There is one material used with ubiquity across the pharmaceutical industry. In one way or another, it enables nearly every drug treatment given today. It has become so fundamental to medicine, that it is treated in a vast number of cases as part of the medicine itself. It is used because of a well-understood and repeated safety record, and because it enables high-volume, reliable, and repeatable manufacture, and is made from a commonly extracted raw material.
It is, of course, the range of synthetic materials called plastics. Yet despite being easy to work with, and to make safe for medical use, it is difficult to manage at the end of its life, doubly so for drug contaminated medical devices typically made from the higher-performing end of the plastic spectrum.
At end of life, plastic medical waste is either sent to landfill or incinerated. It is vanishingly rare for recycling to be considered.
Combination products, capitalised in the case of the FDA term ‘Combination Product’, consist of a device element and a drug element, which combine to provide the necessary efficacy – the drug formulation is designed to work with the device, and vice versa. Intrinsically, they are proven and regulated in combination.
Ideally, the often-plastic device element would be designed based on circular design principles, to eliminate waste and pollution, circulate products and materials (at their highest value), and regenerate nature, as defined by the Ellen MacArthur Foundation. Circular design in practice is typically achieved by design for device reuse or full recyclability. However, this switch does not come without possible impacts on usability, and therefore efficacy, and is currently not compatible at scale with the end-of-life disposal that is required today.
The environmental impact of plastic is also an important consideration for devices which are on sale today, or are soon to become marketed products, where expensive and time-consuming development work is already complete. Circular design should be pursued, but it cannot deliver an instant impact.
What we are left to work with then, is the plastic materials themselves. Even better if we can remove the dependence on the extraction of oil and gas for their production.
Vectura’s Open Inhale Close (OIC) device is a good working example of the device element of a combination product. It has been developed with ease-of-use (to help patient compliance), and therefore medical efficacy in the hands of patients, at the core of its design philosophy. The OIC, therefore, makes great use of a small number of robust injection-moulded plastic components, and with conventional end-of-life considerations. The OIC Device has a significantly lower component count than other blister-based open-inhale-close DPI devices, including devices for which it was designed to be a substitutable generic device.
