Big data is the big buzzword in healthcare, and Edwards Lifesciences Corp. (NYSE: EW) is no exception—it’s made it part of a strategy to continue growing one of its three main business lines: critical-care technologies.
“The trend is digital healthcare and artificial intelligence … and the window into digital healthcare for Edwards is its monitoring platforms,” said Catherine Szyman, corporate vice president of critical care for the Irvine-based medical device maker and Orange County’s largest public company with a market value of about $33 billion as of press time.
Edwards is best known for developing artificial heart valves, its main source of business. The products allow less-invasive, catheter-based heart repair and replacement procedures.
Edwards reported revenue of $3.4 billion last year; transcatheter valve therapy and structural heart valve therapy products—its two main business lines—generated $2 billion and $807 million of those revenues, respectively.
The critical-care division—which includes a variety of catheters, monitoring systems and other products used for hemodynamic, or blood flow, monitoring—made up about 17% of revenue last year with $601 million.
While overshadowed by the two heart valve divisions, the company’s critical care group “had quite an impressive growth [last year] based on their innovation,” said Chief Executive Michael Mussallem at its annual investor conference last week. The segment recently posted sales of $164 million for the quarter ended on Sept. 30, up about 15% from year-earlier levels on an underlying basis.
HemoSphere, the company’s next-generation “all-in-one monitoring platform,” drove much of the increased sales.
The group’s year-end sales are projected to be $610 million to $650 million.
More is anticipated headed into next year, thanks to the increased use of big data, according to Szyman, who’s been in her current position since 2015. Before that, she had 20 years of experience with Medtronic PLC, including a five-year period as president of its global diabetes business.
Szyman said the Irvine-based segment is looking to hire employees well-versed in predictive analytics, big data and artificial intelligence.
Hypotension
Szyman said that with the company’s tremendous amount of accumulated data—“we monitor roughly 13 million patients a year”—it’s a leader in hemodynamic monitoring, collecting valuable information on blood pressure, blood flow, and blood oxygen levels.
Its initial focus has been monitoring hypotension, or abnormally low blood pressure.
The company received Food and Drug Administration approval in March for its Acumen Hypotension Prediction Index software, a predictive monitoring software product that uses algorithms to analyze cardiovascular vital signs to predict potential hypotension in surgical patients.
The software has been commercially available in Europe since 2016.
“Physicians haven’t had a way to predict hypotension during surgery, so they have to be reactive, and treat it immediately without any prior warning,” Dr. Maxime Cannesson said in a study published in Anesthesiology, the peer-reviewed medical journal of the American Society of Anesthesiologists.
The professor of anesthesiology and vice chair of perioperative medicine at UCLA Medical Center said the risk of serious complications increases the longer a patient remains hypotensive, and that the ability to predict hypotension would allow doctors “to be proactive instead of reactive” and avoid complications, including postoperative heart attack, acute kidney injury, and sometimes death.
Smart and Smarter
The machine learning, data-driven algorithm used in the new software adds artificial intelligence to Edwards’ hemodynamic monitoring capability.
The software’s analytics are powered by data from more than 200,000 patient events.
The company announced last week that the FDA cleared its latest HemoSphere platform, which incorporates the Acumen suite of advanced hemodynamic monitoring and smart decision-support functions.
Szyman said Edwards plans to take its monitoring platform further, moving beyond predictive.
“Four years ago we were [providing] descriptive monitoring, just tracking data,” she said. Descriptive analytics, as the name implies, describes or summarizes raw data to make it interpretable.
The next phase is predictive analytics, where Edwards’ technology is currently. It takes that data and applies statistical models to forecast events.
Szyman said that the company plans to eventually go a step further with prescriptive analytics, which recommends actions.
“In order to pioneer this new category, we’ve got to build clinical evidence,” she said, noting that much hasn’t been done in the monitoring space.
Edwards is partnering with Cleveland Clinic to do a single-center 220-patient study of its software to manage intraoperative hypotension.
The company also plans to expand the use of its monitoring to assisted fluid management.
Szyman said that assisted fluid management is pretty difficult for physicians to calculate in their heads, and a new U.K. study has shown that physicians manually giving fluid in surgeries only get it right 30% of the time.
It plans to submit the results of its multicenter 330-patient study to the FDA in the first quarter next year.
Future Hospital
When asked for her view on the evolving healthcare landscape, in which hospitals are increasingly moving care functions traditionally delivered in hospital settings to outpatient locations, Szyman said the trend makes Edwards’ technology more relevant.
“Right now, our strategy is to stay in the hospital,” she said, explaining that the more hospitals move lower-risk patients to outpatient care facilities, the more high-risk patients there are in hospitals.
“My view is that hospitals are becoming large ICUs … and the really sick should be monitored,” which she said is where Edwards’ leadership in hemodynamic monitoring comes in.
