We consider ourselves bilingual; we speak ‘human’ and we speak ‘engineer’. We know how to effectively engage and empathise with your end-users and patient populations to conduct effective research. Then, we systematically translate our research findings into a clear set of user needs and technical requirements for your development team.
From in-home healthcare products to invasive surgery systems, Sento has experience partnering with manufacturers to successfully implement the entire usability engineering process for a wide variety of medical devices.
Our consultants generate use specifications, usability plans, use-related risk analysis, user interface requirements, plan and execute formative and summative studies, compile your Usability Engineering File and FDA Human Factors Engineering Summary Report, and so much more.
Sento also provide expert independent review of your usability engineering and human factors strategy and documentation ahead of your regulatory submission.
Formative studies are a highly cost and time effective way to quickly surface shortcomings and areas for improvement in your medical device design.
Summative studies, or human factors validation studies, are a highly effective way to validate that your product meets its user’s needs. Product validation is a regulatory requirement for any medical device across all regions.
Sento provides access to Australian and US healthcare professionals and lay users through our global recruitment and test site partners.
Good usability has a profound impact on market success. If you want to unlock this for your existing, or new, product, we would love to share some of our secrets. Have one of our experts deliver an interactive workshop in usability best practices.
Sento also provides a variety of training courses on Usability Engineering and Human Factors to support your organisations training needs in regulatory compliance. These courses can be customized to deliver the most relevant and applicable know-how to your team.