Case Studies > How the Partner Ecosystem Has Been Key to Market Success for Spark Biomedical

How the Partner Ecosystem Has Been Key to Market Success for Spark Biomedical

Customer Company Size
SME
Region
  • America
Country
  • United States
Product
  • Greenlight Guru
  • Galen Data
  • Velentium
Tech Stack
  • Medical Device-to-Cloud Connectivity
  • Data Analysis
  • Quality Management System (QMS)
Implementation Scale
  • Enterprise-wide Deployment
Impact Metrics
  • Productivity Improvements
  • Customer Satisfaction
  • Innovation Output
Technology Category
  • Platform as a Service (PaaS) - Connectivity Platforms
  • Application Infrastructure & Middleware - Data Exchange & Integration
  • Application Infrastructure & Middleware - Database Management & Storage
Applicable Industries
  • Healthcare & Hospitals
  • Life Sciences
Applicable Functions
  • Product Research & Development
  • Quality Assurance
Use Cases
  • Remote Patient Monitoring
  • Regulatory Compliance Monitoring
  • Remote Control
Services
  • System Integration
  • Software Design & Engineering Services
  • Testing & Certification
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
  • The partnership with Velentium enabled Spark Biomedical to meet an aggressive hardware development timeline, ensuring they secured their next investment tranche and submitted their FDA application on time.
  • The collaboration with Greenlight Guru resulted in a robust quality management system, which was validated by a recent internal audit that revealed only minor findings.
  • The integration with Galen Data facilitated seamless device-to-cloud connectivity and data analysis, enhancing the overall functionality of Spark's app.
  • The strong partner ecosystem allowed Spark Biomedical to reduce the timeline for their second-generation product approval and compliance by half compared to their first-generation product.
Quantitative Benefit
  • The timeline for the second-generation product approval and compliance was reduced by 50%.

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