Zumio – Clitoral Stimulator
Design 1st Portfolio Zumio Case Study Zumio - Clitoral Stimulator World's #1 Selling Adult Massage Oscillator Turn Your Idea Into...
Nuraleve - Neuromodulation Pain Therapy
Revolutionary Pain and Addiction Therapy Using Neuromodulation
An Inside Glimpse Into the Development of Nuraleve's SmartStim for Cravings™
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
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.
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
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
Related Case Studies
