BIO Professional Development
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Medical Device Commercialization Primer
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. Register now
Takeaways
- Choose the appropriate clinical trial level based on the patient's risk assessment.
- Explain the approval process to initiate human clinical trials to test a new medical device.
- Summarize the challenges of launching a new medical device regarding marketing, sales, reimbursement, and manufacturing scale-up.
- Outline a reimbursement strategy for medical device coverage, coding, and payment.
- Write a post-launch assessment and surveillance protocol.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Explore medical device development stages: market evaluation, concept design, engineering, verification, validation, & manufacturing transfer. Understand FDA process guidelines & risk assessment for product advancement.
Discover medical device approval to commercialization process: regulatory submission, scale-up, reimbursement, launch, post-assessment. Gain game plan for successful launch.
Explore diagnostic accuracy measurements: false negatives, false positives, variability, sensitivity, specificity. Essential for regulatory approval."
Explore US medical device regulation: classification, approval pathways, FDA guidelines, quality regulations, risk management.
Explore PCR, microarrays, gene sequencing & microRNA in diagnostics. Learn machines, workflow & result interpretation.
Discover the expanding molecular diagnostics field, saving lives by pinpointing disease causes and guiding personalized treatments."