Our human factors for medical device design services ensure products are intuitive, safe, and compliant with global regulatory standards. By integrating usability engineering early in the development process, we help identify potential user errors, improve device interaction, and support both FDA and MHRA expectations for human factors validation.
Through formative and summative usability testing, we gather real-world insights from representative users to refine interfaces, instructions, and ergonomics. This evidence-driven approach reduces risk, enhances user experience, and leads to devices that perform reliably in diverse healthcare settings.
HD’s collaborative team combines deep experience in medical device design and development with human factors expertise, ensuring that every decision — from concept sketch to clinical use — is informed by user needs and practical context. Our structured yet flexible human factors engineering process helps clients accelerate approval, minimise redesign costs, and ultimately deliver safer, more effective healthcare technologies.
We are advocates for user centred design. Whilst we have a network of specialists, healthcare professionals, and users in a number of sectors, we also harness your network throughout the design and development process.
Beyond grave scenarios, there are many wider benefits to incorporating HFE into device design & development including;
In addition to our multi-disciplinary in-house team, we utilise our network of industry experts to ensure impartiality and provide services to support you with;
HD provided the design & development of an innovative urinary drainage device with a number of novel features drawn from user needs.
In light of Diabetes Week, we spoke to Chris Harrison, who has been living with Type One Diabetes for over 40 years to learn about the role that medical devices play in his Diabetes Care:
In light of World Continence Week we chat to Tayla Collinson to learn about her experience of living with a catheter:
Despite regularly working on a variety of product and medical device projects, there are always improvements to be made and taking the time to really understand user needs is often a crucial piece to the...
User experience and human centred considerations can, and should, be applied to the design and features of all medical devices – it’s just that they sometimes aren’t. While its paramount that a user is not injured...
It is no secret that risk management isn’t the most exciting subject to speak about, but it is an essential part of all design and engineering, particularly for medical devices. Whether you’re new to the...
Although they differ in finer detail, both the European and U.S. regulatory laws discuss Design Controls. Failure to comply with these laws can result in a series of penalties including your device being taken off...