Agile vs Waterfall: What’s Your Best Bet for SaMD Success?

If almost 90% of all software as a medical device (SaMD) projects use Agile as the method of project management, why would you even consider using the Waterfall method?

When you're developing Software as a Medical Device (SaMD), choosing the right project management methodology isn’t just a preference—it can make or break your company’s success. In this video, we break down both methodologies in simple, practical terms. Our conclusion is that both methods result in delays, but at different development stages and for different reasons. The best approach is a hybrid methodology.

🔍 What You’ll Learn:
The fundamental differences between Agile and Waterfall
Why Waterfall has traditionally dominated the medical device industry
Why Agile is the dominant method of project management for software
When each method of project management fails
A practical hybrid strategy that avoids the downfall of each method

💡 Why This Matters:
Project managers are taught Agile and Waterfall methods, but there is no clearly defined hybrid model. Safety and regulatory compliance is absolutely necessary for the success of medical device software. Embracing the genius of both methods is the key to finding the best method of project management.

🛠️ Perfect For:
Software developers, quality managers, regulatory affairs professionals, clinical teams, startups, and anyone responsible for SaMD development or compliance.

⏱️ Chapters:
0:00 Introduction
0:46 Myths
6:57 Characteristics of both methods
11:12 Why did regulators choose Waterfall?
12:06 Benefits of Agile
13:22 Benefits of Waterfall
16:00 More Benefits of Agile
16:54 Failures of Agile
21:14 Failures of Waterfall
23:22 Risk Controls
29:40 Resources
32:09 Vote in the comments: Agile, Waterfall, or Hybrid?

If you’re looking to speed up development and your FDA review, this video will give you a clear, practical roadmap. Don’t forget to like, comment, and share with your friends and colleagues.

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