JGS Group LLC

AI-Native MedTech Commercialization Intelligence & Strategy

JGS Orbit LLC is the developer of DIRA, an AI-native commercialization platform designed to help medical device and diagnostics companies navigate the complexities of entering and expanding in the U.S. healthcare market.

Dira integrates three critical dimensions of MedTech commercialization: FDA regulatory strategy, reimbursement and market access, and clinical evidence development. Rather than addressing these independently, Dira evaluates how regulatory decisions, reimbursement requirements, and clinical evidence needs intersect to influence commercial success.

What Dira Delivers

• Regulatory Intelligence & Strategy: FDA pathways, device classification, predicate analysis, regulatory requirements, and strategic recommendations.
• Reimbursement & Market Access: Coding, coverage, and payment assessments across Medicare and commercial payers, including identification of reimbursement barriers and opportunities.
• Clinical Evidence Strategy: Identification of evidence gaps, clinical study planning, and development of evidence strategies aligned with regulatory, payer, and provider expectations.
• Integrated Commercialization Strategy: Identification of critical risks, strategic opportunities, and actionable implementation roadmaps to support U.S. market entry.

Who We Serve

Dira supports MedTech startups, emerging technology companies, international manufacturers, investors, accelerators, government agencies and innovation organizations seeking to improve commercialization readiness and navigate the U.S. healthcare market.

Our Mission

FDA authorization is an important milestone, but successful commercialization requires much more. Dira was developed to help companies identify potential barriers early, make better-informed decisions, and build coordinated strategies for bringing innovative medical technologies to patients.

Founded by MedTech commercialization expert Jen Murray, with nearly 30 years of experience in FDA regulatory strategy, reimbursement, and market access, JGS Orbit is a TEDCO-supported company introducing Dira to the international MedTech community at MEDICA 2026.

Connect With Us

We welcome discussions with MedTech innovators, investors, accelerators, and strategic partners interested in advancing U.S. market entry and commercialization.

www.withdira.com