Professors: Preview Copies and Orders
“Healthcare game-changer.” This was Sotera’s waking dream in the spring of 2012. By the end of summer, the 67-employee firm was buzzing as the PR team finalized it’s much anticipated press release:
SAN DIEGO, Aug. 21, 2012 /PRNewswire via COMTEX/ — Sotera Wireless, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its full ViSi Mobile® System and is commencing sales to hospitals nationwide. The ViSi Mobile System, as approved, uses WiFi (802.11) wireless technology for transmission of patients’ vital signs, keeping hospital clinicians connected to their patients, whether patients are in bed or up and moving around. Earlier this year, Sotera announced 510(k) clearance for its first generation ViSi Mobile Monitor, which encompasses the stand-alone device portion of the system that for the first time provides continuous monitoring of all the core vital signs on a patient worn platform.
The ViSi Mobile platform allowed for continuous, non-invasive monitoring of a host of critical vital signs that could reduce patient length of stay, increase Intensive Care Unit (ICU) throughput, improve patient safety, and reduce frequency of uncompensated events like bed sores and pressure ulcers. “Continuous vital signs monitoring is crucial to detecting early deterioration in a patient’s condition and facilitating early intervention or rapid response,” said Tom Watlington, Sotera’s chief executive officer. “The ViSi Mobile System will stretch the boundaries of patient monitoring by enabling clinicians to receive this information without limiting a patient’s freedom to move about the hospital.”
While the FDA approval was a huge milestone, work to expand the usefulness of the platform was in full swing. The approval did not include the company’s patented cuffless non-invasive blood pressure sensor. Commenting on the cuffless monitor, Watlington noted, “That will be the last vital sign we’ll add. The holy grail of vital signs is continuously monitoring blood pressure without a cuff,” Sotera planned to submit the monitor for FDA approval in the fall.
ViSi Mobile’s potential for value creation was clear to many and the complete system was now ready for sale. But success would require cooperation, investment, and operational changes across a range of actors in the healthcare ecosystem. Development was successfully completed. The challenge now was to develop a deployment strategy that would safeguard long-term success in the market.