Medical devices demand nothing short of manufacturing excellence. We have opened the conversation about the world of cutting-edge automated technology and how we help to sculpt the way medical devices are produced. From robotic work cells to advanced imaging systems, these innovations are revolutionizing the machines that make life-saving products. This blog uncovers the exploration into the incredible advancements of medical device assembly as we share our own experiences designing and building automated machines to produce these assemblies that have helped shape the healthcare landscape as we know it.
Intro to Medical Device Assembly:
The term “medical device assembly” can mean many things, but is commonly referred to as the process of joining together various components to create a complete medical device. The tools and technology used can vary greatly depending on the device that is being made and the manufacturing environment. Automated machines often use robotic arms, specialized parts feeding systems, and advanced vision inspection.
“SDC utilizes the latest technology, designs innovative solutions, and develops advanced software methods to successfully create machines for demanding applications.”
– Tim Spehar, SDC Chief Electrical Controls Engineer
Medical device assembly requires a high level of accuracy, repeatability, and quality assurance. This can be accomplished through a combination of automated and physical inspections which verify the product passes safety and quality standards. It is important that the parts are properly composed to create a functional device and there are many factors to consider when designing and building an automated assembly machine to complete this process. At SDC, for medical device assembly machines and all other projects, we work with our customers to make sure the design and functionality of our machine meets their expectations which can include considerations like:
- Product and safety standards
- Material compatibility
- Design specifications
- Environmental requirements
- Production volume and cycle time
Parts Feeding Innovation
The design of traditional medical device manufacturing machines begins with how to best separate, organize and feed individual parts from bulk and into the automated machine platform. These parts are supplied to the machine using the feeding technology that is best suited for each part. After determining which parts feeding system is best, our team can design stations within the automated machine complete the next automated assembly steps, supported by machine vision and key sensors to ensure accurate assembly. Oftentimes, there is a challenge while flowing through the machine design elements, for example, during the mechanical design of a medical tubing port, our engineers needed to find out how to best join pieces that require specific adhesives like medically compliant glue in the assembly process.
Adding to standard automated machines, more advanced systems offer adaptive capabilities to produce different sized products when demand fluctuates. To accommodate these changes in incoming parts, our team can design changeover tooling that can be changed manually or automatically based on customer preference and machine dynamics. Most of our cutting-edge machines today use robotics and automation to improve efficiency and quality while reducing costs. By leveraging the latest technology, medical device manufacturers can stay ahead of the competition and ensure that their products are assembled with precision and quality.
- Dereeling and Other Parts Feeding
One area that SDC is an expert in medical device assembly machines is handling medical tubing, which my nature can be difficult to automatically handle. Most medical tubing is produced on a continuous basis, meaning that it is extruded in long lengths that are then cut to size as needed. This can create a lot of waste if not managed properly, so many manufacturers are turning to dereeling and part feeding technologies to improve their process.
Dereeling is the process of cutting the extruded tubing into shorter lengths for use. This can be done manually or with the help of a machine, and many manufacturers are now using robotic dereeling systems to increase efficiency. Parts feeding is the process of feeding individual pieces of tubing into the assembly line for further processing. Both dereeling and parts feeding are essential steps in the medical tubing manufacturing process. Over the past many years SDC has developed proprietary medical tube dereeling technology. Our technology is unique because it takes the characteristics of medical tubing, including the ‘sticky’ nature of the material and the fact that it is not perfectly cylindrical, into consideration. Our system begins with medical tubing on a reel that is manually loaded in to our automated dereeler. The dereeler, which is controlled by the machine PLC, automatically unwinds the tube material, and feeds it into an automated assembly machine.
After exiting the dereeler, the material is fed through a series of straightening rollers that work together to straighten the tube so the machine encoder can get an accurate length reading. When the material is the correct length, our system automatically cuts the tube, while holding on to both ends of the tubing and feeds one into the automated machine and the other end is used as the starting point for the next measurement.
