Chemical characterisation is used to assess the safety or biocompatibility of a medical device, usually though in vivo tests. This test looks at whether device components or extracts from the device have the capacity to cause irritation, damage or toxicity through leaching in a biological system.
Material characterisation refers to identifying all the component materials of a device. For example, this can include plasticizers, colourants, metals or ceramics. Mechanical or performance tests are usually used to determine how the material make up of components function in use. This identifies any compositional changes due to fatigue, processing or in some cases accelerated ageing.
Both methods are fundamental to accurately carrying out a successful medical device characterisation project but shouldn’t be set apart. They both offer a fantastic insight into the characteristics, performance and life cycle of a device. However, there is more to medical device characterisation than just these two methods. At HD we don’t focus on one area of the device during a characterisation project, instead we look at the device in its entirety, evaluating all aspects: chemical, material, design, fit, form & function.
The first step in device characterisation is simply to understand the device and how it works! Walk through the user steps from the IFU (Instructions for Use) and become accustom to how the device operates, understanding the functionality and identifying the critical features. It is important to identify the physical features of the device and how the individual components interact with each other, looking for snap fits, running fits, clips, threads, living hinges etc. stripping down the device into its individual components, then building it back up again is always a great way to help understand the function and the anatomy of the device.
Once there is an understanding of how the device physically functions, then the chemical / material characterisation section of the project can be kicked off. Correctly identifying the specific polymers or other materials used in the device is extremely important when trying to replicate the characteristics of the clips and fits etc. Having this material knowledge is a huge time saver and a key part of a characterisation project!
Next step, Measurement of components…
For all other Characterisation articles, please click the below links:
Discover how Haughton Design's diverse team leverages their extensive experience to drive innovation in device development. Learn about our expertise and unique insights that ensure successful project...
Explore how commercial constraints influence innovation in businesses. Discover whether budget limits, regulations, and market pressures drive creativity or stifle progress in today's competitive land...
HD strive to foster effective collaboration on all projects to push boundaries in innovation. We discuss how collaboration with the NHS can provide unique insight....
Why do we trust the accuracy of digital devices more than their non-digital counterparts? HD discuss the 'why' and how this improves device development....
We discuss the whether the medical device industry can embrace paper as a viable alternative to plastic as we advance towards Net Zero....
What is the impact of emerging technologies on medical device and product development? Design Engineer, Dan Kirkham, discusses their applications....
We discuss transforming medical device development through the utilisation of interdisciplinary, and cross industry teams....
A pharmaceutical company approached HD to enhance the performance and improve the usability of a Dry Powder Inhaler within a short timeframe and, a tight budget. ...
Pharmapack 2024 was a captivating blend of innovation, collaboration, and foresight. Read our round up of the eco-focused event here....
2023's DDL event brought together industry experts in the field of respiratory health. Here we discuss the latest breakthroughs and innovations....
Should Human Factors as a standalone discipline be made redundant? Design Engineer, Elena, considers this for medical device development?...
Can we achieve the perfect balance of usability, sustainability & connectivity in medical device design? Design Engineer, Rob, considers how....
2023's PDA & PODD conferences provided valuable insight into the drug delivery industry. Here we discuss trends and hot topics from the conferences....
Ahead of the 20th PDA Universe of Pre-Filled Syringes and Injection Devices Conference, we cover where medical device innovations are expected to go....
As the world becomes increasingly connected and user needs constantly evolving, the design of safety critical IFU’s must keep up with this. Design Engineer, Rob, discusses the future of IFU’s, and...
With the speed at which the medical device world is changing, collaborative partnerships will be essential for success. HD discuss the benefits....
