Medical Device Usability

We are a consultancy of usability experts, psychologists and designers assisting medical device developers in applying the science of human factors engineering. We work across the design life cycle to help mitigate risk and maximise user device safety.

Why us

We provide that essential human factors expertise into the development of usable and safe medical device products. We facilitate getting structured feedback from real end users throughout the design process. We can provide programmes with the necessary compliance with product standards covering human factors and support regulatory certification. We bring our team of human factors experts together with graphic & information designers to bring concept visualisations to life and support rapid prototyping.

We provide simple, visual and pragmatic recommendations into your design process from early user research, concept testing and through to summative tests and in-service evaluations.

We are experts at integrating human factors within the medical device product development lifecycle and support taking safe and effective products to market.

Services

Concept Development

We use ethnographic & design research methods to understand your users developing personas and use cases

Analysis & Requirements

We can deliver task analyses along with conducting failure modes effects analysis & capturing usability requirements

Design & Development

We use heuristic evaluations and formative testing to help you capture initial user feedback within an iterative design process

Testing & Evaluation

We support design verification where we can help you refine the design and prove its safety through to the important final summative studies. We help gain that vital regulatory approval

Post Launch Monitoring

Once your product is in the hands of real users, we do field and market studies to look at adverse effects so you can refine the product and make improvements for the next generation

Our thinking

Drug Delivery Devices

 

We optimise drug delivery design through human factors analysis, testing, and validation. The intent is to improve the quality of the user interface such that errors that occur are either eliminated or reduced. Designers and manufacturers of medical devices are now accountable for assessing and mitigating user error. Coupled with IEC 62366:2015 and AAMI’s HE75, there are clear guidelines for applying best practices for human factors and usability engineering in product design, for assessing and controlling use error, and for developing the evidence needed to support regulatory review of the product. Failure to consider human factors and usability can result in costly delays caused either by designing a suboptimal product or by lengthening the process of obtaining regulatory approval.

Digital Platforms

 

Mobile health is the game changer. More patients are seeing the benefit from innovative features and apps. These people are not just the young: research shows a wide range people wanting to adopt digital services.  Now that patients around the world have grown more comfortable with using digital products and services, even for complex and sensitive issues such as healthcare, we believe the time has come for healthcare systems, users, and providers to go “all in” on their digital strategies for medical devices. The question is, where should they start?

Instructions for Use

 

User error is a growing problem with home care medical devices. One factor that contributes to the increase in these errors is the difficulty that lay users have understanding the instruction manuals that were written with health care professionals in mind. When the device is dispensed for the home, users may not receive adequate advice on its use or have the  experience that the professional has. So safe usage is often dependent on the quality of the instructions.

We use our understanding and research into users to help write simple text and use graphics to help end users. Our research also helps to explore other more innovative ways of delivering instructions. We provide iterative testing with real end users to ensure they understand and can use the instruction material first time out of the box.

Early Stage User Experience

 

If you have a medical device product that no one likes or that no one can use, no matter how good the idea or the technology, it will fail. We put the user at the heart of our thinking and processes.

In the early stages of your project or development of your company, you need to understand your user. Who are they? What do they want? We perform the early design research to help navigate a path through that chaos and emerge with confidence that you have a good potential market. Get this right, and we’re off to a great start for your user experience.

Ethnographic Research

 

This is about real world, direct observation of medical device use that is in context. Ethnographic research is a great approach to providing insight into how your product will be used in peoples’ day to day lives.

We help you determine what is needed from your device, what the key differentiating characteristics should be. Ultimately we want to save you time, effort and enhance efficiency by getting the design right.