MyndTec, a Canadian medical technology company, has developed a new therapy for the treatment of arm and hand paralysis caused by stroke or spinal cord injury. MyndMove™ therapy is based on advanced non-invasive functional electrical stimulation (FES) and proprietary stimulation protocols to improve voluntary movement of the arm and hand following injury to the brain or spinal cord. MyndTec approached Prolucid in 2012 to assist in the commercialization of MyndMove™.
To successfully commercialize MyndMove™, MyndTec required a partner with expertise in medical system design, to create a device capable of delivering this therapy. The device needed to accurately output the prescribed treatment through electrical stimulation, provide an intuitive control interface for the therapist, as well as seamlessly integrate with a cloud data management system.
Additionally, the software development for this device required compliance with IEC-62304, a standard describing the life cycle for medical device software. Also, proper security for data transferred and stored on the device was required to comply with HIPAA (the Health Insurance Portability and Accountability Act).
- Prolucid assisted in early phases of MyndMove™, to identify high-risk items and make preliminary design decisions. The creation of mockups and prototypes were used to clarify design and ensure the proper technologies and platforms were chosen for each subsystem.
- After the planning and preliminary design phases, Prolucid worked closely with MyndTec and other partners to generate a detailed requirements specification, design description, and testing plan for the full integrated system.
- Prolucid used an interactive development process through frequent meetings with MyndTec demonstrating progress, integration sessions with hardware developers, and usability studies to refine human interactions.
- After completing development, Prolucid was involved in the execution of field trials, gathering user feedback, and final deployment of the device.
- Prolucid developed a real-time firmware application for an embedded ARM-based controller. This component was responsible for interpreting the treatment protocols used during the therapy session, and controlling up to eight channels of electrical stimulation applied to the patient. Each treatment protocol is created using a standardized set of commands, allowing for future expandability.
- Prolucid developed a user application for a windows-based tablet computer using the LabVIEW development environment. This component is the main interface for the therapist to control the device while administering therapy to the patient. The tablet and user application provide an intuitive method of choosing a treatment protocol, personalizing the protocol to produce optimal results for the patient, and controlling the device while treatment is being administered.
- Prolucid developed an integrated cloud-based data management system using Microsoft’s Azure platform. This component manages the therapist and patient data and also allows for data to be synchronized across multiple devices. This cloud-based system also allows for devices to gain access to new feature releases and the most up-to-date treatment protocols available. Additionally, therapists and patients are able to visualize the long-term progress being made as the patient advances through the MyndMove™ therapy.
With Prolucid’s strong medical device commercialization and technical expertise, MyndMove™ was able to successfully go from prototype through to commercialization under an aggressive schedule and obtained Health Canada approval in April 2014 within two weeks of submission! In addition, tight collaboration throughout the process and extensive field testing will ensure MyndMove™ is not only easy to use but also seamlessly integrates into clinics and hospitals to enable effective training and patient treatment. MyndTec’s MyndMove™ therapy is now available for stroke and spinal cord injury patients in Canada and MyndTec is looking to expand their product to US, and European markets after FDA and EU approvals are obtained.