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For decades, PCBs have used essentially the same configurations to serve the internet application needs of big tech companies. Whether supporting a search engine like Google or an email application such as Microsoft Outlook, traditionally designed and assembled PCBs have been sufficient. Now, however, the increasing reliance on AI is rapidly driving new requirements for PCBs, including the need for new types of components. Designing boards advanced enough to keep up with the demands of AI technology—AI PCB design—is redefining electronics manufacturing.

How AI is Driving Changes in Computer Design

Gordon Moore first posited his famous law in 1965, then updated it ten years later. Since then, Moore’s Law—that the number of transistors in an integrated circuit (IC) doubles about every two years—has been the most famous (if not most important) truism driving the electronics industry. AI is about to change that.

Manufacturers who understand the unique challenges of AI PCB design, as well as appropriate solutions, will be better prepared to ride the AI wave.

According to OpenAI, the amount of computing power—aka “compute”—used for training the largest AI models has been increasing exponentially since 2012, growing 10-fold every year compared to the doubling of chip transistors every two years per Moore’s Law.

This rapid growth is making AI models smarter, but it also requires more energy and resources, posing challenges for sustainability and infrastructure. For example, one ChatGPT query, on average, takes 10 times the electricity to process as a Google search. And while traditionally a single server was sufficient for AI tasks, modern AI applications require global data centers. In fact, by 2026, AI operations could consume over 40% of global data center power, according to Deloitte.

 “AI’s transformational potential is analogous to paradigm-shifting technologies like the advent of the internet or the mobile phone, and it has the potential to touch every sector of global industry,” according to a 2023 U.S. Data Center Market Overview by Newmark.

So, what does this AI revolution mean for electronics manufacturers? A lot. PCBs are at the heart of AI hardware, providing the platform that integrates the various components essential for AI systems—processors, memory modules, sensors, and interfaces. Therefore, PCB designers play a crucial role in tailoring the layouts of these boards to meet the specific requirements of AI applications in terms of scalability, efficiency, and performance. Manufacturers whose designers understand the unique challenges of AI PCB design, as well as appropriate solutions, will be better prepared to ride the AI wave.

Challenges in AI PCB Design

A PCB designed to meet the needs of AI will be substantially different from a traditional PCB. AI-focused PCBs are more complex and need to be able to handle more: more component density, more layers (to accommodate dense routing), more data being processed, more frequency, etc. All this complexity creates significant challenges, requiring engineers to design architectures that optimize power consumption while also accounting for heat dissipation, signal integrity, and other factors.

High Density and Complexity

A PCB built for AI applications is more complex and denser than traditional PCBs. It is also likely to have a much higher layer count to allow for more intricate designs and the ability to include more components.

High-Frequency Requirements

To enable rapid data transfer and processing, AI applications often operate at frequencies above 1 GHz. PCBs designed for AI apps must therefore be able to handle high-frequency signals with minimal loss and distortion.

Thermal Management

The high performance requirements and massive data processing of AI applications generate a lot of heat. Properly managing this heat is critical to the performance, reliability, and lifespan of the PCB and its individual components.

Rapidly Advancing Technology

The exponential growth of AI is creating a large demand for PCBs capable of meeting the technology’s requirements. At the same time, manufacturers are scrambling to keep up with the latest AI standards and technologies. This constant need for innovation, combined with the demand for large-scale production, requires product manufacturers to creatively balance product quality and cost efficiency.

Given the engineering and production demands of rapidly advancing AI technologies, what are some ways that product manufacturers can meet these challenges? Here are five best practices to keep in mind when it comes to AI PCB design.

Choose Components Carefully

Be selective in choosing the components to include on AI PCBs, since they determine the functionality and performance of the board. AI algorithms have unique demands, requiring high-performance computing, large data storage, and accurate data acquisition. This is why, as AI hardware has evolved, new components have been developed to meet this technology’s demands, like the accelerator chips that are essential for carrying out the autonomous processes that AI applications rely on.

Unfortunately, there is only so much room on a board. One creative solution to this problem of limited space has been to repurpose existing components. Silicon Valley chipmaker Nvidia, for example, has found that the graphics processing units (GPUs) it developed to render graphics in video games is well suited to the demands of AI.

A close-up of Google’s proprietary AI chip on a stylized circuit board
Google’s proprietary AI chips allow for greater customization.

While computer manufacturers have relied for nearly 50 years on the central processing unit (CPU)—a single, do-it-all chip—it turns out that GPUs are better for AI tasks. Why? A GPU outshines the jack-of-all-trades CPU in performing the simple math that powers the neural networks of AI. In the time it takes a CPU to do a single calculation, a GPU can perform thousands, allowing AI’s neural networks—the basis of chatbots and other AI technology—to analyze significantly more data. By running millions of calculations, they allow a computer to “think” about a problem rather than just calculate simple data.

Joining GPUs, CPUs, and memory chips on the board are sensors and application-specific integrated circuits (ASICs). Unlike the more general-purpose CPU and GPU chips, ASICs are custom designed for a specific application. For example, a smartphone might use an ASIC chip for power management tasks such as battery charging control, display backlight regulation, and power distribution.

With the demands of AI making the PCB ever more crowded, manufacturers should choose the most efficient components for specific tasks. Likewise, careful component selection early in the design phase, a long-established design for manufacturability (DFM) best practice, will make it easier, more efficient, and less expensive to manufacture a board.

Address Thermal Management

Due to intense computational demands and power consumption, AI hardware generates significant heat. Therefore, it’s imperative to design a thermal management system to dissipate heat effectively and quickly. Failure to do so can lead to solder joint failure, delamination, and thermal runaway—a self-reinforcing cycle where components draw more current as they heat up.

Thermal runaway poses significant safety concerns, especially in applications like electric vehicles, consumer electronics, and energy storage systems. For example, if cooling fails in an electric vehicle, localized overheating may cause a sensor failure—resulting in a crash, and possibly a fatality.

One way to address overheating is with proper materials. The most common material used for PCBs is FR-4, a composite of woven glass fabric and epoxy resin. While FR-4 offers dielectric strength and good mechanical properties, and has traditionally been adequate for most applications, it’s not as effective for the high-frequency operations required by advanced AI applications. This has led to the increasing use of a different type of board. Metal Core PCBs (MCPCBs), which use metal substrates, dissipate heat more effectively than traditional FR-4 boards.

