October 12, 2021
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
Audience
Sponsors and regulators who want to use RWD and real-world evidence (RWE) in regulatory submissions.
October 1, 2021
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
October 12, 2021
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.
The modules are based on webinars created by Marina Kondratovich, Ph.D., associate director for clinical studies in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).
Module 1 Webinar:
June 1, 2021
This document is intended to serve as a study design blueprint for analytical validation of IVDs using capillary whole blood specimens collected by fingerstick, herein referred to as “fingerstick” or “FS” specimens.
This document provides general guidance on considerations for study design. Considerations for specific devices may require modifications to implement these studies.
Reading and following this document does not guarantee either FDA approval/clearance or payment from insurance companies.
The Blueprint is organized into seven key sections:
- Section One: Introduction introduces the scope of the Blueprint, provides key definitions and explanation of acronyms, and reviews regulatory considerations of point of care testing (POCT) devices.
- Section Two: Study Designs for Candidate Device Clearance/Approval as a Non-Waived Test reviews design considerations including collection and testing sites and operators, overall study design for FS and FS and venous whole blood (WB) specimens, and detailed considerations for method comparison studies and precision studies.
- Section Three: Study Designs for CLIA Waiver Application for the Candidate Device reviews design considerations including collection and testing sites and operators, as well as the sequential and dual approaches for CLIA waiver studies for non-waived and new devices, respectively.
- Section Four: Considerations for the Use of Surrogate Samples outlines design considerations for method comparison studies and precision studies that use surrogate samples.
- Section Five: Considerations for Data Analysis in Method Comparison Studies discusses over sampling in method comparison studies and considerations for data analysis, including visual presentation of data, regression analysis, and bias at medical decision levels (MDLs).
- Section Six: Considerations for Data Analysis in Precision Studies reviews components of variability and considerations for visual presentation of precision study data.
- Section Seven: Additional Considerations for Precision Studies with Fingerstick (FS) Specimens reviews additional precision study design considerations not covered earlier in the Blueprint.
April 5, 2021
There are key distinctions between device trials and drug trials that present unique opportunities, challenges, and resource needs for engaging patient insights in the device field. In developing this report, the Science of Patient Input (SPI) Participation in Clinical Trials Working Group of the Medical Device Innovation Consortium evaluated a series of device trial characteristics (level of invasiveness, outcomes assessment, trial enrollment, and trial design) and prioritized them based upon their relevance for patient engagement.
It is hoped that this report provides a concise set of considerations for medical device developers to evaluate as they pursue patient engagement in their clinical trials and product development activities. Recognizing that this work is complex and made increasingly so by the heterogeneity of the device development landscape and understanding that no single compilation of information can provide everything a sponsor would need, the resources presented within this report are offered as a foundation from which sponsors can advance their efforts to generate and incorporate patient input into trial design and conduct.
March 17, 2021
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.
March 8, 2021
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 the Forum included presentations, panel discussions, and interactive activities inspired by the best practices and examples contained within the recently released MDIC Best Practices for Communicating Benefit, Risk, and Uncertainty Report.
Overall, this event offered the medical device community a platform from which to evaluate current communications efforts, identify gaps, and prioritize additional needs for advancing progress on this topic. Key lessons learned and themes emerging from the Forum provide the foundation for this report.
March 2, 2021
As part of the Science of Patient Input (SPI) Initiative to develop a Framework for Patient Input in Medical Device Clinical Trials, the Medical Device Innovation Consortium (MDIC) conducted three surveys and one set of telephone interviews to compile information about patient engagement activities among device and diagnostic industry stakeholders, individuals identifying as patients, and a select group of medical device study investigators. Collectively, the information gleaned from these three surveys provides detailed perspectives on patient engagement during clinical research from key stakeholders in medical device clinical trials. This information will also be incorporated into the MDIC’s report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials.
In 2018, MDIC surveyed 53 device and diagnostic industry stakeholders and separately surveyed 123 individuals identifying as patients. The goal of the complementary surveys was to inform future work to develop guidelines for industry on how to involve patients in the design of clinical trials. For the third survey in 2020, we focused on investigators who received research funding from the Patient-Centered Outcomes Research Institute (PCORI) because PCORI requires investigators to engage patients and other stakeholders in their study.
Current as of March 2, 2021
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