BB&T

DÜSSELDORF, Germany — Celebrating its 40th birthday, Medica, the world's largest trade fair dedicated to medical devices, showed no sign of a mid-life crisis, let alone any effect from the global financial crisis.

Begun as a modest exhibition called “Diagnostikwoche“ (Diagnostic Week) with 135 German exhibitors and 4,700 participants, the three-day event that opened Wednesday has grown to 4,279 exhibitors from 65 countries and will attract an estimated 137,000 visitors, a slight increase over last year.

While the event organizers proudly promote different themes and focal points, the event defies neat categorization sprawling across 16 exhibition halls that resemble an Arab souk more than an orderly German trade fair, and effect only amplified by the cacophony of foreign languages in crowded corridors or shouted halfway around the world through portable phones.

Exhibitors cover every category in the healthcare supply chain from disposable bedpans to high-end scanners including laboratory, diagnostics, physical therapy, orthopedics, consumables, health information systems, furnishings, and textiles.

A fully equipped ambulance or integrated operating room can be bought off the showroom floor, and where medical device manufacturers rarely expect direct sales at a trade show, filling the order book is precisely the goal of executives on the stands at Medica.

Hospital administrators from Germany, Austria and German-speaking Switzerland are regulars at Medica to price out new capital acquisitions or everyday supply contracts in face-to-face negotiations.

As part of Germany's recent e4.7 billion ($7 billion) Economic Stimulus Package, hospitals will receive up to e1 billion ($1.5 billion) for the modernization of local institutions with an estimated 45% allocated to capital equipment purchases.

Medica remains a militantly German event, despite 40 years of international influence, and a showcase for German industry head-to-head in the massive exhibition halls with an invasion of Asian competitors, many of whom began in business less than 10 years ago thanks to technology transfers from German companies.

In a survey of 110 of its 222 members released this week during its 10th Media Seminar, the German medical device trade association BVMed (Berlin) reported participating companies said they grew by an average of just under 4% so far this year and are continuing to hire new staff.

In addition to the stimulus package funding, Germany enacted the Innovation Clause (NUB; Neue Untersuchungs und Behandlungsmethoden) to expedite reimbursement for the adoption of new technologies and treatments in hospitals.

In 2009 7,500 NUB applications were approved and 87 new treatments were included in the German DRG system, boosting the early adoption, and sales, of advanced technologies.

“The aim is a competition for the best possible medical technology provision, in order to buck the trend of cut-price medicine,“ according to BVMed CEO Joachim M. Schmitt, adding “The focus must lie on the quality of medical care instead of on price alone.“

Fifty-eight percent of member companies said the focus on healthcare delivery quality instead of price focus has boosted demand for their products.

It is not only the Asians who compete fiercely for a share in the European, and especially German, market, the largest on the continent for population and spending.

The large U.S. pavilion at Medica stands as a solid reminder that American companies tend to dominate key markets, such as orthopedics.

In a survey released at Medica for the British Standards Institution (BSI; Bristol, UK) of 1,100 medical technology executives, Emergo Group Consulting (Austin, Texas) found a fourth of all companies targeting Europe as the single new international market they hope to enter in 2010.

Europe was the dominant target among the largest companies among the survey respondents, of whom 60% are based in the U.S.

It is not only Medica but the medical technology sector generally that continues to advance each year.

In the face of the economic crisis last year 64% of respondents to the BSI survey said they nonetheless expected sales to increase in 2009, while this year a modest but steady increase was reported among executives, of whom 70% said they were looking forward to greater sales in 2010.

Both European and U.S. companies reported positive growth from international markets during the previous three months, and a modest increase in exports from North American companies were attributed in part to the weak U.S. dollar compared to one year ago.

'Smart' patient monitoring needed

In the operating room (OR), a surgeon typically is surrounded by 11 different medical devices, “and they all keep beeping at us,“ complained Martin Schuster, MD, from Charité University Hospital (Berlin).