Of course, PCBs don’t operate in isolation—they are part of a computing environment that includes external methods for controlling heat, such as fans, heat sinks, thermal pads, and liquid cooling. Therefore, PCB designers need to account for the end application, i.e., make allowances for the ambient temperature and airflow of the environment where the PCB will eventually operate.

Use Rapid Prototyping

Another way to meet the challenges of AI is through rapid prototyping. AI engineers need to experiment with different designs and repeatedly test their AI algorithms, and time is of the essence. Through rapid prototyping, manufacturers can achieve the quick turnaround time for board design and development that AI demands.

Traditionally, it could take weeks or months to design a PCB, test it, adjust it, and then reprint it for validation. Now that process can be completed in days. By drastically reducing the time from concept to functional prototype, rapid prototyping allows manufacturers to more efficiently and economically produce PCBs.

Improve Signal Integrity

AI systems rely on chips that process huge amounts of data at lightning-fast speeds. Because of this, it’s essential to design boards that facilitate clean signals. Here are four ways to ensure high signal integrity on PCBs.

Optimal Trace Design

Designing a PCB trace to maintain signal integrity is much like designing a freeway. Just as a gentle curve on a road allows for smooth traffic, especially at high speeds, gentle bends in a PCB trace will allow for better signal flow. Therefore, sharp 90-degree bends in traces are discouraged when designing for high-speed and high-frequency applications. A more gradual bend of 135 degrees, or even an arced curve, will enable a smooth transition.

Shielding

Just as noise-canceling headphones can protect your listening experience, a good PCB design can protect signals from outside interference. Surrounding signals with a special metal layer, a technique known as shielding, keeps signals clean and protected from electric noise.

Termination

In the same way that bowlers want to keep bowling balls from bouncing back down the alley, PCB designers want to prevent signals from bouncing back at the end of their paths. Bowling alleys use pit cushions to prevent bounceback; a good PCB design employs the appropriate resistors to absorb signal energy.

Filtering

Filtering is just what it sounds like—dampening unwanted parts of a signal, much in the same way a water filter removes impurities. In board design, this means placing the right components, such as capacitors and inductors, strategically near noise sources or sensitive areas, thereby suppressing interference before it spreads across the board.

Optimize PCB Layout

Another important factor affecting AI PCB design is the layout. Carefully selecting the physical arrangement of the components and traces on boards is especially important for AI applications, as AI requires complex and dense layouts, often involving many components, multiple layers, and numerous vias to allow signals to travel between those layers.

Designers must also account for the electrical, mechanical, thermal, and ergonomic requirements of the layout. For example, a key consideration in ergonomic design is flexible PCBs, a quality that is especially important in wearable technology and medical devices that have size and weight constraints.

According to Deloitte, AI operations could consume over 40% of global data center power by 2026.

The Future of AI PCB Design

While processing units will remain an integral part of the PCB for the foreseeable future, the units themselves are evolving. Although GPU chips have a leg up on CPU chips, some companies are going further by developing their own chips. For example, Google has designed an AI chip known as a Tensor Processing Unit (TPU). This unit is an application-specific integrated circuit (ASIC) designed to accelerate machine learning tasks, particularly for neural networks. Unlike GPUs and CPUs, these TPUs are specifically optimized for high-volume, low-precision applications, making them ideal for deep learning model training.

Designing its own chips has brought Google several advantages. These include lessening the company’s dependence on chip manufacturer Nvidia; lowering Google’s costs for large-scale AI deployments; and allowing for more customization specific to Google’s AI workloads.

Other tech giants, such as Amazon, Apple, and Microsoft, are also developing proprietary chips, shifting away from traditional manufacturers like Intel. Some experts predict it’s only a matter of time before smaller companies follow suit. As AI continues to evolve, AI PCB design will require more specialized components, flexible boards, and creative engineering solutions to meet the growing computational demands of AI applications.

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The first manufacturing robot was installed in a General Motors plant in 1961. Called Unimate, it was able to stack hot die-cast metal pieces accurately, but that was all it could do. Since then, robots have come a long way, taking on jobs previously done by humans: precisely building small electronic components, washing windows on high-rise buildings, or assisting surgeons in the operating room. Purina even fittingly employs a quadruped “dog” robot, dubbed Spot, that can literally climb stairs as it makes routine inspections. Now collaborative robots (cobots), which are designed to work alongside humans, are taking robotics in yet another direction. Cobots in manufacturing are boosting flexibility, productivity, and safety—often at a fraction of the cost of traditional manufacturing robots.

With their flexibility, affordability, and ease of use, cobots can be a powerful manufacturing solution for companies of all sizes.

Because of their ability to work alongside humans and enhance human output, cobots in manufacturing are a fast-growing segment of the robotics industry. Fueled by shortages of qualified workers as well as increasing labor costs, the cobot market is expected to explode from $1.5 billion in 2023 to $23.5 billion by 2033, according to Tech Target. Automation—especially in the industries of healthcare, manufacturing, and logistics—is one of the primary drivers for the growth of these collaborative machines.

When is a Robot a Cobot?

While they are a segment of the robotics industry, cobots are different from traditional industrial robots. Cobots, by definition, are collaborative, intentionally designed to physically interact with humans in a common workspace. While a traditional robot may be designed to replace a human, a cobot is made to augment human capabilities with extra precision, strength, and data capability. Simply put, cobots allow humans to do more.

Cobots have many of the capabilities of traditional robots, with the addition of enhanced safety features that make them suitable for collaborative applications. These features include one or more of the following:

  • Safety Monitored Stop—enables the cobot to halt motion when safety parameters are triggered
  • Hand-Guided Programming—allows an operator to program the cobot by manually guiding it
  • Speed and Separation Monitoring—enables the cobot to adjust its speed based on its proximity to humans
  • Power and Force Limiting—triggers a drop in the cobot’s power or force to prevent harm to humans or objects

5 Advantages of Cobots in Manufacturing

Cobots in manufacturing usually have an arm with joints that allow the arm to bend, rotate, and extend. These cobots are ideal for assembly, machine tending, and product quality inspection and control, and they offer many advantages over traditional robots.

