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.
Open Opportunities
Request for Participation (RFP) 23-MP1001
View the Full Request for Participation 23-MP1001
Request for Participation Scope:
Overview:
NESTcc set the foundational infrastructure and partnerships to propel the use of Real-World Evidence (RWE) in regulatory setting including: a) the establishment of a Research Methods and Data Quality Subcommittees that developed
the NESTcc Research Methods and Data Quality Frameworks, designed processes for demonstrating conformance, and made recommendations for their implementation, and b) the creation of a NEST Research Network which under NEST’s leadership executed of 21 Test Case Projects to accelerate its progress and provide proof of concept for generating high-quality RWE for medical devices across the total product life cycle.
In 2022 NESTcc established its first strategic partnerships to start building the NEST Marketplace. With
this Request for Participation, NESTcc intends to grow the NEST Marketplace which will allow for wider participation of the RWE ecosystem in NESTcc RWE projects. Building on the NESTcc Research Network, the Marketplace will be made up of RWE partners that provide access to capabilities such as, but not limited to, data, data curation, data aggregation, data linkage, and data analysis. NESTcc will facilitate efficient study development and execution using a transparent process designed to comply with the regulatory needs of FDA, and other evidentiary needs.
NEST is now focused on generating fit for purpose RWE to support FDA premarket regulatory decisions. However, NEST also aspires to build the capability to generate RWE that is fit for purpose to fulfill FDA postmarket regulatory requirements, other national jurisdictions’ pre- and post-market requirements (e.g., the EU MDR CER and PMCF requirements), enable collaborations in the TPLC Advisory Program (TAP), and generation of evidence to support CMS coverage decisions. By managing evidence generation needs across the diverse landscape of expertise and input necessitated by each project, NESTcc is reducing the timeframe, resources, and costs in conducting, high-quality RWD studies, increasing the reliability of study results. NESTcc’s processes for generating RWE are designed to align with FDA’s expectations. The goal is for RWE studies conducted via NESTcc Marketplace to use best practices that are agreed upon by FDA and can therefore be readily reviewed and accepted by FDA.
Expanding on previous work, the objective of this Request for Participation is to establish additional strategic partners to form the NEST Marketplace. The Marketplace and its partners will be able to efficiently curate, aggregate, and analyze health data, and will contribute to advancing the capabilities of the NEST Marketplace. This Request for Participation serves as a vehicle for NESTcc to select and qualify new strategic partners to serve in the Marketplace. It requests proposals describing what each respondent can do in five critical aspects of impactful RWE studies. Unlike a Request for Proposals, this Request for Participation does not request specific deliverables or their costs. These will be defined between NEST and selected Marketplace partners in a subsequent master services agreement (MSA) and/or statements of work (SOWs) via which specific deliverables and compensation for those deliverables will be defined and agreed upon. The Marketplace partners will work with NESTcc and with each other, as necessary, to optimize data access, quality, completeness, and analysis viable for generation and synthesis of fit for purpose RWE.
Eligibility:
This opportunity to become a partner in the NEST Marketplace is open to private-sector, nonprofit, and for-profit organizations, especially those with experience in medical device evidence generation methodologies and supporting infrastructure (e.g., governance, IT and security, using interoperability standards [via FHIR or CDM] to enhance collaboration and automation).
Details and Requirements:
Each respondent is encouraged to frame the response in terms of how your organization can participate in the marketplace to further the NESTcc goals. The proposal should be submitted in the form of a presentation (e.g., PowerPoint, Prezi, Canva Google Slides), not to exceed 40 slides, and should include a plan for development and implementing the following:
Key Dates for the RFP:
| Key Dates | |
| Posting Date | November 15, 2023 |
| Indication of Interest Deadline | December 15, 2023 |
| Due Date | January 15, 2024 |
| Invitation to Pitch | January 23, 2024 |
| Pitch Days | February 5 thru 9, 2024 |
Request for Proposal (RFP) 23-AS1001
Request for Proposal (RFP) 23-AS1001
NESTcc Releases a Request for Proposal Relating to its Medical Device Active Surveillance Program
NESTcc and the FDA intend to develop and implement an active surveillance system of electronic health data to better understand the safety of medical devices as used within clinical practice. Once realized such a system will optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess potential and ongoing safety signals in a timely manner. The active surveillance program is focused around achieving better data capture, detection of potential safety signals, and a timely assessment leading to actionable findings. In addition, the data structure developed for the active surveillance system will be viable for generation of real-world evidence fit for purpose for regulatory decisions.
