Applying Quality Management Best Practices for Medtech

A look at how one medical device manufacturer automated quality management along with ideas on how shared intelligence can drive quality from the shop floor to the top floor.

11 Min Read
Applying Quality Management Best Practices for Medtech
Quality auditor checks at a manufacturing center. Image courtesy of EtQ and IQMS. 

Building a reputation for world-class quality and compliance is essential for medical device manufacturers to stay in business and grow. But doing so is often a complex and expensive process. Still, savvy companies are thriving even as newer regulations, such as FDA’s Medical Device Single Audit Program (MDSAP), come into play.

This article examines the steps a medical device company has taken to optimize its quality initiatives, and it reviews the three best practices that define the fastest-growing and most profitable medical device manufacturing companies today. These include:

  • Taking a business initiatives-based approach to optimize the mix of analytics, business intelligence (BI), mobile technologies, and real-time monitoring to revolutionize compliance and quality management.

  • Gleaning valuable insights, including overall equipment effectiveness (OEE), by analyzing real-time data streams to define specific continuous improvement goals and roadmaps of how to attain them.

  • Making quality audits a core part of the medical device manufacturer’s DNA.

Compliance Moves Manufacturer to Automate Quality Management

The medical device manufacturer referenced above has been able to reduce the time to register some products with FDA by 92% while saving about $71,400 per year. The company achieved this by replacing its manual audit system with an automated one. Additionally, like other high-performing medical device manufacturers, the business relies on key metrics obtained from its systems to define individualized roadmaps for achieving its enterprise-wide compliance and quality goals. Consistent with the third best practice mentioned, metrics and audits have become part of the manufacturer’s DNA.

This company has a business profile familiar to many manufacturers in the industry. The business creates products in infection prevention, surgical solutions, respiratory health, digestive health, pain management, and IV therapy. It operates 11 manufacturing facilities worldwide and sells its products to more than 100 countries.

As an international organization with many locations, this company conducts many audits, which include internal audits as well as ones to satisfy the requirements of many regulations and standards. Among these are FDA’s MDSAP and Code of Federal Regulations (CFR) as well as ISO 9001 and 13485 standards.

Planning and scheduling audits in the company’s paper-based system were time consuming and difficult. Additionally, its internal audit program used various approaches, creating complexity. With the 2016 launch of MDSAP, the manufacturer recognized that its current audit system could not effectively support the new inspection guidelines in addition to 100 to 200 internal audits per year. It was time to move to an automated quality management system (QMS) with built-in audit management capabilities to handle the large volume and variety of audits.

Importantly, the automated system would need to support specific needs critical to the company in conducting audits. These included the ability to be configured for multiple audit approaches, support for MDSAP grading, and views of an overall summary of findings along with simultaneous summaries of ISO 13485 and other standards.

By implementing an audit management system, the medical device company has been able to move from a paper-based approach to a formalized electronic process that provides a unified audit system with an increase in visibility of audit observations across all facilities. In doing so, the business has gained visibility into global issues, identified risks, and now has the ability to share knowledge, in near real time, across its facilities leveraging existing digital/mobile devices.

Additionally, the manufacturer has configured automated and custom processes to best fit its audit needs. Among these are auditor training, an auditee profile, a question profile/MDSAP task list, scheduling, an audit execution, an audit approach, and external audits notifications.

The system has proven to be comprehensive, accurate, detailed, simple, and cost effective. Within nine months, the medical device company has seen a 92% reduction in the waiting period for registering certain products. The move has freed the resources of two full-time employees who were doing mainly clerical work related to the paper-based audit process. Additionally, it has eliminated the need for an external auditor to collect additional results for MDSAP, saving about $71,400 per year. Overall, the manufacturer estimates that it has seen a return on investment (ROI) of 315% from automating its auditing and quality management processes.

Automation is just one part of the equation for optimizing quality management, however. Equally important is the ability to utilize real-time monitoring and analytics and apply OEE best practices.