  • Safety: Traditional robots routinely work at high speeds and quickly perform repetitive tasks. Unfortunately, these speeds can pose immense danger to humans, necessitating safety measures like fences to keep humans separate—and safe—in their presence. In contrast, cobots are specifically designed to collaborate with humans and comply with enhanced safety standards. For example, fenceless cobots, also known as speed-and-separation cobots, have laser scanners that create safety zones around their workspaces. These scanners detect when a person is nearby so that the cobot can stop or slow down to avoid an accident. Likewise, speed limits, power limits, and ergonomic designs all contribute to the safety of cobots.
A closeup of a cobot working on a device assembly.
Cobots cost less than traditional robots, with payback periods measured in months not years.
  • Flexibility: Cobots are much more flexible than traditional industrial robots. For example, they can more easily be re-programmed to perform different tasks. Likewise, their smaller size makes them adaptable to multiple workspaces. This flexibility can be especially useful for mid-sized businesses that might not have a level of production that justifies large, dedicated automation systems. For these businesses especially, flexibility helps justify an investment in robotics.
  • User-Friendly: Gone are the days when you needed to be a technical expert to take advantage of digital technology. Today, an iPhone can act as a human-machine interface for your glucose monitor, your washing machine can send you a text for required maintenance—and an average factory worker can reprogram a cobot. To do this, a worker simply guides the cobot through the required paths and positions to complete the new task. The cobot literally learns by doing. Hand-guided programming is one of the breakthroughs that has made cobots practical. And it’s especially useful in situations where a cobot needs to move between stations to accomplish different tasks, as it eliminates the extensive downtime traditionally required for reprogramming.
  • Lightweight and Compact: Cobots are lighter than traditional robots, allowing them to be easily moved and positioned. Likewise, they are more compact, enabling them to fit into tight workspaces and existing workstations. These attributes make it easier for manufacturers to integrate automation into an existing workspace, without the need for major modifications to a facility. 
  • Cost/Return on Investment: Automate.org reports that the positive cash flow from robotic systems can turn a $250,000 investment into approximately $1.5 million of positive cash flow by the seventh or eighth year, primarily through labor savings and productivity gains. Yet, despite the exponential payout from robotics, not all companies desire—or have the means—for the large initial investment required of traditional industrial robots. Cobots, however, cost a fraction of their traditional robotic counterparts, meaning payback periods are measured in months not years. So, while a fully automated smart factory may be the ideal for a large company, cobots are leveling the playing field for medium-sized companies.

Cobots in Manufacturing are Boosting Efficiency

Cobots in manufacturing are bringing increased efficiency to many industries. In the car industry, for example, cobots are the newest automotive technology to be added to the factory floor. Passenger safety is a top priority for car manufacturers, and even a small misalignment on a critical part during assembly can compromise a car’s safety. Cobots, working alongside humans, can add precision and accuracy that are beyond human capabilities.

One example of cobots in action is at BMW Group’s Spartanburg site in Greer, South Carolina. At this manufacturing plant, four cobots equip the insides of the BMW X3 model door with sound and moisture insulation. Previously, workers used a manual roller to adhere the insulation. This highly labor-intensive task is now performed by systems with roller heads on robot arms. The cobots can handle the job with much more precision—better protecting the electronics in the door and the entire vehicle against moisture.

“Robots that assist production workers by assuming labor-intensive tasks will characterize the factory of the future,” explains Harald Krüger, member of the Management Board of BMW AG. “Their benefits are strength and mechanical accuracy—and they perfectly complement humans’ flexibility, intelligence, and sensitivity.”

5 Tips for Integrating Cobots in Manufacturing

Before investing in cobots, it’s important to make a detailed plan for implementation, and to develop well-defined protocols for equipment maintenance. Here are five issues to keep in mind when developing your plan.

  • Set Goals and Key Performance Indicators: Before jumping in with a cobot purchase, you need to define clear goals and key performance indicators. What will success look like? What are you trying to accomplish? In setting your goals, remember to include qualitative as well as quantitative goals. For example, in addition to setting a goal for an increase in units produced, set goals like improved employee safety or increased employee satisfaction.
Hand-guided programming means factory workers need only minimal training to reprogram cobots.
  • Understand the Limitations: According to Ron Potter, Director of Robotics Technology for Factory Automation Systems, Inc., “many people don’t understand that collaborative robots are not a direct replacement for conventional robots.” While cobots have many unique advantages, keep in mind that cobots can’t compete with traditional robotic systems in some areas. For instance, your company needs to set realistic expectations for payload and speed when working with cobots in manufacturing.
  • Choose the Right Cobot: Cobots in manufacturing vary in size, power, price, precision, and functionality. The right cobot for you will likely depend on your budget and the problems you are trying to solve. If the world of automation is new to you, you may want to consult with a robotics specialist or an experienced integrator.

    Keep in mind when choosing a cobot that you aren’t just planning for the present. You need to account for compatibility with future expansions as well as existing systems. Fortunately, the versatility of cobots in digital manufacturing—the integration of digital technologies into the manufacturing process—can make the transition process less painful. Since cobots can easily be reprogrammed, they make it simple to meet changing production needs without significant additional costs or downtime.
  • Involve your current employees: In your automation journey, it’s important to involve your current employees. Your transition will go more smoothly if you emphasize that automation is not about employee replacement. Instead, it’s a way to allow employees to focus on higher value-added activities rather than the manual, repetitive, mundane tasks that can be given to robots. Another way to gain employee buy-in is through employee feedback. For example, most companies will need to analyze current manufacturing processes before choosing a cobot. Therefore, if you are doing a time-and-motion study to identify bottlenecks, don’t forget to solicit employee input. Employees can be one of the best resources for identifying tasks that are repetitive, dangerous, or labor-intensive—and therefore possibly a good fit for a cobot.
  • Develop a Detailed Road Map/Plan: You will need a detailed plan to keep all parties coordinated throughout the implementation process. This plan should include a timeline, a clear definition of roles and responsibilities, and steps to address potential risks. Your plan should also outline the parameters for a simulation test. Fortunately, specialized software is available that will allow you to create realistic simulations of your production process without risking production delays or defective products as you prepare for full cobot integration.

    Your road map should also include instructions for the actual integration, including proper employee training. And your plan shouldn’t end at cobot integration. Be proactive in monitoring and maintaining your new robotics system—establish a schedule for preventive maintenance and address problems promptly.

Because of their ability to leverage the best of humans and robots, cobots are here to stay. Through seamless integration with human workers, cobots are enhancing safety, productivity, and efficiency. With their flexibility, affordability, and ease of use, they are providing powerful solutions for companies of all sizes that are seeking to take advantage of the world of automation. Manufacturers that develop a detailed cobot integration plan—and prepare their human workers in advance—will be poised to take advantage of the cobot evolution that is underway.

