DÜSSELDORF, Germany – Lights, cameras and political action!
For the first time in its 40-year history, the world's largest trade fair for medical technologies found itself at center stage as the German Chancellor, Angela Merkel, arrived for the opening ceremonies at the massive Düsseldorf Messe.
In her inaugural speech, Merkel moved medical devices into the public eye and forward on Germany's political agenda ranking the sector alongside automobiles as a leading engine for exports and job growth.
“Set against the background of its economic significance and demographic developments, it is important that this sector should be put in focus,“ Merkel said.
The pack of photographers and reporters following the Chancellor into the exhibition halls for a tour of Germany companies stirred excitement at an event that is normally the crowded but quiet province of distributors cutting deals for new products.
Medica 2010 saw a parade of political dignitaries following the path of the German Chancellor, each equally determined to show the national flag in order to boost exports of medical devices.
Merkel was followed on the second day of the event by Courtney Gregoire, director of the National Export Initiative (NEI) for the U.S. Department of Commerce, and the third day saw a visit by the Right Honorable Lord Ara Darzi, MD, the high profile former Under-Secretary for Britain's National Health Service (NHS).
Germany leads the parade not only because it is the host country for Medica, but more importantly for the robust growth medtech brings to the nation's economy.
The sector grew by 5.5% in 2010 with 41% of the revenues coming from exports and is creating more jobs than can be filled by qualified personnel.
First steps overseas for Obama's export initiative
A high growth sector with a strong profile for future growth, medical technologies are a priority for support for the export initiative, Gregoire told BB&T.
“We have over 420 U.S. companies here at this show, and the U.S. Foreign and Commercial Service is working directly with 250 of them setting up meetings at Medica,“ she said.
According to Gregoire, the worldwide market for medtech is $341 billion and American companies can be leader in several segments for both the manufacturing and innovation.
U.S. exports of medical devices are estimated to be over $36 billion, “and I believe we can do better,“ she said.
“This translates into a tremendous potential for creating jobs at home both in research and development and manufacturing, which is the right combination.“
NEI was established following a pledge made by President Barack Obama in his State of the Union Address to create two million new jobs by doubling exports over the next five years.
Gregoire said she began work in May crisscrossing the country meeting with companies and, specifically, attending a Medical Device Exporter Seminar in Minneapolis for small and medium-sized companies sponsored by Medtronic (Minneapolis) and hosted by the Department of Commerce's International Trade Administration (ITA) and the Advanced Medical Technology Association (AdvaMed; Washington).
“There were more than 40 suppliers who developed a product, signed a deal with Medtronic, and then never thought any further about exporting the product themselves,“ she said.
Gregoire said Medica is her first visit to a foreign trade show.
“After seeing the traffic at this event, the message I am taking back is that Medica is a premier show U.S. companies need to seriously consider,“ she said.
There is a tremendous opportunity to test market products, to grow from one market into a second then a third, she said, adding, “This is a fast track into international markets.“
“I met with one U.S. business that has been coming for eight years, that is profitable working in 15 countries, and whose chief executive told me his entire international marketing effort is Medica,“ she said. “He gets the biggest bang for the buck in three days here meeting with all his distributors and buyers.“
“I have heard there can be barriers to entering foreign markets, but this is where distributors and partners like the U.S. Foreign Commercial Service can open doors and help align with local requirements,“ Gregoire said.
Where Germany has won share of exports with high-end and high-priced products, and China is gaining share with low-end products at low prices, Gregoire said the positioning for U.S. companies will be with high quality and innovative products.
“What I have heard here is there is a recognition that American companies deliver quality products, which attracts distributors, and the other piece is staying on the cutting edge and remaining innovative, continually finding the unmet needs and creating the next products to fill that need,“ she said.
Quality in healthcare is cheaper
Darzi arrived at Medica 2010 describing himself as an ambassador for healthcare and life sciences and “proud to be wearing the British hat.“
Asked whether he was a buyer or a seller, he replied, “A bit of both, actually.“
“We have some 300 companies here for exporting, and I am meeting with them, as well as with larger companies, such as Panasonic, who represent an inflow as investors interested in establishing operations in England,“ he said.
