A part can be designed in CAD as shown, but can it be manufactured? Micro sized parts have many of the same features as traditional molded parts such as a gate, venting, knit line, and parting line.

Tip 7 — Don’t forget about qualifying. Medical micromolded components must be qualified like any tradition component. Knowing what validation and qualification a part needs is half the battle. How is a part measured when it’s viewed 10X to 100X? How to measure the inside of a 0.020-in. diameter hole? How to maintain critical dimensions on something so small it can hardly be seen with a good microscope? The tight tolerances of micro parts often mean that gage R&D studies can vary more than tolerances allow. Special jigs, fixtures, and measuring devices can be needed to qualify the component and sometimes even the device after final assembly. Understanding how the part will be used helps establish the best tolerances for the process. Reviewing these details early-on helps in establishing the best measuring system.

Tip 8 — Rethink early phase development. When designing a micro molded part, it’s important to engage the supplier early, often during the R&D phase. Discussing things such as design features, tooling, and final packaging helps ensure your success.

A micromolded component is often defined as one that yields 10,000 parts/ lb, is less than 0.003 cubic inches, and weighs 0.04 grams or less.

Tip 9 — Look at the whole picture. The micro component is just one piece of the medical- device puzzle. How will the part interface with the device? What about handling assembly? Properly planned micromolding features can help eliminate assembly and reduce the overall size of the device as well. Here, a supplier that deals with contract manufacturing and micro molded components can be of value in this assessment.

Tip 10 — Don’t forget about packaging. Often, micro components are so small that handling them can be a challenge. Understanding final delivery can help determine the packaging needed. Clarify in advance such things as the quantities involved and whether the product needs custom trays or special packaging for delivery.

The upshot: Our special manufacturing approach targets products requiring Class 7 or 8 cleanrooms and high or low volumes. An efficient material approach lets us deliver yields of 10,000 parts or 10,000 shots/lb minimum, including runner. An expertise in validation protocols and processes assures conformance to requirements. In addition, we can work with a wide variety of materials including PEEK, Ultem, bioresorbable, and other engineered resins.