Isometric’s Microns Matter® PFMEA Process

Isometric’s Microns Matter® PFMEA Process

General, White Papers
Isometric's Microns Matter® PFMEA Process Figure 1.1 Isometric Micro Molding “Average” Tolerance Risk Assessment Strategy Each phase of Isometric's Microns Matter® PFMEA process allows for the accurate estimation of percentage micron tolerance risks, which mitigates risks during each phase. Truly, components and devices with micron tolerances can only be successfully manufactured by applying years of tooling and plastics engineering experience. These phases include: ULTRA-PRECISION TOOLING METROLOGY MATERIAL DRYING MATERIAL LOT TO LOT VARIATION MICRO INJECTION MOLDING PROCESS The histogram in Figure 1.1 shows the average percentage error in each of these phases for a molded part with a tolerance of +/- 8 microns (16 microns total) and a process capability index (Cpk) of 1.33. From a risk mitigation standpoint, it's critical to select a micro molding partner with a vertically…
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Microns Matter® Proven Process in Medical Micro Molding

Microns Matter® Proven Process in Medical Micro Molding

White Papers
Isometric's Microns Matter® Proven Process for Medical Micro Molding Micro molding for critical applications requires extreme precision and a consistent, proven process. After all, micro-sized components are often the key enabling elements of Class II or Class III medical devices and drug delivery devices which, because of their size, often require micron-level tolerances. With 30 years’ experience in micro injection molding, Isometric Micro Molding has developed a best-practice risk assessment strategy called “Microns Matter®”, which is used for the development and high-volume production of critical-to-function micro molded devices. The Microns Matter® Approach The Microns Matter® process follows a Japanese-like strategy — essentially, “plan, plan, plan, execute”.  The axiom “fail to plan, plan to fail” is never more accurate than when it's applied to micro manufacturing projects. But the failure of…
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5 Steps to Micro Molding Success

5 Steps to Micro Molding Success

White Papers
Microns Matter® 5 Steps to Micro Molding Success With over 30 years of experience in micro injection molding, Isometric Micro Molding has developed a unique 5-step risk assessment strategy called, "Microns Matter®". This proven process is especially important for the successful manufacturing of medical devices, from the development stage to high-volume production of these critical-to-function micro molded devices. Vertical integration and transparency are key to our unique risk mitigation. We've repeatedly heard from OEMs that it's not uncommon for micro-molding suppliers to say that the work is “proprietary”, contains “trade secrets” or, “you can’t see that part of the process”.  This level of secrecy leaves a large gap in design history files, which can result in increased design and clinical trial resources, time, and, in many cases, a restart with…
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