Designing safer, more sustainable pharmaceuticals and medical devices

Ensuring that pharmaceuticals and medical devices are both safe and sustainable is becoming an increasingly important challenge for the healthcare sector. While current regulatory frameworks primarily focus on patient safety during the use phase, less attention is often paid to safety and sustainability across the full life cycle of a product – from production to disposal. The SSbD framework offers a way to address these gaps by integrating safety and sustainability considerations already at the earliest stages of product development. 

How can the Safe and Sustainable by Design (SSbD) framework reshape safety assessments in pharma and medical devices?

The demand for new products to be safe and sustainable has increased in recent years in many industries. Despite this, current regulations for pharmaceuticals and medical devices mainly focus on the safety of products to patients during their use phase and place less importance on safety and sustainability during production and end-of-life phases.

I believe that safety for the patient extends far beyond just the use of the product. If harmful or persistent chemicals are released into the environment during production or after disposal of the products, they can end up harming humans as well – including the very patients that the regulations aim to protect. Similarly, unsustainable practices can lead to strain on the environment and, consequently, on human well-being.

As such, I believe sustainability and environmental safety are not “just” important for the environment, but also an additional aspect of patient safety that should be considered when making decisions on product design, manufacturing, use and disposal.

What are the biggest challenges in applying SSbD principles to complex medical products?

The Safe and Sustainable by Design (SSbD) framework is a useful approach for addressing safety and sustainability of new products early in the development process. One of the biggest challenges in this framework is the wide variety of expertise needed to apply it, thus requiring good communication and collaboration skills between researchers performing life cycle assessments (LCA), toxicologists evaluating human and environmental safety, and experts ensuring that the products also perform effectively within their field of application.

Additionally, striking a balance between sustainability, safety and efficacy of the products is a difficult task, since the current solutions to address these three aspects can sometimes lie in contrast to one another.

What future trends will most influence sustainable safety assessment in healthcare?

There are many exciting scientific developments taking place in this area. One important trend is the increasing use of computational tools, such as predictive models. We work with these approaches early in the development of new products to make informed decisions about the production, use and disposal of new materials before they are even created.

This allows safety and sustainability considerations to be integrated at an early stage and enables more informed decision-making during product development.

My favourite thing about working with safety and sustainability

We are currently working on several research projects aiming to develop novel and improved methods for addressing safety and sustainability criteria in various industrial applications. This has led to strong collaborations between experts in computer science, toxicology, chemistry, materials engineering and life cycle assessment at RISE and across industrial and academic partners within various research projects.