Mechanizing Medtech Mfg with Assembly & Automation

Investment in assembly and automation for medical device manufacturing is on the rise. And for good reason—by streamlining production through automation, manufacturers can produce high-quality devices at a quicker pace while lowering costs.

Medical device manufacturing necessitates a great deal of precision and accuracy because they affect patient health and well-being. Using automation technology like robotics and machine learning can help manufacturers produce products with minimal intervention by humans. These machines can make assembling tiny components easier.

Automated inspection systems can also make sure every product is checked for quality before being sent to customers, helping reduce errors in production that could cause costly recalls or harm patients.

Automation extends beyond robotics. It’s the creation and application of tech to manufacture with minimal human intervention, which spans from semi-automated to fully automated. In general, automation processes are designed to perform repetitive tasks like sorting, picking, placing, processing, assembling, inspecting, packaging, and labeling.

It can be most effectively used where there’s repetitive motion, a requirement for environmental and process control, or a necessity to minimize the work method’s variation.

The cost of products made using automation is likely to be lower because of a reduced labor overhead as well, allowing for a more competitive price. The likelihood of a quality issue can also be reduced because there’s less of a chance an issue will arise due to a training issue, a variation in skill set, or ability gap in the workforce.

Assembly and automation technology has become accessible to organizations of all sizes, opening up new possibilities in medical manufacturing. In addition to robotics, product lines can be advanced by implementing technologies like intelligent vision systems, smart sensors, digital twins, and energy monitoring. These will be vital to help medical manufacturers future-proof their processes by increasing efficiency and boosting sustainability.

In order to explore this topic, MPO reached out to several industry experts over the past few weeks, including Dr. Brian Romano, director of technology development, and Mark Paggioli, VP of Sales & Marketing, at a Bristol, Conn.-based developer of tailored assembly machinery solutions.

Sam Brusco: What market forces are impacting assembly and automation for medical device manufacturing at present?

Dr. Brian Romano: We see a trend of medtech assembly companies “de-risking” capital expenditures by starting with a more organic development of their product lifecycle. With the current cost of capital, companies want to ensure their investment will have the real ROI and ROA baked into the overall product manufacturing scope. Aggressive marketing projection estimates have caused companies to react to buying full-scale automation without taking the progressive steps of development related to their product lifecycle, while also considering their ability to sustain the complexities related to higher levels of automation.

Part of the reason for this is the workforce shortage and skills gaps. With the baby-boomer “silver tsunami”, Covid, and the “great resignation,” there’s a shortage in the workforce that had been in place to set up and sustain automation equipment operations.

Coupled now with the skills gap, resulting from the lack of students going to schools with automation curriculums (at any level), there’s a large hole in the overall workforce needed to design, operate, and sustain automation machinery.

There are initiatives to solve the delay between today and when a properly educated and trained workforce is available and a gap has formed between these. This gap has forced companies to rely more on OEMs and systems integrators to control the equipment’s maintenance and operational upkeep.

Brusco: What new innovations have been developed for medical device assembly and automation? What specific market needs do these innovations address?

Mark Paggioli: The increased focus on the use of data and optimizing OEE with monitoring being provided to help maximize value has become more popular. We see more need for obsolescence assessments, especially now as tech is changing more rapidly.

The desire to better understand production, outputs, and paybacks have also become more common. Product change and shorter lifecycles changed the way companies evaluate automation equipment. Remote service has become more sought after to help customers rapidly address any issues, keep things running, and minimize downtime while keeping production levels high.

The market needs, as I have been seeing it, a way to help companies with automation equipment needs and an approach that accounts for the speed of product change when accurate product forecasting is getting harder to do. There’s more demand for new lines that are smaller or producing lower volumes than was once wanted and the higher costs for smarter products has caused a more conservative approach to new lines. It’s part of the de-risking approach, which has companies wanting to better understand productivity and volumes, especially if tech will change more rapidly in the products they supply.

Brusco: How can medical device manufacturers leverage Industry 4.0 technologies to build flexible, agile factory floors?

Dr. Romano: Industry 4.0 and Lean manufacturing have common elements where data-driven decisions are key and where Deming’s Plan, Do, Check, Act and Lean Six Sigma’s DMAIC (Define, Measure, Analyze, Improve, and Control) emulates the technology needs to acquire data, analyze it, and apply the learning. This iterative learning cycle, in my opinion, is a key differentiator between what is now defined as Industry 3.0 capabilities and Industry 4.0 outcomes. Of the nine accepted pillars of Industry 4.0, seven can be directly applied to the support of the medical device manufacturing floor, with the last two, autonomous robots and additive manufacturing, having possibilities to augment production. The premise of Industry 4.0 technologies is to connect the full enterprise by connecting the supply chain and the customers. This is an all-encompassing proposition requiring buy-in and resources.

Additionally, by leveraging the network and data infrastructure needed for an Industry 4.0 implementation, medical device manufacturers can monitor production data while using tools like AI to provide insights into production anomalies and bottlenecks, as well as recognize trends based on historical data to generate predictive maintenance and prescriptive handling of the identified issues.

This connectivity also enables OEMs and systems integrators to provide remote support for the production equipment. One of the pillars of Industry 4.0 is augmented reality; this functionality allows plant floor technicians to engage with the engineers at the OEM or other support personnel. This provides more rapid support, reducing downtime and retaining higher OEE levels.

Click here to read the full article with responses from all of the panel of experts.