What you'll learn

  • Identify key success factors in the medical device industry and recognize the importance of addressing user, clinical, and market needs.

  •  Explain the regulatory requirements and risk-based classifications of medical devices.

  •  Examine how medical device companies align product development with stakeholder values—patients, physicians (clinicians), providers (health care facilities), payers, and policymakers.

  •  Outline the typical steps in the medical device development process.

  •  Describe post-market activities and explain their importance in ongoing evaluation, risk detection, and improvement of medical devices.

Course description

In Medical Device Development and Commercialization, led by Ilsa Webeck, MBA, you will gain an insider’s perspective on the essential phases medical device companies navigate to address unmet needs—from initial ideation to product development, regulatory approval, and market launch.

Along the way, explore device classifications, approval pathways, and key factors that drive innovation, ensure patient safety, and support lasting market success in the dynamic medical device industry. 

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