{"type":"profile","id":"profile=medica2026.3087384","exhSeoId":"fobmGUsyQemZ5qCJOV8juA","name":"JGS Group LLC","email":"jmurray@withdira.com","getInTouchEmail":"jmurray@withdira.com","profileAddress":{"address":["6518 Maplewood Road"],"city":"Baltimore, MD","zip":"21212","country":"USA","countryCode":"US"},"phone":{"phone":"+1 703 6223465"},"links":[{"id":"link=FVbmTad9SJiXCZdAMbfquw","type":"link","link":"https://www.withdira.com","parentType":"profile","order":1,"visibleInLang":["en","de"]}],"media":[],"locations":[{"areaId":"16","area":"Hall 16","stand":"F03"}],"location":"Hall 16 / F03","locationIsVirtual":false,"events":[{"key":"medica2026","label":"MEDICA 2026"}],"eventIcons":[{"label":"MEDICA 2026","src":"https://www.medica.de/vis-content/event-medica2026/all-exh/Event-0mOSbpheSRej6t2ZLcI1AA.png"}],"eventMap":"https://iahapla02.messe-duesseldorf.de/en/2dexgroundV2/medica2026/3087384.svg","areaMap":"https://iahapla02.messe-duesseldorf.de/en/3dhallV2/medica2026/16/3087384.svg","areaId":"16","premium":false,"exhIsLead":false,"logoUploadedByPubimport":false,"tags":[],"xtags":[],"socialMedia":[],"synonyms":[],"text":"DIRA | JGS Orbit LLC <p><strong>AI-Native MedTech Commercialization Intelligence &#38; Strategy</strong></p><p><br></p><p>JGS Orbit LLC is the developer of <strong>DIRA</strong>, 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.</p><p><br></p><p>Dira integrates three critical dimensions of MedTech commercialization: <strong>FDA regulatory strategy, reimbursement and market access, and clinical evidence development.</strong> Rather than addressing these independently, Dira evaluates how regulatory decisions, reimbursement requirements, and clinical evidence needs intersect to influence commercial success.</p><p><br></p><p><strong>What Dira Delivers</strong></p><ul><li><strong>Regulatory Intelligence &#38; Strategy:</strong> FDA pathways, device classification, predicate analysis, regulatory requirements, and strategic recommendations.</li><li><strong>Reimbursement &#38; Market Access:</strong> Coding, coverage, and payment assessments across Medicare and commercial payers, including identification of reimbursement barriers and opportunities.</li><li><strong>Clinical Evidence Strategy:</strong> Identification of evidence gaps, clinical study planning, and development of evidence strategies aligned with regulatory, payer, and provider expectations.</li><li><strong>Integrated Commercialization Strategy:</strong> Identification of critical risks, strategic opportunities, and actionable implementation roadmaps to support U.S. market entry.</li></ul><p><br></p><p><strong>Who We Serve</strong></p><p>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.</p><p><br></p><p><strong>Our Mission</strong></p><p>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.</p><p><br></p><p>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.</p><p><br></p><p><strong>Connect With Us</strong></p><p>We welcome discussions with MedTech innovators, investors, accelerators, and strategic partners interested in advancing U.S. market entry and commercialization.</p><p><br></p><p> www.withdira.com </p><p><br></p>","businessData":[{"id":"founded","type":"year","title":"Foundation","values":[{"id":"founded","label":"2025"}]}],"pdfs":[],"tol":[],"categories":[{"id":"prod=medica2026.02.08","label":"Data platforms & cloud health","catalogIndex":"02.08","eventIcons":[{"key":"medica2026","small":"https://www.medica.de/vis-content/event-medica2026/all-exh/Event-SzHinHZFRDix2fwVNyP4ag.png","tiny":"https://www.medica.de/vis-content/event-medica2026/all-exh/Event-0mOSbpheSRej6t2ZLcI1AA.png","label":"MEDICA 2026"}],"productList":[],"hierarchy":[{"id":"02","label":"Digital Medicine, Data & Artificial Intelligence"},{"id":"02.08","label":"Data platforms & cloud health"}]}],"write":false,"lastModified":"2026-11-03T20:50:49Z","tagsAreEditable":false,"xtagsAreEditable":false,"isGetInTouchAllowed":false}