In the medical industry, medical moulds, as the core tools for the production of precision medical devices, require a balance of technical precision, material performance, and regulatory compliance in their cost calculation. Unlike ordinary industrial moulds, medical moulds must meet stringent standards such as biocompatibility, corrosion resistance, and high precision, resulting in significant differences in their cost composition and calculation methods. This article will systematically analyze the cost calculation logic of medical moulds from three dimensions: cost composition, quotation methods, and industry practices.

1. Core Components of Medical Mould Costs

The cost of a medical mould consists of direct and indirect costs, with direct costs accounting for approximately 70%-85% and indirect costs accounting for 15%-30%. The specific components are as follows:

1.1 Material Costs (30%-50%)

Medical moulds have extremely high requirements for material performance and must use special steels with corrosion resistance, high-temperature resistance, and biocompatibility:

• Mould Core Materials: Commonly used materials include S136 stainless steel (excellent corrosion resistance, suitable for medical devices in contact with body fluids), 2344 hot work die steel (high hardness, suitable for high-temperature forming), and NAK80 pre-hardened steel (good polishing performance, used for optical medical components). For example, the cost of the mould core for a cardiac stent mould using S136 steel can be three times that of ordinary P20 steel.
• Mould Frame Materials: Usually, S50C medium carbon steel is selected, with a cost of about 10-15 yuan/kg. However, medical moulds require nickel plating on the surface to enhance corrosion resistance, increasing the cost of a single mould frame by 20%-30%.
• Standard Parts: Guide posts and ejector pins need to be made of medical-grade stainless steel, with costs 50%-100% higher than ordinary parts.

1.2 Processing Costs (25%-40%)

The processing precision of medical moulds needs to reach ±0.005mm, and the processing complexity is much higher than that of ordinary moulds:

• CNC Machining: Five-axis simultaneous machining centers are used, with machining costs 1.5-2 times those of ordinary moulds.
• Electrical Discharge Machining (EDM): Used for the precision forming of complex cavities, with processing time 30%-50% longer than that of ordinary moulds.
• Surface Treatment: High-gloss mirror polishing (Ra≤0.05μm) requires manual grinding, increasing costs by 30%-50%; texture etching (such as leather grain) is charged according to complexity, adding 5,000-20,000 yuan per set of moulds.

1.3 Design Costs (8%-15%)

The design of medical moulds requires a combination of CAE simulation analysis (such as Moldflow runner optimization) and DFM manufacturability reviews, with a design cycle 40%-60% longer than that of ordinary moulds. For example, the design of an insulin pen mould requires simulation of the plastic flow's impact on sealing performance, with design fees accounting for 12%-15% of the total mould cost.

1.4 Mould Testing and Validation Costs (5%-10%)

Medical moulds need to pass ISO 13485 certification, and the mould testing process includes:

• Material Compatibility Testing: Verifying the chemical stability between the plastic and the mould material.
• Biocompatibility Validation: Complying with USP Class VI or ISO 10993 standards.
• Lifespan Testing: Simulating more than 100,000 mould opening and closing cycles to ensure mould stability.

1.5 Indirect Costs (15%-30%)

These include equipment depreciation (the cost of medical-grade CNC machines exceeding 2 million yuan is twice that of ordinary equipment), management expenses (requiring GMP certification), and risk expenses (the rework cost of medical moulds is high, usually set aside at 10% of the total cost).

