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Remote Patient Care: The Future Of Remote Monitoring And Diagnostics

The field of in vitro diagnostics is going through a period of rapid growth and innovation. Rising healthcare costs have led to a greater emphasis on evidence-based medicine and a focus on improved patient outcomes. An aging population along with the growing epidemic of chronic diseases and some infectious diseases are creating a demand for diagnostic devices for a variety of conditions. Development of these devices is challenging. Regulation of IVDs in the U.S. largely falls to the FDA, though other federal and state agencies play a role, and there are multiple development pathways to consider. And then commercialization strategies must evolve as IVDs become increasingly prescriptive. Harry Glorikian’s new book, Commercializing Novel IVDs: A Comprehensive Manual for Success, provides an overview of the major components to IVD development, from product conception through commercialization. –The Editor

Link to Article: http://www.clinicalinformaticsnews.com/2017/2/7/remote-patient-care-the-future-of-remote-monitoring-and-diagnostics.aspx

About the Book :

Harry Glorikian’s new book, Commercializing Novel IVDs: A Comprehensive Manual for Success,

Harry Glorikian, MBA

Classroom and bulk orders contact Dan Miller
 
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?