Tag: ai

Writing a Perfect IFU for Medical Devices

Understanding the need: Any machinery released in the market is packed with its IFU as this includes information for the user to understand the product’s purpose, instructions to use it correctly and also precautions when installing or using it.

IFU or Instructions for Use is prepared by the manufacturer and it gets reviewed and approved by the FDA. IFU content structure varies widely as it depends on the product’s complexity and risks that can occur while handling it. These are needed across industrial machinery, household appliances and medical device labelling industries the most.

Where is it needed?

IFUs are used mostly in the medical industry. These are prepared to instruct the user about medical devices and prescription drugs.

An ideal format for IFU which is generally accepted by the FDA would include the following in sequential order:

  • Table of contents
  • Glossary
  • Purpose of the device
  • Setup instructions
  • Operating instructions
  • The need to monitor device activity
  • Cleaning instructions
  • Storage instructions
  • Information for troubleshooting
  • Index

How does a good IFU help?

  • It ensures safety: As safety instructions are correctly given in the IFU, users can easily understand how to install and handle the particular medical device safely. Thus, any damage or injury is avoided.
  • Mitigates liability risks: Clearly laid out instructions can help in minimizing risks for the manufacturer. IFUs are prepared in a manner to ensure the user gets complete idea of handling the device.
  • Less errors: With everything explained to the user, the chances of committing errors on the user’s part are considerably reduced. Be it a prescription drug or a medical device, the correct dosage or the instructions to setup the device is mentioned accurately.
  • Easy to adopt for the user: IFUs are user-friendly and they provide a hassle-free experience of adopting the device. They also aid in better usage and facilitate word-of-mouth facility,
  • Educational document for anyone: IFUs are essentially educational by nature and they are useful for caregivers, healthcare professionals and patients. Anyone adhering to the instructions given in an IFU will understand how to correctly use the device/ product.
  • Enhances user experience: When the user can follow instructions without any difficulty, they find the device/ product easy to handle or use. This instills trust in the manufacturer as it proves how much the manufacturer commits to user experience and safety by providing the smallest details.

What to consider before preparing an IFU

Writing and organizing an IFU format and content needs a systematic process. The manufacturer should think of the following to before preparing directions or instructions for use:

  • Intended use of the IFU for a device
  • Engineering design process
  • Methods to manage risks
  • Disposal instructions (depending on the product)
  • Troubleshooting guide
  • Standard format of documents
  • General safety
  • Cleaning instructions
  • Product requirements
  • Legal requirements

It is not a user manual

It is important for manufacturers or authors to note that an IFU is not a user manual. While a user manual is more of a comprehensive approach to operating and maintaining a product, an IFU is focused on accomplishing a particular task. A IFU is prepared putting focus on how to perform tasks for safe and accurate handling of a medical device/ product.  

Best Practices for Version Control in PLM (Product Lifecycle Management)

It is widely accepted that end-to-end product lifecycle management has become more complicated than before. Professionals face challenges like:

  • No centralized visibility or data which makes it challenging to work
  • There is no connected process across supply chain and hence it is difficult to work on a product, meeting customer requirement
  • No proper version control of the design files, resulting in technical issues later
  • Lack of proper collaboration across departments or teams

If we work on PLM process manually, using Excel, Word or just email, it will not yield desired results. However, buying and simply implementing a PLM software won’t solve the issues too.  There are some practices which we have discussed below, which help in streamlining the PLM lifecycle with a proper connected process. This can solve all data visibility and collaboration issues.

  1. Identifying the purpose: As a manufacturer, it is important to understand the reasons for which PLM is implemented. PLM can be required for removing duplicate bills, centralizing product data, improving compliance and more. Once the goal is established, it becomes easier to create steps for implementing it.  
  2. Converting current processes to a workflow: Assessing current processes makes it easier to understand how these can be converted to the PLM workflow. Professionals need to identify the gaps and the opportunities for improvement as they map the workflow with the PLM software.
  3. Assessing data quality: The source of data and how it establishes contact with other data, storing and retrieving data are some of the basic queries that should be addressed. Assessing the present data helps in evaluating its integrity and relevance. It should be made clear that any data used can be trusted, is meaningful and available.
  4. Educating employees and avoiding resistance: People are often not open to newer strategies and technology. It is important that employees are explained and trained about the change. Creating such awareness and educating them isn’t a simple one-day task but a whole process altogether to ensure everyone is aligned with the new, required standard of work. This is how a new method is successfully incorporated within an organization’s work culture.
  5. Determining roles and assigning responsibilities: Once employees have understood about the necessity and role of the software, the organization needs to assign responsibilities in order to make sure the PLM implementation is done successfully. Creating clear and distinguished roles with objectives will help the employees to prepare a plan with steps. They will monitor progress of this new task to keep track of the implementation and check if it is yielding desired results. They can answer and solve issues regarding this along with collaborating with other teams. This ensures that everyone understands the value and follow the steps explained.
  6. To provide training: While the SaaS-based systems can be easy to learn and implement, the organization still needs to create a proper path for training employees. It enables them to adapt, giving way to a smooth workflow and more efficiency. Once personalized training is given to the employees by delivering the same to laptop or other screen, it will enhance their skills. This will encourage them to stay engaged with the new process and accept the same.