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
June 3, 2022

Case for Quality Forum

Leadership Engagement & Voluntary Improvement Program (VIP)

MDIC‘s June Case for Quality Forum, hosted virtually June 14-15, focused on Leadership Engagement and the highly innovative and quality focused Voluntary Involvement Program (VIP).

Two Days, Four High Quality Sessions, Countless Opportunities to Collaborate and Learn

Learn more about the Voluntary Improvement Program Learn More About the Case for Quality Collaborative Community

Participants engaged with industry leaders, gained key insights and advanced their knowledge in a collaborative, solution-focused environment.

Want to learn more about the Case for Quality Initiative? Visit the CfQ to see a project overview, history of the program and key deliverables produced.

Day 1

Day 1 | June 14

MDIC, in collaboration with the Center for Devices and Radiological Health (CDRH) launched a pilot version of the pilot version of the Voluntary Improvement Program (VIP) in 2018. In May of 2021, MDIC’s Case for Quality In collaborative community (CFQcc) announced the transition of the VIP from a pilot to a full program.

VIP is a highly innovative and quality focused program that empowers stakeholders across the medical device ecosystem to both improve quality and patient outcomes.

On behalf of the Case for Quality Collaborative Community and in recognition of the one-year anniversary of its transition from pilot to full program, the programming of this forum will highlight the success stories of participants since their enrollment, benefits of the appraisal program and more. Join us for Day 1 of the Case for Quality Forum to hear these exciting updates and their implications for the industry.


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FDA Program Update

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VIP Participant Success Stories

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ISACA Presentation

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VIP Working Groups Update

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Day 2

Day 2 | June 15

Join MDIC for the Case for Quality Leadership Engagement Forum to gain the latest insights into how the medical device manufacturers are producing higher quality products, how leadership involvement affects the quality of outputs and an interactive analysis of the recent CfQ community Leadership Engagement Benchmarking Survey.

The Leadership Engagement program was developed to understand the impact of leadership engagement on company performance and the quality and safety of its products. While the focus of the program is to advance the medical device industry, the principles apply to all industries. This forum will discuss the results of the Leadership Engagement Survey.

Welcome and Introductions

Joe Sapiente, Francisco Vicenty, Ravi Nabar

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FDA Introduction

  • FDA Quality Metrics perspective
  • Leadership engagement in metrics towards driving continuing improvement
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Leadership Presentation

  • CfQ Metrics Survey (Pat Shafer, FTI Consulting)
    • Overview
    • Background
    • Scope & Purpose
    • Methodology
  • CfQ Metrics Survey Results (Jacqueline Torfin, Leadership Consulting & George Zack)
    • Raw results
    • Analysis
    • Take aways (Interpretation)
  • Conclusions
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Industry Guest Speakers (Metrics Experiences Highlight)

  • Lisa Walker, DISH
  • John Kelly III, IBM-Watson
  • Jim Brunke, Boeing
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Case for Quality Collaborative Community Leadership Presentation

  • Gap Analysis of leadership engagement/ metrics in the device industry when benchmarked to other industries
  • Future opportunities / Recommendations
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  • Panel (60 mins, Virtual, – Leadership and guest speakers, Moderator: Jacqueline Torfin)
    • Francisco Vicenty, FDA-CDRH
    • Lisa Walker, DISH
    • Jim Brunke, Boeing
  • Discussion/ questions centered around survey results
  • Significance/ importance of metrics in today’s environment
  • Leadership engagement in metrics towards driving continuing improvement
  • Audience Q&A
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Have Questions? Contact Us!

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:

April 5, 2023

The Early Feasibility Studies Electrophysiology Best Practices Workshop Key Insights Report from MDIC’s EFS Program is now available. Gain Insights from MDIC’s, February Workshop which focused on bringing together stakeholders from FDA, CMS, Industry, and clinical sites to discuss how best to implement EFS trials.

March 31, 2023