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)
** Reading: Postmortems on diagnostic testing start-ups

Video 2 | Product Development Process (22 min)
** Reading: Developmental roadmap for antimicrobial susceptibility testing systems

Video 3 | Design Control (48 min)
** Reading: FDA design control guidance
** Reading: Medical devices — Quality management systems — Requirements for regulatory purposes
** Reading: FDA Quality System Regulation

Video 4 | Quality Management System (25 min)
** Reading: Medical devices — Quality management systems — Requirements for regulatory purposes
** Reading: FDA Quality System Regulation

Video 5 | Good Lab Practices (31 min)
** Reading: FDA Good Lab Practices
** Reading: General Requirements

Video 6 | Case-Study: Why the Fundamentals Matter (31 min)
** Reading: Analysis of the initial lot
** Reading: What went wrong?
** Reading: Medical devices — Quality management systems — Requirements for regulatory purposes
** Reading: FDA Quality System Regulation

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