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.

May 1, 2019

MDIC’s Clinical Diagnostics Cancer Genomic Somatic Reference Samples working group seeks public comments on the draft list of prioritized tumor suppressors.

The goal of the initiative is to develop reference samples that can be made available to the public to improve the accuracy, reliability and transparency of Next-Generation-Sequencing (NGS) based oncology tests. In addition, the samples will improve the efficiency and cost-effectiveness of accurate NGS-based test development and validation by establishing and organizing a collaborative community effort to develop needed reference samples.

Availability of reference samples will aid in efficient NGS test development and validation which will in turn streamline and possibly obviate steps in the regulatory process for diagnostic companies, provide transparency, and compress development timelines for targeted therapeutics developers.

The team was asked to create a prioritized list of tumor suppressor genes that would be covered in an ideal set of reference materials. To ensure that this list identifies the most useful targets to benefit the most patients today, they drew the targets from the work of objective third parties without vested commercial interests in any particular target. Sources should therefore:

  • Represent current standard medical practice
  • Originate from a public sector or independent non-profit organizations
  • Represent the collective opinion of a broad swathe of clinicians and / or laboratory scientists.

The sources used included: OncoKB (oncokb.org),National Comprehensive Cancer Network (NCCN), and ongoing oncology trials catalogued on clinicaltrials.gov

We prioritized genes with Levels 1 and 2 clinical evidence as defined in CDRH’s tiering system for NGS. Level 1 representing those genes that are associated with approved companion diagnostics and Level 2 representing mutation with evidence of clinical significance, such as by inclusion in guidelines. Level 3 Variants will be presented later. We also prioritized variants relevant to solid tumors. HemOnc variants are out of the current scope.

You can access the draft Tumor Suppressor Gene list and instructions here.

 The public comment period is open from May 1 – 30, 2019.
April 24, 2019

On April 2, 2019, MDIC’s External Evidence Methods (EEM) program hosted an Executive & Fellows meeting with about 70 subject matter experts from FDA, industry, and non-profit organizations to discuss the existing methods and identify gaps for the use of external data.

MDIC’s EEM program aims to establish a more predictable pathway for use of external evidence methods, such as new, innovative (Frequentist/Bayesian) methods and the cataloging of existing methods for evidence fusion from data external to a clinical trial. External trial data includes but is not limited to real-world data (RWD), real-world evidence (RWE), engineering modeling and simulation, and similar device clinical trial data to support regulatory medical device decisions and other stakeholder decisions.

The meeting started with updates about MDIC and the program, followed by morning sessions led by FDA representatives highlighting the utility of the Medical Device Development Tools (MDDT) program in promoting innovation in medical device development and regulatory science to help bridge the gap between the research of medical devices and the delivery of devices to patients. Attendees also heard about the progress made through NESTcc initiative towards sustainable generation and use of timely, reliable, and cost-effective RWE throughout the total product lifecycle, using RWD. NESTcc’s Data Network Director Robert Zusterzeel also outlined the efforts made by NESTcc Data Quality and Methods Subcommittees towards developing data quality and methodological standards, design processes for demonstrating conformance to the standards, and recommendations for their implementation.

The morning concluded with a demonstration of one of the novel industry-FDA collaborative projects aimed at transforming the medical device innovation ecosystem with InSilico clinical trials and hearing ase studies focused on leveraging external data to generate evidence. Attendees were also able to learn how FDA and industry collaborated on a mock IDE submission sponsored by MDIC to augment a clinical study with Virtual Patient models. All resources related to this mock submission can be found here.

In the afternoon, the SMEs were split into four breakout sessions, as shown below – each group with equal distribution of FDA and industry members – and addressed different buckets of external data.

  1. Historical Clinical study data (US/OUS); Led by Chris Mullin (NAMSA)
  2. Registry Data; Led by Yun-Ling Xu (FDA)
  3. Modelling and Simulation; Led by Tarek Haddad (Medtronic)
  4. Admin Data (EHR, Claims etc.); Led by Ted Lystig (Medtronic)

The groups discussed characterizing data type (data quality; access; relevance), cataloging existing statistical methods that can be utilized (Frequentist/Bayesian), describing limitations of existing methods/data type, identifying areas where new methods need to be developed, and identifying examples for the use of external data as evidence.

Please follow MDIC’s EEM webpage for the latest updates.