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Software as a Medical Device – Part II: Development & Regulation

Software as a medical device has its own development needs and regulatory guidelines. Find out what qualifies as SaMD, the best practices for developing it, and how to do so in line with regulatory guidelines.

Before you jump into SaMD development and regulation, find out if your product qualifies as software as a medical device (SaMD) by reading Part I of this article: What is SaMD?

SaMD Development

Software, whether SaMD or SiMD, requires a different approach to development than hardware. If you’re creating SaMD, you have the advantage of not having to develop software and hardware at the same time. But, because this software is likely meant to interact with hardware in one form or another, it still requires special development practices in order to find success.

Agile vs Waterfall

Most hardware medical devices are created using a waterfall approach to development. In this process, one step must be achieved before the next can be started. This approach works well to build physical devices but is not optimized for software development. 

Software is best developed using Agile methodology. This circular process allows for constant testing, reviewing, and refining of software. With each pass, bugs are removed to avoid the compounding of issues as new layers are added. An iterative methodology, Agile lends itself incredibly well to the development of both standalone software products and those that must work directly with hardware. 

Agile benefits both the developer and the customer. For the developer, this iterative approach allows for better control, reduces risks, increases flexibility, and allows for continuous improvement to produce a final product in less time, for less money, and with less risk. For the customer, Agile provides a superior quality product that is highly adaptive both during development and once the final product has been created. This is key in the medical technology market since regulations are constantly shifting and technology is frequently advancing.

Component Architecture

Componentized architecture is a framework for building software that allows for a flexible, highly adaptable product. This process relies on independent, modular components that communicate to form a whole but can be replaced, repurposed, and rebuilt without affecting the other components. 

For SaMD that is meant to work with different medical device products, both hardware and software, this approach allows for broader uses. You can easily build your software with certain products in mind and add or change which devices it is compatible with as the market changes. And do it all without having to rebuild your software from square one.

Component architecture keeps your product fluid throughout the development process and even after the market launch. Bugs, changes to regulations, and updates to associated software and devices can all be easily accommodated with little time and monetary investment. Given how quickly the medical technology landscape is changing these days, component architecture is truly the only way to approach building SaMD.

Software Development Kits

Very few SaMD products work in a vacuum. Most are meant to connect to other medical devices in one form or another. As the biometric landscape continues to evolve, we will only discover more ways to track health through physical and behavioral sensors and data-tracking applications. Each of these products will require software to interpret the data gathered. The best products will be able to integrate multiple devices to provide the most useful data to the end user.

To assure your product is ready for this degree of interoperability, partner enablement, and scalability, you need to create a highly useful software development kit (SDK). Your SDK is what allows other companies to integrate your product into their platform or device. Likewise, if you want to add additional functionality to your SaMD using new devices or software, you’ll be reliant on the SDKs provided by these other companies.

Developing SaMD In Line with Regulation

Beyond the technical aspects of how to develop, build, and prepare your software for the market, you must also consider how you will accomplish these steps while staying in line with government regulations.

Launching your product on the global market requires meeting the regulations of multiple governing bodies. Luckily, medical technology quality guidelines have undergone much global harmonization in the past decade. This allows software development companies to create products following international standards that closely align with the guidelines of most regulating bodies. The most important, in terms of software development, are ISO 13485, ISO 14971, and IEC 63204.

ISO 13485

ISO 13485 is a standalone quality management system (QMS) standard. It is based on the ISO 9001 process and features the same flow model. But this process is designed specifically for the medical device industry. By creating a prescriptive process for the development of safe and effective SaMD, ISO 13485 ensures regulatory compliance while helping you create the best software product possible.

In the medical technology industry, a QMS is vital for meeting regulatory guidelines as well as the needs of the end user. This standard exists to help med tech companies effectively deploy their own QMS specific to the framework of their company while allowing them to still meet external requirements and ensuring a safe end product.

ISO 14971

ISO 14971 is a nine-part standard focused on a framework for risk analysis, evaluation, control, and review. It includes procedures for reviewing and monitoring risk during production as well as after market launch. Like other ISO guidelines, forms of this standard have been harmonized with the EMDD, FDA, and other major regulatory bodies.

This standard helps software development companies reduce risk in many ways. It starts by identifying hazards associated with the medical device software. By assessing those hazards, it can help companies estimate and evaluate the risks associated with each. From there, the standard provides guidance for controlling those risks and monitoring the effectiveness of the applied controls.

IEC 63204

IEC 63204 is a safety standard that functions as a software lifecycle framework. It provides processes, activities, and tasks for the safe development and maintenance of software specific to medical devices. It can be used for SaMD as well as SiMD and software used in the creation of medical technology.

This standard sets different classifications to determine the safety risk to the end user based on the product’s function. These classifications are as follows:

  • Class A – No injury or damage to health is possible due to software failure
  • Class B – Injury is possible with software failure, but would not be serious
  • Class C – Software failure could result in serious injury or death

Based on the classification, the standard guides the manufacturer through different components to maximize safety based on risk analysis. As a lifecycle process, it provides guidance from planning all the way through post-market surveillance. 

Like other standards listed here, IEC 62304 is meant to be implemented from day one in the planning process.

Successful SaMD Development Depends on the Right Partner

Whether you’re a hardware medical device company creating SiMD, or a software company creating SaMD, you need the knowledge and experience of the other. After all, creating software for the medical technology field requires a deep understanding of both software development and medical device regulation.

To further complicate the process, many of the standards that govern medical device software development are written for waterfall-style developmental approaches. To create the highest quality, most adaptable software, you need to find a way to apply these guidelines to Agile methodology.

At Sequenex, we have decades of experience in all facets of the medical technology field with an emphasis on developing SaMD for the diabetes market. We can help your company determine the status of your software, in terms of SaMD and SiMD, and help you develop it using the best practices for creating highly adaptable, scalable, and interoperable technology. We are very familiar with all applicable standards and global regulations and have developed succinct practices for applying them to Agile workflows to develop the safest, most effective software in less time for less money.

If you’re interested in a partner with the know-how to turn your diabetes technology into successful SaMD for the medical technology market, contact us today.

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