An exhausting, though a very vital, part of the whole medical device manufacturing process is the development of the Instructions for Use (IFU). Why exhausting, you may ask? Well, I am sure that any medical device manufacturer who has had the pleasure to generate an IFU would definitely back me up on this.
So, what is needed to make this process flow without skyrocketing your anxiety levels?
- Communication is the Key!
A huge variety of products circulate in the medical device field, and each of them is manufactured by a number of professionals scattered throughout several departments. As a result, extracting the required information becomes labour intensive and it could leave a mark on the manufactures’ resource plan.
The first thing to do is to place the burden on to the right shoulders. A team member: let’s call him ‘Peter’ who has the right type of knowledge, unquestionable communication skills and direct access to the relevant people involved in the device manufacturing processes.
- The ‘’Skeleton’’.
Now that we have the right person for the job, we need to construct our ‘’Skeleton’’, which is the map of the IFU to be, essentially, how it will look like and what sort of information it will offer.
Each of these elements require a lot of consideration because all of them play a significant part and represent the structure of today’s IFU development process.
- The Plan.
To be able to connect the relevant people and extract the right information, outstanding skills are paramount, as well as a good plan! Power without control is just another young spiderman – With great power comes great responsibility.
The planning should start from the Content Analysis, as it is the backbone element of the IFU development process. The content should be divided into chunks of information, which then processed through the filter of ‘Regulations’. This means that sections, which are complaint/part of to the future market regulations/guidance’s should be mapped out and incorporated accordingly. The most recently published guidance ‘’Instructions for Use (IFU) Content and Format Draft Guidance for Industry’’, even though just draft, it is still informative enough to assist you during the IFU development process.
Below you can see an example of Content Analysis presented in a form of several sections.
- Device Details
- Operating instructions
Sections should be broken down into phases. And this is where it gets interesting and challenging at the same time. The identified phases should be associated with the relevant team members as the information will need to be extracted from them during the IFU development process. Most likely the device itself will be in development, so the information will change weekly or even daily, but I am sure ‘Peter’ will be able to connect all the dots in time. It is also worth mentioning that each phase needs to be treated as a stand-alone sub-project.
Next, we have training, which is extremely important in the development process of the IFU. If you are a manufacturer who is outsourcing the IFU development it is mandatory to carry out individual training sessions for each identified phase followed by a draft layout afterwards. This helps to minimise the amount of resources wasted on recapturing the information that has already been given. Online communication tools are perfect for recording training videos, through which all the important details can be captured and safely stored for future use.
- Keep it mindful
Graphics, layout design and aesthetics should be analysed and realised together.
It is entirely up to you how you want your IFU to be presented. An example below uses two completely different ways to explain the ‘’Cleaning’’ stage of two similar products.
There is no right or wrong way to present the information as long as it remains presented. The question is which of these options are more likely to be easily perceived, understood and performed by the user? That is where Human Factors comes along. Each part of the IFU development needs to be carefully observed from the user’s perspective. Companies have been generating IFU’s without such mindset in place and that is exactly why IFUs have developed such a negative reputation.
The most commonly observed use errors, during Human Factors Studies, are generated because the user could not perceive or understand the information provided in the Instruction Materials. It is then most likely that the feedback from the participants from a Human Factors Study will advise to implement a number of changes, which will reflect on the manufacturer’s funds. To avoid such a scenario and be prepared when the time arises to perform a Human Factors Study the right measures must be incorporated in an early stage of product development.
It is extremely difficult to convince the user to pick up the IFU and find the required information in today’s fast paced- world/reality. Therefore, everything needs to not only make sense, but be informative and user friendly. It also needs to be magnetic, attractive and good-looking, if you like. The goal is to make the user want to pick up the IFU. The era of black and white IFU’s is long gone and we should make the effort to keep it that way.