People are increasingly looking to the manufacturing sector to provide the critical components needed to combat the outbreak of COVID-19 in the U.S. – but few commentators outside the industry are familiar with the challenges shops face in producing parts for the medical industry. As one of the most heavily regulated industries in the world, the medical sector has its own ISO quality management standards and a wide range of FDA standards that must be met here in America. And one of the key requirements for meeting these regulations is attention to traceability, process security and tolerances.
Much like the aerospace industry, every part in medical manufacturing requires exhaustive documentation and must meet a variety of quality standards. This regulatory framework helps to keep patients and medical professionals safe and healthy, but it does add considerable complexity to the manufacturing process. Whether it’s “Current Good Manufacturing Practice” (CGMP) rules from the FDA or the ISO 13485:2016 standards for medical devices, shops that seek success in the medical field will need to produce parts in strict accordance with the highest standards for quality – and prove that they’ve done so via thorough documentation, which is now accomplished via specialized software solutions.
To meet these criteria, medical part manufacturers must pay particular attention to tolerances and process security. Whether it’s components for ventilators or custom-made implants, medical parts are made from advanced materials in high-performance CNC equipment and designed with complex, functional geometries – often with extremely tight tolerances. And because of the throughput required to meet the exceptionally high demand for medical products, production risks must be minimized, as interruptions caused by scrapped parts, broken/pulled-out tools or stalled processes can be costly.
For this reason, many medical manufacturers have turned to REGO-FIX to obtain toolholding solutions that meet their needs and exceed their precision requirements. These solutions include the industry’s widest variety of Swiss-made collets and holders for cutting tools as small as 0.0079″ (0.2 mm) in diameter. For the highest performance on tough medical parts, many shops choose the powRgrip system, the industry-leading collet-holding system that uses a tabletop hydraulic press for tool loading or unloading in less than 10 seconds. With a 1,100 Nm clamping torque rating, Z-axis length adjustment repeatability of <0.0004″ (10 µm) and system runout of less than 0.0001″ (3 µm), powRgrip is ideal for achieving the tight tolerances for medical parts with the least possible risk and highest level of process stability.
Many medical parts are also well-suited for production with REGO-FIX’s micRun system, an ER collet solution manufactured to even tighter standards than standard ER collets and designed specifically for high-speed micro machining. Even at 3xD, these collets deliver <0.0001″ (≤3 µm) system runout for an optimal balance of TIR, clamping force and operator ease of use.
Medical manufacturing isn’t easy or simple – it has required shops to overcome some of the biggest challenges in part production. Learn more about how REGO-FIX helps manufacturers achieve success in the medical industry at REGOUSA.com/industries/medical.