Therapeutic and Diagnostic Device Outcomes Research


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  • Stacey J. Ackerman, MSE, PhD, Vice President, Covance Market Access Services Inc., San Diego, CA
  • Marilyn Dix Smith BSPharm, PhD, Executive Director, International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville, NJ, USA
  • Jenifer Ehreth MHA, PhD, Principal, International Market Access, Paris, France and Adjunct Professor, University of Lausanne, Health Economic Institute, Lausanne, Switzerland
  • Randa Eldessouki MBBCh, MSc, MD, Director, ISPOR Scientific Initiatives, ISPOR, Lawrenceville, NJ, USA; Lecturer, Faculty of Medicine, Fayoum University, Fayoum, Egypt
  • Erin Sullivan MPH, PhD, Vice President, Health Economics & Outcomes Research, Avalere Health LLC, Washington DC USA
  An outcomes research primer for those in the therapeutic and diagnostic device field with the purpose to inform:
  1. Health outcomes researchers on the unique characteristics of therapeutic and diagnostic devices, and
  2. Medical device developers and researchers on the basic principles of clinical, economic, and patient-reported outcomes research for therapeutic and diagnostic devices

Table of Contents

Part 1: Introduction
Part 2: Research and Development
Part 3: Regulatory Requirements in USA & Europe
Part 4: Clinical Outcomes Research
Part 5: Therapeutic Device Clinical Outcomes Research
Part 6: Diagnostic Device Clinical Outcomes Research
Part 7: Drug-Device Combination Research
Part 8: Economic Evaluations
Part 9: Patient-Reported Outcomes Research
Part 10: Evidence Development and Reimbursement
Book Prices  
  • Regular price: $80.00
  • ISPOR member discounted price: $40.00 (a 50% discount)
  • North American Spine Society members discounted price: $30.00 (a 62.5% discount)
  • Student/Library/Academic discounted price: $30.00 (a 62.5% discount)
  • Pay by credit card, check, money order, traveler's check, bank transfer
  • Receipt and invoice generation for reimbursement

“During my tenure in the medical device industry, the evolution of successfully entering the market has been eclipsed by patient access challenges encountered. Whether challenges come during regulatory body reviews or through barriers to patient access in the post-launch market, it is apparent the historical approach to reimbursement is no longer effective. The need for medical device manufacturers to demonstrate improvements in actual patient outcomes and clinical delivery in addition to improved safety and performance have become great game-changers. To succeed in this new market environment, accelerating the knowledge base of how to utilize economic modeling to ensure we are delivering clinically relevant and cost effective therapies is essential.

The comprehensive information in this books provides an invaluable resource that has not been readily available. I'm sure it will become a standard reference tool as the economics of healthcare continue to develop”

Diana L. Bogard
VP Evidence Development, Medical Education & HCE
COVIDIEN Respiratory & Monitoring Solutions

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