August 18, 2020

September 26, 2019

 

TCT (Transcatheter Cardiovascular Therapeutics) is an annual scientific symposium of the Cardiovascular Research Foundation that provides an educational meeting space to discuss interventional cardiovascular medicine. This symposium provides hands-on training, interactive learning, live case demonstrations, networking opportunities, and learning from world-class faculty. Chip Hance, one of MDIC’s board members, and Andrew Farb from the FDA that works closely with MDIC, presented in the TCT 2019 meeting in San Francisco, California.

Download Materials Presented:

July 14, 2020

June 12, 2019

 

Following the MDIC’s EFS Site Best Practices workshop in March 2019, Martin Leon, MD (Columbia University Medical Center), Aaron Kaplan, MD (Dartmouth-Hitchcock, Serial Entrepreneur), Michael Mack, MD (Baylor), Chip Hance (Regatta Medical) and David R. Holmes, Jr., MD (Mayo Clinic), conceived a meeting focused on the issues of Early Feasibility Studies from the clinicians’ perspective. Specifically, the meeting focused on the following three areas:
●Identification of relevant patient population/Patient screening
●Patient consent
●Procedural and clinical follow-up issues
The program addressed these specific topics with different presentations followed by robust audience participation for discussion with clinical investigators and industry sponsors. This program took place on Wednesday, June 12, 7:00-9:30 pm, at the Sheraton Grand in Chicago.
This event was sponsored by MDIC in collaboration with CRF.

Panelists Include:
• Howard C. Herrmann, Penn Medicine
• Vinod Thourani, Medstar Heart and Vascular Institute
• Michael Mack, Baylor Scott & White
• Scott Lim, University of Virginia
• Bernard Vasseur, FDA

Event Materials:
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.

Individual Event Material:

Full Event PDF Packet:

EFS Symposium at TVT 2019 PDF Packet

June 26, 2020

March 6-7, 2019

The first EFS workshop of 2019 focusing on site best practices took place on March 6th & 7th at the MDIC offices located in Arlington, VA. In this workshop, sponsors, EFS sites, and regulators gathered over a two-day period to discuss:

• Managing risk, SAEs, & IRB reporting
• Timely & Effective Contracting-Sites Achieving 60/60/60 or Better
• Budgeting between EFS Sites and Sponsors
• EFS Staffing and Resources-Patient Identification, Enrollment, & Retention
• Coverage Determinations & Site Budgets.

Throughout the workshop, Sponsors and Sites gave their perspectives of best practices for EFS clinical studies. Sponsors highlighted the importance of collaborating with the FDA to structure protocols for quick patient enrollment and conducting site qualification visits early prior to protocol finalizations. From the site perspective, the importance of working with highly engaged and qualified research staff, as well as collaborating with IRB, was emphasized as key points to improve the launch of an EFS clinical study.

Workshop Materials:
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.

Individual Event Materials:

Agenda & List of attendees

Workshop Overview | Chip Hance, MDIC EFS Initiative Board Champion

EFS Overview | Andrew Farb, MD, FDA, CDRH

EFS Value to Innovation | Rick Geoffrion, Mitralign, Inc.

EFS Best Practices: Importance of Identifying Them | Martin Leon, MD, Mayo Clinic

Session II: Timely & Effective Contracting | Jaime Walkowiak, BSWI

Session III: Budgeting Between EFS Sites and Sponsors

Learnings From Sites Achieving “60:60:60” or Better | Beth Wilson, OHSU

Learnings From Sites Achieving “60:60:60” or Better | Lynne Goodreau, Northwestern

EFS in the context of FDA Priorities and Initiatives | Bram Zuckerman, MD, FDA, CDRH

Session V: Patient Identification, Enrollment, & Retention | Sara Vidmar, preCARDIA

Session V: Patient Identification, Enrollment, & Retention | Necole Kell, BSWRI

Session VI: Coverage Determination & Site Budgets | Jill Trekell, Edwards Lifesciences

Conclusions & Next Steps

Full Event PDF Packet:

2019 EFS Best Practices Materials

June 24, 2020

Following the MDIC’s EFS Site Best Practices workshop in March 2019, Martin Leon, MD (Columbia University Medical Center), Aaron Kaplan, MD (Dartmouth-Hitchcock, Serial Entrepreneur), Michael Mack, MD (Baylor), Chip Hance (Regatta Medical) and David R. Holmes, Jr., MD (Mayo Clinic), conceived a meeting focused on the issues of Early Feasibility Studies from the clinicians’ perspective. Specifically, the meeting focused on the following three areas:

●Identification of relevant patient population/Patient screening
●Patient consent
●Procedural and clinical follow-up issues

The program addressed these specific topics with different presentations followed by robust audience participation for discussion with clinical investigators and industry sponsors. This program took place on Wednesday, June 12, 7:00-9:30 pm, at the Sheraton Grand in Chicago.
This event was sponsored by MDIC in collaboration with CRF.

Panelists Include:
• Howard C. Herrmann, Penn Medicine
• Vinod Thourani, Medstar Heart and Vascular Institute
• Michael Mack, Baylor Scott & White
• Scott Lim, University of Virginia
• Bernard Vasseur, FDA

Event Materials:
Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.

 

Individual Event Materials:

Full Event PDF Packet:
EFS Symposium at TVT 2019 PDF Packet

April 23, 2020

This online training course was developed to provide users with a high-level overview of the proposed Corrective and Preventive Action (CAPA) process, including insights for auditors.

November 6, 2019

MDIC held its final Case for Quality Forum of 2019 on November 6 in Arlington, VA. Download slides from the forum below.

April 7, 2020

Welcome and Introductions


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MDIC Case for Quality Overview


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Strategic Foresight Session


Download Summary

Panel Discussion: VIP and Expansion


Download CDRH Slides
Download CMMI Slides

Presentation: MDIAS SafeSpace


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Advanced Manufacturing Working Group Update


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Fixing CAPA Working Group Update


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VIP Working Group Update


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NCS Pilot Working Group Update


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Debrief and Q&A

Closing Remarks and Next Steps


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March 13, 2020

February 26, 2020

 

In 2017 and 2019, MDIC collected metrics in the first ever collaborative sharing of Sponsor administrative data. Average time from the site packet received at the site to first patient enrolled was improved from 320 days to 252 days thanks to improvements in IRB review cycles and more timely first patient enrollment. However, contract negotiations between sponsors and sites – and more specifically reaching agreement on a study budget – actually worsened from an average of 133 days to 164 days. Reaching agreement on a contract and budget, a purely administrative (yet, critical) task in clinical trial setup is taking nearly six months in back and forth between sponsors and sites thereby delaying the actual performance of the clinical study.

MDIC has collaborated in two workshops with Baylor Scott & White Research Institute to develop an EFS Master Clinical Trial Agreement (MCTA) template to help sponsors and sites streamline this aspect of contracting. EFS Study Sponsors who have used the agreement report that contract negotiations based on the MDIC MCTA template have enabled some contract negotiations to be completed in as little as a month – a dramatic improvement.

MDIC sought to bring the same effort on improving the efficiency of sponsor-site budget negotiations as has been demonstrated in contracting. Budget negotiations are consistently troublesome and rank the highest of issues to address to streamline EFS studies going forward. On February 26, 2020 in Arlington, VA, MDIC led a workshop of leading sponsors and sites with extensive EFS experience to share EFS budgeting best practices and roundtable discussions to identify concrete improvement steps that can be taken.

The objectives for the one-day workshop were:

• Share leading sponsor and leading site best practices for timely and efficient EFS budget negotiations
• Consolidate these best practices and determine as a group those approaches that will make the biggest differences across the landscape of sites and sponsors
• Establish a working group from interested participants who want to standardize budgeting approaches and communicate them throughout the medical device clinical trial ecosystem

Workshop Materials:

Download workshop materials below. Note: File opens in web browser by default. Please save the file and open in a compatible PDF viewer to utilize navigation indexes.

Individual Event Materials:

Conclusions & Next Steps | Chip Hance, Jaime Walkowiak, Liliana Rincon-Gonzalez

 

Full Event PDF Packet:

 

February 26, 2020

The NESTcc Methods Framework is applicable to many different data sources and defines the key components of a study protocol for the evaluation of medical devices.

The document promotes overall study design, outlining principles to follow and evidentiary requirements for core elements including disease and device information, target population and patient selection, study outcomes and procedures, sample size, monitoring and statistical analysis.