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

Advanced Manufacturing accelerates industry adoption of advanced technologies to improve production processes, quality and safety.

Advanced Manufacturing Clearing House

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

Case for Quality promotes a holistic, data-driven approach to quality across the device lifecycle, addressing inconsistencies that impede safety and process, and enhancing outcomes for manufacturers.

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.

Advancing Quality Excellence Collaborative Community

The Advancing Quality Excellence Collaborative Community (AQEcc), formerly known as the Case for Quality Collaborative Community, offers a unique opportunity…

Clinical Diagnostics

Clinical Diagnostics advances tools, models, and methods to create clear and compelling evidence during diagnostic development.

Artificial Intelligence and Machine Learning for In Vitro Diagnostics

The AI/ML project aims to build on AI/ML best practices designed for imaging and other applications to develop an industry…

Data Standardization

The Data Standardization project is taking practical steps towards developing data standard recommendations within the in vitro diagnostic ecosystem. Focusing…

Open Hand

The Open Hand project offers a unique approach to the regulatory review process in which IVD manufacturers engage with an…

Somatic Reference Standards Initiative

The Somatic Reference Samples (SRS) Initiative seeks to create well-characterized reference samples to validate NGS-based cancer diagnostics. Funded by industry…

Specimen Stability

The Specimen Stability project will develop a best practices framework to establish short-term specimen stability recommendations. Using the 2023 CLSI…

Computational Modeling & Simulation

Computational Modeling & Simulation reinforces science, tools, and practices to drive validity and adoption of models and simulations.

Computational Modeling & Simulation - Overview

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

Human body simulation models provide insight into clinical performance of medical devices and can potentially improve patient care by accelerating…

Cybersecurity

Cybersecurity promotes and benchmarks mature risk management practices and nurtures approaches to address system-level risks.

Medical Device Cybersecurity - Overview

Cyber threats pose significant risks to patient safety and accessibility. MDIC Cybersecurity program promotes and benchmarks mature risk management practices and nurtures…

Cybersecurity Benchmarking

Medical Device Cybersecurity Benchmarking aims to improve overall industry cybersecurity risk by providing participating companies with a high-level assessment of…

Cybersecurity Threat Modeling

A key piece of managing medical device and diagnostic cybersecurity risks is the integration of threat modeling (TM). TM provides…

Medical Device Penetration Testing

Penetration testing, or ethical hacking, involves simulating cyber-attacks to identify and address vulnerabilities in systems before malicious actors can exploit…

Digital Pathology

The Pathology Innovation Collaborative Community advances accurate and timely diagnoses by establishing better practices for digital pathology, diagnostics and research.

Pathology Innovation Collaborative Community

Convened by MDIC the "Pathology Innovation Collaborative Community" (PIcc) uniquely elevates discourse, identifies challenges, and establishes better practices for digital…

Early Feasibility Studies

Early Feasibility Studies drives efficiency, timely testing, and faster access to innovative treatments by removing barriers to effective early clinical studies.

Early Feasibility Studies - Overview

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

Health Economics & Patient Value advances evidence generation to meet payer requirements for coverage decision making.

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

Medical Device Software & AI facilitates data sharing, promotes the use of real-world evidence, and educates stakeholders on regulatory pathways.

Medical Device Software & AI - Overview

Global regulatory frameworks involving digital health technologies, particularly for the areas of medical device software including Artificial Intelligence and Machine…

Pre-determined Change Control (PCCP)

The PCCP discussed in FDA’s 2019 AI Discussion Paper and 2021 AI Action Plan enables software developers to describe anticipated…

Software Design Considerations

FDA currently has in place a 510(k) software modification guidance that provides guidelines and a flow chart on when modifications…

Medical Extended Reality

Medical Extended Reality advances regulatory science for surgical, therapeutic, and diagnostic applications of extended reality technology.

Medical Extended Reality (MXR) - Overview

The primary objective of the Medical Extended Reality (MXR) Program is to advance the safe and effective implementation of medical…

5G Enabled Healthcare

The purpose of the MDIC 5G Enabled Healthcare initiative was to gather ideas that would facilitate the incorporation of 5G…

Medical Extended Reality (MXR) Regulatory Science of Surgical Applications

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

NEST leverages a unique public-private partnership to catalyze the use of real-world evidence across the medical technology ecosystem.

Science of Patient Input

Science of Patient Input creates resources and methods for the inclusion of patient voices during device development.

Science of Patient Input - Overview

Collaborating to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations…

Adopting Patient Preference in Device Development

Established in tandem with the initial creation of MDIC itself, Patient Preferences have been a core pillar of MDIC's and…

Modeling Patient Engagement Throughout TPL

Provide framework and pathway for industry to incorporate patient input and patient centricity throughout device development and each stage of…

Patient Centered Digital Health

Evaluate how the industry evaluates the rapidly growing implementation of Digital Health Technologies (DHTs) within the MedTech field., and how…