MethodSense Announces Growth Plans to Meet the Demands of a Rapidly Evolving Regulatory Landscape
With new leadership, platform innovation, and an AI-era focus, MethodSense is scaling its service offerings to help MedTech innovators meet regulatory demands.
MethodSense is moving beyond traditional consulting into a fully integrated platform model combining strategic expertise with cutting-edge software, most notably the company’s flagship product, LuminLogic®. As the life sciences industry confronts a new regulatory paradigm shaped by digital transformation, AI/ML, and intelligent systems like the FDA’s Elsa, MethodSense is stepping up to guide clients through this uncharted territory.
The company’s growth strategy includes:
• Expanding LuminLogic’s capabilities to support AI/ML regulatory submissions and structured formats like eSTAR
• Strengthening strategic partnerships with clinical strategists, technology collaborators, contract manufacturers, research institutions and accelerators
• Scaling consulting operations through new practice areas and international collaborations
• Investing in education, insights, and thought leadership, including a new MethodSense podcast series
“In just the last few months, we’ve welcomed two high-caliber leaders who share our vision,” said Rita King, CEO of MethodSense. “Richard Holcomb brings decades of software innovation and business scaling expertise as our Chief Growth Officer, and Anna Galea joins us with a deep background in organizational leadership and operational excellence. Together, they’re helping position MethodSense not just to grow, but to lead.”
Richard Holcomb, a serial entrepreneur with a history of building successful software companies, was drawn to MethodSense by what he describes as a Phase 3 opportunity, a moment when industry disruption and company readiness intersect. “MethodSense is poised to become the regulatory platform partner for companies seeking speed, scale, and certainty in a time of massive regulatory change,” said Holcomb. “With LuminLogic, we can institutionalize best practices, automate complexity, and extend our reach globally.”
“I joined MethodSense because the mission is real,” said Anna Galea, Senior Regulatory Strategist, who will help guide operational scale and workforce development. “This company is serious about empowering regulatory professionals and saving lives by accelerating access to safe, effective technologies.”
As the regulatory environment becomes more digitized, data-driven, and AI-aware, MethodSense is committed to meeting clients’ needs with clarity, foresight, and scalable infrastructure. The company’s growth is anchored in its long-held values of integrity, partnership, and regulatory excellence. These are now amplified by the tools and leadership to drive systemic impact across the life sciences.
About MethodSense
MethodSense is a regulatory and quality consulting firm specializing in the medical device and life sciences industries. With deep expertise in FDA, EU MDR, and global regulatory pathways, MethodSense helps companies achieve compliance, accelerate market entry, and ensure product quality. Its LuminLogic® compliance management platform integrates regulatory processes, quality management, and lifecycle documentation into a seamless solution for achieving regulatory success.
Karl von Gunten
MethodSense
kvongunten@methodsense.com
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