Medical device manufacturers embrace automated quality management

Medical device manufacturers face more challenges than most industries and those challenges are worse today than ever before. Heightened regulatory scrutiny, unpredictable economic and geopolitical factors, persistent labor shortages, significant supply chain variability and rapid technological change are some of the challenges keeping business leaders up at night. And, if that isn’t enough, quality concerns, patient safety, and the constant threat of FDA Form 483 warning letters or actual product recalls play into every decision these organizations make.

In the face of such challenges, manufacturers are continually evolving their strategies to ensure they have the resources they need to meet demand, while keeping patient safety top of mind. This is where quality initiatives come into play. No longer merely a regulatory imperative, quality has moved center stage as a strategic lever and competitive advantage.

According to The ETQ Pulse of Quality Manufacturing 2025 Survey, 70% of manufacturers indicate the current labor shortage is impacting operations, with 88% saying it has negatively affected product quality. Medical device manufacturers in particular are faced with a short supply of experienced personnel, as retirements accelerate and fewer new entrants possess the specialized skills needed to ensure compliance to regulations such as ISO 13485 and EU MDR. Manufacturers are struggling to train new staff on quality systems and meet regulatory expectations, while trying to avoid productivity delays and risk exposure. To address these labor issues, manufacturers are employing strategies such as:

• Deploying AI and automated tools: By implementing artificial intelligence (AI) and electronic Quality Management Systems (eQMS) manufacturers can reduce reliance on manual processes and paper-based procedures while standardizing workflows, improving traceability, and embedding compliance checks.
• Leveraging connected worker solutions: Bridging workforce gaps with connected worker platforms and AI-assisted knowledge can help flatten the learning curve, deliver real-time work instruction, and improve first-time quality outcomes.
• Creating upskilling and retention programs: Investing in continuous training and career development, emphasizing quality leadership and data analytics competencies can empower staff with structured learning paths tied to certifications and help retain and nurture talent and deepen internal expertise.

According to the ETQ survey, 75% of medical device manufacturers surveyed have experienced a product recall in the past five years, with nearly half attributing the recalls to supply chain issues. Component variability or supplier quality deviations can lead to non-conformances in critical devices such as implants, diagnostic tools, and sterile systems. Recalls carry an enormous financial cost with severe brand and regulatory consequences, including costly remediation plans, not to mention the most important issue – patient safety. To improve quality and reduce recall risk, manufacturers are embracing new strategies such as:

• Improving supplier quality management: The ETQ survey data highlights the critical role suppliers play in overall product quality. Integrating supplier performance tracking with real-time data exchange and inspection criteria can strengthen the supply chain. A strong supplier management program also improves visibility and enforces standards across the entire supplier ecosystem.
• Using predictive quality analytics: Data analytics and machine learning solutions can detect emerging patterns and trigger corrective actions pre-emptively, before they can impact business or patient safety.
• Establishing end-to-end traceability: Comprehensive traceability across manufacturing processes and supply chains enables quick root cause analysis and targeted corrective actions when deviations occur.

© istock | 537016810-monstArrr

As technology shifts from a tactical tool to a strategic asset, impacting workflows, processes, and culture, ETQ survey results have shown AI adoption is keeping pace. A reported 33% of manufacturers have stated they’re already using AI and 49% plan to implement it in the next two years. Some of the most commonly cited applications include document automation, core process automation, defect detection, and trend prediction.

Despite these digital advances, a reported 17% of medical device manufacturers are still relying on paper-based quality programs, citing the high costs of switching, a fundamental resistance to change, outdated regulatory requirements, and the fear of operational disruption. Most manufacturers, however, are realizing it’s not a question of whether to replace manual methods with digital tools, but when and to what extent.

Automated processes for quality management, resource planning, logistics, supplier management, and other applications are reducing the risk of manual errors, product defects, and recalls, and enabling more efficient operations. Many manufacturers are even establishing centers of excellence to guide the strategic rollout and governance of AI, offering training to employees, and focusing on the highest-value applications first.

Manufacturers are increasingly leveraging automated quality systems, AI, and predictive analytics to not only navigate the difficult challenges facing them today, but also to transform quality into a core competitive differentiator. In the process, they’re creating cultures of continuous improvement.

Quality is no longer solely about compliance. Quality-forward organizations already see it as a strategic driver of revenue and growth, central to product innovation, time-to-market, patient safety, and customer trust. Manufacturers are learning firsthand that investing in quality tools, analytics, and workforce competencies directly correlates to lower risk and improved supplier management, as well as reduced defect and recall rates. This not only leads to better business outcomes, but improved safety for the consumers who rely on medical devices to live.

 

About the author: David Isaacson is vice president of product marketing at ETQ, where he develops market strategies and product positioning for the company’s cloud-based ETQ Reliance quality management solutions. He can be reached at disaacson@etq.com.