STUTTGART, Germany — The European economy that is built on medical technology now tops 155 billion ($83.6 billion) annually, and Germany accounts for two-thirds of that trade, or a whopping 135 billion ($53.2 billion).
And like any healthy economy, two-thirds of Germany's med-tech business comes not from giants like Siemens (Erlangen, Germany) or Draeger (Lubeck, Germany), but instead is built upon myriad small- and medium-sized businesses that rarely make headlines and almost always are privately held, never reporting sales figures.
About 1,200 of these manufacturers are located in Germany, according to figures from by the U.S. Department of Commerce, and their robust, export-driven business contributes substantially to the country's vigorous economy and positive trade balance that makes it the envy of its neighbors.
What makes Germany stand out internationally is its reputation for precision manufacturing, a prowess powerfully presented at the MedTec 2008 exposition in the new Stuttgart Landemesse, where 650 companies sprawled across 110,000 square feet of space, with noisy demonstrations of robotic production and in-line packaging assembly, as well as brightly-lit display cases featuring magnifying glasses so visitors could see micron-level machining of intricate components used in devices that perform medical miracles.
With a focus on the techniques of manufacturing rather than the devices, MedTec offers a view far upstream in the flow of technology toward clinics and patients.
Visitors to the exhibit space for Kl ger Spritzguss (Dornstetten, Germany) were fussing over pellets of aluminum oxide and zirconium that one day may be used to form the medical-grade ceramic tip encased in an endoscope. The final endoscope tip on display was all but ignored.
The company's Jens Graf said the pellets are a problem-solver for medical device designers due to their bio-friendly qualities, combined with an ability to withstand high temperatures, extreme durability and resistance to chemicals that would be encountered in sterilization of an endoscope, for example.
The pellets lend themselves to injection molding of components as small as the head of a needle that feature both internal and external geometries in a single-shot extrusion while withstanding tolerances for thin wall-thicknesses.
Ceramic compounds always have been more expensive than other materials used until now, said Graf, but today high price is now called "value" because of unique characteristics for applications in electro-surgical devices, laser systems and fluid handling.
Micro Precision Systems PS), located across the border in Biel-Bienne in German-speaking Switzerland, is the manufacturer of an implantable titanium pump used for Medtronic's inneapolis) SynchroMed II drug infusion pump that precisely delivers a prescription according to pore-programmed instructions.
"We build the key component and it is assembled in Minneapolis," said Markus Hug, project manager for MPS, showing a second generation of the pump. Though a palm-sized and complex device, the pump weighs just half an ounce.
"It is titanium, which weighs nothing but is extremely durable," he said. "We are studying how to make it even smaller, of course, and to make it cheaper. We have to do so — we are always doing so."
The third generation is still four years from market.
The ongoing assignment to reduce both the size and price assures the competitive edge for the region's companies, Hug said. The core competency here is to identify for every device where precision is needed, ideally reducing it to just two critical components. The rest of the product can then be contracted to any outsource manufacturer by the customer.
Alexander Syndikus of W.C. Heraeus Medical Components Division (Hanau Germany), specializing in precious metal alloys for implantable devices, told a similar story about the strategy for German engineering.
Heraeus makes electrodes that give the life-saving impulses to the heart in pacemakers, as well as the wire from the pacemaker to the electrode.
He said he is not allowed to say which manufacturers use the products, "but it is safe to say that our components are used on at least six different models. And for pacemakers where we are not the direct supplier, we sell the components, such as the wires, to those companies that have the direct contract with a manufacturer."
A new hologram authentification seal for medical packaging was being shown to visitors by Bernard Schilling, sales director for the SteriClin brand of Veringte Papierwarenfabriken (Feuchtwangen, Germany). Similar to the hologram technique used for bank cards or on euro bank notes, the identification strip targets counterfeiting of medical devices that Schilling says is estimated to be worth several hundreds of millions of euros annually.
"They copy everything," he said, adding that while the hologram authentification mark would not be worth the expense for everyday bandages, "for a pacemaker it could be very well worth it to assure the device is an original and is backed by its manufacturer.
"This is so new we do not even have a product name for it yet," he said, adding that for the German audience. it is called — literally translated — the "originality feature."
Moving far upstream into the heart of the German med-tech economy becomes a voyage of discovery among businesses with fewer than 10 employees who collectively rent an exhibit stand at the MedTec event to display or test their products.
Sometimes it takes a moment to even understand what is being shown in a display —for example, one filled with screws and false teeth.
And the few words of English suggesting exciting news in the wetting properties of titanium is not a grabber for dinner conversation, unless the speaker recently had a tooth implant that healed in record time.
Heinz Busch from NTTF (New Technologies for Thin Films) in Rheinbreitbach, Germany, near Bonn, is betting the future of his small company of eight employees on this new hydrophilic solution for titanium.
While the first product application is for a dental implant that went into a testing phase mere weeks ago, titanium screws are used to hold implants throughout the human body, he said, in spines, knees and hips.
In the first minutes of screwing titanium into the bone, blood needs to have a good contact against the surface of the screw at every encounter point, Busch said. An enhanced biocompatibility through hydrophilic properties will accelerate healing from four months to six weeks and greatly reduce the risk of complications from infection. Howeve,r liquids bead up on titanium, as it is naturally hydrophobic. NTTF's solution reduces the angle of the liquid bead from 85 degrees to near zero.
While other manufacturers offer competing solutions for making titanium surfaces hydrophilic, these screws tend to lose their properties just minutes after being removed from the special liquid packaging, he said. If there is a complication that slows down or delays the surgery, the screws must be thrown away. NTTF screws resist this oxidation for up to six hours.
"We are now looking for a partner to take this to market," said Busch, who said that he had his first meeting with a distributor on the first morning of MedTec.
He said that NTTF launched another surface coating last year that is returning excellent results from follow-on studies and is reducing costs to the German healthcare system for treatment of urinary infections in women after implantation of a urethral stent.
In 90% of cases, bare-metal uteral stents quickly become encrusted with calcium oxalate crystals that lead to infections and complications that can only be treated with antibiotics. The German government's health fund claims it spends hundreds of millions of euros each year for some 250,000 nosocomial infections of the urinary tract associated with this condition.
The ProntoSafe Diamond line of urinary stents from NTTF feature layers of carbon coating applied at low temperatures that resist, or prevent completely, encrustation of crystals.
A clinical trial found after six weeks that an uncoated stent presented the telltale deposits of crystals where none were present on the ProntoSafe stents. Staged studies show no build-up at three months and the longest test is on patients at 13 months, who continue to exhibit no encrustation.
The product is articulated across 10 versions, with single-J and double-J stents, as well as tumor stents with reinforcing stainless steel helix in both closed- and open-tip versions. The ProntoSafe kit includes guide wire, pusher and clamps.
NTTF has produced English-language materials supporting the product and with CE approval in hand, is negotiating with distributors.