Over the years, Microdyne Plastics has worked closely with the inventors and designers of micro-precision plastic medical devices and components. Precision medical devices we manufacture may fall into one of these broad categories:
- Invasive or implanted
Typically, an assignment like this starts with Microdyne expert engineers meeting with the product engineers and designers. First, we make sure that we have a clear understanding of how the product is to perform and how it was designed. Then, we go into an intensive review and evaluation of the manufacturing viability of the plastic components. Since the product designers are usually not plastics experts, these reviews and evaluations frequently include recommendations to the developers about how to improve the design to facilitate manufacturability. Our input often also benefits cycle time — which affects costs; and durability of the component – which can improve the performance and value of the overall product.
Medical devices often require clean room molding and we have these special facilities. We are a certified medical device manufacturer. We have our (FDA) Device Manufacturing License from the California Department of Health Services, Food and Drug Branch, and we maintain current ISO 9001:2008 certification.
A recent example is the 36 precise components we manufactured for our client. We designed and manufactured 11 complex molds. These components are part of a complex system that revolutionizes treatment for diseases like Parkinson’s, by allowing MRI-guided neuro-interventions (operation while the patient is awake and in the MRI). We hold their tolerances to the micro level. Holding these tight tolerances can be a challenge for mold design, mold tooling and component manufacturing. Microdyne Plastics thrives on this type of challenge!