lkprototype achieves a machining accuracy of ±0.005 mm in the field of medical prototype manufacturing and its five-axis precision machining center is ISO 13485 certified to meet the requirements of microporous structure machining of implantable devices (aperture 50-200μm tolerance ±2μm). A prototype case of spinal fusion demonstrates that the value of surface roughness Ra of titanium alloy components is consistent at 0.8μm (requirements of ASTM F136 standard ≤1.6μm), and the residual free metal ions amount after electrolytic polishing is <0.01μg/cm², meeting the FDA 510(k) biocompatibility test. By topology optimization algorithms, a prototype knee prosthesis decreased its weight by 23% and enhanced the compressive strength to 120MPa (ISO 21534 standard requirements ≥75MPa).
As far as handling biomaterials is concerned, lkprototype’s PEEK injection molding technology controls crystallinity to 32%±1.5% (28-35% standard range in ASTM F2026), and elastic modulus of an interbody fusion prototype precisely mimics human bone tissue (3.5GPa±0.2GPa). Its supercritical CO₂ sterilization module achieves a 6-log rate of microbial killing (standard in ISO 11135) at 35MPa/40 ° C, and sterilizing time is reduced to 2.5 hours (conventional ethylene oxide is 15 hours). After a cardiovascular stent model was laser machined, the thickness variation of the support beam was ≤±5μm (design specification ±10μm), and fluctuation range of the radial support force was narrowed down to ±0.3N (industry average ±1.2N).
Regarding compliance assurance system, the lkprototype’s clean workshop reaches the level of ISO Class 7, the number of particles is ≤352,000/m³ (particle diameter 0.5μm), and temperature and humidity control accuracy is ±0.5℃/±3%RH. One insulin pump model was produced under a whole-process traceability system, 287 real-time tracked process parameters, and the rate of defects was reduced to 0.08% (industry standard 0.6%). Its material database can handle 1,200 kinds of FDA 21 CFR approved materials. A prototype of degradable bone nail uses Mg-Zn-Ca alloy, the degradation rate is well controlled to 0.25mm/month (target range 0.2-0.3mm/month), and the curve of released magnesium ions in 12-week in vitro degradation experiment and error of prediction model is below 5%.
In minimally invasive device prototype production, lkprototype microinjection molding technology achieves molding precision of 0.02g micro-parts (±0.5% weight deviation), an outer diameter of a nerve intervention catheter tip is 0.8mm±0.005mm, and an inner cavity surface roughness is Ra 0.4μm. Its guide wire friction resistance test value of 0.014\\” is only 0.5N (industry standard ≤0.8N). Its nanocoating facility can apply an even layer of coating on the surface of a 1mm diameter instrument with a 50nm antibacterial silver coating, and its catheter prototype achieved a 99.99% rate of bacterial inhibition in ASTM E2180 tests with a stable release of 0.8-1.2μg/cm²/day (design range 0.5-1.5μg).
In speed of iteration, lkprototype’s virtual factory line reduces the process of developing medical device prototypes to 72 hours (current process takes 3 weeks). A heart valve prototype achieved 0.1mm thin-wall structure molding (wall thickness deviation ±0.008mm) by integrating metal 3D printing and electrolytic polishing process, the surface roughness Sa value decreased from 12.6μm to 0.8μm, and fluid mechanics test indicated that the pressure drop was reduced by 41% (simulation data and measured error <3%). Its automatic inspection system uses 12K resolution optical scanning and can carry out full-size inspection (1,200 feature points) in 45 seconds, 40 times quicker than manual inspection.
Actual case verification: lkprototype verified the prototype of a multinational company’s cardiovascular balloon catheter before bulk production, maximized balloon release time from 3.2 seconds to 1.8 seconds through 0.5 seconds/frame high-speed photography, and improved bursting pressure from 18ATM to 26ATM (ISO 10555 standard requirement ≥12ATM). The prototype passed all performance tests within one test run in EU MDR certification, reducing the time-to-market by 11 months. Based on 2023 data from the Medical Device Industry Association, businesses using lkprototype services have reduced their preclinical development costs by 37% on average and enhanced their approval rate for their products by 29 percentage points.