March 31, 2023
January 27, 2023

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

October 18, 2022

May 11, 2022

The Medical Device Innovation Consortium (MDIC) has had the privilege
of partnering with the FDA Center for Devices and Radiological Health (CDRH)
to advance the Case for Quality, a transformational initiative to shift the medical device industry from a focus on regulatory compliance to a focus on quality maturity.

This kind of cultural shift doesn’t happen overnight. MDIC, FDA and our industry partners have worked together to develop tools and methods to encourage and appropriately incentivize quality practices.

Beyond the tools, MDIC has sought to cultivate trust between medical device manufacturers and the FDA. That trust is fundamental to developing a culture based on a mutual commitment to quality maturity practices, rather than “check the box” compliance activities.

In December 2017, CDRH launched the Voluntary Medical Device Manufacturing and Product Quality Program Pilot, utilizing a maturity model refined
in collaboration with the Capability Maturity Model Integration (CMMI) Institute, MDIC, and regulatory and industry partners. The maturity model is leveraged as a resource for medical device organizations to measure their capability to produce high quality, safe and effective devices.

This measurement can then be used by organizations to drive targeted continuous improvement activities throughout their facilities. For manufacturers who complete the independent (third party) appraisal of quality maturity, the FDA will adjust their engagement activities and modify their submission requirements and routine inspection plans.

Industry participation is critical to long-term implementation of the maturity model as an alternative to the traditional path of a routine FDA inspection. Participation in the pilot requires an investment, both of personnel and money.

However, companies will receive many valuable benefits. Participating companies can expect to improve organizational processes and reduce variability that could lead to reduced costs of quality, decreased rework, and increased return on investment.

The FDA will also benefit from this program by potentially reducing the internal resources required for evaluation of inspections and manufacturing review submissions. The combined focus on safety and quality can be a win-win for both FDA and manufactures as we advance the health and safety of patients.

 

May 10, 2022

MDIC’s External Evidence Methods (EEM) program aims to assist stakeholders with use of EEM, such as new, innovative, and existing methods for evidence fusion from data external to a clinical study. The purpose of incorporating external data is often to create efficiency in medical product development and regulatory decision-making, thereby bringing new, safe, and effective technologies to market sooner to help patients in need. External data may also provide insights into the clinical performance of the diagnostic device being studied. External data can potentially be used in regulatory decision-making throughout the total product life cycle (TPLC).

MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical device manufacturers, the document catalogs different sources of external data and some of the traditional and novel statistical methods (Frequentist and Bayesian) applicable to the design and analysis of a clinical study in which external data play a role. It also provides references to actual past studies leveraging external data in which some of these statistical methods were successfully applied to support the approval/clearance of medical devices, or the modification of their indications. In all these examples, the external data being leveraged are subject-level data. Most methods cataloged in this document rely on subject-level external data for their implementation.

This framework is in alignment with other MDIC’s initiatives, including the National Evaluation System for health Technology Coordinating Center’s (NESTcc’s) mission of accelerating the timely, reliable, and cost-effective development of RWE to enhance regulatory and clinical decision-making. The EEM Framework expands the repertoire of MDIC resources that focuses on reliable and cost-effective Real-World Evidence (RWE) throughout the medical device total product lifecycle NESTcc’s Research Methods Framework and Data Quality Framework as well as the Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs) Framework.

Purpose of the EEM Framework

This framework is intended to help stakeholders navigate their way through leveraging external data by:

1. Cataloging different sources of external data
2. Cataloging statistical methods that can be considered to leverage external data
3. Considering uses of external data, when appropriate, for regulatory decision-making for medical devices
4. Providing examples to illustrate the application of various statistical methods where external data have been leveraged

If you would like to learn more about the project as well as explore the opportunities for collaborating with MDIC, please contact us at jveetil@mdic.org

Click here to download the framework.