At a time when the healthcare industry is undergoing profound foundational shifts and the regulatory and legislative environment continues to evolve in new directions, the stakes for the medical device manufacturing industry have never been higher. As designers and engineers work to bring innovative new concepts and lifesaving devices to market, pressure grows to ensure that manufacturing errors are reduced or eliminated and that each and every device is assembled and distributed correctly.

This combination of heightened regulatory pressures and extraordinary (and sometimes competing) demands for quality, consistency, and efficiency leads to an environment where business-as-usual is unlikely to be successful; new solutions are needed to meet new challenges. For medical device manufacturers looking to meet the demands of a growing market and produce devices with growing complexity and customization–while keeping costs and exposure to liability under control– augmented reality offers an intriguing way forward. (See Figure 1)

A handful of forward-thinking medical device manufacturers are embracing the augmented reality technology that has had a transformative impact in the automotive industry, where manufacturers and suppliers have deployed augmented reality technology to streamline processes, boost efficiencies, reduce production errors, and increase productivity.

Fig. 1 – Using projected work instructions, a technician is guided through the steps required to properly clean an endoscope.
Augmented reality is not a science fiction theory, but an effective tool that is already in place in manufacturing environments across the country and around the globe. The most efficient and effective augmented reality technologies are designed to enhance existing manufacturing and assembly processes. In lieu of a comprehensive overhaul, they ensure that manufacturing professionals follow the correct steps in the correct order, virtually eliminating many of the common issues and potential bottlenecks in manual assembly and manufacturing procedures. The concept is straightforward, but the technology’s potential is virtually unlimited.

Augmented reality provides the right information, at the right place, and at the right time. The speed, complexity, production pressures, and safety concerns that are present in the medical device manufacturing industry are familiar challenges for automotive manufacturers and assemblers, and the augmented reality solutions that have worked so well for them have the potential to transform the medical device manufacturing industry. (See Figure 2)

Costs and Consequences

Fig. 2 – A technician works on an automotive OEM headliner using augmented reality work instructions.
For medical device manufacturers, minimizing production mistakes and ensuring consistent quality is critically important. But as medical devices become more sophisticated, and the field becomes more competitive, the production pressures on the industry continue to mount. The race to market is a reality for many manufacturers, and that race becomes harder to run as logistical and consistency challenges arise in an increasingly globalized supply chain.

These pressures lead to innovation and to extraordinary advances, but they can also lead to quality control issues, safety concerns, and potential recalls. In that context, it is not particularly surprising that, despite vigilant efforts to maintain quality and reduce or eliminate avoidable errors, medical device recalls are on the rise—and the scale of that increase is alarming.

The FDA reported in 2014 that annual recalls of defective medical devices virtually doubled during the previous decade, increasing from 604 in 2003 to 1,190 in 2012. Even more troubling is the fact that Class I devices (where a faulty product confers a reasonable probability of death) experienced one of the biggest spikes.

Whether a recall is voluntary or involuntary, the results are the same for medical device manufacturers: a significant, and potentially devastating financial impact. Costs associated with recalls cost the industry an estimated $2.5 to $5 billion per year. A single major recall can carry a price tag north of half a billion dollars, a figure that can obviously have a dramatic effect on not just an individual company, but an entire industry. But those eye-opening numbers are potentially just the tip of the iceberg.

The legal, communication, and logistical expenses required to respond and recover from manufacturing errors or recalls often means that fewer resources are dedicated to research and new product development. And beyond the direct financial impact, the damages that result from negative publicity in an increasingly connected and social media-dominated world can be far more damaging than the initial exposure. The lasting damage from a significant recall can go well beyond a onetime expense or a transient drop in share prices. It can taint the brand in a way from which it is difficult (and sometimes impossible) to recover.

Medical Design Briefs Magazine

This article first appeared in the April, 2016 issue of Medical Design Briefs Magazine.

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