In the rapidly evolving and highly critical world of medical device assembly, automating processes greatly enhances efficiency and can even improve compliance. As an industry with a multitude of regulations and demanding quality standards, precision is key. 

We’ve broken down 10 processes for medical device companies to automate for improved efficiency and accuracy in development, production, packaging, and logistics. 

1. Precision Component Placement

Because of the regulations surrounding medical devices and the increasing complexity of components (down to the nano level), precise component placement is imperative to medical device assembly. As devices are increasingly designed for Point of Care applications or as insertables, automated precision part component handling is becoming increasingly common.  Automating placement ensures that the component is in the same place every time, eliminating human error. 

2. Nano Dosing and Micro Dispensing

Nano dosing and micro dispensing are complex processes that require a high attention to detail. For example, many diagnostic devices use exotic reagent materials that are expensive - necessitating smaller dispense volumes and higher accuracy. When dispensing or dosing is at the micro, nano, or pico scale - automating these processes enhances quality control and precision. As a bonus, productivity is positively impacted through automation. 

3. UV and Thermal Curing

Crucial to medical device assembly, ultraviolet and thermal curing systems impact the reliability and safety of a product - from catheters to syringes and hearing aids. The systems ensure that materials are appropriately tailored for use by precisely controlling factors like curing time, temperature, and UV light intensity. Automating these processes allows for high-speed UV curing and controlled thermal curing, in addition to meticulous documentation of the processes for regulatory compliance. In other words, increased accuracy and productivity. 

4. Leakage and Pressure Testing

For patient safety and regulatory compliance, leakage and pressure testing are necessary for many common medical devices, such as catheters, ventilator tubes and other devices that transport fluids, gasses or come into contact with body tissues. Miniaturized devices are particularly vulnerable to even the smallest leaks, which can compromise functionality - all of which is critical for precise dosing. When this process is automated, assembly is not only streamlined but ensures proper documentation and improved accuracy. 

5. High-Speed Linear Handling

Referring to moving parts across a facility floor in a linear fashion, high-speed linear handling is beneficial to optimizing assembly, especially in cases where many steps are required in one facility. From inhalers to IVD test cartridges to insulin pens - medical devices continue to increase in complexity, requiring the integration of multiple stations for bonding, welding, testing or inspection. As an automated process, assembly becomes faster, more precise, and requires less intervention - critical when part placement is measured in microns and demand continues to surge. 

6. Soft and Delicate Part Handling

Many medical devices are fragile and require careful handling - particularly those that are miniaturized. Soft and delicate part handling can be tricky due to the nature of the part - consider contact lenses for example, which need to be placed in blister packs in a sterile environment. By meticulously automating the process, the part will be safe from damage. Automation can ensure that the highest level of care is taken with each individual part. 

7. Needle Assembly and Separation

[body] In needle assembly, separation testing ensures that there is no safety risk when the needle is used, meaning the needle does not detach from the hub of the device. This process becomes dramatically more complex when devices need to accommodate needles of varying gauge sizes and lengths. With a part as small as a needle, automating the process eases the difficulties that come with doing this by hand, and machine vision inspection systems provide tireless high-speed inspection/testing and documentation capabilities. 

8. Automated Optical Inspection (AOI)

Automated Optical Inspection is often used in medical device automation to detect defects and ensure quality, and has become essential as devices increase in complexity and shrink in size. AOI is used to ensure quality for products ranging from insulin pumps to surgical instruments. The high-tech cameras can detect issues like cracks, surface irregularities, assembly misalignments and missing components without the need for manual inspection. AOI systems are typically paired with robust data logging systems for regulatory compliance and process improvement. This detailed approach ensures products are of the highest quality, without inconsistencies or misplacements. 

9. Cleanroom Assembly Operations

Cleanroom environments are often essential for medical device assembly - particularly when implantables such as stents, drug delivery systems, or catheters are produced. Automation can significantly reduce the need for a human presence in the cleanroom environment - minimizing the risk of contamination. Understanding the intricacies and requirements when automating cleanroom assembly operations is crucial to upholding a high level of quality and safety. When cleanroom assembly operations are automated, productivity, precision, and repeatability are positively impacted. 

10. Packaging

Automating the packaging process can directly improve the overall operations of assembly. Medical device assembly receives an outsized benefit from automation compared to other products, as it frequently involves multiple stages of packaging (primary packaging - inserting a product like a contact lens into a blister pack; secondary packaging - bundling multiple sets of contact lenses into a carton, and tertiary packaging - palletizing many cartons of contact lenses for shipping). Further, it may be necessary to package instructions or other components for a kit - or the product may have strict environmental tolerances that must be maintained during packaging. When packaging is automated, traceability and tracking become easier as a result. For medical devices, there are many standards and requirements for packaging. Automation ensures sterile and safe handling of products. Additionally, automated packaging allows for packaging multiple products and multiple variants.  

Our expert engineers at  JR Automation will create a custom solution for your medical device assembly automation needs. Automating your processes is crucial to keeping up with the demands of medical device manufacturing. 

Explore Our Custom Automation Solutions for Medical Device Companies