Key Dates for the RFP:
| Key Dates | |
| Request for Proposal Released | July 17, 2023 |
| Deadline for Questions | July 21, 2023 (Updated to COB August 4) |
| Indication of Interest | July 26, 2023 |
| Responses to Questions | July 31, 2023 (Updated to COB August 9) |
| Deadline for Proposals | August 28, 2023 |
| Projected Notification of Interest in Presentation | September 1, 2023 |
| Presentation of Proposals | September 11-12, 2023 |
| Projected Notification of Selection Date | September 18, 2023 |
| Projected Start Date | September 30, 2023 |
The RFP can be found here.
Answers to questions as of August 4 can be found here.
To submit your response, click here.
NESTcc will be unable to accommodate 1:1 meetings. Please submit questions to nestcc@mdic.org by COB August 4.
Request for Information (RFI) 23-001
Request for Information (RFI) 23-001
NESTcc Medical Device Real-World Evidence Marketplace
Summary of Information Requested
The National Evaluation System for health Technology Coordinating Center (NESTcc) is soliciting the interest of organizations to partner in generating high-quality solutions and expertise with real-world data (RWD) to support improved evidence for medical devices. Expertise is sought in five strategic areas to realize the vision of the NESTcc real-world evidence (RWE) Marketplace:
- Data platforms: providing a foundation for data gathering and curation, especially platforms that put the patient in the driver’s seat, to gather health data into one place and share with the device community
- Data sources: creating a national resource mirroring the experience of patient care in the United States and general experience of health throughout an individual’s life
- Data connectors: deliver continuity of care and experience between data sources (e.g., via aggregation/ linkage) while maintaining patient privacy and protections
- Data science and research methodology: design and analysis expertise and experience necessary to obtain the epidemiological, informatic and statistical rigor inherent in fit-for-purpose RWD analysis
- Analytic cores: conducting analyses of ingested data or packaging analytics for data sources to conduct analyses, ensuring rapid, valid and verified analysis suitable for RWD research
Given the complexity of working with RWD and transforming it into RWE, it is understood that many entities involved with RWD/RWE may provide services and technologies that do not fit neatly into these five areas. NESTcc is interested in learning of any relevant service or technology which may improve the ability of RWE generation.
The RFI can be found here.
To submit your response, click here.
Closed Opportunities
Call for NESTcc Governing Committee Member Nominations (deadline for response has passed)
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 GC Charter.
NESTcc is seeking nominations for additional Governing Committee members from the following example stakeholder groups:
- Medical Device Industry (including manufacturers and data services)
- *NESTcc Research Network Organization
- Health Systems (outside of the NESTcc Research Network)
- Patient organizations or patient advocacy groups
- Payers
*An executive-level position from a member NESTcc Research Network Organization involved with data management such as Chief Information Officer
The NESTcc Governing Committee will select up to ten (10) new members who represent current stakeholder groups and/or new stakeholders that would provide important insights and perspectives for the future of NESTcc. The final number selected for each stakeholder group will be dependent on the composition of membership as defined in the NESTcc Charter.
A full description of the Targeted Expansion Call for NESTcc Governing Committee Member Nominations opportunity is available here.
The NESTcc Governing Committee Nomination Form is available here.
Applications are due to NESTcc (nestcc@mdic.org) by 5:00 p.m. ET on Friday, March 31, 2023.
A Playbook for Health System UDI Implementation at the Point of Care (deadline for response has passed)
NESTcc engaged the medical device ecosystem via a public comment period for a Playbook created to advance health system Unique Device Identifier (UDI) implementation at the point of care (POC) as part of our Collaborative Community UDI Adoption and Application project. NESTcc encouraged all stakeholders who may have experience with, or interest in, the topic of health system UDI integration at the POC to submit their comments regarding the Playbook.
NESTcc will consolidate all submissions and send the de-identified comments to the project team for consideration in the design of the final Playbook. Public comments are non-binding, and the project team is not obligated to implement any recommendations submitted.
This opportunity is now closed. Comments were due to NESTcc by Thursday, December 15, 2022.
Update (January 18, 2023)
The project team’s response to the public comments received is posted here.
Governing Committee Members (deadline for response has passed)
The NESTcc Governing Committee is comprised of key stakeholders from across the medical device ecosystem committed to the success of NESTcc and charged with guiding 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 GC Charter.
