The purpose of this series is to provide education on key aspects related to using real-world evidence (RWE) in regulatory submissions. The series expands upon the content presented in the Medical Device Innovation Consortium (MDIC) In Vitro Diagnostic (IVD) RWE Framework.
Module 1 Overview
This module covers:
- Study design considerations for an IVD clinical performance study using real-world data (RWD) to support a premarket submission
- A step-by-step comparison of traditional IVD clinical study (wet study) design and a study design that uses RWD (dry or virtual study) for a hypothetical IVD
- How to address missingness in RWD
Sponsors and regulators who want to use RWD and real-world evidence (RWE) in regulatory submissions.
The medical device industry is in a unique position today. The industry has seen increased attention due to COVID-19 and the impacts of the pandemic, and the issues it presented for companies to meet the new demand. These circumstances have raised many questions about the state of the industry. Medical device companies that are leading the digital transformation to advanced manufacturing technologies moved to a remote work environment and barely slowed down as the pandemic raged. Those behind and still reliant on paper-based or disconnected processes have seen production slow, employees become less productive, and have been slower to introduce new products to the market. While other situations may have caused similar issues, none have gained more people’s attention than what transpired in 2020.
With this unique position comes opportunity – the opportunity to finally make a case for embracing advanced manufacturing technologies. Technology partners are eager to help the industry modernize and become an agile force in the future, capable of adapting to any unexpected disruption that may come along. It’s also an opportunity to improve product quality, reduce costs, speed up new product introduction, and not only meet regulatory standards, but exceed them.
All of this is possible. This paper will take you on a journey to advanced manufacturing and lay out the benefits, the roadblocks and how to navigate around them. With the attention and focus on the medical device industry, there has never been a better time than now. Regardless of where you are on the journey, there is a path to advanced manufacturing, and it starts here.
The white paper covers the following topics:
- What is advanced manufacturing?
- Medical device industry drivers
- Advanced manufacturing enabling technology
- Digital threads
- Current adoption of advanced manufacturing techniques
- Current state of the medical device industry
- Survey results and analysis
- The path forward
This document provides an updated Literature Review for the Medical Device Innovation Consortium (MDIC) Science of Patient Input (SPI) Working Group for submission as a deliverable under the MDIC Broad Agency Agreement (BAA) contract.
This high-level review reflects a broad scan of publicly available information about relevant organizations, initiatives, materials, and publications.
While it is up to date as of December 2020, this summary is not exhaustive and should be viewed as a representative snapshot of activities and resources within the highly active and evolving field of patient engagement in clinical research. As new organizations, resources, and publications are being developed and launched continually, this work should be updated regularly to ensure its completeness and relevance over time.
The Medical Device Innovation Consortium (MDIC) Virtual Patient Engagement Forum held on November 18, 2020, engaged approximately 100 participants, including patients, patient advocates, medical device leaders, regulators, healthcare providers, payers, and experts in communication and shared decision-making. Participants joined in a day-long, interactive meeting focused on communicating benefit-risk and uncertainty for medical devices. Content for […]