Nuraleve - SmartStim的渴望

...

Revolutionary pain and addiction therapy using neuromodulation.

瞿iso - 13485 -医疗设备
奥西mindtomarketaward

所面临的挑战

Transform unique neuromodulation technology into a system level product suitable for clinical applications with minimal training.

解决方案

Conduct early stage user-testing of a treatment device including headband design concepts to determine the right mix of accuracy and usability.

Video: Interview with Nuraleve Director, Matt LeMay

01.

艰难的设计决策

Balance accuracy of electrode placement with ease of clinical use.

02.

临床试验的原型

Provide Nuraleve with fully functional prototypes for clinical user trials.

03.

电子产品集成

Simplify ease of use by blending electronics into compact device housing.

04.

管理文档.

Help expedite ISO 9001 and ISO 13485 medical device regulatory approval.

概念设计原型

A

设计

Nuraleve approached 365游戏平台 with a functional black box prototype that worked but failed to meet clinician and patient expectations. The design challenge was transforming this technology into a design that made the neuromodulation device feel safe for patients and easy-to-use for clinicians.

为了解决这个挑战, 365游戏平台 began interviewing clinicians from early Nuraleve trials to understand their needs and get patient feedback. This 信息rmation helped support the creation of a clinician-friendly tool with an easy to adjust headband design that met user and regulatory requirements.

“让设备看起来和感觉对病人来说都是安全的."
爆炸视图

带头带人的头部三维CAD模型.

“适合人类头部大小的95%."
B.

工程

Building out the design concepts of the main electronics unit in 3D CAD was straightforward, 挑战在于发带. Creating a user-friendly headband that would fit the myriad of head shapes, sizes and electro-contact locations took some creative ingenuity and human factors experience.

The solution came from exploring sizing mechanisms that could easily adjust the headband with two fingers to fit 95% of human head sizes. After testing the function on multiple users and clinicians, the solution was built in 3D CAD and prototyped for testing.

SLA model with electronics integration for clinician testing.

C

测试

Once the design concept was finalized for both the headband and main device, pre-production prototypes were built in the 365游戏平台 prototyping lab. These prototypes were sent off for clinical trials to gather user feedback and compare the new design function to the original black box units.

4周后, 365游戏平台 received feedback and was glad to hear the results were better than expected. The time it took clinicians to set up and place electrodes on a new patient went from 10 minutes down to 2, 使其成为第一个行业. This time saving allows for more patients to be seen, directly impacting revenue.

“准备时间从10分钟缩短到2分钟."

主要神经调节装置的前期制作单元.

ISO 13485和ISO 9001认证."
D

制造业

作为一种医疗设备, Nuraleve needs to meet strict regulatory and process guidelines on the development, assembly and manufacturing of the SmartStim neuromodulation to receive both ISO 13485 and ISO 9001 certification.

365游戏平台 helped support Nuraleve with documentation of the development and production process. This documentation helped Nuraleve expedite their certification process and receive the internationally renowned ‘健康 加拿大 Medical Device’ license.

“We came to 365游戏平台 with an ugly black box and knew we needed a better solution. 365游戏平台 came through and gave us ideas we never thought possible that exceeded our expectations.”
- Matt Lemay,365游戏平台交付副总裁,  ‎Nuraleve

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