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 cybersecurity@mdic.org to provide the feedback or comments on the Playbook OR to enquire about upcoming threat modeling bootcamps for medical device stakeholders.

October 28, 2021
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 
June 1, 2021

April 5, 2021

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 […]