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.
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?
A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification process, the primary pathway for new devices to enter the market.
Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic asset, and product lifecycle is an intelligent process.
While some wearables may be tailor made for trial use, they face challenges translating to real-world patient applications outside of a stringent trial setting, and vice versa. This creates a unique challenge for med-devs looking to bring their devices out of the trial setting and into patient 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.
Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent regulatory strategy required by investors.
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.
While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.
In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?