Medical Devices: Precise Tolerance Analysis Solutions

It’s all about controlling the design and Staying Out of the News! Medical device companies recognize the need for accurate, precise tolerance analysis and GD&T solutions. Utilizing Sigmetrix’ CETOL 6σ and GD&T Advisor products empower our customers to:

  • Comply with increased regulatory requirements
  • Products are predictable and inherently safe
  • Validate software tool internally
  • Allow for easy reporting
  • Balance quality and cost

Because of the unique regulatory requirements and significant liability issues inherent in many markets today, the more visibility a medical device engineer has into the actual performance of the design after manufacturing, the greater his ability is to control risk via the design and minimize liability exposure.

Medical device companies recognize the need for accurate, precise tolerance analysis solutions. Medical device industry customers consist of leaders in the following areas:

  • Blood monitoring and diabetes care
  • Imaging
  • Implantable devices
  • Orthopedic and spinal implants
  • Surgical instruments


APPLICATION  – Biopsy Harvesting Instrument, Precise Tolerance Analysis for Lifesaving Devices.

Objective: Analyze jaw alignment to ensure full sample extraction and minimize patient discomfort. Cost control was imperative, as this is a disposable device. Competitive nature of device is extreme and patient comfort critical. Tissue sizes must be consistent.

Results: Sigmetrix’ solutions used to identify critical functional dimensions and tolerances to meet performance requirements. Identified “side bite” and “over bite” issues. Optimized design dimensions and precise tolerances, resulting in reduced scrap and unnecessary rejections.

APPLICATION  – Surgical Instruments, Precise Tolerance Analysis proved value when product was not viable. Saving company millions of lost production & time by forecasting assembly tolerances in design phase.

Objective: CETOL 6σ analysis of electrical surgical knife design. Needed assurance that the knife would deploy every time. First design exhibited electrical plug insertion problems; unit could not maintain power.

Results: The design was never manufactured. Four design solutions were evaluated; CETOL 6σ showed that the tolerance levels required were in excess of what could be held with manufacturing without design changes. This led to the scrapping of the project.

APPLICATION – Medical Bed, Variation Analysis for Parts Assembly

Objective: Identify the potential problem areas with this complex mechanism. The caster part of the operating room bed was having issues.

Results: CETOL 6σ was used to develop assembly and adjustment procedure to reduce variation as well as to optimize dimensions and tolerances to improve performance and reduce manufacturing costs.