Development of SW-intensive, connected medical devices requires multiple design iterations to create a successful product. These iterations create a challenge for rigorous risk management because the device design is a moving target. Waiting until the design stops iterating is not a solution. Instead, product teams need to take a dynamic approach to risk management. This requires embracing some key concepts: (1) everyone is responsible for risk management, (2) risk management is ongoing throughout development, and (3) methods are optimized for implementing and verifying risk controls. 

Managing product risk data and traceability in a SW platform instead of a spreadsheet supports all of these concepts. The risks, risk controls, design elements, and tests can all be dynamically linked in the platform. This platform-based approach has multiple benefits: 

• Visibility and accessibility: The risk data are visible to everyone, creating a single source of truth. Team members can immediately see the latest changes and can write and revise linked content for multiple documents simultaneously.

• Integrated workstreams: Risk management is integrated with design controls so the identified risk controls can be easily incorporated into workstreams for different functional groups (Mechanical, Electrical, SW, UX, Mfg., etc.).

• Change management: Linked risk data enables rapid and comprehensive change impact assessments.

• Scaling: Efficient management of large numbers of risks, risk controls, and tests even with distributed product teams.

This presentation will explain how this approach overcomes common problems for devices with rapidly evolving designs, how it simplifies workflows, and how companies can successfully adopt it. Excellence in risk assessment alone is not sufficient; companies need a dynamic approach to managing risk assessments and risk controls to keep up with fast moving product teams, especially for SW-intensive, connected medical devices.