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3 Key Challenges Facing Medical Device Quality Leaders

Medical Device Quality Leaders

Medical Device Quality Pressures

Quality leaders face a lot of pressure in their role in delivering safe, high-quality products to market. In the medical device industry, that weight is even greater as the quality of their products can have a direct and dramatic impact on a person’s health. Successfully navigating a sea of FDA, ISO, and other regulatory requirements is a primary source of this pressure to deliver medical devices to market effectively and efficiently.

Here, we’ll discuss three challenges quality leaders are facing in the medical device space and offer potential ways to address them.

Alleviating the Anxiety of FDA Audits on Medical Devices

Challenge 1:

Maintaining constant readiness to respond to audits

Fundamentally, medical device regulations exist to protect patient health. Given the importance of that goal, it shouldn’t be surprising that the FDA and other regulatory bodies are keen to ensure that these standards are properly adhered to. Medical device companies should be prepared for an audit at any time, yet many are left scrambling when an audit arises. It’s important to remember that FDA inspectors aren’t required to give advance notice that they will be performing an audit, so don’t be caught off guard if you only find out on the day that it’s happening.

Addressing and passing audits often hinges on whether the impacted teams provide auditors with the latest product records, quality documents, and training procedures. To do this successfully, medical device companies need to be able to quickly compile all quality and training information related to the entire product, which is usually comprised of hundreds or thousands of discrete electrical, mechanical, and software components.

Too often, quality teams use a quality and training system that is separate from the systems used by the engineering and manufacturing teams. When systems are siloed, it is harder for quality leaders to find the right information quickly and demonstrate compliance due to reduced visibility and traceability, especially under the pressure of an audit. Stress levels rise, valuable time is wasted, and people are tapped out by tedious, unproductive tasks.


Assure your QMS is connected to the full product record for improved traceability and control

Successful quality leaders recognize that product records for complex medical devices are more than just a set of documents—they include components and assemblies, too. The entire product record, including the bill of materials (BOM), needs to be captured, controlled, and managed with connections across all the associated quality records and processes. This enables better control, traceability, and accuracy.

When individuals, teams, and supply chain partners span multiple time zones and geographies, traditional document-centric or disconnected quality system silos can cause confusion, errors, and audit issues. Establishing a linked single source of truth for quality and the entire product record prevents misalignment and promotes an environment where all impacted teams are on the same page. When audits occur, quality managers can quickly and confidently show auditors every element of their quality management system at every phase of the new product development (NPD) and new product introduction (NPI) process.

Important Tip: FDA audits also cover training record management. Having a single system to manage product, quality, and related training records helps ensure accuracy and adherence to FDA regulations and ISO standards.

Read more on this topic in  5 Tips to Pass Your FDA or ISO Audit with Confidence.

Enabling Closed-loop CAPA Processes

Challenge 2:

Linking products, quality processes, and corrective actions from design through manufacturing

If you make medical device products, the FDA requires you to establish CAPA processes as outlined in 21 CFR 820.100. CAPA processes involve several stages, from identifying issues through analysis and final resolution. Identification of issues is typically straightforward, but being able to establish the root cause of the issue can be difficult, especially when QMS systems are separated from the product record. Many medical device manufacturers have QMS and CAPA processes that are either completely disconnected or only loosely connected to the product record. This makes it harder to zero in on the part of the product or manufacturing process that is responsible for quality issues and product defects.

Closing the loop involves implementing the necessary corrective and preventive actions to remedy future quality issues. It also requires a system to be capable of capturing, tracking, and identifying product and/or process improvements. Improvements are not one-time events or actions in many cases—instead, they involve continuous monitoring and incremental adjustments to prevent non-conformances, defects, and product failures. Ultimately, having sound CAPA processes allows manufacturers to resolve issues with procedural updates, product design modifications, manufacturing and test documentation changes, and better training processes. Without a solid and final resolution of the issue, the CAPA process is not complete or closed. Closing the process in a timely and effective manner can only be done if the quality and product information are connected or linked so that correlation or root cause analysis can be more easily determined.

Furthermore, when CAPA processes do not facilitate the passing of information to downstream systems where the product record is used for sourcing, assembling, and shipping final products, the manual data entry and intervention required to get information from the QMS system to systems like enterprise resource management (ERP) systems will cause additional challenges.


Design CAPA processes that extend from quality and training processes through manufacturing

A single quality issue may affect one or many products and multiple stakeholders.

Connecting quality and CAPA processes directly to the affected product record can only be accomplished with a product-centric QMS solution where all parts, assemblies, and documents are managed in a relational, multi-level BOM which serves as the foundation for the QMS system and all associated records that comprise the device master record (DMR). Without a comprehensive way to manage every phase of the new product development (NPD) and introduction (NPI) process, impacted teams and quality leaders will struggle to identify, analyze, and correct quality issues in a timely manner. Product-centric QMS approaches provide better control and traceability to give all impacted stakeholders the confidence to address audits and resolve problems fast.

Recommended Reading: 5 Essential Elements of a CAPA System

Elevating Medical Device Quality Management Spurs Innovation

Challenge 3:

Having a product-centric QMS approach that streamlines collaboration and drives continuous improvement

Quality and operations leaders find it difficult to build a foundation for strategic innovation when they lack a single, cohesive system to address quality management and the product record. Relying on disconnected, patch-quilt systems involves duplicate data entry, introduces more human errors, hinders collaboration, and ultimately delays new product launches. Regulatory compliance becomes more challenging as teams struggle to identify, track, and control the necessary records throughout the entire product lifecycle.

For complex medical device manufacturers, traditional document-centric systems lack the full product record and require teams to spend more time comparing related information to determine how product and quality records interrelate. Increased manual efforts and reliance on tribal knowledge create additional risks and prevent first-mover advantages.


Create a transparent quality culture

Having a product-centric QMS solution creates more transparency for all teams and introduces a continuous improvement in quality culture. Tracking and correcting issues faster and in a traceable system provides a competitive advantage that speeds regulatory compliance and delivery of products to market. This also helps medical device manufacturers design and produce safer and more reliable products.

Having a unified, single source of truth system promotes information integration and cross-functional collaboration, bringing about tangible and intangible benefits across the enterprise. Fewer systems and silos remove obstacles to innovation and drive strategic benefits, including reduced costs and improved profitability. This creates a strategic advantage for medical device manufacturers as they deal with increased regulations, distributed teams, and global competition.

Overcoming Challenges to Ensure Medical Device Quality

With a QMS solution that maintains a persistent link to the product record, closed-loop CAPA processes are streamlined, audit responses are simplified, and overall quality and product safety are improved. Today’s innovative medical device manufacturers must adopt product-centric QMS methodologies to stay ahead of the competition and deliver compliant and more reliable products to market quickly.

Learn about the 7 Principles of Product-Centric Quality Management in our latest ebook.