Opportunities for Engagement

NESTcc relies on engagement with the broader medical device ecosystem—including industry players, health systems, patient groups, clinician groups, payers, and regulators—to achieve its mission. Explore the open opportunities for below, or contact us directly to develop a partnership.

Open Opportunities

Cloud Infrastructure for NESTcc Active Surveillance System Request for Proposals (RFP) (Deadline Extended to 12/17/19)

The timely and accurate detection of safety signals for medical devices is a high priority for the U.S. Food and Drug Administration (FDA).  In order to further this work, the FDA has provided the National Evaluation System for health Technology Coordinating Center (NESTcc) with dedicated funding to advance active surveillance activities for medical devices.

NESTcc is seeking a full-service contractor to develop and maintain a cloud platform that can be used to support active surveillance projects.

Key activities under the awarded Scope of Work will include:

  • Phase I: Developing and maintaining initial cloud infrastructure for NESTcc’s active surveillance work.
  • Phase II: Scaling and maintaining the system to allow for additional users and more complex pathways and analyses.

Links to the relevant documents are provided below:

Responses must be submitted via NESTcc’s Catch-All Intake Submission Portal by 5:00 p.m. ET on Tuesday, December 17, 2019.

Update (November 25, 2019)
NESTcc Responses to Submitted Questions have been posted. The .pdf document is available for download here.

Update (December 5, 2019)
The original deadline of 5:00 p.m. ET Tuesday, October 10, has been extended by one week to 5:00 p.m. ET Tuesday, December 17.

Closed Opportunities

Data Network Expansion (deadline for response has passed)

The National Evaluation System for health Technology Coordinating Center (NESTcc) solicited applications from organizations with access to high-quality real-world data (RWD) to join the NESTcc Data Network as Network Collaborators. Expansion of the Data Network is intended to increase the capacity and capabilities of the Data Network.

Additional information this opportunity can be found in the full announcement.

Applications were due by Thursday, October 3, 2019 at 5:00 p.m. ET.

NESTcc Solicits Public Comments for Data Quality and Methods Frameworks (deadline for response has passed)

The Data Quality & Methods Frameworks, developed by NESTcc’s Data Quality & Methods Subcommittees were available for public comment.  The public comment period opened on Tuesday, May 28 and closed on Friday, July 26.  Comments will be evaluated for incorporation into the Frameworks by the Subcommittees before the release of the final versions in Fall 2019.

  • The draft Data Quality Framework can be found here.
  • The draft Methods Framework can be found here.

NESTcc hosted a public webinar to discuss the Frameworks on Monday, June 3 – the full presentation slide deck can be found here.

Please contact nestcc@mdic.org with any questions regarding the Frameworks or public comment period.

Call for NESTcc Governing Committee Member (deadline for response has passed)

In 2016, the U.S. Food and Drug Administration (FDA) awarded a grant to establish The National Evaluation System for health Technology Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC).  NESTcc’s mission is to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research.

The inaugural NESTcc Governing Committee was formed in July 2017.  The NESTcc Governing Committee is comprised of key stakeholders from across the medical device ecosystem committed to the success of NESTcc and charged with inaugurating a Coordinating Center that is inclusive, patient-focused, and anchored in accountability and transparency.  For additional information about the Governing Committee and NESTcc, please review the NESTcc Charter.

Please be aware that the deadline for submitting NESTcc Governing Committee nominations has passed.   A full description of this opportunity, including the summary of the criteria and selection process and required nomination application, is available here.

Become a NESTcc Network Collaborator (deadline for response has passed)

NESTcc is seeking data partners and solutions to collaborate with to advance evaluation and use of high-quality Real-World Data (RWD) from various sources, including but not limited to:

  • Health Systems
  • Health Payers
  • Registries
  • Sources of Patient- or Device-Generated Data
  • Data Network Solutions
  • Analytics Offerings

NESTcc will work with data partners to:

  • Understand existing capabilities for evaluating and using RWD for medical devices
  • Identify technical challenges and gaps in the ecosystem
  • Discuss the role of data partners within the broader medical device ecosystem and the connections needed to facilitate the use of real world evidence
  • Share perspectives of the value of RWD
  • Understand the progress partners have made on integrating Unique Device Identifier (UDI) in EHRs and claims data

NESTcc is not currently expanding the Data Network with new Network Collaborators.  Future opportunities to join the NESTcc Data Network as a Network Collaborator will be posted here.  Information on the current Network Collaborators can be found here.

