.
- After the high-temperature and high-humidity test (60℃/95% RH, 500 h), microcracks appeared on the surface.
- The injection molding process window has narrowed, requiring the temperature to be raised to 210℃, which in turn increases energy consumption.
- Conclusion : Weather resistance is improved, but mechanical properties and processability are deteriorated. NG 。
4. Baseline return plan: ES35A-XND (final OK)
- Improvement measures :
- Retain the original formulation and optimize the injection molding parameters (hold pressure time +10%, mold temperature +5℃).
- Strengthen control over the stability of raw material batches and narrow the range of performance fluctuations.
- Verification results :
- Mass production yield has been increased to 98%, and the cost per unit has been reduced by 5% (through process optimization).
- Customer’s actual test over 12 weeks: average daily usage of 8 hours, deformation rate of 4.7%, and recovery rate of 94%.
- Conclusion : OK , passing final acceptance and entering mass production.
III. Key Issues and Solutions
IV. Case Summary and Value
- Technical Insights :
- The development of TPE materials requires striking a balance among the “performance-cost-process” triad; optimizing along any single dimension alone can easily lead to systemic imbalance.
- In the medical field, long-term reliability is given greater priority; material stability takes precedence over short-term cost advantages.
- Commercial value :
- After the successful introduction of ES35A-XND, the customer’s order volume increased by 30%, and the product has expanded into the rehabilitation insole market.
- Establish a “rapid trial-and-error—data feedback” model to shorten the development cycle of similar projects by 40%.
- Follow-up plan :
- Develop the ES35A-XND Pro series, supporting customized hardness levels (30A-50A) and antibacterial functionality.
- Explore supercritical foaming technology to further reduce material density (target: 0.80 g/cm³).