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National Evaluation System for health Technology Coordinating Center (NESTcc) Selects Booz Allen Hamilton to Partner on Medical Device Active Surveillance Program

Retrieved on:

Tuesday, November 21, 2023

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The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it has selected Booz Allen Hamilton to partner on the Central Data Operations Hub as part of an ongoing collaboration between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to build an Active Surveillance Program for medical devices.

Key Points:

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it has selected Booz Allen Hamilton to partner on the Central Data Operations Hub as part of an ongoing collaboration between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to build an Active Surveillance Program for medical devices.
View the full release here: https://www.businesswire.com/news/home/20231121987503/en/
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.
The active surveillance program is focused on 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.

Chip Hance Assumes Chairmanship of the MDIC Board of Directors

Retrieved on:

Tuesday, October 24, 2023

Data Management, Medical Devices, Health, Technology, Health Technology, General Health, Chairperson, Medtech, Diabetes, GTCR, MDIC, Partnership, CDRH, Management, Pharmaceutical industry, Hance

Chip Hance assumed the position of Chair of the Board of Directors of the Medical Device Innovation Consortium (MDIC) at the organization’s most recent Board meeting.

Key Points:

Chip Hance assumed the position of Chair of the Board of Directors of the Medical Device Innovation Consortium (MDIC) at the organization’s most recent Board meeting.
Hance, a longtime leader in the medical device field, reflected on the opportunities ahead for MDIC as he assumed Board leadership from the outgoing chair, Dr. Jijo James, Chief Medical Officer, MedTech and External Innovation at Johnson and Johnson.
“I am humbled by the opportunity to serve as Chair of the MDIC Board of Directors,” said Hance.
A 35-year industry veteran of cardiovascular, diabetes and diagnostics devices, Hance has long served as the primary MDIC champion of the Early Feasibility Studies program.

AM Best Comments on Credit Ratings of Integris Group’s Members Following Announced Acquisition of MedMal Direct Insurance Company

Retrieved on:

Friday, October 13, 2023

Insurance, Professional Services, AM Best, Acquisition, Integris Health, Credit, Risk management, AM, MedMal Direct Insurance Company, PTI, Glastonbury, News, ALL, MDIC

AM Best has commented that the Credit Ratings (ratings) of Integris Insurance Company (Glastonbury, CT) and its sponsored risk retention group company, Integris Risk Retention Group, Inc. (District of Columbia) (collectively referred to as Integris Group) remain unchanged following the announcement that it has agreed to acquire MedMal Direct Insurance Company (MDIC) (Jacksonville, FL).

Key Points:

AM Best has commented that the Credit Ratings (ratings) of Integris Insurance Company (Glastonbury, CT) and its sponsored risk retention group company, Integris Risk Retention Group, Inc. (District of Columbia) (collectively referred to as Integris Group) remain unchanged following the announcement that it has agreed to acquire MedMal Direct Insurance Company (MDIC) (Jacksonville, FL).
On Oct. 11, 2023, Integris Group announced that it had agreed to acquire 100% of the stock of MDIC and its agency, CorePro Insurance, from PTI.
For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best's Credit Ratings .
For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments .

Implicity Expands Senior Leadership Team with New U.S. Chief Commercial Officer

Retrieved on:

Wednesday, September 27, 2023

MDIC, Hospital, Boston Scientific, Artificial cardiac pacemaker, Chief commercial officer, ECG, CCO, U.S. FDA, Organization, Hunting, Heart, Patient, Growth, RPM, FDA, Management, Medical device, Implications of U.S. gene patent invalidation on Australia

CAMBRIDGE, Mass., Sept. 27, 2023 /PRNewswire/ -- Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, announced that Jon Hunt, PhD., has joined the company as its new Chief Commercial Officer (CCO), North America. In this role, Hunt will focus on business and sales strategies for the U.S. market to maximize growth, scale operations, and support technological innovations that help meet the growing demand for remote cardiac monitoring.

Key Points:

Most recently, Hunt served as Executive Vice President and Chief Business Officer at HeartBeam (NASDAQ: BEAT), a cardiac technology company that developed the first 3D vector ECG platform for heart attack detection.
As a vital member of the senior leadership team, he played a critical role in taking the company public.
Prior to HeartBeam, Hunt held multiple leadership positions at organizations such as the Medical Device Innovation Consortium (MDIC), Cryterion Medical and Cameron Health.
"I could not be more excited to join the Implicity team at this important juncture," said Hunt.

FDA Announces Formal Support for Voluntary Improvement Program (VIP)

Retrieved on:

Monday, September 25, 2023

The United States Food and Drug Administration (FDA) has announced its support of the Voluntary Improvement Program (VIP) through final Guidance published 14 September 2023.

