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Agile for Medical Device Development: Guide & Best Practices

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Agile for Medical Device Development: Guide & Best Practices

Medical device development is a complex and time-consuming process that requires a lot of coordination and collaboration between different teams. In order to meet the many regulatory requirements in the industry, companies have traditionally relied on tried and tested methods like Waterfall development. However, with software becoming more and more important in medical technology over time, organizations are having to rethink the way they approach medical device development – including using Agile as a methodology to speed up production and increase their productivity.

What is Agile?

Agile is a product development methodology that emphasizes iterative development, team collaboration, and customer feedback. With Agile, teams can move faster and be more flexible in their approach to product development.

In other words, Agile project management is a team-based technique. A sprint is a fixed length of time set by the team (typically two weeks long). Teams create deliverables for each sprint based on consumer input at the beginning of each session. After every session, both the staff and consumers evaluate their efforts and make improvements for future sessions.

Standups are another agile technique. These check-ins bring team members together to report on the progress made in sprint objectives and identify any roadblocks or impediments. Daily standups consist of responding to the following questions:

  • What did I do yesterday?
  • What am I doing today?
  • What are the problems I am facing? (if any)

Agile in Medical Device Industry

Healthcare organizations should adopt agile practices to improve patient satisfaction and deploy working solutions more quickly. Healthcare experts should begin by learning about agile applications in the sector’s history, principles, and advantages.

Historically, the development of medical goods has been done using a “waterfall” approach, in which each stage of a project builds on the one before to deliver exactly what was specified in the requirements document upfront. Agile provides a more adaptable method than traditional waterfalls do, allowing for learning and evolving requirements to arrive at a better solution.

The following are AAMI TIR45:2012’s requirements for medical product development that were identified in the prior section: 

  • Quality
  • Productivity
  • Predictability
  • Product Effectiveness
  • Safety

The quality of a product is measured throughout the development process rather than after completion. The Agile approach uses testing as you go to establish the concept of “done.” As a result, productivity improves since engineers who work on the project know what it means to be “done” before beginning any work. Engineers on a regular basis and at every stage of development show an operational product to the owner.

When the owner is regularly shown, touched, and felt the product throughout the process, product effectiveness increases. This also aids in predicting when and where the project will fall behind schedule or exceed the budget. 

Why Use Agile for Medical Device Development?

Agile was formed in response to the need to improve software development processes. Traditional, front-end planning techniques caused software engineers to become impotent and powerless; the conventional waterfall technique frustrated developers who frequently found themselves blocked by hiccups in the product development pipeline. 

Project management software developers recognized a need for an adaptive and responsive project management technique to help workers and customers achieve better results with more consistency. Enter agile, a collection of principles and ideals for project management. 

Agile is now used in a range of sectors, including finance, construction, marketing and advertising, healthcare, and several others.

There are many reasons why companies might want to consider using Agile for medical device development:

  • To meet the needs of customers who are increasingly demanding faster turnaround times
  • To speed up production and increase agility
  • To improve coordination and collaboration between different teams
  • To reduce the risk of errors and defects in the final product

How to Implement Agile for Medical Device Development?

If you’re thinking of implementing Agile for your medical device development process, there are a few things you need to keep in mind:

  1. Make sure you have a clear understanding of the Agile methodology and how it can be applied to your specific development process.
  2. Work with your team to create a detailed plan for how Agile will be implemented, including what tools and processes will be used.
  3. Be prepared to adapt your plans as necessary – Agile is all about being flexible!

Considerations when applying Agile

Consideration of these factors must be given during the implementation of an agile development process for medical devices:

  • Hazards & Protections — When developing medical devices, a variety of factors must be considered. identify the end user’s needs as well as any potential hazards that the product might pose to users, and make sure your goods are safe and effective by ensuring that risk mitigations are included in the design. You must comprehend how risk management works into an agile project plan before you can incorporate it into the schedule.
  • Architectural Planning — When employing an agile development approach, software design is always changing as a result of the iterative nature of agile and the lack of a complete upfront design. However, it is critical to plan for architectural issues while developing medical devices.
  • Team Management & Collaboration — Automated techniques for collaboration are required in medical device development projects. Medical device development teams struggle with a lack of or insufficient collaboration between team members. Even when agile development methods (e.g., daily standup meetings) aren’t used in accordance with an agile process, implementing them can help facilitate and encourage cooperation among team members, resulting in higher product quality and team efficiency.
  • Early Conclusions — Demonstrating a functioning product to stakeholders, even if it does not contain all of the features, allows important input that can help shape and perfect the final result. FDA and ISO rules now demand usability testing and human factors evaluations. These are two key methods for obtaining vital comments. 
  • Changes by Stakeholders — Agile gives you a lot of freedom, which can be abused to the point where it harms the project. Because agile was intended to aid change, stakeholders frequently request more changes (e.g., adding new features to a product), which naturally extends the project duration and cost. To put it another way, individuals like squeezing as much stuff as possible into one submission. It’s critical to know how to handle and avoid this danger correctly.

Visure Requirements ALM Platform

Visure is an example of a tool that supports medical device development processes from requirements gathering to design and implementation, all the way to testing, validation, and delivery.

Visure helps you Transform medical device development work across all design control, hardware, and software engineering teams with a modern platform that is designed for medical device development safety-critical standards and regulations, resulting in speed time to market without sacrificing compliance, or product quality. It supports Agile practices in medical device software development and AAMI TIR45 as well.


Agile is a popular software development methodology that can be used for medical device development. It offers many benefits, such as shortened time to market and increased customer satisfaction. However, it can be difficult to implement agile for medical devices without the right tools. Visure Requirements ALM Platform is one such tool that can help you successfully adopt agile for your medical device development projects. Request a free 30-day trial at Visure Requirements ALM Platform today to see how this tool can help you achieve success with agile.

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