Clear and comprehensive requirements documents have always been critical to developing safe and effective medical devices, and software as a medical service (SaMD) is no different. From 2022-2027, SaMD will grow by an estimated 11% CAGR to reach USD $8.2 billion. As this boom occurs, technology and healthcare join forces and must collaborate to ensure all medical innovations meet regulatory guidelines and mitigate risks to the users of their devices. Much of this is managed through the requirements process, which creates documents that serve as a blueprint, guiding the development process to ensure the software meets functional, non-functional, and regulatory standards.
In this blog, we will outline the best practices and common challenges for developing requirements documents for SaMD and offer guidelines for the key components of effective requirements documents.
The 3 types of requirements for SaMD
- Functional requirements specify what the software should do directly for the user. For example, "The system shall enable the patient to input their name".
- Non-functional requirements focus on other aspects such as performance, scalability, usability, security, and availability. For example, "The system must support up to 2,045 concurrent users".
- Regulatory requirements involve compliance with specific regulations or standards, such as healthcare and data privacy standards.
Key components of effective requirements management process
Companies must develop a structured process that spans the entire requirement lifecycle, from requirements gathering and analysis to review, risk analysis, approval, and change management. Below are some of the key elements to consider when creating this process:
- Stakeholder involvement: Engage stakeholders early and maintain regular communication to capture and refine their needs.
- Clear and concise definition: Ensure requirements are unambiguous, complete, and prioritized to prevent misunderstandings.
- Effective documentation: Use standardized templates and maintain version control to ensure consistency and clarity.
- Requirements traceability: Implement tools to track requirements from definition to testing and deployment.
Benefits of the requirements management process for SaMD
- Provides input for the development process and is a basis for the product backlog, which can, in turn, be used to build a product roadmap.
- Facilitates clear communication among stakeholders (developers, healthcare professionals, regulatory bodies)
- Enables teams to fully understand the required functionality later in the development process when they are creating the user story and a definition of done.
- Reduces ambiguities and confusion about requirements.
Common challenges when developing SaMD requirements documents
- Reaching consensus among key stakeholders around the critical requirements and goals in the early stages of SaMD. It is helpful to partner with analysts who understand how to take a high-level idea and extract business goals and requirements from it.
- Defining the SaMD's desired functionality so developers can map a path forward. All SaMDs are not required to consider the nuances of critical elements such as cybersecurity or data protection. As they progress, the number of requirements will likely increase in line with the device's complexity.
- Ambiguity and misunderstandings can arise in situations where poorly defined goals exist. By partnering with SaMD experts, medical device companies can ensure that they have a team equipped to assist them in understanding the complexity of the development cycle and that requirements documents are adequately designed to facilitate the process.
- Shifting requirements as the development cycle progresses. As products are tested and validated, requirements may shift. The need for new features may become apparent based on usability. All changes must be properly documented and agreed upon to mitigate any risk.
- Balancing detail with the usability of the document when creating requirements. It's necessary to cover sufficient detail to clarify what needs to be done. However, it's time-consuming and counter-productive to become too granular in this detail too early, as it can make it difficult to move forward. Often, solutions to requirements may not be obvious in the early stages. Developers will solve issues as they enter sprints rather than trying to solve all the problems simultaneously. Requirements documents should create a clear path forward without veering into restricting the agile software development process. That’s why teams often split requirements documents into high-level product requirements as an output of the pre-development phase and then more detailed functional and non-functional requirements specified during the development process.
- Changing regulations due to technological advances are of particular concern to those incorporating AI or machine learning into their SaMD. Teams need to be aware of any changes to requirements based on updates to standards by regulatory bodies.
- Adhering to the guidelines set out in IEC 62304. Companies unaware of these guidelines will run into unnecessary challenges, so teams must become familiar with and adhere to the processes outlined. The standard offers a method for structuring the development process so that, when carried out properly, the SaMD is considered safe and effective.
Best practices for developing effective SaMD requirements documents
- Starting the requirements documentation process early enough.
- Making sure there is clarity around the business-level goals from day one.
- Using clear language so that requirements are not left open to interpretation.
- Structuring documents in a clear, consistent, and comprehensive way.
- Updating and revising requirements documents throughout the development cycle.
- Investing in standardized templates and tools to ensure sufficient levels of transparency and traceability.
- Paying attention to regulations and changes to guidelines set out by the regulatory bodies.
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