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.

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
May 10, 2023

May 1, 2023

This white paper is a continuation of a transformational CAPA Process Improvement story put in motion in 2018 by MDIC. It was initiated in response to the cry of engineers everywhere within the medical device industry whom, if asked what they like most about their jobs, would point to solving problems and driving product improvements. But what do they like least? Often, they will tell you that it’s the CAPA process. Today’s CAPA process has become highly focused on compliance, many manufacturers taking a “one-size-fits-all” approach. What’s worse, the fear of findings by regulatory bodies leads companies to spend an out-sized amount of time on paperwork, regardless of identified product and/or process risk levels, often slowing down the implementation of improvements.

It was in light of this reality that the MDIC Case for Quality Collaborative Community (CfQcc)1 launched its CAPA Process Improvement program, with the goal of enabling faster continuous improvement through the use of a more efficient and effective CAPA process. This opportunity to work together to improve the CAPA process and enable greater improvement quickly mobilized organizations from around the world to voluntarily join the global CAPA Process Improvement team, including MDIC members from more than 20 medical device organizations and representatives of consulting firms and the FDA.

The team’s true north throughout this multi-year project was to work to enable organizations to achieve faster process and product improvements. To do this, the proposed framework shifts the focus away from documenting just to achieve compliance and moves it toward the central purpose of CAPA: problem-solving. The team recognized that documentation should be commensurate with risk while adding value to the organization and that systems should be implemented to ensure a healthy problem-solving process is in place. The objective was to make today’s CAPA process more effective, efficient, and user friendly—while still meeting the intent of regulations.

April 27, 2023

Advanced Manufacturing in Action: A look at Gore’s Digital Transformation provides insights on the efforts to adopt advanced technologies. From millions in cost savings to increased satisfaction, Gore’s digital transformation serves as a compelling example for the value-added potential that can be achieved through the adoption of advanced manufacturing technology.

Some of the results obtained in their transformation include:

  • 85% reduction in Quality Control (QC) process time
  • $30M Savings over 5 Years
  • 45% reduction in Non-Conformance Reports (NCR)
  • Increase in Associate satisfaction

Learn more about AMCH: https://mdic.org/program/advancedmanufacturing/

April 5, 2023