Case: The Levacor Heart Pump

Since 1982, when the first artificial heart (the Jarvik-7) was implanted in the chest
of Barney Clark, a major quest of the medical device companies has been to im-
prove the well-being of heart failure patients. The goal for the patient is indepen-
dent existence. Dr. Clark needed to be attached to a large external machine that
powered his mechanical heart, which managed to prolong his life for 112 days.
Today, of course, the goal is to make the devices as thin as possible, such that
they can be implanted in the body and allow the patient essentially to go about a
nor- mal existence. In view of the ultra-thin smartphones and other similar
products already available to consumers, medical device engineers are eager to
use similar technologies to develop slim devices to support the functioning of the
heart.
According to the American Heart Association, about 80 million adults in the
United States have cardiovascular disease of one type or another, and about 5
mil- lion suffer from heart failure. When looking at the demand for medical
devices to aid the heart, the aging baby-boomer market cannot be ignored. This
active age group “wants to live, and demands, a full, rich life now we have
medical con-
sumers, a market that didn’t exist 20 years ago,” notes designer Allan Cameron.
This target audience would certainly be receptive to a device that would allow
long-term freedom and independence, even if major heart disease strikes. In fact,
the heart pump industry is profitable and growing. In 2005, the leading heart-
pump maker, Thoratec, had annual sales of $201 million on its HeartMate XVE.
Analysts see the market as going nowhere but up, especially after Medicare an-
nounced that it will be expanding the number of hospitals permitted to do heart-
pump implants.
Recent efforts have been to develop implantable heart pumps that assist the
patient’s own heart, rather than mechanical devices that actually replace the
heart. One of the most promising of these is the Levacor, which by late 2006 was
in de- velopment at WorldHeart, based in Oakland, California. By this time, the
Levacor had been in feasibility trials in Europe only for a few months; clinical
trials in the United States (and ultimate FDA approval) were still far into the
future. The most distinctive feature of the Levacor is that it uses magnetically
levitated rotary tech- nology to power the pump.
The Levacor story begins in the early 1990s at a company called Medquest
(since acquired by WorldHeart). Pratap Khanwilkar and his team at Medquest
were studying the heart pumps of the time and identified several problems asso-
ciated with their use. Their size limited their usefulness: A pump that fit into the
body of a large man might not be supported by a small adult, teenager, or child.
There was also the problem of longevity. The heart pumps needed to be replaced
every so often, exposing the patient to the risks and stresses of repeat surgery;
this would be a concern especially in the case of a very young patient who might
be relying on the pump for decades. The term used in the medical community
for an implant that will never need to be replaced is “destination therapy.”
Another con- cern is the actual functioning of the pump: It must be gentle
enough not to rupture blood cells, cause as little vibration as possible, and not
require much power to operate.
 The Medquest team settled on magnetic levitation technology as a possible so-
lution. Magnetic levitation involves suspending a rotor using a balance of mag-
netic fields so that it moves without touching other parts: It literally levitates.
Since nothing contacts the rotor, there is no friction or heat buildup, and also no
ero- sion due to wear and tear, leading to longer life. The technology had been
used for some time in large-scale projects such as power turbines, but had never
been tried on such a small commercial application and certainly never in a heart
device.

Together with an engineering firm, LaunchPoint Technologies, Medquest devel-

oped a small, proprietary magnetic levitation system that could serve to pump
blood from the heart throughout the rest of the body. The “suspension in air” of
the rotor had a distinct advantage in a heart pump application: since there was
less to obstruct blood ow, life-threatening clots would be unlikely to form. The
development team designed a three-dimensional version of the pump using
computer-aided design (CAD) software, which also was used to make a real-size,
clear plastic prototype using rapid-prototyping technology. Using a blood substi-
tute, the team was able to watch liquid ow through the prototype.
By early 2006, a working prototype made of a titanium alloy was available,
about the size of a hockey puck and one-fourth the size of WorldHeart’s previous
model (which did not use the magnetic levitation technology). The device pro-
vides full mobility: The pump itself is implanted in the patient’s abdomen, and
the external device is a small battery pack and controller that the patient straps
on. The first patient, a 67-year-old Greek man, was well enough 50 days after the
implant to climb stairs on his own and was released from hospital to live a
normal life at home not long thereafter. By this time, WorldHeart and
LaunchPoint were also working on an even smaller device designed for babies.
As of early 2007, it was still unclear whether the magnetic levitation heart
pumps would be the long-term industry standard; however, Mr. Khanwilkar
(by now serving as WorldHeart’s vice president for rotary systems and business
development) was optimistic.

Based on the description in this case, discuss the new products process appar-
ently underway at WorldHeart, in comparison to that outlined in this chapter.
How is it similar or different? The launch phase is, of course, still well into the
future at the time the case occurs. What are the problem areas the company
might face at the time of launch? At the time of the case, what are the
uncertainties that still exist? What could the company do now to manage these
uncertainties?