Engineering a path to improved patient outcomes

New manufacturing technologies and the rise of artificial intelligence (AI) are creating opportunities to better manage, diagnose and treat medical conditions and adoption of these new technologies and techniques requires good design and validation processes to ensure that final products are safe and effective for patients, according to Aengus O Curraidhin (pictured), senior medical design/development engineer at global engineering technologies company, Renishaw.

He explained: “A lot of important work goes on behind the scenes in medical device design. For instance creating design verification testing is an important part of the design phases, where engineers verify that design outputs meet design inputs and ensure the device has been designed correctly. There are numerous ways of testing devices to ensure that when used by a healthcare professional or a patient it works correctly and is safe.

“For example, with Renishaw’s neuroinfuse drug delivery system, catheters are inserted into the patient’s brain, as part of an intraparenchymal drug delivery system. This bypasses the blood brain barrier to deliver drugs directly to planned targets within the brain for the treatment of neurological conditions. At the design verification phase, there are many factors to investigate. For example, how much pressure can the line take — if the patient sneezes or if there is a blockage, will it dislodge the implant?

“These verification processes can be very interesting. Performing them involves clever planning and testing to mimic human body conditions in the laboratory. These include placing the neuroinfuse system in a water bath at 37°C during testing and/or attaching to a material that mimics bone to ensure it is fit for purpose and can withstand the conditions it is subjected to during implantation and ongoing use.”

Manufacturers are responsible
Mr O Curraidhin added: Medical devices are under constant scrutiny, and manufacturers are responsible for ensuring that the design is correct and clinical trials are performed sufficiently to safeguard patients and avoid the risk of recalls or legal action. The industry is embracing improved technologies to ensure manufacturers can do this more effectively and safeguard end users and will continue to do so.

“Improvements in manufacturing methods can also help design engineers to create devices that are smaller and more intricate than those currently available. For example, micromachining technology that can do milling and turning on the micrometer scale, and the rise of companies that specialise in small components, will help accelerate the production of minimally invasive devices.

“Many medical devices come in either one size fits all, or standard sizes (typically small, medium and large), but manufacturing technology, such as additive manufacturing, can help designers and manufacturers to produce customised implants. The added design freedom that 3-D printing provides will enable design engineers to make devices with complex geometries that are an exact match to a patient’s anatomy.”

Historically, metal AM has been prohibitively expensive for smaller medical device firms, but as the costs come down and machines get more sophisticated, its use is likely to expand. With 3-D printing technology, medical device manufacturers will not only be able to make mass customised implants. For example, hospitals may be able to integrate equipment on site to rapidly make patient-specific prosthetics and prostheses that fit patients better.

Mr Mr O Curraidhin continued: “As AI becomes more integrated into people’s everyday lives, I am excited to see where it can assist in the MedTech sector. Researchers are investigating the possibility of AI simulations of the human body, which would enable us to test a medical device virtually before it is implanted into a human during clinical trials. This approach could reduce risk to patients and help influence design engineers to produce better devices more efficiently. AI may also be able to simulate some elements of clinical trials. While I do not see AI replacing clinical trials, they could be an added source of data that helps streamline the process and reduce costs.

“It is certainly an exciting time to be involved in medical device design. As AI becomes more sophisticated, new manufacturing techniques come to market and design engineers bring forth new ideas. The sector is one of huge opportunity, and it is exciting to work for a company that is at the forefront of innovation.”