The effect of changing patient requirements on manufacturing the latest medical devices

The effect of changing patient requirements on manufacturing the latest medical devices

9th September 2020

It is no secret that healthcare is constantly evolving. The need for enhanced equipment, coupled with an increasingly diverse range of patient requirements, is having a significant impact on the processes involved in producing the latest generation of medical devices.

For companies like LTi Metaltech – which manufactures and supplies critical components used in Siemens MRI scanners – quality assurance is an essential part of meeting both patient and customer requirements.

In 2019, it was estimated that there were some 50 000 examples of medical technologies[1] in hospitals across Europe, ranging from everyday items such as plasters and screening tests through to full-body MRI scanners. And within the UK, the NHS treated some one million patients every 36 hours[2].

The devices in NHS and private hospitals use nowadays are vastly different to those seen 15 years ago. Whether that is driven by a need for greater patient comfort or improving diagnosis, there’s no doubt that the landscape of healthcare has transformed.

 

Technology has certainly played a key role in this. For instance, modern MRI devices have been proven to provide clearer imaging, thereby improving diagnosis, and ensuring a patient receives the right course of treatment. However, technology has also had an influence in device production.

Close review and continuous evaluation are essential throughout the design process of any medical device, but especially those which operate under extreme working conditions. Identifying areas which can be strengthened at the earliest possible opportunity maintains device integrity and patient safety, and this has been made possible largely due to technology such as 3D modelling and computer-aided design (CAD).

Software innovations also have the potential to demonstrate how devices such as MRI scanners operate in accordance with demand. It’s well-documented that hospitals are always looking to reduce waiting times and improve accessibility; enabling these settings to know exactly how many patients per day the equipment can handle allows for efficient management of personnel and assessing priorities, therefore more urgent cases are moved towards the top of the list.

However, the supply chain needs to stay one step ahead. It is no longer enough to simply put equipment together and distribute; healthcare settings are looking at other means of value, not least saving time and money.

This change can be demonstrated on the factory floor. We as fabricators are keen to deliver outputs in a lean and efficient manner, without a heavy cost or having to repeat a procedure unnecessarily. Consequently, selecting a material which is straightforward to manufacture using our existing machining capabilities removes the need for repeated processes and provides the end user with a product designed for both safety and longevity.

What happens after the finished product is delivered and installed is just as important as its construction. According to a report by KPMG, evaluating the medical device market through to 2030[3], device manufacturers are being called upon more regularly to include preventative maintenance to ensure optimum working order and in conjunction, strengthening their processes for maximum efficiency. These, and other factors, all tie in with the need to deliver person-centric, holistic care.

Although the medical device world is constantly shifting, there is one attribute which remains constant – quality. And it is here that the manufacturing of vital components has perhaps seen the greatest adaptation.

The aforementioned software is now routinely being used in conjunction with cloud-based programmes. This is the result of quality starting to become embedded into the physical processes of manufacturing a device, but it is only through a company-wide culture of safety and meeting the strictest standards that a fabricator truly outlines its credentials.

Quality regulations within the European Union have been tightened considerably in recent years. This is expected to reshape the device landscape again over the coming months and years, putting the onus on suppliers and their own supply chain to innovate.

Everyone involved in the timeline of bringing next-generation equipment to market should have quality and patient security at the front of their minds. Starting with the design and fabrication, clear processes should always be outlined and followed to the letter, taking accreditation marks such as ISO 9001 as the minimum standard to meet.

And it is not just on the factory floor where there should be quality-driven mindset. It is throughout the entire corporation, from the top rung of the ladder to the bottom. By driving home the importance of quality and precision at all levels, these aspects will naturally transfer into the final product.

Regardless of whatever innovation or change in requirements, the patient always takes priority. As the first in the supply chain, it is vital manufacturers stay one step ahead to set the standard for delivering consistency and quality, for the benefit of hospital and patient alike.

 

[1] https://www.medtecheurope.org/wp-content/uploads/2019/04/The-European-Medical-Technology-Industry-in-figures-2019-1.pdf

[2] https://www.pharmaceutical-technology.com/sponsored/uk-healthcare-industry-analysis-2019/

[3] https://assets.kpmg/content/dam/kpmg/cn/pdf/en/2018/04/medical-devices-2030.pdf