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What is the Future of Orthopedic Innovation? Insight from HSS.

In moving to the provider side of orthopedics after spending decades in industry, Doug Leach has learned a valuable lesson that he wished he had known while still leading OEM engineering teams: Partner with providers. Not just the surgeon.

“Industry does a poor, if not non-existent, job of partnering with the provider side,” Leach said. “For cultural reasons, industry has always done a great job of partnering with physicians. But everybody knows that the relationship between the physicians and the hospitals is shifting drastically.

“The hospital has a much, much, much greater influence over the physician. And, at the end of the day, the hospital is the one that knows how its operations work.”

Leach advises from an interesting perspective. He previously served as a vice president in product development roles at Stryker and OrthoSensor. Now he leads medical device innovation as Managing Director, Biomechanical Innovation at the Global Innovation Institute (GII), Hospital for Special Surgery’s tech transfer and incubator function.

Surgeons, nurses, legal, outside startups, you name it, come to GII with their app, drug, implant or instrument idea. GII decides whether the idea is commercially viable. If it is, they take it as far as their resources allow in the commercialization process. More than $41 million in royalties have been earned, more than 237 patents have been filed and more than 218 inventors have been served, according to the institute’s website.

For his role, Leach works with the internal or external inventor, analyzing market and clinical applicability, while keeping surgeon and provider needs top of mind.

A primary reason for his provider partner argument is that operational efficiency has become the new lens through which all decisions must be viewed.

Leach will give the Thursday Keynote at OMTEC®, “How to Build a Culture of Innovation in Orthopedics: Lessons from HSS.” Ahead of this, we spoke with him about three primary topics: What technology should musculoskeletal companies prioritize in the coming years? What projects is GII working on that he finds of great interest? And, how do you go about building a culture of innovation?

Themes that resonated throughout our discussion were the use of digital tools and the advancements and efficiencies that they can bring to musculoskeletal diagnosis, implant design and manufacture and inventory management.

What is the Future of Musculoskeletal Technology?

When Leach considers HSS’ technology needs and the organization’s forecast for where technology is headed, he settles on these primary areas: additive manufacturing, artificial intelligence (AI) and big data. All three can serve as standalone technologies or be integrated, and all three are being prioritized by large orthopedic players and startups that seek to enter the space.

Additive Manufacturing

Additive manufacturing is an obvious answer, Leach said.

“The challenge is going to be how to be smart about where additive manufacturing is applied,” he said. “Industry has done a good job of figuring out how to use it to address their own cost and technology issues. I’m not sure that they’re using it to address their own innovation issues. They’re looking at it too much from an operational perspective, as opposed to an innovation opportunity.”

Premier hospitals are additively manufacturing anatomical models and custom implants. It would behoove industry to closely watch how providers continue to innovate in this space, he said. For example, HSS and LimaCorporate plan to launch the first additive manufacturing facility for custom complex orthopedic implants in a hospital setting later this year. Lima will run the facility, making custom implants for HSS surgeons, as well as other hospitals.

Artificial Intelligence

AI and machine learning (ML) are being considered for myriad technologies from pre- through post-surgery. Leach said that AI will be an essential technology for orthopedic companies to consider, and will be an important tool for providers as they look to identify organizational efficiencies. GII is partnering with Imagen to develop AI and ML technology that aims to improve diagnostic accuracy of fractures and pathologies in radiology.

Using an example of sensors, Leach cautioned industry to find the best applications for these tools.

FDA is starting to learn more, and similar to additive manufacturing, you could throw sensors in just about anything. That may not be the right answer. The key is, what kind of information will be necessary where sensors will actually help make the care process better?” Leach said.

Big Data

Hospitals and industry hold a wealth of data. How should the data be analyzed? How can it impact future product development or procedure outcomes? Should you share the data with your partners?

“Everybody is looking into data, but nobody knows what they’re doing,” Leach said. “I think everybody is really trying hard to figure it out. Good for them. But I go back to my other point from earlier; if they don’t partner with the providers, they’re never going to really figure out the answer of what to do with it.”

What’s in HSS’ Technology Pipeline?

GII counts the number of ideas it's balancing in the dozens. Leach shared with us three projects in development. Each of the following examples include stakeholders from inside and outside of HSS.

