DÜSSELDORF, Germany – The little world of microtechnology and nanotechnology is big for medical devices.

"There are not too many markets left for these suppliers," said Uwe Kleinkes, managing director of IVAM Research, the association of 300 manufacturers and service firms working at the micron and nano-component level.

"In the automotive, everyone believes there are even more hard times to come," he said, "but they will hang in that segment, too, because we all believe it is like our German soccer team, they always come back."

Meanwhile the medical sector is hot, judging from participation at the IVAM-organized pavilion for MEDICA 2008 with a 62% increase in exhibitors – from 30 at last year's meeting to 48 at this year's exhibition, which concluded last week.

Demographic changes are driving the interest in miniaturized components for medical devices, Kleinkes said.

"The killer application for medical devices is ambient assisted living," he said, "and the required portability and remote-based applications bring medical device product developers to the mobility features that come from our members.

"There are so many ideas out there," Kleinkes said, but with no standards established for medical electronics and materials, the industry is far from identifying the winning applications and combinations of available technologies.

"That devices need to be mobile and wireless is clear," he said, "But what those devices will be and why they will be successful is far from clear."

The normal product development process in the medical field also is more complicated, he said, compared to other industries where his members also supply components such as consumer electronics, automotive, telecommunications or aviation.

In the consumer electronics or telecommunications industries, Kleinkes said, "You make a product, like a phone, and you start selling it. Punkt [period]. You go direct to the market."

In healthcare, he said, the access to the market is complicated by layers of regulation to place the product on the market, and then by another layer of reimbursement that dictates what you will be paid.

"In Germany we have in the category of assistance devices the Hilfmittelliste, and if you are on this list of certified and approved devices, it is a license to print money," Kleinkes said.

But, he cautioned, "At the agency that publishes the Hilfmittelliste, they do not like innovations."

Kleinkes added, "It is the opposite of a clear and open market, making it more difficult with requirements to prove that a new product is better than what is already on the list." He noted that there is a heavy pharmaceutical lobby watching the new product introductions.

Meanwhile, among IVAM members "2008 was a very good year, at least the first three-fourths of it was," said Kleinkes, adding that members are looking at 2009 as "a building year."

Visiting with IVAM members exhibiting at the sideshow to the main MEDICA exhibition turned up fresh examples that sometime innovation is fostered and planned, and sometimes, "we just got lucky," according to Gregor Gross with Alpha-Board (Berlin).

Alpha-Board is an engineering office with a strong client base in aviation that was making its first showing at a medical device fair.

It is a family-run business of 20 people run by CEO Brigitte Gross, Gregor's mother, who is also an engineer.

Though, he said, "I made a power move on her recently and we are now about equal" in ownership.

It was not a company strategy to diversify to medical devices, he explained. Instead, "We kind of stumbled into this."

Gross said Alpha-Board was looking at applications for placing radio frequency identification tags (RFID) on printed circuits board onboard medical devices and someone in the marketing department placed an article on a Scandinavian web forum.

"We had 11,000 downloads in a few weeks," he said, adding the e-mail address of the marketing person had to be changed, "because there were so many inquiries, he could not find his own mail."

Everyone knows RFID, but few are using it to track and trace products, he said, with barcodes leading the market at the moment.

In the aerospace industry there are two main customers who decided to use RFID, "and then the U.S. Department of Defense got behind it, so that was it," he said. "Everyone supplying that industry is doing RFID now."

Gross said, "In the medical market, there is not this kind of market lever. Some people know about it, but mostly we are educating customers."

Draeger Medical (Lübeck, Germany) embeds RFID in its accessories for increased patient safety, to simplify handling and improve workflows, the company says.

For example, incorrectly inserted breathing circuits trigger an alarm from the RFID tags. The tags also are used to remind caregivers when to replace certain products.

"The advantage to RFID is that it is secure and embedded, you can both read and write data to the electronic tag, and it is readable anywhere in the world," said Gross.

With a passive reading range up to about six meters, "you can read an RFID tag through the Great Wall of China," he said, "but barcode readers need a one-foot direct line of sight and at a specific angle."

A barcode has a 100-byte data capacity, or 1,000 bits, compared to the 8,000 bits on an RFID tag, or 64 kilobytes, the equivalent of two pages of typed data.

Customers are intrigued by the possibilities for not only reading a product's identification but writing data to the RFID tags as well.

"But they worry about the costs compared to bar-coding," said Gross, who added the features are more sophisticated, "and therefore more expensive."

Implantable drug delivery devices

The Hahn-Schickard-Gesellschaft Institute for Micromachining and Information Technology (HSG-IMIT), located in Villingen-Schwenningen in the automotive-intensive state of Baden-Württemberg, diversified its portfolio with medical applications during earlier shakeups in two other sectors of activity – automotive and production, and automation technology.

HSG-IMIT was showing at MEDICA prototypes from European Union-funded projects where it is applying its experience with thermal sensors, inertial sensors, energy autonomous systems, micro dosage systems, lab-on-a-chip and micro-medical technology.

The goal of the IntelliDrug project, funded under the EU's Sixth Framework Program, is to build a tooth that elutes drugs at programmable doses.

The device integrates a pressure generating osmotic pump, a flow sensor, a micro-valve, electronics and energy supply to delivery consistent doses of a drug over days, weeks or months.

The bad news is losing two teeth to fit the apparatus on your jaw, though Stefan H berle with HSG-IMIT said the tooth is being further miniaturized.

Another EU project, NeuroProbes, is focused on a complex microfluidic dosage system for brain implants using sophisticated silicon-based microneedles that pick up and record brain signals, but also deliver a drug through microchannels integrated into the shaft of the needles.

The goal is to create an implantable device for the pharmaceutical therapy of brain diseases such as epilepsy, Alzheimer's or Parkinson's.