Agile medical device development (AMDD) is a product development approach that is characterized by iterative and incremental progress. Its main advantage is that it allows for project scope or requirement changes midway through development. This can help developers work new requirements into their projects without having to start from scratch.
In all industries, adopting a non-linear project timeline speeds up results. This is simply because unexpected changes can be quickly worked into the project scope without backtracking.
Fast, adaptable deployment is increasingly important for medical device manufacturers. The aging population has recently caused a surge in medical device demand, which means manufacturers need to find ways to get more devices to market faster without compromising quality.
If the agile approach is new to you, this article is here to help.
Understanding Agile Design Methodology
The concept of agile design began in software development, but has since spread across industries. In contrast to the traditional linear project management workflow, agile processes focus on a circular approach that involves testing, feedback, and redesigns before product launch. Most agile projects go through multiple iterations before they are complete.
Source: Kanbanize
How to Apply The Agile Design Process to Medical Device Development
With that in mind, here is a step-by-step outline on how you can apply the agile development process to medical device manufacturing. Please bear in mind that this is a general guideline that you may have to adjust as it suits your project.
1. Plan Your Project
No matter how you approach development, the first step is always to clearly articulate the goals and objectives of your project. This would include regulatory requirements, user benefits, and safety considerations. From there, outline the minimum viable product for your device and assemble your project team.
| What’s a Minimum Viable Product (MVP)? In the context of medical devices, a minimum viable product (MVP) is the initial version of the device that only includes the necessary core features. It’s used to demonstrate its basic functionality and value proposition. This allows for early testing, feedback, and validation before the official version is released. |
Once your goals and team are established, plan out your project timeline. Divide it into smaller iterations for each phase of product design. Each iteration should have a clear goal and set of features to be developed. Prioritize your iterations based on which features are most needed and compliance requirements.
2. Build Your Prototype
Create a prototype of your device based on your MVP. Each set of features for the prototype should go through the same testing, feedback, and redesign phases that the full prototype will (see the following steps). This will reduce the number of critical errors in the final prototype and give you more time to focus on optimizing it for the market during that phase.
Remember, the goal isn’t to create a perfect product in your first round. Focus on your MVP first, and then perfect it for the public.
3. Test & Collect Feedback
For each iteration of your project timeline, rigorously test the prototype or feature set to assess its functionality, usability, effectiveness, and safety. Throughout your tests, collect feedback from knowledgeable, relevant personnel such as medical professionals, potential users, and regulatory advisors.
Analyze your findings and their feedback to assess possible flaws or enhancements in your current design. Cross-reference as much information as you can to ensure a better product after refinement.
4. Redesign as Needed
Redesign your prototype or features based on the feedback and data collected during testing. This could involve making minor adjustments to improve user experience, a significant redesign due to safety concerns, or anything in-between.
5. Repeat Until Satisfied
Agile development is a circular process. As such, repeat the preceding steps as many times as necessary to create a market-ready device. All these steps may seem time-consuming upon first glance, but it is a much more time-efficient process compared to needing to restart a linear project if a flaw is found post-launch.
Regulatory Considerations
After all that, you are still required to go through the regulatory approval process. Keep that in mind when you plan your project and consider how that may affect your project launch date. This process varies depending on your region and the classification of the device. Get to know yours in detail so you can inform your design process and expedite approval.
| Learn More About Medical Device Design Best Practices |
Medical device companies have the added challenge of adapting their agile methodology to strict IEC 62304 and FDA regulated design control standards. The challenge is that the rapid iterations of the agile method can initially seem at odds with these highly controlled standards.
Get to know your requirements early so you can seamlessly incorporate them into your agile practices. The careful, detailed planning and execution required can fit within the rapid iterations of the agile approach. You may also have to adjust the practices used in other industries to fit medical device development.
For example, many industries base their work on simple descriptions of what users want. However, regulations require more detailed descriptions that go beyond user demands. You will have to work these details into your approach.
Make an Already Efficient Medical Design Development Practice Even More Efficient
The agile method is increasing efficiency across industries. While this article provides a good point to get you started with it, there’s more that you can do to perfect your process.