Computer Vision and Motion Analysis for Injury Prevention and Rehabilitation 

GII is partnering with HSS’ Biomotion Analysis Lab (yes, they have one of those, too) to develop technologies and protocols related to injury prevention and rehabilitation. He used athletes as an example, but the technology could correlate to anyone.

“Think about the technology that Hollywood uses with CGI and motion capture. It is unbelievably sophisticated, and it has the perfect applicability in orthopedics and gait analysis,” he said. “If we can work with the computational tools that are out there—computer vision and to a certain extent AI—and come up with models about how athletes should move, or how an athlete’s movement has evolved over time, we can help athletes train better,” Leach said. “Or in some cases maybe even ways of preventing injury by knowing where you started, knowing where you are and, with enough prediction, know where you’re headed.”

Imaging for Preplanning and Inventory Purposes

GII is researching a method by which it can leverage two-dimensional images from x-rays and predictive AI modeling to zero in on implant size. Numerous orthopedic companies are focused on perfecting imaging for operating room efficiency purposes, whether that be preplanning the surgery or inventory logistics.

“We have 35 joint surgeons on staff here. As you can imagine, there’s a lot of inventory to manage,” Leach said, noting that HSS has a small footprint in New York City. “We have to be super smart about how we manage volume in terms of case flow and sheer hardware that we have available. But we have the knowledge and the expertise around how joints are put in, how to read x-rays, the statistics around templating. We’re looking at methods of automating the templating process so that we no longer require an entire bank of implants for one total hip case.”

Computational Modeling for New Joint Replacement Implants

The institute is leveraging its computational modeling, biomechanical engineering and clinical expertise to develop new devices related to unresolved total extremity joint replacement conditions. Leach needed to be light on details, but said that advancements in computational modeling will allow the organization to establish new treatments.

“These are areas where the industry really just has not had the wherewithal or time or expertise to go off and find solutions for foot and ankle and hand applications,” Leach said. “We’re using tools that we have here to solve problems that clinicians are seeing on a frequent, very regular basis, but they’re accepting very old ineffective treatments for. We’re pioneering new treatments, realizing that the regulatory path is going to be tough.”

How Do You Build a Culture of Innovation?

Competitive organizations maintain cultures of advancement, innovation and expertise. HSS is one of those organizations. You have to look no further than its top-ranking position amongst orthopedic hospitals and its creation of an entity like GII.

When Leach translated the culture into a series of steps, interestingly, it was a list of practical business practices. It served as a reminder that the bold are good at the basics.

The first step, Leach said, is to build a relationship with those deemed as the organization’s innovators. “Listen to them,” he said.

From there, it’s important to gain a different perspective and identify the capabilities and resources available to deliver on the idea. Leach noted that GII’s success is partially due to its diverse group. He brings an industry and engineering background. The Chief Innovation Officer is a nurse by education and profession. The Care Delivery Director came from HSS’ value department and has a healthcare economics background. Other perspectives include attorneys and investors.

In execution, keeping a predictable process for everyone to adhere to is important. Of course, every project will have a “different stripe,” he said.

“When you start having success, people come to you. Then that culture of innovation starts to pervade because Dr. X or Nurse Y realize that their friend or their colleague brought something to, in our case the Innovation Institute, and we delivered on it,” Leach said. “Delivering on it could mean that we did an assessment of the idea and made a prototype, and then realized that it’s a clever idea but doesn’t have a place in the industry and, therefore, is not a good idea for us to pursue. Be objective and professional, and they’ll appreciate that.”

Leach expects that more software and service ideas will be presented to him from internal colleagues and from orthopedic companies as provider needs shift from tweaks to hardware to the overhaul of processes. He stresses that as industry seeks to build greater hospital relationships, they should seek out individuals like him within provider settings. From hospital to hospital the person may vary, but he advocates that companies identify the chief operating officers, chief innovation officers and value analysis committees to ask what efficiency means to their organization. And then, listen to their answers.

“Let’s face it, the design for hips, knees and traditional implants, all of them are really good,” he said. “The room for innovation in devices—in the absence of anything drastically different from a material perspective—is very, very small. The areas where we’re going to need innovation moving forward are areas that impact the economic side of things. Again, I’m not saying anything new, but the hospital has a huge amount of experience in terms of how to do that. Industry needs to wake up and realize that.”

Carolyn LaWell
is ORTHOWORLD’s Chief Content Officer.