Preparing for and Managing Contract Organizations in the Development of Medical Devices

Event description

Presenters: Diane Earp, MSHS, SBB(ASCP)

This is the second webinar in a 3-part series dedicated to effective partnerships with external research or manufacturing organizations. Approaching Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMO), or Contract Development and Manufacturing Organizations (CDMO) to perform necessary studies to aid your product's success can be daunting. Many investigators turn to the Catalyze technical team with questions like:

  • What does FDA expect from a Contract organization for medical device submissions?
  • How do I know what services to request from a CRO/CDMO?
  • What can I expect to pay for a CRO/CDMO's services?

Join us for a webinar presented by Diane Earp, an expert in regulatory affairs and quality assurance in the development of medical devices. Diane will answer common questions about how strategic partnering with a CRO/CDMO can benefit your product and what you can expect as you integrate these efforts into your overall product development life cycle. This presentation is meant to give academic and small business investigators a better understanding of the regulatory process and tools to set their medical device up for success.

Webinar presented on January 26, 2024 to an invited audience.

This video is provided for educational purposes only.

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Chapters

00:00
Introduction
01:09
Objectives and Disclaimers
02:58
Background
08:34
Device Design and Development Life Cycle
09:39
What are Contract Organizations?
14:13
How to Choose a Contract Organization
21:40
Top 10 Contract Manufacturing Mistakes
28:11
Benefits of Contract Manufacturing Organizations
31:14
Benefits of Contract Research Organizations
35:38
Types of Contract Manufacturing Agreements
37:59
General Costs for Medical Device Development
42:21
Examples of Medical Device Contract Manufacturing Organizations (CMOs)
44:54
Examples of Medical Device Contract Research Organizations (CROs)
46:37
Q&A
57:54
Upcoming Events & Reminders
This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.