Work groups seek to identify metrics to ensure quality is maintained throughout the total product life cycle
The Medical Device Innovation Consortium and Xavier Health have come up with suggested metrics to help medical device manufacturers improve the quality of their products and help the U.S. Food and Drug Administration enhance the consistency and quality of their inspection assessment.
The proposed metrics address medical device quality from R&D, to product assembly or manufacturing, to their use in the hospital or other healthcare facility. While work continues on that process, MDIC is also developing metrics that may help supply chain executives, clinicians, value analysis professionals and others determine whether improved quality systems and processes would lead to improved patient outcomes.
Case for Quality
In 2014, the FDA awarded a grant to the non-profit Medical Device Innovation Consortium to launch an ongoing “Case for Quality” initiative, designed to foster broad-based collaboration and improve the tools and methods used in advancing device quality.
The roots for Case for Quality lie in an October 2011 report by McKinsey & Company for the FDA titled “Understanding Barriers to Medical Device Quality,” explains Dwight Abouhalkah, program manager, Case for Quality, who is on loan to MDIC from Johnson & Johnson.
“Research showed that the interaction between industry and the FDA is fairly complex, with multiple challenges,” says Abouhalkah. “The Case for Quality was created to facilitate ongoing dialogue that will ultimately benefit patients, providers and the medical technology community.”
Case for Quality shifts the medical device culture away from compliance to regulations, to “higher sustained product quality, for the benefit and improvement of patient outcomes,” he says.
Identifying risks to quality
The FDA and Xavier Health brought their Quality Measures Initiative under the MDIC Case for Quality initiative in late 2014 with a working group comprised of manufacturers, consultants and FDA officials. “The goal of this initiative was to identify ways for industry to proactively and predictively measure the risk to its own product quality, which would therefore enable industry to focus on improving product quality commensurate with the need,” reports MDIC in a recently published report. These metrics are the first in a series of recommendations coming this fall from the MDIC’s Case for Quality initiative.
Convening at scheduled forums through 2015 and 2016, the Case for Quality participants worked to identify quality-related metrics intended to answer three key questions:
- How can manufacturers improve their design, engineering and manufacturing processes to ensure the reliability, safety and effectiveness of their devices?
- Are there early, quality-related signals or red flags that manufacturers can identify and correct in real time?
- After a device is marketed, is there adequate monitoring and feedback to alert manufacturers about problems either in product design or their manufacturing processes?
Once developed, these metrics would be piloted by volunteer organizations in order to analyze their effectiveness to predictively measure risk to product quality.
“Ideally, metrics assist in the detection of underlying root causes that need to be addressed in order to prevent recurrence,” said MDIC in its report. “The ultimate goal of a robust metrics program is continual improvement throughout the total product life cycle, such that the root cause of the failure is taken back to the earliest stages of development as possible in order to improve the outcome for any current and future product.”
Metrics for manufacturers
The three metrics suggested by the working group concern the pre-production, production and post-production processes.
- Pre-production: “If the research and development process is conducted with rigor, the rate of change to the product and/or process during device transfer should be minimal,” reports MDIC. As a result, the pre-production metric is designed to track the number of changes that occur during the transfer stage – that is, at the point in which products switch from the concept stage to production – that were triggered by product and/or process inadequacies. Assessing this metric enables organizations to track the frequency and volume of changes that could possibly have been avoided by a more robust research and development system.
- Production: The production metric calculation that was chosen is the Right-First-Time (that is, no defects) metric that many organizations already track, according to MDIC. Rather than use the metric solely to assess the efficiency of the production process, however, the working group recognized that by triaging the root causes so as to isolate those related to product and process inadequacies, manufacturers could continue assessing the effectiveness of their development processes.
- Post-production: The work group found a number of post-production metrics to be important in painting a holistic picture of product performance on the market, so multiple indicators are included in the final metric that are commonly tracked by organizations: service records, installation failures, complaints, medical device records, recalls by number of units involved, and total number of recalls.
The FDA is exploring the use of the three MDIC metrics as well as additional metrics that may specifically address product quality in the FDA’s upcoming metrics pilot initiative.
What’s next?
The initial work of the Case for Quality has focused on the FDA and industry, says Abouhalkah. But MDIC has already added providers to the mix.
For example, one of the Case for Quality’s working groups is investigating developing a “maturity model,” that is, a standard model that providers could use to identify which device firms have a mature quality system, demonstrating an ability to reliably develop and manufacture high-quality medical devices. That information could help providers make product decisions, as public and private payers institute risk-based payment programs based on quality metrics, such as reduction of healthcare-acquired infections.
A second group is investigating working on a tool offering Consumer-Reports-like ratings of quality for use by value analysis teams, says Abouhalkah. The Product Quality Outcomes Analytics (PQOA) team embarked on a pilot to determine whether cross-manufacturer comparative analysis of quality would be feasible and effective to support hospital value analysis team purchase decisions. The pilot experience was well-received by the VAC, says Abouhalkah, and pilot hospitals saw the data as potentially very valuable. Learnings and recommendations will be published by the MDIC PQOA team by early October 2016.
Editor’s note: More information about the MDIC Case for Quality initiative is at mdic.org/cfq/