Authored Harry Glorikian, MBA & Presenter of Commercialization Boot Camp: Manual for Success in Molecular Diagnostics

The Commercialization Boot Camp Short Course provides an overview of the commercialization process, shares real-world case examples, and details some of the necessary requirements for bringing an IVD from product conception through market launch. It’s a lot of information in a short amount of time. With a topic as complex as IVD development and commercialization, it became obvious that there was a real need within the industry for a source that could serve as a reference guide, something to refer back to after the class. The Commercializing Novel IVDs: A Comprehensive Manual for Success was created to do exactly that. Indeed, from scientists to executives, this book is designed to provide guidance about the big ideas that need to be considered and the small details that should not be overlooked.

This unique manual will provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process including:
  • How do I approach the regulatory process?
  • How can I plan for market access, and what can I do to make sure my IVD will be reimbursed?
Specific chapters in the manual:
  • An Overview of the IVD Industry and Market
  • Product Concept Development and Validation
  • Diagnostic Development
  • Regulatory Considerations and Pathways
  • Market Access Planning
  • Commercialization Planning and Operations
  • Wrapping Up and Looking Ahead

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