“Tariffs may have negative consequences for a continually growing market due to an aging population and the increasing prevalence of long-term illnesses. Companies will be forced to increase prices to make up for losses incurred by the proposed tariffs which may cause supply chain disruptions.”
Could MedTech find itself as the collateral damage if an RFK Jr. run HHS “goes wild” with FDA regulation of pharma and processed foods?
AI and real-time data enhance care efficiency and access. And with healthcare workers in short supply, the rapid advancements in AI, IoMT, and related innovation offer patient access freedom, enhanced care delivery, and better outcomes.
MTI Regulatory Report 2024 data overwhelmingly suggests regulatory resources throughout the industry are being stretched. Time/Bandwidth is the top medical device regulatory challenge faced during 2024, potentially leading to industry-wide regulatory fatigue and driven by changing global compliance regulations in recent years.
Nearly 2/3 of device makers say their regulatory intelligence may be insufficient and they lack the resources to complete all product compliance needs this year. See the executive summary of this MedTech Intelligence audience research.
An analysis from the Life Sciences legal team at Hogan Lovells.
As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.
FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.”
The Exploit Prediction Scoring System (EPSS) can help healthcare organizations prioritize security vulnerabilities, but it has limitations in IoMT environments. While EPSS provides valuable data-driven prioritization, it should be combined with other risk assessments, cybersecurity frameworks, and strategies to more comprehensively secure healthcare systems’ IoMT devices.
Information polarization affects public opinion. It can also affect investors. As we approach upcoming elections in different countries, it is crucial to understand how these political events could significantly reshape the landscape for MedTech investments. This article outlines an approach to help investors navigate and understand the interplay of political climates, cultural norms, and healthcare policies without getting emotionally attached to them. It emphasizes the importance of open dialogue, diversity, critical thinking, and cross-cultural collaborations to determine the true potential of MedTech innovations.
