Human factors engineering
Usability and human factors engineering play a vital role in design of medical devices, ensuring that products are safe, comfortable, and intuitive to use. In the context of medical regulatory frameworks, human factors work includes focus on mitigating potential use-related risks.
How does human factors engineering work?
Human Factors activities start with understanding the intended users, uses and use environments of a medical product. It then extends through expert analysis of the tasks and use cases, before undertaking Formative and Human Factors Validation Summative studies to test and validate the use of products and systems with real users.
Aspects of your product that can benefit from Human Factors considerations include:
- Physical capability
- Visual intuitiveness
- Cognitive understanding
- Workflow and logic
- Packaging and labeling comprehension
The importance of understanding your users
It’s important to consider the range of users that will interact with your product and their different user needs – this may include healthcare professionals, clinical technicians, nurses, pharmacists, carers or patients.
We explore user needs and product requirements through proven research methods to uncover use challenges during the development phase, mitigating risks and enabling the final product to reach its potential for safety, effectiveness, and appeal.
Steps involved may include:
- Observational research
- Contextual enquiry
- Diary studies
- User interviews
Our expertise with human factors
Our experienced team of human factors consultants can help you audit existing products, or to develop entirely new concepts. Working closely with you, we can provide expert review and guidance on:
- Identification of potential usability risks and opportunities
- Recommendations for product improvements
- Proposals for Human Factors testing strategies
- Advice on approaches to Human Factors documentation
Formative usability testing
Testing with users forms the cornerstone of good design for usability. This can start with relatively informal testing of early prototypes, through to more structured formative testing to check usability, understanding, and provide comparison with alternative design proposals.
Studies can be undertaken in simulated settings, in clinical settings, or in users’ homes depending on the product and the agreed test plan, helping you achieve the most accurate and easily usable final product.
Human factors validation summative testing
To support submission for regulatory approvals, human factors summative studies may be required to validate that the intended use of the product or system can be performed by intended users in their intended environment.
Our team has experience of planning, running, and documenting human factors summative studies in Europe and the US, meaning you can be sure we’ll deliver a quality result through a comprehensive process informed by the industry best standards.
Packaging, labeling, and instructions for use (IFU)
The design of packaging, labeling, and usage instructions are important tools to support usability and to help achieve intended use. Increasingly, digital IFUs and videos play an important role in supplementing product use instructions and training.
Our human factors team, in collaboration with our design team, have significant experience in designing packaging, labeling and IFUs for medical devices, supplying you and your end customer with a clear understanding of your products.
Our accreditations
Our quality management system is ISO13485 certified and works in compliance with the FDA’s human factors guidance documents, IEC 62366 application of usability engineering to medical devices and AAMI/ANSI HE75 human factors principles for medical device design, as well as other key standards including ISO14971 application of risk management to medical devices.
Get in touch
Eliminate variance and deliver a medical product that truly meets your users’ needs by getting in touch today.