Joanne Belshaw, business development manager healthcare at ALBIS, explains how to maximise project team potential by leveraging plastic supplier’s support.
ALBIS
Project Management, with its emphasis on efficiency and value addition, demands meticulous planning and resource optimisation. Nowhere is this more apparent than in the healthcare industry, where stringent regulations and exhaustive testing protocols dictate material choices, constraining flexibility and options for adaptation.
In this intricate landscape, the roles of plastic suppliers extend far beyond mere material provision. They serve as essential partners in innovation, design, and function, ensuring that every component aligns with project objectives and industry standards. Moreover, they can play a pivotal role in quality assurance, production optimisation, cost management, and navigating the maze of regulatory compliance.
Innovation, design & function
Plastic suppliers often have technical specialists that can advise options to meet design and function requirements. Whether that is living hinges, jointing options, materials for complex shapes or providing surface functions like laser marking or embossing, aesthetics and haptics. As well as in-use considerations like chemical resistance and sterilisation. Engaging with suppliers early in the design process can avoid the complex task of solving issues down the road, saving time and money.
Quality assurance
In the medical and pharmaceutical industries, stringent control is required over both materials and suppliers. Medical grade plastics come with support packages, including consistency of formulation, change notifications, single-site sourcing, medical compliance statements and Drug Master Files (DMFs). However, the specifics of these packages vary among polymer manufacturers. Some offer healthcare specific quality agreements that are not available with standard materials. While the VDI guideline helps standardise this process, it is not a prerequisite for using the term 'medical grade'. Therefore, before delving too deeply into a project, it is advisable to discuss the support packages for the materials under consideration with the suppliers to ensure alignment with regulatory requirements and project objectives.
Production
Sometimes a new medical application is difficult to transfer into production. Especially if moulding is done by a different company to that of the design and development team. Suppliers usually have technical support functions that can assist converters with processing and help identify issues with materials or tool design to resolve any conversion problems. However, discussing earlier could potentially avoid the issues in the first place.
Cost
As commercialisation is often years ahead, feasibility pricing is normally used at the start of the project. Healthcare projects are often small volumes, so it is worth discussing with suppliers options to minimise the cost – for example, looking at an available colour to avoid development costs and the higher price of a small volume bespoke colour.
Availability
COVID and global conflicts have shown how supply chains can be easily disrupted. It is worth considering at an early stage in material choice, where production could be now and in the future. Some materials are available globally, some have regional equivalents and some are only sold in specific regions. Discussion early on helps clarify this, thus assisting material selection.
Regulations
Knowing the regulatory status of a material can be critical to a project. Food contact can assist with some pharma applications whilst European Pharmacopoeia would reduce testing. Grades with USP class VI, parts of ISO 10993 and DMF exist but statements are not always easily found. Upfront discussion with suppliers helps clarify material compliance and availability of supporting documentation.
Risk management (materials)
Most plastics manufacturers have a medical policy that outlines accepted applications and those for which they do not wish their products to be used, or for which a decision will only be made after assessment. Initiating work on a material without discussing the manufacturer's risk management policy could result in wasted time and effort on a material that the manufacturer does not support. Quality and regulatory information may be withheld until a risk assessment has been completed. ALBIS has observed an increase in requests from notified bodies for proof that the application has been approved by the supplier.
Sustainability
While other industries have successfully integrated mechanically recycled products, the healthcare sector, faces unique challenges in doing so due to traceability, NIAS and lack of the medical support package. However biobased alternatives to fossil-based monomers are now widely used, with medical grades included in many producers’ portfolios. Although this doesn’t reduce the plastic waste it reduces carbon footprint and has no impact on the recyclability of the article or its end-of-life options (e.g. take back schemes). Additionally, these drop-in solutions relate to a “change” in how monomers are produced. This means there is no change in the polymers (specification or processing), which makes the type of change easier to get through regulatory barriers.
Chemical recycling of polymers is coming and will remove most of the obstacles of mechanical recycling whilst actively reducing plastics heading for landfill or incineration. Where these options don’t suit, the choice of material will still influence the environmental impact of the finished product. Therefore, suppliers can help find the right materials for the task including consideration of the best LCA data whether virgin, mechanically recycled (rarely suitable), biobased or selecting a material that could later come from chemically recycled product.
Summary
Many companies manage extensive project teams navigating industry complexities. Often material selection begins before engaging a plastics supplier, bringing them in only when a sample is required. While preliminary research is beneficial, solely involving suppliers at a late stage overlooks their valuable resources, material expertise, and partnership potential. Collaborating from an early stage enables project teams to leverage supplier knowledge, ensuring the selection of the most appropriate polymer solution for the project's specific requirements.