The Medical Device Cybersecurity Gap Hiding in Plain Sight
In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.
Tag Archives: Focus Article – Homepage
From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market
Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.
The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms
Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.
The Healthcare Burnout Backlash (pt 1): Burnout Reaches Well Beyond Clinicians
In this part 1 of a 4-part series, we look at how the burden of digital transformation is impacting the entire healthcare ecosystem, and that while burnout in healthcare is most often framed around clinicians, it does not reflect where the full transformation work is actually being carried…or its impact across healthcare.
Clinical Trials Have Too Much Data…That’s the Problem.
Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?
Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?
To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.
Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care
Rene Zoelfl, Global Industry Advisor for PTC’s MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.
AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore
Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.
How is AI Enabling Darwinian growth for Life Science Professionals?
The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.
Digital Companion for the Perioperative Surgical Phases
A digital companion, purpose-built for surgical patients’ pre- and post-operative journeys, is now an imperative for providers, payers, and medtech leaders aiming to achieve competitive differentiation, clinical excellence, and sustainable business value.