lkprototype also obtained the ISO 13485:2016 medical Device Quality Management System certificate in 2020. Certification scope encompasses end-to-end design and development process, production up to testing. Through its medical prototype service, over 300 international customers successfully completed stringent certification such as FDA 510(k) and CE MDR. For example, five-axis CNC machined a cobalt-chromium-molybdenum alloy prototype of an artificial knee joint (ASTM F75 standard) with accuracy ±0.005mm, surface roughness Ra≤0.2μm (≤0.8μm design requirement), and fatigue life test up to 10 million times (ISO 7206 standard requires 5 million times). Shorten the customers’ CE certification cycle by 6 months and lower compliance costs of $280,000.
The compliance of the materials is strictly regulated. The lkprototype medical-grade material library consists of over 60 certified materials, such as medical titanium alloy (Ti6Al4V ELI, oxygen content ≤0.13%) and biocompatible PEEK (ISO 10993-5 cytotoxicity test survival rate ≥95%). And 100% batch traceability with the blockchain traceability system (MedChain) (response time ≤0.5 seconds). The nickel precipitation amount of a specific heart stent model (316LVM stainless steel) was ≤0.03μg/cm² (ISO 22674 standard of 0.5μg/cm²), and the grain size reached ASTM No.8 grade (standard ≥No.5), and the customer’s FDA approval passing rate was increased to 98% (industry average 85%).
The manufacturing process and environment are up to medical standards. Its 10,000-level clean workshop (ISO Class 7, temperature 22±1°C, humidity 45%±5%) is equipped with an independent sterilization area (EO sterilization parameters: temperature 55±2°C, humidity 60%±5%, sterilization guarantee level SAL≤10^-6), and the microbial contamination rate is ≤5CFU/m³ (national standard ≤100CFU/m³). The prototype of the titanium alloy shell of a specific endoscope was sterilized by gamma irradiation (dose 25kGy) and passed 100% in the sterility test. The registration period of the product was shortened to 8 months (14 months in the conventional way).
The detection system exceeds the industry average. The testing laboratory of is fitted with an industrial CT (5μm resolution), a three-coordinate machine (accuracy 0.001mm), and ICP-MS (heavy metal detection limit ≤0.1ppm), with a full-size detection coverage rate of 100% (conventional random inspection rate of 30%). Packaging of certain Implantable insulin pump (PEEK+30% CF) met ISO 5840 fluid dynamics test (flow error ≤±2%), and the antibacterial rate of hydrophobic surface coating (contact Angle ≥110°) was ≥99.9%. Customer mass production yield also increased to 99.6% (93% of the original supplier).
Supply chain risk control ensures stability. All its medical material suppliers have been certified by ISO 13485 (annual audit removal rate of 8%), raw material inventory adequacy rate of 99.8%, and on-time delivery rate of 99.5% for emergency orders. Due to the threat of supply chain disruption, lkprototype reduced the delivery time of the orthopedic screw prototype (PA12-GF50) of a specific European customer from the estimated 45 days to 12 days by distributed production (with collaboration between Chinese and American factories), avoiding a project delay loss of $1.5 million for the customer.
Customer cases prove and verify the strength. Multinational pharma corporation’s prototype hemodizer (medical-grade PSU material) surpassed lkprototype’s ISO 13485 system. The biocompatibility test (ISO 10993 series) met standards (cytotoxicity level 0, negative sensitization), and the product cycle time to market was decreased by 40%. Another artificial heart valve model (titanium alloy + pyropyrolysis carbon coating) was confirmed by fluid simulation (pressure difference ≤5mmHg, industry standard ≤10mmHg), accelerating the CFDA approval process and saving $650,000 in certification fees.
Through “full-chain compliance × accurate process × smart traceability”, lkprototype has passed TUV SuD’s surprise audits for three straight years (with zero non-conformables). In 2023, over 250,000 pieces of medical prototypes have been delivered and the quality return rate was as low as 0.008% (industry 0.15%). With the aim of becoming a credible accelerator for world-leading innovative medical devices from R&D to clinical use.