A renowned pioneer of minimally invasive and robotic surgery who holds the Hamlyn Chair of Surgery at Imperial College (London), Darzi led a year-long review of the NHS that resulted in the 2008 report calling for a controversial overhaul of the system.
“Quality needs to be the organizing principle for healthcare, which is the one industry where quality is cheaper and a lever for reducing expenses,“ he told BB&T. “It is not quality that is straining healthcare systems today but the large-scale of inefficiencies in those systems.“
“When we look at the manufacturing of a diagnostic test see here at Medica with the efficiencies of moving it through the supply chain, and then if we map out the inefficiencies in a patient pathway for care where that diagnostic is used, the contrasts are startling,“ Darzi said. “If we get that right in healthcare, we will save huge sums of money.“
Among the vast displays of products at Medica, Darzi sees the future in Halls Two and Three dedicated to bio-chemical assays.
“The impact of molecular diagnostics is going to be a complete disrupter and will force a rethinking of the models of healthcare,“ he said. “There are tremendous opportunities in diagnostics for preemptive treatment, more personalized care and greater patient participation in that care.“
Draeger monitors to feature novel imaging modality
Presenting a totally new imaging modality to the medical world seems to be the right moment to strike up the brass band or at least start tweeting to create a bit of buzz.
Draeger Medical (Lübeck, Germany) preferred a soft launch for electrical impedance tomography (EIT) at Medica 2010, discretely demonstrating the first commercial application of this new imaging capability as part of a respiratory monitoring package.
The company declines to call it an imaging modality, and has not released a name for the product that is due out in the first quarter of 2011 once it wins approval to carry a CE mark.
Yet the screen images tracking patient breathing seem to have been sent up from radiology.
A cross section of the lung looks like a map on the Weather Channel turning from dark blue to powder blue or white as warm air masses flow in and remaining darker where tissue is less saturated with gas. Adjacent tissue filled with water or collapsed lung tissue are depicted in black.
The clinical benefit is the functional information of EIT that complements morphological images from CT or MRI.
Where a physician may see an area of concern in the lung with CT or MRI, EIT shows vividly the regional ventilation distribution and is expected to have a high clinical value in assessing therapies to increase air inflow.
Currently treating physicians rely upon experience to assess the effectiveness of treatments to reopen collapsed lung regions, ranging from a simple repositioning of the patient to applying high ventilation pressures.
EIT enables physicians to see immediately the effects of therapy at the patient's bed and also introduces a capability to individually tailor ventilator settings.
Draeger's EIT system also provides a quantification of lung capacity, dividing the cross section into four quadrants with readouts for air intake in the left dorsal, left ventral, right dorsal and right ventral areas.
EIT images of the lung are constructed from data collected by 16 electrodes on a belt strapped to the patient's thorax.
An emitter paired to each electrode sends an electrical current in the same low range as an electroencephalogram (EEG), and this signal is picked up by all the electrodes.
The impedance of the signal passing through tissue is filtered, a complex challenge considering the number of cross currents of electricity in the human body, and more so for patients attached to ventilators.
By sequentially firing the emitters in a rotational pattern around the patient's chest 208 data sets are collected to construct a single image.
Up to 50 images can be acquired per second, depicting a video-like motion that tracks the patient's breathing patterns.
The electrode belt is minimally invasive, resting on the skin of the often fragile patients in an intensive care unit (ICU), and no gel is required to enhance conductivity.
EIT brings a functional diagnostic tool to the patient's bedside that may alleviate the need for transporting patients to a radiology lab for CT or MRI.
“This is a therapy monitoring image attached to a therapy device and not purely a diagnostic imaging modality,“ insists Anne-Catherine Grüntges who heads the marketing efforts for Draeger Respiratory Care in Europe.
She said the technology is expected to be most often employed in ICU, operating rooms and sleep labs.
As this is the first serial production model of the EIT, Draeger has not yet funded a large-scale clinical study, she said, though there are numerous studies done at academic centers that Draeger provided with earlier versions of the technology.
