The company’s immersive healthcare division is developing virtual reality (VR) technology to enhance patient care. The REAL system gives clinicians tools to monitor patient progress, improve engagement and enhance satisfaction during rehabilitation, as well as address cognition and mental wellbeing. By integrating VR technology with patient-centric design principles, Penumbra aims to transform the therapy experience.
“It’s a really different point of view. It’s leveraging the perspective of Penumbra versus a lot of the other companies that are in the space,” Penumbra Immersive Healthcare President Gita Barry said in an interview with Medical Design & Outsourcing. “There’s incredible tech expertise in this space looking to bring the technology into healthcare. But what we do very differently is we see this no different than any other medical device that we’ve created.”
There are several companies in medtech that use virtual reality for surgical planning. For example, AppliedVR’s RelieVRx is an immersive therapy to help patients adjust their cognitive, emotional and physical responses to chronic pain. MindMaze’s MindMotionPRO is an augmented reality approach to hone therapy. But Penumbra’s REAL Immersive systems were the first exerciser and measuring VR platforms for physical medicine that were FDA cleared, according to the FDA’s Digital Health Center of Excellence.
The company is developing VR platforms for rehabilitation, mental wellness, and cognition. Penumbra designed its REALy-Series VR rehabilitation tool for clinicians to monitor and advance patient goals, drive patient engagement and increase satisfaction and adherence to therapy. Its mental wellness and cognition VR system, the REAL i-Series, has VR-enabled immersive experiences for cognitive activation, distraction therapy, reminiscence therapy, mindfulness therapy and relaxation therapy.
Penumbra’s VR systems measure and gather insights that Penumbra gives to the therapist, who can then give them to the patient. Barry says the systems can collect new information beyond what therapists could previously only capture with eyeballs.
“The idea that you can immerse and you can see things in a different way – that’s where patients can benefit. That’s where clinicians can benefit. And it really comes down to how [to] create some really interesting use cases that are really well designed from the clinical ground up to really be able to advance the field, just like you would with a catheter or coil or anything else that you were designing to address the clinical condition,” Barry said.
Virtual reality also has the potential to transform medical training. It can help with communication and collaboration as clinicians visualize patient cases in VR. Using VR during actual procedures allows clinicians to plan the best surgical approach and pathway before an operation, based on patient imaging. It also enables new opportunities for patient education by visualizing procedures and conditions. Once clinicians see the benefits of VR training, it opens doors to exploring other uses of immersive technology.
How Penumbra’s VR technology works
Penumbra’s REALy-Series product uses full-body sensors with Velcro straps on patients like a motion capture suit. These sensors facilitate the creation of an avatar and skeleton, enabling comprehensive patient movement tracking.
This proprietary sensor positioning approach offers advantages over camera-based tracking, as it ensures a broader range of motion that is accurately captured even when the patient’s movements aren’t directly visible to the headset’s camera.
The collected data is then processed using AI, machine learning and algorithmic analysis, creating valuable measures and insights for clinicians to enhance the therapeutic experience.
“Because we use our own proprietary tracking technology, you have a much broader world of motion that you can do, which is really well suited for physical therapy and occupational therapy,” Barry said.
Penumbra gamifies the therapy experience to create better outcomes for the patient. Typically, the company would focus on the physician’s needs, such as how they hold a catheter or how the catheter can be incorporated with other devices.
“But we apply game design principle. We apply the fun of, ‘How do we take advantage of this incredible immersive technology to engage the patient in a way to achieve those outcomes?’ And I’ve never had a medical device where we’ve had that kind of experience,” Barry explained.
The patient-centric design behind VR and resulting positive outcomes
In the context of patient-centric design within VR therapy, the primary goal is to engage patients and enhance their overall clinical progress actively. The effectiveness of VR therapy hinges on patient engagement. Unlike traditional medical interventions, which focus primarily on physician-centric aspects, VR therapy involves meeting patient needs and creating a beneficial experience that the patient can enjoy.The process begins with defining specific patient actions and outcomes. Similar to creating a marketing specification in medical device design, VR therapy lays a foundation rooted in clinical science. The emphasis is placed on the desired outcomes and the metrics that need to be generated for the patient’s benefit.
VR therapy introduces the possibility of challenging, enjoyable, and safe activities for patients, which may not be feasible in a typical clinical setting. Activities like playing catch or dodgeball can be incorporated into therapy, providing patients with a sense of accomplishment and positive reinforcement.
Game design principles are crucial, guiding how settings and difficulty levels are adjusted. However, the design is approached from a clinical perspective, aligning with parameters like range of motion, ease of movement, and the speed at which challenges are presented. This approach ensures that the therapy remains tailored to the patient’s needs while providing an immersive, game-like experience.
One significant advantage of VR therapy is its ability to help patients overcome pain-related fears. Patients often shy away from specific movements due to the anticipation of pain. In the immersive world of VR, the focus shifts from pain avoidance to enjoying the experience, encouraging patients to push their boundaries.
The impact of VR therapy is evident in the immediate response of patients, Barry said.
“The first thing that happens when you put a headset on someone is they smile uncontrollably. They don’t even know they’re smiling. It’s an amazing thing to just see somebody smile, especially someone who’s not excited about going to therapy,” she said.
Navigating regulatory challenges
Penumbra’s key strategy for ensuring compliance and safety when developing immersive technologies is to assume the technology is a medical device from the beginning of development. It applies a quality system and works closely with its regulatory team as it would for any other medical device.
“We see it as a medical device, treat it like a medical device, treat claims as a medical device, treat the way you think about your product,” Barry said. “If you think about your FMEA (failure mode and effects analysis) in terms of how does this device function, you’ll get to the right spot.”
Cybersecurity and personal health information (PHI) is also a concern with the transfer of personal information through technology. A lot of information about the patient is included in the therapy, so the company engages with partners and customers as it relates to any data. It offers an offline version of the treatment that won’t store data, but HIPAA, personal health information and personally identifiable information are also concerns that Penumbra takes into consideration when developing the VR systems.
“We bring all of those fundamentals together and we’re currently we’re SOC 2 certified. We’re continuing to look at how do we continue to increase the level of security of our devices in terms of what that looks like and making sure that we’re complying with all the applicable standards that are out in the space for medical devices, but also FTC standards,” said Barry.
The future of Penumbra’s Immersive Healthcare business
Penumbra’s plans for the future involve creating more awareness about the technology, advancing the technology and scaling it for more widespread use and building trust with doctors and therapists to encourage more adoption. According to Barry, these elements form the crux of a transformative journey poised to reshape the landscape of patient care.
One of the main objectives is to shine a light on the existence of these technologies and their capacity to enhance patient care. Whether catering to veterans or individuals seeking healthcare in commercial settings, the need for awareness is essential.
There are many types of therapists in healthcare. While occupational therapists (OTs) and physical therapists (PTs) can benefit from these immersive technologies, but Barry said Penumbra is committed to advancing the technology for more applications.
She also thinks this evolution hinges on the technology’s scalability to support clinicians.
“There are a lot of therapists in the world, and there are a lot of different settings in which therapy is provided on a daily basis,” Barry said. “We’ve got more work to do. … We just scratched the surface.”