Human Factors for Medical and Scientific devices
Human Factors is a critical part of medical and scientific device development.
As well as being essential for regulatory compliance, it plays an important role in ensuring that devices have both a competitive edge and a positive impact on patient experience.
Human Factors is an integral part of our approach to design and development
System design informed by Human Factors
We are highly experienced at integrating Human Factors as part of device systems development, following the principles of IEC 62366. Our Human Factors experts draw on a diverse toolkit to ensure insights are gained early and often and are used to inform system requirements, risk analysis and design implementation. We have a deep understanding of the connections between medical and scientific devices, instructions for use, packaging, companion apps and web portals.
We also understand medical and scientific devices at a portfolio/platform level. Such device platforms must be informed by a detailed appreciation of user expectations alongside the specific needs of different patient and user groups. Consideration of these insights has helped us to develop device solutions that can be appropriately customised and differentiated within efficient manufacturing frameworks.
Inclusive design for diversity
We strive to design for the widest spectrum of sensory, cognitive, and physical capabilities of all users in the target population profiles.
With diversity in mind, within these population profiles, we consider how aspects such as age, gender, ethnicity, culture, illness, disability and similar factors, impact different people’s ability and desire to engage with the devices and systems that we help to design, seeking to improve outcomes and minimise errors.
Evidence based Human Factors that inform design decision making
Human Factors play a vital role throughout the design process. From our extensive range of tools we use the most appropriate processes to evaluate existing designs seeking to improve them and to inform and evaluate early conceptual ideas and developing designs, even before they become physical artefacts. As the design further develops, formative evaluations can be conducted with representative users remotely or in-person, to help gather further evidence, validate decisions, identify opportunities and design strengths, weakness and unanticipated use errors, all of which feed back into design development.
Our suite of tools, methods and expertise are also applicable to summative evaluations with the intent to obtain objective validatory evidence that the user interfaces can be safely and effectively used.
Usability benchmarking and Threshold Analysis
Comparing the usability between two or more products is often useful to understand opportunities to improve performance and avoid or mitigate potential user errors and misuse scenarios. When developing a new medical device for a generic drug, we typically conduct Threshold Analysis to demonstrate that the proposed device is suitable for substitution – meaning that the generic combination product can be prescribed in place of a legacy, approved, product without additional training or other HCP intervention. This involves demonstrating that either:
- There are no differences between the two products
- The differences between the two designs do not impact critical tasks
- The differences that may impact critical tasks, do not influence the safe and effective use
Comparing usability performance for generic applications
Human Factors is a core expertise
By combining our inherent evidence-based approach to understanding people’s interactions with products and devices of all kinds, together with our in-depth knowledge of technologies and device markets, we can more efficiently focus design development to help optimise compliance and system performance for better user outcomes. With our considerable and ever growing experience across a wide range of medical and scientific device developments as well as our experience in fast moving consumer health products, we bring a robust set of tools, techniques and expertise to every new challenge.
DCA is a registered consultancy with the Chartered Institute of Ergonomics and Human Factors.
Read more about our Human Factors, Usability and Inclusive design expertise.
We are experts at integrating Human Factors as part of device systems development, following the principles of IEC 62366
Helping our clients achieve success through great product design
