Medical Device Development
Video Series

Welcome to the Medical Device Development Video Series

Whether it is to support a Premarket Approval (PMA), 510(k), or post-market strategies, your clinical trial is a crucial next step in the life of your medical device.  Understanding the multiple facets necessary to consider in the clinical development process will provide you with a holistic view of the road ahead, and allow for realistic short- and long-term planning for your device development and commercialization.

Watch our short video series on Medical Device Development and discover how to prepare for your medical device clinical trial, including regulatory pathways, reimbursement planning, and study design and operational considerations.

Medical Device Development – Part 1

When in the medical device development process should companies begin to think about their regulatory strategy?

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Medical Device Development – Part 2

At what development stage should a device company make initial contact with the FDA?

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Medical Device Development – Part 3

What advice would you offer a device company that is preparing to approach the FDA for the first time?

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Medical Device Development – Part 4

At what stage of development should device companies begin to think about their reimbursement strategy?

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Medical Device Development – Part 5

How do the expectations for data endpoints differ between the FDA and other stakeholders like insurance payers, hospitals and physicians?

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Medical Device Development – Part 6

What types of tools and resources are available to help device companies develop their reimbursement strategy?

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Medical Device Development – Part 7

How can device companies take a realistic and efficient approach to clinical trial design?

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Medical Device Development – Part 8

How does a device company’s regulatory and reimbursement strategy impact study design?

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Medical Device Development – Part 9

What should device companies consider when deciding which services to outsource versus which services to keep in-house?

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Medical Device Development – Part 10

What approach should device companies take when selecting sites for their clinical trial?

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