To date, NESTcc has developed partnerships with organizations across the medical device ecosystem. To learn more about partnership opportunities, contact the NESTcc inbox.

NESTcc Requests Concepts for Second Round of Real-World Evidence Test-Cases (deadline for response has passed)

The National Evaluation System for health Technology Coordinating Center (NESTcc) is soliciting a second round of recommendations from medical device stakeholders, including manufacturers (“industry partners” or multi-manufacturer initiatives), health system providers and health payers for test-case concepts. These test-cases will generate Real-World Evidence (RWE) in collaboration with NESTcc’s Network Collaborators. This round of test-cases will continue to assess the feasibility for key stakeholders to work with the NESTcc Data Network’s Real-World Data (RWD) sources to support a range of studies and analyses, as well as address high priority areas of interest for NESTcc, including requirements outlined in MDUFA IV and the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017 (FDARA).

The goals of the test-cases are to:

(1) Explore the feasibility for key stakeholders in the medical device ecosystem to use Real-World Data sources (i.e., electronic health records, public and private claims, registries, and patient-generated health data) offered by NESTcc’s Network Collaborators.

(2) Contribute to NESTcc’s development of operational processes (e.g., contracting, IRB, data sharing agreements, publication policies).

Please be aware that the deadline for submitting recommendations for test-cases has passed. Submissions are currently under review by the NESTcc team. Information regarding confidentiality of submissions is below. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here.  Please contact us at NESTcc@mdic.org with any additional questions.

To learn more about examples of current test-cases and the selection and review process, download the NESTcc Call for Concepts Webinar presentation here.

NESTcc Requests Concepts for Real-World Evidence Test-Cases Leveraging Patient-Generated Health Data (deadline for response has passed)

The National Evaluation System for health Technology Coordinating Center (NESTcc), in partnership with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), is soliciting concepts for test-cases that use patient-generated health data (PGD) to characterize and evaluate patient outcomes, perspectives, and preferences on the management and treatment of their condition. The solicitation for concepts is open to all medical device stakeholders, including manufacturers, health system providers, health payers, academia, and non-profits, including patient advocacy groups and should involve prevention, diagnosis, treatment, or surveillance with a medical device, imaging, or diagnostic technologies.

The goals of the test-cases are to:

(1) Explore the feasibility of generating and using patient-generated data for regulatory and coverage purposes using the NESTcc Data Network and identify the characteristics of the infrastructure necessary to support this.

(2) Improve the understanding of the opportunities and challenges of using the NESTcc Data Network to support studies that capture and evaluate patient-generated data to identify and measure health outcomes that matter most to patients.

(3) Provide learnings to advance patient input and involvement in the regulatory process.

(4) Contribute to NESTcc’s development of operational processes (e.g., contracting, IRB, data sharing agreements, publication policies).

Please be aware that the deadline for submitting recommendations for test-cases has passed. Submissions are currently under review by the NESTcc team. Information regarding confidentiality of submissions is below. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here.  Please contact us at NESTcc@mdic.org with any additional questions.

To learn more about targeted test-case concepts that leverage patient-generated health data and the selection and review process, download the NESTcc PGD Call for Concepts Webinar presentation here.

NESTcc Request for Proposal to Plan for the Sustainability of the Coordinating Center – (deadline for response has passed).

MDIC is seeking contractor support to develop sustainability planning for the long-term viability and sustainability of NESTcc after the initial funding from the U.S. Food and Drug Administration (FDA). Through the MDUFA IV legislation, the FDA is supporting the initial development of NESTcc through a five-year investment. After the initial investment, the goal is that NESTcc is sustainable.

Proposals should include a plan for developing and implementing one or both of the following scopes of work to support this effort:

  • Market Analysis
  • Business Plan Development

MDIC may make up to two awards under this RFP. MDIC expects to make one award per scope of work. The awards may go to the same contractor or distinct contractors.

Please be aware that the deadline for submitting a response to this opportunity has passed. Submissions are currently under review by the NESTcc team. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here. Please contact us at NESTcc@mdic.org with any additional questions.

Call for Experts for NESTcc Data Quality and Methods Subcommittees – Membership announced June 6, 2018 (deadline for response has passed).

