Tech Talk: Technologies Used in Assembling Medical Devices

Assembling medical devices is an industry found at the crossroads between bleeding-edge science and tried-and-true fabrication processes. There are only so many ways to build a particular plastic, electronic device – the form that most modern medical devices take. That said, the technological breakthroughs in medical devices are often found in the internal design of the product (being smaller, lighter and more energy efficient), as well as in the intended application (taking new approaches to treating conditions).  

For manufacturers of these devices, the technologies employed to produce these novel solutions can be broken down into three categories: business infrastructure technologies, manufacturing process technologies and quality assurance technologies. As devices themselves progress, so must these three manufacturing domains. Here we introduce examples of each category so you can become more familiar with the ways medical device manufacturing technology is evolving.

Business Infrastructure Technologies 

Let’s start by looking at a few facility technologies that a medical device manufacturer utilizes. These infrastructure systems make up the “brick and mortar” side of the manufacturing business, and are where many new technology advances seek to improve the reliability and continuity of our medical device supply chain.  

• Controlled atmosphere manufacturing areas are most well-known as clean rooms and white rooms. These designations are defined by ISO 14644 classifications (e.g., ISO 1 through 9, with ISO 1 being the most stringent standard and ISO 9 being the least stringent).
• Access control and security technologies, such as key pass and closed-circuit camera systems, used to assure the safe storage and handling of materials by approved personnel only, while actively restricting access to sensitive areas for all others. 
• Hygiene and sterility systems take many forms from gowning and handwashing equipment in specially-designing hygienic entry rooms, all the way up to material irradiation tunnels that disinfect incoming raw materials entering a manufacturing process.

As an example, medical device manufacturing facilities with robust atmospheric, material flow and sterility systems in place allow for fast product change-over and line retooling for emergent needs. This factor played a paramount role in the recent urgent mass production of vaccines.

Manufacturing Technologies 

While it can be said that there are only so many ways to drill a hole or cut a sheet of plastic, manufacturing technologies still see continued improvement even today, especially in the form of advanced automation and novel materials. Common equipment and processes used in assembling medical devices are:  

• Cutting systems used to initially size raw materials (e.g., die cutting, press cutting, tube cutting, scarfing).
• Forming equipment used to shape raw materials into their final profiles (e.g., punching, molding, bending and thermal tipping).
• Joining systems generally used to bond separate pieces of an assembly together (e.g., ultrasonic, spin, RF, induction or laser welding; adhesive or solvent bonding; sealing; soldering; and heat staking).
• Surface treatment solutions that treat the outside surfaces of a final product, adding functional or environmental protection to the assembly (e.g., lamination, chlorination, coating, dipping, printing).
• Testing solutions that perform critical evaluation of finished products, making sure they satisfy all requirements and will be safe to use (e.g., pressure decay, hermetic leak, electrical, compression/tension/stress, functional).
• Packaging systems that wrap the finished product into a packing container, protecting the device during its trip to an ultimate end user (e.g., sealers, sleevers, cartoners and many more, with special requirements such as meeting ISO standard #11607-1:2019-Packaging for Terminally Sterilized Medical Devices).

Quality Assurance Technologies 

Manufacturing medical devices has just as much to do with managing out risk of product failure after a product leaves the facility, as it does with managing risk within the manufacturing line. To address both, quality assurance (QA) technologies provide sophisticated, proactive methods in maximizing process and end-use outcomes. We might consider these to be technology solutions, as they are partially rooted in physical testing equipment and on-machine instrumentation. Also, QA solutions are usually operated as technological systems needing constant maintenance, inspection and testing. Common QA systems used in medical device manufacturing include:  

• ISO 9001 quality management systems used for overall business management.
• Specialty ISO-compliant and certified quality processes, such as ISO 13485 (Medical Device Quality Management Systems) and ISO 14971 (Medical Device Application of Risk Management).
• Statistical process control (SPC), which provides a data-driven approach to continuous process improvement, waste reduction and overall quality improvement.
• Robust validation batteries, such as the IQ/OQ/PQ (installation, operation, performance qualification), that model, test and confirm a manufacturing systems’ ability to produce quality products.

Medical Devices Technologies for You

Automated Machine Systems (AMS) is an industrial automation integrator in Cincinnati, Ohio. We specialize in advanced automation solutions for medical, plastic processing, consumer goods and transportation industry manufacturers. With 99.5 percent on-time delivery, 97 percent customer satisfaction ratings and 24/7 service, AMS is your partner for industrial automation. To chat, reach us at (513) 771-3525, or book a meeting with one of our application engineers.