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Plastic examples in medical device competence

Plastic examples in medical device competence

News 01.11.2019

During COMPAMED Spang & Brands GmbH, Friedrichsdorf, Germany, will exhibit a variety of different plastics engineering solutions for applications in medical technology, such as connectors, caps and closures with piercing membranes, implant components, and parts for minimally invasive medicine, plus components for infusions and blood reserves, as well as transition and connection systems (for instance with precisely defined predetermined breaking points or linking points). Visi-tors can see assembled systems and in-house produced complete systems with high-precision ge-ometries and features ready-to-use.

19 16 01 Steril Connector

Spang & Brands reacts consistently and quickly to the current demands of the market. Competence under one roof: Three years ago, medical device competence was bundled in the technology centre. Flat hierarchy: it improves the interdisciplinary communication, transparency, cooperation and ef-ficiency of the individual divisions, i.e. development, sales, order processing, construction, materi-als management, quality assurance/certification, toolmaking, injection moulding, assembly/clean room, dispatch and after-sales service. This was accompanied by the restructuring on the basis of three focal points: Strengthening the range of market services from product development to valida-tion, driving forward the development of proprietary products and expanding core competencies. The family business in the third generation builds its success on the advantage of medium-sized businesses and an organically grown network, in which partners in raw material producing compa-nies, in special mechanical engineering firms, in IMM manufacturers and IT companies play a tar-get-oriented role in the exchange of complementary knowledge.

In view of high initial costs of medical devices customers expect speedy product development from an all-inclusive provider in order to reach validation, clinical trials, and introduction to market. Validation is one of the overriding topics in the medical device value chain of a company such as Spang & Brands that is certified according to DIN ISO 13485. Mould making for medical devices in plastic differs fundamentally here from toolmaking in automotive and white goods sectors, for example. An injection mould has to comply with typical regulations that are common in medical technology. "Process optimisation and traceability are essential. Looking at the patient, it is important to be able to prove the origin of the individual components and the various stable process stages on the way to fault-free medical devices”, explains Friedrich Echterdiek, CEO of Spang & Brands GmbH. It is for this purpose that Spang & Brands appointed a validation officer in 2016 to work seamlessly with quality assurance and report directly to the company management. “Starting with the initial 3-D prototype or 3-D printed trial mould inserts, analysis of the prototype status leads to quicker and more flexible optimisation of the individual parts, components and assemblies – in respect of design to value and design for manufacturing and assembly”, adds Friedrich Echterdiek.

19 16 01 Nosy

Across the entire value-added chain of a medical devices specialist, Spang & Brands demonstrates ground-breaking R&D technology and, supported by a state-of-the-art tooling facility and machine park, i.e. the entire diversity of optimized plastics technological product ranges. Consequently, special plastics compounds, such as TPU, TPE, TPV, resomere materials, and polylactides are used. ‘Employing multi-component injection moulding technology our starting point is to embrace increased comfort enhanced with innovative functions and benefits based on the very latest mould-ing technologies’, emphasizes the CEO of Spang & Brands GmbH.

Spang & Brands has specialised in precision and cleanroom injection moulding technology for the medical and pharmaceutical industry for over 35 years. In addition to its own products, the company sees itself above all as a competent contract partner for customer projects. Product innovations at Spang & Brands go through all process stages - from the idea to the finished product, ready-to-use. The company ensures consistency of CAD tool data and maximum precision in CAM production of moulds for medical and pharmaceutical devices in its own technology centre. Spang & Brands has at its disposal latest equipment, as well as a team with a high level of competence and experience, which masters the technology: part development, mould design and construction, injection moulding with 70 mainly all-electric single and multi-component IMM, as well as the importance of cleanroom production. Fully automatic and manual assembly and packaging of parts and assemblies are located in cleanrooms - from pre-series or just-in-time batch sizes, extremely small series, and right up to full production running into millions of products. Strategically positioned control points and 3D measuring technology support quality assurance. The company is certified e.g. according to DIN ISO 13.485.

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