Undergoing surgery has always been somewhat of a personal experience. Once inside the operating room (OR), the patient is reliant on the surgeon for their quality of life in a way unlike any healthcare experience. And yet, it’s in those moments during surgery that things become less personal for the surgeon and more formulaic. That’s because traditional surgery, and especially orthopedic surgery is not “personalized” in the way that we have come to know most iterations of personalized medicine. Surgery is approximated. It’s estimated. It’s evolved in a way that’s based on how well patients generally respond to certain protocols.
“Surgery is based on the law of averages,” says Pete Verrillo, CEO at Enhatch, a software as a service (SaaS) company based in Hasbrouck Heights, NJ, that develops artificial intelligence (AI) applications that streamline various elements of the surgical pathway. “If most patients need five degrees of correction [for an intramedullary rod during knee surgery], that’s what you get. But that’s not personalized surgery. It’s pure systems and processes. And research indicates that about one-third of these patients are not happy with their outcomes. That’s a real concern.”
Verrillo and Enhatch are looking to bring more specificity to these types of surgeries and to foster a more cohesive atmosphere through the Intelligent Surgery Ecosystem, a system that intends to personalize and accelerate clinical workflow by improving access to technologies that enable better surgical outcomes and collaboration throughout the healthcare industry.
“We’re here to connect all of the different pieces that tie surgeries together and to learn from every procedure to produce better patient outcomes — to be that key connector and to foster that environment,” Verrillo said.
Introducing personalized surgery
The general public was introduced to the concept of “personalized medicine” in 1999, when a Wall Street Journal article discussed how drugs could be targeted for individual patients based on each person’s unique genetic profile. At that time, orthopedic surgeons were completing an average of 100 to 150 traditional orthopedic cases, such as knee surgeries and hip surgeries, compared to between 400 to 500 cases today, Verrillo estimates. Looking ahead, surgical volume is only expected to increase, despite the temporary reductions that the Covid-19 pandemic once caused, which has the potential to pull surgeons farther away from the personal aspects of the patient’s surgery as their caseloads multiply.
“The demand for orthopedic surgery will double over the next 10 years and is quickly outpacing global surgeon capacity,” Verrillo said. “With this increased demand, there are greater risks and challenges for all involved. By the end of this decade, we could be at 11,00 to 12,00 surgeries on average. There needs to be other ways of conducting healthcare.”
Surgical advancements have certainly led to safer procedures that can be done more quickly with the help of extramedullary solutions, robotic surgery, and navigated surgery, but that’s not the same concept that personalized medicine is meant to deliver.
“When we say ‘personalized surgery,’ we’re talking about doing all the work that we can do outside of the surgery to make sure we have everything that we need to be as efficient as possible inside the OR,” said Verrillo. “To date, personalized surgery has been attempted with instruments that could work for anyone to get a decent outcome, but they’re not designed to be a perfect fit. But with personalized surgery, we’re actually planning that ahead of time. We’re understanding that it’s going to be a certain size implant that will best replace the bone. That’s a key difference.”
The ecosystem originates during the preoperative phase with a pre-op planning application that offers surgeons the ability to learn more about their patients and to bring that intel into their surgeries for assistance. For instance, surgeons can build a customizable patient questionnaire that shares details for the surgery that can be referenced at any point during the surgical sequence. Available technology also allows for 2D images, such as CT scans, X-rays, and MRIs, to be converted into 3D models of the patient’s anatomy to help determine the correct sizing of implants for each surgery. These images can be patient-matched, printed, and referenced during surgery to appropriately guide the surgeon’s use of surgical instruments.
“The surgeon goes in with a precise plan that will definitely work for that patient because all the homework has already been done,” Verrillo said. “This allows surgeons to take the instrument and place it directly on the bone in the beginning of the surgery to help them make their cuts for their procedure.”
This functionality is expected to reduce intraoperative surgical time and strengthen the communication that occurs between surgeons and medical device representatives prior to any procedure because of the opportunity to make decisions about an upcoming surgery before entering the OR.
“We can produce a score on how well the [implant] fit will be, which you can’t do when the patient is cut open and bleeding on the table and you can barely see the bone,” Verrillo said. “You have very little access to the full joint during many of these types of procedures. You can’t get that true visualization.”
During surgery, better real-time visibility and the use of products is also anticipated with the ecosystem to deliver more precise implantation of devices.
“The surgeon can’t do a virtual comparison of the knee intraoperatively, but we can do that with a CT scan. We can do a full analysis to know where the implant should go and what degree of fit it will have.”
Postsurgical insights and analytics
The ecosystem’s postsurgical data collection includes the gathering of a host of data to assess clinical outcomes as well as business-related logistics and management. Postoperative tracking with the use of wearables reduces the need for follow-up operations and can benefit future implant placement for other patients with similar disorders.
Inventory logistics include product-related seasonal trends throughout the year and reports on which products are utilized most frequently to build an idol inventory and establish inventory optimization. The ecosystem also helps to navigate the sales cycle process by handling purchase orders and sales orders.
“Most businesses are centered around the ‘old world’ of bringing hundreds of pounds of instruments and implants into the surgery, but it costs a lot of money to make the products and put them on shelves,” Verrillo said. “That ‘old world’ worked fine when there were fewer implants on the market for knees and hips. Today we’re doing all parts of the body, with multiple product lines, and different versions for men and women. And we can’t sacrifice results.”