Medisize Corporation will be presenting versatile solutions for plastics products in the sectors medical technology and diagnostics at the trade show Compamed in Düsseldorf, Germany, between November 16. and 19. The company, with its head office in Vantaa in Finland, will be demonstrating a wide range of products from peristaltic pumps, titration plates and mixing-injectors to complete sets for MDD-applications, for instance for eye contact rinses.
“From the initial idea to the finished product, from the design to the medical product in sterile packaging, ready to be used: We convince our customers by presenting the complete value chain. Our market and our strength are complex disposables in particular, controlled throughout by highly prioritized quality assurance according to ISO 13485 and FDA-Standards or by CGMP (current good manufacturing practice)“, emphasizes Ulrich Schmid, Business Development Manager at Medisize.
The company has five production centers worldwide – Finland, the Republic of Ireland, The Netherlands, Switzerland and the Czech Republic – providing state-of-the-art clean room facilities and concentrating on four market segments: medical & diagnostic devices, drug delivery devices, primary pharmaceutical packaging, and airway management.
In discussions with the experts at the trade fair, visitors can obtain information about the latest Medisize products or discuss ideas and their feasibility. Ulrich Schmid: “In the field of medical technology, we encourage discussions of design and functionality with our customers, based on partnership. We can create product prototypes in our in-house mould making facility in Finland. The project will enter the injection moulding process and on to assembly only when everything is perfect and to the customer’s full satisfaction – in clean-room conditions class 7/8.“
Among other exhibits, Medisize will show a peristaltic pump, where a tube is being actuated by contraction, to inject, for instance, a contrast medium into a patient’s vein. The material used for the pump casing is polycarbonate, the material for the tube is PVC. The peristaltic pump is a typical medical technology Medisize product where the entire industrialization process takes place within the company, that is from the prototype right through to the injection molded and ultra sound hermetically sealed pump.
Each project is under the control of an independent project manager. Other exhibits shown include a bone cement mixing gun with a plastic attachment for either this device or various transfer systems, offered as complete solutions including tube sets. In the sector disposable diagnostic devices, Medisize will exhibit a titration plate with 1536 bores for polymerase chain reaction in DNA replication (PCR). Consistent fluorescence of the base material has to be guaranteed here. Other important factors are the heatability of the plate at a high stability rate as well as an accuracy in the lower range of one hundreds of a millimeter.
“These characteristics, as sought by the customer, have been developed specifically for this product. That is what gives Medisize its unique market positioning, as we predominantly offer tailor-made solutions“, reiterates Ulrich Schmid. In the sector diagnostics, Medisize also produces reaction tubes to be used, for example, for blood tests and single-direction sets for point of care diagnostics. A strong research and development department and several Business Development Managers in the Medical & Diagnostic Devices division emphasize the high ranking of this sector within the entire organization.
Quality control and quality assurance are of essential importance with products in the medical technology field: Medisize has the appropriate in-house control facilities to check and test all products and also uses cytotoxicity tests, bioburden testing, LAL or risk analysis through FMEA. Validation of the processes follows DQ-, IQ-, OQ- und PQ procedures.
The wide variety of Medisize products is demonstrated by further exhibits at Compamed: For example, an assembly device for hip replacement procedures using a specific high temperature tolerant polyetherimide (PEI). In addition, a cutting template has been produced for cochlear implant operations using thermoplastic elastomers approved for medical technology applications.
