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Sprint to success: Enhancing productivity with Agile methodologies in Med Tech

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Jul 05, 2024

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

Agile software development has revolutionized numerous industries, and its impact on medical device software development is no exception. McKinsey&Company reports that 70% of projects experience delays and software deliveries have taken longer over the past decade. On the other hand, there is a growing need for rapid, reliable, and high-quality software development. This is one of the reasons why adopting Agile methodologies has become more essential for medical device software engineers than ever before.

This article explores how Agile practices enhance productivity, the benefits they bring to medical device software development, and the challenges Agile development might face, revealing insights into the future of this field

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Productivity in Medical Device Software Development

In Medical Device Software Development, productivity is a critical factor because it impacts various aspects such as project delivery time, regulatory compliance, and patient safety, all are directly related to cost-effectiveness. Maintaining high productivity ensures that milestones are met, reducing the risks of not meeting deadlines. In the fast-paced and highly regulated environment of SaMD development, Agile methodologies have proven to be a game-changer in enhancing productivity and efficiency.

Agile development, characterized by iterative progress, collaboration, and flexibility, enables teams to adapt quickly to changes and deliver high-quality medical software faster. This approach not only accelerates the project timeline but also minimizes wasted efforts and resources, ensuring that products meet regulatory standards and market needs. That’s why implementing Agile practices in medical software development is not just a productivity booster but a strategic step for businesses that want to stay competitive and responsive to healthcare demands.

According to McKinsey’s report the below are medical device software productivity drivers and how agile could help.

Medical device software development has significantly increased complexity since 2006, yet productivity has remained relatively flat. Despite this, product quality continues to improve, with medical device companies achieving a 17% higher software quality, as measured by defect density at release, compared to other industries.

2. Addressing Project Delays and Quality Improvement

Approximately 70% of projects experience delays and software deliveries have taken longer over the past decade. However, Agile methodologies help manage these delays by promoting iterative development and continuous feedback, which enhance product quality and reduce the time to market.

3. Managing R&D Footprint

Increasing team size and the number of R&D sites can negatively impact productivity. Agile practices advocate for small, cross-functional teams that work collaboratively, improving communication and reducing overhead.

4. Requirements Definition and Management

Defining requirements for medical products has become increasingly challenging, with a 29% increase in time to define requirements and an 81% increase in unplanned requirements churn. Agile’s flexibility allows teams to adapt to changing requirements more efficiently than the Waterfall approach.

5. Impact of Third-Party Software Suppliers

While incorporating third-party software can lower product quality and increase schedule slips, Agile practices help mitigate these risks by integrating continuous testing and validation processes, ensuring higher overall product quality. It is also important to remember risk management while choosing any SOUP – software of unknown provenance as we need to ensure that medical device software development is risk-based and sticks to the highest safety standards.

Why Agile Wins the Productivity Battle: Understanding Agile vs. Waterfall

Agile and Waterfall are two prominent methodologies in software development.

  • Waterfall is a linear and sequential approach, often used in traditional project management. Each phase (requirements, design, implementation, verification, maintenance) must be completed before the next begins. This method is straightforward but can be rigid, making it challenging to adapt to changes.

  • In contrast, Agile is an iterative and flexible approach that allows continuous feedback and improvement. It breaks projects into small, manageable increments called sprints, typically lasting two to four weeks. Agile emphasizes collaboration, customer feedback, and adaptability, making it particularly suited for complex and evolving projects.

Agile and Waterfall Workflow for Med Tech sector

For a detailed comparison, refer to our previous article difference between Agile vs. Waterfall in medical device software development.

The Advantages of Agile in MedTech Development

Speed, Efficiency, and Flexibility

Agile’s flexible, iterative approach significantly boosts efficiency and speed in development. This methodology allows for quick changes in response to stakeholder and customer feedback, helping companies avoid costly delays. As a result, release and feature cycle times are shortened, ensuring that sprint and PI deliveries remain on schedule, facilitating “releasing on demand.”

Customer Value

Agile practices emphasize a customer-oriented mindset by prioritizing early and continuous feedback from stakeholders and customers. Early testing, reviews, and demos ensure that the project evolves with customer input, allowing the core team to prioritize effectively. This approach leads to an end product that better meets customer needs.

Transparency and Accountability

Early customer feedback and the ability to manage changing requirements enhance overall team transparency. Increased project visibility and improved cross-functional communication result in more fluid collaboration. Agile practices, coupled with a cross-functional team, help dissolve the business silos that often hinder traditional software development.

