Can You Sell Poor Quality Devices in Compliance with Regulations?

You shouldn’t, but you absolutely can. After all, you can conduct a recall of poor quality products in compliance with all applicable regulations.
 
But you don’t have to take my word for it.
 
Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health (CDRH), put it this way, “…one device manufacturer can meet FDA requirements and still make a poor quality device, whereas a second manufacturer may not comply with all FDA requirements and yet make a high-quality device.”
 
Following the Rules Isn’t Enough
On March 8, I had the privilege to present Axendia’s latest research on Change and Configuration Management at the MDIC Case for Quality Forum and discuss opportunities to shift the focus from compliance first to a quality-centric approach that includes compliance, but also moves beyond it. I used the following sports analogy to illustrate the point.
 
A team that simply follows all the rules and finishes a game without penalties is not assured of winning the game. On the other hand, it is not unusual for a team to win the game after penalties have been imposed. (Check out an infographic that fleshes out this analogy to compare compliance vs. quality.)
 
That’s not to say that following the rules is not important, but rather that it’s not sufficient to ensure the successful outcome of a game or high quality medical devices.
 
Compliance and Quality Are Not Equivalent
Compliance and quality are paramount to ensuring the safety and effectiveness of medical devices. Regulatory compliance and quality, however, are not equivalent, even though in our industry, they are often used interchangeably. Quality must be the driving principle within all medical technology organizations. This drives continuous improvement to enhance the quality of life and health of every patient touched by medical devices.
 
The FDA recognized that its traditional approach to enforcement had the unintended consequence of driving industry to “hyper-focus” on regulatory compliance.
 
According to FDA figures, the number of medical device recalls increased by 97 percent from FY 2003 to FY 2012. The agency estimates that as many as 400 recalls each year could be prevented if manufacturers addressed issues before product is shipped to the field.
 
The agency’s analysis also uncovered that serious adverse event reports related to medical device use outpaced industry growth by 8 percent a year from 2001 to 2011. In addition, it found that that issues related to product design and manufacturing process control caused more than half of all product recalls.
 
This analysis also identified that companies that managed risks by driving quality across their organization had fewer complaints and investigations per device batch. Those with an established quality culture were also able to accelerate device design, innovation, and market introduction by using the increased capacity gained from avoiding quality failures.
 
As a result, following an in-depth review of device quality data and feedback from industry stakeholders, FDA launched the Case for Quality in 2011.
 
Building a Culture of Quality
The Case for Quality (CfQ), under the management of the of the Medical Device Innovation Consortium (MDIC), represents a unique forum for medical device stakeholders, including the FDA, medical technology companies, healthcare providers, and payer organizations, to work together to foster a new culture of quality in the medical device industry. CfQ includes top officials from FDA as well as leading experts representing a cross section of the medical device industry, each committed to advancing product and manufacturing quality and ensuring regulatory policy and practice are aligned and transparent.
 
CfQ aims to improve product quality for the benefit of patients by enhancing product design and manufacturing processes, better informing regulatory practices and changing the very nature of interactions between FDA and industry in relation to quality and compliance.
 
This new culture requires a paradigm shift where compliance is the baseline and improved product quality is the goal. (Check out another infographic that explores this concept is illustrated through comparison to a restaurant.) This call for a new approach to product design, manufacturing, and regulation, which drives the focus on product quality and patient safety, adapting to advances in science and technology, and enabling rapid response to events that may impact patients. To support this cultural shift, CfQ stakeholders are working to identify and disseminate evidence-based, critical-to-quality practices across the medical device lifecycle that correlate to higher-quality outcomes.
 
Building on its shared commitment with industry, the CDRH has made Case for Quality a strategic priority for 2016-2017 and will identify policies and practices within the agency itself that encourage adoption of critical-to-quality practices.