Digitalizing Design Quality: A Path for MedTech Start-Ups

This case study highlights how JuneBrain, an early-stage medtech startup, transformed its design and manufacturing processes through the implementation of a Design Quality Management System (DQMS) in collaboration with MDIC’s Advanced Manufacturing Clearing House (AMCH). Focused on developing the Neuro-i Optical Coherence Tomography (OCT) device—a telehealth retinal imaging system for monitoring eye and brain diseases—JuneBrain sought to improve patient safety, compete with established industry leaders, and build scalable, compliant operations.

The digital transformation delivered significant results within three months of going live:

• 33% reduction in development cycle time
• 90% cut in audit preparation time
• 50% faster FDA 510(k) submission prep
• Identification and mitigation of critical design risks
• Improved team alignment and documentation traceability
• Increased appeal to investors and potential acquirers, with projected $1M cost savings in the first year

Key lessons for other startups include involving a hands-on Quality Manager early, consolidating requirements and risks before system configuration, and ensuring organization-wide access to the QMS. JuneBrain’s ongoing roadmap leverages the DQMS for clinical feedback integration, streamlined verification and validation, efficient regulatory submissions, manufacturing transfer, and robust post-market surveillance.

This case underscores the role of digital quality systems in enabling innovation, compliance, and market readiness for emerging medtech companies.