Cost and Time Savings

The iterative nature of Agile allows for adjustments to changing requirements and early error fixing, reducing the time and cost of reworks. Shorter, customer-focused development cycles lower costs further. Frequent evaluations and feedback ensure that working software is available earlier, making it more customer-oriented and of higher quality. Enhanced collaboration and efficient processes reduce overtime and wasted effort, improving team morale and boosting productivity.

Increasing Developer Productivity

Agile improves productivity by fostering an environment of continuous improvement and adaptability. Here are several ways Agile enhances developer productivity:

  • Iterative development: Breaking down projects into smaller, manageable sprints allows teams to focus on specific tasks, making it easier to identify and resolve issues promptly.
  • Continuous feedback: Regular feedback from stakeholders ensures that the development aligns with user needs and regulatory requirements, reducing rework.
  • Collaboration: Cross-functional teams working closely together enhance communication and collaboration, leading to more innovative solutions and faster problem resolution.
  • Flexibility: Agile’s adaptability to changing requirements reduces the time spent on extensive planning and documentation, allowing teams to respond quickly to new challenges.

Best Practices for Unlocking the Power of Agile

If you’re considering adopting Agile for medical device development, start with these steps:

  1. Research Agile best practices specific to medical device development.
  2. Align all stakeholders with the Agile approach.
  3. Establish a core team responsible for Agile implementation.
  4. Experiment with different approaches (such as Hybrid Agile) and continuously improve.
  5. Use the right tools to support your transition and Agile journey.

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Supporting Standard

AAMI TIR45: This technical information report guides using Agile practices in the context of medical device software development. It helps bridge the gap between regulatory requirements and Agile methodologies, offering a framework for compliance while maintaining Agile’s benefits.

By understanding and addressing these challenges, medical device companies can successfully integrate Agile methodologies into their development processes, ensuring compliance while reaping the benefits of increased efficiency, collaboration, and innovation.

Challenges of Implementing Agile in Medical Device Software Development

Implementing Agile in the highly regulated field of medical device development presents unique challenges. While Agile methodologies bring flexibility and innovation, navigating the regulatory landscape can be difficult. Medical device software development must comply with several stringent regulations, including ISO 13485, IEC 62304, and ISO 14971. Despite these challenges, Agile practices can still thrive in medical device development, offering new levels of efficiency, collaboration, and innovation if properly implemented and supported by standards like AAMI TIR45.

Here are some key points to consider:

Regulatory Compliance:

  • ISO 13485: This standard outlines quality system requirements, including design controls. Its broad applicability to various medical devices, from bandages to pacemakers, can make it challenging for SaMD developers to align their Agile processes with these requirements.
  • IEC 62304: This standard addresses specific considerations for software development in medical devices. It traditionally follows a linear development process, akin to the Waterfall model, which contrasts with the iterative nature of Agile.
  • ISO 14971: This standard focuses on risk management for medical devices, requiring thorough documentation and assessment of potential risks throughout the development lifecycle.

Iterative vs. Linear Processes:

  • Agile’s iterative approach, which promotes flexibility and rapid feedback, often clashes with the linear and rigid nature of traditional regulatory processes.
  • Extensive and inflexible requirement specifications, design specifications, testing, and integration plans are common in traditional methodologies, leaving little room for iteration.

The Future of Medical Device Engineering

The role of a medical device engineer is evolving with the adoption of Agile methodologies. Engineers now need to be proficient in both technical and Agile skills, including iterative development, continuous integration, and collaboration. Medical device systems engineers focus on designing and integrating complex systems, while quality engineers ensure that all products meet strict regulatory standards.

Medical device engineers will increasingly leverage these methodologies to enhance productivity, reduce development costs, and improve product quality. The future will likely see a continued emphasis on iterative development, rapid prototyping, and continuous feedback, ensuring that medical devices meet the highest standards of safety and efficacy.


Agile software development offers significant benefits for medical device software development, enhancing productivity, reducing costs, and improving quality. By adopting Agile methodologies, medical device companies can better manage complexity, respond to changing requirements, and deliver high-quality products on time. As the industry continues to evolve, Agile practices will play a crucial role in shaping the future of medical device engineering, ensuring that innovative and reliable medical devices reach the market more efficiently.

HTD is your trusted partner, experienced in both Agile and SaMD development. We bring many years of experience to ensure that we develop your medical device software quickly while ensuring highest quality standards. Reach out now to discuss your project with us.

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