“Which one of these alarms is important,“ he asked, adding that blood pressure, oxygen saturation and ventillator alerts can sound between 10 and 12 times during each case.

“We need smart alarms, and I know that some manufacturers are sensitive to this problem, but it is really a work-in-progress,“ he said.

For example, loud alarms are effective, but only for being turned off more quickly, not because the information is more important. Adding a rising tone for an alarm according to the severity of the patient condition would be smarter, he said.

As for visual alarms, a blinking light is difficult to notice these days when everyting is flashing, but a more useful visual is a graphic display showing a clinician the critical state in relation to the past few minutes.

Responsible for five ORs at Charité Hospital, Schuster led a presentation on “Patient Monitoring : Friend or Foe of OR Workflow.“

The English-language sessions in the program for Medica 2009 were a first, a token acknowledgement of the heavy international influence on the world's largest trade fair, which celebrates its 40th anniversary this year.

Schuster's key theme was the challenge that complexity in the OR presents for productivity, and ultimately for patient safety.

“We counted 81 different types of medical devices in the Charité OR,“ he said, including 15 anesthesia machines, nine respirators, 16 infusion pumps and 13 cardiovascular monitoring devices, all from different manufacturers.

“We are required, of course, to train OR personnel on all of this equipment, which takes a considerable amount of time,“ he said.

Yet for any given type of device, the downtime in OR was found to be an average of 40%.

Devices dedicated to a single location and redundancy are two areas where this problems needs to be addressed, he said.

Schuster asked why a patient can not be continually monitored, for example, by the same device throughout the perioperative pathway, a device that is as transportable as the patient.

Integration of devices with hospital information systems would also help answer the most frequently asked question in the OR, “Where is the next patient?“

“Just over 14% of OR time is unused, and half of this is because we do not know where the patient is located, at what state the patient is in preparation,“ he said.

“Since the patient is connected to a patient monitor in these spaces, why can we not know from this monitor the location and the patient's status?“ asked Schuster.

“Sometimes such information conveniently displayed would allow us to improve workflow, or sometimes it simply would let us know that we can take a break for 15 minutes,“ he said.

As POC testing grows, so does risk of errors

Today testing of patients at the point of care (POC) accounts for 25% of all testing, and these portable assays are increasing their penetration into medical practice at a rapid rate of 12% each year.

Yet along with the growth comes an increasing risk of errors that adversely affects quality of clinical decision-making and patient safety.

“Already healthcare is not as safe as it should be,“ said Christian Falk, MD, from Zurich University Hospital (Zurich, Switzerland), citing a death rate due to medical errors that places hospitals among the top 10 leading causes of death.

“If a Boeing 747 crashed each week, this would be the equivalent of deaths in the healthcare system due to errors in either the United States or Europe alone,“ he said, adding, “not many people would want to fly.“

POC testing brings great benefit to healthcare with rapid results for glucose levels, cardiovascular monitoring, or even simple pregnancy tests, he said.

Yet these tests are increasingly performed by non-laboratory personnel and subject to errors such as inappropriate testing, excessive testing, inconsistent specimen collection, mistimed tests or critical results that are either not recognized or not documented.

An especially wide area for simple error with serious consequences is misidentification at any of the stages in a process that includes pre-analysis, analysis and then post-analytic results.

At his hospital in Zurich, Falk has studied the variations in patient identifications that are alternately taken from a bed number, a patient medical record, or a patient wrist band, which is rare in Zurich.

The workflow error potential is great, he said, at a large medical center when it turns to “rush hour“ at the blood analyzer with unreadable bar codes and syringes stacked on paper toweling marked with bed numbers.

Falk, who made a career transition in 2004 from the hospital's lab to its info systems, believes POC testing should follow a similar path.

He has conducted a pilot program in Zurich that integrates POC test results with the patient medical record through the health information system.

