Dexcom Stock Rises on FDA Approval

GlucoseSensor

Dexcom's stock rose 7 percent Monday on news that the FDA granted 510(k) approval for their STS Continuous Glucose Monitoring System.


The Dexcom STS Continuous Glucose Monitoring System device, about the
size of a ballpoint pen cap, is injected into a diabetic's body, on the
arm or the stomach, where it stays near the surface of the skin and is
held in place by adhesive tape, similar to existing insulin pumps. The
sensors are then read by a monitor that helps set the appropriate level
of insulin to be injected. The system can be used to treat both Type I
and Type II diabetes.

Touted by some as a disruptive technology, none of Dexcom's competitors – the likes of Johnson & Johnson, Roche, Bayer, Medtronic, and Abbott (who reportedly has a similar device in development) – have a product more advanced than established pin-prick test strips. The intended use for STS is as a supplement to traditional disposable tests. But stock market analysts are already talking up “off label” use where many patients will give up pin-pricks for good and use the injectable continuous monitoring solution.


Patients will undergo a one-hour training session to learn how to use
the injection and monitoring system, according to [Dexom CEO, Andrew] Rasdal. They can then
begin using the pump, monitor and insulin-injection systems in diabetes
care centers and at home. He said patients would then buy new sensors
directly from Dexcom. “While I've been pleased by the FDA approval, we
urge realistic expectations,” he said. “This is still a
first-generation product.”

As you might imagine, there is a lot of buyout talk.


“The way these things work, in these fields dominated by oligopolies,
most of the big companies are already surveying the landscape and
typically make some sort of equity investment or buy it outright,” she
says. “I would fully expect that if there's real potential in the idea
that this is disruptive technology, one of the big guys would come in
and just swallow it up.”

Any small medical device company, start up or otherwise, has a fine line to walk if they're going to grow their business without being crushed. Offering a wireless sensor based system will offer patients clear clinical benefits, but the introduction of new technology will also prove fertile ground for the competitive weapon of choice for market leaders with older technology: FUD – fear, uncertainty, and doubt. Now that the R&D is (mostly) out the door, it will take world-class
sales and marketing execution to tell the right story in the right way
and overcome FUD.

You can read previous posts on Dexcom here and here.

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Other Factors Behind Hospital Building Boom Than Aging Population

UCLA-Westwood-HospitalIn recent stories about the current hospital building boom (here, here and here), many factors are mentioned. Aging physical plants, patient flow bottlenecks, and competition for market share are all mentioned as factors, but the prominent reason sites is the aging population. Researchers at the Center for Studying Health System Change did a study to determine what really drove the boom (press release).

Between 2005 and 2015, the study estimates that population aging will raise
utilization of inpatient services by only 0.74 percent per year—or 7.6 percent
over the entire decade, compared with a projected overall 64.8 percent increase
in inpatient utilization during the same period.

Local population trends and medical technology advances will be far more important
in forecasting community needs for additional inpatient hospital capacity than
population aging, according to the study.

Changing practice patterns were also mentioned as a key driver in the building boom. It all goes to show, that any expansion plans should be carefully thought out, based on on local conditions. And construction should be contemplated only after everything possible has been done to optimize current operations, especially patient flow.

You can download the paper here (pdf).

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Health Care Innovations from War

Flying-ICU

Admittedly a bit off topic, this story in USA Today describes in detail ways in which the military is advancing medicine.

New ways of healing are as much a product of war as are new ways of
killing. To save lives on the battlefield, medical innovations are born
in days rather than in years, military and civilian doctors say. And as
with wars past, the new ways of treating the injured and sick in Iraq
and Afghanistan [...] could have benefits beyond
the battlefield.

Some very cool new technologies and devices are described. A staunch left wing paper, USA Today can't resist making things sound worse than they are with comments about, “a river of casualties.” Referring to the Air Force's wounded airlift capability; they make it sound as if “thousands of casualties from the war zone” are airlifted daily.

Pictured right is a C-17 configured to transport the wounded for more advanced care at larger hospitals in Europe and then the US. These planes have networked patient monitors with a central station, and even sport ventilators.

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