Medical Art of Machining Stabilizes Fractured Bones

The goal of osteosynthesis is to fix the fragments with one another in the most normal position possible. Unlike a cast, osteosynthesis normally enables early movement or even loading on the fracture. The choice of whether a fracture should be handled with a cast, osteosynthesis, or no treatment is made depending on localization, stress, misalignment of the fragments, results of movement loss, and the operation risks. One company, relying heavily on Mikron machines, continues to pioneer its development and deliverance of high-quality medical devices.

Medartis, headquartered in Basel, Switzerland with U.S. operations in Kennett Square, PA, produces titanium plates on Mikron machines for osteosynthesis procedures. In 1954, Professor Reinhard Straumann founded the Institute Straumann AG, specializing in the fields of metallurgy and physics for the clock-making and watch-making industries, so precision has always been their niche. Working closely with the Association for the Study of Internal Fixation (AO), his son, Dr. Fritz Straumann, merged the company's expertise in metallurgy, physics and medicine to apply the specific metallurgical and physical findings to the development and production of metal implants for the surgical management of fractures.

In 1989, the company sold the osteosynthesis division. In 1990 the Straumann Group, under the leadership of Dr. Thomas Straumann, concentrated exclusively on oral implantology. However, by 1997 Dr. Thomas Straumann decided to return to his field of osteosynthesis in cranio-maxillofacial surgery and formed the Medartis Group.

In 2004, Medartis expanded the product portfolio by entering the orthopedics and hand surgery markets. Expansion of a new factory in Bretzwil, (Basel-Land) Switzerland, offers more manufacturing space and more than 100 employees. Medartis continues development in metallurgy, boasting over a half a century of know-how in metallurgy, osteosynthesis, and oral implantology, and today they are known for their knowledge in the production of highquality titanium implants.

The goal of Medartis is to provide surgeons and the operating teams working in the mouth, jaw and facial surgery; plastic hand surgery; and orthopedic surgery with innovative implants, instruments, and services that mean advancement in the osteosynthesis and therefore quality of life for the patients. Safety, durability, tolerability and user-friendliness are requirements that must be met. In order to satisfy these high-set goals, the intensive cooperation with surgeons, scientists, universities and clinics are of the utmost importance to Medartis. Using the best technical equipment leads to the creation of their "masterpieces" in osteosynthesis, ultimately resulting in shorter convalescence periods for patients.

Plate production

After the 2005 facility expansion, two Mikron UCP 600 Vario's and an HSM 600U were included in the facility. One use of the machines is for the production of special plates for the underarm and hand. Prototypes for this are milled on the UCP 600 Vario. Product development starts with Medartis working in close contact with its customers. When working on new product concepts for which the optimum application is planned, working with the surgeons to develop the implant is a must. Detailed 3D CAD construction drawings and computer simulations make up the basis of the first prototypes, which are then evaluated in clinical testing. The products are manufactured in-house and with the cooperation with external partners on the most modern CNC systems. The highest level of quality testing according to internationally-recognized standards and guidelines secure a constantly high product quality. Medartis meets the quality standards the EU directives on medical devices and medical device legislation, as well as standars of the FDA.

Everything at Medartis is very clean, light, organized and almost clinical already. The workstations with microscopes and other measurement and testing equipment abound, since medical products must often be tested thoroughly before they arrive on the market.

"We manufacture medical products here in Medartis. You can imagine that quality and the technology used have the highest priority, especially after realizing that the various implants are used for people," explains Peter Weisskopf, member of Medartis management. "Naturally, we decided upon a manufacturer that we know builds high-quality machines. The decision for Mikron was of course preceded by comparisons with other companies. The price/performance ratio of the Mikron machines convinced us. The fifth-axis is an investment in the future. The Heidenhain controller is also important to us and is proven in operation. It is also no problem to transfer programs from the HSM 600U to the UCP 600 Vario; this type of compatibility is a strong advantage as well. One of our employees, who had already had some good experience with machines by Mikron, also provided some positive influence."

The implant line is vast. Modus is what they call their art of osteosynthesis in cranio-maxillofacial surgery line. While there are many variations on the line, some for example that they machine are the Modus 0.9/1.2 for cranial fractures of the skull, nasal and orbital region, and zygoma region. They offer 41 different plate types in titanium. Plate thickness is 0.5mm. Each line is designed for specific areas of cranio-maxillofacial surgery. Modus 1.5, for example is for cranial fractures of the skull, central and lateral fractures of the midface, and maxillary osteotomies, while Modus MDO 1.5/20. is for hemifacial microsomia, mandibular hypoplasia and microglossia, and microsomia of the mandible.

Plates and screws are designed specifically for work with the implants Medartis produces. Modus implant screws are selftapping, commercially pure titanium screws for inert, biocompatible behavior in body tissue. The extremely low profile of Modus screws ensures cosmetically flawless results. Sophisticated manufacturing techniques ensure optimal interface between screws and screwdrivers. Different thread pitches for different screw lengths are another unique feature. This results in shorter inserting distances when using longer screws and improved retaining forces with shorter screws in thin bones. Implants, screws, and screwdrivers are all color-coded for optimal efficiency. In addition, Medartis offers exclusive instruments that work with their implants such as the Vario plate cutting pliers and plate holding and positioning instrument.

Indispensable automation

Both the UCP 600 Vario and the HSM 600U are set up with palletand tool-changers for automatic operation, to guarantee 24-hour operation. The automation was also an important aspect for purchasing the Mikron machines, stresses Weisskopf. "The machines have to run for 24 hours and this is possible because of palletizing. The Mikron-offered "smart machine" module RNS works better and cheaper than if we would have run the operation in shifts. RNS makes it possible to obtain information about the operation status of the Mikron machining center, as well as the milling process, regardless of the location. The operator can receive information about the operating status or program status of the machine via SMS to a mobile phone."

Titanium plates are milled on both Mikron UCP 600 Vario's in the Medartis plant.

Where precision and surface quality are concerned, there are no compromises at Medartis. Since these parts are for use in medical products, aesthetics are also important. Since the Mikron machines are known for their good milling results and for the exceptional surface quality of the parts they process, they meet the requirements of Medartis perfectly.

"We've made a good decision with the Mikron machines. The two UCP 600 Vario's and the HSM 600U are very versatile. They are dependable and are designed very well for the automation. The parts that are milled with them have a quality surface and are very precise, exactly what we need," Weisskopf says.

With its UCP 600 Vario, Mikron has a convincing 5-axis solution for automated production. As well as the compact basic machine itself, the Vario system has: a multitude of high-performance milling spindles; a scaleable, modular tool changer system, the best known pallet changer from other Mikron machines; and the right disposal or cleaning solution for every chip and coolant situation. It is up to the customer to decide just how variable their UCP 600 is to be. However, one thing is guaranteed to stay the same: access to the machine and peripheral devices is wonderful.

The basis of the UCP 600 Vario has everything required to be used successfully in tool and moldmaking, medical technology, and the entire machining process.

GF Agie Charmilles,
Lincolnshire, IL
agiecharmilles.us

Medartis Inc.
Basil, Switzerland
medartis.com