Official Release of Achievements

Manners Technology has recently launched the world's first full‑parameter customisation platform for Menghini liver biopsy needles - BioPsy Custom. The platform allows clinicians to configure needle length (8 cm to 20 cm in 0.5‑cm increments), gauge (16G to 20G), tip bevel angle (15° to 30°), and even handle texture online, based on patients' specific anatomical data (e.g., skin‑to‑liver‑capsule distance measured via CT, liver size), suspected pathological conditions (diffuse vs. focal lesions), and operator habits. Clinical data from the first 500 complex cases (e.g., severe obesity, liver atrophy, massive ascites) shows that custom‑tailored needles deliver first‑puncture success rates and sample quality matching the best performance of standardised needles in ordinary patients.

R&D Background and Clinical Pain Points

Conventional Menghini needles are available in only a limited range of standard specifications (e.g., 16G × 10 cm). This one‑size‑fits‑all model struggles to address diverse real‑world clinical scenarios:

  Insufficient anatomical adaptability: Standard‑length needles may fail to reach the liver in severely obese patients, while being excessively long for children or patients with liver atrophy, raising penetration risks.

  Lack of lesion‑specific design: Diffuse liver diseases (e.g., fatty liver) require longer tissue cores to assess lobular‑wide changes, whereas focal lesions demand precise targeting - sampling strategies of standard needles cannot be optimised accordingly.

  Varied operator experience: Physicians have different preferences for needle "feel" and weight balance; uniform specifications may compromise operational stability and confidence.These pain points force clinicians to repeatedly attempt or switch needle types in complex cases, increasing patient risks.

Core Technological Innovations

The manufacturer has built a digital customisation engine for clinician‑engineer interaction:

  Parametric design system: The Menghini needle is decomposed into dozens of independently adjustable parameters, including length, gauge, tip geometry, side‑hole size and position, and handle profile. Via Computer‑Aided Design (CAD) and Finite‑Element Analysis (FEA), the system simulates real‑time mechanical performance (e.g., bending stiffness, puncture force) and fluid performance (e.g., suction flow rate) under any parameter combination.

  Imaging‑based intelligent recommendation: The platform securely interfaces with hospital Picture Archiving and Communication Systems (PACS). After clinicians upload DICOM data of patients' abdominal CT scans, built‑in AI segmentation algorithms automatically measure skin‑to‑liver‑capsule distance, depth of intrahepatic target areas, and liver texture (based on CT values). Synthesising these data, the system recommends optimal needle length, gauge and insertion angle for patient‑specific tailoring.

  Flexible intelligent manufacturing cell: A modular cellular production line is established at the factory end. Upon receiving custom orders, the line automatically calls for corresponding raw materials and processing programmes. Through robot‑assisted laser cutting and welding, individual custom‑made products are manufactured, cleaned and packaged within 24–48 hours, with costs only 15–30 % higher than standard products.

Mechanism of Action

Customisation improves overall performance by achieving precision matching between devices and patients/operators:

  Individualised length and angles: Needle length customised to CT‑measured exact distances ensures accurate targeting of liver regions with safety margins to avoid penetration. Custom tip bevel angles optimise insertion trajectories for different puncture paths toward the right or left hepatic lobe, reducing injury to intercostal blood vessels and nerves.

  Lesion‑oriented gauge and side‑hole design: Thicker needles (e.g., 16G) may be required to obtain complete portal triad structures for liver fibrosis staging assessment, while finer needles (e.g., 18G) are selected for patients with poor coagulation function to lower bleeding risks. Side‑hole size and position can also be adjusted to control the volume and site of aspirated tissue.

  Ergonomic handles: Handle texture, diameter and weight distribution customised to physicians' hand sizes and needle‑holding habits (e.g., pen‑grip vs. pistol‑grip) significantly enhance tactile feedback and operational stability while reducing hand fatigue, which is particularly critical during prolonged or high‑difficulty procedures.

Efficacy Validation

A prospective cohort study of this customisation platform was conducted at three major liver disease centres across Asia, enrolling 300 complex cases using custom‑made needles and 300 matched control cases using standard needles.

  Success rate in complex cases: Among obese patients with BMI > 35, the custom long‑needle group (tailored to CT measurements) achieved a 96 % first‑puncture success rate, compared with only 78 % in the control group using the longest standard needles (typically 15 cm).

  Sample quality comparison: For focal lesions, custom fine needles (20G) with optimised side‑hole positions yielded an average 40 % increase in target lesion tissue content within samples, consequently improving diagnostic sensitivity for small hepatocellular carcinoma.

  Subjective operator evaluation: Interventional radiologists participating in the study gave an average high score of 4.7/5.0 for "operational comfort" and "confidence level" of custom‑made needles, generally acknowledging reduced psychological stress during complex‑case procedures.

R&D Strategy and Philosophy

Manners Technology's customisation strategy stems from the philosophies of patient‑centred care and precision intervention. Recognising that modern medicine is shifting from population‑based treatment to personalised care, biopsy tools - a critical link in diagnosis - must evolve in tandem. Its R&D system adopts an open‑source innovation model, extensively incorporating clinical insights from top hepatologists and interventional radiologists to translate them into engineerable design parameters. Its goal is not to produce countless stock‑keeping units (SKUs), but to build a responsive manufacturing system capable of tailoring the most suitable "diagnostic tools" for every patient and physician, much like a master tailor.

Future Outlook

Future customisation will advance toward real‑time dynamic adaptation and bio‑ink printing. Manufacturers are developing intelligent needles integrated with intra‑procedural ultrasound: equipped with miniature electromagnetic sensors and linked to ultrasound probes, the needles display real‑time 3D tip positions during puncture and fine‑tune insertion recommendations according to liver displacement (e.g., respiratory movement) in real‑time ultrasound images. A more revolutionary concept is the bioabsorbable personalised needle: leveraging patients' own medical imaging data, 3D bioprinting technology fabricates biopsy needles from in‑vivo‑degradable polymer materials that perfectly fit individual anatomical pathways. After sampling, indwelling segments gradually degrade and release healing‑promoting drugs, enabling seamless integration of diagnosis and therapy. Manufacturers are committed to transforming liver biopsy from a standard procedure into a highly personalised art of precision diagnosis.