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When the Wright brothers built their first plane, its construction was straightforward. A simple 12-horsepower engine powered the 40-foot-wide aircraft, which was made mostly of fabric and wood. The plane’s most technologically advanced component was its mechanical control system, which used pulleys and levers. Today, planes are in many ways more like flying computers. And the PCBAs of aerospace electronics have become as integral to aerospace technology as the pulleys and levers of the Wright era.

PCBAs are used in a variety of aerospace vehicles, including planes, satellites, and space shuttles. And because of the demanding conditions of air and space travel, and the serious consequences of a component failure, the manufacture of PCBAs destined for this industry must adhere to the highest standards. Whether enabling a plane’s collision avoidance system or providing satellite communication, PCBAs used in aerospace technology must perform within strict parameters.

Material and Manufacturing Considerations for Aerospace Technology PCBAs

PCBAs destined for aerospace technology are a special breed, required to withstand the harshest of conditions, in situations where failure can be catastrophic.

The requirements for PCBAs used in aerospace technology are similar to those for car electronics—with the important distinction that operating conditions are much harsher. PCBAs used in aerospace applications must hold up to extreme vibration and intense temperature fluctuations. And, unlike car electronics, routine maintenance isn’t as simple as a trip down the road to the local mechanic. For example, once launched, satellites are rarely repaired, because of the prohibitive cost. For this reason, reliability is an essential quality for PCBAs used in aerospace technology.

To meet the high demand for reliability, manufacturers use materials that are specific to aerospace technology. Whereas a traditional PCBA application might incorporate a copper weight of one ounce per square foot, aerospace PCBAs need heavier copper—at least three to four ounces per square foot—to achieve higher current-carrying capacity and greater heat dissipation.

Specific manufacturing methods are also required to produce aerospace PCBAs that can withstand harsh conditions. Conformal coating—a thin protective polymeric film that is applied to PCBAs—is especially important in the aerospace industry. This breathable coating allows moisture to escape while still protecting the board from contamination. It also provides electrical insulation, enhances reliability, and prevents failures such as current leakage and corrosion.

In addition to using conformal coating, aerospace technology manufacturers often press component pins to the circuit board rather than simply soldering them. This press-fit technology helps a PCBA hold up better to extreme vibrations. Additionally, this approach enables the PCBA to withstand thermal cycling—the back and forth between extreme temperatures that planes experience.

PCBAs destined for aerospace technology are a special breed, required to withstand the harshest of conditions, in situations where failure can be catastrophic. This is why adherence to best practices is especially critical for this industry. If a PCBA isn’t able to withstand high levels of radiation, for example, it will damage easily, since there is no atmosphere in space to absorb high-energy particles. And this is just one of many considerations that PCBA manufacturers must contend with.

So how can you be sure your company is meeting these high standards? And how do you show your aerospace customers that they can rely on your PCBAs? In a nutshell: Test and certify.

Perform Proper Testing

To be successful, manufacturers of PCBAs used in aerospace technology must prioritize quality control. One way to do this is to properly test PCBAs under a variety of harsh conditions. For example, testing for temperature variations is important, as aircraft cycle through extreme temperatures multiple times a day, reaching an exposure of -50 degrees when at 10,000 feet. In addition to extreme temperature variations, other variables include pressure changes, radiation exposure, and vibration. Below are tests that should be performed on any PCBA designed for aerospace use.

  • Peel-Off Test: This test evaluates the adhesion strength of coatings, such as conformal coatings, to the circuit board surface.
  • Drop Test: Dropping the PCBA from various heights simulates sudden impacts or vibration during flight and enables manufacturers to assess mechanical robustness.
  • Thermal Aging: Exposing a PCBA to elevated temperatures for extended periods of time simulates long-term aging, testing the board’s durability.
  • Pressure Test: This test evaluates the PCBA’s ability to operate under high-pressure conditions such as high altitudes.

If your company lacks any of these testing capabilities, consider teaming up with a contract manufacturer. A good third-party partner can be a great resource as they will have the design-for-excellence (DFX) capabilities to meet your design and testing requirements. Further, an experienced partner can ensure best-in-class manufacturing by having SMTA-certified engineers in house.

Exposing a PCBA to elevated temperatures for extended periods of time simulates long-term aging, testing the board’s durability.

Follow Aerospace Technology Standards and Obtain Certifications

Because there is little room for error, manufacturers of aerospace electronics must adhere to exacting standards that address safety, testing, and other considerations.

The gold standard for the manufacture of machines and parts for the aerospace industry is AS9100. This standard emphasizes risk identification, assessment, and mitigation, and has requirements specific to the aerospace industry for such factors as airworthiness, safety, risk management, and product configuration.

Many aircraft manufacturers, defense contractors, and suppliers worldwide require AS9100 certification or compliance as a condition of doing business. Adhering to this standard—or using a third-party manufacturer with AS9100 certification—provides consistency, reduces verification audits, improves supplier performance, and cuts oversight costs in the manufacturing process.

IPC Class 3 is another important set of standards, as they ensure the highest level of quality and reliability for PCBAs—essential for boards that are used in high-stress applications such as aerospace technology. These standards ensure continuous, uninterrupted performance and are crucial for creating high-reliability electronics where any amount of downtime is unacceptable. One key standard in this class is IPC-6012. Both IPC-6012, and the related standard IPC-A-610, should be met when producing class 3 boards. An addendum to the IPC-6012 standard, known as IPC-6012 ES, specifically addresses requirements for rigid printed circuit boards used in space and military applications.

Don’t Forget Registrations

A satellite in orbit above Earth
PCBAs used in planes, satellites, and spacecraft must operate reliably under demanding conditions.

Beyond certifications, you must also consider necessary registrations. For example, companies working on defense-related aerospace projects need to have International Traffic in Arms Regulations (ITAR) registration. ITAR registration is not a certification. Rather, it is a legal requirement to register with the U.S. Department of State’s Directorate of Defense Trade Controls (DDTC). Registration helps the U.S. government control sensitive military technology by restricting physical components—and the knowledge of how to produce those components—from access by non-U.S. entities.

ITAR registration is mandatory for all individuals and companies involved in manufacturing, exporting, temporarily importing, or brokering defense services. To comply with ITAR, you must make sure that all your staff are either U.S. citizens or qualify for an exemption by meeting certain criteria for residency and proof of independence from foreign influence. In addition, any third-party partners you work with on sensitive products must also be ITAR-registered.