NESTcc sought nominations for a targeted expansion of additional Governing Committee members from the following stakeholder groups:
- Patient organizations or patient advocacy groups
The member will represent their organization as well as patient organizations/advocacy in general.
This opportunity is now closed. Nominations were due to NESTcc by Friday, March 18, 2021.
Active Surveillance Data Partners and Initial Use Cases RFI (deadline for response has passed)
NESTcc sought to identify organizations that have real-world data (RWD) systems (e.g., electronic health records [EHR], claims system, registry or other) and are interested in participating in a federated active surveillance system as a Data Partner.
Key priorities for the work include:
- Delivering a national system to advance safety signal detection (generation) and refinement
- Establishing procedures to ensure data quality and reliability
- Building technical services in secure, scalable and modular environments to accommodate the addition of future, innovative methodologies
- Developing applications beyond post-market safety while designing business practices and controls to encourage use by diverse constituents of the medical device ecosystem.
This Active Surveillance Data Partner RFI opportunity was open to medical device, imaging and diagnostic technology manufacturers as well as hospitals and academic research institutions regardless of whether they are currently a NESTcc Network Collaborator.
Applications were due to nestccnominations@mdic.org by Monday, January 10, 2022 at 5:00 p.m. ET.
Additional information, including eligibility and detailed submission instructions, can be found here.
Call for Experts for NESTcc Data Quality Subcommittee (deadline for response has passed)
NESTcc sought experts to participate on the NESTcc Data Quality Subcommittee who have real-world data (RWD) quality expertise in the following areas:
- Medical Device Industry
- Coverage/reimbursement/payor
- Health Systems
- Medical Informatics
- Electronic Health Records (EHR) Vendor
- Digital/Health Technology
- Health Technology Assessment (HTA)
In Fall 2020, the Data Quality Subcommittee was tasked with the development of a tool, derived from the Data Quality Framework, for assessing data quality on an ongoing basis. The Data Quality Subcommittee created self-assessment tools for both EHR and claims data using the NESTcc Data Quality Maturity Model. Both assessment tools describe key concepts of data quality according to the stages of maturity listed in the Data Quality Framework.
The Data Quality Subcommittee will be charged with updating the Framework to include development of operable standards which will ensure the reliability of the data used in RWE studies. The new Data Quality Subcommittee is recruiting up to 12 members representing different stakeholder groups, including: industry, health systems, EHR vendors, payors, medical informatics, digital health technology and the FDA.
Applications were due to nestccnominations@mdic.org by 5:00 p.m. ET on Friday, November 19, 2021.
Read the full announcement here. Access the application here.
Draft NESTcc Active Surveillance Roadmap open for public comments (deadline for response has passed)
The National Evaluation System for health Technology’s (NESTcc) Active Surveillance Roadmap summarizes progress made to date and describes forward-looking plans and activities needed to develop NESTcc’s active surveillance capabilities. The Roadmap details the technical characteristics of a cloud-based, federated learning environment to perform safety signal refinement and signal detection using real-world data via a planned data network. Additionally, the document describes planned research methods and procedures to ensure data quality along with guiding principles around signal management and communications to ensure active surveillance capabilities are scalable, secure and equitable to all stakeholders.
NESTcc sought public comment on the draft Active Surveillance Roadmap to ensure the stated capabilities and strategy meets the needs of the medical device ecosystem. NESTcc reviewed all submissions for consideration in the development of the final Active Surveillance Roadmap.
View the full draft Roadmap here.
Comment Submission
Comments were submitted through the online submission portal here. The public comment period closed on Monday, October 11 at 5:00 p.m. ET.
Informational Webinar
An informational webinar on the Roadmap was held on Thursday, September 23 from 2:00 p.m. to 2:30 p.m. ET. A recording of the webinar is available here.
Additional Questions
Please contact nestcc@mdic.org with any questions regarding the Roadmap or public comment period.
Call for Experts for NESTcc Active Surveillance IT Cloud Working Group (deadline for response has passed)
NESTcc is seeking subject matter experts, scientists and engineers with experience in federated learning, federated analytics, cloud architecture and interoperability to join the Active Surveillance IT Cloud Working Group. Members are also being sought through a separate call to join the Data Curation Working Group to focus on data standardization and harmonization using a common data model (CDM), common vocabularies (e.g., LOINC, SNOMED) and distributed data quality checks for the Active Surveillance program.
