It is obviously incumbent upon device manufacturers to do the research to prove that their tools will be effective in the surgical suite, delivering the best possible outcomes for patients. Increasingly, the expectation has expanded. As payment schemes start squeezing tighter, demonstrating efficacy is joined by a market mandate to show that devices are simultaneously likely to help a healthcare facility’s bottom line.

As Ethicon launches a 45mm version of the popular ECHELON FLEX GST System Endocutter, the company is also able to tout some promising research that shows how the technology is making a difference, both clinically and economically.

“As the Endocutter portfolio has evolved over time, we’ve started to dive into the analytics behind the outcomes of these devices,” explains Joe Schowalter, Senior Marketing Manager for the Endocutter line in Global Strategic Marketing at Ethicon.

The manufacturer dug into data pulled from the Premier Perspective Hospital Database that covers approximately 20 percent of all hospital discharges in the U.S., ultimately reviewing outcomes of over 21,000 bariatric surgery patients across several hundred hospitals.

“We looked at the surgeries that used powered endoscopic staplers and compared them with those that used manual devices,” says Sanjoy Roy, Director of Health Economics and Market Access at Ethicon. “We found interesting outcomes when we adjusted for all patient and provider differences that we could. We found that not only does using the powered staplers reduce the overall cost to the hospital, there was actually some differences we started picking up in the real world data in terms of clinical outcomes such as hemostasis-related complications.”

The research revealed a 47 percent lower rate of bleeding complications associated with the procedures that used Ethicon’s powered endoscopic staplers compared to market-leading manual staplers. Although the device was being compared against manual staplers, Ethicon points out the benefits shouldn’t solely be attributed to the presence of power. Instead, it’s likely the entire design that aids in controlling movement and creating a stable platform for the surgeons to deploy staple lines. 

(Image credit: Ethicon)

It should come as no surprise that the significant improvement in hemostasis also translates to reductions in related expenses. The same analysis found a 14 percent decrease in OR time and a 13 percent drop in overall hospital costs associated with the use of Ethicon’s powered endoscopic staplers. Add those savings up and the total could exceeds $ 35 million.

“This is not a projected cost savings,” notes Tom O’Brien, leader of Endo Mechanical at Ethicon. “These are the actual costs in the 20,000-plus cases. Over $35 million reduction to the healthcare burden. That’s real dollars. It’s a real difference in cost.”

This sort of focused examination of the financial repercussions of new devices and evolving methods is simply a response to current concerns in the healthcare field.

“It’s becoming a value-based discussion rather than a price-based discussion,” says Schowalter. “We need to support product innovation with real world evidence that demonstrates better outcomes. As more and more scrutiny is placed on the costs of healthcare, this evidence is going to be increasingly important moving forward.”

Roy adds that the awareness of how a device must respond to healthcare providers’ needs in a multifaceted way is in play from the earliest stages.

“All of those considerations are now being made very early on, as opposed to after the product is out the door,” he says. “It’s now part of the very creation of the target product profile. When you are even discussing a change to an existing technology or a new technology altogether, you have all those parties at the table discussing what is it going to mean clinically, as well as, from an economic and a humanistic perspective.”

It’s equally imperative to pass that knowledge to those who will be using the devices on a daily basis in the OR.

“It’s not just giving our customers — both surgeons and non-surgeons — a product and saying, ‘It’s better and just take our word for it,’ but to also provide the wraparound evidence and information to say, ‘OK, this is what it might mean to your patient, and to your system — in terms of your costs and other outcomes — and here’s the data to prove that.’”