Profound experiences in life can impact our way of thinking, and may change the trajectory of our careers. This was true for Javad Parvizi, M.D., who dedicated himself to studying infection prevention after seeing a patient suffer during his residency, and for Justin Barad, M.D., who changed his aspirations from video game programmer to doctor after a family illness and has now managed to marry the technical skill sets of both professions.
Both surgeons are leading conversations in orthopaedics. Both have become entrepreneurs to spur innovation.
And both are asking industry to think differently about product development.
|Javad Parvizi, M.D.|
As orthopaedic device manufacturers consider ways to address infection prevention, it’s important to understand how surgeons prioritize their concerns.
In July, the International Consensus Meeting (ICM) on Musculoskeletal Infection convened more than 800 delegates from 98 countries. To give indication of the meeting’s importance and significance, surgeons, infectious disease professionals, researchers, FDA, the National Institute of Health and industry were in attendance and discussed 650 different aspects of infection prevention, diagnosis and treatment.
“Although we’ve been trying hard to generate evidence over the past few years in terms of prevention, diagnosis and treatment, there are a lot of areas where we have no evidence,” says Dr. Parvizi. “It’s critical for us to bring together a group of experts who can make recommendations related to any specific issues that would impact patient care.
“Infection is the number one expense item on the government’s list. Hospital acquired infections are extremely expensive and carry huge morbidity and mortality for the patient. Efforts are being made to minimize this dreaded complication.”
Dr. Parvizi, a hip and knee surgeon at Rothman Orthopaedic Institute, has dedicated his career to studying surgical infection. The experience led him to organize ICM in 2013 and in 2017, launch the Parvizi Surgical Innovation incubator (PSI).
Specific efforts introduced from ICM include an app to calculate a patient’s infection risk; new diagnostic criteria for hip, knee, shoulder, elbow, foot and ankle procedures and a 2,600-page summary of delegate recommendations on everything from how many pairs of gloves should be worn during a procedure to what implantable technology resists bacteria.
As device companies consider development and commercialization of products related to surgical infection, the aforementioned tools provide a greater understanding of surgeons’ specific concerns and how they themselves are prioritizing and addressing them.
Surgical infection rates vary among procedures, institutions, surgeons and patients. Total knee and hip replacements, for example, have an average infection rate of 0.3%-1.5%, says Dr. Parvizi. After revision, the rate jumps to 20%-30%. Further, infection is not a one-time event, nor does it necessarily show up right after surgery. It could appear 15 to 20 years post-op.
Infection prevention is the lowest-hanging fruit in medicine, Dr. Parvizi says. He launched PSI with 30 orthopaedic surgeons to develop and market technologies based on their research, believing they could get to market faster than industry.
The product closest to submission for FDA clearance is an antiseptic that appears to kill about a million bacteria within one minute of exposure. Other developments include a hand-held, point-of-care device that can use one drop of fluid from the joint to determine if infection is present, as well as a nanotube surface technology to prevent bacteria from attaching.
In reflecting on his 20+ years of research, Dr. Parvizi says, “The science of microbiomes is emerging as an important science. We do research related to genomics and how genes control microbiomes and the potential to develop infection. We’re looking for effective agents that could eliminate infection—diluted betadine agents that you could use during the operation to eliminate bacteria that managed to access the wound.
"The diagnosis of infection has come far. Treatment-wise, there are now new biological agent technologies that can be applied to the surface of implants that can prevent infection, and the list goes on. Because we’re paying attention to this issue, we’re now much more likely to make an impact on the future.”
Virtual Reality Training
|Justin Barad, M.D.|
As orthopaedic device companies consider commercialization of their next device, it’s important to understand how surgeons will train and engage with the technology during its adoption.
Throughout his career as a surgeon, Justin Barad, M.D., has recognized a frustration in needing to learn too much about a new implant or procedure in too little time. The pediatric surgeon combined his knowledge in medicine and video game programming to launch Osso VR, a virtual reality surgical training platform designed for surgeons, hospital staff and device company sales teams. Individuals or teams can put on off-the-shelf gaming hardware, like Oculus, and insert themselves into a virtual O.R. with all they need to perform a procedure. The remote technology allows for "post-op" performance assessment, including time/motion and instrument handling.
“One challenge of healthcare is that newer technology is theoretically of higher value, so it’s better for the healthcare system in that it either decreases costs or increases patient outcomes, yet because the technology is typically more complicated and the training burden is so high, it is not being adopted,” Dr. Barad says.
“Fellowship-trained surgeons need to use a device 100 times before they can use it proficiently. A surgeon will try a new technology, something will go wrong, and they’ll perceive it to be unsafe, so they’ll revert to an older technology that is not as good for patients and the hospital. This is a massive problem within every specialty. What we’re trying to do is bridge the course-to-case gap by preparing people for in-person bio skills courses and reinforcing and assessing them afterward—and in some cases, replacing certain courses—to increase adoption of new technology.”
Osso VR is targeting resident programs and device companies for partnerships; the majority of its business comes from the latter. As a surgeon, Barad wants to use new, innovative technology. Therefore, the company’s mission includes increasing adoption of higher-value techniques by overcoming the commercialization bottleneck of surgical team and sales training.
As more surgeons adopt interactive experiences (VR, navigation, robotics, etc.), it’s important for industry to consider how to leverage technology to enhance hardware.
"Industry is no longer selling metal and plastic devices; they are selling patient outcomes," Dr. Barad says. "The biggest gap in patient outcomes seems to be training and assessment. You can invest hundreds of millions of dollars in making a knee replacement slightly better, and it’s likely not going to have an impact on patient outcomes, or you can implement an affordable system on global training that can have a massive impact on outcomes. That makes a difference when a value analysis committee is deciding between two different implant systems that look very similar.
"If they see that one system leads to better outcomes and reduced costs because of training, better efficiency and better assessment, they’re going to go with that.”
*Main article image courtesy of OSSO VR
Carolyn LaWell is ORTHOWORLD’s Chief Content Officer. She can be reached by email.