Run 1: An Introduction to Product Development & Quality Systems for Health & MedTech Innovations

This workshop offers a practical and strategic overview of developing health and medtech innovations. Participants will gain insights into the key milestones required to advance a concept into a user-ready medical device, understand how to systematically de-risk innovation through early-stage risk assessment frameworks, and learn how to lay the groundwork for quality management systems suited for early-stage projects. By the end of the session, innovators will be equipped with actionable tools and knowledge to navigate development pathways, address risks proactively, and integrate quality practices from the outset.

By the end of this module, you should be able to

• Analyse and articulate key design requirement specifications
• Assess technology to design and develop functional proof-of-concept prototypes, and determine what tests are required to de-risk the project.
• Respond and manage potential product development risks, develop a mitigation plan and manage risks.
• Collaborates with different internal stakeholders (e.g., engineers and scientists) to define product requirements, develop prototype and validate results.
• Understands the required regulatory and quality requirements, i.e., guidance documents, standards for different kinds of innovation projects; Able to design and carry out necessary tests and documentation.
• Apply basic quality management standards to ensure adherence to ISO standards in the early product development stages