A recent report from the Medical Device Innovation Consortium (MDIC) takes a small step toward a system that would ease FDA's burden by encouraging aggressive, transparent competition on product quality.
The ability of a medical device manufacturer to not only survive but to triumph over the most withering scrutiny a team of suitably experienced FDA investigators can subject it to has long been thought--in some circles--to be a potent marketing tool.
Now comes the Minnesota-based Medical Device Innovation Consortium (MDIC) to invent and apply a process that could actually achieve this across the board. Its Case for Quality sub-unit issued its first report in late September.
Dubbed the Feasibility and Effectiveness of Analytics for Medical Device Product Quality Outcomes, this 29-page document seeks to accomplish for all companies a mechanism for supporting their customers' purchase decisions with objective product quality information. Or, in the report's own words, a "formal approach to measure and provide feedback to reward the market for quality."
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But first, a little history.
Since enactment of the 1976 Medical Device Amendments, medical devices have often been seen as the stepchild of FDA regulation and enforcement, comparing unfavorably with its more stringent oversight of drugs, which come into the market from a manageably small universe of companies, a fraction of the number of device manufacturers.
Indeed, over a decade after the agency began implementing the new law, its enforcement officials confessed that they were still discovering device manufacturers they didn't know existed--hardly a sign of an FDA-naïve industry rushing to be regulated!
This laxity of government effort, often blamed on budget restraints, was exacerbated by the device industry's general disinterest in the concept that better compliance with FDA quality requirements could be a marketing tool. This disinterest in turn was justified by arguments that FDA's inspectors simply didn't understand the technologies they were dealing with.
Thus there came about, in 2011, the Institute of Medicine's report on the 510(k) Clearance Process at 35 Years, which boiled down to a recommendation that the process be scrapped and reinvented.
Fast-forward to now and see in MDIC's extramural report, supported by active FDA and industry involvement, a serious effort that although not explicitly intended to do so could ultimately solve most if not all of the above shortcomings through a focus on product quality.
After all, if the industry could reliably resolve essentially all the quality concerns of its customers, medical professionals, and patients, the oversight burden on FDA would obviously be eased substantially.
Based on a pilot program designed "to determine whether cross-manufacturer comparative analysis of quality would be feasible and effective to support value analysis team purchase decisions," MDIC's study has made an impressive but cautious start in this direction.
Its report says the pilot "focused on knee and defibrillator implants. Voice-of-the-Customer feedback was gathered through surveys and focus group sessions."
It used seven standardized definitions of quality:
- Patient Experience
The pilot tested the hypothesis that if hospital value analysis committees (VACs) had "access to specific data about product quality outcome and they applied analytic techniques to this data, they would have information to make better purchase decisions that improve patient access to high quality medical devices."
Current obstacles to this goal were identified as being a lack of unbiased, relevant, and available data, a need for consistently applied performance measures and analytical methods, and lack of a secure process or operating model to enable and encourage individual companies to be fully transparent about product quality.
Obtaining input from VACs at Baptist Health, Kettering Health Network, Providence Health, and the U.S. Department of Veterans Affairs, among others, the pilot developed a list of six commonly used device quality data sources and from these calculated six key performance indicators for the two studied devices.
To assess product quality outcomes for the devices, the pilot developed four dashboards: Overview, Rankings by Data Source, Rankings by Manufacturer, and Rankings by Product and sent them to VACs at Baptist Health, Providence Health, and Veterans Affairs.
Overall response was positive, the report said. VAC respondents all expressed the need for reliable data from more independent sources, and most "expressed frustration that there is a lag or delay in being able to obtain evidence-based research from third parties."
Then MDIC surveyed its 80-some member device manufacturers for feedback on the usefulness of having independent and unbiased quality analytics, and received responses from 24 of them. Among these, the report says "most" saw the proposed analytics as beneficial "to benchmark other companies with similar products. Most respondents also indicated that they would use the information as a means to improve their product quality."
Seemingly chastened by the relatively low turnout of respondents, the report is sanguine about the future of product quality outcomes analytics, identifying three key areas that remain to be addressed:
- Third-party adoption and development of the analytics across the seven quality domains;
- Creating demand for, and broad-based acceptance and utilization of, the quality criteria across provider stakeholders, and
- Development of formal feedback mechanisms to manufacturers based on the outcome of analytics across the seven quality domains.
On top of these issues, the report describes "hurdles" that need to be addressed, which include access to, cost of, and lack of any reporting standards. "These challenges," it says, "have made it extremely difficult to coalesce the available information into actionable or reportable data, as well as the development of a comprehensive solution.
"The limited number of unbiased reports available is another hurdle that may need to be cleared," it adds.
To address these and related issues, the report makes eight recommendations, all of which involve more work for its authors in fiscal year 2017 and are of a largely technical or administrative nature.
It's an impressive, if small, step toward a desirable end--a marketplace in which manufacturers aggressively but transparently compete on the basis of product quality, minimizing their and FDA's regulatory burden, to more rapidly deliver better products to patients.
Jim Dickinson is MD+DI's contributing editor.
[Image courtesy of STUART MILES / FREEDIGITALPHOTOS.NET]