The National Evaluation System for health Technology Coordinating Center (NESTcc) was established in 2016 by the Medical Device Innovation Consortium (MDIC). NESTcc’s mission is to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research. As NESTcc establishes its role as the leading organization within the health technology and medical device ecosystem for conducting efficient and timely high-quality RWE studies throughout the total product life cycle (TPLC), it is seeking experts to participate in two subcommittees to fulfill two mechanisms outlined in the NESTcc Charter:

  1. Data Quality Subcommittee
  2. Methods Subcommittee

As NESTcc establishes these mechanisms, the intention is to fully leverage efforts from leading groups including the PCORI Methodology Committee, PCORnet, MDEpiNet, Sentinel, the International Medical Device Regulators Forum (IMDRF), the Clinical Trials Transformation Initiative (CTTI), and other organizations that have initiated work in this space.

Please be aware that the deadline for applying to the Data Quality Subcommittee and Methods Subcommittee has passed. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here.  Membership to the Data Quality and Methods Subcommittees was announced on June 6, 2018. Additional information is available here. 

NESTcc Requests Concepts for Real-World Evidence Test-Cases (for Medical Device Manufacturers) – Deadline for response has passed.

NESTcc is interested in receiving recommendations from industry for test-cases using Real-World Evidence that could be implemented with NESTcc’s early data partners. Test-cases are being sought to assess feasibility and are intended to explore the data partners’ ability to capture the data needed to support a range of studies and analyses. The goals of the test-cases are to:

  1. Explore the feasibility for industry to use Real-World Data sources offered by NESTcc’s initial set of partners. Other sources of Real-World Data could be explored if needed (e.g., registries, de-identified claims data, patient-generated data).
  2. Identify areas where NESTcc could play a role in reducing transaction costs (e.g., contracting, IRB, data sharing agreements, publication policies).

Please be aware that the deadline for submitting recommendations for test-cases has passed. Submissions are currently under review by the NESTcc team. Information regarding confidentiality of submissions is below. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here. Please contact us at NESTcc@mdic.org with any additional questions.

To learn more about how real-world test-cases align with NESTcc’s overall Strategic and Operational Plan, download the NESTcc Call for Concepts Webinar presentation here.

Please Read: Important Information Regarding Confidentiality

Manufacturers have the option to request to sign a Non-Disclosure Agreement (NDA) with NESTcc team at any time during the submission and review process. The NDA should allow NESTcc to use de-identified, high level information on the test-case for NESTcc’s communications. NESTcc data collaborators may also be consulted to assess the feasibility of test-cases using the de-identified Concept Proposals. If not already covered under an NDA, prior approval from the manufacturer about level of disclosure of information will be sought by NESTcc staff.

If you have concerns about who may see your test-case concept during the review process, please reach out to us directly to discuss confidentiality and how to meet your needs.

NESTcc Request for Proposal to Establish the Value of Using Real-World Evidence for Regulatory and Coverage Decisions: Case-Studies in Medical Technologies – Deadline for response has passed.

NESTcc is seeking a contractor to complete a review and analysis of the value for industry stakeholders of using Real-World Evidence (RWE) for regulatory and coverage decisions through a series of case-studies.

The goal of this RFP is to identify a contractor to conduct a review of up to 10 case-studies with analyses of the returns on investment, uses of Real-World Data (RWD) for regulatory decisions, and, if available, coverage decisions.

Please be aware that the deadline for submitting a response to this opportunity has passed. Submissions are currently under review by the NESTcc team. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here. Please contact us at NESTcc@mdic.org with any additional questions.

NESTcc Request for Proposal to Assess Appropriate Uses of Real-World Evidence for Medical Devices – Deadline for response has passed.

NESTcc is seeking a contractor to complete an assessment consistent with the Medical Device User Fee Amendments (“MDUFA IV”) of 2017 and the FDA Reauthorization Act of 2017 (“FDARA”), which will “evaluate the strengths, limitations, and appropriate use of real-world evidence for regulatory and coverage decisions, and determine whether current methods, systems, and programs for real-world evidence can generate reliable and timely evidence about the effectiveness or safety surveillance of devices.”

The goal of this RFP is to identify a contractor to conduct an assessment of the strengths, limitations, and appropriate use of Real-World Evidence for informing pre-market and post-market decision-making for multiple device types and to determine whether current methods, systems, and programs for Real-World Evidence can generate reliable and timely evidence about the effectiveness or safety surveillance of devices.

Please be aware that the deadline for submitting a response to this opportunity has passed. Submissions are currently under review by the NESTcc team. A full description of this opportunity, including a summary of the review process and approximate timeline, is available here. Please contact us at NESTcc@mdic.org with any additional questions.

Submit a Demonstration Project

The current submission cycle for NESTcc Demonstration Projects is now closed. Please contact the NESTcc team with any questions, or click here to learn more about NESTcc’s selected Demonstration Projects.

Follow us @NESTccMedTech

Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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