Medical Device Commercialization Primer

Medical Device Commercialization 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 Commercialization Primer navigates the intricacies of the approval pathways, the excitement of a launch, and the rigors of post-market surveillance. This class reveals best practices for business preparations, sales, marketing, and reimbursement—ensuring corporate-wide readiness and effective healthcare promotion. It wraps up by highlighting the sponsor’s responsibility for monitoring device performance to ensure ongoing patient safety and FDA compliance. Join us for the fast-paced Medical Device Commercialization Primer and equip yourself with the tools and knowledge to create a successful commercialization plan for your medical device.

• Section 1: Approval: Discusses the importance of selecting the right clinical trial level for a medical device based on its risk assessment, outlines the steps for obtaining approval for human clinical trials, emphasizing the significance of comparing the new device with a reference device for FDA approval, and provides an overview of the time cycle for submission approvals.
• Section 2: Commercialization: Explains the complexities of a product launch, covering marketing, sales, reimbursement, and manufacturing challenges. It underscores the manufacturing scaling process, outlines reimbursement strategy creation, details pre-launch preparations, instructs on post-launch assessment and surveillance protocol development, and touches on FDA-required medical device reports.

By the end of the course, participants will be able to:

1. Choose the appropriate clinical trial level based on the patient’s risk assessment. 
2. Explain the approval process to initiate human clinical trials to test a new medical device. 
3. Summarize the challenges of launching a new medical device regarding marketing, sales, reimbursement, and manufacturing scale-up. 
4. Outline a reimbursement strategy for medical device coverage, coding, and payment. 
5. Write a post-launch assessment and surveillance protocol.

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