CEO Rolland Carlson: When Advancing a Medical Device, Be A Partner First & Seller Second to Hospital Systems

Immunexpress CEO Rolland Carlson was recently featured on HITConsultant, which provides healthcare technology news, analysis and insights for healthcare executives, physicians and providers.

“US hospital systems validate the safety, clinical utility, and robustness of newly FDA-approved devices, 510(k) cleared, before adopting them into clinical practice. This work occurs alongside evaluating how to integrate the medical device into the hospital system’s diagnostic paradigms, including in relation to quality improvement programs. Companies can have a role but there are 415 US hospital systems (comprising ~5,000 hospitals), and each has a bespoke process and ever-changing set of considerations. Navigating this new reality is challenging for companies and hospital systems. The pandemic only made it more complex and slower. It is important for company executives and hospital system leadership teams to talk about what is working. In that spirit, I am sharing insights from my team at Immunexpress for our lead test, SeptiCyte® RAPID, which is clinically validated and has received FDA 510(k) clearance indicated for the diagnosis of sepsis in adults. ”

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