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AniMed LLC has developed a physical therapy game, Squirrel Fall, for individuals affected by lower body impairments to create a more interactive and immersive experience compared to traditional physical therapy techniques. The objective is to strengthen the patient’s core strength, flexibility, and range of motion by emphasizing lateral bending movements.

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Technology is becoming exponentially more entrenched into society's daily life. With this, there is now opportunity to integrate these technologies with healthcare and medicine to develop new innovative approaches to treatments and patient-centered care. The target market for this product is gamified therapy within the market of physical therapy equipment. Our customer base would consist of hospitals, outpatient rehabilitation clinics, and individual patients for at-home use. Our value-based pricing model allows us to designate price points based on the type of customer to optimize services for specific needs.

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In Squirrel Fall, the player is a squirrel falling from a building that is currently under construction. The objective is to move left and right, collecting the target number of acorns while dodging steel beams. Ideally, this game should also be able to function in conjunction with the implementation of other equipment such as weights and stability trainers at the physical therapists discretion. By using motion-sensing input devices (sold separately) with our motion mapping system, player movement is tracked and reflected back to the player in real-time while also monitoring the accuracy of those movements.

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The performance metrics per session and patient are recorded to evaluate success and progress. Sessions can be played back using a 3D virtual avatar, demonstrating visual feedback of the session. An interface is also provided to adjust settings and parameters of the game such as focused body regions, speed, and range of motion, amongst others to accommodate for player ability and progress over time. All of these features are available remotely for both the patient and therapist via our user portal to access any information at any time. This interface and database are appropriately encrypted and secured in order to abide by HIPAA regulations to ensure compliance regarding the proper protection of patient health information.

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Our product and motion mapping system software has completed the design and development stages our product development. We are looking to conduct performance testing for 510(k) submission and clearance for clinical applications. Although human clinical testing data is typically not necessary for 510(k) approval, this product cannot be tested on animals and therefore must use humans to collect viable clinical data.

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The ethical considerations regarding our product is centered around efficiency and safety. The viability of efficiency of our game within a clinical setting and ability to act as a tool for physical therapy is significantly more important than the dynamics and aesthetics of the experience. It is therefore critical that we can support that it is, in fact, applicable for patient-use. We must also take safety and injury prevention into serious consideration. Despite the competitive nature of games, we must ensure enough flexibility in our software design to accomodate player ability to prevent injury. Also, if this game is played by an individual at home without supervision, the likelihood of injury increases which also has to be accounted for within the design and delivery of our product.

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Center for Devices and Radiological Health. (n.d.). 510(k) Clearances. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/

Friedman, Y. (2014). Building biotechnology: Business, regulations, patents, law, politics, science. Washington, DC: Logos Press.

HHS Office of the Secretary,Office for Civil Rights, & OCR. (2013, July 26). Summary of the HIPAA Security Rule. Retrieved from https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html

Kortagere, S., Dr. (n.d.). New Device Development [PPT]. Drexel University College of Medicine.