Reflexion Health’s virtual rehab assistant posts similar results to traditional therapy

Reflexion Health’s VERA telemedicine rehabilitation platform shown at patient home (Image from Reflexion Health)

Separate studies have found that Reflexion Health’s virtual exercise rehabilitation assistant (VERA) was as safe and effective as traditional physical therapy while saving $2,745 per patient in a bundled-payment setting, the company announced.

Reflexion designed VERA as a digital therapy platform that integrates several components for a comprehensive, home-based rehabilitation experience without the need for patients to apply or wear any sensors or monitoring devices.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Reflexion Health’s virtual rehab assistant posts similar results to traditional therapy appeared first on MassDevice.

The biggest takeaway from the annual meeting of orthopedic surgeons (AAOS)

If you walked through the sprawling exhibit floor of the San Diego Convention Center last week, you would have noticed products galore. Mannequins being pretend treated on hospital beds, and all kinds of medical devices being touted for surgeons and other buyers.

And yet the annual meeting of the American Academy of Orthopaedic Surgeons was less about rods and screws and the latest techniques in surgery, and more about bundled care and the shift from volume to value. And this despite the fact that the Trump administration appointees are putting a temporary pause on programs that expand or implement bundled care.

This is an important shift given that device vendors in the past would dazzle surgeons with the latest technologies as physician preference and large egos would rule hospital purchasing decisions. All of it without a thought placed on how much those shiny objects cost.

And now the pendulum has swung to where device manufacturers are casting themselves as partners to help solve hospital’s problems.

Take Johnson & Johnson’s DePuy Synthes for instance.

“We have more than 25 people in supply chain that goes to the hospital and help hospital management looking at end-to-end supply chain to look for opportunities for efficiencies and in inventory management,” declared Juan-Jose Gonzalez, president of DePuy Synthes, in an interview at AAOS in an enclosed area of its exhibit. “And outside you will see the Johnson & Johnson Care Advantage that are looking at supporting patients before a procedure, during a procedure, and in the recovery phase.

Care Advantage is J&J’s services business and this year at AAOS, all the major orthopedics players were eager to flex their services muscle.

In fact, even when Stryker launched its total knee on the reportedly million-dollar Mako surgical robot — that a Zimmer-Biomet executive dismissed as a “showbot” without directly naming it — the Kalamazoo, Michigan company was stressing the economic evidence and value to surgeons rather than a feat of engineering.

Here’s Stuart Simpson, vice president and general manager, Stryker, explaining how doing a partial knee replacement using the Mako robot has proved value, in a phone interview last week.

“We have seen the 30-day complication rate reduced by 36 percent with Mako versus nonMako. And we have seen the cost of complications and readmissions for Mako cases 66% lower than nonMako cases in the 90-day period,” he said. “And that’s even accounting for the additional cost of using Mako.”

The hope is the economic value will extend to the robotic use of total knee replacements as well.

Plus, just as J&J DePuy Synthes has its Care Advantage services platform and its own strategy to gain market share, Stryker has its Performance Solutions business aimed at improving hospital and OR efficiency, among other things.

Not to be outdone, the biggest hip and knee company by market share — Warsaw, Indiana-based Zimmer-Biomet — has also tweaked its consulting business to highlight its services chops. It’s called Signature Solutions. At AAOS, the company’s exhibit contained an impressive circular zone that showed off how the company is leveraging both new technology and partnerships to stay with the patient and the hospital from before a joint replacement or orthopedic procedure all the way to recovery at home.

Patient engagement is part of the new focus at Zimmer-Biomet’s services business. The company has partnered with a firm called HealthLoop for better supporting patients who have to deal with information overload as they get ready for a joint replacement

“What HealthLoop does is really two key components – no. 1, it helps to break down that information so the patient gets messages before the stay and then also afterwards. So their care plan is sent to their phone, tablet or computer,” explained Joe Tomaro who leads the go-to-market strategy of the Signature Solutions business, in a booth interview at AAOS. “The other part that Health Loop does is that it collects patient-related outcomes information as well as information post-surgery as to the number of physical therapy visits, home care visits, when did home care start – all of which is real important to estimate how much [the procedure] costs and all of that information you don’t get from the payer until six months later.”

