Agile medical device development – What you should know

Agile methods are a staple in software development, even in regulated sectors like medical technology. But applying them to product development is tricky. It’s a multidisciplinary effort where everyone needs to understand and collaborate efficiently. Agile projects in this realm are often more complex due to the integration of physical components that are also under development, unlike pure software projects. Below, we delve into three major challenges and tips to navigate them. These are not just limited to the medtech field but are common across various industries.

When different disciplines first come together, initial excitement can turn into skepticism. Electronics developers and engineers may view software developers’ methods as chaotic, while software developers might see the hardware teams as sluggish. Overcoming this skepticism requires open, honest communication and a willingness to understand each other’s perspectives. It’s crucial for each discipline to explain their processes clearly, for instance, understanding why a PCB or engineering prototype needs thorough planning or why software iterations happen faster due to shorter integration cycles.

Good communication hinges on regular coordination and a shared language and is indispensable for creating high performance teams. Misunderstandings often arise from different interpretations of technical terms. For instance, a software developer sees a prototype as disposable, while for an engineer, it’s nearly production-ready. Implementing a system glossary can ease this issue. Teams should habitually specify terms like ‘software prototype’ or ‘device prototype’ to avoid confusion, fostering seamless communication across disciplines.

When organizing an agile project, integrate technical components early and ensure no one waits on others’ deliverables. For example, use an evaluation board for initial development, transitioning to a developed motherboard later, or use a temporary motor controller until the final version is ready. The key is balancing strict adherence to the integration plan with the flexibility to address challenges swiftly. This is where an integration vision and a system integration plan become invaluable.

The integration vision outlines steps for integrating functional models and prototypes, providing a shared project direction. It’s not a detailed sequence but a guide for progression. The system integration plan, on the other hand, specifies technical steps needed to achieve this vision, focusing on major risks and key functions. It should allow room for adjustments as new insights arise.

Adopting agile methods can be daunting, but gradual, consistent changes are more effective than a drastic overhaul. This aligns with the agile mindset, enabling you to progressively realize benefits regardless of the agile methodology chosen, such as SAFe, LeSS or Nexus, to support agile development and the accompanying cultural change.

Following the integration vision and plan leads to an incremental build-up of the final product, adhering to agile methodologies. Each integration step must be tested for regression through automated testing. This ensures quick validation and maintains system functionality amidst updates. Automation isn’t just for development; it’s a valuable tool for end-of-line testing, maintenance and post-launch improvements.

Beyond automated tests, gather external feedback to ensure product-market fit. Agile’s strength is in early, frequent user feedback, allowing course correction when needed. Utilize your network, from colleagues to pilot customers, to test integration models. Be creative – simulate missing parts with paper or manual operations to gather insights early.

In summary, agile methods can significantly reduce product development risks and costs by emphasizing early testing and feedback, ultimately speeding up time-to-market.