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Medical device testing and the continuous momentum to automate

Medical device testing and the continuous momentum to automate

Paul Schaffner, director, test development, Benchmark examines the continuous momentum to automate manufacturing test in the medical industry, including the benefits of reduced labour cost but and reduced reliance on human action and judgement.

The technology industry in the U.S. has grown rapidly over the last ten to fifteen years. However, as more companies come to market with game-changing innovation, there’s also a significant shortage of skilled assembly talent. The inability to consistently find high-quality assemblers is creating a roadblock for design, engineering, test, and manufacturing providers like Benchmark, as well as for our customers.

Without the proper assembly staff, the ability to bring products to market quickly is hampered and new product introduction (NPI), including product testing, can be significantly slowed. To meet market demands, original equipment manufacturers (OEMs) are spending a great deal of time seeking manufacturing partners with the highest availability of talent. To serve our customers more effectively and alleviate the critical shortage of skilled labour, Benchmark aides our talent pool by implementing fully- or semi-automated testing processes.

The use of robotics and automation has been a growing trend in factories around the world for many years. Automated processes using robotics are rising in use on production lines, shipping facilities, and manufacturing plants. The ability to automate repetitive processes has created a more efficient and cost-effective go-to-market plan for many OEMs.

Medical device testing is an area where we are particularly seeing automation take hold and grow. For this highly regulated and complex industry, reducing human error with automation can mean the difference between success or failure in bringing the device to market. The proliferation of the miniaturisation of electronics in medical devices is also creating scenarios in which precision robotics is just better suited for the tasks required.

As this trend to automate more testing processes progresses, there are a number of pros and cons to implementing automation that are important to understand. First and foremost, it can be an expensive and time-consuming process. In today’s fast-paced and competitive technology industry, most OEM’s are looking for the quickest and most cost-effective testing process to get their product to market.

Determining return on investment (ROI) is also difficult. When we engage in a medical test project with a new customer and product, it’s difficult to tell how many test or inspection stops the product will have. This makes it difficult to calculate the immediate and long-term impact of automation.

Some organisations and product development cycles would benefit from a fully- or semi-automated test process upfront, while others may need more time to prepare before they implement it. There may be little doubt that automation will provide a positive ROI in the future, but how do you know if you are ready now? Ask yourself these questions:

Is my product proven?

By looking at the history of the production of your medical device, you’ll have a more accurate picture of when you will see a positive ROI on an investment in automated testing. If labour-intensive processes have already been identified, the automated testing process will be more efficient and less costly. If you’ve been manufacturing the product for a long time, you’ll also have the necessary data to determine exactly which test processes would be most beneficial. If the answer to this question is no, you’ll want to get more data to better understand the manufacturing needs for your product.

Are there miniaturised parts, optoelectronics, or any other processes that would be difficult for a human tester to manage?

The answer to these and similar questions may force your hand. If there are multiple components and processes that are too small or too difficult for humans, it may be a necessity to implement automated testing. A semi-automated test line could be more cost-effective and would allow you to utilise precision robotics for some of the more intricate and delicate processes. It’s imperative that devices for medical use work flawlessly. Manufacturing test implementation must be accurate, precise, and repeatable. This expectation places high demands on test hardware, software, and operability of test solutions.   

Is my product high volume? Or, are there multiple repetitive motions and assembly?

If you’re manufacturing a high-volume product, or if there are repetitive motions and assemblies in the testing process, automated testing will definitely provide a more immediate ROI. In this circumstance, automation will also allow you to move your talented operators off a repetitive task in the production line and into an area of greater need.

It’s also important to note that the only way you can accurately answer the questions above is if you have the correct data to track and monitor the product and test development process. Here at Benchmark, we use our own “Process Feedback System” which allows us to push manufacturing process data directly to our customers through a shared portal. We treat test no differently and leverage industry leading tools like TestStand from National Instruments to make a product’s pass/fail, parametric, and other test data available to all key stakeholders. If you are exploring automating test, it’s critical that you utilise a system that allows you to aggregate data to better understand the test processes for your device. With the appropriate information, you can more accurately determine what your short- and long-term ROI may be on an investment in automated testing.

Automation in the medical test environment is an incredibly powerful tool. It reduces error and reliance on assembly operator talent. Beyond filling labour gaps, it can provide productivity gains and floor space and material savings. In the long run, it can also significantly speed up your time to market. If it’s something that is feasible today, I recommend exploring that option.

If it’s not the right time to implement automation in your testing strategy, make a plan and schedule a review internally or with your manufacturing partner six months to a year after production begins to review the data. Once your product is on the market and you have enjoyed some success, you may be able to build on that momentum with an automated testing line.   

Either way, automation can help ensure the launch of your next product is streamlined and ready for market volume production. And if you’re in the process of selecting a new manufacturing partner, consider choosing one with in-house test development capabilities to get the most out of your investment.

Med-Tech Innovation

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