In the News

12/27/17 – CDRH is looking for medical device manufacturers for pilot to measure quality system maturity. Read more from MedTech Insight.

11/17/17  Jeff Shuren on the MDIC Case for Quality: “Ultimately what we’re looking for is value to patients – that we have better product out on the market, and we’re rewarding those companies that have that greater focus on quality.” View slides from the November 15 Forum here and read more from MedTech Insight.

10/11/16 – A push for broader national awareness of CfQ has launched as CfQ hits the trade media newswires with a press release announcing the new report and recommendations on comparative analysis of medical device quality.

9/26/16 – Just released! The full report from the Case for Quality working group on Product Quality Outcomes Analytics is now available in the CfQ Resource Center for Sustained Quality.  “Feasibility and Effectiveness of Analytics for Medical Device Product Quality Outcomes” summarizes the team’s work, observations and recommendations as they explored the use of medical device quality data to guide provider value analysis committee purchasing decisions toward better outcomes and cost management.

8/19/16 – Medtech Insight (formerly the Gray Sheet) offers highlights and insider commentary on the just-released best practices report from the Case for Quality Working Group on Medical Device Quality Metrics. Find it in this August post from writer Schawn Schmit or here on our CfQ website.  The full report includes recommended metrics across the product lifecycle, principles for implementation, and a process for enterprise-wide continual improvement.  Article courtesy of Medtech Insight.

7/14/16 – Recommendations from the Case for Quality Working Group on Medical Device Quality Metrics made headline news in the latest FDANews/International Devices & Diagnostics Monitor. Read how the CfQ Metrics pilot project landed on three metrics that span the product lifecycle. FDA plans to release draft guidance on medical device quality metrics in the coming months.  Newsletter courtesy of International Devices & Diagnostics Monitor, FDANews.

7/6/16 – Now available! View presentations from the Case for Quality June 28 Forum exploring product and design quality metrics. Must-see content includes presentations on the FDA Quality Metrics Project; a Baldridge examiner’s take on lessons learned from other industries and frameworks, case studies from BD and Boston Scientific and an update on the Case for Quality Working Group on Medical Device Quality Metrics.

6/23/16 – The FDA’s Library of Quality Practices offers medical device professionals tools that can help them advance their approach to quality in the design and manufacturing of medical devices. Developed as part of FDA’s Case for Quality initiative, the Library enables the FDA and industry partners to leverage existing knowledge and engage collaboratively with the goal of improving device quality. The American Society for Quality (ASQ) and AdvaMed contributed to the library.

6/8/16 – A free Gray Sheet podcast explores the efforts of the Case for Quality Metrics Work Group to identify, pilot, plan and publicize predictive quality system metrics for medical devices. Marla Phillips, Director, Xavier Health, who leads the work group, explains the team is looking at developing a system of metrics across the total product lifecycle to enable companies to assess and improve the robustness of their critical-to-quality practices and, therefore, risk to product quality.

5/25/2016 – In an online exclusive, Medical Product Outsourcing examines the often misunderstood relationship between quality and compliance in “Can You Sell Poor Quality Devices in Compliance with Regulations? Author Daniel Matlis, President, Axendia Inc, also reviews how the Case for Quality movement is driving a paradigm shift where compliance is the baseline and improved product quality is the goal.

1/19/2016 – The just-released 2016-2017 Strategic Priorities of the FDA’s Center for Devices and Radiological Health identifies the Case for Quality as a key strategy for CDRH to strengthen medical device product and manufacturing quality. The collaborative brings industry and the FDA together to advance a culture of quality and approaches that foster continuous product quality for the ultimate benefit of every American.

1/19/2016 – The December Journal of Healthcare Contracting introduces supply chain leaders to the Case for Quality and the collaborative’s transformative potential. “If, as a medical technology community, we can agree on defined quality metrics that feed information back into the design and manufacturing process, we will reduce problems, reduce costs, and pass on the benefits to the consumer,” says CfQ Program Manager Dwight Abouhalkah.