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

In September 2019, NEST was named by the FDA’s Center for Devices and Radiological Health (CDRH) as one of the first Collaborative Communities. The NEST Collaborative Community aims to provide a forum for stakeholders from across the medical device ecosystem to address shared challenges by leveraging their collective voice.

NESTcc has selected unique device identifiers (UDIs) as a key area of focus for 2021. In November 2020, the Collaborative Community will kick off a research project, “Evaluation of Uptake of UDIs by Health Systems and Health Plans” (or the UDI Adoption & Application study), with the primary objective of characterizing UDI adoption and use by health systems, including the facilitators and barriers associated with their implementation.

NESTcc is seeking nominations for the UDI Working Group to provide perspectives and feedback on the UDI Adoption & Application study, and to help shape the response to its findings. Practitioners, researchers, experts, leaders, and policy makers representing the following stakeholder groups with an interest in UDI should apply:

  • Clinicians
  • Health system operations / administration
  • Medical device manufacturers
  • Medical researchers
  • Patient organization representatives
  • Payers – public or private sector
  • Regulatory agency or public health representatives
  • Software and IT/data management vendors

NESTcc will select up to fifteen (15) members to support the research team conducting the UDI Adoption & Application study.

Applications must be submitted to nestcc@mdic.org by 5:00 p.m. ET on Thursday, October 29, 2020.

The full description and application form for the Public Call for Experts for Advisory Working Group on Unique Device Identifiers (UDIs) opportunity is available here.

NESTcc is seeking additional experts to participate on the NESTcc Methods Subcommittee. The role of the Methods Subcommittee is to help ensure that NESTcc’s projects can be interpreted based on the most efficient, appropriate, and rigorous methods of analysis.

The Methods Subcommittee is currently composed of seven members representing different stakeholder groups, including academia, industry, and the U.S. Food and Drug Administration. NESTcc is seeking up to five individuals to serve on the Methods Subcommittee, with expertise in the following areas:

  • Statistical and analytical methods for randomized and observational studies, as well as issues with choice of study design
  • Knowledge of statistical and analytical issues, and study design issues, specifically related to medical devices, imaging, and diagnostics
  • Knowledge of analytical and statistical issues related to use of RWD and RWE, as well as the use of distributed data networks

To apply for the Methods Subcommittee, review the call for experts announcement and submit the required application form to nestcc@mdic.org by 5:00 p.m. ET on Friday, September 25.

Closed Opportunities

As NESTcc continues to establish itself as the leading organization for conducting efficient and timely high-quality RWE studies throughout the total product life cycle, in the health technology and medical device ecosystem, it sought applicants interested in serving as compensated members of its External Reviewer Panel.  NESTcc encouraged a diverse group of individuals with Real-World Data/RWE experience to apply and was particularly interested in reviewers who have expertise in the following specialties:

  • Regulatory (U.S. and/or international (e.g. EU MDR, APAC))
  • Coverage/reimbursement/HTA
  • HEOR/cost-effectiveness/healthcare resource utilization
  • Methods in designing studies and collection of RWD
  • Data Quality of RWE generated
  • Epidemiology
  • Biostatistics (e.g. statistical methodologies)
  • Data science (e.g. machine learning, predictive modelling)
  • Data engineering (e.g. software engineer in Hadoop, SQL, Hive)
  • Safety (e.g. medical device safety, surveillance)
  • Digital/Health Technology
  • Software as a Service
  • Mobile Applications
  • mHealth

The charge for External Reviewers is to aid in evaluating the quality and merit of protocols, preliminary results, and final results (research materials) from NESTcc projects in accordance with administrative compliance and responsiveness and against the scientific rigors of NESTcc’s Methods Framework and Data Quality Framework.

Applications were due by Friday, September 11, 2020.

A full description of the Call for Expert Reviewers for the NESTcc External Reviewer Panel opportunity is available here.

NESTcc sought patients/patient representatives to participate as members of the Active Surveillance Methodology Working Group.

