Automated Medical Device Manufacturing Benefits

Are You Missing Out on Automated Medical Device Manufacturing Benefits?

When you hear the word “automation,” do you feel drawn in or pushed away? We find that automation can mean a wide variety of things to different people. To industrial manufacturers specifically, automation tends to either represent an opportunity to trade human inefficiencies for machine reliability, or instead represents an overhyped Silicon Valley trend that costs too much for too little payback.  In this article, we’ll explore automated medical device manufacturing benefits, reinforced by direct feedback from our medical device manufacturing clients.

The Case for Automation 

What do we mean by “automation” anyway? It’s useful to start with a definition so we can focus this conversation on its most relevant features.  To us, automation is conceptually a technical philosophy that examines human workflows and solves for ways to offload portions of this work onto digital or mechanized devices instead. In industrial manufacturing, you can apply this philosophy to practically any step of the production process: If a given task performed by an employee is more a function of physical labor than creative invention, it’s a good candidate to be performed by an automated machine instead.       

Manufacturers of all types apply automation to their production schemes in order to address a number of modern concerns, namely reducing labor demands, improving working conditions and increasing yields. The counterpoint to automation is often considered to be cost. The investment in a sophisticated machine (and the personnel or vendors required to maintain it) can be quite large compared to the salary of a median-skill employee or two.  As automation costs naturally fall (as a function of economics driving down the costs of maturing technologies), manufacturers are increasingly likely to explore and adopt solutions, if not for individual assembly functions within their lines, then for entire lines or processes front-to-back.    

Automation can also refer to the software end of things, and at times gets quite a bad rap.  Silicon Valley entrepreneurs are increasingly found venturing into industrial manufacturing, attempting to create apps, software-as-a-service platforms, industrial-internet-of-things (IIoT) families and Arduino-type, low-cost PLC replacement technologies. For this article, we’ll focus mainly on the equipment, machinery and industry-standard PLC automation side of things, and leave the digital, web-enabled realm for a future discussion.   

Medical device manufacturers in particular find automation to be a key strategy in addressing today’s market challenges. The benefits of automated medical device manufacturing help alleviate these pain points: 

• Blistering demand crossed with cost-sensitivity inflation concerns
• Increasing regulatory scrutiny underlined by consumer transparency expectations
• Raw material supply constraints (including labor) exacerbated by resource trade tensions

To further this point, let’s take a look at specific benefits that automation offers to medical device producers below.      

Medical Device Manufacturers’ Perspective 

Looking back at our projects in the medical device field, we find many overlaps in our clients’ feedback, enough that we started to poll trends. Coming directly from medical device manufacturers upon completion of an automation project, here are the most common benefits delivered, in their words.    

Regulatory Compliance

Automating a process step or line with a PLC-based platform instantly provides a data acquisition source that can be used for documentation, recordkeeping and analytic functions as well. For example, introducing an automated leak detection system into a production line digitizes the test pass/fail result, all of the sensor readings throughout the test and the calibration of the instruments themselves. This information can be used to automatically generate regulatory compliance reports, traceable right down to an individual serial number or batch lot, without human involvement.    

Quality Control 

In a process where an assembly step is first performed and then later separately checked for proper completion downstream, there is a good opportunity to build this step’s quality control check right into the performance stage itself. For example, precision fastening offers a good case of how this can be achieved. Using an automated fastening tool station, the system can monitor, measure and document both the applied position and torque values of a given fastener as it’s being installed. The system can alert a QC pass/fail condition immediately and can even be programmed to automatically revert and re-attempt the assembly step.  

Modularity and Flexibility 

When examining a manufacturing process for automation opportunities, one strategy is to look for steps or sub-processes that are common across many product types or which are repeated multiple times in a given part. Pulling out these repetitive tasks and automating them into a standardized machine solution affords a step in the direction of having a more dexterous, modular line that can be quickly changed over to new products or design versions. For example, a single automated nut insertion machine can insert a nut into a medical instrument in two stages; first on its backplane and second on its outer housing. Further, as demand increases, a manufacturer can add a second identical machine to double the capacity of that process step.  

Labor Offset 

Automating away human jobs is a touchy subject, no question. However, we see this topic entirely as an opportunity to support our workforce, not impede it. Medical device manufacturing line jobs in many cases consist of high precision, sedentary, repetitive work: not exactly the type of work that an employee may love to do long term. The more manual and repetitive the task, the better the chance to automate it. More importantly, the better the prospect of improving an employee’s working conditions by cross training him or her into more critical roles in the company. These types of roles cannot be automated and require an intuitive, creative, conscious decision maker. Our clients’ line employees have all praised the change from tedious labor to automated machine operation, driving their career development, functional knowledge and time for higher-level tasks.    

Sustainability and Responsible Manufacturing 

Solving a manual production step with an automation solution certainly helps the line, but can it help the bigger picture? Consider your yields. Your medical device line has a particular reject rate, a certain amount of raw material waste and an amount of energy consumption built into its operation. Automating process steps allows for optimization in all of these areas. The net result: a more sustainable, responsible, efficient process. If you continue down this line of thinking, the potential for reduction is hard to ignore. For example, automating entire process sequences can allow for lower levels of cleanroom operation, in that you’ve removed humans from the area entirely. This change saves operating costs and a host of wasted commodities such as sanitation supplies, smocks, hairnets and more.  

More Automated Medical Device Manufacturing Benefits

The above benefits are just a sample of the potential that an automated medical device manufacturing solution can offer your business. To learn more about our success in the medical device field, please see our website here, or contact us for a complimentary application review.