Violating ITAR regulations can have serious consequences, including:  

  • Revoked contracts – ITAR registration rules are strict, and ignorance of these rules is not accepted as a reason for non-compliance. Companies that do not fully comply with ITAR requirements may lose contracts.
  • Fines/loss of aircraft – Non-compliance can also result in financial penalties. Organizations, as well as individuals, can face fines of up to $500,000—per violation. Additionally, any vessel, aircraft, or vehicle involved in the non-compliance issue may be seized or forfeited.
  • Criminal charges – Depending on the violation, consequences go beyond civil penalties. Certain types of regulatory breach are considered criminal and carry fines of up to $1,000,000 per violation—and up to 10 years in prison for the guilty parties.

Where Do I Start?

Certifications, registrations, standards—it can all seem overwhelming. So how can you start your journey, or ensure you’re on the right path? Turn to the experts! Manufacturers can learn about certifications, required registrations, and best practices from organizations like the ones below:
  • The Federal Aviation Administration (FAA): This U.S. government agency oversees the manufacture of aircraft and their components. It also evaluates new technology. While the FAA is primarily responsible for overseeing civil aviation, it also has a specific branch—the Military Certification Branch—which is dedicated specifically to aerospace and military certification.
  • International Aerospace Quality Group (IAQG): The IAQG is a cooperative global organization focused on improving quality and reducing costs throughout the aerospace supply chain. This nonprofit develops standards, such as AS9100, and creates guidance materials as a resource for companies to use throughout the supply chain.
  • Aerospace Industries Association (AIA): The AIA is a trade organization for the aerospace industry, representing manufacturers and suppliers. While the AIA does not directly certify organizations, it does provide publications and guidance documents to help members navigate the strict certification and regulatory requirements of the industry.
  • IPC: This global association was founded in 1957 by six printed circuit board manufacturers. The association’s mission is to help OEM, EMS, and PCB manufacturers; cable and harness manufacturers; and electronics industry suppliers to build better electronics.

Reducing Your Risks

Aerospace technology companies require reliable, high-performance PCBAs manufactured to exacting standards. Meeting these standards can be a challenge, which is why it sometimes makes sense to partner with a third-party manufacturer who has the necessary registrations and certifications. In addition to ensuring your boards comply with the proper standards and regulations, the right partner can reduce your supply chain risk by sourcing quality parts at competitive prices, and can even help you streamline your manufacturing process—without sacrificing the high reliability and durability required of aerospace technology PCBAs.

PCBA Manufacturing for Aerospace Applications

From designers to engineers, PRIDE Industries has the personnel you need throughout your PCBA manufacturing journey. Our AS9100 certification, ITAR registration, and in-house SMTA-Certified Process Engineers ensure you receive the highest quality results while meeting all relevant aerospace industry standards and regulations.
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When the car was first invented, models were built slowly, one whole automobile at a time, just like every other manufactured product of that era. Then in 1901, Ransom Eli Olds introduced the first mass-produced vehicle, the Oldsmobile Curved Dash, which was built using a method developed by Olds—the stationary assembly line. Years later, Henry Ford added a conveyor belt to the assembly line, revolutionizing manufacturing and setting the standard for how products would be made for the next century. Now the industry is undergoing another revolution—digital manufacturing.

What is Digital Manufacturing?

The term “digital manufacturing” describes the integration of computer systems and digital technologies into the manufacturing process. It’s an approach that relies less on traditional manufacturing practices and more on emerging technologies such as robotics, artificial intelligence, and the Internet of Things (IoT). This confluence of new technologies has created such a buzz in the manufacturing world that Klaus Schwab of the World Economic Forum coined the phrase “the fourth industrial revolution” to describe this shift.

Digital Manufacturing Technologies

From design to delivery, digital manufacturing technologies are adding efficiency, flexibility, and productivity to the entire product lifecycle—yielding higher quality products while accelerating time to market. Here are six of the most impactful of these new technologies:

Digital Twins

Digital twins are virtual counterparts of physical objects or systems. These real-time digital replicas allow companies to test new products before they are built in the real world, and can cut the time it takes to go from design to finished product. Volvo, for example, uses digital twins of new vehicle designs to virtually test the aerodynamic properties of different materials and proposed design features. Using this technology, Volvo can improve vehicle performance and create more fuel-efficient models—even before the first prototype is built.

And Volvo is hardly alone. McKinsey & Company reports product development leaders are rushing to build their digital-twin capabilities, with the global market for this technology predicted to grow approximately 60% annually, reaching $73.5 billion by 2027.

From design to delivery, digital manufacturing technologies are adding efficiency, flexibility, and productivity to the entire product lifecycle—yielding higher quality products while accelerating time to market.

An early 1900s model of the Oldsmobile Curved Dash, parked outside.
The Oldsmobile Curved Dash was the first car made on an assembly line.

Additive Manufacturing and Rapid Prototyping

Additive manufacturing, also known as 3D printing, is the process of building objects layer-by-layer using a 3D printer that converts digital data into a physical object. With its ability to create complex shapes and customized products directly from design files, additive manufacturing allows device prototypes to be produced rapidly and cost-effectively. In addition to slashing lead times, this rapid prototyping gives manufacturers greater flexibility. For example, while it’s not practical to produce a small batch of PCBs with traditional prototyping, an electronics manufacturer using rapid prototyping can efficiently produce prototype batches of as little as five units.

Artificial Intelligence

Artificial intelligence (AI) is a specific field within digital technology that focuses on developing intelligent machines that can approximate human thinking. Using machine learning and natural language processing, AI systems can learn, reason, and make decisions—mimicking human reasoning while working far more quickly and processing much larger data sets than the human mind is capable of.

With AI, manufacturers can mine and analyze vast amounts of data to optimize product design, material choice, and other facets of production. Leveraging data can also help a manufacturer better navigate its supply chain, especially when managing inventory. And AI has even been used to help manufacturers determine when it’s more cost-effective to simply raise wages vs. hiring new staff.

IoT Technology

The Internet of Things (IoT) is a network of physical devices embedded with sensors, powered by software that allows communication across the internet. At home, this technology might help you control your lights or notify you when it’s time to put your laundry in the dryer. On the factory floor, IoT technology is transforming the way manufacturers make their products. For example, using electronic tags and sensors, manufacturers can track products throughout the supply chain; inventory managers can locate devices within a warehouse; and plant operators can service equipment before malfunctions occur.  