“The serial model we will release must be something like the fifth generation of EIT,“ Grüntges said. “It is great to have the evidence ahead of release.“
“Now the question is how EIT will influence ventilation therapy practiced at the bedside,“ she said. “The purpose of the Draeger EIT is clear, yet the clinical potential is open to what clinicians will want to do with the technology.“
“People who have seen it have 100 ideas right away about how and where they want to use it,“ she said.
It is early days for EIT as a diagnostic imaging modality.
While the technology was introduced in 1978, its development has accelerated with the increasing processing power of computers but slowed by the complications of filtering relevant signals from the complex electrical currents swirling over and through the body.
EIT has a potential for perfusion studies with blood and tissue as well as breathing, suggesting future applications for the heart, gastrointestinal tract, the brain and limbs.
Combining this functional data with MRI and CT is expected to widen the field for potential clinical applications beyond this first narrow interpretation for patient monitoring.
Companies reveal 'truly hybrid' operating room
In a mad rush to support minimally invasive surgeries, too many fake hybrid operating rooms (ORs) have been built, according to Maquet (Rastatt, Germany).
The truth about the new fashion for interventional surgeries is that they do not always work and the procedure needs to be converted quickly to old-fashioned open surgery to save the patient with scalpels and saws taking the place of catheters and endoscopes.
Yet it takes more than switching out instruments to perform real surgery, according to Klaus Christian, who manages Hybrid OR worldwide for Maquet.
“Ask Siemens and they will tell you they have built 300 hybrid ORs,“ Christian told BB&T. “Ask our partner Philips and they will say they have built over 250 hybrid ORs. But 96% of these so-called hybrid ORs are just cath labs with examining tables, not real operating theaters.“
“Maybe you can do some procedures on an exam table, but a hybrid OR with a real operating table responds to the needs of a surgeon, is flexible and synchronized,“ he said.
At Medica 2010 Maquet presented with its partner Philips Healthcare (Eindhoven, the Netherlands) the integrated surgical suite that combines the modular Magnus operating table system from Maquet with Philip's Allura Xper FD 20 X-ray imaging system.
The Philips-Maquet hybrid OR suite combines the sterility and instruments of a traditional operating room with the imaging systems and the radiation shields of a cath lab.
On the eve of Medica's opening, the Inova Heart and Vascular Institute (Falls Church, Virginia) inaugurated its cardiovascular OR using the Maquet-Philips system that will be shared among cardiac surgeons, electrophysiologists and cardiologists.
It is the first North American installation for the partners who say they have five further projects proposed in the U.S.
The first collaboration between the partners dates to 2000 when Philips imaging and Maquet tables were installed in Basel, Switzerland.
Maquet and Philips began collaborating on the specific product introduced at Medica, the Allura Xper FD OR Table system, 18 months ago, formally announcing the partnership at Transcatheter Cardiovascular Therapeutics in September 2009.
In Europe the partners announced an installation at the Heart Surgery Clinic (Karlsruhe, Germany) and according to Karin Makarow, corporate marketing manager for Maquet, two further installations are underway in Germany.
“The commercial launch starts now, and what is new here is the intelligence linking the Magnus table to Philips angiography,“ she said.
Christian said the partners are jointly proposing a total of 200 projects. “Worldwide, the interest is even higher than the number of project proposals would indicate,“ he said.
The rapid increase in transcatheter aortic valve implantations (TAVI) in Europe that forces interventional cardiologists and cardiac surgeons into a close collaboration is creating the strong demand for more robust operating tables.
The Maquet-Philips OR is built around a synchronized integration of the Allura angiography imaging system and the Maquet Magnus table enabling the two units to communicate and work in tandem.
Automatic position control software drives a delicate ballet between the two machines with servo-motors humming as the table tilts to match the moves of the X-ray projector, and vice versa.
The two units separate just as smoothly with the C-arm of the angiography unit swinging away to a parked position when not required for intra-procedural imaging.
X-ray imaging is used to navigate cardiac interventions performed in a cardiac catheterization (cath) lab.
