MTI Viewpoint: I expect fundamental changes to our medical device ecosystem; not all companies will survive them. The ability to consistently use AI will also determine who will be among the survivors and even the winners. AI will not only be part of the devices but also an internal tool.
For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a vendor-neutral framework to finally achieve plug-and-play interoperability—unlocking scalable, AI-powered MedTech innovation and improving patient outcomes.
AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for free-market-driven deregulation.
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to raise awareness about cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors. These medical devices are used in health care and home settings for displaying information, such as the vital signs of a patient, including temperature, heartbeat, and blood pressure.
With a new executive order to leave the World Health Organization, the Make America Healthy Again (MAHA) movement is driving new policy and promises for faster time to market for product innovation. MedTech start-ups are keen to capitalize on the opportunity, yet funding to push product through early product phases – concept and design through clinical studies and post-market surveillance – can be complex. Daniele Viappiani of GC1 Ventures offers strategies for MedTech start-ups to find the right investors.
Leveraging awareness communications to grasp the potential opportunity for medical devices designed to monitor health and chronic illnesses offered by the new US administration.
According to CDER Director Patrizia Cavazzoni, CDER’s new Center for Real-World Evidence Innovation represents a major step forward in efforts to unlock the full potential of RWD to inform clinical and regulatory decisions.
Advancements in cardiac care and novel therapies are transforming cardiac medical devices, providing new solutions for millions affected by heart disease globally.
What’s getting R&D attention? The impact of upcoming regulations, A.I., new cybersecurity risks, developments in battery power and innovation, collaborative efforts, and other impacts on the industry in the year ahead.
Key trends picking up momentum in the field of healthcare. How GenAI is revolutionizing clinical workflows. The rise of ambient technologies in patient care. IoMT devices and SaMD solutions to enable patient care. Interoperability and automation of data. Cybersecurity to ensure the safety of personal data.
