Medical device industry ensures that users can use medical devices safely, effectively, and efficiently.. Creating Instructions for Use (IFU) for medical devices requires quite a lot of responsibility. It requires a combination of technical communication skills with project management, administrative and legal skills.
IFU is not something that can be referred to in many ways, such as a user guide or an operation manual. It is a document that is instrumental in achieving safety for a medical device and is therefore considered a part of the product user interface.
It is paramount to learn about the target audience to design instructional materials, commonly referred to as end-users, effectively. It can be done through a combination of techniques, such as focus groups, interviews, field research, and contextual inquiries. The more we know about the end-users and the environments they will be using for the IFU, the more capable we will be of designing effective instructional material.
IFU designing requires understanding of tasks that an end user will perform to safely use the products, including the errors that may occur during the use. It is also necessary to have understanding of consequences and impact areas of any such error, this enables a technical writer to focus design efforts on the information that have most significant impact of safety.
Designing usable IFU involves selecting appropriate content, layout, formatting, and use of graphics. IFU usability becomes even more critical if a product requires complex user actions, has confusing steps, or has the potential for harm. IFU is the output of multiple processes, considerations, and requirements. The top components to consider when writing IFU for medical devices are:
- The intended use
- The risk management process
- General safety and performance requirements
- Legal and product requirements
- Operation and maintenance instructions
Apart from the components that must be part of an IFU, there is more to consider to make these components usable and understandable. Below is a non-exhaustive list of usability designs for IFU development. It may not be relevant to all products, but it acts as a starting point for considering the usability of your product given its unique risk profile, indication(s) for use, and specific user/use environment.
- Use short, concise, and action-based sentences
- Prepare an accurate list and present one action in each item to avoid missing steps
- Label all the key components in diagrams to minimize confusion
- State or depict expected outcomes of actions
- Define any necessary technical words and create a glossary list
- Specify units to avoid misinterpretation of abbreviations (e.g., “5 seconds” versus “5s”)
- Redundantly present critical information in a “Frequently Asked Questions” (FAQs) section, within relevant steps, to minimize reliance on memory
- Provide images that match the textual information in the instructions, while accurately depicting proper use of the product
- Select a font size that is legible during use
- Consistently associate information categories with visual cues to avoid critical information being overlooked or misinterpreted by users (e.g., if some actions are numbered steps, all actions are numbered steps)
- Present conditional determination as part of a step to prevent the step from being missed or inappropriately followed
Unlike some kinds of technical writing, content for IFU includes an additional challenge – how to interpret the regulations you are working to comply with? There are different requirements for the components of an IFU depending on country compliances and regulations. The EU countries have their relevant EU regulations, and it is the US Food and Drug Administration (FDA) and Code of Federal Regulations (CFR) in the USA. This also depends on what the device is and what it does. Is it software? Surgical equipment? A home-health device?
Designing IFU for medical devices is more than just technical writing. It is about gathering and analyzing technical, marketing, compliance, legal and quality information. It is about structuring and developing content to publish, distribute, and maintain it. It inevitably involves collaboration and working closely with several departments.
Most IFUs are long and tedious, but it is essential to include information to pass through various country regulations and ensure the medical device's safety and effectiveness throughout its use.
Are you a medical device manufacturer? Do you know how to design quality IFU for your devices? Reach out to a Regulatory expert like Freyr for designing compliant IFUs. Stay informed. Stay compliant.