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POC product development: early involvement of automation partner pays off

Image caption: Tool-based system solution for rapid diagnostic tests. The teamtechnik system operates on a 3-second cycle with an output of twenty cartridges per minute, currently producing three million in a year. This volume can easily be increased if demand for the product rises.
Photo: teamtechnik (no fee for printing – notification requested)

Interaction between system planning and product optimization enables the costs for subsequent series production of point-of-care products to be reduced and punctual ramp-ups to be ensured.

Point-of-care tests, performed and evaluated independently of a laboratory, can deliver rapid and precise information about a patient's condition. In recent years their importance as a monitoring and diagnosis tool in medicine has greatly increased. The transfer of newly developed POC products to automated production remains a particular challenge however. Volker Patz, Director of Mechanical Engineering for Medical Devices at the teamtechnik Group, therefore recommends that the automation company be brought into the development process at the earliest possible stage: "The manufacture of POC diagnostics products involves highly demanding processes such as dosing technology and biomarker spotting. The task is to insert fluids or freeze-dried reagents into cartridges with microgram precision. A small product design detail can determine how much the subsequent mass production will cost."

Collaboration from the prototype to series production
teamtechnik therefore offers close collaboration with its customers from the prototype stage until series production of the POC product. By ensuring interaction between system planning and product optimization, the precision assembly processes and functional testing necessary for POC diagnostics products can be realized cost-effectively and on time. ‘Prototypes of a POC testing system are often developed in such a way that they can be used for different samples. There are thus also other design variants for which the assembly line and testing process must also be designed from the start’, says Volker Patz.

The involvement of teamtechnik from an early stage also enabled Alere Technologies GmbH to move quickly from manual sample assembly to reliable series production. This rapid diagnosis test specialist needed an automation partner to enable a newly-developed test for regular progress monitoring of HIV infections to be mass produced and had previously chosen teamtechnik on two occasions. The company's TEAMED platform family has been specially developed for the production of medical technology and pharmaceutical products. All TEAMED production system platforms enable demanding processes to be integrated right up to 100% end-of-line testing. They are thus not only suitable for medical technology products in general but in particular are ideal for the highly sensitive field of POC diagnostics products.

The TEAMED platform strategy
TEAMED platforms – from proof-of-principle systems and standalone solutions to series with linear or rotary transfer systems – enable production in conformity with all the guidelines and monitoring systems applicable worldwide, such as cGMP, FDA and CE and is designed for clean room class 6. The special feature of the platform is that processes from prototype production can be transferred directly into series production without frictional losses. Volker Patz describes the benefits: "All production stages are first verified on the proof-of-principle, a simple, operator-controlled system. This also means that samples for clinical studies and product approval can be produced".

 

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A short portrait: teamtechnik Group

Based in Freiberg/Germany, teamtechnik has been developing and building intelligent and reliable automation solutions for the medical and solar technology and automotive sectors for 40 years. teamtechnik is considered an international leader in highly flexible automation technology. The senior management team has set a sales target of €150 million for the current business year. The company employs 900 people around the world. The majority of the workforce are engineers and highly qualified specialists. teamtechnik Group has 6 production sites in Germany, Poland, China and the USA.

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