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.
