Commercializing Novel IVDs: A Comprehensive Manual for Success
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 book 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
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
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Link to Publication: http://www.insightpharmareports.com/Commercializing-Novel-IVDs-Report/