DÜSSELDORF, Germany – The world's largest exhibition of medical devices is often overwhelming but never disappointing.
Marking its 40th anniversary, the event has grown to become the leading marketplace for medical equipment, with a staggering attendance of more than 130,000 delegates representing the full range of buyers. Their numbers include surgeons, general practitioners, hospital administrators, nurses, product development engineers, and business and marketing executives.
The 4,300 exhibitors spread across 16 cavernous halls of the Düsseldorf Messe not only display their products but are closing deals left and right.
Maquet (Hirrlingen, Germany) said it closed a deal with the Dutch army for a new portable heart-and-lung support system before the doors had even formally opened.
CardioHelp is the world's smallest and lightest heart-lung support system and is meant to provide oxygenated blood supply to all vital organs for patients whose heart has stopped beating or whose lungs are not functioning, or both.
A ruggedized unit weighing 22 pounds that can be carried by one person means this critical intervention will be available for the first time outside of an operating theater and can move into intensive care units (ICU), and even beyond for field duty with the armies of trauma response teams around the world, including those in the military.
"When a soldier has both lungs pierced, there is no sense pumping air into leaking lungs, yet with oxygenated blood he might be saved," said Marcus Felstead, who heads Maquet's marketing efforts.
Felstead said CardioHelp will not be available until April 2009, when a CE mark is expected. He said an FDA 510(k) approval is hoped for by the end of 2009.
MEDICA narks the first public showing of the device, though the company gathered top customers for a special showing in June at Porsche Center in Leipzig that generated early orders.
Extracorporeal circulation devices is a niche market to this point, said Felstead, who estimated global sales among all competitors at €85 million ($107 million), selling to roughly 3,600 heart centers worldwide.
Expanding to ICUs will take the market potential to €500 million ($629 million), he estimated.
He said that in Germany there are 79 heart centers that fit in the existing market model, and there are 800 ICUs that would fit Maquet's marketing plan for CardioHelp, a ratio of 10-to-1.
Applying the same ratio to the 3,600 heart centers worldwide, "Oh my God," he said, assessing the potential.
"And then there is the military market," he added.
CardioHelp was introduced in a big way with a Las Vegas show set against the backdrop of an emergency helicopter that had been brought into the exhibition hall and took up only a fraction of Maquet's booth space.
"We are the largest exhibitor at this year's MEDICA," Felstead said with pride.
"We beat Siemens this year with 1,690 square meters ([18,191 square feet]," he added.
CardioHelp was designed in-house by a special team of engineers recruited by Maquet, not from Germany's burgeoning medical technology community but from the German automotive industry based in nearby Stuttgart.
"We wanted a robust and ruggedized machine designed specifically for ICU and trauma, something that could be carried." he explained.
"For more than a year we watched patients in these severe medical conditions, and saw how they are moved around quite a lot within hospitals and even between hospitals. And we saw that many things can go very wrong if the supporting blood pump is knocked around," Felstead said.
"It was an amazing design process with new insights and a few surprises," he said.
For example, the electronic interface of the system is based on a CAN-bus found in the top class of BMW cars, centralizing and simplifying the wiring with the microprocessor and various peripheral functions.
The touch-screen interface with humans had to be redesigned as well, as ICU personnel require different vital sign readouts than does an operating room team.
CardioHelp is the only device in its class to integrate sensors for pressure, temperature and venous saturation into the pump housing, eliminating the spaghetti-like junction of wires on other heart-lung support models.
Resembling a small power generator, about the size of a suitcase that would fit in the overhead compartment on a commercial airliner, CardioHelp has an open back-end of machinery and the electronics enclosed in a housing, with the touch-screen control panel facing forward.
"Medical staff like to see things working," Felstead explained. "It is part of their mindset that they need to know what is happening."
The unit is designed to run on any available electrical current from 10 volts to 240 volts and across a range of voltage frequency up to the 400 hertz used on fixed-wing aircraft, eliminating the need to take along a power generator, "which is another reason the military is so interested," he said.