Isometric Micro Molding logo, white letters on blue background

Isometric's
Microns Matter® PFMEA Process

PLAN, PLAN, PLAN, EXECUTE

At Isometric Micro Molding, mitigating risk is our fundamental goal. To achieve this goal, we’ve developed the Microns Matter® best-practice risk assessment strategy. This proven process is used for the development and high-volume production of critical-to-function micro molded devices.

The Microns Matter® PFMEA Process follows a Japanese-like methodology — 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. The risks associated with the failure to plan are numerous. Design re-iterations, re-assessment of manufacturing protocols, and adjustment or reworking of tooling can be catastrophic with time, cost, and the difference between project success and project failure

Photo of a computer with the Microns Matter® PFMEA chart on the screen, with meeting note materials and hands of employees resting on a table

Risk Mitigation That Works

SUCCESSFUL MICRO MANUFACTURING IS DRIVEN BY RISK PREVENTION

Each phase of Isometric’s Microns Matter®  PFMEA Process allows for the accurate estimation of 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, molding, and plastics engineering experience. These phases include:

  • ULTRA-PRECISION TOOLING
  • METROLOGY
  • MATERIAL DRYING
  • MATERIAL LOT TO LOT VARIATION
  • MICRO INJECTION MOLDING PROCESS

Risk prevention is driven by a complete understanding of all phases of the process used to manufacture a micro molded medical or drug delivery device. Isometric Micro Molding will help you to get to market with optimal products in a timely fashion using our proven Microns Matter®  PFMEA Process.

Graphic of the Microns Matter® Process Failure Mode Effects Analysis risk mitigation at Isometric Micro Molding

MICRONS MATTER® PFMEA PROVEN PROCESS:

TOOLING < 20% tolerance
• Living document through validation

MATERIAL < 20% tolerance
• Multiple Plastics Engineers on staff to assist with the selection process
• Partial List: PES, PSU, PP, PA PC, COC, COP, LCP, PMMA, PPA
• Implants: PEEK, PLA/PLLA/PLGA, TPU
• Testing
• Qualitative, Quantitative, and Predictive
• Mechanical & Physical Property Lab
• Empirical Testing

MICRO MOLDING PROCESS < 20% tolerance
• Scientific Micro Molding
• Micro molding machines with integrated automated assembly cells
• Residence time balancing
• 2 gram-14 gram shot capacity
• Process window/DOE rigor

METROLOGY < 20% tolerance
• Gage R&R: CT Scanning < 10%
• Humidity and Temperature Controlled Metrology