Qmed has partnered with Clarimed to provide DeviceMatters, providing access to and analysis of medical device approval specifics, postmarket safety performance, and typical failure modes. The intention of the partnership is to help medical device professionals to better understand the regulatory and medical device landscape. Qmed/MPMN editors recently spoke with Nora Iluri, founder and CEO of Clarimed and DeviceMatters, on the current spike in adverse events, industry reporting compliance, barriers to quality improvement, and other pressing issues related to medical device quality and safety.
MPMN: What do you believe are the most effective ways to spur improvements in the medical device industry?
Iluri: Traditionally people have tried to drive improvements in medical device quality either by proposing stricter testing and regulations or by proposing fewer regulations to help incentivize greater innovation and more-rapid delivery of improvements to the market. Truth is, this is a very careful balancing act, but these are not the only levers that can impact device quality. The biggest issue that I see is a lack of transparency into quality performance across the industry. We have a lot of anecdotes about unsafe devices and new advances, but no one has been able to show a metric that tells us whether people are indeed safer or healthier using medical devices today. Physicians and patients are forced to make their choices based on old data, anecdotes, and brand reputation. Improved postmarket quality metrics could help provide transparency into how devices actually perform in market conditions and drive quality-based purchasing and quality-based market competition.
MPMN: What does the industry need or what does it need to do in order to overcome these issues?
Iluri: From a philosophical perspective, the industry needs to recognize that it is in its best interest to fight for improved quality transparency, which could help get it recognized for its performance and reduce anecdote-based credibility risks. Furthermore, we need greater regulatory and public demand for improved quality transparency, not just more regulation.
From a more tactical perspective, there are two main challenges to tracking medical device quality. First, low levels of reporting quality remain a significant obstacle, for which we need simpler and clearer postmarket reporting requirements. Second, is the lack of normalization data for adverse events, such as the number of devices in use.
We need to establish better—and publicly transparent—ways to track high-value and high-risk devices currently in use. This approach would enable the industry to distinguish between concerning and natural trends and to evaluate how devices perform in real market conditions. If we can track cars in the United States using vehicle identification numbers, there is absolutely no reason why we should not be centrally tracking pacemakers and hip implants.
MPMN: How would you generally describe the medical device industry’s current quality of reporting?
Iluri: Quality reporting is improving rapidly, but it’s still very poor. Reporting has doubled over the past three years, yet in 2011, fewer than 30% of device reports associated with death or injury contained a valid reason for failure. For most devices, it should be possible to identify the reasons for failure in the majority of cases, and this information should be reported to FDA. Reporting categories and requirements are also messy and confusing. Standardized ‘keys’ should be used for critical information, such as company and product names, and we need improved standardization and reporting guidelines around device failure reasons and similar metrics. For example, ‘implant removed’ should not qualify as a failure reason in my opinion.
MPMN: The number of adverse event reports—and serious adverse event reports, in particular—have increased dramatically in recent years. To what would you attribute this trend?
Iluri: Yes. Adverse event reports doubled in the last three years, and serious patient outcomes associated with these events tripled during the same time. I believe that this trend can be attributed to several factors. Among them are improved reporting rates, especially driven by increased awareness and focus on medical device quality; medical device prevalence growing even faster than the 6 to 9% market growth due to increased use of long-term implants; increased device complexity, especially in the growing use of software and electronics; and greater use of devices in higher-risk populations, such as the elderly. None of these factors necessarily mean that we are less safe today, but they do imply that there is a need for greater awareness and transparency in understanding medical device risk/benefit tradeoffs.
Iluri: We were trying to answer the question: “How do you drive radical improvements in the medical device industry?” Improvements in the approval process and regulations have all been tried without great success. With this in mind, I recommended that we should explore data transparency and the concept of a ratings agency for the medical device industry. After all, the presence of a ratings agency has been the most radical driver of quality improvements in other industries, such as the automotive market. Transparency helps to align economic incentives with quality and patient outcomes without increasing the financial hurdle to innovation through regulation.
Iluri: DeviceMatters aims to deliver postmarket safety data to medical device professionals, among other helpful regulatory and approval information that can help them spot concerning trends, focus R&D on the most impactful device issues, and guide management to develop a product roadmap that targets the most pressing safety concerns in the industry. Hopefully, as the data improve, we can also start to offer relative ratings of devices to help guide physician and patient choices.
Iluri: The information we provide can benefit several key groups of industry professionals.
- Medical device engineers can learn when and why things go wrong postmarket with a particular product type in order to improve the next-generation product or to spur innovation of radically new solutions.
- Quality professionals can use the information to spot adverse event trends as an early warning system for potential issues. They can also easily and quickly identify the product categories associated with the greatest patient risk, where quality improvements can have the greatest impact on patient outcomes. Finally, the data can assist with identifying device failure modes across categories that might be indicative of broader, systemic issues, rather than specific product design or manufacturing concerns.
- Strategy teams and consultants can employ the information to optimize future product roadmaps by better understanding issues faced within a particular area or to assist with defining patient needs and spotting adverse event trends that can help identify opportunities for safer, next-generation solutions. Furthermore, from a safety perspective, such information can help better define product differentiation than the market can.
- Marketing teams and consultants can track and compare safety performance of like devices—such as strengths and weaknesses and impact on subpopulations—to help refine the intended target populations and marketing messages for existing products.
- Corporate management and investors can look at adverse event trends as an indicator of safety performance and risk for the company. Management can also use the information for benchmarking and goal-setting purposes.
Iluri: DeviceMatters is currently the only site that provides adverse event reporting of medical devices based on unbiased and independent FDA data, among other sources. We also offer standard information on regulatory requirements and the current medical device landscape, including approval specifics.
MPMN: How can such information ultimately help manufacturers improve medical device quality?
Iluri: In the future, improved transparency into medical device quality can hopefully help drive development and purchasing patterns. In turn, this trend will hopefully result in a radical improvement of medical device quality across the industry, similar to what happened when J.D. Power first began rating cars for the automotive industry.
MPMN: What is the potential overall business and patient impact of increased awareness and tracking of quality information?
Iluri: I truly believe that transparency helps align economic incentives with quality and patient outcomes without increasing the financial hurdle and time-to-market for innovation through regulation. In fact, increased transparency will help improve the reputation of high-quality manufacturers, enable the industry to celebrate improvements and successes with facts and metrics, drive quality improvements by forcing companies to compete on measurable quality performance and make it much easier for regulators to spot and react to issues in the marketplace, dramatically reducing negative patient outcomes and regulatory costs. Of course, we will still need premarket regulations to ensure that medical devices entering the market have been adequately tested. But through improved transparency, it will become a lot clearer what would be required of newer-generation devices and which requirements might not make a difference for patients.
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