In this issue, learn why you can’t afford to ignore the value-based train that’s coming down the tracks. I’ve also highlighted a few different pieces regarding direct-to-patent changes within healthcare. And lastly, if you have questions regarding the 510(k) process, don’t forget to check out these tips.
Pearl Harbor. Blockbuster. The dot-com bubble. All have one thing in common. Leaders missed subtle signals that warned of pending danger. Michael Leavitt, former secretary of the Department of Health and Human Services, urged healthcare leaders not to ignore the signals accompanying the shift from fee-for-service to value-based payments.
Doctors at Mayo Clinic recently had an idea: What if they could aim the wire at the valve using a special catheter with a small funnel on the end to capture the blood flow and center the gadget right above the jet? That idea will be put to use in a human clinical trial later this year as part of a collaboration between Mayo and Boston Scientific Corp. — a long-running collaboration that was recently publically unveiled.
Many procedures – including even joint replacement – are moving toward the outpatient surgical setting. And now a recent report from Blue Cross Blue Shield shows how moving surgeries to an outpatient center can actually lower costs, even for patients. All the more reason for device makers to redouble their efforts to work with surgeons who operate in ambulatory surgery centers and develop or maintain close ties to these facilities.
Digital healthcare has been heating up over the last few years. But while the structural and cultural change in the healthtech industry is moving toward B2C, we’re still in a B2B2C world, where an insurance company, or an employer, still stands in between.
If you are developing a medical device in the United States, there is a good chance your path to market involves a FDA 510(k) submission. FDA expectations for 510(k)s have changed dramatically over the last handful of years. Here are some tips that will help you adjust to the new normal.
Until the next issue of the Medsider newsletter, cheers!