May 11, 2022

The Medical Device Innovation Consortium (MDIC) has had the privilege
of partnering with the FDA Center for Devices and Radiological Health (CDRH)
to advance the Case for Quality, a transformational initiative to shift the medical device industry from a focus on regulatory compliance to a focus on quality maturity.

This kind of cultural shift doesn’t happen overnight. MDIC, FDA and our industry partners have worked together to develop tools and methods to encourage and appropriately incentivize quality practices.

Beyond the tools, MDIC has sought to cultivate trust between medical device manufacturers and the FDA. That trust is fundamental to developing a culture based on a mutual commitment to quality maturity practices, rather than “check the box” compliance activities.

In December 2017, CDRH launched the Voluntary Medical Device Manufacturing and Product Quality Program Pilot, utilizing a maturity model refined
in collaboration with the Capability Maturity Model Integration (CMMI) Institute, MDIC, and regulatory and industry partners. The maturity model is leveraged as a resource for medical device organizations to measure their capability to produce high quality, safe and effective devices.

This measurement can then be used by organizations to drive targeted continuous improvement activities throughout their facilities. For manufacturers who complete the independent (third party) appraisal of quality maturity, the FDA will adjust their engagement activities and modify their submission requirements and routine inspection plans.

Industry participation is critical to long-term implementation of the maturity model as an alternative to the traditional path of a routine FDA inspection. Participation in the pilot requires an investment, both of personnel and money.

However, companies will receive many valuable benefits. Participating companies can expect to improve organizational processes and reduce variability that could lead to reduced costs of quality, decreased rework, and increased return on investment.

The FDA will also benefit from this program by potentially reducing the internal resources required for evaluation of inspections and manufacturing review submissions. The combined focus on safety and quality can be a win-win for both FDA and manufactures as we advance the health and safety of patients.


May 10, 2022

MDIC’s External Evidence Methods (EEM) program aims to assist stakeholders with use of EEM, such as new, innovative, and existing methods for evidence fusion from data external to a clinical study. The purpose of incorporating external data is often to create efficiency in medical product development and regulatory decision-making, thereby bringing new, safe, and effective technologies to market sooner to help patients in need. External data may also provide insights into the clinical performance of the diagnostic device being studied. External data can potentially be used in regulatory decision-making throughout the total product life cycle (TPLC).

MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical device manufacturers, the document catalogs different sources of external data and some of the traditional and novel statistical methods (Frequentist and Bayesian) applicable to the design and analysis of a clinical study in which external data play a role. It also provides references to actual past studies leveraging external data in which some of these statistical methods were successfully applied to support the approval/clearance of medical devices, or the modification of their indications. In all these examples, the external data being leveraged are subject-level data. Most methods cataloged in this document rely on subject-level external data for their implementation.

This framework is in alignment with other MDIC’s initiatives, including the National Evaluation System for health Technology Coordinating Center’s (NESTcc’s) mission of accelerating the timely, reliable, and cost-effective development of RWE to enhance regulatory and clinical decision-making. The EEM Framework expands the repertoire of MDIC resources that focuses on reliable and cost-effective Real-World Evidence (RWE) throughout the medical device total product lifecycle NESTcc’s Research Methods Framework and Data Quality Framework as well as the Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs) Framework.

Purpose of the EEM Framework

This framework is intended to help stakeholders navigate their way through leveraging external data by:

1. Cataloging different sources of external data
2. Cataloging statistical methods that can be considered to leverage external data
3. Considering uses of external data, when appropriate, for regulatory decision-making for medical devices
4. Providing examples to illustrate the application of various statistical methods where external data have been leveraged

If you would like to learn more about the project as well as explore the opportunities for collaborating with MDIC, please contact us at

Click here to download the framework.

November 23, 2021

Medical devices are increasingly complex systems that exist in complex connected ecosystems of healthcare delivery and are thereby prone to cybersecurity vulnerabilities. For several years, the Food and Drug Administration (FDA) has recognized the value of threat modeling as an approach to strengthen the cybersecurity and safety of medical devices. To increase adoption of threat modeling throughout the medical device ecosystem, FDA engaged with the Medical Device Innovation Consortium (MDIC), the MITRE Corporation, and Adam Shostack & Associates to conduct threat modeling bootcamps in 2020 and 2021. The Playbook has been developed by this team based on the learnings from those bootcamps to further increase the outreach and adoption of threat modeling best practices for medical devices.

Note that the Playbook is not prescriptive in that it does not describe one approach to be used when threat modeling medical devices but focuses on general threat modeling principles. The Playbook can be used as a resource for threat modeling training within an organization. Individuals can work through the examples, filling in the details left to the reader, applying the different methodologies discussed in the Playbook to those gaps, and researching additional approaches using the references in the playbook as starting points. An organization could develop its own training using the Playbook as a basis.

The playbook can also be used to educate stakeholders on threat modeling: what it is, its role in improving product safety and security, and how it fits with quality processes. For example, the playbook may help:

  • product line managers understand how threat modeling fits into existing processes;
  • systems engineers to understand how threat modeling informs design requirements;
  • design engineers and architects understand how threat modeling informs design choices;
  • design verification and validation (V&V) engineers understand how to use threat models in designing test strategies;
  • regulatory specialists understand how to present and document threat models; and,
  • contract manufacturers and consultants who may not be experienced in threat modeling.

Each of these stakeholders can select the portions of the playbook that can help them fulfill their roles and responsibilities in making their devices safe and secure.

This Playbook has benefited significantly from contributions and feedback made by numerous individuals and organizations including the bootcamp participants and facilitators. We are grateful to these contributors for their willingness to share their expertise and invest their valuable time to ensure that this playbook will be useful to the industry.

Please email us to provide the feedback or comments on the Playbook OR to enquire about upcoming threat modeling bootcamps for medical device stakeholders.

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


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.