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Timeline

2014 | ROTEM® sigma - Dynamic process - dynamic form

Timeline

2014 | ROTEM® sigma - Dynamic process - dynamic form

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QUICK CERTAINTY FOR ACUTE OPERATIONS

‍July2014 | If a patient's bleeding cannot be stopped during acute operations or complicated births, the ROTEM® sigma provides information about the cause within a very short time. The manufacturer Tem International GmbH wanted a new, attractive product design for the sophisticated technology and brought the WILDDESIGN team on board.

The ROTEM® sigma consists of a multi-part device cover, a monitor and a monitor arm. While the existing monitor and its arm met the customer's requirements, he was not satisfied with the previous block-like design of the device cover. A new, attractive product design - with simple usability and easy cleaning - was to be developed.

DESIGN DEVELOPMENT IN A FEW WEEKS

‍Withinjust a few weeks, the WILDDESIGN team developed four proposals and presented them to the project team. One of the basic requirements was that the existing technical structure should be changed as little as possible in order to keep the tried and tested components inside. In the end, the "Dynamic" design was selected: the characteristic feature here is the beveled front, which gives the appliance a flowing, dynamic design. A blue stripe in the middle marks the heart of the device and thus illustrates the process flow, as this is where the sample input and the technical core are located. In this area, the sample tube containing the patient's blood is inserted into the cartridge and analyzed.

Housing technology using the thermoforming process

SEAMLESS DESIGN - HIGH STANDARD OF HYGIENE

‍Sincethe device is used at the point of care (POC) in hospitals and is often used in stressful situations - for example, if the patient's bleeding cannot be stopped during an operation - the hygiene factor plays a major role. What is needed here is a design that is as seamless as possible and easy to disinfect and clean. In addition, the area around the front insert is recessed so that blood spilt in hectic situations can drain away.

FULLY AUTOMATED SAMPLE HANDLING REDUCES OPERATING EFFORT AND SOURCES OF ERROR

‍Anew feature of the analysis system is its simplified operation. Manual pipetting, as with the previous model, is no longer necessary as the device analyzes the blood samples fully automatically. This means that medical staff can get back to other tasks more quickly. The "handling" of the ROTEM® sigma is thus reduced to inserting the cassette and reading the barcode or applying the blood sample. The automatic test selection of the cartridge makes everyday work easier, especially for new users. Operating effort and possible sources of error are thus minimized.

Markus Wild, CEO of WILDDESIGN:
"This project was a sprint project. In our collaboration with Tem International GmbH, the prompt and uncomplicated coordination processes in particular led us to quick results. Since our cooperation partner Heilemann also took on the challenges of this project and was able to deliver a housing prototype to us within just two weeks, we were able to realize an extremely short project duration."

FURTHER INFORMATION ON THE PRODUCT:

The ROTEM® sigma is used for major operations, complications in obstetrics, severe trauma and acute operations. If there is unexplained bleeding during or after surgery, the system provides the necessary hemostasis information. The sample tube containing the patient's blood to be analyzed is inserted into the cartridge of the ROTEM® sigma. In less than ten minutes, it identifies the cause and is therefore of crucial importance for the further treatment of the patient.

Fully automated
Simple and safe operation

About the Instrumentation Laboratory (IL)/ Tem Innovations GmbH:

Instrumentation Laboratory (IL) is part of the Werfen Group, a global healthcare company committed to providing the highest quality in vitro diagnostic products. Since September 2016, the Tem Group and its ROTEM® systems form the Patient Blood Management Business Unit within IL. The ROTEM systems are developed and manufactured at Tem's headquarters in Munich. These systems measure the haemostasis status of whole blood samples and thus enable targeted treatment therapy in acute and massive bleeding situations. The use of ROTEM systems in the POC area contributes directly to improved patient treatment as well as to cost reduction in the healthcare sector.

Instrumentation Laboratory Tem Innovations GmbH
Martin-Kollar-Strasse 15
81829 Munich / Germany
Tel: +49 89 45 42 95 15
instrumentationlaboratory.com

Short Facts

Project management Tem: Dr. Oliver Kohr (CEO), Holger Chab (Development)

‍Project managementWILDDESIGN: Milan Marovac, Tim Meier‍

Development period: 09-12 to 2013‍

Launch of the product: 2015

Cooperation with external parties

KVH Hartung GmbH from Krailling near Munich, plastics manufacturer

Supplied the housing using the particularly efficient negative deep-drawing process, which was further developed by KVH Hartung for housing construction. It makes it possible to produce a surface quality so close to injection moulding that a closed housing is no longer recognized as a deep-drawn part. Compared to injection molding, tool costs can be reduced by up to 90%.‍

Heilemann GmbH from Wilhelmsdorf (Bavaria), metal processor

Delivered the prototype of the sheet metal chassis and housing within two weeks.

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