By Sean Fenske, Editor-in-Chief
 
Medical device manufacturers are facing an array of challenges, from material shortages to a lack of labor. The situation is causing companies to reevaluate strategies and supply partners. As such, they are exploring reshoring options, creating new hiring and retention policies, and expanding sourcing partners.
 
Another area being investigated is the incorporation of automated systems on the production floor. Automation solutions bundle a number of benefits with the technology, such as repeatability, quality, and speed, while also helping address labor shortage concerns. This type of equipment is not ideal for every medical device manufacturing application, however, so it’s important to know when it should be implemented and where.
 
To help clear-up any confusion whether automation could prove to be a valuable tool or an unnecessary expense, Matthew Knutson, VP of Manufacturing Operations at Donatelle, took time to address questions around automation. He speaks to the role it can play, addressing staff shortages, costs, and benefits.
 
Sean Fenske: Many view automation as a solution for high volume parts manufacturing and, as such, better suited to consumer industries and electronics, but not medtech. How do you respond to this?
 
Matthew Knutson: Automation can be a very effective option for medical device manufacturing. Flexible automation cells and collaborative robots can be good options where volumes don’t warrant dedicated automation lines for high-volume production. Integrating automation cells with primary manufacturing processes to perform value-added secondary operations can be an efficient method for leaning out a manufacturing process.
 
Fenske: As we face an ongoing labor shortage, how can automation help alleviate this challenge?
 
Knutson: Direct labor continues to be a constraint. In many cases, by deploying flexible automation, we have been able to reduce the number of labor units required for assembly, insert molding, and automated inspection. Our in-house automation resources integrate automation with primary work centers on many new programs. New programs are quoted with more automated approaches up front as compared to in the past where it was part of a continual improvement project.
 
Fenske: How do automated systems compare to human labor in terms of accuracy? Is quality compromised at all?
 
Knutson: It depends. In many cases, accuracy is improved because a robot is programmed to perform the same operation, repetitively, in the same fashion. There are no human-to-human technique differences, and throughput rates are maintained throughout the shift and production work order. Additionally, if there is inspection and testing involved, a properly validated system will consistently separate rejected product and discard in the intended container. This is difficult to guarantee with 100 percent human visual inspection.
 
There are still some applications where automating an assembly process would be very difficult and/or not cost-effective. In such cases, there may still be a need for qualified, highly trained operators to perform an operation. This is especially true when there are more subjective visual criteria involved.
 
Fenske: Is automation expensive? That is, when compared to using labor in low-cost regions, transportation of product, etc., how does automation compare?
 
Knutson: Automation can be very cost effective, if deployed correctly. Depending on the complexity of the process and products being produced, it may be highly desirable to not manufacture in a low-cost region. Automation coupled with efficiently designed manufacturing processes is a good way to be competitive with other regions of the world.
 
Depending on the quantity and complexity of automation deployed at a facility, there will likely be a need to increase the capabilities of the company’s automation technicians. Additionally, manufacturing engineers will have to gain a greater understanding of automation capabilities, limitations, and applications.
 
Fenske: What did we learn from the pandemic with regard to using automation? Were companies with an automated manufacturing floor able to better maintain on-time delivery or increase production as demand grew?
 
Knutson: Throughout the pandemic, medical device product demand remained strong. The shelter-in-place orders, remote work, and overall impact from positive cases and quarantines showed us that scaling up direct labor commensurate with customer demand and new program launches was more difficult than in the past. Additionally, work centers and production lines needed to be spread out to promote social distancing.
 
Certainly, the more flexible automation and robotics deployed in a facility make it easier to run at capacity since they are not impacted by the aforementioned pandemic constraints.
 
Fenske: Will automation likely be part of any near-shoring effort as companies continue to reevaluate the region of the world for their parts/manufacturing?
 
Knutson: Company leaders continually assess potential supply chain risks to their businesses. One important aspect of these risk assessments is the geographic location of their critical suppliers and business partners. The pandemic has indeed amplified many of these geographical risks, and prudent leaders may consider looking at redundancy and domestic supply options for critical materials and components. In some cases, domestic suppliers can close the cost gap between them and overseas manufacturing by deploying automated manufacturing solutions.
 
 Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Knutson: At Donatelle, we make products that enhance—and save—lives. We manufacture complex medical devices and components for low- and high-volume needs. That’s all we do. And we do it with the utmost precision, consistency, and rigor, because for you—and your customers—quality is essential. Reliability is a must. And delivering on what’s promised is vital.
 
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