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.
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.
CE Marked and 510(k) pending, Philips says Rembra’s advanced image reconstruction technology delivers up to 106 images per second and a high throughput of up to 270 patients per day [2] to support faster diagnosis by making scans available in near-real time.
The Revello™ Vascular Covered Stent is designed to combine the flexibility of a nitinol self-expanding stent with the radial resistive force tailored for the iliac arteries. Iliac artery disease is a key component in lower‑extremity peripheral artery disease (PAD), and according to a company Press Release, Revello™ can help reduce a substantial disability burden across the EU’s aging population.
What is driving the need for increased transparency across the MedTech organization relative to product innovation, development and commercialization?
New patient-specific solution expands Catalyst’s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy .
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.
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 software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.
The FDA announced the TEMPO pilot, an approach to encourage the use of digital technologies that meet people where they are. The pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.