Harvey Medical Consulting are passionate about carrying out these influential studies rigorously to the highest standards and providing your product with reliable usability and safety information as well as providing key insights into your product’s key stakeholders.
Truly understanding the user is pivotal in designing any medical device. This can be most powerful when there isn’t even a design concept for block model. We can help you understand what users want. We can then input into designing block models and potential user steps which will be most effective.
We have the latest tools onsite to take anthropometric measurements which can be used to look for trends in our studies e.g. people with lower grip strength might struggle to use a particular design.
We can work with you, patients, healthcare professionals to co-create concepts in our usability lab.
We are frequently asked by early-stage companies to see if there is a market need for their concept. We can run small-scale studies to assess this need and write a final study report, which can be sent to potential investors or submitted for grant applications.
We like to ensure our formative study methods are well thought-out often using innovative ways to deepen our understanding of how future users will interact with prototype medical devices to ensure that any critical tasks are defined early, and any errors associated with these are highlighted in the formative studies and these errors mitigated through design. We conduct in depth instruction for use (IFU) testing. We can use the latest eye-tracking software to aid our understanding.
Most of our summative (validation) studies are carried out in the USA. We can help you design the study protocol, and submit this to the FDA for review prior to carrying out the study. Our studies are conducted in line with the current human factors guidance and standards globally.