How the Partner Ecosystem Has Been Key to Market Success for Spark Biomedical
公司规模
11-200
地区
- America
国家
- United States
产品
- Greenlight Guru
- Galen Data
- Velentium
技术栈
- Medical Device-to-Cloud Connectivity
- Data Analysis
- Quality Management System (QMS)
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Innovation Output
- Productivity Improvements
技术
- 应用基础设施与中间件 - 数据交换与集成
- 应用基础设施与中间件 - 数据库管理和存储
- 平台即服务 (PaaS) - 连接平台
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 产品研发
- 质量保证
用例
- 监管合规监控
- 远程控制
- 远程病人监护
服务
- 软件设计与工程服务
- 系统集成
- 测试与认证
关于客户
Spark Biomedical, founded in 2018 by industry veteran Daniel Powell, is a medical device company based in Dallas, TX, USA. The company focuses on developing solutions to combat the opioid epidemic by providing a withdrawal process with minimal symptoms. Spark Biomedical's mission is to empower individuals to eliminate opioids from their lives without the fear of withdrawal. The company operates in the FDA-regulated market and holds ISO 13485:2016 certification. With a strong commitment to quality management, Spark Biomedical has built a partner ecosystem to support its product development and market success.
挑战
Spark Biomedical faced the challenge of bringing a medical device to market to combat the opioid epidemic. The company needed to ensure that their device was safe, effective, and compliant with FDA regulations. Additionally, they required a robust quality management system to avoid issues like those experienced by Powell at St. Jude Medical. The company also needed to develop an app for device-to-cloud connectivity and data analysis, and they required engineering expertise to finalize the hardware for their Sparrow Therapy System.
解决方案
To address their challenges, Spark Biomedical leveraged a partner ecosystem that included Greenlight Guru, Galen Data, and Velentium. Greenlight Guru provided a quality management system (QMS) that was far superior to traditional paper or manual options. Galen Data offered a solution for medical device-to-cloud connectivity and data analysis, which was essential for developing Spark's app. Velentium, an engineering firm specializing in medical devices, was brought in to finalize the hardware for the Sparrow Therapy System. These partnerships allowed Spark Biomedical to accelerate their development timeline and ensure high-quality standards.
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