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

Edit This Case Study Record

	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

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration Application Infrastructure & Middleware - Database Management & Storage Platform as a Service (PaaS) - Connectivity Platforms
Applicable Industries	Healthcare & Hospitals Life Sciences
Applicable Functions	Product Research & Development Quality Assurance
Use Cases	Regulatory Compliance Monitoring Remote Control Remote Patient Monitoring
Services	Software Design & Engineering Services System Integration Testing & Certification
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

Application Infrastructure & Middleware - Database Management & Storage

Platform as a Service (PaaS) - Connectivity Platforms

Applicable Industries

Healthcare & Hospitals

Life Sciences

Applicable Functions

Product Research & Development

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Remote Control

Remote Patient Monitoring

Services

Software Design & Engineering Services

System Integration

Testing & Certification

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.

About 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.

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.

Impact #1	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.
Impact #2	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.
Impact #3	The integration with Galen Data facilitated seamless device-to-cloud connectivity and data analysis, enhancing the overall functionality of Spark's app.

Impact #1

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.

Impact #2

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.

Impact #3

The integration with Galen Data facilitated seamless device-to-cloud connectivity and data analysis, enhancing the overall functionality of Spark's app.

Benefit #1	The timeline for the second-generation product approval and compliance was reduced by 50%.

Benefit #1

The timeline for the second-generation product approval and compliance was reduced by 50%.

Download PDF Version

Overview

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

Operational Impact

Quantitative Benefit