Medical device design and manufacturing is a balancing act between improved patient outcomes and the cost of development, with the scale leaning toward patient health and safety. Over the last few years, innovations in manufacturing have made volume electronics more cost-effective. This trend enables critical advancements in medical device development, resulting in products that allow healthcare professionals to improve safety and quality control while making patient care more flexible.

Advances in designing and engineering complex electromechanical and robotic assembly and test systems are primary drivers of cost-effective electronics manufacturing. Not only does manufacturing automation help lower costs, but it can also improve quality and reliability by removing the possibility of human error in high-precision or repetitive processes.

In addition to automation, electronics miniaturization has a significant effect on the cost of producing medical devices. Top-of-the-line electronic design and manufacturing firms have developed new engineering and production processes to create high-density interconnect circuit topologies in high-layer count boards. This manufacturing method can create the smallest total electronics packages available, allowing user comfort to drive device design in medical devices.

The reduction in electronic manufacturing costs drives two trends improving patient care: sophisticated single-use devices and medical device consumables. Up until a few years ago, the cost of electronic manufacturing at volume made reusable devices the more feasible approach. But today, these types of one-time-use technologies are in high demand because they are more affordable, help healthcare professionals meet strict regulations, and offer improved patient outcomes.

Single-Use Devices

Some of the most popular single-use devices are endoscopes and guides used in laparoscopy, arthroscopy, laryngoscopy, colonoscopy, and other gastrointestinal procedures. Up until recently, these devices were designed to be reusable. There are multiple reasons for this, but one of the main reasons is the simple fact that optics development has been far too costly.

In addition to process automation, a significant force enabling single-use devices is improvements in complementary metal-oxide-semiconductor (CMOS) and light-emitting diode (LED) technology. The development of these technologies has fundamentally changed how manufacturers design camera technology, revolutionizing the optics industry by allowing significant reductions in devices’ size and weight.

Medical Device Consumables

Medical device consumables are single-use components, such as a lab-on-chip consumable, used in conjunction with a reusable platform. This technology is found in various applications, including in-vitro diagnostic (IVD) platforms, blood glucose monitoring tools, ambulatory systems, and clinical wearables.

Meeting the demand for medical device consumables is more challenging because the electronics involved in these applications are complex and often require repeatable, high-precision assembly. Medical device consumable manufacturers can benefit considerably from automated manufacturing and test platforms to solve this challenge. Automation in medical device consumables helps meet high-volume production needs while managing costs effectively and ensuring quality.

Benefits of Traceability

One-time-use devices significantly improve traceability and quality control for both manufacturers and healthcare professionals while enhancing patient safety. When a device can only be used on a single patient, it is far easier to identify a bad product or a bad batch of products and remove them from use. With reusable devices, it’s much harder to manage and identify a problematic device when it has been in rotation for a long time.

Consider the example of single-use versus reusable endoscopes and guides. The cost for single-use devices is slightly higher up front; however, the cleaning and sanitizing process for reusable devices is very resource-intensive and creates waste by-products. Both reusable and single-use medical devices must be safe and effective by design. While there is always a risk for infection during any operation, the medical community is interested in investigating whether single-use devices reduce infection risk.

Improving patient outcomes and reducing healthcare costs are the main goals when developing any new medical technology. Significant advancements in manufacturing automation and electronics miniaturization make this possible by enabling single-use devices at reasonable costs. These technologies will never wholly replace reusable devices, but it’s clear they constitute a significant trend among the leading medical device manufacturers and healthcare professionals.

This article was written by Dan Johns, Director of Design Engineering, Benchmark, Tempe, AZ. For more information, visit here .


Medical Design Briefs Magazine

This article first appeared in the August, 2021 issue of Medical Design Briefs Magazine.

Read more articles from this issue here.

Read more articles from the archives here.