The design of a glass fibre enhanced PP compound
Designing high-performance, safe, and user-friendly medical devices involves navigating a range of complex challenges. At Unitron, we guide our customers through every stage of the product journey, from initial concept to full-scale production. One of the most decisive factors in ensuring the success and reliability of a medical device is the selection of materials. The right material choices directly impact functionality, safety, compliance, and overall product quality, making this a central focus in every project we undertake.
Since the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) in May 2021, there has been an increased emphasis on safety, demanding greater awareness and compliance throughout the development process. This shift means that the materials used in medical devices must meet increasingly stringent requirements. For our designers at Unitron, this consequently underscores the importance of selecting materials with good characteristics in flame retardancy, biocompatibility, and sustainability.
Additionally, with the upcoming trend of home healthcare devices, including wearable electronics, the importance of such suiting material for medical device enclosures, will increase.
Finding a material that meets these requirements is challenging due to the contradictive characteristics of flame retardant additives towards biocompatibility. Available materials that meet these requirements are limited. Increasing the number of alternative materials will improve design freedom, resulting in a better product for our customers.
In response to this, Unitron collaborated with two consecutive companies in the production chain: Borealis, a world-leading specialist in the development and production of high-quality medical grade polymers, and MOCOM, an expert in compounding and material optimization. The goal of this unique collaboration was to design a material specifically suited for electrical medical enclosures, offering high mechanical quality with the key features of biocompatibility and flame retardancy.
The combined effort resulted in the launch of a new glass fibre enhanced polypropylene compound, specially developed to meet the heightened requirements of the medical sector. The new injection moldable compound, named Alcom® MED PP 2020 FR WT1127-23, is based on a Borealis BormedTM polypropylene homopolymer, reinforced with 20% glass fibres to enhance stiffness and reduce molding shrinkage. The polypropylene base material benefits from the BormedTM concept, which ensures commitment to long-term availability, conformance to stringent regulatory standards, and dedicated service tailored to the healthcare industry. The compound will be available in the portfolio of MOCOM as well as through MOCOM’s distribution partner ALBIS, including medical certifications and change notifications.
The introduction of Alcom® MED PP 2020 FR WT1127-23 marks a step forward in the evolution of materials for the medical device industry. By participating in this unique collaboration, Unitron is proud to offer our designers and customers solutions that are ready to address the challenges of the future.
Following initial testing on injection-molded sample enclosures produced by our trusted partner ENBI Plastics & Silicones BV, further tests are now being performed to evaluate the material’s suitability for various use cases.
Interested to find out if this new material will suit your product? Or are you looking for a development, compliance and production partner with experience in medical device design, material selection, and design for manufacturing?
For more information or to get in touch with our team, please visit our website: www.unitron.nl or contact us by mail: sales@unitron.nl or phone: +31 (0)117 307 300
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