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.
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
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.
Reality, But Augmented
Fortunately for medical device manufacturers, augmented reality provides an effective (and cost-effective) way forward: a technology solution that directly addresses the consistency, quality, and customization challenges facing the industry.
Augmented reality describes a broad category of systems and technologies that are designed to provide workers with the hands-on guidance needed to complete specified tasks correctly and efficiently. Unlike written or monitorbased instructions, the best augmented reality solutions provide real-time guidance with dynamic, interactive, and adaptive functionality. The classic example of augmented reality in action is one that many people are intimately familiar with: the GPS guidance that elevates a smartphone into a device that not only provides visual and sometimes verbal navigation instructions, but also delivers ongoing confirmation, confirming that the correct turns are being made and adapting when a driver temporarily veers off course.
Augmented reality uses similar principles to assist medical manufacturing professionals, utilizing a wide range of different technologies to “walk” users step-by-step through even the most complex assembly and production processes, confirming that steps have been completed correctly before allowing the user to proceed.
This “No Faults Forward” functionality works to ensure that not only are the correct parts and processes used, but also that the correct assembly sequence is followed at all times. Some innovative augmented reality systems use heads-up displays and projection systems to project a kind of digital “canvas” directly onto the work surface or work space. This virtual overlay makes it possible to provide direct and highly precise color-coded visual guidance with audio prompts, pacing, sequencing, and direction. (See Figure 3)
In a medical manufacturing environment, where precision is so critically important, the visual guidance and instruction of augmented reality can be enhanced with sophisticated sensors and tools, such as machine vision cameras. The high level of detail and precision that these tools provide makes augmented reality systems the ideal solution for manufacturing products and processes with exceptionally tight tolerances.
At a time when medical devices are becoming more complex, the flexibility and customizable capabilities of augmented reality manufacturing solutions is another appealing aspect of the technology. The best systems are highly flexible and completely programmable, designed to accommodate a range of custom preset programs that can be cycled through with the push of a button or the scan of a bar code. That rapid and easy reconfiguration to allow for different processes and products is much more than a convenience. It is a level of functionality that can translate to potentially dramatic savings in both time and money.
A Custom Tech Solution
The exciting potential for augmented reality in the medical manufacturing space is underscored by the ways in which the new technology directly addresses the primary challenges facing the industry—risk, complexity, customization, and cost—while successfully satisfying the top priorities of medical manufacturing professionals.
- Standardizes manual processes,
- Automatically measures and confirms that critical steps are correct and complete,
- Improves medical device manufacturing outcomes by allowing for greater flexibility in manufacturing/assembly without added risk for error, and
- Reduces risk for critical timelines and project goals.
- Projects visual information about processes (timing, alerts, next steps, process tips, and reminders),
- Connects with existing systems and tools,
- Removes the need for written work instructions and keeps eyes on the task at hand, and
- Mobility and flexibility, the system can be moved throughout various locations.
- New associates can self-train on manual processes,
- Easily programmed for various applications, and
- Allows highly qualified personnel to take on more complex tasks and work on more technical science.
The training and tracking benefits of augmented reality are a significant and sometimes underappreciated benefit. The same solutions that can have a dramatic positive effect on the manufacturing floor can also be utilized effectively as a tool for inspection, training, and logistics support. The ability to create digital “birth certificates” enhances traceability, ensuring that detailed process data is gathered for every individual build cycle.
Metrics such as cycle time and other critical information are gathered and stored for analysis. This detailed tracking, feedback, and reporting can be used to identify bottlenecks, resolve challenges, and facilitate procedural refinements and strategic improvements.
Augmented reality clearly demonstrates that getting it right the first time saves time and money over traditional quality control and inspections infrastructure. Even the most robust inspection protocols are never 100 percent effective, and experienced medical manufacturing professionals know that you cannot “inspect in” higher quality. Medical manufacturers are understandably more inclined to invest in technology solutions that that help them to get it right the first time, rather than identify and correct mistakes after the fact.
As new demands and new regulations continue to impact the medical device manufacturing industry, the ability to streamline and virtually error-proof medical device-specific manual assembly and manufacturing processes is becoming increasingly critical. New augmented reality systems and solutions are setting a new standard for innovation, efficiency, and consistent quality.
The result is improved medical device manufacturing outcomes: safer, higher-quality products that have been manufactured more efficiently and cost-effectively, with more innovation and reduced liability and exposure for medical device manufacturers. For industry professionals, that describes a reality that is not just improved, but augmented.
This article was written by Paul Ryznar, Founder, President, and Chief Executive Officer, who created the Light Guide Systems, OPS Solutions, Novi, MI. For more information, Click Here .