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Device Giants Stryker And Baxter Embrace A ‘Quality First’ Culture – And Yield Positive Results

Executive Summary

From cutting costs to getting products to market faster, experts at the two companies explain why it pays to keep quality at the fore.

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Success Of Case For Quality Program Triggers ‘Culture Shift’ At FDA's Device Center, Officials Say

The US FDA’s Cisco Vicenty and Bleta Vuniqi say the Case for Quality Voluntary Improvement Program has shifted the culture at the agency’s Center for Devices and Radiological Health. That shift is “starting to … feed and percolate into other areas and other activities that the center’s been engaged in,” Vicenty says.

Leadership Engagement Playbook Gives 10 Best Practices To Cultivate Quality Culture

The new playbook from the Case for Quality Collaborative Community aims to shift the mindset of device manufacturers from one of regulatory compliance to one of organization-wide quality.

Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites

The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.

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