Agile in Medical Device Development: Insights, Strategies, and Best Practices

Written by: Hanna Taller

Read Time: 5 min

Over time, traditional development approaches for medical devices have proven inefficient and hard to scale, making it difficult to keep up with increasing market demands. Leveraging Agile in medical technology development offers significant benefits and the promise of an edge in an increasingly competitive market. However, many MedTech developers still feel that this approach is not compatible with meeting requirements for product development in highly regulated industries.  

Nonetheless, many organizations are already reaping the benefits of Agile, with the right planning and processes in place to tailor the methodology to MedTech device development. Read on to find out our top insights and best practices for using Agile in medical device development, and how your organization can start enjoying its benefits.

Agile in medical device development

With the lives of patients and healthcare professionals at stake, MedTech developers often see new development approaches as an unnecessary risk. In addition, Agile as an approach seems unsuitable for regulated medical device delivery to developers who are married to traditional methods, mainly because they believe that constantly changing requirements and decentralized development are not compatible with achieving the compliance needed to bring MedTech products to the market safely. Since Agile was originally developed with software in mind, many also maintain that it is not an appropriate methodology for combined hardware and software development, since incremental or iterative development when it comes to hardware becomes much more complicated than just changing lines of code when needed. 

Is Agile suitable for medical technology development?

Why Agile may not have always been ready in the past to deal with the regulatory requirements of MedTech development or the needs of combined hardware/software systems development, this can be solved by adapting Agile strategies to the specific needs of regulated medical device development. Many organizations are already doing so – and reaping the benefits. 

In response to the growing interest and use of Agile methodologies in medical device development, the Association for the Advancement of Medical Instrumentation (AAMI) published a guideline called the AAMI TIR45:2012 “Guidance on the use of Agile practices in the development of medical device software” in 2012. The AAMI TIR45 guideline outlines how exactly businesses can leverage the benefits of Agile while still maintaining compliance with international standards like the IEC 62304, ISO 14971, or FDA requirements for example, and demonstrated to the industry that Agile is in fact a legitimate approach for medical device development. 

What company size is Agile medical device development for?

Most companies considering an Agile approach to medical device development typically want to improve one or more of the following: 

  • How fast they can go to market 
  • The value they provide to customers 
  • The efficiency of their collaboration 

However, many case studies about Agile initiatives often come from larger software organizations with more mature teams and the budget to experiment, or conversely from start-ups who have used Agile from the get-go. This can leave mid-sized organizations feeling a little bit lost about whether or not it’s suitable for them, and where to start. That being said, while mid-sized enterprises have arguably the largest challenges when it comes to implementing Agile, they can take advantage of the learnings from small and large organizations to make their journeys to Agile smoother. 

What are the advantages of Agile in MedTech Development?

Speed, efficiency, and flexibility

One of the key benefits of Agile is increasing efficiency and speed with a flexible, iterative approach to development. Since changes can be made more quickly in order to respond to stakeholders and customer feedback, companies can avoid costly delays and shorten both release and feature cycle times significantly, while staying on time with sprint and PI deliveries to work towards “releasing on demand”. 

Customer value

In other words, this refers to having a truly customer-oriented mindset. Agile practices put an emphasis on getting feedback from stakeholders and customers early on through testing early, as well as conducting reviews and demos. This means that the project is molded by feedback from the beginning, allowing the core team to prioritize correctly and ultimately create an end-product that is more faithful to customer needs. 

Transparency and accountability

Being able to get feedback early from customers and manage those changing requirements as a result also leads to much more transparency in the team as a whole. Essentially, better transparency means more fluid collaboration due to increased visibility of the project and boosted communication across functions. This is one of the main perks of Agile practices alongside a cross-functional team; dissolving the business silos which have become obstacles in traditional software development.  

Cost and time saving

Due to the iterative nature of the Agile methodology, it is easier to make adjustments to changing requirements and fic errors early on, which saves time on costly reworks. Shorter, customer-oriented development cycles are another way to lower costs. Working software is available earlier through frequent evaluation and feedback, which ultimately makes it more customer-oriented and of higher quality. Meanwhile, with better collaboration and more efficient processes, teams also reduce overtime and wasted effort, which improves team morale overall and helps boost productivity. 

Best practices for unlocking the power of Agile

If you’re considering an Agile approach for medical device development and you’re not sure where to start, you can hit the ground running with a few simple steps: 

  1. Research Agile best practices for medical device development 
  2. Get all your stakeholders on the same page 
  3. Establish a core team who will be responsible for the Agile implementation 
  4. Mix and match, fins an approach that suits (Hybrid Agile for example) and continuously improve as you go along 
  5. Use the right tooling to support your transition and journey to Agile 

+1 Rely on knowledge from established experts and the experiences of Agile practitioners 

Closing thoughts

MedTech companies can and should leverage Agile medical device development to improve efficiency, product quality, and collaboration while meeting regulatory requirements at the same time. Since the increasing use of Agile methods across different industries and with combined software/hardware initiatives, the industry has made sure that complying with healthcare regulations and using established Agile practices are not mutually exclusive. Plenty of successful companies all around the world in the business of medical device development has already been explored and deemed safe, with plenty of existing experiences to draw on. 

Ultimately, Agile has significant advantages over plan-based approaches previously used for medical device development. All you need is the right information and tooling to support the transition.

Unlock the Power of Agile in MedTech Development

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Tags: Application Lifecycle Management (ALM) Codebeamer Agile Life Sciences

About the Author

Hanna Taller

Hanna Taller is a content creator for PTC’s ALM Marketing team. She is responsible for increasing brand awareness and driving thought leadership for Codebeamer. Hanna is passionate about creating insightful content centered around ALM, life sciences, automotive technology, and avionics.