Artificial intelligence (AI) and machining learning (ML) are increasingly being utilised across many sectors in Industry 4.0, and the medical device field is no different. AI and ML can be used to provide valuable feedback to improve the development of medical devices, as well as change the way that patient’s data is analysed, both for the benefit of the patient themselves and possible clinical trials.
The prevalence of AI and ML in the medical device field has become so prevalent that in 2019 the FDA published its “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”. This paper discusses the potential approach to premarket review for AI and ML software modifications. Furthermore, remote monitoring medical devices are one of the fastest-growing corners of the medical device market, and these are the devices providing patient data.
Data collection is the foundation of AI and ML, and without reliability collected, rich data, neither are possible. This demand for data collection has put the pressure on medical device manufacturers to design and develop devices that provide continuous feedback on the well-being of the patient and the status of the device itself. In addition to AI and ML software, there is another essential component in this process: the medical wire.
Medical wire is responsible for sensing and transmitting data within the human body. Without a medical wire component that has been calibrated to work efficiently for the application, whether it be glucose monitoring or heart rate monitoring, the collection and subsequent transmission of important data is not possible.
According to Gary Davies, manager at Sandvik Materials Technology’s business unit for medical wire manufacturing: “A lot of devices now are trying to incorporate a lot of different functionality into these composite wire-based products, and I think the next step for the next evolution is really going to make these wires smarter and there will be far more sensory-type based device.”
When it comes to sensing devices, a widely used application is remote monitoring, which enables patients and healthcare workers to monitor their health and the efficiency of their device without performing checks or visiting a hospital or clinic. Sensing devices send data to a computer or mobile device where it can be stored or analysed, and in many cases can even set up automated health alerts if the readings fall outside of pre-set healthy parameters.
For these automated alerts and data analysis to be effective, medical devices need optimised medical wire. As a trusted supplier of steel and metal alloys, the ultra-fine medical wire branded EXERA from Sandvik has been trusted by manufacturers for the development of a range of products and applications, including vascular therapy, sensing and neurostimulation, continuous glucose monitors, cochlear implants and pacemaker leads.
With more than 200 alloys and an extensive range of customisations such as coiling and polymer-coated coatings, medical device manufacturers have worked with Sandvik to create devices that safely monitor a patient’s health and collect data to track medical device performance. Download the Sandvik whitepaper below to find out more about their range of metal materials and coatings.