Background Machine‐learning algorithms and big data analytics, popularly known as
'artificial intelligence'(AI), are being developed and taken up globally. Patient and public …

In spite of the fact that risk management has developed into an essential component of the
process of developing medical devices, as mandated by both domestic and international …

Objectives: The aim of this study was to get an overview of current theory and practice in
early assessments of medical devices, and to identify aims and uses of early assessment …

Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that
devices minimise the risk of unintended harm during use. However, development teams face …

Background Electronic health (eHealth) solutions are considered to relieve current and
future pressure on the sustainability of primary health care systems. However, evidence of …

Background: Technical innovations have the potential to compensate for loss of upper-limb
motor functions after stroke. However, majority of the designs do not completely meet the …

Design thinking has been increasingly adopted as an approach to support innovation in
healthcare. Recent publications report design thinking application to various innovation …

This paper focuses on the challenges of meeting agency requirements as it pertains to the
application of human factors in the medical device development (MDD) process. Individual …

Background Parkinson's disease is the second most common long-term chronic,
progressive, neurodegenerative disease, affecting more than 10 million people worldwide …

The growing number of emerging medical technologies and sophistication of modern
medical devices (MDs) that improve both survival and quality of life indexes are often …