Harry Glorikian, MBA
Does your company have an idea for a novel biomarker test, but you’re unsure what the market potential will be?
Have you invented a more sensitive test to diagnose a common autoimmune disorder, but you’re unsure of which regulatory pathway to pursue?
The process of developing a successful in vitro diagnostic (IVD) relies on the expertise of a diverse group of individuals, including the scientists who identify the biomarkers of significance, engineers and assay developers who translate those ideas into a tangible product, and the sales and marketing staff who get the product into the market.
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:
Top 10 Reasons to Buy:
- Comprehensive book that looks at the entire IVD development process, from market planning and design through reimbursement strategizing and market launch
- Written by an industry leader with more than 30 years in the global IVD field and innovation
- Goes beyond the ‘checklist’ mentality to offer an overview of key trends impacting the market
- Identifies common pitfalls IVD manufacturers face bringing a product to market
- Outlines key job functions/roles essential to make the development process successful
- Describes evolving regulatory pathways and the business implications of choosing each pathway to develop an IVD
- Explores how digital health will impact the IVD industry
- Describes the role data will play in value-based reimbursement for IVDs
- Essential for start-ups looking to capitalize on the Cancer Moonshot Project or Precision Medicine Initiative
- Excellent reference manual for IVD executives and those involved in some aspect of the IVD development process
This is not a checklist or how-to manual with step-by-step instructions to build an IVD. It is meant to provide an overview of the major components to IVD development, from product conception through commercialization, and important considerations about individual aspects of the process: 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? These ideas don’t exist in a silo, but people are so focused on individual steps in the process they are responsible for, that the overall picture is sometimes missed. This is understandable—no one person can be an expert on every aspect of the IVD development process. The scientists in the lab may have little to no understanding about the different regulatory options and requirements that influence an IVD, and the sales staff may not completely understand the engineering process; neither is expected to! But it’s essential to understand and identify the necessary job functions to move an IVD from product ideation through successful commercialization. This book attempts to do that by describing the overall process of IVD development, who needs to be involved, and highlighting challenges and points to consider along the way.
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A Letter From the Author:
For many years, I’ve taught a short course called the “Commercialization Boot Camp” to provide an overview of the commercialization process and sharing of real-world case examples. After the course, I’ve been asked again and again to go into detail on certain topics or give advice on different situations. Realizing the industry lacked a comprehensive source for this information, I took the initiative to create one. Based on the most recent 2017 Commercialization Bootcamp Course and experience, this book greatly expands on the fundamental topics everyone in or around the IVD industry needs to know - from product ideation and design to regulation to planning for market entry and reimbursement. For companies just starting out, this book is like having your very own IVD reference manual at your fingertips, providing you with a comprehensive overview to help make the process as smooth as possible. For those of you already in the field, it’s a guide that may help bring you up-to-date on the key trends impacting the industry, evolving regulatory issues, and changes that are impacting the way IVDs are marketed and sold. I have tried to present not just the big picture, but highlight the details that might be critical for success. In short - I’ve tried to capture something for everyone involved in the IVD industry. I hope you find the contents of this book as a valued resource.