Empowering Medical Device Start-Ups and Corporates through Lightweight Systems Engineering

In the dynamic realm of medical device innovation, both start-ups and corporates encounter unique challenges in aligning their product visions with stringent regulatory standards. In this presentation, Helbling introduces a pragmatic approach to guide medical device developers through regulatory complexities by harnessing Lightweight Systems Engineering principles.

At the core of our approach is the strategic deployment of an 'Exploratory Phase' for eliciting requirements, complemented by iterative prototyping. Emphasizing agility and adaptability, we advocate for a streamlined documentation approach, tailored to regulatory demands without sacrificing quality or compliance.
Additionally, our approach encompasses documenting crucial exploratory activities, such as in-vivo and ex-vivo animal studies, pivotal for demonstrating safety and efficacy.

As the Exploratory Phase consolidates system knowledge, transitioning to 'Design Control' phases becomes more efficient, mitigating risks through Systems Engineering practices. This facilitates cross-functional collaboration and rigorous verification, enabling iterative design refinement while meeting regulations.

From concept refinement to prototype iteration, and from verification testing to clinical studies, our cohesive Systems Engineering framework empowers clients to navigate each development stage with clarity and confidence. Attendees will gain actionable insights into leveraging Systems Engineering principles to bridge the gap between product conception and regulatory compliance, ultimately expediting their journey towards market success.