The latter becomes exceedingly important in the Comprehensive Care for Joint Replacement Program which reimburses hospitals for collecting patient-reported outcomes. Zimmer-Biomet has also acquired a virtual rehab company called RespondWell to help joint replacement patients perform their daily physical therapy at home, thus reducing the need to go to a physical therapist.

Meanwhile, all this focus on services and value-based care by all the major players have not gone unnoticed by surgeons at AAOS.

“If you go out to the floor right now in Technical Exhibits, the big booths within all the large total joint companies — Zimmer, DePuy, Smith & Nephew — are all taken up with their programs to manage the bundles because they have now seen that managing the bundle is really important,” declared Thomas Barber, an orthopedic surgeon with Kaiser Permanente and chair of AAOS’ Council on Advocacy

And that’s a sea from just being focused on titanium and steel implants and products.

Photo: Gregory Kramer, Getty Images

The robotic have-not: How J&J plans to woo hospitals, knee surgeons

Johnson & Johnson and Verily Life Sciences (formerly Google Life Sciences) have a joint venture to create the next generation of robotic surgery souped up with digital technologies in the future. (Watch out Intuitive Surgical.)

But when it comes to hip and knee replacement today, J&J Depuy Synthes is a robotic have-not.

Competitors have robots or are close to having something robotic in joint replacement.

On Tuesday, Stryker launched its total knee application on the expensive Mako robot during the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego. That same day at AAOS, Smith & Nephew previewed its hand-held robot-assisted device for total knee replacements in advance of a market release in the second quarter. And Zimmer-Biomet was also proudly displaying its robot on the exhibit floor — the Rosa robot acquired with the purchase of French firm Medtech SA – although the robot won’t be doing total knee replacements until 2018.

There is a general notion that robotics will gain ground in orthopedic surgery though the predictions around adoption pace vary greatly.

One analyst — Brandon Henry from RBC Capital Markets — believes Stryker will be the clear winner with the launch of its total knee on its Mako robotic system and will take market share away from Johnson & Johnson DePuy Synthes and Zimmer-Biomet in the next few years. Another — Richard Newitter from Leerink Partners — believes robotics adoption will be much more gradual and only in complex cases but still having one in the short term is better than not having one.

So in the meantime without a robot, how can J&J DePuy Synthes woo hospitals and knee surgeons, some of whom are part of Medicare’s mandatory 90-day bundled payment program called the Comprehensive Care for Joint Replacement.


Attune Knee on Bone

Company executives are relying on the wide breadth of J&J’s knee offerings, its services chops and a new company-sponsored whitepaper that touts the economic value of its Attune Knee.

“We as a company are moving from a titanium and steel focus to really looking at how can we bring more value to the surgeon,” said Ciro Römer, company group chairman, DePuy Synthes, in an interview on Wednesday at AAOS. “If you look at the actual [knee] platform, 400,000  have been implanted until now with outstanding outcomes. Not great outcomes only with regards to survivorship but more importantly the economic benefit of the Attune knee.”

So what are those economic benefits?

A whitepaper produced by the company and based on data from company-initiated studies, investigator-initiated studies, and independent studies and national joint registries found the following per a company news release: [ Note: Both the whitepaper authors are financially compensated by DePuy Synthes. Dr. David Fisher, director of the Total Joint Center of Excellence at OrthoIndy Hospital in Indianapolis, is a consultant. Co-author David Parkin, an honorary visiting professor at City University  London, and a senior visiting fellow, Office of Health Economics, London, has no formal consulting contract with DePuy Synthes but was paid to analyze the data and produce the report.]

  • The published report from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) showed that the ATTUNE Knee’s estimated cumulative percent revision was 1.39% at three years (98.61% survivorship)for 4,463 knees, comparing favorably to the class of Cemented Total Knee Arthroplasty that has an estimated

    cumulative percent revision of 1.50%.

  • A U.S. hospital database analysis showed 39% lower odds of patient discharge to a skilled nursing facility when implanted with an ATTUNE Knee, compared to patients who received total knee replacement with a Triathlon Knee. [The Triathlon is the total knee implant made by Stryker.]

The latter data point is important at a time when hospitals are racing to reduce the post-acute costs of a joint replacement procedure. The rationale is that if you can reduce use of a skilled nursing facility after the joint replacement implant procedure, some dent may be made in the overall cost.

