Patient First AI Assisted Risk Engineering for Medical Wearables

Abstract: The goal of risk management in medical device development has always been patient safety. But identifying every relevant risk, without gaps and without bias, is difficult, and the depth of that first step shapes everything that follows. This session picks up where a prior INCOSE Canada presentation left off (   • AI Agents for MBSE: Connecting processes t...  ). Neha and Jonas, from Matrix One, walk through how AI can help surface risks earlier and more completely, reducing the blind spots that come from human familiarity with a design. That said, AI is only the starting point. Clinical context, tradeoff decisions, and the judgment calls that determine whether a device is truly safe still require human expertise. The presentation takes an honest look at where AI adds real value in risk management, and where it can't replace the engineers who ultimately own patient safety. Speaker Biographies: Neha Sam bridges deep technical expertise with commercial impact, helping customers understand and adopt complex technology. She holds both a Bachelor's and Master's in Biomedical Engineering and she got her foundation as a Systems Engineer at MOLLI Surgical (now part of Stryker) and Boston Scientific, leading requirements, test, and risk for next-generation capital equipment. Now at Matrix One, she brings that product and systems background to the commercial side, helping medical device teams see how technology can work for them across the full product lifecycle. Jonas Müller is the Head of Enterprise Solutions at Matrix One, where he partners with enterprise customers across medical devices, pharma, and biotech as their strategic technical advisor. With a background in Medical Computer Science and certification as a First and Second Party Auditor for Medical Devices, he brings deep regulatory and technical expertise spanning risk analysis, complex solution design, and quality management to every customer engagement. Jonas began his career at Matrix as a Support Engineer before progressing to Senior Solution Consultant, building hands-on experience with the technical challenges life sciences organizations face daily. He is passionate about helping manufacturers bring safer, more effective products to patients through smarter, more efficient software solutions.