Industrial Robots

Worldwide, there are approximately 3.9 million industrial robots, according to the International Federation of Robotics. Increasingly, these machines are helping manufacturers become more efficient. For example, German automaker Mercedes-Benz has entered into an agreement with robotics company Apptronik to test humanoid robots at select Mercedes-Benz factories. These robots—such as Apollo, a 160-pound, 5’8” bipedal robot—will be used to automate repetitive tasks, according to Mercedes-Benz and Apptronik.

Augmented Reality

Augmented reality (AR) uses computer-generated images, projected onto or near a real object or scene, to enhance our perception of the real world. From flight training to road navigation, this technology is changing our world. For manufacturers, AR has proven to be a productivity-boosting enhancement in production. 

A robot stands next to a couple of pieces of equipment in a large warehouse.
While still a novelty, humanoid robots are expected to make their way into factories and warehouses over the next several years.

Traditionally, manufacturers share work instructions through physical or digital manuals. This requires workers to switch their attention from the product they’re working on to a book or computer screen. But with AR, important information is projected directly onto the work surface, eliminating switching time and decreasing the distraction and fatigue that workers can experience when required to constantly shift focus.

Some Key Benefits of Digital Manufacturing

Digital manufacturing technologies offer many benefits to manufacturers.

  • Increased Efficiency: Digital technologies allow manufacturers to create new efficiencies. In 2019, for example, General Electric discovered that using AR glasses at its jet engine manufacturing facility increased the productivity of the engine mechanics.
  • Faster Innovation Cycles: Advanced design tools and virtual prototyping allow products to go from design to finished product faster than ever before.
  • Improved Customer Satisfaction: Digital manufacturing technologies give manufacturers the flexibility to rapidly adapt to market shifts.
  • Cost reduction: AI systems are enabling manufacturers to streamline manufacturing processes to save time and reduce material waste. Access to detailed data also enables manufacturers to keep manufacturing machinery in peak operating condition through predictive maintenance, avoiding costly shutdowns and delays.
  • Better Quality Control: With real-time monitoring of manufacturing processes, product issues can be identified and corrected immediately. Manufacturing processes can also be more easily standardized, leading to higher quality products.
  • Greater flexibility: With advanced technology, manufacturers can now quickly reconfigure production lines for different products and varied batch sizes.

How to Start Your Digital Transformation

Given the many benefits of digital manufacturing, it may be tempting to dive straight into the process. But before starting your digital transformation, you need a plan. A blueprint, or operating model, will provide a clear vision of what your finished manufacturing system will look like once it is complete, and will help you stay on track during your transformation.

In order to develop a reliable blueprint, you need to first evaluate your operational value stream—the sequence of activities required to deliver your product or service to your customer. Once you’ve clarified your production steps, you can prioritize the business process improvements that will have the most impact. For example, if your goal is to cut production time in half, what process improvements will be required to reach that state? Can you eliminate steps or streamline a process through automation? Can you analyze data better to save time in the long run?

Industrial robots, augmented reality, IoT technology—implementing these digital technologies can be a daunting process. How do you figure out the right balance between new technology and your traditional processes? How fast do you transition? How much can you afford to spend on new technology? Fortunately, you may not need to stress over these difficult questions. A reputable third-party vendor will likely already understand how to deliver the services and products you need in the most efficient and cost-effective way. For many manufacturers, this approach is the right solution as they grapple with the best way to transition into the new world of digital manufacturing.

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The integration of human machine interfaces (HMIs) in medical devices has changed the way healthcare is delivered. Take, for example, a hospital setting. Just 20 years ago, patient monitoring was accomplished by frequent in-person checks and manual recordings. Today, doctors and nurses monitor vital signs remotely in real time through mobile devices or centralized monitoring stations. Advanced HMIs in operating rooms enable doctors to remotely control robotic systems. And medical records are easily accessible to both patient and doctor through user-friendly computer interfaces.

This technological evolution shows no signs of slowing down. Forward-thinking manufacturers in the medical device industry are continuing to innovate, using human machine interfaces to meet customer demand for products that deliver better healthcare more efficiently.

What Are Human Machine Interfaces?

A human machine interface (HMI) is a dashboard or other medium that connects a person to a device or system, usually for the purpose of controlling the device. There are two types of interfaces: input controls and output controls.

The ideal human machine interface is intuitive and simple, so that the medical device can be successfully used in stressful situations by people without advanced medical expertise.

Input controls—such as keypads, touchscreens, knobs, and displays—capture a human’s commands to a machine. Output controls allow the device to provide feedback. While feedback may initially take the form of complex data, an output control transforms this information into a form that’s easily interpreted by humans. For example, a diabetic’s continuous glucose monitor (CGM) would be of little use if all it did was sense the individual’s blood sugar level. The real power of a CGM is the human machine interface—the display device, such as an iPhone, where information is transformed into instant glucose readings, trend graphs, and alarms that can alert a patient and medical staff to a serious issue.

3 Reasons Healthcare Providers are Demanding HMI-enabled Medical Devices

Doctors and other healthcare providers are adapting to several trends that are reshaping medical care. And these same trends are driving demand for human machine interfaces in medical devices.
  • An Aging Population:  According to the National Council on Aging, older adults are one of the fastest-growing demographic groups in America. In fact, it’s predicted that there will be 80.8 million Americans over 65 by 2040—over twice as many as in the year 2000. Since some of these users may be experiencing physical or cognitive issues, medical device manufacturers should ensure that their human machine interfaces are easy and intuitive. Consistent and familiar interfaces reduce the cognitive load on the user, thus increasing the likelihood that the device will be used properly.  And when an essential medical device is used properly and consistently, it greatly increases the quality of life for those in their golden years.
  • Chronic Illness Management: According to the CDC, almost half of the people in the United States are living with at least one chronic health condition, and 40 percent of adults suffer from two or more such conditions. All these health issues—from hypertension to diabetes—need to be monitored, often by the patient. Since most patients lack the medical device know-how of healthcare personnel, they (and their doctors) will choose medical devices with easy-to-use, intuitive human machine interfaces.

