Welcome to the MDIC Resource Library

This library offers a comprehensive collection of reports, studies, and publications for and about the medical device and diagnostics industry. The Resource Library is just one more valuable information-sharing service MDIC offers to the public in order to share the work that we’re doing to advance the future of healthcare for patient benefit.

Innovative Reimbursement Strategy for Digital Therapeutics

Chronic pain has a substantial economic impact on the United…

How Can Medical Device Manufacturers Make Best Use Of Patient Preference Information?

There is a growing need for real-world-evidence (RWE) and patient…

Integrating Real-World Evidence Into Evidence Generation Strategies To Expand Payer Coverage and Improve Patient Care

The importance of integrating real-world evidence (RWE) into…

Science of Patient Input (SPI) Survey on Digital Health Technologies and Patient Input

IMPACT – CfQcc Quarterly Newsletter

Make CAPA Cool White Paper

This white paper is a continuation of a transformational CAPA…

Advanced Manufacturing in Action: A look at Gore’s Digital Transformation

Advanced Manufacturing in Action: A look at Gore’s Digital…

Early Feasibility Studies Electrophysiology Best Practices Workshop Key Insights Report

Advanced Manufacturing Clearing House (AMCH) Overview

Landscape Report & Industry Survey on the Use of Computational Modeling & Simulation in Medical Device Development

Landscape Analysis of 5G in Healthcare

The Landscape Analysis of 5G in Healthcare surveys the role of…

5G Security Enhancements

The 5G Security Enhancements one-page overview outlines several…

How Can Patient Preference Information Be Used in Payer Coverage Decisions and Health Technology Assessment?

The white paper How Can Patient Preference Information be Used…

Using Patient Preference Information in the Design of Clinical Trials Framework

MDIC Medical Device Cybersecurity Maturity: Industry Benchmarking Report 2022

Case for Quality Forum – Leadership Engagement & Voluntary Improvement Program (VIP)

FDA CASE FOR QUALITY: 2018 COMPREHENSIVE REVIEW

The Medical Device Innovation Consortium (MDIC) has had…

External Evidence Methods Framework

MDIC’s External Evidence Methods (EEM) program aims to…

Playbook for Threat Modeling Medical Devices

Medical devices are increasingly complex systems that exist in…

MDIC Public Forum: RWE in the Context of Payer Decision-Making

IVD RWE Education Series Module 1: Application of the MDIC IVD RWE Framework

The purpose of this series is to provide education on key aspects…

IVD RWE Education Series

The Road to Advanced Manufacturing in the Medical Device Industry

The medical device industry is in a unique position today. The…

Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens

Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

Patient Engagement in Clinical Trials – Literature Review

This document provides an updated Literature Review for the…

MDIC Patient Engagement Forum Lessons Learned

The Medical Device Innovation Consortium (MDIC) Virtual Patient…

Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives

Case for Quality Video Series

Emerging HealthTech Series: Case for Quality

Learn more about…

Frequently Asked Questions about the ASC Pilot Study

Leadership Engagement Playbook

A culture of quality in life sciences organizations transcends…

Accelerate Sustainable Capability Pilot Study: Pilot Site Playbook

The objective of this pilot study is to leverage a quality system…

Case for Quality Forum: December 7-8, 2020

MDIC-FDA Workshop: Advancing EUA IVD Products Toward Full Marketing Status

Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices

Appropriate communication of benefits, risks, and uncertainty…

Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs)

The MDIC In Vitro Diagnostic (IVD) Real-World Evidence (RWE)…

Screening Consent Form: Informed Consent and HIPAA Authorization

Cardiology Research at Columbia University Irving Medical Research…

2019 EFS Best Practices Workshop

EFS Symposium: Implementation Strategies for Early Feasibility Studies at TVT 2019 Structural Heart Summit by the Cardiovascular Research Foundation

Following the MDIC’s EFS Site Best Practices workshop in March…

CAPA Process Improvement Auditor Training

This online training course was developed to provide users with…

Case for Quality Forum: March 12, 2020

Welcome and Introductions


Download Slides

MDIC…

EFS Budgeting Best Practices Workshop

February 26, 2020
 

In 2017 and 2019, MDIC collected…

NESTcc Methods Framework

The NESTcc Methods Framework is applicable to many different…

NESTcc Data Quality Framework

The NESTcc Data Quality Framework focuses primarily on the use…

Incorporating Patient Perspectives in Clinical Trial Design and Research

Parkinson’s patients Margaret Sheehan and Anne Cohn Donnelly,…

EFS Express Archive

Case for Quality: CAPA Process Improvement

Case for Quality Forum: November 6, 2019

MDIC held its final Case for Quality Forum of 2019 on November…

EFS Symposium: Implementation Strategies for Early Feasibility Studies Presentations

