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

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December 15, 2022

The 5G Security Enhancements one-page overview outlines several security enhancements in 5G compared to previous cellular communication technologies while highlighting security configurations and scalable security solutions / protections.

This one-page overview accompanies the Landscape Analysis of 5G in HealthcareLearn more about MDIC’s 5G-Enabled Health Technologies. Read the press release.

Contact  

Contact us at 5G@mdic.org or reach out the MDIC program staff: 

December 15, 2022

The Landscape Analysis of 5G in Healthcare surveys the role of 5G connectivity in current and future applications within the healthcare continuum of care. The report provides an overview of 5G technology along with several healthcare use cases, such as 5G-enabled simulation with extended reality, 5G-enabled robotics, mobile units, and remote care.  Key challenges and knowledge gaps identified must addressed to deliver the benefits of 5G in healthcare more safely to patients.

This report is accompanied by the 5G Security Enhancements one-page overviewLearn more about MDIC’s 5G-Enabled Health Technologies. Read the press release.

Contact  

Contact us at 5G@mdic.org or reach out the MDIC program staff: 

December 6, 2022

The white paper How Can Patient Preference Information be Used in Payer Coverage Decisions and Health Technology Assessment? aims to encourage the use of patient preference information by payers and health technology assessment organizations. In this resource, MDIC clarifies the standards and role of generating this data and presenting it in a more consistent, systematic format.

As patients become more engaged with their care, healthcare stakeholders want to understand how to better incorporate patients’ wants and needs into their processes. This is the first MDIC resource focused specifically on awareness of patient preference and methods as a tool for payers and the medical industry.

Read the press release.

November 4, 2022