Missing ‘bodies’ threaten integrity of EU’s regulatory system
Another notified body has pulled out of the European regulatory system, compounding concerns that the number of providers across the EU will be insufficient to support the new Medical Device Regulation, which goes into effect on May 25, 2020. QS Zürich explained that the investment was too high for a small company such as itself to provide the demanding services that are required.
QS Zurich joins the UK’s Lloyd’s Register Quality Assurance and Spain’s Agency of Medicines and Medical Products, which also recently announced plans to abandon the notified body program for medical devices.
Notified bodies are an essential element of the EU’s regulatory system, as they conduct conformity assessments under the relevant directive or rule. They perform audits of quality systems and, under certain circumstances, review technical documentation, necessary steps before manufacturers can put a CE mark on their devices and sell them throughout the EU and other countries that recognize the marking.
“News of QS Zürich’s decision continues a spate of withdrawals that add to concerns about whether the European Union will have the notified body capacity needed to support the incoming Medical Device Regulation,” reported Medtech Dive.
The robodoc is in
Would you trust an automated doctor? asks Adi Gaskell in a piece in Forbes. The answer depends a lot on how tech savvy you are.
The jumping off point for Gaskell is research from Penn State investigating how comfortable humans are interacting with autonomous systems when it comes to medical matters. "There is increasing use of automated systems in the medical field, where intake is now often conducted through a kiosk instead of by a receptionist," the researchers explained. "We investigated user acceptance of these 'robot receptionists,' along with automated nurses and doctors. In addition, we tested whether the form that these roles took—human-like, avatar or robot—made a difference in user acceptance."
The volunteers for this survey were recruited from Amazon’s crowdsourcing tool, Mechanical Turk, noted Gaskell, “which must surely have resulted in a more tech savvy audience than is perhaps the norm.” Not surprisingly, the researchers found that “power users,” meaning people with advanced computer skills, were more likely to accept a robot doctor than, say, my mom.
The confluence of automation and artificial intelligence (AI) represents a tremendous opportunity in the healthcare space. The medical profession has a high burn-out rate, and the researchers believe that “AI-based technologies can do a lot of work for doctors [by crunching] huge quantities of data 24/7 without needing breaks or holidays,” writes Gaskell. Will the general population accept automated healthcare? The more comfortable people are with technology, the more likely they are to embrace the concept, the research showed. That’s good news when generations that grew up with computers, the Internet and smartphones start seeking medical attention, but it will be an uphill struggle to convert the older demographic to this brave new world.
Robots have a proven track record of success in the surgical suite, and that was the topic of a recent article by Daphne Allen, Editor in Chief of sister brand MD+DI. She reported on a panel discussion revolving around the future of robotic surgery at the MD&M East show in New York last week. The panel featured Gianluca De Novi, PhD, CEO at XSurgical; Anthony Fernando, Chief Operating Officer and CTO at TransEnterix; and Dave Saunders, Chief Technology Officer at Galen Robotics.
The panelists agreed that there is plenty of growth potential for the use of robotics in surgical procedures, but that reimbursement remains a significant obstacle. “It’s really difficult right now, especially in the U.S., because there aren’t any specific reimbursements that are going to allow you to do robotic surgery. . . . You have to fit into the existing economic model,“ said Saunders. “So I have to build a robot that not only has great utility for surgeons, but I have to have something that fits into their economics. And if that isn’t a consideration upfront, the company is going to have no traction.”
Cost considerations aside, the technology is here today and its capabilities are almost limitless. Here again, AI could have “a profound effect,” said De Novi. “We are in the early [stages] of technology adoption,” said Fernando. “It will progress into collecting data, and more data will help drive machine learning and artificial intelligence and augmented reality. So there has to be some progress, but the foundation is being set, and I think it will evolve relatively fast into data-driven, decision-driven surgery. We are expecting a very rapid adoption within the next 10 years.”
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