The Magnus modular operating table system features a radiotranslucent carbon fiber top for optimum X-ray imaging and is offered in six variations of length and configurations to support diverse procedures.
“With carbon fiber tops the absorption of X-rays is close to zero,“ Christian said.
OR table tops can be exchanged on the Magnus pedestal, for example, switching out a universal table top with an anatomical positioning top with body bend joints for thorax surgery.
Monitors and lights are ceiling suspended and can also be programmed according to a surgeon's preferences for viewing, he said, demonstrating the ability to rapidly shift the arrays of overhead flat screens and mushroom-shaped light panels.
For the Hybrid OR featured on the Maquet stand at Medica, Philips also installed its HeartNavigator, OR lights, monitors, and radiation protection walls for the demonstration.
Beyond heart and vascular surgery, the hybrid OR can be used for trauma surgery, neurology and orthopedics.
“This unique patient-focused environment will directly benefit patients through having multiple clinicians in the same room collaborating on the patient's care,“ said Niv Ad, MD, chief of Cardiac Surgery at the Inova Institute near Washington.
The system installed for Inova features what the manufacturing partners call a bi-plane configuration using two synchronized C-arm scanners.
Other than the table, a truly hybrid OR requires a larger floor plan than a cath lab, Christian said.
“For open surgery you need significantly more equipment than for interventional cardiology, starting with a heart-lung machine,“ he said.
According to European sale staff from Philips and Maquet, an installation costs from upwards from $4 million starting from a bare space.
The partnership is not exclusive and Maquet is adapting the software for orchestrating its table with other manufacturers imaging systems.
According to sales staff, Siemens (Erlangen, Germany) will likely be the next announced partner, while technical issues are frustrating an integration with GE Healthcare (Waukesha, Wisconsin) systems.
“Where other companies have software modules that can be adapted, GE software is written like a book from A to Z and you can't just modify the middle parts,“ explained one salesman.
Philips, meanwhile, has an established partnership with Steris (Mentor, Ohio) integrating imaging, monitors and lighting with that company's Harmony iQ OR Integration System for endoscopes and robotics, as well as surgical tables, and customized surgical suites.
Ultrasound partners bring endoscopes to next level
Partnering with ultrasound companies, leading endoscope makers are bringing advanced diagnostics deep inside the human body enhancing not only the ability to see diseased tissue but to treat in the same intervention.
At Medica 2010 both Olympus Europe (Hamburg, Germany) and Fujinon Europe (Willich, Germany) introduced new endoscopes with more sophisticated features for the staging and treatment of tumors.
Both Fujinon and Olympus have offered for many years ultrasound endoscopes using their own branded ultrasound processors. To upgrade performance to a higher level, each has formed partnerships with ultrasound innovators.
In 2006 Fujinon began working with Zonare Medical Systems (Mountain View, California) to integrate that company's unique scan engine with its endoscopes for the Japanese market. The partners are now extending the developed technologies to the European market.
At Medica, Fujinon rolled out a new ultrasound processor and three new endoscopes that will be commercially available in January, according to Carlo Thurau, international sales manager for Fujinon Europe.
The EG 530 UT2, a longitudinal endoscope with fine needle aspiration, and the EG 530 UR2 radial diagnostic probe are existing scopes upgraded to work with the new processor Zonare developed for Fujinon.
The EB 530 US, is a new endoscope in the Fujinon line, an ultrasound-capable bronchoscope for staging of lung tumors and lymph nodes.
The SU 8000 Sono-Processor shown at Medica was developed in the joint venture to enhance image quality and acquires images 10 times faster than line scanning using the novel beam-by-beam scanner pioneered by Zonare.
Cited for a third straight year as one of the fastest growing companies in Silicon Valley, Zonare was rumored to be struggling financially.
“The company's financial troubles will go away thanks to the joint venture with Fujinon,“ Thurau said.
Zonare also recently agreed to co-market an ultrasound system for intracardiac (inside the heart) imaging with St. Jude Medical (St. Paul, Minnesota).
