Medical devices have always been a challenging field in which to develop testing standards. The industry struggles to develop predictive methods to determine safety and efficacy due to the variability in how these products are applied by the end user, the variability of patients, and the variability of the condition they are treating. The introduction of new technologies, such as biodegradable materials, cell therapy, or combination devices, exponentially increases the inherent variability and the difficulty of the challenge. But the standards community is facing the challenge head on by developing working groups comprised of industry, research, clinic, and patients to comprehensively evaluate how these new technologies affect current and future standards. Read our full article that was featured in the October issue of Quality Magazine.