Human Factors & Design Controls

Dec 2, 2018 | Human Factors, Three Circles

Human Factors is key to your success in Medical Device Development.  As a recognised device development discipline, Human Factors should follow a clearly defined methodology.   If you are struggling to get to grips with incorporating Human Factors processes into your Design Controls system or in your development activities, then Three Circles can help.

Human Factors is not a magic wand that fixes all of your device problems.  Human Factors tells you whether your customers will encounter problems with your design configuration.  If implemented early in development, Human Factors will give you the advantage of a heads-up, before design problems become locked in.  Acting on the results of HF activities helps smooth your path through development and provide you with an all-important compliance audit trail.

Usability Engineering Process

Understanding user needs is essential to medical device design.  Meeting those needs with an elegant solution requires the involvement of Human Factors methods (the science of understanding human capabilities and behaviour and translating this knowledge into risk assessed design solutions for products and systems).

Three Circles provides Human Factors consultancy and support across the entire medical device development process.  Our approach combines the requirements of regulatory authorities in the USA and European Union, along with Internationally recognised Standards for Human Factors (ISO 62366) and Medical Device Development (ISO 13485 and ISO 14971).  Key areas where our clients seek us out to give them guidance and support include:

  1. Integrating the Human Factors Engineering process into a Design Controls system and understanding what it means to incorporate HFE into a development project.
  2. In addition to creating and incorporating new elements within an existing Design Control system, Three Circles provides training workshops to help project teams get to grips with HF testing and what regulators are looking for.
  3. We can also take care of the Human Factors Engineering role for clients’ development projects (whether it be for a discrete part of development or throughout the project’s life)
  4. We provide support by creating bespoke HF Plans &Formative and Summative Validation Testing to support your device development. We help define the most suitable Human Factors methodologies for your project and our testing team devise each HF study based on your HFE documentation. We test your device with real users (appropriate for the Intended User profile), providing you with insight into the effectiveness of your device design and supportive data for your project risk analysis.
  5. We also create key HF documents to fill any gaps in a client’s HFE file. HF documents such as; detailing who your users are (Use Specification); supporting your product design specification with HF input (User Interface Specification); identifying potential use errors (Task Analysis and uFMEA) and generating the required Human Factors Summary for regulatory authorities

Benefits of Applying Human Factors

The typical benefits our clients gain are;

  • Demonstrable risk mitigations, tested effectively
  • Data-based design decisions
  • Increased user satisfaction and reduced use error
  • Market advantage features included in the design
  • Increased market uptake
  • Evidence based marketing claims