June 1, 2022

The Master Clinical Trial Agreement (MCTA) working group and Informed Consent and Institutional Review Board (ICF) working group within the Early Feasibility Studies (EFS) program have completed updates to two key EFS resources.

Building on the 2017 EFS project success, in 2018 the EFS Contracts working group set out, for the first time, to (A) develop an EFS-specific Master Clinical Trial Agreement (MCTA), and (B) make that EFS MCTA publicly available on the MDIC website for both medical technology and care provider EFS participants. With engagement of diverse stakeholders including industry, care provider organizations, and regulators, the goal of releasing this MCTA is to facilitate efficiencies in the EFS contracting process by developing an EFS MCTA providing (1) a starting point for contract negotiations with a priori agreement of 90% or greater, and (2) allow both parties to focus remaining legal resources on the remaining 10% (or less) of the EFS MCTA requiring negotiation. The Early Feasibility Study Master Clinical Trial Agreement can be found here.

A template of a patient Informed Consent Form (ICF) for adult patients considering participation in a study being conducted under an IDE through the FDA’s EFS Program was developed as part of the 2016 Blueprint for Early Feasibility Study Success. Updated for 2022, the ICF throughly outlines how those conducting studies can explain the process of participating in a study, the benefits of contributing to research as participant of early feasibility studies, the risks associated with participation and the patients rights to potential participants. Click here to see the full template.

May 5, 2022

The Medical Device Innovation Consortium (MDIC), today announced the publication of the MDIC External Evidence Methods (EEM) Framework. This framework, developed by subject matter experts from industry, academia, and the U.S. Food and Drug Administration (FDA), is a document intended to help stakeholders navigate their way through the process of leveraging external data by harnessing the power of statistics. The 21st Century Cures Act, as well as the learnings from the COVID-19 public health emergency, underscored the need to expand the role of relevant external data in the total product lifecycle of medical devices.

 

To read the full release click here.

September 19, 2019

The U.S. Food and Drug Administration (FDA) today announced that the National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has achieved recognition as one of the first collaborative communities with participation by the FDA’s Center for Devices and Radiological Health (CDRH). 

CDRH identified participation in collaborative communities as a strategic priority for 2018 to 2020. The purpose of a collaborative community is to bring together medical device stakeholders in a continuing forum of private- and public-sector members, including the FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Ultimately, collaborative communities seek to contribute to the improvement of areas affecting U.S. patients and healthcare. 

The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging real-world evidence (RWE), and innovative research. In support of this mission, NESTcc works with stakeholders across the medical device ecosystem to catalyze the timely, reliable, and cost-effective development of RWE to enhance regulatory and clinical decision-making.

NESTcc aimed to become a collaborative community as part of its 2019 strategic and operating plan, and amended its charter to align with the FDA’s Collaborative Communities Toolkit. Members of the NESTcc Governing Committee represent their own perspectives, as well as those of their larger stakeholder communities, with the intention of ensuring diverse and distributed leadership of NESTcc among patients, payers, the medical device industry, health care professionals and regulatory bodies.

In addition to the National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community, FDA announced that CDRH will also participate as a member of the Ophthalmic Imaging Collaborative Community.

For more information, see the FDA announcement.

August 21, 2019

MDIC, FDA and Digital Pathology Association (DPA) are working to prioritize the areas of Digital Pathology and AI where MDIC can bring industry, users, government, insurance companies, and patients together to collaboratively work on several new projects. This alliance aims to work on:

  • Temporary framework to synergize and tackle larger scale projects
  • Harmonizing & standardizing a reference set to be used in end to end workflow by:
    • Creating tools and datasets
    • Progressing and enabling market access
    • Creating clarity on regulatory pathways via mock submissions
    • Harmonizing efforts between various stakeholders to optimize interoperability, integration and implementation

A successful initial meeting was held at the FDA on July 18, 2019. Over 50 attendees from various entities were in attendance. Attendees shared an interest to encourage innovation and commercialization by developing evaluation tools, methods and standards, and clarifying regulatory pathways in digital pathology and specifically in the AI space were present. A temporary alliance has been established between the different participating entities with the intent to grow the alliance to incorporate additional stakeholders. We encourage your participation as we develop project aims and deliverables. If you’re interested in this new effort, please contact MDIC program directors Jithesh Veetil or Carolyn Hiller for more information on how to get involved.

