Embarking on the journey of medical device development without a deep understanding of user needs is like setting sail without a compass—you might end up anywhere but your intended destination. That's why this hands-on course zeroes in on the critical process of pinpointing exactly what healthcare professionals, patients, and stakeholders truly require from medical technologies. Through engaging modules, you'll learn to conduct effective user interviews, design comprehensive surveys, and perform thorough market research. By diving into real case studies, we'll not only cover the theory but also the nitty-gritty of extracting meaningful insights from user feedback and translating them into actionable design inputs.

But wait, there's more to it than just asking the right questions! The course also emphasizes the importance of aligning user needs with regulatory requirements and business objectives, ensuring that your product development pathway is as smooth and efficient as possible. Upon completion, you'll be equipped with the tools and confidence to craft a user-centered design specification for your medical device—a crucial blueprint that can significantly reduce costly redesigns and accelerate the path to market. This isn't just about building a device; it's about shaping a solution that fits seamlessly into the hands of those who need it most.

With a seasoned background in Quality Management Systems and Regulatory Compliance, I have devoted my career to ensuring that medical products meet and surpass industry standards. My hands-on experience spans the creation and remediation of QMS for diverse medical product companies, shaping robust regulatory strategies, and steering successful interactions with international regulatory agencies such as the US FDA, ANVISA, and Health Canada. I bring this wealth of practical knowledge directly into the classroom, making the lessons concrete and applicable.

My enthusiasm as an educator is fueled by the profound connection between quality management and the delivery of life-changing medical devices. I've led quality and regulatory roles in product development teams, achieving successful submissions across multiple jurisdictions. Each audit conducted and submission overseen has strengthened my conviction that understanding user needs is foundational to innovation and success in the medical device industry. It's this passion and insider insight that I share with my students, to not only meet their educational needs but to inspire them to build products that resonate deeply with the end-users they are designed to help.