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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! 

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.

Five Takeaways

 

  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.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

FAQ

  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.

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