When most people think about product liability lawsuits involving surgical robots, they imagine the scenario where a patient undergoes an unsuccessful operation and then sues the robot manufacturer for damages. But few...more
Artificial intelligence (“AI”) will likely drive many complex medical devices in the near future. But as with all things, AI can sometimes fail. Companies relying on AI to elevate their medical devices above the competition...more
Today, major healthcare companies are investing heavily into various AI-powered devices. For example, Zimmer Biomet and the New York City-based Hospital for Special Surgery recently inked a three-year deal to create the...more
During product development, it’s not unusual to discover certain failure points in a surgical robot’s design. For example, certain components, like nuts or bolts or screws, may become brittle when exposed to various...more
Until they become fully autonomous, surgical robots will only be as good as their human operators. Training for all surgeons, nurses, bedside assistants, and other surgical team members is critical to ensuring optimal patient...more
Recently, an artificial intelligence-guided robot successfully performed a laparoscopic surgery to connect two ends of an intestine in four pigs, without any human intervention. And according to the researchers involved, the...more
This week, the European Commission unveiled new proposed rules “aiming to turn Europe into the global hub for trustworthy” artificial intelligence. The 108-page first-of-its-kind policy outlines how companies and governments...more
It’s no secret that defending against product liability lawsuits can be costly. But surgical robot manufacturers sometimes ask me to give them hard numbers. To read the tea leaves and estimate how much they’ll have to spend...more
Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world....more
Death and taxes are unavoidable. And if you create a popular product, so too are product liability lawsuits. In my practice, companies sometimes ask, “How soon after our surgical robot hits the market will we get sued?”...more
Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. ...more
3/8/2019
/ Artificial Intelligence ,
Bodily Injury ,
Cancer ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Medical Malpractice ,
Off-Label Use ,
Patient Safety ,
Pharmaceutical Industry ,
Robotic Surgery ,
Robotics
As more and more surgical robots make their way into operating rooms, companies are learning valuable lessons about how their devices function in the real world. ...more
Over the last decade, robotics have revolutionized healthcare. Surgical robots are rapidly making their way into many of our nation’s operating rooms, and are being used in a wide variety of surgeries ranging from...more
Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed. Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or...more