Quality Challenges Facing the Medical Device Industry July 8, 2021 Medical device challenges don’t just affect compliance. They affect patient safety, pose a recall risk, affect the total cost of quality and more. Often, the impact of these quality challenges isn’t realized until the business is affected. Challenges related to supplier management, quality-related risk and complaint handling and reporting are some of these key areas. These challenges can increase the risk of patient harm and significantly impact a company’s competitive edge and bottom line. Here’s why. Lack of Supplier Visibility and Traceability Many medical device manufacturers still rely on manual communication methods for supplier quality management processes. This results in siloed information streams, lack of management oversight and poor visibility into supply chain quality-related issues. Manual processes can result in communications delays between the supplier and medical device company or even across divisions within the company such as between procurement and quality. This results in limited ability to trace, control and report supplier related quality issues. In addition to compliance risks, inadequate supply chain management can also negatively impact the business. Inefficient Complaint Handling Process The increased complexity of medical device companies can lead to a high volume of complaints. This, with stagnant budgets, can lead to longer resolution times for investigations and poor regulatory compliance. In addition, greater volume of complaints require a large number of resources to process the records quickly. When rushing to process complaints companies often lose the opportunity to gain actionable insights that can improve product quality. The result is slow response and reporting times as well as the potential for higher risk issues going unrecognized and, ultimately, unresolved. On top of this, variability in root causes of similar complaints, duplicate efforts, and lack of signal detection and trending result from poor complaint handling and reporting. The result is the inability to gather insights, react, and continuously improve products. Organizations must focus on shifting away from processing records, and toward identifying signals, identifying trends, and supporting fast and data-driven decision making. No Oversight into Quality-Related Risks Even with increasing regulatory focus, risk management has continued to be one of the most overlooked challenges facing medical device quality. Successful risk management requires a strong link between data and information that goes beyond checking-the-box. Effective risk management is challenging as risk management information and data exists across the enterprise, in different data structures, and with different key personnel. Different teams across the enterprise may be using alternative naming conventions for the same patient harm or occurrence level, challenging the ability to aggregate that data. This puts a strain on resources and manual risk management and post-market processes that are ad-hoc or periodically done. It also increases the chance of human error and impacts the ability to identify and act on adverse trends. This can have a significant effect on understanding the evolving product risk profile as a result of a lack of production and postproduction data being fed back into the development process. Mitigating these Challenges with the Digital Quality Management System Medical device companies need a solution that mitigates these three critical challenges and improves supply chain quality management, complaint handling and reporting processes and provides insight into quality-related risk. A digital Quality Management System (QMS) can address and alleviate these quality challenges. Download the white paper to find out how. DOWNLOAD WHITE PAPER Share via: Twitter LinkedIn Facebook Email
EVENT Honeywell Life Sciences Innovation Days Honeywell invites you to join us for one of our Life Sciences Innovation Days, a series offered throughout the globe in 2024. We will present a variety of process innovations to support the digital transformation of life sciences manufacturing. Themes will include orchestrating systems and data, preventing and containing cyber incidents, quality control and management, modular automation, and the Honeywell life sciences roadmap. Discussion will address streamlining manufacturing, creating batch records, and fulfilling regulatory reporting requirements. Learn more
EVENT TUG Europe Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Enjoy a networking at our pre-event receptions, as we celebrate 30 years of TrackWise! Take advantage of a FREE TrackWise Digital pre-event training workshop. Learn more
WEBINAR AI-Driven Innovation: Redefining Quality Management in Life Sciences Take a deep dive into the confluence of AI and life sciences, exploring how artificial intelligence is poised to revolutionize the realm of quality management in the sector. Learn more
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WEBINAR EUDAMED 2024 and Beyond: Preparing for the Future of Medical Device Oversight Watch our on-demand webinar and gain valuable insights into the transformative impact of EUDAMED on the Medical Device industry. Learn more
WHITE PAPER Bridging the Gap: Integrating Quality and Document Management When quality and document management systems are integrated, life sciences companies can maximize the value of each platform and create a “total quality” environment. Learn more
WHITE PAPER Harnessing Quality Management Innovation in Life Sciences Discover the Power of Quality, Data, and Patient-Centricity in Life Sciences through Exclusive Whitepapers with CIO.com and Salesforce Learn more
ON-DEMAND TrackWise Digital®: Managing Complaints with AI QualityWise.ai: Auto-Categorization Product Demo Video Learn more
ON-DEMAND QualityWise.ai: Leveraging AI to Achieve Proactive Quality Product Demo Video | QualityWise.ai Autocategorization & Insights Learn more
WEBINAR Transforming Quality Operations in the Digital Age Learn how Orion is using TrackWise Digital® to transform quality operations and enhance traceability among suppliers to continuously improve quality and patient safety. Learn more
WEBINAR Seamless Collaboration with a Digital Supplier Quality Management Solution Join Darrius Kilpatrick for this insightful 30-minute webinar as we showcase TrackWise Digital® for Supplier Quality Management (SQM). Learn more
WEBINAR Risk Management: An Antidote to Managing Supply Chain Uncertainty In this session, we will delve into the complexity of risk management and provide a comprehensive framework for effectively managing risks. Learn more