ABOUT

Springboard Solutions LLC helps medical device companies solve the challenges that sit at the intersection of engineering complexity and regulatory reality — the problems that are too technical for regulatory consultants and too compliance-critical for engineering firms.

Founded by Dan Raymond, a dual executive with simultaneous VP Engineering and Director Quality/Regulatory experience on one of the most complex Class II medical devices ever FDA-cleared, Springboard brings a consulting perspective that is genuinely rare: built in the trenches of a proton radiation therapy program spanning a decade, three continents, and every stage of the device lifecycle.

The Radiance 330® proton therapy system — a $50M+ device requiring a $200M+ host facility — encompasses eight technology domains: particle accelerator, 100-ton treatment gantry, robotics, X-ray imaging, treatment planning, patient monitoring, facility integration, and an overarching safety system. Leading its engineering and quality/regulatory functions simultaneously meant operating at COO scope: 27-person cross-functional organization, ~$5M annual budget, two FDA 510(k) clearances, 17 issued US patents, three-continent installations, and direct engagement with investors, regulators, and government officials.

That experience — earned rather than studied — is what Springboard Solutions brings to every engagement.

WHAT MAKES SPRINGBOARD DIFFERENT

Most medical device consultants approach compliance from one direction: either the engineering side or the regulatory side. Dan Raymond has operated from both simultaneously. His quality and regulatory knowledge was built through direct, daily engagement with a Washington DC regulatory attorney over six years — applied in real time to product design decisions, supply chain risk, FDA inspections, 483 remediation, ISO 13485 preparation, and international regulatory strategy (Australian TGA).

This dual perspective enables Springboard to close the gap that most firms cannot: translating regulatory requirements into engineering decisions, and engineering realities into compliant documentation — without the back-and-forth that slows most projects and costs most companies their timelines.

THE SPRINGBOARD FRAMEWORK

Every Springboard engagement is structured around the People → Process → Tools → Technology framework — a systematic approach to identifying where breakdowns occur and how to close them efficiently. Strategic services address forward-looking organizational design. Tactical services execute well-defined projects. Regulatory services optimize and implement FDA 21 CFR 820/QMSR and ISO 13485 compliance processes.

AI-ENABLED CONSULTING THROUGH THE VALERE PARTNERSHIP

Springboard Solutions is proud to partner with Valere — named Top AI Company 2024 by Clutch, with 220+ in-house engineers and five global offices. Together, Springboard and Valere deliver AI-enabled regulatory strategy, QMS/QMSR compliance automation, and systems integration for medical device manufacturers and life sciences organizations. Where Springboard maps the regulatory and systems landscape, Valere builds the intelligent infrastructure.

THOUGHT LEADERSHIP

Dan Raymond publishes weekly on LinkedIn on topics including FDA QMSR, ISO 13485, AI in medical devices, requirements traceability, and supply chain risk. He is an invited speaker at the Life Sciences Risk Insurance Industry Forum (April 2026) on "Medical Device Compliance: A Practical Perspective."

CONNECT

If your organization is navigating a 510(k) submission, a QMSR transition, a failed FDA inspection, or a systems integration challenge — let's talk.