Advantage Platforms™ by RBC Medical Innovations are proprietary, FDA-cleared platforms that help you streamline your agile development process. Advantage Platforms™ are designed with quality and regulatory compliance in mind. So, you can implement changes quickly and progress through development iterations faster without worrying about sacrificing compliance.
Alongside Advantage Platforms™, we offer comprehensive services in medical device design and development, proof of concept prototyping, and contract manufacturing. Whether you’re just starting out or looking to scale up production, we have the expertise and resources to support you.
Contact us today to get started.
“The Sterling Approach” to medical device design focuses on our customers’ experience – a critical component is our Agile project management. Agile development in a medical device company is a powerful asset that saves time and money, while creating an exceptional product.
What is Agile in Medical Device Design?
Agile project management focuses on being able to adapt to change and fosters customer-driven change. Its core technique builds a project in incremental pieces, encouraging stakeholder review and feedback throughout. This allows for more feedback overall, a better understanding of if the project is poised for success, improved customer experience, and insurance the product meets a customer’s expectations. Agile development in a medical device company is time and cost saving and is highly respected in the industry – the U.S. Food and Drug Administration supports it, and the American Society of Mechanical Engineers has a standard around the Agile development process.
Benefits of Agile Development in a Medical Device Company
Agile in medical device development offers many advantages, including that the technique:
Provides a quick feedback loop for incremental improvements
Reviewing and getting feedback along the way allows changes to be made as early as possible in the process and manage risks down the line. It allows us to be very responsive to our customers’ requests and make sure we are fulfilling our customers’ desires.
Helps refine your requirements and features
There are a lot of unknowns in medical device development, many of which are not uncovered until the development life cycle. The incremental nature of Agile development in a medical device company helps incorporate requirements at each step – defining and understanding requirements before the design phase, analyzing associated risks, testing and verifying the product using a quality assurance process, and deploying it for end-user or acceptance testing. And then the next increment begins.
Throughout the process, you may learn that some requirements or features are no longer needed. In fact, prioritization is a huge part of Agile development in a medical device company. The technique can help you understand which features have a high business value, and which are difficult or easy to implement. It also allows the customer to inform the priority order of features that are implemented. It is not always comfortable for our customers to do so, but we find that understanding your goals and the potential value of each feature, and then making difficult but strategic decisions on your priorities, is essential. That ensures the most important things are done first, increasing the return on investment for the product.
Supports effective time management and saving time
Agile project management utilizes “time boxing,” meaning it targets a specific time – usually two to four weeks – aligning it with a development iteration so that you can compare that effort to future efforts. These time periods, referred to as “sprints,” help you understand how much a team can accomplish during that window and allows you to size your features relatively. This indicates how many features a team can accomplish over the length of an entire project, and how many sprints you would need to complete the number of features that you have waiting on the sidelines, ultimately saving you time by helping properly plan for your entire project. It also incorporates more testing efforts and risk analysis, improving the quality of the product overall.
Ensures return on investment and saving money
Agile development in a medical device company provides customers with a high return on investment on the time they spend on their project. This is especially true for small startup companies that have a small margin of error. At Sterling, we often have customers with ambitious ideas for their product and a laundry list of things that they want to do. But many of those features will never be utilized by the client. By using a more traditional approach, the product would be developed according to the customer’s desires, potentially wasting a lot of time and money on features that are obsolete. Agile development gives the customer the opportunity to change their mind, adapt, and change the direction of their product as they learn more through the process.
Creates a positive customer experience
Agile development in a medical device company keeps open the lines of communication and everyone informed on progress. When using more traditional project management styles, a customer may not see their product until the final stages, increasing the risk it does not meet their expectations.
The techniques used in Agile development in a medical device company are rooted in practices derived from the software industry, where development occurs in a less structured way. However, structure is critical in the medical device industry, where strict standards, design controls, and documentation are needed, especially in a rigorous approval process like classifying your medical device. “The Sterling Approach” seeks to provide the best customer experience possible, blending structured, traditional medical device development with innovative, adaptive practices included in Agile development in a medical device company. If our team of experts can bring this balanced method to your project to help save you time and money, please contact us today.
