Medical device evaluation, especially for high-risk and implantable devices, is associated with multiple methodological and interpretative challenges. At the DCRI, our expertise in device research spans from Phase I studies through post-market surveillance. Our faculty members and research and operational teams work with experts from industry, government, and academia to conduct device studies in every therapeutic area. For device trials, we offer the following services.
Device Trial Services
- Protocol Development
- Project Management
- Site Management
- Site Monitoring
- Risk-Based Monitoring
- Patient Recruitment and Retention
- Data Management
- Statistical Programming, Analysis and Reporting
- DSMB Oversight and Coordination
- Regulatory Oversight and Compliance
- Medical Writing
- Quality Assurance
NESTcc Call for Demonstration Projects
In 2016, the FDA awarded a grant to the Medical Device Innovation Consortium (MDIC) to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). The NESTcc is beginning to identify Demonstration Projects aligned with the Coordinating Center's mission. The goal is for NESTcc to collaborate closely with projects that are developing, verifying and operationalizing methods of evidence generation and data use, demonstrating scalability across healthcare systems and device types and manufacturers, and will help inform NESTcc's strategy as it builds out critical functions and processes for a future sustainable organization.
At this time, we are pleased to announce a call for demonstration projects. NESTcc will give designation for mature projects currently underway that have existing sources of funding for core activities. A short submission form to request the designation is available.
First-round submissions are due by or before 11:59 pm ET on September 13, 2017. Submissions sent after September 13, 2017 will be accepted and reviewed on a rolling basis.
Coordinated Registry Network for Devices
The creation of a coordinated registry network (CRN) is a key element in building a national medical device evaluation system, according to a new editorial by the DCRI’s Mitchell Krucoff, MD.
Bridging Unmet Medical Device Ecosystem Needs With Strategically Coordinated Registries Networks
The article, co-authored with Art Sedrakyan, MD, PhD, of Weill Cornell Medical College and Sharon-Lise T. Normand, PhD, of Harvard Medical School, appears in this recent issue of JAMA.
MDEpiNet Strengthens Device Surveillance
Last year, the Medical Device Epidemiology Network (MDEpiNet) convened the Medical Device Registries Task Force (MDRTF) to strengthen the medical device postmarket surveillance system using existing resources and develop an integrated system to facilitate premarket device clearance and approval.
Is a drug-eluting stent or a bare-metal stent the safest option for patients requiring percutaneous coronary intervention (PCI), including those with a bleeding history or a risk for bleeding? What are the revascularization and stent thrombosis risks?
Hear this and other presentations in the Interventional Cardiology Podcast series from DCRI Education.
Mitchell Krucoff, MD
Co-Director, Cardiovascular Devices Group
Director, Electrocardiology Core Lab
Professor of Medicine, Cardiology