Medical Device Development Primer
*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.
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Optional CPE Credits: 1.5
Overview:
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.
- 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.
By the end of the course, participants will be able to:
- List the five phases of medical device development in order.
- Explain the techniques to effectively evaluate the market opportunity for a novel medical device.
- Determine the manufacturing feasibility by analyzing a medical device’s design.
- Recommend required prototype specifications needed in medical device design, documentation, and testing.
- Explain the FDA validation guidance for process design, qualification, and monitoring.
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