Focus On The Entire Process Quality Control System - Six Layers Of Protection, Achieving 'Zero Foreign Objects: Establishing A Quality Defense Network For The Full Lifecycle Of The Puncture Device
May 22, 2026
Announcement of the Results:
Manas Technology has officially introduced its unique "6+ Quality Inspection System," which is a comprehensive quality control network covering the entire process from the warehousing of raw materials for disposable puncture devices, machining, cleaning, assembly to final production. The core objective of this system is to ensure that every puncture device produced is absolutely clean inside, fulfilling the commitment of "zero foreign objects, zero burrs, and zero hazards." It shifts the quality control from the final screening stage to every manufacturing step, building a solid process safety defense line for minimally invasive surgeries.
Research and Development Background Pain Points:
The puncture device serves as a passage for entering the body cavity, and the cleanliness of its interior directly affects patient safety. Microscopic metal debris remaining in the metal tube cavity, plastic components with release agents, or environmental dust, if flushed into the abdominal cavity during surgery, may trigger unpredictable inflammatory reactions, adhesions, or even more serious complications. Traditional quality inspections mostly rely on random inspections of the final products, which carry the risk of missed detections and cannot effectively trace the source of contamination. The industry's pain point lies in the lack of a systematic, traceable, and process control solution that can cover all key risk points (especially internal cavity cleanliness and hidden defects). Doctors' concerns about "whether the instrument is absolutely clean" persist.
Core Technological Innovation:
Our "6+ Quality Inspection System" is not a single technology, but an innovative control system that integrates "people, machines, materials, methods, and environment." Its core lies in "the entire process, multiple dimensions, and emphasis on the interior."
Incoming material inspection: Conduct material reports and appearance reviews for each batch of stainless steel pipes and plastic particles.
In-process inspection: Immediately use industrial endoscopes to conduct 100% inspections of the inner wall of the pipe cavity after lathe processing, ensuring there are no visible processing residues or excessive burrs.
Inspection after polishing and cleaning: Conduct random checks on surface smoothness and cleanliness after electrochemical polishing and ultrasonic cleaning.
Inspection after injection molding: Conduct size, transparency, and material shortage checks for plastic components.
Final overall inspection after assembly: Conduct functional tests (such as sealing, valve opening and closing) and final full appearance inspection on the finished products.
Factory inspection before shipment: Conduct destructive inspections (such as opening the pipe cavity) and performance rechecks according to AQL standards. In particular, the mandatory manual inspection of the inner cavity by "human eyes + optical magnification" is the soul of our system, compensating for the shortcomings of machine vision.
Mechanism of Action:
The mechanism of this system is "multiple layers of filtration, stopping risks before they occur." It is not a "goalkeeper" who only intercepts at the end point, but a "filter net" distributed along the production line. Each inspection is a verification of the previous process and a guarantee for the next process. By embedding inspection points after key processes (such as after processing and after cleaning), problems can be detected and isolated immediately, preventing defective batches from flowing and escalating. Endoscopy inspection directly targets the most concealed and risky issues of internal cavity cleanliness, achieving 100% coverage of the most critical quality characteristics. Multi-dimensional inspections (size, appearance, function, material) ensure the comprehensiveness of product quality. This pre-incremental and all-staff participation quality culture ensures that defects are eliminated at the earliest stage and within the smallest scope.
Efficacy Verification:
Since the full implementation of this system, the complaint rate of our products at the client end, especially those related to cleanliness and foreign objects, has decreased by more than 95%. During multiple surprise client audits and third-party system reviews, our process control records and traceability have received extremely high evaluations. The destructive sampling (dissection of finished products) conducted internally on a monthly basis by us shows that the detection rate of internal cavity foreign objects is infinitely close to zero. Many long-term cooperating hospitals' purchasing and infection control departments have reported that our products are a "no-risk" choice, directly reducing their inspection costs and risks for purchasing.
Research and Development Strategy and Philosophy:
Our quality philosophy is: "Quality is not something that is detected; it is designed and manufactured. However, excellent inspection is the ultimate vow to ensure the perfect realization of the design intent." We believe that sophisticated equipment and processes are the "body," while a rigorous quality control system is the "nervous center." Our R&D strategy is to develop and invest in "quality control" itself as the core technology, without sparing the use of the seemingly more costly but more reliable approach of "human-machine combination," especially for those fatal defects that pose a direct threat to patient safety. We believe that the obsession with quality is the greatest respect for life.
Future Outlook:
In the future, we will continuously upgrade this intelligent quality network. We plan to introduce an AI automatic detection system based on machine vision, which will be used for rapid screening of appearance defects, allowing human resources to be more focused on complex judgmental inspections. At the same time, we will explore to assign each product a unique "digital twin" traceability code, recording all the process data from raw materials to production and inspection, to achieve full lifecycle management of quality data. Our goal is to build an "adaptive" quality system that can predict process deviations through big data analysis and achieve a leap from "defensive inspection" to "predictive control."