A test profile is created by zapping the bar codes on the ID badge of the healthcare worker performing the test, on the POC test device being used, and then on a patient identification badge.

This profile is bundled in a central process analyzer with the test results and simultaneously sent to the patient medical record and the POC test result device.

He said the system is not completely stable at the moment, nor is it scalable, meaning it is not yet ready to be deployed across the entire university hospital campus.

Yet it is an essential first step, he said, in approaching POC testing the same as other critical healthcare functions, such as the medical device supply chain, or medication tracking with single unit doses.

He also said that increasingly, the manufacturers of POC tests need to support embedded data transfers in their applications to integrate with web-based reporting portals at hospitals.

Product focus advances Welch Allyn expansion

Just as a great chess game can begin with the advance of a modest pawn, the CEO of Welch Allyn (Skaneateles Falls, New York), Julie Shimer rolled forward the new CP 50, a transportable electrocardiograph (ECG) that represents the leading edge of the company's ambitious plans for international expansion.

“We have been working in Europe for 35 years,“ said Shimer, “yet this is the first product we have designed exclusively for the specific needs of the European market.“

To this point the privately held Welch Allyn has been a traditional American player in international markets.

“Up to now products have been developed for the American market and then sold in other markets with similar needs,“ Shimer explained.

“In recent year we have shifted from this U.S.-centric focus and have become more open to Europe especially in our product development,“ she told Biomedical Business & Technology.

Encouraging this strategy are the strong numbers, she said, explaining that while Europe currently is one-fourth the size of the U.S. business, “it is growing at a much faster rate, nearly twice the growth rate in the American market.“

Growth in Europe is driven by a two-fold strategy centered on products and management, she said.

“I love our European team, which is very enthusiastic,“ she said, crediting the group with maintaining a strong presence in hospitals.

On the product side, Welch Allyn reaches across a broad range of product categories, perhaps too far, she suggests, yet at the same time the wide offering is fueling the growth with increases over the full range.

CEO Shimer said she is also actively seeking out opportunities for acquisitions, “not to expand out product categories any further, but to create access to new markets or else to create depth in the categories we already have.“

The new CP 50 ECG unit was developed by Welch Allyn specifically to meet emerging needs in the European market and Shimer said there are not any plans at this point to bring the unit into the U.S. market, that she said is not quite ready for the same features for connectivity.

“The whole telemedicine concept is much stronger in Europe than the United States,“ she said, adding “there is not the same demand for remote clinical care and home care in the U.S.“

“It is coming in the American market, of course, and in another five years there will quite likely be the same level of sophistication, so that in a sense our European team is helping us to develop products for the future in the U.S.,“ she said.

“What we have been hearing in Europe is the need to capture patient data in either the general practice or clinical setting so that it can be sent to specialists and shared with other care givers on the patient pathway,“ Shimer explained.

“There is a higher penetration in Europe of electronic medical records in front line care, driven largely by government-based systems,“ she said.

“So in Europe customers have an established data structure to feed,“ said Shimer.

In the U.S., similar Welch Allyn vital signs products like the ECG unit are designed around proprietary software that feeds data to closed health information system, in contrasted to the more open and interoperable platforms in Europe.

As a result European customers require a software development kit that enables them to integrate with their shared health information systems, she said.

With the information transmission capabilities of the CP 50 ECG, Welch Allyn has solved a part of the emerging connectivity continuum, according to Shimer.

“The next generation platform that is now being developed will go even further in addressing segments of this continuum,“ she said.

Beyond connectivity, competitive advantages for the new CP 50 ECG are that it is lightweight, it's easy to use and it's easy to transport.

“Flexible monitoring units, recording fewer parameters but portable, are very popular in Western Europe,“ said Shimer, where they are used in home care or palliative settings, for unmonitored hospital beds outside intensive care units or for patient transport.

Wii could take motion game to a new level

Motion detecting is more than just fun and games.