Medical device manufacturers that turn compliance and quality management into a competitive advantage excel at optimizing the best possible mix of analytics, BI, mobile, and monitoring. These companies have an innate sense of how to use technology to set the foundation for continuous improvement that overcomes barriers to growth and fuels innovation. They also work hard to create company cultures where all decisions are backed by solid data and treat data as a corporate asset. Moreover, they’ve mastered the ability to turn real-time monitoring into a continual stream of high-quality data they can use to measure compliance and quality from the shop floor to the top floor.

The rest of this article looks at best practices that have been applied by medical device manufacturers, including the company profiled above.

Capturing Insights in Real Time

Leading medical device manufacturers use real-time monitoring to feed a series of analytics that show ongoing compliance and quality levels, all on a mobile dashboard. This makes it possible to immediately see what’s going on across the shop floor, identify issues, and empower resources to correct problem areas, before they force a line shutdown.

Real-time data streams are also invaluable for triggering alerts about potential issues so manufacturers can resolve them quickly before they stop production. Increasingly mobile devices—including smartphones and tablets—are the preferred means of receiving up-to-the-moment information. In particular, shop floor managers, supervisors, and production engineers have remarked how valuable real-time dashboards are on mobile devices, since they give these users the freedom to walk through the plant or production center and stay on top of potential production issues.

Maximizing the Ability to Make Informed Decisions

Beyond keeping production on track, data from the shop floor captured via real-time monitoring also gives senior executives the manufacturing intelligence they need to make more informed decisions. Metrics and key performance indicators (KPIs) are captured at the machine level via manufacturing execution software (MES), aggregated using analytics and BI, and then displayed on dashboards. The resulting insights empower high-performing medical device companies to continuously improve—helping manufacturing managers to make trade-offs and collaborate with senior management to reach operations-based and financial goals. Furthermore, analytics offer a strategic view of the factors that contribute most and least to a medical device manufacturer’s performance across the core dimensions of its business.

Notably, by orchestrating analytics, with BI and real-time monitoring, medical device manufacturers gain several important advantages. First, this practice provides the intelligence needed to direct suppliers, production, quality, and compliance to excel on each customer order. Second, it enables companies to stay focused on their highest-priority goals for compliance and quality management, using the product quality and compliance levels achieved today to predict what business will be like tomorrow.

Third, when production management, product engineering, and senior management all use the same base of analytics, BI, and mobile apps, manufacturing intelligence starts to become a core part of the company’s DNA. This enables close collaboration from the shop floor to the top floor based on shared insights into key areas, such as yield rates, quality levels, scrap rates, production efficiency,and cost of quality. As a result, companies can avert production delays and stabilize product quality to maximize customer satisfaction while minimizing unnecessary costs.

Fourth, the technology orchestration enables medical device manufacturers to attain new levels of scale, speed, and accuracy. In particular, companies can gain insights from trending in each production area. For manufacturers with multiple production centers, this information can provide a baseline for comparing relative production efficiency and quality levels by location.

Finally, one of the most valuable benefits of orchestrating analytics, BI, mobile technologies, and real-time monitoring applications is the ability to streamline compliance reporting and track OEE levels in real time. By having compliance, quality, and OEE levels on a single mobile dashboard, manufacturing managers, engineers, and their teams are saving valuable time while progressing toward their manufacturing and growth goals.


Above: The technician obtains the data used to make shop-floor decisions in real time from the production machine, which is displayedon his mobile computer.

Prioritizing OEE in MedTech

Medical device manufacturers that harness insights from real-time monitoring, analytics, and BI are becoming adept at evaluating and acting on OEE, which is based on a calculation of Availability x Performance x Quality. These OEE values can quickly be compared to communicate an overall plant utilization rate and then split into production areas, production lines, and individual metrics. Also, the OEE data analyzed across different production areas bring new insights and correlations.

Comparing actual OEE performance to plans brings additional insights and enables medical device manufacturers to evaluate their current and historical progress, like internal benchmarking. Specific machines and production assets often have a consistently higher OEE performance rating for one specific type of product versus another. Knowing this helps the planning department better optimize scheduling to maximize resources and results. This new knowledge also can be usedby quality and process engineers and R&D professionals to determine what is driving OEE performance, so the results can be replicated plant-wide and in the development of new products.


