Transforming Component Qualification for the Medical Industry

Dec 17

A top medical equipment manufacturer based in the Midwest partnered with Herold Precision Metals to streamline its component part qualification process. Known for their stringent quality standards, the medical equipment manufacturer required a fabrication partner capable of ensuring precision, reducing costs, and accelerating product development timelines in the highly regulated medical industry.

The Objective

Medical Equipment Manufacturer sought to address inefficiencies in their component qualification process, including lengthy inspections, over-dimensioned drawings, mismatched CAD models, and unclear DFM guidelines. They needed a strategic fabrication partner to enhance precision and accelerate production while maintaining compliance with medical industry standards.

The Scope

HPM collaborated closely with the medical equipment manufacturer’s engineering and quality teams to redefine their fabrication and inspection processes. The partnership focused on:

Streamlining Design and Documentation: Simplified component drawings by reducing non-critical dimensions and relying on CAD-driven tolerances. Leveraged 3D CAD models as the source of truth for design and manufacturing, minimizing translation errors and manual adjustments.
Employing Advanced Fabrication Technology: Deployed HPM’s Mitsubishi 10K Laser, Salvagnini P4 Panel Bender, and laser scanning technologies for increased precision. Automated the creation of machine code directly from the medical equipment manufacturer’s CAD files for consistency and accuracy.
Optimized Inspection Processes: Replaced time-consuming manual inspections with automated laser scanning to verify part dimensions. Conducted first-part inspection scans for accuracy before production runs.
Using Riveting Over Welding: Shifted assembly strategies from welding to riveting where feasible, reducing warping and post-process grinding costs. Maintained tight tolerances on large assemblies without compromising structural integrity.

Client Impact

HPM’s process improvements delivered significant benefits for the medical equipment manufacturer, including:

Reduced Costs: Reduced first article inspection (FAIR) costs from $60,000 to $6,000, saving $54,000 per part family.
Improved Yield: Achieved a 90% first-pass yield, drastically reducing rework and scrap rates causing delays.
Accelerated Production: Simplified design and streamlined approval processes resulted in faster project turnarounds.

Community Impact

By supporting the medical equipment manufacturer’s ability to produce medical testing equipment more efficiently, HPM indirectly contributed to faster development and delivery of healthcare solutions that impact lives worldwide.

Ready to Transform Your Own Fabrication Processes?

Contact Herold Precision Metals today to learn how we can help your business achieve precision, efficiency, and growth in even the most demanding industries.