Historically, interactions between industry and the FDA have been described as complex, challenging and even adversarial. Many a time, our firm has been asked to serve as an “anonymizer” for a medical device company that had a question for the FDA, but was concerned about interacting with the agency directly.
Would interactions be different if meetings between the agency and industry
stakeholders started with a hug? They did at the most recent Case for Quality Forum where industry and the FDA literally embraced, stating that providing medical products of the highest quality is their main focus.
The Case for Quality (CfQ) Forum consistently provides an open venue to discuss and exchange ideas on improving medical device product quality. The Case for Quality program was created to facilitate ongoing dialogue that will ultimately benefit patients, providers and the medical technology community. The initiative brings together industry stakeholders – including the U.S. Food and Drug Administration, medical device manufacturers, payers, providers, industry advisors and patient advocates.
The paradigm shift for all stakeholders is that compliance with device regulations does not ensure high product quality. To improve product quality, we must develop, define and implement quality metrics across the ecosystem. “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,” said Dwight Abouhalkah, program manager, Case for Quality in an article published by the Journal of Healthcare Contracting.
To learn more about the Case for Quality Initiative, read the Journal of Healthcare Contracting article titled “Will You Know Quality When You See It?”
To learn more about compliance versus product quality, read “Compliance-First Approach Still Obstacle to Product Quality”
To learn why “Compliance should be the baseline. Quality should be the goal!” see this Infographic: Food for Thought on Quality and Compliance.