Automated machines can improve product quality by offering inspection, sensing and repeatability. Let’s use a medical port assembly for an example: Our team designed an automated inspection system at the hose insert station on this machine that was performed by an industrial camera with automated defect detection programmed into the system. Assembly defects that would not be readily visible to operators are caught which alerts the machine to pick the defected part and place into a different output bin so the part does not proceed to the packaging station and can be further inspected by an operator. Another example of automated inspection for assembly devices is inspecting after packaging to validate the presence and correct placement of all components in the medical device, like a warranty card along with the assembled product. Additional sensors throughout the machine can detect and prevent defects that would not be visible to an operator or vision system after the fact.
Another benefit of automated medical part assembly is that it often requires less manpower. This frees up workers to do more beneficial and less repetitive tasks while reducing labor costs. In some cases, it may even be possible to eliminate certain positions altogether. However, it’s important to note that not all tasks can or should be automated. Some tasks, such as final inspection, will still need to be done by an operator.
Robotic Work Cells for Medical Device Assembly
Robotic work cells are often used for medical part assembly. This is because they can provide a high degree of flexibility, accuracy, and repeatability, which is essential for manufacturing. In addition, robotic work cells can be reconfigured to accommodate changes in production requirements.
Some of the benefits of using SDC for our expertise in medical device assembly machines include:
- Hands-on experience in multiple facets of the medical device industry including medical device assembly, feeding tube assembly, dialysis equipment assembly, syringe assembly, microscopic camera assembly and lens focusing, and even stent electropolishing systems.
- Extensive robotic and electrical controls programming for precision and accuracy. Even though this may sound intimidating, after machine training is complete, these machines are easy to operate.
- In-house machine building. Through a project’s lifecycle, each stage is completed on our shop floor by a team of experts.
- Project management team keeps the project on time and provides transparent communication between the entire SDC team the customer.
Quality Control Measures for Automated Assemblies
As medical device equipment continues to evolve, so too must the assembly processes used to produce them. These significant advancements promote the investment in automated equipment, and not just to upgrade to the latest assembly technology. When medical parts are assembled by hand, there is always the potential for human error. Even with the best workers, an honest mistake can happen at any time. This can lead to serious problems if not caught prior to leaving the manufacturing facility. Quality is crucial and automated medical device assembly machines help to prevent these errors.
Automated assembly offers many benefits over traditional manual methods, including increased speed and accuracy, reduced labor costs, and improved product quality. However, it is important to note that not all automated assembly systems are created equal. In order to ensure that your medical devices are being assembled properly, it is important to implement quality control measures for your automated assembly process.
The Challenge of Technology and Implementing Automation
Cutting-edge technology emerges every day. When there is an opportunity for improvement on an already successful piece of technology, it becomes an impressive solution that exceeds expectations, which in turn raises the industry standard. When applied to the medical field, these new and advanced technologies can enable manufacturers to develop better, more appropriate devices that properly address medical needs.
Implementing cutting-edge technology can also present some challenges. For instance, new equipment and processes may require significant upfront investment, additional training and even certifications for operators to oversee and run these machines. Ultimately, the potential benefits of automated equipment make the investment worth a serious consideration for manufacturers in the medical industry and beyond.
Some of the key quality control measures to consider for an automated assembly process include:
- Implementing a rigorous testing program: All medical devices must undergo extensive testing prior to being released on the market. When using an automated assembly system, it is important to have a consistent and robust testing program in place to ensure that all products meet quality standards.
- Conducting regular maintenance and inspections: Automated assembly systems require regular maintenance and inspection and replacement of common wear components to function properly. By conducting these activities on a regular basis, you can help prevent defects and ensure that your products are being assembled correctly.
- Documenting all process changes: Any time a change is made to the automated assembly process, it is important to document this change. This documentation will help you track trends and identify potential areas of improvement for the future.
- Training employees on proper use of the system: For an automated assembly system to operate as intended, any person interacting with the machine must have training on operations, safety and other relevant areas.
We have explored the various cutting-edge technologies available for medical device assembly machines that continue to evolve and improve the manufacturing sector for medical devices. From robotic arms to automated vision systems, these advanced integrations are providing solutions that can help improve efficiency, accuracy, and safety while significantly reducing cost. Ultimately, the potential benefits of automated equipment make the investment worth a serious consideration for manufacturers in the medical industry and beyond. Investing in the right tools and solutions like a custom SDC assembly machine with our flex feeding system could make all the difference when it comes to staying ahead of the competition. Who knows, this may open the door to unlocking new opportunities within the marketplace.