Rapid Prototyping for Medical Devices with Ross Dehmoobed
Jan 11, 2024
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Ross Dehmoobed discusses challenges in developing safety-critical medical devices, the use of simulators and rapid prototyping, the importance of fast and actionable feedback in agile development, and navigating regulatory bodies like the FDA.
Defining the scope and regulatory pathway are crucial in developing medical devices, requiring high-level scope and milestones early on for effective planning and goal alignment.
Using agile methodologies and fast prototyping techniques, early tangible results can be demonstrated in the first few weeks of a project, such as wireframes or CAD drawings, aiding in project progress and stakeholder communication.
Deep dives
Challenges in Developing Safety-Critical Medical Devices
Defining the scope and regulatory pathway are key challenges in developing safety-critical medical devices.
Importance of Early Definition and Planning
Having a high-level scope and defining milestones early on helps in planning and aligning the project goals.
The Agile Approach for Faster Prototyping
Using agile methodologies and fast prototyping techniques, the team is able to demonstrate early tangible results, such as wireframes or CAD drawings, even in the first few weeks of a project.
Incorporating Agile Principles with External Reviews
While involving external reviewers like the FDA typically happens at the end of a project during the submission phase, involving quality and regulatory experts within the development team helps in ensuring compliance and alignment with regulatory requirements.