MedTech Product Development: Regulatory Pathways

This module introduces students to the fundamentals of medical device product development. It covers the complete development lifecycle, emphasizing the structured approach necessary for successful medical technology creation. Students will learn about the multi-phase development approach that characterizes medical device innovation, understanding the distinct stages a product must progress through from concept to market. The module focuses on the early stages of development, including discovery, engineering, and verification processes, providing students with a comprehensive understanding of how medical device ideas are transformed into tangible prototypes ready for testing and evaluation.

Skills you'll gain

This module explores the critical intersection of medical devices and their human users. Students will learn how to develop human-centered design specifications that ensure devices are intuitive, efficient, and suitable for their intended users. The module covers usability research methodologies that help identify user needs, preferences, and limitations. Students will gain understanding of risk mitigation strategies focused on minimizing user error, a crucial consideration in medical device design where mistakes can have serious consequences. The module also introduces verification and validation testing concepts specifically related to human factors, teaching students how to systematically evaluate whether devices meet user requirements and perform effectively in real-world scenarios.

Skills you'll gain

This module builds on the foundation established in Product Development 101, continuing the exploration of the multi-phase development approach for medical devices. Students will learn about the later stages of product development, including pilot studies where devices are tested in limited real-world settings to evaluate performance and identify potential improvements before full-scale deployment. The module also covers post-market surveillance, teaching students how manufacturers monitor device performance and safety after market release. This ongoing monitoring is essential for identifying unexpected issues, complying with regulatory requirements, and continuously improving product quality. Students will gain comprehensive understanding of the complete product lifecycle from initial concept through market release and beyond.

Skills you'll gain

This module introduces students to the regulatory framework governing medical device development and commercialization. Students will learn about the "Laws" of the MedTech world, understanding the legal and regulatory landscape that shapes every aspect of the industry. The module covers key regulatory concerns and requirements that medical device developers must address throughout the product lifecycle, from initial design considerations to post-market obligations. Students will gain detailed knowledge of FDA submission requirements, understanding the different pathways to market approval, the documentation needed, and strategies for successful regulatory submissions. This regulatory knowledge is essential for navigating the complex approval process and bringing compliant medical devices to market efficiently.

Skills you'll gain

This module focuses on the quality aspects of medical device development and manufacturing. Students will learn how to navigate FDA quality requirements, understanding the standards and expectations for ensuring device safety and effectiveness. The module covers FDA systems navigation, teaching students how to work within the regulatory frameworks that govern quality management in the medical device industry. Students will also learn strategies for avoiding costly pitfalls in quality assurance, identifying common mistakes and understanding best practices for maintaining compliance while operating efficiently. This knowledge helps students develop robust quality management systems that satisfy regulatory requirements while supporting business objectives.

Skills you'll gain

This module examines the critical role of clinical trials in medical device development and regulatory approval. Students will learn about the various types of clinical trials used for medical devices, understanding the different study designs and methodologies appropriate for different device classifications and intended uses. The module covers how to plan and manage clinical trials effectively, teaching students about protocol development, patient recruitment, data collection, and regulatory compliance throughout the trial process. Students will also learn how to partner with clinical research organizations (CROs), understanding when and how to leverage external expertise for trial execution. This knowledge is essential for generating the clinical evidence needed to validate device safety and effectiveness for regulatory submissions and market acceptance.

Skills you'll gain