But not everyone is buying the easy correlation between implant quality and reduced skilled nursing facility use.

Dr. Thomas Barber, an orthopedic surgeon with Kaiser Permanente said he doesn’t pay a lot of attention to company-produced reports.

“You have to take them at face value,” Barber said in a media roundtable at AAOS on Wednesday. “I saw something the other day from a particular vendor who shall be nameless that said that using their total knee replacement will actually lead to lower SNF length of stay and lower SNF use, and I was like, “Really?”

Meanwhile, while such data may not sway hospitals and surgeons, the technology that DePuy Synthes possesses in it services suite might pique their interest.

The company has a partnership with IBM Watson Health through which the Big Data crunching supercomputer can comb through patient profiles and help providers understand their risk profile.

“The system is fed data about patient profiles and based on the patient profile — whether you have high BMI, whether you have diabetes — and that can help determine what kind of preparation, procedure and very importantly the kind of rehabilitation you will need to have and the most likely complication,” declared Juan-José Gonzalez, president, DePuy Synthes, U.S. in an interview with Römer. “No other company has those capabilities.”

Photo: jpa1999, Getty Images and Johnson & Johnson DePuy Synthes

Stung by opioid crisis, doc warns European counterparts while researcher develops possible solution

Don’t make the same mistake we did.

That’s the message of Dr. David Ring, a hand surgeon and chair of the committee of patient safety at the American Academy of Orthopaedic Surgeons, to doctors across the pond. On Wednesday, Ring was joined by Dr. Sommer Hammound, a lead author on a study about orthopedic pain management and opioid use being presented at the annual meeting of AAOS in San Diego this week.

Orthopedic surgeons are the third-highest prescribers of opioids, Hammound pointed out from a specialty standpoint indicating that it is incumbent that they understand their risks and look for alternatives. One such alternative may be on the horizon if a Mass General researcher is successful.

Based on the opioid study, Hammound concluded that multimodal medications and surgery pretreatment plans should be explored before going the narcotic route. Ring laid the phenomenon of rampant opioid prescription at the feet of the pharma industry.

“Why were we using so many opioids – why were we emphasizing opioids in our pain regimen,” Ring asked. “It’s because the pharmaceutical industry was really pushing it.”

He acknowledged a level of complicity by noting that surgeons didn’t want to receive calls on the weekend from angry patients unhappy with the pain they were in and ended up ordering narcotics for them.

“The culture became, ‘We undertreat pain. Who wants to be a bad person like that,  and the way to treat pain is opioids,” Ring said describing the rationale for opioid prescriptions.

But it’s also ironic that “opioids are not great pain relievers,” he declared. He noted how overseas physicians are cautious about prescribing these addictive drugs. In places like Chile, they use Tylenol to manage pain from orthopedic procedures, for instance.

“Keep in mind that that most of the world does the same operations that we do … and uses minimal opioids,” Ring said.

The pharma industry has been less aggressive in marketing these drugs in places like Chile because of the culture of how pain is managed, he said, but across the Atlantic it’s a different story.

“If you look at Europe they are starting to use more and more opioids and it’s [because] of the pharmaceutical industry,” Ring charged. “They are not very aware of the epidemic here.”

He added that orthopedic surgeons are trying to send a message to their European brethren: “Pay attention. Don’t make our mistake.”

Now, the goal for orthopedic surgeons should be to communicate better with patients to try and get them ready mentally for the procedure ahead because it is those who believe that they will be able to get through the pain are those that end up needing less opioids, he said.

“The thing that really works well is self-knowledge,” Ring said, noting that cognitive behavioral therapy may need to be added to the mix in dealing with pain instead of opioids because opioids cannot treat stress or worry.

“You could train your mind just as well as you could train your body,” he said.

Meanwhile, Orhun Muratoglu, director of the Harris Orthopaedic Laboratory and director of the Technology Implementation Research Center (TIRC) at Massachusetts General Hospital, believes he may have hit upon an idea of continuous pain relief even after patients have undergone a joint replacement procedure.

That would reduce or even eliminate the use of opioids post-procedure for pain relief.

In an interview during the AAOS annual meeting Wednesday, Muratoglu explained that doctors usually inject a local anesthetic like liposomal bupivacaine or bupivicaine to help with pain relief, but the effect wears off soon after the joint replacement.

