Target-oriented structure in the value-added chain for medical device production

Zweikomponenten Brechkappe (Foto: Spang & Brands) / 2-component cap with rated break point (Photo: Spang & Brands)

Zweikomponenten CUD Compule (Foto: Spang & Brands) / 2-component composite unit dose (CUD) (Photo: Spang & Brands)

2port cap – mit Dichtelement aus TPE (Foto: Spang & Brands) / 2PortCap – with TPE seal (Photo: Spang & Brands)

During Medtec, on stand G21 in hall 1, the team of Spang & Brands GmbH plastic technology for medical care is well prepared for negotiations with trade visitors who are looking for a partner specialized in all services involved in the manufacture of medical and pharmaceutical devices. Friedrich Echterdiek, CEO of the Friedrichsdorf, Germany-based company, gets to the point: “We have been active for more than 30 years in these sectors exclusively and achieve optimum solutions on the shortest possible routes, mainly due to the advantages of our new tech-nology center.”

Along the complete value-added chain of a medical device specialist, Spang & Brands is able to offer the entire diversity of products optimized in plastics – thanks to its new technology center, state-of-the-art R&D equipment, modern mould making, as well as a park of more than 60 injection moulding machines, over 30 of which are all-electric including several multi-component units. “We have the right approach, supported by CAD-3D development and MoldFlow analysis”, says Friedrich Echterdiek. Medical devices are produced and packed ready to use. With precision and cleanroom injection moulding technology the most intricate filigree components are moulded. They simply must not exceed the very tight tolerances – in the micron range. They are thus able to withstand permanent loads to guarantee purity, hygiene and safety on and in patients. Consequently, special plastics compounds, such as TPU, TPE, TPV, resomere materials or polylactides are being used. “With multicomponent injection moulding, our approach is to combine comfort with state-of-the-art functionality. We continue to focus on TPE as an alternative to polyisoprene. Here, many applications and new shaping techniques are conceivable”, emphasises Spang & Brands’ managing director.

The patients’ well-being is top priority! Functional, ergonomic, haptic, aesthetic and costworthy – these are the most important patient-oriented prerequisites. When negotiating a new medical device, the business partners must always keep an eye on these fundamentals. “Triggered by high initial costs, a swift product development process is mandatory. That is what customers expect in order to achieve validation, clinical trials and market launch as soon as possible,” emphasizes F. Echterdiek. From the first model (via rapid prototyping) and the first trial mould (possibly with 3D-printed inserts) the project analysis leads to the optimization of individual parts, components and sub-assemblies ensuring Design to Value and Design for Manufacturing and Assembly. This implies that the feasibility study must also cover scalability of a projected medical device – including its production mould(s) – from pilot series up to batches of several million units.

The wide span of “plastically engineered” medical device solutions is showcased by Spang & Brands during Medtec: syringes, hollow needles, puncturing membranes, implant parts and components for keyhole surgery, componentry for infusion and blood bags, transfer and connection systems as well as assembled componentry and ready-for-sale systems, whose geometries and characteristics (e.g. rated break points responding to twisting or breaking power) must comply with the highest demands for precision.

Final step: fully automated and manual assembly and packaging of parts and components – from pre-production to just-in-time batch sizes, from small series to million-piece batches – takes place in cleanrooms of various classifications. Validated manufacturing processes as well as strategically positioned testing stations with 3D measuring technology and visual and tactile control support quality assurance. Conformity with national and international legal regulations for medical devices are safeguarded across the entire value-added chain of a product – from its prototype to applications which benefit patients. Among several validations, the company has been certified in accordance with ISO 13.485.