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solution brief

Avoid challenges of complex medical device design controls

Reading time: 7 minutes

The medical device industry is shifting toward country-specific regulatory demands, in-country manufacturing and supply chains, and improved affordability of health care. This shift requires a significantly more complex approach to the development of the quality practices and procedures that ensure device quality and compliance known as design controls.

Manufacturers today rely on document management systems implemented in the last decade to piece together their product innovation programs. The need to refer back to their design controls is becoming more frequent. However, when companies use cloud-based design control, they can consistently reuse design control elements to save time and costs and ensure a standard approach for every use.

Transition from a document-centric model of information to a data-centric one

To establish the traceability and consistency of design information needed to meet regulatory demand and control costs, manufacturers must move away from a document-centric model of information to a data-centric one. Creating granular traceability of design evolution will be the catalyst for reduced time to market, better risk management and superior design quality. This change enables companies to rely on computers to catalog and codify complex recall of information. A data-centric model will also reduce dependency on experts to re-imagine evidence of the relationships between different pieces of information.

The result shows that the workforce can be freed up to complete more valuable design activities with better productivity. If companies play to the strengths of their staff and machines, they can accelerate product development.

Accelerating product development through connection of teams and data with cloud-based solutions

The key to accelerative product development is to connect teams and data with cloud-based solutions. Rather than using static documents, it is important to empower mechanical, electrical and software teams to author and manage design control information as linked data elements. This is the foundation for effective collaboration.

Managing complexity across an organization through automated generation of design documentation and real-time information sharing via the cloud will allow teams to work more confidently and quickly. As a result, it facilitates faster, higher quality and more predictable product development.