Medical Device Commercialization

Case Study | Functional Electrical Stimulation Device For Stroke And Spinal Cord Injury

By October 24, 2014 No Comments

At Prolucid, we are always saying that solving interesting and complex challenges motivates us. What does that mean? This case study says it all.

Customer Overview

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™.

Customer Challenge

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).

Approach
  • 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.

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