The Active Surveillance Methodology Working Group is a key contributor to the building of the NESTcc Active Surveillance Cloud Infrastructure that will support research operations and facilitate collection and analysis of real-world data for medical device safety signal detection and assessment.

The Active Surveillance Methodology Working Group conducts its work independently, with oversight provided by the Active Surveillance Task Force. The Active Surveillance Task Force is a multi-stakeholder group charged by the NESTcc Governing Committee with providing input and guidance throughout the Cloud Infrastructure development process, overseeing all Working Groups and reviewing and commenting on high-level system and functional requirements for the Cloud Infrastructure build.

NESTcc sought nominations for a targeted expansion of up to two (2) additional Active Surveillance Methodology Working Group members comprised of patients and/or patient group representatives.

Nominations were due by Monday, August 17, 2020.

A full description of the Targeted Expansion Call for NESTcc Active Surveillance Methodology Working Group Member Nominations opportunity is available here.  

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.

NESTcc sought nominations for a targeted expansion of up to two (2) additional Governing Committee members from the following stakeholder groups:

  • Digital Health/Software as a Service (SaaS)
  • Healthcare Supply Chain Management (preferably within a Hospital System)
  • Public and Private Payers
  • Health Technology Assessment

Nominations were due by Friday, August 7, 2020.

A full description of the Targeted Expansion Call for NESTcc Governing Committee Member Nominations opportunity is available here.  

NESTcc sought methods experts from stakeholder groups across the medical device ecosystem for its Active Surveillance Methodology Working Group.

The Active Surveillance Methodology Working Group will be composed of six to eight members.  Membership in this Working Group will represent different stakeholder groups, including academia, industry, and regulatory, among others.

It is anticipated that the Working Group will conduct a literature review to determine what types of tools have been developed and are currently used for active surveillance safety signal detection, create a list of priorities NESTcc should include in methodologies for implementation into the Cloud infrastructure, and provide technical expertise, input, and review on the NESTcc-drafted report regarding the strengths and weaknesses of safety signal detection methodologies currently utilized in the medical device ecosystem.

Applications were due to NESTcc at nestcc@mdic.org by Thursday, July 2.

Read the full announcement here.

NESTcc is currently engaging the medical device ecosystem through a public comment period for a study protocol of one of our Test-Case projects. The Test-Case aims to assess the capacity of EHR data to evaluate long-term adverse events following synthetic surgical mesh implantation for female stress urinary incontinence.

NESTcc encourages all stakeholders who may have experience with, or interest in, the topic of surgical mesh safety to submit their comments regarding the study protocol through NESTcc’s Community Engagement Portal.

The comment period closed on Friday, June 12, 2020.

NESTcc will consolidate all submissions and send the de-identified comments to the Test-Case research team for consideration in the design of the final study protocol. Public comments are non-binding, and the research team is not obligated to implement any recommendations submitted.

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.

NESTcc is seeking nominations for additional Governing Committee members.  Currently, the NESTcc Governing Committee is made up of diverse stakeholders, including:

  • Industry
  • Patient Organizations
  • Health Systems
  • Clinicians
  • Payers
  • Regulators

The call for nominations is open to all stakeholder groups.  The NESTcc Governing Committee will select up to six (6) members who represent current stakeholder groups and/or new stakeholders that would provide important insights and perspectives for the future of NESTcc.  The Governing Committee is particularly interested in expanding or adding new representation from the patient organization, health system, and policy stakeholder groups.

A full description of the Call for NESTcc Governing Committee Nominations opportunity is available here.  
The NESTcc Governing Committee Nomination Form is available here.

Applications were due by Tuesday, March 31, 2020.

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 sought 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:

NESTcc Responses to Submitted Questions have been posted. The .pdf document is available for download here.

Applications were due by Tuesday, December 17 at 5:00 p.m. ET.

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.

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.

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.

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.

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.

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.

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.

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 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 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 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.

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.