In today’s global marketplace, medical device manufacturers are challenged to maintain quality controls consistently across all operations. Demand has increased for both product complexity and personalized product designs, so quality control processes are also becoming significantly more complex in terms of implementation and management. With established, early-stage regulatory systems checks that are executed in conjunction with best-in-class engineering practices, medical device quality has quickly become much more than ensuring minimum safety standards.

Critical-to-quality (CTQ) processes and systems are increasing in importance and must now be adopted for proactive quality assurance, in addition to the traditional, more reactive methods. Early-stage quality-focused analyses and action management is an effective overall strategy to increase efficiency, reduce auditory risk and eliminate sub-standard products.

“Quality by Design” is the Siemens PLM Software perspective on how companies can take a more insightful, modern approach to ensuring medical device quality management by identifying and resolving quality issues as early as possible in the product design and manufacturing processes. Our Integrated Quality solution has raised the standards in software innovation for quality data and analytics management throughout the product lifecycle processes, as well as in the ultimate quest for the safest, most effective medical devices.

This balanced approach towards design and manufacturing quality supports faster production rates, significant reduction in cost of goods, and heightened levels of innovation. This all comes while still maintaining the highest levels of quality and safety associated with every device produced. By embedding quality data and analytics across all phases of product design and development, along with the core corrective and preventative actions (CAPA) and change control processes, true product innovation within the medical device community is a reality.

Quality Products and Planning for Quality

Designing quality into medical devices is the initial step in developing best-in-class products. It begins and ends with sophisticated specification management processes which allow for complex devices and systems engineering. Identifying CTQ characteristics and managing the cascaded links to related customer needs and design inputs help ensure that quality is designed into product specifications. Use of 3D product and manufacturing information (PMI) to document and communicate product specifications provides an efficient method of authoring and translating product specifications, thus reducing the risk of misinterpreting PMI.

The past decade has also shown a rise in both the number of adverse events and product recalls in the medical device industry. These increases clearly indicate the need for heightened system controls within all process phases. By establishing a manufacturing process plan which clearly reflects a single, concurrent engineering environment, product designers and manufacturing engineers are able to collaborate more effectively, and thus isolate and correct manufacturing quality issues as early as possible in the product lifecycle.

CAPA and Quality Controls

We recognize that quality initiatives require quality systems. Utilizing an enterprise-class system to centrally harmonize and synchronize medical device processes includes implementing a unified change control and corrective action – preventative action platform that integrates quality processes with product and engineering processes. A CAPA platform that enables faster root-cause analysis and verification can impact all departments of your organization including research and development (R&D), manufacturing, and delivery/services functions.