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Revolutionary Pain and Addiction Therapy Using Neuromodulation

Turn Your Idea Into Reality
Render of the Nuraleve Nordocs SmartStim therapy device with two yellow electrode pads

An Inside Glimpse Into the Development of Nuraleve's SmartStim for Cravings™

Concept Sketches of Table Top Device With User Interface

Background & Design Requirements

Nuraleve came to Design 1st to transform their innovative neuromodulation headband technology into a manufacturable medical device for clinical use of pain and addiction therapy. Design requirements included:

  • Develop an MVP prototype for informal testing and clinical trials
  • Comfortable one-size fits all headband with integrated electronic sensors in precise locations.
  • Base unit with intuitive user-interface design
Product Prototype - Custom user interface, display and integrated electronics

Industrial Design Challenges

Implementing Design 1st’s proven process, the team was able to overcome several obstacles to:

  • Develop a one-size fits all headband through multiple user testing of prototypes with various materials.
  • Meet all medical regulatory requirements to accelerate Health Canada and FDA approval
  • Design a volume production unit, to optimize material and shipping costs.
First Volume Production Run Part Inspection

Results

Through creativity and technical understanding, the Design 1st team developed an innovative medical device:

  • Fully-functional pre-production prototype ready for clinical testing in under twelve months.
  • Positive user feedback from both patients and medical professionals.
  • Successful first volume production run that met ISO 9001 and ISO 13485 medical device regulatory approval
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Play video: Revolutionary medical device technology for pain and addiction therapy using neuromodulation.

Revolutionary medical device technology for pain and addiction therapy using neuromodulation.

“We came to Design 1st with an ugly black box and knew we needed a better solution. Design 1st came through and gave us ideas we never thought possible that exceeded our expectations.”

Matthew Lemay VP of Service Delivery, Nuraleve

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