Use-related risk management workshop with Swiss MedTech company
Training Courses, December 2019
Use-related risk management workshop with Swiss MedTech company

Business situation

Ergonomics Factory was approached by a Swiss MedTech company in 2019, in the interest of refining their use-risk systems. Our expertise across the areas of human factors, risk management, and regulatory affairs elevated Ergonomics Factory as the ideal partner for this endeavor. While the client had plenty of expertise, their products needed to be more efficiently optimized towards use-related safety and usability – and as such, a newly designed system was required.

The Challenge

With a hand in many different baskets, this client specializes in research, development, and the manufacturing and marketing of diagnostic, therapeutic, pharmaceutical, and biological products. With so much emphasis placed on the design and development process, key company members and workers required a greater understanding of:

  • How to assess use-related risks,

  • How use-related risk assessment relates to the risk management procedure in compliance with ISO 14971, and

  • How to document use related risks and validate the effectiveness of the implemented risk control measures.

It was vital that the solution both solved current bottlenecks and addressed the knowledge gaps of key team members.

The Solution

The first step in partnering with the Swiss client was to educate; namely, through an all-day workshop at the client’s premises. The company development and risk management teams were in attendance to learn more about:

  • The current approaches, bottlenecks, and pain points of the company

  • Presentation of the regulatory framework to assess the client’s processes

  • Activities to systematically incorporate use related risk information into the risk assessment, design, and verification and validation processes

As a practical demonstration, our workshop chose one of the manufacturer’s real products to be the subject of use-related failure modes and effects analysis. The team worked together to clearly define the appropriate risk control measures and establish full traceability.

THE RISK MANAGMENT PROCESS

RISK MANAGMENT PLANNING

RISK ANALYSIS

RISK ASSESSMENT

RISK EVALUATION

RISK CONTROL

EVALUATION
OF OVERALL
RESIDUAL RISK

RISK MANAGMENT REVIEW

PRODUCTION AND POST-PRODUCTION ACTIVITIES

Outcomes

Through the in-depth, intensive workshop designed to assess and optimize the client’s current processes, the development and risk management team learned:

  • Which inputs drive your use-related risk analysis (URRA),

  • Best practices for performing and documenting a URRA,

  • How to integrate URRA results into the design and development process,

  • How to derive effective use-risk controls from URRA results,

  • The required steps for verifying and validating the effectiveness of the identified use-risks,

  • How to ensure traceability between the identified use-risks and the implemented use-risk controls, and

  • Common mistakes to avoid when performing and documenting a URRA.

BENEFITS

More effective use-risk management within the company

More effective use-risk management within the company

Optimal traceability from use-risk identification through verification and validation

Optimal traceability from use-risk identification through verification and validation

Consistent compliance with regulatory requirements and guidelines

Consistent compliance with regulatory requirements and guidelines

Updates

After successfully completing our workshop, the client implemented a new use-risk assessment procedure for better outcomes, and continues to work with Ergonomics Factory on other projects. For future design and development projects for novel medical devices, the client wishes to make use of the Ergonomics Factory Human Factors, User Studies, and User Interface Design services.