The fall sports season is tantalizingly near; players and fans alike are gearing up for the Friday night lights and Sunday afternoon showdowns. But the season comes at a cost; every bone-jarring hit and wince-inducing header carries the risk of sustaining a concussion.
Most media coverage focuses on the National Football League’s professional players, but 65% of traumatic brain injuries are sustained by children. The majority are thought to be undiagnosed, but the Center for Disease Control estimates that 1.6 to 3.8 million sports-related concussions occur each year. This puts athletes at risk of sustaining a second concussion before their brains are fully healed, leading to longer recoveries, permanent neurological damage, and the potentially-fatal Second Impact Syndrome.
A just-released app hopes to change that. Sway Medical, founded by Chase Curtiss in 2011, aims to help health professionals objectively rate the risk of concussion at the source: on the football field or soccer pitch. On-the-spot concussion diagnosis is just the beginning, though; in the near future, the young company plans to enter the hospital space by the end of the year.
The FDA-approved app, called Sway Balance, uses proprietary software and the iPhone’s accelerometer to assess an athlete’s balance over time. In a phone interview, founder and CEO Chase Curtiss said that the app can be used by a health professional to “set up a baseline,” then “compare an athlete over the course of a season to that established norm.” Poor performance compared to baseline is indicative of a possible concussion.
Health care professionals can purchase a yearly subscription to the app for $199 – a fraction of the cost of a typical balance platform – and the patient-facing app is free to download.
Sway Medical has partnered with ImPACT Applications, an organization which Curtiss described as conducting the “gold standard of concussion testing on the market.” ImPACT uses baseline cognitive testing – verbal and visual memory, processing speed, and reaction time – and synchronous testing immediately after a hit to assess if a concussion has occurred.
“But you don’t have an element of physical control of the body,” Curtiss said – which is where Sway Balance comes in. “[ImPACT’s] interest in us is in pairing a balance test with cognitive testing.”
Dr. Andrew Blecher, a sports medicine physician and certified ImPACT consultant, stressed in an interview that “the diagnosis of concussion is very subjective” but that “more information is a good thing.”
Curtiss noted that Sway Balance merely adds one more objective piece of information. “We have this tool to be able to have a quantitative number to say, yes, here’s their score now, here’s how it compares to before,” Curtiss said. “That’s really the value of our tool is objectifying that, to have a real score.”
Blecher is sanguine about Sway Medical’s partnership with ImPACT. “I think Sway in and of itself is, is you know, maybe a hit-or-miss type thing, but partnered with ImPACT, it’s kind of a home run,” Blecher said. “The partnership between the two is really big.”
Dr. John Schumann, a general internist and medical educator at the University of Oklahoma School of Community Medicine, agreed. “Something like that has the potential anyway of becoming the standard of care…. We can use this as an objective criteria to judge his balance and his or her abilities.
Off the Field, Into the Ward
But the application was cleared by the FDA to do much more than on-the-field concussion testing. “Our indications of use are [as] a prescriptive device [used] by a… qualified health professional… and it’s prescribable for the assessment of balance as a symptom of head injury, fatigue, nausea, orthopedic injury, and medication use,” Curtiss said. “It was a pretty broad issuance from an indication standpoint.”
That broad issuance opens the door for balance assessment and testing at the point of care, and allows Sway’s use in a variety of contexts, like post-surgical assessment and falls prevention.
Sway Medical’s entry point into the hospital market will be the orthopedic ward, used by physicians and physical therapists to assess a patient’s balance after a hip or knee replacement. It hopes to start there by the end of the year.
In an outcomes-based reimbursement model, objective measurements become critically important. “That’s where we think our objective assessment tools can help more rigidly establish what those numbers are,” Curtiss said. “Hopefully [we will] help kind of push that pay-for-performance metric based on objective scores.”
Another potential use of the app is to assess the falls risk for elderly patients or residents of nursing homes. Between 700,000 and 1,000,000 patients fall in hospitals each year, costing billions of (often non-reimbursable) dollars; one-third are thought to be preventable. The app could be used by physical therapists or physicians to assess a patient’s balance frequently, with lower-than-baseline scores triggering increased attention and fall risk precautions.
Balancing Efficacy and Reimbursement
“I think what has to be looked at is, how do we fit in the health care system now and how do we fit into the healthcare system of the future?” Curtiss said. “Our company is really focused on ‘how do we do both of those?’”
Sway Medical’s goal is to amplify existing physician and physical therapist behaviors rather than modify current practice wholesale. “[Our app] is a structured balance test like [physicians] have been doing their entire careers that is much more objectively and clinically valid than the subjective tests they’ve been relying on,” Curtiss said. “We really think that our tool should be much better at creating more time efficient and more data-supported decisions of the physician.”
