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3 Critical Steps for Efficient Medical Device Software Development

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Apr 18, 2024

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

In the evolving landscape of healthcare technology, the role of software in medical devices has never been more crucial. From enhancing device functionality to ensuring user safety, the stakes are high. In this article, we’ll delve into three key strategies for streamlining the medical device software development process.

For those looking to understand the broader context, we recommend checking out our detailed exploration of the 5 phases of the medical device software development lifecycle.

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Medical Device Software Development

Medical device software development, often referred to as SaMD development, is a specialized field focusing on creating software solutions that are integral to or used alongside medical devices. These solutions range from diagnostic algorithms to software that controls or monitors medical equipment. For a deeper dive into what this entails, have a look at our “What is SaMD?” article, which makes this nuanced subject easier to understand.

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Critical Step #1: Choosing the Right Methodology - Agile vs. Waterfall

When embarking on software development for medical devices, one of the first decisions is choosing the right project management methodology. The two main contenders are Agile and Waterfall. The Waterfall methodology is a sequential design process, often used in hardware development, where progress flows downwards like a waterfall through phases such as conception, initiation, analysis, design, construction, testing, deployment, and maintenance. Agile, on the other hand, is iterative and adaptive, focusing on collaboration, customer feedback, and small, rapid releases.

Why is Agile often the better choice for medical device software development? Simply put, Agile’s flexibility is suited to the dynamic nature of software development, where requirements can change and rapid prototyping is valuable. For a comprehensive comparison, don’t miss our article detailing the differences between these methodologies and why Agile might be your best bet for software, while Waterfall is often better suited for hardware aspects.

Critical Step #2: Choosing the Right Partners

The complexity of SaMD developmentis in many ways like climbing a mountain. Having experienced partners can be like having an expert guide; they know the paths to take and the pitfalls to avoid. Look for partners who have not only the technical expertise but also a proven track record in the medical device field. Their experience can accelerate the development process, navigate regulatory requirements, and bring invaluable insights that only come from having been through the journey multiple times.

Experienced partners serve as the seasoned guides in the journey of SaMD development, equipped with the knowledge, skills, and tools necessary to navigate the complex terrain.

Here’s how they make a difference:

Technical Expertise

The development of medical software requires a deep understanding of both software engineering and the specific demands of medical applications, such as interoperability with other devices, data security, and user privacy. Experienced partners bring a wealth of technical know-how, ensuring the development of robust, reliable software that meets the exacting standards of the medical industry.

Regulatory Navigation

The regulatory landscape for SaMD is both complex and constantly evolving. Partners with experience in this domain can steer the development process in compliance with regulations from bodies like the FDA in the United States, EMA in Europe, and other international organizations. They understand the documentation, testing, and validation processes required to achieve compliance, significantly smoothing the path to market.

Proven Track Record

A history of successful SaMD projects is a testament to a partner’s ability to deliver. It indicates not just technical proficiency, but the ability to complete projects on time, within budget, and to the satisfaction of regulatory authorities and end-users. This track record is often accompanied by a portfolio of case studies and testimonials that can give you insight into their capabilities and working style.

Invaluable Insights

Experience brings with it not just an understanding of how to do things right, but also what pitfalls to avoid. Experienced partners can provide insights into user needs, potential technical challenges, and market trends that can inform the development process, ensuring the final product is not only compliant and functional but also competitive and user-friendly.

Critical Step #3: Leveraging Off-the-Shelf Tools

There’s no need to reinvent the wheel in situations when it’s not required. Many tools and components already exist that can significantly accelerate the development process. The key is to choose the right tools for the right tasks. Whether it’s software frameworks, libraries, or platforms, using off-the-shelf solutions can free up your team to focus on innovation and customization where it truly matters, rather than getting bogged down in creating basic functionalities from scratch. As a result, you’ll be able to focus  on what differentiates you among others and ensure success.

The key to effectively leveraging these tools lies in selecting the right ones for your specific needs. Consider the following criteria:

  • Compatibility: Ensure the tool integrates seamlessly with your existing development environment and other tools you’re using.
  • Regulatory Compliance: Particularly relevant in medical software development, the tool should facilitate compliance with relevant regulations and standards.
  • Support and Community: Opt for tools with strong support and an active community. This can be invaluable for troubleshooting and enhancing the capabilities of the tool.
  • Performance: Assess the tool’s performance and scalability to ensure it meets the demands of your application, both now and as it evolves.
  • Security: Given the sensitive nature of medical data, prioritize tools with robust security features.

Strategic Integration

Integrating these tools requires a strategic approach. Begin with a thorough evaluation of your project’s needs and identify areas where off-the-shelf solutions could have the greatest impact. Plan for integration from the early stages of your project to ensure a smooth development process.


Medical device software development is undoubtedly challenging, like climbing Mount Kilimanjaro. It’s a field where precision, reliability, and adherence to regulatory standards are just the base camp. As daunting as it may seem, the journey is also immensely rewarding. Reaching the summit—delivering a product that enhances healthcare delivery and improves patient outcomes—is an achievement worth striving for. And just like in mountain climbing, having the right partners to guide you through the SaMD development process can make all the difference in reaching the peak successfully.

Let HTD be your guide during the SaMD development journey. We have an experienced team that can help you be successful and reach to the top.  Feel free to contact us at and we will be thrilled to help!

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