With medical devices ranging from simple needles to life-saving high-tech implants, ensuring the highest possible level of safety is one of the industry’s greatest priorities. Here, as the chair of the ISO technical committee for quality management and related general aspects for medical devices, Eamonn Hoxey, Ph.D., shares his thoughts about the industry, its exponential growth, and why uniform and consistent standards are important.

Many medical devices are invasive by nature—they probe in and around the human body. While some explore the anatomy, cut away disease, and repair damage, others remain inside the body, such as a prosthetic hip, an artery stent, a new valve, or a pacemaker.

Combining the highest-of-standard design and performance characteristics for medical devices with the complicated business model of healthcare itself—and the field’s stiff regulatory requirements—makes for one of the most complex and demanding industry sectors known for any manufactured product.

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