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Understanding Barriers To Medical Device Quality

Abstract of a report by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), October 31, 2011 with a purpose to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement.

In recent years, a growing number of patients have suffered from adverse events due to medical devices. To better understand the reasons for these lapses in quality and safety, the US FDA conducted interviews with medical device industry thought leaders and FDA leadership and in parallel analyzed FDA adverse event reports and recall data.

Their efforts revealed that there are systemic gaps within the medical device industry’s quality approach that result in these issues. Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the Agency’s regulatory approach. Moving toward greater visibility into device quality and properly aligning FDA’s regulatory approach will be important to catalyzing industry movement towards improved device quality. Investment by FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well made as they are innovative.

Executive Summary

This report is the result of an initiative launched by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), as part of an effort to assess and understand gaps in medical device quality. The work focuses on marketed product quality assurance, rather than pre-market activities. Its purpose is to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement.

The work was conducted with input from several sources: interviews with internal and external quality experts; a set of blinded industry interviews, a scan of databases, relevant articles, and conferences; and an outside press search.

These inputs uncovered several key facts about marketed medical devices as well as potential catalysts for quality improvement.

The medical device industry has enjoyed tremendous growth in both revenues and the technical complexity of the products that it produces over the past 10-20 years.

Serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001.1

Quality risk is not evenly distributed across the industry. This reflects the heterogeneity and complexity of the devices, manufacturers, and use environments. Cardiovascular, in vitro diagnostic (IVD), and general hospital/surgical devices account for nearly 60% of adverse events reports. Only 20 of the 1189 active product codes account for 65% of all serious adverse events reports between 2005 and 2009.

An analysis of root cause data reveals that failures in product design and manufacturing process control caused more than half of all product recalls. The root causes of quality issues are tied closely to device type. Therapeutic area was not as strong a predictor for recall root cause.

There are seven major opportunities for improving quality within the industry:

Enhanced operating systems

a. Design and reliability engineering – specifically, validation of actual product use, design-for-reliability and manufacturability, and software robustness.

b. Robust postproduction monitoring and feedback into design and manufacturing that goes beyond base compliance requirements.1For purposes of this report, the term “serious adverse events” encompasses death, life- threatening events, hospitalization, disability, congenital anomalies, and/ or required interventions, and disabilities. This term should not be confused with the regulatory definition of “serious injury,” which is defined under the medical device reporting regulations (21 CFR Part 803.3).

c. Supplier management processes, particularly in material and process change controls.

Enhanced management infrastructure

d. Quality metrics and measurement systems that go beyond regulatory compliance measures.

e. Quality organization that integrates cross-functionally throughout the organization, rather than solely focused on compliance.

f. Performance management, where those in key roles associated with quality outcomes, like design engineers, are measured and incentivized around quality performance.

Enhanced mindsets and behaviors

g. Quality culture can be improved where companies have experienced severe quality-related issues.

• Broadly, companies are experiencing three key challenges related to improving quality:

a. Low quality transparency, driven by a lack of information for consumers and decision-makers around comparative quality (i.e.,quality differences among competitor products), time to market competition, and cost pressures, limits significant quality upgrades. However, the economics of quality may be changing as risks and costs of poor quality increase and transparency into comparative quality increases.

b. Increasing complexity of medical devices and usage environments is straining the current quality system infrastructure. Companies report that they have not systematically upgraded their quality infrastructure due to the unclear economics and concerns about regulation.

c. Companies perceive that the regulatory framework is misaligned with assurance of quality outcomes, in that compliance with regulations does not ensure quality, and that current intervention practices may de-incentivize improved quality.

• Interviews and analysis also identified several steps the FDA can take to accelerate momentum around adoption of quality best practices. These steps should address seven key themes:

a. Focus regulatory efforts to address industry quality gaps.

b. Enhance visibility of comparative quality to harness market forces to drive quality.

c. Optimize consistency and clarity of Agency expectations and requirements.

d. Learn from practices of regulators of similar high-tech and complex industries.

e. Bolster data collection and analysis to maximize potential impact.

f. Leverage wealth of Agency data and analysis to continuously refine FDA’s compliance initiatives.

g. Increase level of engagement and collaboration with industry around enhancing product quality.







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