Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...

Developing a complex medical device requires a delicate balance between innovative design intent and real-world manufacturing execution. When original equipment manufacturers (OEMs) transition a ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Opinions expressed by Digital Journal contributors are their own. Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a ...

Josh Spaulding, Design Engineering Manager with New England Wire Technologies on what designers need to know to make the right cable choice for medical devices. Imagine an electrical design ...

Hospitals and healthcare facilities are grappling with high turnover among nurses and medical technicians. This is a challenge that’s reshaping medical device design. As staffing shortages make ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...

The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...

Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process ...