Building medical devices has traditionally followed the process of most hardware development. That is, the device is created using a rigid plan outlined by Waterfall or similar step-based product development methodologies.
While this approach works well enough for simple hardware, it falls short when creating software as a medical device (SaMD) and medical device systems that incorporate software for connectivity and interoperability.
Here, the most useful methodology, both for the customer and the developers, is Agile. With an Agile workflow, the developing product undergoes constant testing and review, allowing bugs to be fixed early on and setting the stage for a more adaptable product with fewer risks and a shorter development timeline.
Today, we’ll look at what Agile development is and the many benefits of choosing an Agile approach over more traditional alternatives when building SaMD.
What Is Agile Software Development?
In the most basic terms, Agile is the implementation of development and project management practices set forth by the Agile Manifesto. In a more specific sense, it is an iterative methodology that incorporates a cyclic process of reviewing and testing increments of a whole that are developed concurrently.
This methodology relies heavily on the collaboration of small teams with set directives known as features. These features undergo reviews that allow for constant improvement and opportunities for adaptation based on changing needs. In medical device software, specifically, this constant review process provides frequent opportunities to assure each feature is in compliance with applicable regulations and standards, such as FDA guidelines and ISO 13485.
The end result is a finished product that has been cleared of bugs throughout development, has undergone real-time adjustments to meet changes in the market, and is already in compliance with applicable regulations. And, because Agile requires fewer developers and builds all aspects of the project simultaneously, it achieves this end result in less time with a lower cost.
The Benefits of Agile
Agile methodologies focus on completing projects within the given project constraints without sacrificing quality or value. The iterative and inclusive nature of this approach has many benefits both for the customer and the developers involved in bringing the customer’s vision to fruition.
BENEFITS TO THE DEVELOPER
The linear design of more traditional hardware development approaches often leaves developers waiting for their turn to begin work on their select feature. When the time comes, they must work without transparent input or resources from other departments who are busy fixing or adapting their own features. This lends itself to a piecemeal final product with bugs that were introduced early on and were left to compound throughout development.
Agile overcomes many of these drawbacks, providing a number of benefits to the developers working on the project.
Better Control
Agile works with a degree of transparency between departments that plan-based methodologies just do not have. This transparency gives those in charge a unique ability to retain control over every aspect of the project from beginning to end. Meanwhile, feedback integration and quality control measures give each feature team more control over the feature their producing and its place within the finished product.
Easier to Identify and Predict Risks
This transparency comes with increased visibility that allows for the quick identification of problems before they grow. Increased risk prediction and the ability to implement effective mitigation efforts before bugs and other problems interfere with production keep the project on schedule while conserving resources. While traditional approaches leave risks to be discovered only after the product is finished, Agile allows for constant refinement for a bug-free final product.
Reduced Risks
Being able to effectively predict risks is just one way that Agile reduces the overall risk inherent in any project. The cyclical nature of this iterative approach creates an environment of constant refinement, basically guaranteeing success. No matter how big or small the problems are, they will inevitably be purged from the process long before the final product is complete. This differs greatly from linear approaches with the potential to produce a product so flawed that it must be completely rebuilt.
More Relevant and Accurate Metrics
While Waterfall only allows for measuring production against estimated cost and timeline models, Agile provides real, useful metrics like cycle time and lead time. These help measure each individual team’s performance to quickly identify problems. Bottlenecks in processing and other relevant issues can be analyzed and resolved using real-time data and employee feedback.
Increased Flexibility
Because development teams within Agile projects work in small bursts, they have infinite opportunities to add changes. This combined with the constant feedback provided by the customer results in a product that can evolve during production without increasing costs or lengthening timelines. This increased flexibility is especially important in medical technology development given how quickly the Med Tech and SaMD landscapes change.
Continuous Improvement
The same factors that allow for constant flexibility also provide an avenue for continuous refinement. One of the core principles of the Agile manifesto is self-reflection and striving for improvement. The iterative nature of this method provides the opportunity for each sprint to be better than the previous attempt. Combined with an environment of open collaboration that encourages idea exchange and communication about problems and solutions, Agile assures the delivery of a better product.
Employee Involvement
Because of the open communication structure of Agile, each team member has more opportunities to learn. They are also given more autonomy due to the self-organizing nature of the smaller team units and the need for self-management. All of this breeds a healthier environment for improved team morale. This inherently leads to better productivity and a higher quality of work.
Greater Customer Retention
All of the above advantages help assure customer satisfaction. This is especially true for customers invested in the Agile method. Here, they will have the unique opportunity to remain involved in the development of the system throughout the process. This collaboration gives the customer ample opportunities to add feedback and adjust their expectations. Both of these assure they will be more satisfied with the final product, opening the doors for repeat business.
BENEFITS TO THE CUSTOMER
You would expect a system developed by software developers to benefit people in that position. But the advantages of Agile go beyond those creating the product.
The customer will also see a wealth of benefits from embracing the Agile approach to developing and building their medical technology and software.
Superior Quality Product
As we discussed above, the iterative process of Agile lends itself to constant improvement. This assures the customer receives not just the product they envisioned, but the best possible version of that product. With each iteration of every feature, bugs are purged from the system and the efficiency of the process is increased. While rigid development involves building upon previous steps that have met estimated milestones, Agile brings together tested and retested features built concurrently to assure maximum compatibility.
Constant Involvement
Agile also gives the customer the unique ability to remain involved with the project long after the specs have been turned in. In the medical tech market, this is especially important. It allows the customer to intervene should the project specifications need to change due to regulatory adjustments, moves by competitors, or advancements in technology. Through it all, the customer is included in the decision-making process.
Better Adaptability
When developing technology for a constantly shifting market, such as what is seen in SaMD, it is vital to create an adaptable product. Agile does this through iterative development and collaboration between teams. If the technology available advances, the product scope can shift without forcing development to restart.
Progress Visibility
The customer gets to see progress in real-time. Features can be demonstrated during each successive iteration allowing for a visible means of progress evaluation. If changes need to be made, they can be submitted during these review periods and reevaluated during the next iteration. As fewer changes are requested and the project moves toward completion, both the developers and the customer receive a real-time sense of accomplishment.
Reduced Production Times and Lower Costs
Because the review process is constant and repeated throughout Agile development, issues are caught and corrected in real-time. With each successive iteration, fewer issues arise, and less time and resources are used to correct them. This is different from Waterfall, where issues arise early and continue to compound throughout development only to be tested and revealed at the end. Removing bugs at this stage requires far more work, which means higher costs and longer development times overall. With Agile, go-to-market times and overall costs are significantly reduced compared to traditional development methodologies.
Creating SaMD Requires Agile Workflows
While traditional, rigid workflows lend themselves well to building simple hardware, utilizing these practices when developing software puts you at a disadvantage. Not only do these more linear methods require more time, resources, and money, but they produce inferior products. These products are less adaptable, riskier to build, and often leave both the customer and developers frustrated.
Agile development, on the other hand, creates a workflow that allows for more flexibility, continuous improvements, and an overall superior product. In the modern medical technology field, you cannot afford to invest in a product that isn’t adaptable to the constant changes in the market and frequently updates to regulations handed down by governing bodies.
When looking for software development partners to aid in the development of an efficient, functional, and successful SaMD system, it is vital to find a company that understands and implements Agile methodologies.