Traditionally, the development of medical products was done using a “waterfall” development process where each phase of a project builds on the previous phase to deliver exactly what was defined in the requirements upfront. Agile methodology offers a more flexible approach that maintains the needed medical rigor maximizes learning and allows requirements to evolve to a more optimum solution.
As identified in AAMI TIR45:2012, the Agile approach to Medical Product development is intended to improve development in 5 basic areas:
- Quality
- Productivity
- Predictability
- Product Effectiveness
- Safety
Quality is measured during development rather than waiting until the project is complete. The Agile methodology builds the concept of “done” into the process by requiring testing as you go. This, in turn, improves productivity as the engineers who work on the project understand before approaching a task what it means to be “done.” The engineers, on a regular basis, and regardless of the stage of development, demonstrate an operational product to the “owner”.
These frequent demonstrations improve product effectiveness as the “owner” is able to see, touch, and feel the product during the entire process. This also helps to predict when and where the project is in relation to schedule and cost.
Questions concerning product safety, clinician-backed confidence, and consumer opinion are a few of many inquiries that can direct the course of a medical product’s development. Setting strict feature sets without the ability to adjust; strict schedules without the ability to adjust; and rigid budgets without the ability to adjust can be detrimental to the end goal. As a result, Agile product development has become an increasingly popular approach to developing medical products.
The Agile methodology enhances an engineer’s fundamental thought process by:
- Decomposing large problems into manageable tasks called stories
- Defining “Done” for each story
- Providing better visibility for team members, management, and the client about the progress of projects
- Consistently building products using the same process throughout the company and with all disciplines
Agile product development is customer focused. The process encourages stakeholder and developer collaboration, and bases success on the safety and efficacy efficiency of the final product. A few ways to approach this type of project management style in the development of medical devices are:
Safety and Risk
With the needs of the end user clearly identified, the solution must be designed to solve the problem at hand without undue risk and safety exposure. Risk management activities are part of the development process, and integrating risk management into product development is critical to ensure safety and efficacy. Risk mitigations are converted into requirements, and ultimately into Agile stories and managed like any other feature. These safety requirements are decomposed into manageable tasks and put into stories.
System and Software Architecture
System and Software development is highly iterative by nature, more so when using the agile development process. Developing robust system and software architectures during the planning phases provides a proper foundation for the subsequent design phases.
Team Synergy
Collaboration among team members is essential to ensuring that product development stays on track. Knowledge barriers can be avoided when team members are aware of the bigger picture and understand where the project is and where the project is going. Agile development encourages collaboration to break down roadblocks and spur productivity. Using Agile development across the organization helps engineers and managers to coordinate activities across disciplines including electrical and mechanical engineering.
Feedback Loop
As mentioned above, demonstrations of prototypes to stakeholders in the early phases can yield valuable feedback to improve and refine the final product before costly V&V activities commence. Required usability studies for medical products by the FDA and ISO are other more formal opportunities to gather feedback. The Agile process requires the product to be operational after each step in the process, ensuring working prototypes for testing.
The Sunrise Solution
Developing medical products is fun. Our goal at Sunrise is to keep it that way and make it a more predictable process that meets the customer’s needs. An Agile methodology is a powerful tool that can be utilized in the medical product development process to allow flexibility and aid in creating improved products.
Sunrise Labs has the expertise to take innovative ideas from concept to reality. The commercial medical device industry is complex and in constant flux, therefore clients leverage our expertise to overcome design challenges while satisfying regulatory requirements. At Sunrise, our passion is improving patient outcomes by helping our clients succeed in the development of beneficial medical devices.
FAQ’s
1. What is the traditional approach to medical device development?
The traditional approach is a “waterfall” method, where each development phase follows the one before it in a linear fashion. Requirements are defined upfront and the final product must meet those exact requirements.
2. What is the Agile methodology?
Agile is a more flexible approach that emphasizes iterative development, testing, and feedback. It allows requirements to evolve as the project progresses and learning is incorporated into the design.
3. How does Agile improve medical device development?
- Quality: Testing happens throughout the development process, not just at the end.
- Productivity: Engineers understand what “done” means for each task.
- Predictability: Frequent demonstrations help predict progress and identify potential issues early.
- Product Effectiveness: Stakeholders can provide feedback throughout the process, leading to a more effective product.
- Safety: Risk management activities are integrated into the development process.
4. How does Agile methodology impact the way engineers think?
- Large problems are broken down into smaller, more manageable tasks (stories).
- Each story has a clear definition of “done”.
- Team members, managers, and clients have better visibility into project progress.
- A consistent process is used throughout the company for all projects.
5. How does Agile promote customer focus?
- Stakeholders and developers collaborate throughout the process.
- Success is based on the safety, efficacy, and efficiency of the final product.
6. How are safety and risk management addressed in Agile development?
- Risk management activities are part of the development process.
- Risk mitigations are converted into requirements and managed like other features.
7. How does Agile development impact system and software architecture?
- A robust architecture is developed during the planning phase to provide a foundation for design.
- The iterative nature of Agile allows for adjustments to the architecture as needed.
8. Why is team synergy important in Agile development?
- Collaboration helps ensure the project stays on track and avoids knowledge barriers.
- Agile encourages teamwork to break down roadblocks and improve productivity.
9. How is feedback incorporated into the Agile process?
- Working prototypes are demonstrated to stakeholders early and often to gather feedback.
- Usability studies are conducted to formally gather feedback.
10. What are the benefits of using Sunrise Labs for Agile medical device development?
- Sunrise Labs has expertise in Agile development and medical device regulations.
- We can help you develop a plan that meets your specific needs.
- Our goal is to make the medical device development process more predictable and successful.
