With nearly three decades of experience in MedTech, specializing in the engineering and industrialization of complex medical devices. He has led the development of 125+ products, including multiple FDA 510(k)-cleared devices, with several approved for over-the-counter use. His core expertise spans system architecture, embedded electronics, firmware, and electro-mechanical systems, with strong grounding in ISO 13485 and 21 CFR 820–compliant development. He focuses on turning complex ideas into validated, manufacturable products, driving programs from concept through regulatory approval to scalable, high-volume production.
Medical devices rarely fail because of weak ideas - they fail when strong concepts cannot survive the transition from design to manufacturing, validation, and commercialization. The challenge is not an invention; it is an integration.
Syrma Johari MedTech will show how this challenge can be solved by managing the entire product lifecycle as one connected system, rather than a series of disconnected handoffs across design, engineering, manufacturing, and regulatory functions - A lifecycle-driven approach linking design to industrialization.
This perspective is brought to life through a real-world collaboration with a pioneer in point-of-care diagnostics, where a complex device program was advanced from concept through engineering to production readiness. The journey reveals a critical truth: scalability is not achieved at the end - it is engineered from the beginning.
Session will also focus on 2 critical dimensions often underestimated. First, scalability - how design and engineering decisions were aligned early to support reliable, repeatable manufacturing at higher volumes. Second, Cost - addressing the practical challenge of achieving cost efficiency even before scale is realized. This will demonstrate how engineering and design choices drive cost efficiency without relying on scale.
Attendees will hear both the product owner perspective and the lifecycle partner execution perspective, gaining practical insights into what worked, what didn’t, and how integration across stages enabled seamless progression from idea to scalable product.