June 5, 2024

Heart Failure Patients’ Preferences for Treatment Risks and Benefits

This Executive Summary by the Science of Patient Input (SPI) Heart Failure Working Group of the Medical Device Innovation Consortium (MDIC) underscores the importance of patient preferences in clinical trial designs for health technology. The FDA’s CDRH weighed in on the study conducted by the Preference Evaluation Research Group at the Duke Clinical Research Institute (DCRI), which employed a discrete-choice experiment (DCE) to gauge patients’ risk-benefit trade-offs. We invite you to explore the full study with this summary as your guide.

The SPI HF Working Group of MDIC also engaged QLS Advisors, statistical modeling and clinical trial design experts, to investigate how the results of the patient preference study could potentially be incorporated into HF clinical trial design. The findings from the Bayesian decision analysis (BDA) study showed that the HF patients surveyed would be willing to accept a Type-I error (alpha) rate of 3.2% for the primary e­ffectiveness endpoint– 28% greater than the one-sided significance level of 2.5% used in a standard study design. This innovative approach highlights the importance of early regulatory engagement and may pave the way for more patient-centered clinical trial designs, ultimately speeding up the availability of life-saving treatments.

July 10, 2024

Click the download button below to access the full Top 10 Guide

Top Strategies for Achieving Market Access and Reimbursement for New Medical Technologies

MDIC’s Health Economics and Patient Value Program has released its Top 10 Strategies for achieving market access and reimbursement for successful commercialization and widespread adoption of new products, services, or offerings. In the rapidly evolving landscape of medical technology, companies often face challenges navigating complex reimbursement environments and securing payer acceptance while demonstrating the clinical and economic value of their innovations.

Without a strong reimbursement strategy, even the most innovative technologies can struggle to reach their intended market and patients. By taking into consideration the top 10 strategies in this quick reference guide and integrating them into commercialization planning, companies can better position themselves to overcome these challenges, ensuring their products achieve sustainable market penetration and reimbursement success. This proactive approach addresses needs of diverse stakeholders, from payers to healthcare providers, ultimately providing broad patient access to new technologies.

Looking for more reimbursement resources? MDIC recently partnered with leading industry experts to review key components of developing a successful reimbursement strategy in a three-part series of informational videos. These videos highlight how to achieve commercial product success by securing favorable payer coverage, coding, and payment for new technologies.


February 22, 2024

Chronic pain has a substantial economic impact on the United States, costing an

estimated $635 billion annually. While VR has been studied and used in various

acute and chronic pain conditions for decades, headset technology has only

recently become simple to use and broadly accessible, and it continues to improve.

AppliedVR, a California-based company pioneering immersive virtual reality for

medical therapeutic use, has achieved a remarkable feat, working with the Centers

for Medicare & Medicaid Services (CMS) to include RelieVRx® in the existing benefit

category for durable medical equipment (DME), the first immersive VR therapeutic

to follow this strategy to tap into existing payment authority.


Home-based VR therapies like RelieVRx® hold the potential to broaden access

to effective and on-demand nonpharmacologic treatments for chronic lower

back pain that are durable well beyond the end of treatment. Understanding

reimbursement as a combination of coding, coverage, and payment provides the

context for the hurdles all new technologies must clear. Regulatory strategy may

be underappreciated in terms of its influence on reimbursement success, and this

was certainly key to the decisions related to code assignment and granting the

benefit category as DME for RelieVRx®.


Understanding the intricacies of reimbursement codes and benefit categories is

crucial for innovators seeking to navigate the evolving landscape of virtual reality

in healthcare. It is essential to keep an eye on emerging trends and codes to make

informed decisions and leverage opportunities for reimbursement in this rapidly

evolving field. Founders of VR healthcare companies should vigilantly monitor the

evolving reimbursement landscape and how changes may influence their business

model. By capitalizing on these established reimbursement options and staying

attuned to emerging trends, healthcare providers can harness the full potential

of VR technology in delivering innovative and effective treatments.

May 22, 2024

Explore Key Insights from the second quarterly meeting of the MDIC Commercial Payer Council, held on April 2, 2024 .MDIC’s Health Economics and Patient Value (HEPV) program served as a neutral convener, bringing together executives representing an integrated healthcare delivery network and payer, a device company, a health plan, a health technology assessment organization, and a law firm, as well as consultants involved in health policy, market access, and reimbursement.

The experts shared their perspectives and insights on two timely topics:

1. Utilization management (UM), prior authorization (PA), and health equity in Medicare Advantage 2. The impact of new obesity drugs on the medical device industry: Payers’ Views on the Current Rise and Future of Obesity Drug Coverage

The following key insights are intended to help individuals working in device and digital health technology companies develop a strategy and pathway for working with commercial payers.

May 6, 2024

Explore Key Insights from the inaugural quarterly meeting of the MDIC Commercial Payer Council, held on January 30, 2024. Facilitated by MDIC’s Health Economics and Patient Value (HEPV) program, this gathering served as a neutral platform for executives from diverse sectors—including an integrated healthcare delivery network, payer, device companies, health plan, health technology assessment organization, law firms, and consulting firms.

During this session, industry experts delved into two crucial topics: Navigating Medicare Advantage and Reimbursement for digital health technologies. Their insights and perspectives are condensed into this Key Insights summary, tailored to aid professionals within device and digital health technology companies. Whether you’re seeking to understand market dynamics, policy implications, or pathways for collaboration with commercial payers, this resource provides valuable guidance for strategic decision-making.

Download Key Insights from the MDIC Commercial Payer Council’s inaugural quarterly meeting.

August 28, 2023

There is a growing need for real-world-evidence (RWE) and patient perspectives when bringing new pharmaceuticals and medical technologies to market. An emerging metric in the RWE arena is patient preference information, which can provide  supplemental data that empowers device manufacturers to demonstrate value and meet expectations of regulators, payers, hospitals, and patients. As defined in the introduction to the case study, “Patient preference information captures the value that patients place on aspects of a treatment option, while also accounting for their perspectives on trade-offs they are willing to make for the benefits and risks that come with the treatment.”

June 27, 2023

The importance of integrating real-world evidence (RWE) into the evidence gathering process for determining the placement of new medical technologies on the market cannot be underestimated. RWE derived from real-world data (RWD) can offer more reliable evidence than traditional evidence generation models, leading to improved patient outcomes, greater access, and faster delivery.

MedTech companies often will generate evidence for one specific purpose at a time, such as waiting for regulatory approval before initiating an outcomes-based study.  While this has served the industry well to satisfy regulatory requirements, it has had the unintended consequence of delaying evidence planning for reimbursement.

Instead, adopting an early and integrated approach across all departments can help optimize evidence generation.  A successful comprehensive strategy will provide decision makers with evidence that is delivered earlier, through more efficient and representative studies, and is better tailored to the payer, provider, and patient.

To facilitate this process, the Medical Device Innovation Consortium has created a comprehensive guide for MedTech companies. It assists in embedding RWE throughout their organization and establishing an enterprise-wide RWE strategy. This strategy drives innovation, expands payer coverage, and increases patient access.


This resource guide includes the following topics and more:

  • The role of RWE in technology innovation
  • The value of real-world evidence in medical innovation
  • Assessing long-term outcomes and expanded indications
  • Increasing the development and use of RWE for medical devices
  • Best practices for developing and assessing the quality of RWD and RWE
  • Incorporating RWE in future strategies



May 4, 2023