The Definitive Guide to Agile in MedTech

At first glance, Agile software development practices can seem at odds with the stringent regulatory requirements associated with medical device manufacturing. That being said, many MedTech companies are already embracing Agile to improve the quality, usability, and effectiveness of their products. When executed correctly, Agile can improve your organization’s time to market and even accelerate compliance efforts. Read on to learn more about the best approaches to using Agile in medical product development.

The Definitive Guide to Agile in MedTech

What is Agile?

Agile is an umbrella term for software development frameworks based on the 2001 Agile Manifesto

It was created by a group of industry thought leaders who had become frustrated with traditional software development practices and the exhaustive documentation, long lead times, and rigid decisions that came with them. Looking to create a faster and more responsive way to build software, they laid out a set of Agile principles and practices which have become increasingly popular in both software development and other fields since.

Learn all you need to know about Agile in our fundamental guide:

Agile 101: A Beginner’s Guide to Agile Software Development

Agile is an iterative approach to software development that helps teams consistently deliver value to their customers. Because this approach focuses on working in small increments (rather than a “big bang” launch) with constant testing and feedback, it empowers teams to quickly respond to change as they go along. 

Implementing Agile in Medical Device Development

Becoming Agile is an ongoing journey, not a destination (cheesy but true!). Unlike other working methodologies, the Agile Manifesto is not a prescriptive framework that lays out the perfect way to implement and use it. In other words, there isn’t one single way to ‘become Agile’.

Related reading:

Introduction to AAMI TIR45: Agile Guidance in Medical Device Development


The good news is that this means you are free to apply Agile principles and processes in a way that best suits your MedTech organization’s needs. The tricky part is to decide where to start and what to do first.

Here are the basic steps you will need to take into consideration as medical device developers when embarking on your transition to Agile:

Learn and follow the basic principles of Agile

Everything in Agile is rooted in providing as much value to consumers as possible, in the most efficient way possible. Here are the basic principles of Agile that you need to familiarize yourself with when beginning your Agile journey:

1) Put the customer first, always
2) Welcome change (even late in the game)
3) Deliver software frequently and consistently
4) Use cross-functional collaboration
5) Build projects around motivated individuals
6) Use face-to-face conversations where possible
7) Measure progress with working software
8) Promote a sustainable pace of development
9) Emphasize good design and technical excellence
10) Strive for simplicity
11) Let teams self-organizee
12) Reflect and tweak regularly

Find the right Agile method for you

As we’ve already mentioned, Agile refers to a variety of project management and software development methods based on the principles laid out in the Agile Manifesto. 

Which one is the best fit for your organization will depend on a few factors such as:

  • Organization size
  • Team types
  • Company culture

Here are some of the most common Agile frameworks to start with:

  • Scrum: Breaks down projects into smaller parts which are carried out in short iterations.
  • Kanban: Organizes work in a highly visual way on a board where project statuses are tracked as you go along.
  • XP (Extreme Programming): Like Scrum, XP emphasizes frequent releases and continuous value for customers.
  • FDD (Feature-Driven Development): Focuses on the development team and requires more rigid organization and documentation.
  • Crystal: A lightweight Agile framework designed for short-term projects carried out by a team of developers using a single workspace.
  • LeSS (Large-Scale Scrum): Allows you to scale Scrum to multiple teams who are working together on the same product.
  • SAFe® (Scaled Agile Framework®): Implementing Agile for enterprises, focuses on streamlining collaboration and delivery from multiple Agile teams.

Mix and match Agile practices as you go along

Since Agile is an umbrella term that refers to several agile methodologies, there is no single way to go about implementing them in your organization. Feel free to explore the variety of frameworks and come up with a combination of processes and best practices that best suit the needs of your project, team, or organization.

Learn more about Agile practices in MedTech:

Essential Agile Best Practices for MedTech Development

Decide how you want to implement Agile

There are a ton of Agile methods and they all come with recommended implementation approaches. Some may suggest a top-down or bottom-up rollout, and others recommend starting small and spreading incrementally as you go along.

Before consulting an experienced Agile coach, it can be helpful to learn about other Agile MedTech businesses who are further along in their journeys, as they have plenty of learnings to share which can inform which direction you decide to go in.

