Resources

Bootcamp: In Vitro Diagnostic (IVD) Product Development

Bootcamp: In Vitro Diagnostic (IVD) Product Development

Making the Move from Academia and Entrepreneurship to Product Development

Sponsored by CARB-X, C-CAMP, and FIND

Purpose:
This bootcamp equips academics, entrepreneurs, and early-stage companies with an improved understanding of the skills, principles, and systems required for effective In Vitro Diagnostics (IVD) product development. The video series will help participants make the transition from academic and grant-based research to quality compliant product development, and learn the fundamentals for moving an IVD product from concept through development. 

Audience:
– Academic and entrepreneurial research and development leaders interested in transitioning to infectious disease diagnostic product development
– R&D managers and scientists in early-stage diagnostic companies

Overview
Welcome to the video series (6 min)

Part I: The Fundamentals 
Video 1 |
 Introduction to IVD Product Development (16 min)
Video 2 | Product Development Process (22 min)
Video 3 | Design Control (48 min)
Video 4 | Quality Management System (25 min)
Video 5 | Good Lab Practices (31 min)
Video 6 | Case-Study: Why the Fundamentals Matter (31 min)

Part II: Q&As with experts 
Video 7 | Q&A: Product Development Process (49 min)
Video 8 | Q&A: Design Controls (49 min)
Video 9 | Q&A: Quality Management System and Good Lab Practices (48 min)
Video 10 | Q&A: Case-Study: Why the Fundamentals Matter (50 min)
Video 11 | Q&A: Real-Life Stories: Academia to Commercialization (60 min)

Instructor:
Pete Dailey, Senior Technical Officer, FIND

Moderator:
Betsy Wonderly Trainor
, CARB-X