    For example, in the past diabetics needed to frequently prick their fingers to monitor blood glucose levels. Then the introduction of the continuous glucose monitor (CGM) took away the painful jab. And now, as human machine interfaces become more sophisticated, the data gathered by the CGM can easily be monitored by a patient—as well as doctors and loved ones—with greater convenience than ever before.
A young boy in a doctor’s office has the data from his continuous glucose monitor, displayed on an iPhone, read by a medical professional.
Human machine interfaces provide easy-to-interpret, real-time data to both patients and their healthcare providers.
  • Labor Shortages: The recent pandemic interrupted important education and training for many people entering the medical field. Additionally, a high number of healthcare professionals have experienced burnout and switched careers or retired early. For these reasons, healthcare providers are experiencing severe staffing shortages, and often need to rely on less-experienced workers. This has increased the demand for medical devices that incorporate easy-to-use human machine interfaces, as these devices are ideally suited for use by newer, less-experienced workers. Additionally, improving HMIs supports the use of telemedicine, making it possible for patients in underserved or remote locations to access quality care, despite the current staffing shortages.

Good Human Machine Interfaces Make Operation Easy and Intuitive

To be competitive in this environment, medical device manufacturers must deliver well-designed products that take advantage of sophisticated human machine interfaces. A robust HMI, however, does not mean a complex interface. The ideal interface will be intuitive and simple, so that the medical device can be successfully used in stressful situations by people without advanced medical expertise. For example, one way a device can reduce the risk of user error is to include confirmation prompts before executing critical actions.

Further, products that are easy to operate are more likely to be adopted by users. Therefore, medical device manufacturers should prioritize HMI at the onset of the product design phase, not as an afterthought.  Below are a few guidelines for interface design.

  • Consistent language/colors: Use consistent wording and color coding to guide the user through the interface.
  • Text and fonts: Avoid excessive text and make sure to use as large a font as possible.
  • Simple Graphics: Keep the graphics basic and easy to interpret.
  • Intuitive Navigation: Access to settings and other functions should be straightforward and not require specialized knowledge. Language should be in plain English.

Historically, HMIs have consisted of buttons, switches, and screens. But today’s forward-thinking manufacturers are developing more intuitive human machine interfaces that rely on gestures or voice commands. For instance, some new patient monitoring systems allow nurses and physicians to retrieve vital signs, document their observations, and adjust alarm settings—all through voice commands. This provides medical professionals with greater mobility, enabling them to better focus on patient care.

HMI Considerations Specific to Medical Devices

Across industries, good HMI design emphasizes clarity and ease of use. But with medical devices, there are additional requirements.

  • Ability to Be Easily Sterilized: Whether in a hospital, a doctor’s office, or at home, medical devices must be sterile. This means that whatever form human machine interfaces take, they must be easy to sterilize. One way to achieve this is to use membrane switches. Used for turning circuits on and off, these switches are thin, flexible interfaces made of multiple layers of plastic material. With a flat, sealed design, they make it easy to keep a device sterile by eliminating the need to clean around buttons or other moving parts. Their design also makes them resistant to liquids and more durable, since there are fewer moving parts.

    Another important technological advance for medical devices is the use of in-mold electronics. These electronics employ a manufacturing technique that directly integrates the electronics into the molded plastic components, creating a smart, interactive surface without the need for separate wiring or circuit boards. This not only increases reliability and durability, it also improves touch performance and can make the device easier to clean.
A membrane switch keypad
Used for turning circuits on and off, membrane switches make it easy to keep a device sterile by eliminating the need to clean around buttons or other moving parts.
  • Critical Need for Reliability: An interruption to the interface on a personal electronic device is annoying; on a medical device, that interruption could be life threatening. Robot-assisted heart surgery, for example, is one area where system interruptions could lead to disastrous results. Since many surgeries today are assisted by robots, design engineers are adding an innovative technology called electromagnetic interference (EMI) shielding to the products they design. This shielding protects a medical device’s Bluetooth or Wi-Fi connectivity from interference by other devices within the hospital.
  • Accessibility: It’s likely that many of the people using a medical device will be in less-than-ideal health. Does the HMI design take into consideration those with visual, auditory, or motor impairment? For example, how could a medical device assist someone with impaired movement due to age or disease? Researchers at Harvard, in conjunction with Massachusetts General Hospital, studied that exact challenge. They developed a soft robotic wearable prototype that test subjects were able to learn to operate in less than 15 minutes. The current prototype works by detecting residual movement in the shoulder area, but researchers are exploring potential versions of assistive wearables that could be controlled by brain signals—the ultimate in human machine interfaces.

The Future of Human Machine Interfaces in Medical Devices

Beyond meeting current customer expectations, manufacturers also need to think to the future. Hospitals are facing the perfect storm of an aging population, a shortage of skilled healthcare workers, escalating medical costs, and a rise in hospital-acquired infections. With the increased strain on the existing hospital model, some experts are seeking to shift care outside of hospitals, reserving these institutions for critically ill patients only. Yet to accomplish such a shift, manufacturers will need to produce medical devices that are even more natural, seamless, and intuitive—wherever and by whomever they are used.

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Hippocrates, famous for the Hippocratic Oath, urged doctors “namely to do good or to do no harm.” This admonition—routinely paraphrased as “first do no harm”—is also a good adage for medical device manufacturers to keep in mind, as the practice of medicine relies more than ever on the devices they make. But while most medical device manufacturers are careful to ensure that their products are safe and reliable, they don’t always give medical device packaging the same careful attention.

That oversight can have serious, even fatal, consequences.

7 Common Mistakes in Medical Device Packaging

There are two main purposes for medical device packaging: protecting a product so that it arrives intact and in good working order, and maintaining a sterile environment. Contamination is an especially urgent concern. According to the U.S. National Library of Medicine, viral and bacterial infections are among the ten leading causes of morbidity and mortality in the United States.

One way to prevent contamination—and the subsequent recall—of medical devices is with reliable, high-performance packaging. According to the U.S. Food and Drug Administration (FDA), packaging and labeling issues account for 13% of all medical device recalls, which is why some experts assert that medical device packaging is nearly as important as the device itself.

According to the U.S. Food and Drug Administration (FDA), packaging and labeling issues account for 13% of all medical device recalls, which is why some experts assert that medical device packaging is nearly as important as the device itself.

Now more than ever, healthcare organizations are working hard to reduce the number of hospital-acquired infections. And to help their customers achieve these goals, savvy medical device manufacturers have learned how to avoid the seven most common packaging pitfalls.

Mistake #1: Losing Sterile Integrity

Ensuring the sterility of medical devices is critical for reducing infection, yet it is the most common defect found in medical device packaging. Unfortunately, some medical device manufacturers fail to create a truly sterile barrier system (SBS) in which to encase their products for transport. This means that in some cases, when their products arrive at the point of use, they fail to meet the aseptic standards required by FDA and International Organization for Standardization (ISO) regulations.

