Breakthroughs and Misfortunes in the Maturing of NiTi Medical Device Development

Nitinol has enabled the development of many life-enhancing medical devices from endoscopic surgical tools to aortic replacement valves to orthopedic nails. Breakthroughs, while transforming lives and enabling physicians, may be accompanied by failures. Though the vast majority of have been safe and efficacious, some Nitinol devices have fractured during sterilization, some have failed to deploy as intended, some have broken & failed in vivo, and a few have even been explanted due to patient reactions. But medical device engineers have methodical perseverance: we learn from limitations and mistakes to create better devices. I’ll present stories and learnings in medical devices misfortunes and breakthroughs from manufacturing to testing to deployment to in vivo use to explant analysis.