2. Quotation Methods for Medical Mould Costs

The quotation for medical moulds needs to balance technical precision and market positioning, with common methods including:

2.1 Empirical Calculation Method

Formula: Mould Price = Material Cost + Design Fee + Processing Fee + Profit + VAT + Mould Testing Fee + Packaging and Transportation Fee
Proportions of each component:

• Material Cost: 30%-50% (higher proportion for medical-grade materials)
• Design Fee: 10%-15% (CAE analysis accounts for a significant portion)
• Processing Fee: 30%-40% (higher proportion for precision processing)
• Profit: 15%-25% (high technical premium for medical moulds)
• VAT: 13% (according to national tax rates)
• Mould Testing Fee: 5%-8% (complex validation process)

Case Study: For a diabetes detector housing mould using S136 steel and five-axis CNC machining, the total quotation composition is as follows:

• Material Cost: 80,000 yuan (including mould core, mould frame, and standard parts)
• Design Fee: 20,000 yuan (including DFM + Moldflow analysis)
• Processing Fee: 100,000 yuan (CNC + EDM + polishing)
• Profit: 50,000 yuan
• Mould Testing Fee: 15,000 yuan
• Total Price: 265,000 yuan (excluding tax)

2.2 Material Coefficient Method

Formula: Mould Price = Material Cost × Coefficient
The coefficient for medical moulds is usually 6-8 (4-6 for ordinary moulds), reflecting the complexity of processing and risk premium. For example, for an endoscope lens mould with a material cost of 50,000 yuan, calculated at a coefficient of 7, the total price = 50,000 × 7 = 350,000 yuan.

2.3 Product Structure Quotation Method

Pricing is segmented based on product size, precision, and structural complexity:

• Base Price: Calculated based on projected area or volume (e.g., 5,000-10,000 yuan/ton of material)
• Additional Fees:
  • Sliders/Lifters: 3,000-5,000 yuan each (high-precision guides required for medical moulds)
  • Precision Requirements: ±0.02mm adds 10%-20% (e.g., for surgical instrument handles)
  • Hot Runner System: Adds 5,000-10,000 yuan (precise temperature control required for medical products)

Case Study: For a minimally invasive surgical clamp mould with a projected area of 200 cm², the base price = 200 × 50 = 10,000 yuan, with additional sliders (2 pieces, 6,000 yuan) and precision of ±0.01mm (15% premium), the total price = 10,000 + 6,000 + 15,000 = 31,000 yuan.

3. Industry Practices and Trends in Medical Mould Costs

3.1 Regional and Process Level Differences

• Pearl River Delta/Yangtze River Delta: Mature technology but high labor costs (20%-30% more expensive than inland areas), suitable for high-precision medical moulds (e.g., artificial joint moulds).
• Inland Factories: Lower prices but strict acceptance requirements (e.g., passing FDA approval), suitable for non-core component moulds (e.g., medical tray moulds).

3.2 Supply Chain Integration Models

• One-Stop Service: Mould manufacturers provide a full range of services from design to manufacturing, mould testing, and certification, with a service fee of 10%-15% included in the total price. For example, a supplier of IVD reagent box moulds provides ISO 13485 certification support, with a quotation 8%-12% lower than segmented procurement.
• Modular Quotation: The mould is divided into modules such as mould core, mould frame, and hot runner, and quoted on demand. For example, a ventilator mask mould can be divided into a mould core (120,000 yuan), a mould frame (80,000 yuan), and a hot runner (30,000 yuan), allowing customers to purchase in stages.

3.3 Impact of Technological Upgrades on Costs

• 3D Printed Moulds: Used for rapid design verification, with costs 30%-50% lower than traditional moulds, but a lifespan of only 5,000-10,000 cycles, suitable for small-batch medical products (e.g., customized orthoses).
• Smart Moulds: Integrated with sensors to monitor temperature and pressure, increasing costs by 20%-30% but improving product qualification rates by 5%-10%, reducing total costs in the long run.

Conclusion

The cost calculation of medical moulds is a comprehensive balance of technology, cost, and regulatory compliance. From material selection to processing technology, from design validation to supply chain management, each link must prioritize "quality first." For medical enterprises, when selecting mould suppliers, they should focus on their technical capabilities (such as CAE analysis level), certification qualifications (such as ISO 13485), and historical cases (such as experience with similar medical product moulds), rather than simply pursuing low prices. In the future, with the popularization of technologies such as 3D printing and smart moulds, the cost structure of medical moulds will be further optimized, but the core requirements of "high precision and high compliance" will remain unchanged.