August 14, 2019

MDIC is seeking public comments on its Best Practices for Communicating Benefit, Risk and Uncertainty white paper in support of the Framework for Patient Input in Medical Device Clinical Trials that is set to be complete next year.

MDIC’s Science of Patient Input Steering Committee has worked to understand the best methods to assess patient preferences for benefit and risk in new technologies. As the Committee worked to identify the best methods for assessing patient preferences, they realized there was also a significant need to understand the best evidence-based practices to effectively communicate the benefits, risks and uncertainty of medical technologies to patients and providers. This white paper aims to be a useful resource for all of MDIC stakeholders, including researchers, regulators, clinicians, and patients.

The Framework for Patient Input in Medical Device Clinical Trials will advance methods to integrate patient input into the design of clinical trials, advance a transformative method for integrating patient preferences into the statistical design of clinical trials, and synthesize practical considerations for reducing the patient burden of participation in clinical trials. It will develop and emphasize evidence-based tools for engaging with patients in the design of clinical trials.  Additional resources will be released this fall for public comment, all in support of this larger framework.

View the white paper, here.

The public comment period is open from August 12 – September 13, 2019.

Submit Comments

August 13, 2019

MDIC’s Clinical Diagnostics Program today released the Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics. This Framework is intended to help test sponsors make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility. It is a product of MDIC’s IVD Clinical Evidence Working Group.

The Framework is organized into five sections, outlined below:

Section One: Introduction – introduces the Framework, definitions of analytical validity, clinical validity, and basic concepts of FDA clearance and approval of medical devices, including IVDs.

Section Two: Analytical Validity – provides a library of tests frequently used to demonstrate analytical validity. Useful terms, test considerations and requirements, and related references are provided.

Section Three: Clinical Validity – discusses assay types and measurements of clinical validation, as well as design considerations for clinical validation based on the intended use of the IVD.

Section Four: Clinical Utility – explores the general strategy for developing evidence of clinical utility for payers, presents a clinical utility “self-assessment” framework that IVD developers can use for planning, and details additional clinical utility considerations by IVD test type.

Section Five: References – lists regulatory documents not provided in-line with the text and other references cited in this Framework.

The scope of the statement of work of this Framework is specific to the United States. This Framework should be considered an initial thought piece and not a prescriptive, “how-to” guide. Reading and following this document neither guarantees FDA approval/clearance nor payment from insurance companies.

An informational webinar about the Framework was held on Tuesday, August 13. View the recorded MDICx webinar here.

Download the full framework here.

June 12, 2019

MDIC announced today that CVRx’s President and CEO Nadim Yared has been named chairman of the MDIC Board of Directors and Executive Committee for a two-year term. Yared has served on the MDIC Board of Directors since 2013. He will succeed Abiomed President and CEO, Michael Minogue who will remain on the Board.

Read the full press release here.

June 11, 2019

MDIC is excited to announce the release of our first annual report and share the impact of our work during the 2018 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights from the Annual Report include launching the Health Economics and Patient Access initiative, announcing NESTcc’s Real-World Evidence Test-Cases, and publishing a number of tools and resources for stakeholders. We developed and published a report on cybersecurity for medical devices. These accomplishments would not have been possible without the dedicated members of our public-private partnership who help us promote patient access to innovative medical technologies.

Download the full report here.

June 4, 2019

Today, NESTcc announced 12 new Real-World Evidence (RWE) Test-Cases.  These projects will answer questions of importance to the medical device ecosystem through collaborations between NESTcc Network Collaborators and submitting organizations, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers.  NESTcc’s Test-Case portfolio now includes 20 projects that span the Total Project Life Cycle (TPLC); leverage multiple data sources including device registries, electronic health records (EHR), claims, and patient-generated health data (PGD); and include technologies of interest across 9 disease areas and along the 510(k) and premarket approval regulatory pathways.  Included in these new projects are the first Test-Cases to utilize patient-generated health data (PGD), the first active surveillance project, and the project in response to a question submitted from a patient advocacy organization.

Read the full Press Release, including a full overview of NESTcc’s projects and collaborating organizations, here.