On June 12, 2019, MDIC partnered with the Cardiovascular Research…

Clinical Diagnostics Somatic Reference Samples Request for Proposals

View a Q&A webinar about this Request for Proposals here…

Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs)

This Framework is intended to help test sponsors make decisions…

Surrogate Sample Harmonized Education Modules

Surrogate samples, when properly used, can not only decrease…

Case for Quality Forum: June 20, 2019

Keynote Panel: Intersection of Quality and Cybersecurity


 

 

Intersection…

Patient Engagement in Clinical Trials Survey Report

MDIC surveyed 53 device and diagnostic industry stakeholders…

Literature Review: Patient Engagement in Clinical Trials

This document provides an updated Literature Review for the Medical…

Case Study: Using the MDIC Patient-Centered Benefit-Risk Framework to Support an Expanded Indication

Home hemodialysis device manufacturer, NxStage, used the MDIC…

Clinical Diagnostics Somatic Reference Samples Request for Information (RFI)

This RFI is a request for technical information about available…

SRS Landscape Analysis Report

The Landscape Analysis report was created from the work conducted…

Case for Quality Forum: February 25, 2019

Below are downloadable files from the Case for Quality Forum.

MDIC PCOR Project: From P-Values to Patient Values in Parkinson’s Disease Workshop Summary

On May 18, 2018, MDIC convened a workshop to discuss the outcomes…

Additional Resources & FAQ’s about Conducting Patient Preference Studies

Case for Quality Forum: November 27, 2018

Welcome and goals for the day – Beth Staub | Slides

Keynote:…

Patient Centered Benefit-Risk (PCBR) Framework

Press Release: Patient Preference Collaboration

Patient Centered Outcomes Research Project Overview

TVT 2017 EFS Presentation

EFS/FIH Perspectives Report

MDIC EFS Blueprint

EFS Background Information: IRBs and Site Study Staff

When hospital administration, research staff and IRB members…

Patient Introduction to Consent for Early Feasibility Studies

EFS Patient Informed Consent Form template

A template of a patient Informed Consent Form (ICF) for adult…

EFS Master Clinical Trial Agreement (MCTA)

Early Feasibility Study (EFS) Contracting Resource: Negotiation Range Process and Language Libraries

2017 MDIC EFS Metrics Report: Administrative and Clinical Practices 

EFS Participant Landscape

Maturity Model Report

Medical Device Quality Metrics White Paper

Medical Device Quality Outcomes Analytics Report

Capturing The Value Of Good Quality In Medical Devices

Video: Dr. Jeff Shuren, Director of CDRH, FDA Discusses Case for Quality

Resource Center for Sustained Quality

Somatic Reference Sample Project Proposal

Surrogate Sample Use Survey Results

Surrogate Sample Framework

Medical Device Cybersecurity Report 

Cybersecurity in the Medical Device Sector: Coordinated Vulnerability Reporting RFP

Q&A with Marc Horner

The technical lead for health care at ANSYS reflects on current…

Q&A with Kyle Myers

MDIC Computer Modeling and Simulation (CM&S) project FDA…

Case for Quality Open Forum: September 27, 2018

Welcome and goals for the day – Joe Sapiente | Slides

Fixing…

Case for Quality Open Forum: June 27, 2018

Keynote: TOYOTA North America –  Quality Mindset & Culture…

Case for Quality Open Forum November 15, 2017

MDIC Case for Quality – Beth Staub

Keynote: CDRH’s Commitment…

Case for Quality Open Forum July 20, 2017

Welcome – Bill Murray and Beth Staub | Video

Keynote:…

Case for Quality Open Forum Focused on CfQ Working Groups and Adoption Plan Recommendations October 26, 2016

MDIC Maturity Model– George Serafin, Vizma Carver, Becky Fitzgerald,…

Case for Quality Open Forum Focused on Product Quality Metrics June 28, 2016

Medical Device Quality Metrics – Xavier Health/Xavier University

Metrics…

Case for Quality Open Forum May 10, 2016

May 10, 2016 – Case for Quality Open Forum Replay

May 10,…

Case for Quality Open Forum October 8, 2015

2015 Oct 8 – MDIC CfQ Open Forum – Fiorino

Competency…

Case for Quality Open Forum June 24, 2015 Online

Webinar Presentation