The Orthopedic Insole Industry: From "Insoles" to "Medical Devices"
Publication Time:2025-11-20 14:50

I. Insole Classification and Indications

A. Classification by Function:

① Health and Comfort Type: Uses cushioning materials (such as gel, foam), primarily providing comfort, suitable for daily fatigue.

② Support and Correction Type: Core function, correcting foot alignment and improving gait through support from the medial longitudinal arch, lateral longitudinal arch, and transverse arch. This is the mainstream in the market.

③ Rehabilitation and Treatment Type: Targets specific diseases, such as diabetic foot (decompression), plantar fasciitis, Achilles tendinitis, O/X-shaped legs, scoliosis, etc., requiring strict medical evaluation and prescription.

B. Main Indications: Flat feet/hindfoot eversion High arches Plantar fasciitis Heel spurs Hallux valgus Knee pain Diabetic foot ulcer risk prevention

2. Manufacturing Technology and Materials

① Traditional Handmade Production: Relies on the experience of technicians, produced through mold taking and repair. Inconsistency is relatively poor, but flexibility is high.

② CAD/CAM Digital Manufacturing: Current Mainstream and Future Trend.

a. Scanning/Mold Making: Acquiring foot data (digital scanning or physical plaster model).

b. CAD Design: 3D design on a computer based on scanned data and biomechanical principles.

c. CAM Machining:

Milling: Milling the insole blank from a single piece of material (such as PE, EVA, cork).

3D Printing: The most disruptive technology. Using flexible resins, TPU, nylon, etc., lattice structures can be achieved, providing different hardness, cushioning, and support performance in different areas—something traditional methods cannot achieve.

③ Core Materials:

Support Layer: PP, PE, carbon fiber (high-strength, lightweight support).

Cushioning Layer: EVA, PORON, gel.

Surface Layer: Leather, suede, breathable and antibacterial fabric.

II. Industry Trends and Business Opportunities

1. Digitalization and Intelligentization: The integrated closed loop of "scanning-design-manufacturing" is the core competitiveness. AI-assisted design and big data gait analysis are cutting-edge directions.

2. Personalized Customization Becomes Mainstream: Consumers and patients are increasingly dissatisfied with standard-sized products; precise personalized customization brings better results and customer satisfaction.

3. Popularization of 3D Printing Technology: With the decline in equipment and material costs, 3D printed insoles are moving from high-end to mass-market, achieving a balance between functionality and aesthetics.

4. Service Decentralization and Diversified Scenarios: In addition to hospital rehabilitation departments, the business is expanding to chain pharmacies, sports rehabilitation centers, high-end gyms, running shoe specialty stores, and even elderly care institutions.

5. Shift from Treatment to Prevention: Market education is deepening, and people are beginning to pay for "preventing sports injuries," "improving athletic performance," and "daily comfort."