Helping you develop safe and effective devices
In response to an ageing population and the need to radically reduce healthcare costs across the globe, we are seeing an increase in the availability of more sophisticated medical devices and combined drug devices. Many device companies are embracing new technologies and creating innovative devices that connect to iPhones, iPads and other mobile devices via Bluetooth or wirelessly to existing health systems.
A great device is only as good as the IFU that accompany it. Devices rely almost wholly on their IFU for safe and effective use. Failure to use the device properly can put patients at risk. Luto can help with developing clear and understandable IFUs, Instruction Manuals and packaging as well as applying Usability Testing.
Luto has been successfully working with leading global pharmaceutical companies and medical device manufacturers on high profile device and combination drug device projects for marketing in the US and EU.
Our proven expertise and understanding of good information design and human factors allows us to deliver high quality and cost effective solutions to our clients. Luto has developed considerable expertise writing, designing and testing IFUs and Educational Tools. Our experienced team are involved in every project, they include: information design specialists, graphic designers, psychologists, nurses, pharmacists and academics. We can originate original instructional graphics or work with your existing agency to identify and improve problem areas.
With respect to paper based IFUs, we appreciate that hurdles such as restricted space, lack of colours, folds and paper weight can hinder the patients’ understanding of the material, but good design can mitigate these factors. We also take into account translation requirements and the fact that IFUs may be marketed within the EU, requiring additional room to be left for languages which occupy more space.
Review of house style and alignment
We know that your brand is important and this should be reflected in your IFUs. Luto works with companies to review their existing IFUs and can create a new design template that aligns to your corporate house style and works across your range of devices.
It is essential that IFUs or Instruction Manuals are designed for lay people. They must be understood by people with low literacy, who may have difficulty interpreting instructions. We follow an iterative and formative design process and involve users (patients and healthcare professionals) at key stages of the process. This cycle of planning, developing, studying and refining leads to a product that performs better, reduces the patient’s exposure to risk and helps clients to make modifications much earlier in the design of the device.
Luto can help you right from the start of your medical device development project. We are experts in working with users and can easily access the right people that meet your demographic requirements. We also have access to a variety of healthcare professionals that we can involve in the project if required.
Our expert patients are a core part of our work. We call them expert patients because they use devices and understand what they require from IFUs. We can also involve lay patient representatives who work with patients and information all the time and are able to help ensure the user’s needs are represented.
For information about Usability Testing, Focus Groups and other studies we conduct, please visit our study section.
Contact us today to discuss your requirements for producing Instructions for Use (IFUs) or Instruction Manuals.