NESTcc seeks to form an Active Surveillance IT Cloud Working Group to inform and provide expert recommendations on the implementation of a secure, federated learning system based on the adoption and extension of a Common Data Model (CDM). Membership in this Working Group is anticipated to represent different stakeholder groups, including cloud architects, data scientists (particularly those with experience in federated learning and big data architecture), cyber security and machine learning engineers.
Please send applications to NESTcc at nestcc@mdic.org. Applications are due by 5:00 p.m. ET on Monday, September 27, 2021.
Read the full announcement here. Access the application here.
Call for Experts for NESTcc Active Surveillance Data Curation Working Group (deadline for response has passed)
NESTcc sought experts from stakeholder groups across the medical device ecosystem for its Active Surveillance Data Curation Working Group.
The Active Surveillance Data Curation Group will be composed of up to 15 members. Membership in this Working Group will represent different stakeholder groups, including informatics subject matter experts (SMEs), data interoperability SMEs, clinicians, researchers/scientists with experience cleansing and curating real-world data (RWD) and regulatory/policy agencies such as the U.S. Food and Drug Administration, among others.
The Working Group will be a key contributor to the building of the NESTcc Active Surveillance System. An Active Surveillance Cloud Infrastructure platform will be designed and operated to facilitate analysis of RWD for medical device safety signal detection and assessment. The system will support federated analytics to analyze partner data, undergo quality checks, run analytics and deliver results, compile and present metadata via dashboards and more.
Applications were to be sent to NESTcc at nestcc@mdic.org. The due date for applications was extended to Friday, September 10, at 5:00 p.m. ET.
Read the full announcement here. Access the application here.
Governing Committee Members (deadline for response has passed)
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 GC Charter.
NESTcc is seeking nominations for a targeted expansion of additional Governing Committee members from the following stakeholder groups:
- Patient organizations or patient advocacy groups
The member will represent their organization as well as patient organizations/advocacy in general.
Nominations are due to NESTcc by Friday, May 28, 2021.
A full description of the Targeted Expansion Call for NESTcc Governing Committee Member Nominations opportunity is available here.
Call for Comments: Evaluation of Uptake of UDIs by Health Systems Interview Guide (deadline for response has passed)
NESTcc engaged the medical device ecosystem via a public comment period for an interview guide for our research project evaluating Unique Device Identifier (UDI) adoption by health systems. NESTcc encouraged all stakeholders who may have experience with, or interest in, the topic of UDIs to submit their comments regarding the interview guide.
NESTcc will consolidate all submissions and send the de-identified comments to the research team for consideration in the design of the final interview guide. Public comments are non-binding, and the research team is not obligated to implement any recommendations submitted.
Comments were due on Thursday, March 4, 2021.
The full interview guide is posted here.
Update (April 16, 2021)
The research team’s response to the public comments received is posted here.
Public Call for Experts for Advisory Working Group on Unique Device Identifiers (UDIs) (deadline for response has passed)
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.
Targeted Expansion: Call for Experts for NESTcc Methods Subcommittee (deadline for response has passed)
NESTcc sought 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 sought 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
Applications were due by Friday, September 25, 2020.
Call for Expert Reviewers for the NESTcc External Reviewer Panel (deadline for response has passed)
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.
Targeted Expansion Call for Active Surveillance Methodology Working Group Members (deadline for response has passed)
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.
Targeted Expansion Call for NESTcc Governing Committee Members (deadline for response has passed)
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.
Call for Experts for NESTcc Active Surveillance Methodology Working Group (deadline for response has passed)
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.
Call for Public Comment on Study Protocol for NESTcc Test-Case: Synthetic Mid-Urethral Slings for Stress Urinary Incontinence in Women (deadline for response has passed)
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.
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 comment period closed on Friday, June 12, 2020. Please see the Executive Summary of Changes from the project team.
Call for NESTcc Governing Committee Members (deadline for response has passed)
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.
Cloud Infrastructure for NESTcc Active Surveillance System Request for Proposals (RFP) (deadline for response has passed)
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:
- Cloud Infrastructure for NESTcc Active Surveillance System Request for Proposal (RFP)
- Cloud Infrastructure for NESTcc Application Template
- Cloud Infrastructure for NESTcc Budget Template
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.
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.
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.
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:
- Data Quality Subcommittee
- 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:
- 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).
- 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.
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.
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.
