Interaction between system planning and product optimisation enables 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. However, transfer of newly developed point-of-care (POC) products to automated production remains a particular challenge.
Director of mechanical engineering for medical devices at the teamtechnik Group Volker Patz recommends that the automation company be brought into the development pro-cess 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 de-termine how much the subsequent mass production will cost."
teamtechnik 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 optimisation, the precision assembly processes and functional testing necessary for POC diagnostics prod-ucts can be realised cost-effectively and on time. Volker Patz says: "Prototypes of a POC testing system are often devel-oped in such a way that they can be used for different sam-ples. There are thus also other design variants for which the assembly line and testing process must also be designed from the start".
Involvement of teamtechnik from an early stage also enabled Alere Technologies to move quickly from manual sample assembly to relia-ble series production. This rapid diagnosis test specialist needed an automation partner to enable a newly-developed test for regular pro-gress monitoring of human immunodeficiency virus (HIV) infections to be mass produced and had previously chosen teamtechnik on two occasions.
The company’s TEAMED platform family has been specially devel-oped for the production of medical technology and pharmaceutical products. All TEAMED production system platforms enable demand-ing processes to be integrated right up to end-of-line testing. They are not only suitable for medical technology products in general but are particularly ideal for the highly sensitive field of POC diagnostics products.
TEAMED platforms, from proof-of-principle 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 current good manufacturing practices (cGMP), Food and Drug Administration (FDA) and CE, and is designed for cleanroom 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".