Key Points:

The United States Food and Drug Administration (FDA) has announced its support of the Voluntary Improvement Program (VIP) through final Guidance published 14 September 2023.
VIP, which is facilitated through MDIC, is the first Case for Quality Program recognized by the FDA that offers participants regulatory opportunities to help accelerate improvements to device quality and manufacturing.
The program proactively targets improvement efforts that are most impactful, and promotes a more integrated quality culture, increased employee engagement and higher morale.
To learn more, including which manufacturers are currently eligible to participate in the voluntary program, read the FDA’s federal register notice at https://www.fda.gov/regulatory-information/search-fda-guidance-documents... .

Maravai LifeSciences Announces Appointment of New Director to the Board

Retrieved on:

Thursday, July 20, 2023

Dr. DeFord is the Chairman, Chief Executive Officer and President of privately-held, South Carolina-based Samothrace Medical Innovations, Inc., which he co-founded in March 2022.

Key Points:

Dr. DeFord is the Chairman, Chief Executive Officer and President of privately-held, South Carolina-based Samothrace Medical Innovations, Inc., which he co-founded in March 2022.
Prior to joining Bard, Dr. DeFord was Managing Director of Early Stage Partners, a venture capital fund.
"On behalf of the entire Board, I thank Chip for his valuable perspective and incredible commitment to Maravai over the past six years,” said Carl Hull, Interim Chief Executive Officer and Chairman of the Board.
“His numerous contributions and thoughtful insights have been invaluable, and we are grateful for everything he has done for Maravai."

National Evaluation System for health Technology Coordinating Center (NESTcc) Releases a Request for Proposal Relating to its Medical Device Active Surveillance Program

Retrieved on:

Monday, July 17, 2023

General Health, Health, FDA, Medical Devices, Data Management, Health Technology, Technology, Security, MDIC, RFP, CDRH, FDA Center for Devices and Radiological Health, Data collection, Key date, Device, Food, Safety, Medical device

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it released a Request for Proposal as part of an ongoing collaboration between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) that focuses on the Central Data Operations Hub as part of its Active Surveillance Program for medical devices:

Key Points:

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it released a Request for Proposal as part of an ongoing collaboration between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) that focuses on the Central Data Operations Hub as part of its Active Surveillance Program for medical devices:
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.

National Evaluation System for health Technology Coordinating Center posts Request for Information (RFI) 23-001 for Medical Device Real-World Evidence Marketplace

Retrieved on:

Thursday, June 8, 2023

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium ( MDIC ), 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.

Key Points:

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium ( MDIC ), 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 for the medical device ecosystem:
1.
Data connectors: deliver continuity of care and experience between data sources (e.g., via aggregation/linkage) while maintaining patient privacy and protections
4.
NESTcc is interested in learning of any relevant service or technology which may improve the ability of RWE generation.

Medical Device Innovation Consortium Selects Simon Mason to Lead National Evaluation System for health Technology Coordinating Center

Retrieved on:

Monday, April 17, 2023

The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), has named Simon Mason as its new President.

Key Points:

The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), has named Simon Mason as its new President.
In his new role, Mr. Mason will lead strategy and operations for NESTcc to serve its stakeholders, including patients, providers, payers, medical device manufacturers, regulators, and others.
At Pharmaspectra, he led development and commercialization of a data lake of scientific and medical affairs information utilized by pharmaceutical and medical device companies.
“We’re thrilled to welcome Simon to NESTcc to build on the organization’s strong foundation and accelerate its development to support medical device innovation,” said Andrew Fish, JD, President & CEO of MDIC.

Cybeats Targets Healthcare Sector Following Recent FDA Mandates; Organizations Facing 90 Day SBOM Compliance Deadline

Retrieved on:

Friday, January 13, 2023

Medtronic, BD (company), MDIC, Education, Organization, FDA, Canadian National Railway, History, Exhibition, Bills, Bills, Bills, SAP, Craft Ventures, Supply, Medical device

The education aims to be utilized by medical device manufacturers to assess and improve their cybersecurity posture.

Key Points:

The education aims to be utilized by medical device manufacturers to assess and improve their cybersecurity posture.
Organizations with representatives attending this webinar will notably include MDIC, Medtronic, Becton Dickinson, Cybersecurity Health Sector Coordinating Council.
Suzanne Schwartz, Director at the FDA, spoke about the history of the earliest actions by the FDA during a Cybeats webinar from 2022 that have contributed to the recent inclusion of an SBOM Mandate for Medical Device Manufacturers.
Included in this Bill, FDA medical device manufacturers will be required to submit an SBOM to the FDA that includes all standard, open source, and critical software components used by the devices.