Vertical Slicing for Complex SaMD Development

Developing complex Software as a Medical Device (SaMD) can quickly become challenging. Requirements, software architecture, dependencies, risk management, verification, regulatory evidence, and cross-functional collaboration all need to work together. But what happens when individual software components appear to work correctly while the complete end-to-end workflow reveals something different? In this episode of the Easy Medical Device Podcast, Monir El Azzouzi welcomes Shreya Sridhar from Medtronic to explore vertical slicing for complex regulated software products. Rather than looking at a system only through individual components or technical layers, vertical slicing provides a way to examine functionality end-to-end. In this episode, we discuss: 🔹 What vertical slicing means in practice 🔹 The challenges of developing complex SaMD 🔹 How end-to-end workflows can reveal hidden problems 🔹 How to structure vertical slices 🔹 Integrating vertical slicing into Agile development 🔹 Risk management, verification, and regulatory evidence 🔹 Vertical slicing alongside Design Controls 🔹 Cross-functional collaboration in regulated development 🔹 What “Done” means for a vertical slice in a medical device environment 🔹 The potential role of vertical slicing as AI supports requirements, code, testing, and documentation 🔹 Practical advice for teams that want to start using the approach The conversation connects software development with the realities of regulated medical device development, looking beyond whether individual components work to understand whether the complete functionality works as intended. 🎧 Watch the full episode and discover how an end-to-end perspective could change the way your team approaches complex SaMD development. ----------------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video Shreya LinkedIn:   / shreyasridhar   Links to Articles on Vertical Slicing: 1. Designing SaMD for safety and rethinking risk management through system architecture 2. Decomposing Complexity: A Systems Engineering View of Modern Software — Aligning the V-Model with a Slicing-Based Decomposition Strategy 3. Your roadmap is not a feature list: A two-level slicing framework for better release planning 4. Vertical Slicing as a Foundation for SaMD Development in the Age of Agentic AI ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance