Our Work
Explore MDIC's Impact
MDIC can empower your innovation at every phase of the total product lifecycle. Explore the work happening within each of our programs to discover resources that will transform your company’s journey.
Advanced Manufacturing
Case studies and tool kits on adopting advanced technology across the total product lifecycle, an essential resource collection for every manufacturer seeking to improve design, supply, production, distribution, tracking, device reliability, overall quality, and safety.
Case for Quality
Since 2014, FDA has worked with the MDIC and other stakeholders to foster an elevated level of collaboration between the agency and the medical device industry and to launch initiatives that vary from traditional oversight models.
The Advancing Quality Excellence Collaborative Community (AQEcc), formerly known as the Case for Quality Collaborative Community, offers a unique opportunity…
Clinical Diagnostics
The AI/ML project aims to build on AI/ML best practices designed for imaging and other applications to develop an industry…
The Data Standardization project is taking practical steps towards developing data standard recommendations within the in vitro diagnostic ecosystem. Focusing…
The Open Hand project offers a unique approach to the regulatory review process in which IVD manufacturers engage with an…
The Somatic Reference Samples (SRS) Initiative seeks to create well-characterized reference samples to validate NGS-based cancer diagnostics. Funded by industry…
The Specimen Stability project will develop a best practices framework to establish short-term specimen stability recommendations. Using the 2023 CLSI…
Computational Modeling & Simulation
Paving the way for evaluation of 21st-century medical devices. The Computational Modeling and Simulation (CM&S) Program was developed to achieve…
Human body simulation models provide insight into clinical performance of medical devices and can potentially improve patient care by accelerating…
Cybersecurity
Cyber threats pose significant risks to patient safety and accessibility. MDIC Cybersecurity program promotes and benchmarks mature risk management practices and nurtures…
Medical Device Cybersecurity Benchmarking aims to improve overall industry cybersecurity risk by providing participating companies with a high-level assessment of…
A key piece of managing medical device and diagnostic cybersecurity risks is the integration of threat modeling (TM). TM provides…
Penetration testing, or ethical hacking, involves simulating cyber-attacks to identify and address vulnerabilities in systems before malicious actors can exploit…
Digital Pathology
Convened by MDIC the "Pathology Innovation Collaborative Community" (PIcc) uniquely elevates discourse, identifies challenges, and establishes better practices for digital…
Early Feasibility Studies
Medical technology developers often conduct feasibility studies outside the U.S., which delays patient access to new technologies. The FDA’s Early…
Health Economics & Patient Value
The Health Economics & Patient Value (HEPV) program is a strategic MDIC initiative focused on advancing the field of evidence…
Medical Device Software & AI
Global regulatory frameworks involving digital health technologies, particularly for the areas of medical device software including Artificial Intelligence and Machine…
The PCCP discussed in FDA’s 2019 AI Discussion Paper and 2021 AI Action Plan enables software developers to describe anticipated…
FDA currently has in place a 510(k) software modification guidance that provides guidelines and a flow chart on when modifications…
Medical Extended Reality
The primary objective of the Medical Extended Reality (MXR) Program is to advance the safe and effective implementation of medical…
The purpose of the MDIC 5G Enabled Healthcare initiative was to gather ideas that would facilitate the incorporation of 5G…
The MDIC MXR Regulatory Science of Surgical Applications Project has involved key stakeholders from industry, healthcare, academia, and government to identify…
Real World Evidence - NEST
Science of Patient Input
Collaborating to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations…
Established in tandem with the initial creation of MDIC itself, Patient Preferences have been a core pillar of MDIC's and…
Provide framework and pathway for industry to incorporate patient input and patient centricity throughout device development and each stage of…
Evaluate how the industry evaluates the rapidly growing implementation of Digital Health Technologies (DHTs) within the MedTech field., and how…