Medical Device Innovation Consortium - MDIC

📢 Just announced!

Micky Tripathi, National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services, will be speaking at the MDIC 2023 Annual Public Forum!

Dr. Tripathy will offer insights drawn from his two decades of expertise in the health IT landscape to discuss the imperative of health information interoperability, the current landscape with regard to information blocking policy and data sharing, and the future of a health care system driven by data-rich medical devices.

Register Now!
https://whova.com/portal/registration/mapf_202306/

📣 Just announced!

HHS Deputy Secretary and health policy veteran Andrea Palm will participate in the MDIC 2023 Annual Public Forum!

In this highly anticipated session, HHS Deputy Secretary and health policy veteran Andrea Palm will share her leadership perspective on preventing cyberattacks in the health care system, raising the level of cybersecurity expertise and preparedness, and ensuring resilience among hospitals and other health care organizations.

Register Now! https://whova.com/portal/registration/mapf_202306/

We are thrilled to announce that registration for MDIC's 2023 Annual Public Forum, scheduled for September 19-20 in Washington, DC, is now open! The theme is Insight. Innovation. Impact. This once-a-year event will bring together industry experts, patient advocates, regulators, and other community innovators to transform the future of medical technology and diagnostics. Topics to be discussed: health equity, cybersecurity, real-world evidence, and more.

Register here: https://whova.com/portal/registration/mapf_202306/

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In Case You Missed It ( ): The Article "Early Feasibility Study programme has potential to advance US neurovascular space" discusses MDIC's Early Feasibility Studies program and its role in the advancing neurovascular space.

"At a time when many of Europe’s medical technology markets are effectively going backwards due to complications created by the EU Medical Device Regulation (MDR), corresponding sectors in the USA are receiving an inevitable boost. Alongside the US Food and Drug Administration (FDA), the country’s leading clinicians and industry figures have seized this opportunity—and, thanks to the Early Feasibility Study (EFS) programme, can now potentially play a leading role in advancing novel devices within the neurovascular space."

Visit https://mdic.tech/3qQu5bB to read the full article from NeuroNews!

EFS Express is a quarterly newsletter that provides updates on MDIC's early feasibility studies (EFS) projects, shares educational resources, and highlights EFS success stories and best practices.

Visit https://mdic.tech/44U3FVO to sign up and receive updates on all things Early Feasibility Studies!

In vitro testing of hemolysis and thrombosis is essential for the development of various blood-contacting devices. Computational fluid dynamics (CFD) has also proven to be a useful, complementary tool for understanding mechanical sources of damage, i.e. shear stress, exposure time, and recirculation, but it lacks clear regulatory impact. The goal of the MDIC Blood Damage Modeling Working Group is to generate credible physical test data that can then be used to support the development and validation of computational models of blood damage. These models will help medical device developers understand and optimize their devices to minimize the effects of blood damage during the product development stage and, potentially, assist in assessing safety in a regulatory submission. The group is comprised of industry members developing blood-contacting devices and scientists from the US FDA, Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Labs (OSEL).

MDIC and MDIC's Computational Modeling and Simulation Steering committee welcome subject matter experts who are excited to assist with the development and evaluation of in vitro or in silico methods for estimating mechanical blood damage.

Contact [email protected] for more information.