Above: The technician calculates OEE levels on production machinery.

Three Top Quality Management Best Practices

Beyond OEE, the highest performing, most competitive of all medical device manufacturers have established three best practices involving analytics, BI, and mobile and real-time monitoring to excel at quality.

First is the ability to integrate analytics, BI, mobile tech, and real-time monitoring into a cohesive technology platform that scales to support compliance and quality management business strategies. Medical device manufacturers whose enterprise resource planning (ERP) systems are based on a single, scalable database are better able to flex and respond to quickly changing compliance and customer-driven requirements. They’re also able to track how each phase of manufacturing contributes or detracts from compliance, quality, cost, and time-to-customer delivery goals. By operating from a single unified database, relationships can be correlated across the many sources of data on which medical device manufacturers rely daily to operate their companies. The results are greater insight and intelligence and a stronger knowledge for continually building improvements.

Second is the ability to take the insights from real-time monitoring of compliance and quality metrics and take action to improve. For example, one medical device manufacturer has standardized on OEE across its shop floors and relies on a continual real-time monitoring from a variety of sensor types—including programmable logic (PLCs) and IoT sensors, among others—to provide a very accurate, real-time data stream. These streams feed into a series of analytics and BI applications designed to provide real-time updates on key compliance metrics and KPIs regarding quality yield levels. Additionally, a continual stream of OEE data is calculated in real time for every machine across the shop floor. This level of intensity is needed, since just 30 minutes of downtime on its production lines can cost well over $70,000 in lost sales and operational costs.

Third, the most-effective medical device manufacturers get into a cadence of continually completing audits to identify those areas that need the most improvement and those that are doing well. One North American medical device manufacturer today has a cadence of completing internal audits at least 17 times per year, which provides an exceptional level of new insights into how the firm can improve and mature its business processes. In addition to serving as a supplier for one of the best-known medtech corporations today, this company has a worldwide base of customers that includes foreign ministries of health and human services. Supporting many of these customers means meeting rigorous European compliance requirements that demand thorough and timely reporting on every device produced. Without the increased intensity of having to pass European compliance requirements, the medical device manufacturer says it would have taken years to troubleshoot production scheduling problems. Instead, the audits provide insights into how these issues can be solved in days rather than months or years.


Today's medical device manufacturers are in a race every day to improve compliance, quality, and production scale and speed so they can retain customers and win new ones. Being able to simultaneously compete across these conflicting dimensions of their business makes real-time monitoring essential for providing an accurate, continual data stream that powers analytics and BI applications for insights into improvement. Compliance and quality require exceptional data accuracy and precision to generate the reports and ongoing regulatory filings essential for selling into various countries and industries around the world. By orchestrating analytics, BI, real-time monitoring, and mobile technologies, medical device manufacturers can excel at compliance, quality, and business goals while keeping every phase of manufacturing on schedule.

[All images courtesy of EtQ and IQMS.] 

About the Author(s)

Anthony Parise

Anthony Parise is a medical device product strategist at EtQ, a provider of quality and compliance management solutions.

Louis Columbus

Louis Columbus, Enterprise Software Strategist

Louis Columbus is currently serving as Principal of DELMIAWORKS. Previous positions include product management at Ingram Cloud, product marketing at iBASEt, Plex Systems, senior analyst at AMR Research (now Gartner), marketing and business development at Cincom Systems, Ingram Micro, a SaaS start-up and at hardware companies. He’s also a member of the Enterprise Irregulars. Professional experience includes marketing, product management, sales, and industry analyst roles in the enterprise software and IT industries. Louis’s academic background includes an MBA from Pepperdine University and completion of the Strategic Marketing Management and Digital Marketing Programs at the Stanford University Graduate School of Business. He teaches MBA courses in international business, global competitive strategies, international market research, and capstone courses in strategic planning and market research. Louis has taught at California State University, Fullerton; University of California, Irvine; Marymount University; and Webster University. You can reach him on Twitter at @LouisColumbus.

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