The technology behind the popular Wii from Nintendo is “pretty lightweight technology,“ according to Marc Attia who directs sales for Movea (Grenoble, France), who suggests there is a lot more science, and especially clinically useful information, that can be extracted from monitoring the activities of patients.

Movea holds an interest in the Wii game as it acquired the developer of the motion sensing technology that licensed the patents to Nintendo, Gyration (Saratoga, California).

Yet the Movea is ready to play at a new level with the SmartMotion Development Kit it launched during the world's largest medical trade fair held here last week.

Smart Motion is a software development platform that allows original equipment manufacturers (OEMs) to integrate motion sensors into diverse products for obesity prevention, for functional physical therapy, such as the measurement and diagnosis of joints, for biofeedback, such as estimated calorie burn, for sleep analysis, and for monitoring the elderly patient in home care or long-term care facilities.

The SmartMotion software engine includes sensor fusion algorithms that are “sensor agnostic,“ according to Attia, capable of precisely measure and record body movements regardless of the tiny wireless, and therefore wearable, micro electro mechanical system (MEMS) being employed.

Movea offers an advanced sensor for integration, of course, the MotionPod, a wristwatch-sized device to rapidly integrate and customize the use of wireless multi-sensors in their applications.

It also includes a companion application, the MotionDevTool that has an intuitive graphical user interface for real-time visualization and integration.

“We have more serious science behind motion detectors than scoring points on a game,“ said Attia, calling up a graphical interface for clinicians that extracts specific activities, such as sitting, walking or lying down, and critically, an activity called “transfer“ when a patient changes position that is the most intensive with the use of muscles and the resulting burning of calories.

Human body orientation and precisely quantified motion measures combined with other body-worn sensors for blood glucose, oximetry or heart rate, can remotely provide a wealth of data about a patient's condition.

A first customer for the SmartMotion kit is RM Ingénierie (Rodez, France) that uses MotionPod in its BioVal, a module that allows physical therapists and doctors to quantify joint function, as well as enhance and monitor physical therapy activity with biofeedback game exercises.

The exercises pathology-specific analysis on BioVal make it possible configure rehabilitation programs with feedback, feed-forward visuals and audible warning alerts that frees up physical therapists from repeated tasks while giving patients self-directed programming for re-education.

The BioVal was developed in partnership with the Motion Lab from the French Atomic Energy Commission (CEA) in Grenoble where 10 researchers focus on product development for Movea.

Movea serves as the technology transfer partner for the CEA, one of France's leading research laboratories.

Another early adapter of the SmartMotion kit is CIU Santé (Nice, France), a consortium of leading French companies and research institutes that has integrated the Movea technology into products to clinically validate a rehabilitation and activity monitoring system for seniors focused on monitoring for dependence by analyzing the quality and quantity of physical daily activity.

“Monitoring senior activity includes a lot of subcategories for study that are the subject of a series of clinical trials underway at this moment,“ said Attia.

Back to the realm of fun and games, earlier this year Movea signed an agreement for joint development of monitors for sports activity with Oxylane (Villeneuve d'Ascq, France), the e4 billion ($6 billion) retail distributor that designs in-house its own products

Movea marketing director David Macias said, “We are going to being doing a lot with Oxylane in developing motion sports and motion life style with greater sophistication and accuracy than consumers are familiar with though computer game programs.“

“Motion sensing is a crowded space on the high end where the product configurations are not user friendly and not mobile,“ said Macias.

“We enter this space with a core capability for world class research with Movea and the heritage of Gyration for developing low-cost consumer products,“ he said.

“Together this creates opportunities for more advanced but more affordable applications in healthcare,“ he said.

Founded in March 2007 by a team of researchers from the CEA, Movea raised e7 million in its first financing round, enabling the acquisition of Gyration.

Attia said the company will seek a second financing round in 2010 and also will launch a third generation version of its MotionPod.