MDIC In the News: NEST’s Simon Mason Discusses Real World Evidence Studies

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation.

Participate in the 2024 MDIC Medical Device Cybersecurity Benchmarking Assessment

The MDIC Maturity Cybersecurity Benchmarking Assessment evaluates cybersecurity maturity across the medical device sector. Developed in collaboration with the Health Sector Coordinating Council (HSCC) and Apraciti, this comprehensive tool seeks to establish a standardized measure of cybersecurity practices, identify areas for improvement across the industry, and drive advancements in cybersecurity protocols for medical technologies.

APF 2024: Insights for Innovation and Patient Care

At the 2024 MDIC Annual Public Forum, the “Data Horizons: Insights for Innovation and Patient Care” panel brought together leaders from healthcare, research, and regulation to discuss the evolving role of real-world data (RWD) and real-world evidence (RWE) in shaping medical technology’s future. The panel emphasized RWE’s potential to streamline regulatory pathways and improve access to life-saving devices, while acknowledging the need for broader adoption to maximize its impact.

APF 2024: Shifting Paradigms in the Women’s Health Conversation

Only in the last decade has the global community started to tackle inequities for women in healthcare, from equal representation in clinical trials to reduced mortality. This increased focus is a welcome step toward innovation that moves beyond male biology as a ‘norm’— yet a one-size-fits-all approach misses the mark when it comes to representation of diverse populations. At the MDIC Annual Public Forum experts in women’s health convened to discuss these persisting inequities in health and to share visions of potential pathways to more targeted, effective, and equitable care.

MDIC In the News: SRS Initiative Update

Following a meeting at the MDIC Annual Public Forum, Maryellen de Mars, MDIC’s program director of clinical diagnostics, said in an interview that the consortium’s Somatic Reference Samples Initiative recently confirmed that it has successfully engineered the 10 target reference lines and is ready to start its next steps to confirm its results and establish use cases.

MDIC In the News: Andy Fish on Driving Positive Change in the Medtech Ecosystem

Following a meeting at the MDIC Annual Public Forum, Maryellen de Mars, MDIC’s program director of clinical diagnostics, said in an interview that the consortium’s Somatic Reference Samples Initiative recently confirmed that it has successfully engineered the 10 target reference lines and is ready to start its next steps to confirm its results and establish use cases.

APF 2024: Shaping the Future of Real-World Evidence and AI in Healthcare

The MDIC Annual Public Forum 2024 opened with impactful discussions led by experts from the National Evaluation System for health Technology (NEST)the Centers for Medicare and Medicaid Services (CMS), and the FDA, focusing on the future of real-world evidence (RWE) and the integration of AI into the healthcare ecosystem.

Freespira’s Strategic Approach to Market Access

Freespira, Inc. developed an innovative digital therapeutic treatment to address the need for accessible and effective solutions for panic disorder, panic attacks, and post-traumatic stress disorder (PTSD). As the first FDA-cleared, medication-free, at-home treatment, Freespira stands out in the crowded landscape of digital therapeutics, overcoming the limitations of traditional treatments.