For the best outcome in medical design innovation with highly outsourced teams, having a rock-solid approach to quality is a prerequisite. As regulatory standards, market requirements, and device complexities have evolved, so too has the weight of the burdens device manufacturers face. Unfortunately, traditional tools and staid approaches are not sufficiently lightening the load. Instead, there are increasing demands for sleeker, smaller, smarter, more durable, and longer-lasting devices. So, what are device manufacturers to do? 

In this article, device manufacturers will learn of the critical challenges and proven approaches to overcome common obstacles such as:

• Disconnected quality and product records
• The persistent silos of quality, engineering, operations, and related product teams
• Issues with implementing static methods to manage complex quality processes

Medical device manufacturers must overcome these issues to eliminate new product development and new product introduction process delays, reduce compliance risks, and remove barriers that impede innovation.

Today’s manufacturers must be able to expedite compliance with regulatory requirements. To ensure patient safety, medical device manufacturers must establish and follow quality systems to meet requirements specified by the U.S. Food and Drug Administration (FDA). Quality systems for FDA-regulated products follow current good manufacturing practices as laid out under FDA 21 CFR part 820. 

While quality teams typically understand the need to comply with these mandates well, engineers often underestimate how significantly their design work impacts those responsible for manufacturing, testing, and delivering products to customers. Furthermore, selling into many countries now requires companies to comply with the internationally agreed upon standard, ISO 13485, which specifies requirements for quality management systems. It’s important to note that there is a major emphasis on risk management and risk-based decision making in the newest version of this ISO standard for processes that extend beyond product realization.

A More Holistic Connective QMS
Addressing risks more effectively, as stipulated by both the FDA regulations and ISO standards, requires adopting a more holistic, connective quality management system (QMS) approach to provide better visibility and traceability.

These primary objectives bring us to two important points:

1. Efforts and actions that focus on meeting FDA and ISO standards should not be carried out or managed in isolation.
2. To effectively compete, medical device manufacturers need to adopt holistic, connective QMS approaches to provide better traceability.

The importance of quality goes beyond just compliance. Quality sets the stage for continuous improvement, a learning culture, supply chain collaboration, and greater customer satisfaction. Let’s look closer at how quality and operations leaders can help their teams and organizations realize these rewards.

Traditional or document-centric QMS approaches cover only a subset of what’s needed, focusing on just two fundamental areas of FDA compliance. The first is providing complete document control for managing standard operating procedures (SOPs), specifications, and other documents. The second is process enablement and tracking for auditable processes (including CAPA, requirements management, and training records).

While the automation of paper-based processes is helpful, that function alone fails to connect quality management processes to the comprehensive product record—often comprised of hundreds, if not thousands, of mechanical, electrical, and software components; assembly and test procedures; and other documents specified in a product’s bill of materials (BOM). On the other hand, connected QMS approaches provide increased traceability between the entire design and all related quality processes. This not only improves the ability to track, control, and release product designs, it accelerates the time necessary to identify, perform root-cause analysis, and resolve quality issues.

Realize the Benefits of Product-Centric QMS
While still providing the benefits of automated document management and control, a product-centric approach to QMS is advantageous because it enables better design control throughout the new product development and introduction (NPDI) process. Aggregating the entire product record and connecting it to quality processes within a single system removes design and quality gaps caused by disconnected quality and product silos.

Medical device manufacturers must typically manage complex and constantly changing multilevel assemblies (i.e., BOMs) comprised of hundreds or thousands of interrelated components, subassemblies, and related documentation required to test, build, and ship high-quality products to market. Connecting every aspect of the product record to the quality record speeds the time to ship compliant and safe devices to customers.

Product-centric QMS not only provides better control of the product design, it streamlines resolution of issues and enables continuous improvement. It also supports a multidisciplinary approach spanning design, development, production, installation, and servicing of all finished devices. A product-centric approach provides the BOM foundation necessary to manage quality and training records in context with the product record throughout the entire NPDI process.

It’s important to remember that quality issues can arise during any and all phases of a product’s lifecycle. By maintaining a persistent connection between the product record and quality at all times, it’s easier to comply with FDA and ISO regulations—which helps prevent audit issues, recalls, or customer safety issues from arising.

Linking closed-loop corrective and preventive action (CAPA) processes with the quality and product records is key to avoid harmful—or even fatal—consequences. Preventing serious consequences was the impetus for the FDA’s requirement to establish CAPA processes as detailed in Title 21 CFR section 820.100.

Most medical device manufacturers have closed-loop CAPA processes in place. However, they are often poorly defined, inconsistently applied, and/or are dangerously disconnected from the product record. This is why a connected closed-loop CAPA process is important. Inconsistent or incomplete CAPA processes leave organizations vulnerable to undesired risks and audit impacts such as FDA warning letters, legal consequences, and customer satisfaction issues. In fact, a single quality issue may affect many products and stakeholders. Disconnected CAPA processes could cause unnecessary repetitive actions, or reliance on tribal knowledge and ad hoc processes to identify, address, and correct issues.

Bring Disconnected Teams and Siloed Systems Together
Many companies rely on contract manufacturers and suppliers as they grow from young startups to more mature companies. Communicating with these supply chain partners often involves the use of point solutions like Microsoft Word, Google documents, email, spreadsheets, network servers, file services, CAD design systems, or homegrown solutions. Reliance on these patch-quilt systems or silos to manage product and quality records creates confusion between internal and external teams.

These disconnected silos make it difficult, if not impossible, to identify the latest design revision, which results in manufacturing mistakes, quality issues, and costly scrap and rework. Furthermore, executive management teams cannot get a complete picture regarding NPDI process performance and potential risks getting products to market.

With increasingly complex medical devices, evolving regulations, and use of supply chains, keeping everyone on the same page requires a single, connected solution. Without a single source of truth for product and quality records, identifying the latest design revision leads to confusion and mistakes as companies progress from early design to shipment of finished devices. This, in turn, often results in quality, compliance, and manufacturing issues—giving rise to increased product costs.

When quality records are connected to the product record, the result is a shared, controlled, and unified view throughout the NPDI process. This fosters effective collaboration and faster iterations to deliver high-quality products on time and under budget. 

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Scott Reedy is the senior director of marketing for Arena Solutions (www.arenasolutions.com). He has held strategic roles with enterprise software companies in consulting, sales, and marketing over the past 20 years. Scott has experience selling and implementing PLM solutions and spent a decade managing new product development and introduction processes for a global manufacturing company.