Case StudySingle-Source Partner for 5-Component Device
A customer needed to partner with one vendor who could qualify and manage the manufacturing of their diagnostic portable sensor. It was identified as a breakthrough device by the FDA which allowed it to be fast-tracked through the approval process. They had 3 goals for their project.
With many challenging dimensions and tolerances throughout the 5 components needed for the final device, they wanted to make sure it could be done right the first time.
02. Easy to work with
They needed an FDA-registered facility that could handle the majority of processes, from design for manufacturing to custom assembly.
03. Cost-effective scale
They needed a partner that could make this scalable without adding cost and who could implement multiple automation operations.
Single-Source Partner for an Elaborate, Intricate Process
Design for Manufacturability
DFM was key avoiding an over-toleranced drawing that would drive up the cost during mass production
Injection Molding of 5 Parts
Used design and science to solve molding challenges real-time without delaying the customer’s timeline
Prepared for Secondary Operation
Placed multiple parts in custom fixtures for masking before sending out for custom coating process
Prepared for Assembly
Performed a delicate process for each tiny part, with careful attention to not disturb specialty coating
Completed high-precision assembly steps with precision gluing under a microscope, such as inserting and insulating tiny circuits
Labeled and barcoded assemblies and prepared all packages for shipment to sterilizer
The customer had talked to a handful of molders before talking to MTD. Most had already withdrawn, unable to agree to the challenging part tolerances. The other remaining contender was unable to quote the required commercialization volumes without having manufacturing experience with the product. MTD was chosen because we could provide a quick, proven path to commercialization.