Dr. Blecher isn’t as optimistic about the app’s use in a hospital setting. “I don’t know how much people will be using it in a hospital setting. Maybe they would. I don’t know,” he said.
Partly, this is because of the alternatives hospital-based clinicians have. “The sidelines don’t have a lot of tools that are quickly, readily available; in the hospital there are a lot of tools that are available,” he added. Physicians and physical therapists will have to choose Sway Balance over alternatives they understand, already use, and trust.
Whether Sway Balance is used in the hospital setting will likely hinge on future studies investigating its efficacy compared to these other tools. If it’s as effective and easier to use, physicians and physical therapists will migrate to it over time.
Critically, reimbursement concerns will not be part of clinicians’ hesitancy to use the app: it’s reimbursable by Medicare and other insurers. This mitigates one of the most salient risks healthcare innovators face: getting too far ahead of the system’s ability to pay for their innovations.
As the American health care system moves away from fee-for-service reimbursement to an outcomes-based model, Sway Medical’s success will rely more on its efficacy than its ability to be reimbursed. If it succeeds in pleasing health care professionals, reducing the likelihood of dangerous concurrent concussions, and preventing falls, the company will likely see success.
Mike Miesen is a former hospital operations consultant and current freelance journalist, covering American health policy and international development from east Africa. Follow him on Twitter @MikeMiesen.
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Holding the device makes testing much more efficient, no harnesses that have to be ordered or carried around and the product has been validated with this procedure against force platform (Biodex) and BESS testing. It has also been tested for device sensitivity and test-retest reliability. Here is a link to a white paper about the research performed that was presented to the FDA
http://swaymedical.com/wp-content/themes/sway/library/files/ScienceBehindSway.pdf
Sway Medical has partnered with ImPACT to improve concussion management by employing best practices into an overall concussion management protocol. The multi-factor approach of cognitive, vestibular, visual and symptom assessment are critical to concussion evaluation and this partnership is a big step towards a more well rounded objective assessment. ImPACT is doing great things in this way to provide an even better platform.
Chase Curtiss
CEO/Founder
Sway Medical
chase.curtiss@swaymedical.com
The device is actually “cleared” rather than “approved’ by the FDA, but that’s a difference I won’t get into here.
What this means is that the device was classified as a Medical Device, and a 510(k) clearance application was submitted to the FDA. This application includes information such as indications for use and all claims of intended use (health related), description of the device, detailed technical and design descriptions, descriptions of device testing (verification and validation), including any clinical or patient/user testing.
This evaluation by the FDA ensures that the device is safe and effective. This means that the device was designed following certain rules (i.e. design controls), thoroughly tested and validated to ensure it performs the way the company claims it does. In addition, most companies marketing medical device must operate following Quality System Regulations (similar to Quality System Standards such as ISO 9001 or ISO 13485).
The review of this application and the clearance by the FDA must actually occur prior to the device being placed on the market.
In the end this means that a customer or a user can have a much higher trust in a product that is a medical device and is cleared by the FDA.
Sway Balance was cleared under K121590 (here’s the link to the FDA document http://www.accessdata.fda.gov/cdrh_docs/pdf12/K121590.pdf).
Companies who claim FDA clearance and/or claim intended uses that meet the definition of a medical device but do not have such a clearance or exemption can be enforced by the FDA. (example here http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm353513.htm). In addition, companies with health claims of cures or performance that they do not meet can be enforced by the FTC; for example Acne Cure apps (http://www.ftc.gov/opa/2011/09/acnecure.shtm).
If you have more questions related to the FDA, or any Quality or Regulatory aspects, please contact me.
Michael Zagorski
Director of Quality & Regulatory
michael.zagorski@swaymedical.com
I’m really curious what kind of validation has been done? It looks like an inefficient way to measure postural sway since the athlete is holding the phone to their chest. The spot where the phone is held can change each time the test is administered which would give invalid data. Also, has it be measured against a neurocom or a biodex machine and will integrate with ImPact? It would be nice to see a truly multi factorial test that would also incorporate neuromotor, vistubular and vision in one fully integrated package.
Interesting that this one is FDA approved. Can anybody tell me what this means? This is not in an inconsequential question, given the number of unapproved apps we’re seeing coming in the door. How can an app be FDA approved if the product has not yet been released? This seems a little weird.
Are there marketing regulations simliar to the ones that – what is the consequence if a firm that does not have an FDA endorsement claims one?