Rebus Medical is a human factors (HF) consultancy specialising in medical device development. Our team have worked with some of the world’s largest medical device and pharmaceutical companies. Together we’ve helped to develop innovative and pioneering new medical devices and drug delivery platforms that exceed end user expectations whilst ensuring regulatory compliance.
Our approach to HF strives to place the best possible products in the hands of users; improving the lives of patients, healthcare professionals and caregivers around the world on a daily basis. We build trust with our clients by developing an understanding of their business needs alongside those of the potential device users. Rebus Medical’s philosophy is to build long term partnerships, with a foundation of commercially focused collaboration, respect and shared passion.
Integration of HF activities within a business is vital to successful product development. Rebus Medical has experience of strategically placing HF at the heart of our clients’ medical device design process. Our approach delivers regulatory compliance against key standards including ANSI / AAMI / IEC 62366-1, ISO 14971 and FDA HF Guidance whilst effortlessly dovetailing with existing procedures, systems and organisational structures.
Formative evaluations add value by identifying use-related risks, gaining insight into user needs and assisting in the planning of Validation studies. Our team have extensive experience applying a variety of HF techniques, including formative usability studies, expert reviews, cognitive walk-throughs and contextual inquiry. This extensive toolkit allows us to tailor an approach to help our clients build confidence in the design decisions and reduce use-related and commercial risks.
Our team is highly experienced in planning, executing and reporting HF validation studies (summative testing) for a wide range of devices for FDA submission and European certification. Scientific rigour, robust protocol design, data integrity, precision planning and robust documentation are prerequisites of our HF studies. All of our study documentation follows guidance from FDA, AAMI, IEC, MHRA and industry best practice.
Establishing and maintaining traceability between Risk Management and HF activities is critical to identifying and mitigating use-related risks. Rebus Medical apply ISO 14971 compliant risk management tools, such as HAZOP, URRA and Fault Tree Analysis, throughout all stages of a medical device development process. Starting from the earliest concept stages we utilise HF tools such as HTA to map user interactions and define user interface requirements.
Developing a deep understanding of who will use your device, for what purpose and under what environmental conditions are core principles of HF. We’ve supported our clients to build this understanding and fill in the gaps that help to guide development activities.
Rebus Medical has experience in planning, executing and reporting user needs research studies across global markets.
A clear, comprehensive, yet concise Human Factors Engineering (HFE) Summary Report represents the very foundation upon which your efforts will be reviewed by Health Authorities and Notified Bodies and holds the key to getting your product to market. HFE Summary Reports must summarise all usability and use related risk management activities throughout the development cycle. We’ve assisted a number of clients in preparing HFE Summary Reports, ready for submission.
Which would you feel more confident in interpreting the results of; an Electrocardiogram (ECG) or a pregnancy test? This short blog post discusses how designing a medical device’s user interface can be compared to the English Government’s recent update to its slogan amidst the COVID-19 response from ‘Stay Home’ to ‘Stay Alert’. The task of […]
We’re now several months into the global public health emergency caused by COVID-19. We are starting to see a downward trend in the number of daily cases across the globe and the restrictions we’ve had to adapt to living with are beginning to slowly lift. The big question which is being asked all over the […]
Apparently over 600,000 new businesses are registered in the UK every year. That’s more than every man, woman and child in Bristol starting their own venture every year. So, when we formed Rebus Medical at the end of 2018, statistically speaking, it was no big deal. It felt like a big deal. We both left […]
Interested in joining our team?
Helping our clients make a positive difference to the lives of millions of patients and healthcare professionals around the globe is what gets us out of bed in the morning. There is something special about knowing our hard work, dedication and efforts help people live better lives. If you share the same passion, drive and ambition to make a difference we’d love to hear from you. Click the button below to view our current vacancies.