Doctors sometimes leave ports open on the body for later injections but that increases the chance for infection, also not a desirable outcome.

A couple of years ago an orthopedic surgeon at Mass General approached Muratoglu saying that there must be a better way to provide pain relief than the current standard of anesthetic injections during procedure and opioids thereafter.

That’s when Muratoglu began working with polyethylene a common material used in joint replacement implants. He infused bupivacaine into the material and then tested the effect on rats. Those with just the polyethylene limped along while those with the bupivacaine-infused polyethylene walked normally.

“Bupivacaine works very well if you can deliver it constantly,” he said.

The polyethylene essentially becomes a drug delivery mechanism through which bupivacaine can be delivered.

“What we did is put the bupivacaine into polyethylene and release it from the polyethylene slowly and we can do a release for a week,” he explained.

Muratoglu hopes to be able to convince the FDA about the safety of this and run a small, 20-patient feasibility trial. He will be presenting on this at the Hip Society meeting on Saturday.

Muratoglu has had success in developing novel approaches in the past.Per his bio, “medical implants fabricated using technologies developed by Dr. Muratoglu have been in clinical use since 1998 with over 7 million implantations worldwide.”

The bupivacaine-infused polyethylene approach is likely several years away but if successful, orthopedic surgeons may have a tangible device approach to solve a pressing problem.

Photo:, Getty Images

Stryker launches expensive Mako robot for knee replacement in cost-conscious era

As value-based care and bundled payments begin to take hold in the orthopedics industry and healthcare overall, Kalamazoo, Michigan-based Stryker is doing something counterintuitive.

It is launching an expensive piece of equipment. Coinciding with the first day of the annual meeting of the American Academy of Orthopaedics Surgeons (AAOS) in San Diego, the orthopedics company announced Tuesday that the MAKO robot is now officially launched in the U.S. to perform total knee replacements. (MAKO has been available to perform total hip knee replacements and partial knees in the U.S. up until now.)

Why introduce a reportedly million-dollar piece of new technology at a time when hospitals and orthopedics practices are racing to reduce the cost of hip and knee replacements?

In a phone interview, Stuart Simpson, vice president and general manager, Stryker, shared his confidence that the Mako robot with the total knee application would have both clinical and economic benefits that hospitals would find compelling.

To step back a bit, Stryker made a bold acquisition of Mako for nearly $1.65 billion in 2013. Bold because none of the larger ortho players had envisioned joint replacement procedures to be done by a robot. The company has also bucked the consolidation trend in the marketplace – think Zimmer buying Biomet; Wright Medical buying Tornier – although there leaked reports showed that it was exploring a merger with Smith & Nephew. The bet was new, innovative technology backed by proper clinical and economic validation would win the future.

Mako’s total knee application — where the Mako robot would implant Stryker’s Triathlon knee — won FDA approval back in August 2015. But Kevin Lobo, the company’s CEO made the rather atypical decision to delay a wide sales roll out nationwide until 2017. [ I reported on that decision for a different publication last year].

In that two years, Mako’s total knee application has been used on a limited basis in 65 hospitals in the U.S., U.K., Australia and Germany, Simpson said and more than 1,400 cases have been performed.

Now it’s ready for full launch and the hope is that the clinical benefits noticed in the partial knee application by using the Mako robot will extend to the total knee as well.

Simpson said that the company used the commercial payer databases to do a study on how Mako’s partial knee application stacks up against partial knees performed manually without the use of a robot.

Stuart Simpson, vice president and general manager, Stryker

Stuart Simpson, VP, and general manager, Stryker

“What we have seen in two years, you’re seeing revision rates of partial knees with Mako of about half a percent versus revision rates of nonMako procedures of about 3.5 percent,” Simpson said. “That is a big, significant clinical quality improvement.”

There is a clear economic benefit as well when Mako’s partial knee applications were studied, according to Simpson.

“We have seen the 30-day complication rate reduced by 36 percent with Mako versus nonMako. And we have seen the cost of complications and readmissions for Mako cases 66% lower than nonMako cases in the 90-day period,” he said. “And that’s even accounting for the additional cost of using Mako.”

Simpson declined to comment on the price of Mako though it is reportedly upwards of $1 million, only noting that there are a variety of financing options that are available to hospitals who need only to say that they are interested in one.

