Medical Device Development Primer

Medical Device Development Primer broadly explores the five pivotal stages of medical device development. This class focuses on the workflow at each step, from evaluating market opportunities and rigorously assessing concepts to crafting engineering designs and scaling manufacturing. This primer unlocks the secrets of FDA guidances pertaining to process design, qualification, and monitoring. It ends with a look at product risk assessment and reimbursement, summarizing their role in management’s momentous “go”/”no go” decisions. Enroll today to embark on this exciting quest toward groundbreaking medical device development!

Section 1: Market Opportunity Evaluation

Explains how to evaluate the value and opportunity of the product, the user, and the market.

Section 2: Concept Evaluation

Determines the feasibility of the medical device’s conceptual design and how that blueprint is used to map out the key steps in product design.

Section 3: Engineering Design

Discusses how required medical device prototype specifications are designed, documented, and tested. 

Section 4: Verification and Validation

Advocates for a process of verification and validation in engineering builds, packaging, labeling, human factors testing, and manufacturing.

Section 5: Manufacturing Transfer

Shows the arduous process of how to move from small scale to large scale production.

Five Takeaways


  1. List the five phases of medical device development in order.
  2. Explain the techniques to effectively evaluate the market opportunity for a novel medical device.
  3. Determine the manufacturing feasibility by analyzing a medical device’s design.
  4. Recommend required prototype specifications needed in medical device design, documentation, and testing.
  5. Explain the FDA validation guidance for process design, qualification, and monitoring.

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