Looking for specific strategies for supporting your MedTech organization on its journey to Agile? Learn more here:

Approaches to Agile in Medical Device Development

Agile in MedTech: Best Practices

Agile software development is characterized by the interface of technical and nontechnical best practices. The technical side focuses on high-quality programming practices like test-driven development and continuous integration, while the interpersonal side is equally important and focuses on cross-functional collaboration and learning from each other to work together as efficiently as possible.

Related reading:

Agile in Medical Device Development: Insights, strategies, and best practices

In the context of medical device development, there are several key best practices that both facilitate quality software development while supporting rigorous compliance needs: 

1) Setting your Definition of Done

The Definition of Done (DoD) is when the conditions that a software product must satisfy are met and are ready for user acceptance. Using the DoD consistently and effectively reduces costly delays, rework, and ensures customer satisfaction throughout the development process.

The Definition of Done can be set by development teams themselves and is crucial for ensuring compliance and quality standards. 

2) Incremental compliance

In medical device development, addressing regulatory compliance too late in the development lifecycle can have extremely stressful and costly consequences. If compliance activities only kick off after product development finishes, it is likely that you will miss deadlines, fail to meet business objectives, and suffer increased project costs.

Agile development, on the other hand, makes it possible to achieve compliance incrementally, by integrating compliance into the full product development lifecycle. This means that you integrate compliance activities as you go along, accelerating your team’s productivity and efficiency.

3) Non-Functional Requirements (NFRs)

For medical devices, Non-Functional Requirements (NFRs) are just as important as Functional Requirements and should not be overlooked. Non-functional requirements focus on aspects like performance, safety, reliability, efficiency, usability, security, maintainability, and portability of a medical device.

One Agile practice that comes in handy is User Stories. User Stories are short, simple descriptions of features from a user perspective that can be used to express both the Functional and Non-Functional Requirements of a medical device.

4) Traceability between work items

In order to achieve (and demonstrate) compliance in medical device development, it is crucial to ensure traceability between work items. This means that you need to use the right tooling to be able to clearly outline the path between different work products and software artifacts to their implementations, test results, and any changes that may have occurred. Displaying these relationships effectively is what allows medical device developers to smoothly satisfy regulatory demands.

Interested in learning more about specific Agile practices (i.e. methods, workflows, templates, etc) that are crucial for medical device development? 

Keep reading here:

Agile Best Practices for Medical Device Development

Patterns of Agile Success in Medical Device Development

It may come as surprising news to some organizations that many healthcare companies are already incorporating agile development approaches. Despite Agile seeming at odds with the stringent requirements of medical device regulations, many companies are transitioning away from traditional software development methodologies as they are no longer able to keep up with the pressures of modern-day market demands.

When it comes to implementing agile in medical device development, MedTech organizations typically want to improve:

  • The value they provide to customers
  • The quality of their products
  • Their time to market
  • The efficiency and productivity of their teams

Leading MedTech developers like Abbott, GE, Philips, and Siemens are well on their way in terms of their transition to Agile. They embarked on Agile initiatives dating all the way back to 2003 and as a result, have plenty of insights to report on already. According to their respective case studies, these MedTech developers found their Agile journeys to be a success, fulfilling the key benefits of Agile outlined by the 2020 State of Agile Report such as:

  • The ability to manage changing priorities
  • Project visibility
  • Business / IT alignment
  • Delivery speed / time to market
  • Team morale

Based on the experiences outlined in their case studies, we’ve highlighted a list of best practices that led them to success in their Agile initiatives:

Agile Adoption Best Practices

  1. Learn from previous experiences
  2. Get familiar with Agile methods through training
  3. Get management buy-in from the outset
  4. Use self-organizing teams
  5. Set up feature teams rather than component teams
  6. Get support from an experienced Agile coach
  7. Start the rollout slowly and proceed gradually
  8. Leverage a cross-functional perspective

On the hunt for practical solutions for aligning Agile methods and regulatory constraints in healthcare that come recommended by industry-leading companies themselves?

Find them here:

Patterns of Agile Success in Medical Device Development

Agile has the potential to transform software development in MedTech, despite common industry concerns. It provides significant advantages in comparison to traditional and rigid plan-based methodologies, not only optimizing your speed-to-market and team efficiency, but also supporting compliance efforts and ensuring stakeholder satisfaction across the board. 

Driving innovation in life sciences with Agile is a real possibility, all you need is to get started. Check out our 3-part webinar & white paper series with key insights, strategies, and best practices for adopting Agile in a regulated setting here:

Unlocking the Power of Agile in Medical Device Development

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