While nonsterile packaging can be the result of contamination at the packaging site, often the issue is more fundamental—the design of the packaging itself. It’s important to keep in mind that packaging can only be made sterile on the inside. A package’s exterior will always arrive at its destination in a nonsterile state. This means it’s essential to design packaging that can be opened without introducing contamination.

So, how can you design your package to limit contamination? The National Library of Medicine found that pouches that had outward-curling seals had significantly lower contamination rates. In other words, if the exterior of a package curled away from the interior as the package was opened, it was far less likely that the outside of the package (the nonsterile surface) would come in contact with the interior’s sterile contents.

Mistake #2: Not Accounting for the Device’s Entire Journey

A sterile barrier system is only useful if it stays intact for its entire journey, which is why your package design must include protective material to shield the SBS from the time of assembly to the point of use. Many sterile packages are damaged due to pinholes, slits, cuts, and tears. To avoid these outcomes, wise manufacturers design an entire packaging system that protects the device—and its SBS—throughout the journey from factory to hospital. This means designing resilient packaging that can withstand exposure to road vibration during long hours of transportation. Packaging must also be strong enough to survive warehouse mishaps like a fall to the ground.

Mistake #3: Ignoring Best Practices for Medical Device Packaging

A medical device wrapped in a sterile pouch, part of a sterile barrier system
To keep your product free of contaminants, avoid folding, wrinkling, or creasing the sterile pouch.

Whether you’re shipping something as simple as a box of bandages or as complex and delicate as a tracheotome, your packaging is critical. Both the United States and Europe have stringent regulations for medical device packaging. Yet not all manufacturers adhere to best practices and regulations when it comes to certain aspects of their product packaging.

Some manufacturers, for example, fail to get their medical device packaging properly validated. It’s true that validation is an extensive and at times complex process. But the regulations serve a purpose. Rigorously testing your proposed packaging will ensure that it provides an effective barrier against microbial ingress, moisture, and environmental contaminants. Furthermore, a good validation process does more than ensure your packaging meets regulatory requirements. It also guarantees that your device gets to your customer in sterile condition, able to perform as advertised right out of the box. This preserves your brand reputation, and eliminates liability headaches as well.

Of course, your efforts to comply with FDA and ISO regulations can be negated if your product is contaminated by a vendor. So, if you’re working with third-party contractors, be sure to screen them carefully to ensure they’re also adhering to best practices for medical device packaging and shipping.

Mistake #4: Using the Wrong Packaging Material

Many medical devices are packaged using thermoform trays—plastic trays that are made by heating plastic sheets and molding them into the desired tray shape. But there is a wide range of plastic available for this purpose, and choosing the wrong one can lead to packaging failure. For example, if you’re packaging a medical device with a lot of mass, you might need a high-impact plastic such as polycarbonate to reduce fracturing during distribution and handling.

The design of the thermoform tray is also critical. The tray or case must be tight enough to hold the medical device firmly in place. Otherwise, a loose product could jettison through the tray lid and fracture the plastic casing from the inside out. Conversely, packaging must have a bit of give, so that it doesn’t damage sensitive sensors or other high-tech components. A good package design strikes the right balance between these two extremes.

Mistake #5: Using the Wrong Container

In addition to using the right packaging material, you need to choose the right size and strength for your exterior shipping box. For example, if you are using an outer carton to protect your sterile pouch, you need to avoid squeezing the pouch into a too-small carton. You should choose a container that avoids any folding, wrinkling, or creasing of the ends of your sterile pouch. Otherwise, the vibrations of a moving truck could lead to pinholes at the junctures of the creases or folds of the pouch. Complex pouch folds are even more problematic, as they form a concentrated point of stress at the juncture of the materials.

When it comes to the sterile pouches themselves, however, bigger isn’t always better. Some research has found that increased contamination rates are associated with larger pouches versus smaller ones. Unfortunately, the reason for this is not entirely clear. One theory is that larger pouches require more hands-on repositioning to open, and that this increased handling offers more opportunities for contamination.

Product trays should hug—not squeeze—the items they were molded to protect.

Mistake #6: Inadequate Testing

Just as it’s important to test and inspect your product, you need to test the effectiveness of your packaging material—and package design—to ensure that the SBS and the outer carton will protect the device as it travels from assembly to customer to storage.

Testing might reveal, for example, that a single sterile barrier is not sufficient to maintain a sterile environment for a product that might sit in a hospital storeroom for up to a year; instead, a double barrier is needed. Real-time aging testing like this will enable you to see how your medical device packaging holds up under storage conditions in which both temperature and humidity can fluctuate widely, especially over an extended period of time.

But what if you’re trying to beat a competitor to market? Or more importantly, get a life-saving medical device to patients as quickly as possible? That’s where testing via accelerated aging—elevating temperatures to artificially speed up the aging process—can be useful. For example, subjecting a sterile barrier system to 40 days of +55°C temperatures has roughly the same effect as storing the SBS at +23°C for a year. That’s a huge time savings.

There is a caveat, however. Using temperatures that are too high—in the hopes of cutting a few more days off the testing process—can cause a package to melt or warp in a way it never would under real-world conditions, negating the purpose of the test. So, exercise caution when applying accelerated aging techniques. Or work with a laboratory that specializes in testing via accelerated aging.

Mistake #7: Neglecting to Develop a Recall Protocol

In addition to protocols for testing, manufacturers should develop specific protocols in case the need for a recall arises. Such a protocol might involve plans for recall initiation, reporting, execution, and monitoring. Recall protocols are especially important right now, as medical device recalls are on the rise. Between 2012 and 2022, recalls increased by 125%. (And medical device adverse event reports increased by over 500%.)

Having protocols in place means you’ll be better prepared to initiate a voluntary recall, which will do less damage to your business reputation than a forced recall. That was the case for medical manufacturer Nurse Assist, LLC. In November 2023, the company issued a voluntary recall on its saline and other water-based products over concerns of compromised sterility. These included various bottles, spray cans, cups, and syringes. When the recall was initially released in November 2023, no adverse effects had been reported. And while the FDA has since received reports of adverse events, Nurse Assist’s prompt, voluntary action has enabled the company to mute the damage to its brand.

Diligence is Needed in Medical Device Packaging

As healthcare providers continue to prioritize infection reduction, and medical device recalls continue to rise, designing and deploying effective medical device packaging is more important than ever. Avoiding the seven pitfalls outlined here is the first step in making sure that your packaging performs in a way that increases patient safety—and enhances your company’s reputation.

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