“Understanding the functionality and project goal, along with any commercial, technical, and compliance factors, will enable OEMs and their CMO partners to identify a manufacturing solution that best meets the needs of the project and results in efficiency and quality. In addition, these factors will impact material selection, laser cut geometry, and whether any post-processing will be needed.”  

– Thomas Vacca, Director of Engineering and Tooling, MICRO

Demand for multi-functional, sophisticated surgical products and tools offering ease of use is growing, especially disposable surgical tools that don’t require reprocessing or expose patients to healthcare-associated infections.

Prepackaged, individually wrapped and pre-sterilized, single-use devices offer a convenient, off-the-shelf option for surgeons and other operating room staff. Reusable products can malfunction or wear down over time. Single-use instruments won’t chip, dent, rust, or become dull or damaged with repeated use. Single-use scissors and other cutting instruments are new and optimally sharp out of the package every time. In addition, instrumentation that allows surgeons to deliver care more efficiently and safely translates to faster recoveries and improved outcomes for patients.

A critical success factor in producing high-quality single-use instruments is the contract manufacturing organization’s (CMO) ability to design, produce, and maintain the dies and associated tooling that will be used to produce parts and products for original equipment manufacturers (OEM). Precision tooling for highspeed precision stamped, formed and machined components can be achieved to support the requirements of a single-use instrument development program.

For single-use instruments, manufacturers need to understand the properties that are essential to the optimal functioning of a product. In addition, prototyping and feasibility testing are used to test a functional product design, evaluate material and refine design and production elements. Prototyping can help manufacturers scale up to mass production using the most efficient processes that also meet federal regulatory requirements.

Minimizing progressive tool development costs is an important component of the design process, and it’s essential to design tool and safeties in order to prevent breakage and misfeeds, which can increase costs.

Working with a CMO partner experienced in prototyping to mass production, OEMs can deliver practical, high-quality, reliable solutions while keeping costs manageable and return on investment high for their customers.

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