Case Study: Spark Biomedical achieves faster FDA approvals and stronger quality with Greenlight Guru

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

Spark Biomedical, founded by Daniel Powell to develop a medical device to ease opioid withdrawal, faced the common startup challenge of bringing a safe, regulatory-compliant device to market while keeping a small team focused on quality. To avoid the pitfalls of paper or poorly configured QMS approaches, Spark adopted Greenlight Guru’s electronic quality management software and leaned on Greenlight Guru’s partner ecosystem to scale development.

Greenlight Guru delivered a ready-to-use, quality-first QMS that streamlined Spark’s regulatory work and connected them with partners (Galen Data for device-to-cloud connectivity and Velentium for engineering), helping Spark meet its FDA submission timeline and secure the next funding tranche. As a result, Spark cut the timeline for its second‑generation product roughly in half, passed an internal audit with only a handful of minor findings, and realized implementation savings equivalent to about a year of salary—validating Greenlight Guru’s impact on speed, quality, and compliance.

Spark Biomedical

Daniel Powell

Chief Executive Officer