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Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration ...
Every new medical device feature must live within a quality management system that tracks design control, risk management, ...
The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...
Cardiac monitoring is almost a standard feature of modern wearables but there are still opportunities to get better information and do more with the data. Seizing those opportunities could transform ...
This short review serves as an introduction to the utility of polymeric materials employed in healthcare and medical devices (MD). Some terminology and nomenclature used to commonly describe polymers ...
The beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the ...
A common dilemma for early stage medical device companies is their lack of expertise in medical device development. As expected, the development team is busy establishing the company itself while ...
Human factors engineering (HFE) must be considered by every medical device manufacturer at some phase of the design and development journey to ensure the end product can not only gain FDA approval but ...
Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...
This article is the first of a two-part series; read part two here. The U.S. Food and Drug Administration (FDA) is increasing demands [i],[ii] for drug delivery device developers to demonstrate the ...
Part 1 of this series presented factors that medical device developers should consider when executing HFE studies internally, detailing how to overcome obstacles while acknowledging that executing ...
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