Software as Medical Device is a paradigm shift that is changing the way we think about medical technology; it is no longer just a fad. SaMD is becoming more and more important in patient care, from real-time health monitoring to clinical decision support. The choice of a suitable software development technique for medical devices is one of the difficulties that come with this advancement. The decision-making process for choosing the right software development approach is pivotal to the success of SaMD projects. With methodologies like Waterfall and Agile, each offering unique benefits and limitations, the key question arises: which methodology is most suitable for SaMD development?
What is product development for SaMD?
The development of Software as a Medical Device (SaMD) involves developing medical software using UX design and engineering. This process is marked by a high level of rigor and strict adherence to safety and quality standards. For those interested in the specifics, our previous article details the five critical phases of SaMD development. These phases are designed to guide your journey in developing medical device software, ensuring compliance with regulatory standards, and addressing patient needs effectively.
Software for medical devices using the waterfall methodology
In the medical device sector, the Waterfall methodology has long been the preferred way, especially when it comes to creating hardware. Each step in this method’s sequential operation must be finished before moving on to the next.
Particularly in the context of hardware development, waterfall provides a clear, structured framework that is particularly beneficial for intricate medical device hardware projects with precise, well-defined criteria and goals. Despite its structured nature and suitability for medical device engineering, the Waterfall methodology may not always align well with the dynamic and rapidly changing landscape of Software as a Medical Device (SaMD).
What is Waterfall?
The Waterfall methodology is characterized by a linear and sequential progression of stages, resembling a cascade in a waterfall where each step follows the next. The process begins at the inception of the project and moves through successive stages: initiation, analysis, design, development, testing, implementation, and finally maintenance.
The rigorous order of the waterfall model, which requires that each step be finished before the next one can start, is one of its main characteristics. This paradigm is less flexible because it typically requires a significant amount of work and money to revisit a prior level.
In the context of creating software as a medical device (SaMD), how is the Waterfall methodology used?
When creating medical devices, the waterfall technique is a systematic, sequential procedure. With this method, the project is divided into discrete stages, such as requirements collection, design, implementation, testing, and maintenance. Every stage must be finished before moving on to the next since each one depends on the completion of the one before it.
Software as a Medical Device (SaMD) development may suffer from the waterfall method’s lack of flexibility, even while it provides a well-defined and structured foundation for building hardware medical devices. This factor is especially crucial when comparing the benefits of waterfall and agile approaches in SaMD development—a subject that will be covered in more detail in the section on agile software development guidelines.
Examine a hypothetical project centered on creating software to track blood glucose levels to demonstrate how the waterfall approach is applied in SaMD. The approach would begin with a thorough requirements collection phase, which would be followed by software architecture design. Only after these first phases would coding begin, and testing would take place after development, providing little opportunity for changes or iterative development.
Agile development in SaMD
The early 2000s saw the emergence of the agile methodology as a response to the drawbacks of more conventional approaches, such as Waterfall. Agile divides the development process into more manageable, smaller steps and is based on flexibility, teamwork, and customer satisfaction.
Because medical software development is unexpected and complex, this iterative approach is ideal because it enables quick responses to input and adjustments.Comparing Agile and Waterfall in SaMD software
Planning, development, testing, and review are all included in each Agile iteration, enabling ongoing improvement and modification. Teams can quickly integrate input and adjust to changes thanks to this modular approach, which makes the development process more dynamic and flexible. This adaptability is especially helpful in the rapidly changing and frequently unpredictable field of medical software development.
Agile places a strong emphasis on open, continuous communication between stakeholders, project managers, and developers in cross-functional teams. The development process is tightly matched with user requirements and project objectives thanks to this collaborative environment. Agile’s iterative nature is extremely beneficial when it comes to Software as a Medical Device (SaMD). Rapid technology breakthroughs and changing regulatory requirements are characteristics of the medical software industry.
Agile is a very appropriate methodology for SaMD projects because of its capacity to swiftly adjust to these changes while upholding a high degree of quality and compliance.
Agile offers the structure for ongoing testing and development, which is essential for guaranteeing the security and effectiveness of medical software. Agile approaches assist in detecting and resolving possible problems early in the development process by routinely reviewing and improving every software component. This lowers risks and guarantees a higher-quality final output. Agile offers a contemporary substitute for more conventional, linear approaches like Waterfall because of its flexible, cooperative, and iterative nature, which makes it a perfect fit for the intricate and changing SaMD environment.
Agile’s compliance with FDA guidelines
The Agile methodology, with its cycle of iteration and continuous improvement, not only complies with but also complements the rules established by the FDA. In the creation of Software as a Medical Device (SaMD), which is governed by strict regulations, this alignment is very beneficial.
By dividing the development process into smaller, more manageable cycles, agile’s iterative methodology enables regular product reevaluation and improvement. This approach makes continuous assessment and modification easier, which is essential for fulfilling the strict requirements set by the FDA. Agile guarantees that the software complies with safety, quality, and efficacy standards—all of which are crucial in the healthcare sector—by repeatedly testing and improving the product at every stage. Regulatory compliance greatly benefits from Agile’s emphasis on teamwork and feedback integration.
Consistent stakeholder engagement, which includes end-user and regulatory expert feedback, guarantees that the development process is not only user-centric but also compliant with the most recent best practices and regulatory rules. This Agile feature is especially important in the dynamic field of medical technology, where rules and guidelines are subject to quick changes.
Agile speeds up the process of obtaining regulatory approval by spotting and fixing possible problems early in the development cycle, which lowers the possibility of serious complications later on. Agile’s documentation procedures can be modified to meet the FDA’s thorough documentation requirements, even though they are frequently seen as less formal than more conventional approaches like Waterfall. The dynamic and iterative character of the development process can be enhanced by adapting agile frameworks to generate the required documentation.
Because of its flexibility, agile is ideally suited for developing SaMD in a setting where medical procedures and technology are always changing.
It makes it possible to quickly integrate user input, medical insights, and new technologies, guaranteeing that the SaMD will continue to be applicable, efficient, and compliant throughout time. Agile methodology’s iterative nature, attention to quality and safety, collaborative approach, effective risk management, and adaptability make it a strong and compliant framework for developing SaMD that complies with FDA standards. It is the perfect option for SaMD development because of its capacity to satisfy the FDA’s stringent and changing standards.