Fujinon also introduced at Medica the EPX-4450 High Definition Processor with an improved functionality for Fuji Intelligent Chromo Endoscopy, a virtual or “push-button“ contrast enhancement capability.
“A very important quality of this new processor is that it is meets digital imaging and communications in medicine requirements,“ Thurau said.
The five new products carry the CE mark and are approved under the European Union's Medical Device Directive, he said.
Olympus, Aloka launch new endoscope
At Medica, Olympus showed the GFU UCT 180 Endoscopic Ultrasound Probe that was first introduced at United European Gastroenterology Week in Barcelona at the end of October.
The longitudinal transducer enables surgeons to better see the an aspirating needle in the ultrasound image during biopsy procedures, said Olympus product specialist Simone Köhler.
The electronic curved linear array can be plugged into the Olympus processor EU-ME1 as well as the Aloka Prosound 10 or Prosound 7.
For the Medica demonstration the GFU UCT 180 was patched into the upgraded Prosound 7, a diagnostic ultrasound system that packs the features of Aloka's high-end processors into a more mobile system with a smaller footprint for increasing crowded operating rooms.
In addition to an improved B-mode image, the Prosound 7 is powered for contrast harmonic echo (CHE) that acquires echo signals from microbubbles injected into blood vessels for the detection of malignant lesions.
“CHE is well established for external abdominal examinations and now we have created a transducer sensitive enough to perform this procedure endoscopically,“ Köhler said.
She said Olympus is sponsoring a study across centers in Italy and France to demonstrate the clinical effectiveness of CHE in combination with Olympus narrow band imaging.
The hyperenhancement of vessels with the contrast agent Sonovue from Bracco International (Amsterdam, the Netherlands) can aid diagnostic confidence for adenocarcinoma and, significantly, can better guide endoscopic ultrasound fine-needle aspiration (EUS–FNA).
EUS-FNA has been accepted for routine practice as an effective technique for tissue acquisition of malignant disease, including esophageal, pancreatic, gastric and colorectal cancers, as well as the assessment of benign disease, such as chronic pancreatitis, common bile duct stones and gallstones.
Köhler said the large 3.7 mm working channel of the GFU UCT 180 enables endoscopic surgeons to see and then treat.
Clinicians have found the large aspirating biopsy needle serves as a surgical tool for manipulating a guidewire during therapeutic procedures in the gastric tract, such as placing a stent for pancreatic pseudo-cyst drainage.
Simplifying assay tests a crowd pleaser
Despite the massive scale of the Medica trade exhibition, sometimes it is easy to spot a winning new product. Just look for customers trying to get their hands on the equipment.
The small stand within the USA Pavilion for Magellan Biosciences (Chelmsford, Massachusetts) was drawing a big crowd of normally timid clinical biologists who were elbowing each other to touch the packaging trays for the new ELISA assay test unit, Project 24.
A fully automated lab test analyzer, Project 24 is currently in the final stages of development and not yet available for customer orders, according to Nancy Sandy, the VP of marketing, who added that the final product name has not yet been selected.
But the first look for clinicians during this preview demonstration was feeding Magellan's confidence for the new immunoassay processing system.
“We are very excited to share our next-generation platform with the marketplace,“ said Hiroshi Uchida, president/CEO of Magellan.
Project 24 optimizes microplate ELISA testing by bringing an unexpectedly simple ease-of-use to what historically has been a tedious and time-consuming process.
By removing the manual set-up and data entry from the workflow, Magellan eliminated nearly 50% of the hands-on time compared with traditional systems, Sandy said.
Working with assay manufacturers, Magellan offers pre-loaded kits with a barcode system that electronically communicates all the information needed for a successful run of a test.
“The clinical staff opens the top, places the kit in the system, closes the lid and can walk away confident the system will complete its work list,“ Sandy explained.
The direct-load kit format eliminates manual data entry of kit-specific data, minimizes errors, and tracks all consumable inventory.
Project 24 provides Magellan with a powerful platform for future development, she said, including extension into multiplexed immunoassay and molecular testing.