“Once we’ve established that physicians want a Mako, we can typically find a way that works for hospitals given all the different financial strategies that these hospitals tend to have,” he said.

One small survey of orthopedic surgeons undertaken by RBC Capital Markets seems to suggest that Stryker is poised to take market share away from the likes of Zimmer Biomet and Johnson & Johson Depuy partly because of high interest in robotics.

“U.S. orthopedic surgeons expect strong demand for new robotics systems and believe that [Stryker] will be the leader in the U.S. robotic hip/knee market,” according to a research note published Monday by Brandon Henry, an analyst with RBC Capital Markets. “Surgeons expect Stryker’s Mako to capture ~90% of the U.S. robotic hip/knee market. Separately, surgeons expect strong ~82% and ~56% year-on-year growth in their robotic hip/knee procedures in 2017 and 2018, respectively. Surgeons expect the fastest growth in robotic total and partial knees.”

All of which should be sweet music to Simpson, Lobo, and the Stryker sales team that have waited to sell the device far and wide.

Photo: Stryker 

Correction: An earlier version of the story incorrecrtly stated that the total knee application on Mako was available in Japan. It is available in U.S., U.K.., Australia and Germany.

Virtual rehab to gain ground in orthopedics as bundled payments take hold

If you believe that digital health and orthopedics seem mutually exclusive, then you are sadly out of step with the times.

At a panel presentation about alternative payment models and bundled care at the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego on Tuesday, speakers clearly signaled that virtual therapy would be used more and more in the future. Especially now when bundled care programs like the CMS-mandated Comprehensive Care of Joint Replacement (CJR) is in place in 67 metropolitan statistical areas in the U.S.

That should be good news for digital health startups in the field who are eager to prove the clinical validity of their products, as well as help hospitals to lower the overall cost of joint replacement procedures.

Dr. Owen O’Neill, an orthopedic surgeon with Twin Cities Orthopedics, explained how the large ortho group practice with 116 providers implemented a commercial bundle in 2013 and lessons learned from that program, now in its fifth year.

“I can tell you that 97 percent of our bundles actually are financially positive,” O’Neill declared. “Three percent lose so overall financially they are very successful.”

Still, there are challenges. Under the fee-for-service model, physical therapy offered by Twin Cities Orthopedics was a profit center. Now as the group implemented the bundle, they looked at post-acute care as the area in which costs can be cut. And five years into the program, what was a profit center is now a cost center.

“Future directions, on the therapy side we are looking at things like virtual therapy,” O’Neill said.

Later, in response to a question from this reporter, Richard Iorio, an orthopedic surgeon with NYU Langone Medical Center, echoed O’Neill.

“We are actively moving toward online physical therapy programs and our goal is to eliminate physical therapy for hips, only use in knees when we need it …,” said Richard Iorio, a hip and knee surgeon at NYU Langone Medical Center.

Iorio did not mention which companies and online programs NYU uses but mentioned there are several out there.

Here are a few that MedCity has come across:

Reflexion Health
This San Diego-based virtual rehab company uses sensors, Microsoft Kinect, and the Vera avatar to guide joint replacement patients through their physical therapy at home. This daily exercise routine done in front of a TV reduces the need for patients to go to a physical therapist or can keep them moving in between sessions. The patient’s physical therapist is in charge at all times and can choose to bring him or her in at their discretion. The system also provides a technology solution for hospitals eager to lower their costs to treat joint replacement patients.

The Vera system is cleared by the FDA and also is able to facilitate the collection of patient-reported outcomes as is required for reimbursement.

This Montreal, Canada-based company also uses sensors and Kinect similar to Reflexion Health, as well as adopts elements of gaming to provide visual feedback for users to make physical therapy and occupational therapy exercises more interesting for patients. The company’s FDA-cleared platform targets patients recovering from stroke, hip replacement, hip fractures and knee replacement. It also helps track patients with multiple sclerosis and Parkinson’s disease.

Force Therapeutics
New York-based Force Therapeutics is a remote monitoring company whose digital health platform provides physical therapy to joint replacement patients. What’s more, patients have access to surgeon videos and instructions, and physicians can track patient progress in between appointments. The goal of Force Therapeutics, as with the above companies is to reduce readmission rates that can increase the cost of the joint replacement episode of care.