Wednesday, September 11, 2024 9/11/2024

NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)

Award Number: U01FD006292
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT The Medical Device Innovation Consortium (MDIC) is applying to continue its role as the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is a cooperative network that consists of a coordinating center (MDIC), the U.S. Food and Drug Administration (FDA/CDRH), Network Collaborators, and a Governing Committee that represents the FDA, industry and their relevant trade associations, clinicians/clinician groups, academic health systems and research organizations, digital health and technology companies, payors, and patients/patient advocacy groups. The objectives of NESTcc are to: (1) Support implementation of NEST through sustainable multi-stakeholder partnerships; (2) Develop new systems of data collection/analysis to permit prospective active medical device postmarket risk identification; (3) Support the development of and access to high quality data sources that can be used in comprehensive evaluation of medical device performance and associated outcomes by multiple stakeholders; (4) Develop methodological approaches/systems that facilitates the use of real-world evidence for regulatory decision-making, and for uses by other stakeholders, throughout the entire device lifecycle. As NESTcc, MDIC will continue to provide robust scientific oversight and proven support for the next cycle of this grant, with key responsibilities for leadership in real-world evidence (RWE) research for the Research Network, operational and project management of research studies and projects, medical device safety (MDS) for active surveillance, Collaborative Community (CC); development and deployment of innovative infrastructure and tools; novel approaches for study design and statistical methodologies; and management and distribution of NEST funds. NESTcc will manage relationships among its partners to facilitate the use of RWD in understanding medical devices in a way that is meaningful for the stakeholder communities. NESTcc will monitor, promote, and facilitate infrastructure development for use of RWE for medical device evaluation, not just for regulatory decision-making but for the wider community of stakeholders. NESTcc will optimize the cost of, access to, quality of, and sharing of data related to medical device evaluation; promote the adoption of best practices using RWE; develop a transparent and streamlined process for evaluating and disseminating medical device safety and effectiveness information; and develop a sustainable business model. Our proposed approach represents a strong, experienced leadership team to ensure efficient scientific and administrative support to NEST using advanced and innovative technologies. A multiple PI leadership plan is proposed shared by Pamela Goldberg (MDIC CEO) and Flora Sandra Siami (MDIC SVP and head of NESTcc), with clearly delineated roles and responsibilities for leading and directing NESTcc.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $9,100,000 )
2024	2024	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	001	7	7/24/2024	NON-COMPETING CONTINUATION	$3,050,000
2024	2024	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	000	7	6/13/2024	NON-COMPETING CONTINUATION	$6,050,000
														Subtotal = $9,100,000

Issue Date FY: 2023 ( Subtotal = $20,611,350 )
2023	2023	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	004	6	6/6/2023	SUPPLEMENT FOR EXPANSION	$12,601,350
2023	2023	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	007	6	9/27/2023	SUPPLEMENT FOR EXPANSION	$310,000
2023	2023	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	006	6	8/14/2023	NON-COMPETING CONTINUATION	$2,478,186
2023	2023	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	005	6	8/9/2023	NON-COMPETING CONTINUATION	$0
2023	2023	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	003	6	5/3/2023	NON-COMPETING CONTINUATION	$5,221,814
2023	2022	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	001	5	1/17/2023	NON-COMPETING CONTINUATION	$0
2023	2022	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	002	5	3/7/2023	NON-COMPETING CONTINUATION	$0
2023	2019	THE MEDICAL DEVICE INNOVATION CONSORTIUM	1655 FORT MYER DR FL 12	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	000	3	12/5/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $20,611,350

Issue Date FY: 2022 ( Subtotal = $6,414,276 )
2022	2022	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	000	5	4/18/2022	NON-COMPETING CONTINUATION	$6,000,000
2022	2022	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	001	5	7/15/2022	SUPPLEMENT FOR EXPANSION	$414,276
2022	2022	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	003	5	8/1/2022	NON-COMPETING CONTINUATION	$0
2022	2022	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	002	5	7/22/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $6,414,276

Issue Date FY: 2021 ( Subtotal = $6,000,000 )
2021	2021	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	001	4	4/3/2021	COMPETING CONTINUATION	$6,000,000
2021	2019	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	000	3	3/19/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $6,000,000

Issue Date FY: 2020 ( Subtotal = $6,000,000 )
2020	2020	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	003	3	9/16/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	001	3	5/14/2020	SUPPLEMENT FOR EXPANSION	$6,000,000
2020	2019	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	000	3	11/25/2019	NON-COMPETING CONTINUATION	$0
2020	2019	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	002	3	9/2/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $6,000,000

Issue Date FY: 2019 ( Subtotal = $11,000,000 )
2019	2019	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	003	2	6/5/2019	NON-COMPETING CONTINUATION	$11,000,000
2019	2019	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	002	2	3/19/2019	NON-COMPETING CONTINUATION	$0
2019	2019	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	001	2	3/8/2019	NON-COMPETING CONTINUATION	$0
2019	2019	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	004	3	8/29/2019	NON-COMPETING CONTINUATION	$0
2019	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	000	1	2/7/2019	NEW	$0
														Subtotal = $11,000,000

Issue Date FY: 2018 ( Subtotal = $10,480,000 )
2018	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	002	1	3/21/2018	NEW	$0
2018	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	100 N 6TH ST STE 989C	MINNEAPOLIS	MN	55403	HENNEPIN	USA	Food and Drug Administration Research	000	1	12/12/2017	NEW	$6,000,000
2018	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	006	1	9/25/2018	NEW	$830,000
2018	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	005	1	9/21/2018	NEW	$3,000,000
2018	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	003	1	6/4/2018	NEW	$50,000
2018	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	1501 WILSON BLVD STE 910	ARLINGTON	VA	22209	ARLINGTON	USA	Food and Drug Administration Research	004	1	8/21/2018	NEW	$600,000
2018	2018	MEDICAL DEVICE INNOVATION CONSORTIUM	100 N 6TH ST STE 989C	MINNEAPOLIS	MN	55403	HENNEPIN	USA	Food and Drug Administration Research	001	1	12/15/2017	NEW	$0
														Subtotal = $10,480,000

Grand Total All Awards = $69,605,626

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NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)

Award Number: U01FD006292

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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