What Matters: August's MedTech News You Need to Know

Overheard at GMM HQ

"I’m just hoping the FDA shuts down my diet tracker so I can go back to eating pizza for breakfast."

~ Holley Malia, Founder and President of GMM, commenting on mobile medical app regulation.

Read why it’s pepperoni again for Holley in our recent blog post.



Who bundles up in the middle of the summer? The Centers for Medicare and Medicaid Services (CMS), that’s who. The CMS recently proposed an extensive “pilot” that would require bundled payment and quality measures for hip and knee replacements at hospitals in 75 randomly selected geographic areas.

The proposal is part of the ACA's push toward paying providers for quality health outcomes instead of for specific procedures. With hip and knee replacements being among the most common surgeries that Medicare beneficiaries receive, the plan is expected to save more than $150 million over five years.

The 411

For the first time, Medicare is proposing to make bundled payments mandatory. It seems like integrated care delivery could be for realz. Better get your sweaters ready.



Actually, make that $6.29 billion, or the amount of money drug and medical device manufacturers paid physicians and teaching hospitals last year. Of the total, $2.56 billion were “general payments,” which can include such costs as travel and lodging, and food and beverages. How’s that for a bar tab?

The Open Payments database was created under the Physician Payments Sunshine Act provision of the Affordable Care Act. Since the launch, the CMS has made significant improvements to the Open Payments website to make it easier for people to search financial transactions. But physicians say registering to review data and correct inaccuracies is not so easy.

THE 411

You can now look-up dollar figures of what physician and hospitals were paid from drug and medical device manufacturers. Knowing how much money was given to physicians, including gifts, speaking fees, meals and travel, may influence consumers in their healthcare decision-making choices. Hopefully, The Wolf of Wall Streetdays are over for the medical industry.



Any good summer blockbuster involves robots. Perhaps that’s why the FDA chose July to host its public workshop on robotic-assisted surgery. The workshop discussed clinical, technical, and training questions related to the safe and effective use of these devices.

One topic of discussion was the definition of robotic surgery. Some newer innovations may not require surgeons to learn how to operate in a new way or use a console. They’ll simply augment standard laparoscopic instruments with computer assistance to enhance the surgeon’s ability to operate. As such, the question was should these types of robotic devices require as rigorous a regulatory pathway as one that disrupts standard surgical practices. It’s similar to driving a car with power steering. You don’t have to relearn how to drive a car or get a new license; it just makes steering easier. Doctors at the panel said that robotic surgery devices shouldn't be treated differently than those used in open or laparoscopic procedures, for all of the tools are designed to perform similar tasks, but using a different methodology.

THE 411

Yes, future devices are likely to blur the line between laparoscopic and robotic surgery devices. However, devices should be judged according to whether they can meet standard benchmarks of effectiveness that open and laparoscopic tools are measured against. Domo arigato, FDA, but surgical robots don’t exactly need special treatment.



August is National Immunization Month—unless you live in California. Then you celebrate it every month.

Summer Safety Tips: Stay out of the Shark’s House.

Based on what you have read, we think you might like these posts as well