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. Who is Shreya Sridhar? Shreya Sridhar is a Principal Systems Engineer and technical leader specializing in complex Software as a Medical Device (SaMD) and AI-enabled medical technologies. Her work focuses on systems architecture, requirements, risk management, verification, and cross-functional product development. She has published and presented on systems engineering, vertical slicing, and the development of complex regulated software, with a particular focus on connecting product strategy to end-to-end engineering execution.   Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well. Links Shreya LinkedIn: https://www.linkedin.com/in/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: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.