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Solution Brief

Design control guidance for medical device manufacturers

On average, inadequate design controls cost companies an overrun of $3.5 million in the regulatory approval process.

This executive brief provides design control guidance for medical device manufacturers to gain direct line-of-sight throughout the product lifecycle. Find out how to manage complexity and advance patient safety – without costly slowdowns and overruns.

Consistent design control information in the medical device industry

Consistent design control information in the medical industry is necessary to avoid regulatory setbacks while realizing their importance to patient safety and product innovation. The inefficiency of passing old information from person to person could contribute to a slow-down in product delivery or to a design that does not turn out as was originally intended.

Failing to standardize the level of context at each step of product evolution leaves that context up to the individual interpreting it. A lack of singular truth leaves room for misinterpretation of data at hand and the risk of missing data points entirely.

A comprehensive history of design authoring manages the growing complexity and regulatory oversight challenging medical device development. The medical device industry has a transformational opportunity available to use the design control digital thread to connect disparate information and integrate efficient design processes for competitive advantage, particularly with the advance of smart, connected and personalized devices.

Medical device risk management throughout production lifecycle

Companies may believe they are adequately managing reconstruction of their design evolutions with time and manual effort. In truth, however, the limits of human understanding will increasingly impede the accuracy of these efforts. Without complete context around design decisions, when they happened, and why, companies cannot meet regulatory demand or conquer cost and time challenges.

To establish the traceability and consistency of design information needed to meet regulatory demand and control costs, companies must move away from a document-centric model of information to a data-centric one. This digital approach to design control enables medical device risk management throughout the production lifecycle. A comprehensive solution plays to the strengths of human and machine, enabling companies.

Improved transparency and traceability of medical device design control data

Granular traceability of design evolution is a catalyst for reduced time to market, better risk management and superior design quality. Empowering mechanical, electrical, and software teams to author and manage design control information as linked data elements, as opposed to static documents that lack version control, becomes the foundation for more effective multidisciplinary collaboration.

The improved transparency and traceability of contextualized design control data enables regulators to navigate the entire history of design control implementation. The automation of traceability completely removes the onus on scarce experts to re-engineer and re-imagine this history, potentially saving months on the timeline and millions in avoided non-compliance issues.

These benefits are among the many ways creating a comprehensive history of design authoring helps solve regulatory challenges and drive product innovation in the medical device industry. Download the executive brief to learn more.