Mission

To provide leadership and a multi-stakeholder, collaborative platform for the Medical Device and Diagnostic community to address opportunities, issues and challenges impacting the policy, economic evaluation, and payment landscape for the device and diagnostic space.

Goal

  • Develop and disseminate best practices in outcome research of medical technologies
  • Promote scientific discussions on relevant topics for devices and diagnostics
  • Prioritize, develop and promote research and education related to medical devices and diagnostics. 
  • Provide an international network of stakeholders to advance the validation, adoption and utilization of medical devices and diagnostics.

Background

Medical devices and diagnostics account for roughly a quarter of hospital technology expenditures and are a rapidly growing technology field.  There is a broad group of stakeholders affected by the medical device and diagnostics marketplace that is relevant to ISPOR, including scientists, economists, manufacturers, policy makers, clinicians, HTA organizations, payers, procurement, media, advocacy organizations and patients.  Efforts to define market value of medical devices and diagnostics are confounded by several factors especially a scarcity of verifiable evidence in the early and mid-stages of product commercialization.  Difficulty in performing timely and reliable assessments compounded with fragmented and diverse payment pathways, can limit market access and reimbursement. It is critical to advance this dialogue with multiple stakeholders to ensure appropriate provider and patient access, while ensuring healthcare system value for money.


Leadership:



Chair-Elect

Bjoern Schwander, RN, BSc, MA

General Manager & Founder, AHEAD GmbH
Bietigheim-Bissingen, BW, Germany

Chair

Adam Gaertner

Sr. Manager - Global Access, Value & Economics - Endoluminal, Intuitive Surgical
Sunnyvale, CA, United States

Past Chair

Arthi Chandran, MS, BS, DrPH, MPH

Divisional Vice President, Health Economics & Reimbursement, ABBOTT
Santa Clara, CA, United States

Operational Lead

Jake Benowitz

Sr. Manager, Global Market Access and Value Strategy, W. L. Gore & Associates
Fort Lauderdale, FL, United States

Working Groups:



Member Engagement


These activities allow for a variety of members to participate and also facilitates disseminating content in Webinars, Journal Clubs, Conference Sessions, etc. Medical Devices and Diagnostics Community

Co-Chairs:

Arturo Cabra, MSc, BEc

HEOR Global Lead, GE HealthCare
Miami, FL, United States

Ulises Garay, MSc, BEc

Access Evidence Lead, Roche Diagnostics
Luzern, LU, Switzerland

Liesl Gildea

Associate Director, RTI Health Solutions
Manchester, LAN, United Kingdom

Belinda Mohr, PhD

Associate Director, HEOR, Philips
Phoenix, AZ, United States

Key Projects

Stakeholder Perspectives on Assessing the Value of Medical Devices

Co-Chairs:

Michael Cangelosi, MPH, MA

Associate Director, Health Economics, Boston Scientific
Natick, MA, United States

Akriti Chahar, PhD

Consultant Health Economics Outcome Research, IQVIA
Delhi, DL, India

Simon Eggington, MSc, BSc

Health Policy Consultant, Medtronic International
Tolochenaz, VD, Switzerland

Background and Objectives for Key Project - Stakeholder Perspectives

Assessing the value of medical devices is a key element in making adoption and coverage decisions for medical devices. Several value assessment frameworks (VAFs) have been published with the goal of providing measures which to evaluate medical interventions (Anderson 2014, Schnipper 2016) with some acknowledging the challenges in applying value frameworks to medical devices (ICER 2017). Medical devices have unique characteristics, such as frequent device iterations and user learning curves, which make it difficult to generalize outcomes, and therefore value, to the broader patient population (Drummond 2009). In some cases, such as with high-risk implantables, the value of the device can change over time as users gain experience and outcomes improve, which creates a challenge for value frameworks that aim to assess device value at a point in time. Additionally, a large number of device types exist, each potentially requiring different criteria to assess value, and stakeholders may view the value of any medical technology differently based on their specific needs. The aim of this project is to identify what specific criteria procurement-related stakeholders use to assess the value of medical devices when making purchasing decisions. This will help inform evidence generation strategies for medical device companies and researchers with the goal of generating evidence either through controlled trials and/or taking advantage of real-world data that is more relevant to the stakeholder making the decision. This work aims to fill the knowledge gap by identifying what information is needed for value-based procurement purposes and provide considerations for sponsors and HTA agencies regarding how that information is disseminated.

Questions or ideas? Please send an email.

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