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In 2007, HeartFlow became Fogarty’s first CIR. The company developed software that uses data from a CT scan to create a 3D model of coronary arteries, enabling physicians to noninvasively measure blood flow in cardiac arteries and analyze the impact of blockages on blood flow. El Camino Hospital then became one of the first hospitals in the San Francisco Bay area to use the technology once it became commercially available. HeartFlow recently achieved a valuation of $1.5 billion.

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When its first home was bulldozed to make way for a new building, the innovation lab at Intermountain Healthcare became a virtual organization, with its 15 staff members strategically scattered throughout the 22-hospital health system’s main campus in Murray, Utah. Now the innovation lab is part of the new complex, the Intermountain Gardner Transformation Center, but its mission hasn’t changed, says Marc Probst, Intermountain’s chief information officer. “We want to bring innovative ideas to Intermountain Healthcare and help startup organizations determine the feasibility of their products and take them to market.” One of the strongest aspects of the innovation lab, Probst says, is “our ability to bring interested clinicians together to look at a product, help us decide if it’s a good idea, and ultimately work with us to perfect it and put it into pilot.”

Probst

In a collaboration between clinicians and information services, Intermountain created a software application to customize surgical kits for patients and procedures to avoid waste, which saved the health care system tens of millions of dollars in one year. “We looked at that software and thought, ‘Wow, we could probably turn that into a business,’ and that’s what we’ve done,” says Probst in reference to the founding of Empiric Health.

The technology that launched Velano Vascular, another successful startup, didn’t originate at Intermountain but was piloted through the innovation lab. Velano developed a needle-free device that can draw blood through an inpatient’s existing IV catheter. “We brought nurses and patients into the discussion, and we got to the point where we felt it was safe enough to try in one of our facilities. Now it’s everywhere across Intermountain Healthcare,” Probst says.

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The executives who spoke with CAP TODAY agree that innovation labs are on a growth trajectory that’s likely to continue, due, in part, to the challenges facing U.S. health care. “Paralyzing costs. Shocking inefficiency. Mediocre outcomes. Our health care system must be disrupted,” Dr. Zane insists. “And we, as providers, would like to drive that disruption and drive innovation. But the only way that could work is by partnering with industry.” Adds Regan: “The health care system has become extremely competitive, so for some hospitals, it’s a way to differentiate themselves.” —Jan Bowers

Beckman Coulter introduces latest version of middleware

Beckman Coulter has released version 1.10 of its Remisol Advance middleware system for mid- to high-volume laboratories.

Enhancements to the latest iteration of the software include a centralized dashboard that combines sample status information—pending, stat, validated, and processed—turnaround time data, and quality control alerts in an intuitive format.

“By providing a snapshot display of important analytics in a single location, we are enabling technologists to identify and prioritize critical activities moment by moment,” Erik Johnson, vice president and general manager of workflow and informatics at Beckman Coulter, said in a press release.

Remisol Advance version 1.10 provides enhanced rules writing functionality that allows users to copy rules to multiple tests simultaneously and evaluate rule performance under simulated conditions. It also provides dynamic turnaround-time monitoring that alerts users to samples at risk of delay and displays a custom list of delayed samples.

Beckman Coulter, 800-526-3821

FDA document supports LOINC for IVD tests

The Food and Drug Administration has published “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests: Guidance for Industry and Food and Drug Administration Staff.” The document encourages adoption of the IVD Industry Connectivity Consortium’s LIVD (LOINC to In Vitro Diagnostics) format for the distribution of LOINC codes for IVD tests.

The guidance addresses such questions as, Is LOINC coding mandated by the FDA for IVD tests? Should manufacturers include LOINC codes in device labeling? What are the FDA’s views on manufacturers providing LOINC codes for uncleared or unapproved indications for use? And does the FDA recommend a specific format for distributing LOINC codes? It is available at www.bit.ly/​LIVD_FDA_document.

“LIVD assures that laboratory personnel select the appropriate LOINC codes for IVD tests used by their laboratory,” said Serge Jonnaert, president of the IVD Industry Connectivity Consortium, in a press release. “It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code.”
The FDA document states that “guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

The IVD Industry Connectivity Consortium is a global, nonprofit organization focused on semantic interoperability within and across laboratories.

Dr. Aller teaches informatics in the Department of Pathology, University of Southern California, Los Angeles. He can be reached at raller@usc.edu. Hal Weiner is president of Weiner Consulting Services LLC, Eugene, Ore. He can be reached at hal@weinerconsulting.com.