Plaguing the tech and medtech industries, layoffs have put a harsh spotlight on the realities of running such a company during unsteady economic conditions. On the other hand, medtech manufacturing, which some are toting as currently “recession proof,” continues to see labor shortages of skilled workers, delaying output timelines. That said, even with two vastly different problems at hand, automation could become an alluring prospect.

To understand the benefits and challenges of investing in automation during unstable economic times, MD+DI spoke with Rich Warren, chief commercial officer of Medical Manufacturing Technologies (MMT), and John Hatzis, tech consultant - global industry at Rockwell Automation. The two experts highlighted potential return on investment timelines, the industry outlook on the historical adoption of automation technology, and the ever-evolving developments in technology and design pattern.

What new automation technologies are out there?

Warren: Automation is continually evolving, and some of the recent and interesting developments have been around machine learning in the vision inspection fields. We see increasing demand for these types of solutions in both MMT’s equipment line and within our automation division. Where previously vision inspection was centered around controlling dimensional characteristics or specific features detection (or lack of that feature!), machine learning allows for inspection of characteristic that could be described as subjective such as uneven braiding. The implications for product quality are profound: human visual inspection, especially 100% quality control points are inherently challenging due to issues such as fatigue and differences in training to name but 2 examples. This ability to improve quality with this technology has the potential to make a meaningful change here.

Hatzis: With Pharma 4.0, several new technologies and design patterns exist. Most producers are working towards accelerating their digital maturity to a connected plant which includes:

Has medtech been an "early adopter" industry for automation, or is it lagging behind other advanced manufacturing sectors?

Warren: The medtech industry has seen pockets of automation adoption but certainly not on the scale or depth seen first in the automotive industry, electronics, or pharmaceuticals.  This is a case of Ester Boserup’s “Necessity is the mother or invention” (or adoption!). The automotive, electronics and pharmaceuticals industries were driven by some similar factors (efficiency, cost, and quality) as well as their own unique challenges (miniaturization, contamination control etc). The medtech industry in no different: efficiency and cost are, of course, factors but the current labor constraints and the ability and need to incorporate advance quality inspections and leverage big data within the production floor - which ultimately drive patient safety - are all driving this. The medtech industry is continuing to demand higher levels of automation support from technology partners such as MMT which was why we were excited to announce the formation of the MMT Automation division recently to seemly link our end-to-end equipment offering on our customer’s floor.

Hatzis: I can say that Life Sciences in general has been reluctant to adopt more sophisticated automated solutions because of the regulatory scrutiny around validation of new technology. Pharma 4.0 has changed the game in that regulatory agencies have updated their guidance to be more agile with technology adoption while keeping quality and patient safety paramount, and thus, producers have more appetite to validate modern automated systems of manufacturing.

What are the benefits and challenges of automating medical device manufacturing?

Warren: The benefits to the medtech industry for automation fall in to three categories:

First and foremost are the patient safety / quality aspects where automation can deliver higher levels of repeatability, use data and machine learning for automation feedback and control, and can reduce human error in assembly and inspections while driving higher levels of regulatory compliance through process documentation and traceability.

The second area is in productivity: Within the context of the current labor constraints and the pressure from hospitals to reduce costs, manufacturers need to move to capture the productivity improvements provided through automation.

The third area is the ability to design and develop the next generation of complex products; miniaturization drove automation in the electronics industry, and more complex and smaller devices, beyond the scope of human assembly, will necessity automation.

A key challenge for the medical device industry will be automating legacy products: Two elements stand out here, firstly these products may not have been designed with automation in mind, meaning they were optimized for hand assembly and not machine assembly. People are incredibly adaptable and simple steps such and pick up and orientation might be easy for a person, but difficult to codify in an automated process - engineers have to consider design for manufacture and design for automation in their designs. The second challenge of automating legacy products will be the process validation changes that could be entailed.

Hatzis: Benefits are an increase in quality of product produced and higher productivity for less operational expenditure.
Challenges can be:

Each of these challenges can be overcome but needs to be part of a comprehensive design process between the producer and its chosen engineering firm and vendors.

Is automation better for certain products than others?

Warren: There is sometimes a misconception that automation applies only to high volume simple production. However, applying automation is much more diverse, it can be about solving a specific need such as assembling sometime too complex to be done by hand, or processing a part that cannot come into human contact.  We should think about automation as a broad set of tools in our toolbox with which we can solve a particular challenge, be it productivity, quality, or safety.  We see this in the MMT automation division, there is not a general type of product or process we see more often, rather our customers come with new and unique challenges that require custom solutions.

Hatzis: Automation can take a lot of different forms on a company’s digital maturity journey. Remember that automation can affect not only mechanized equipment but also workflows around materials and people interacting with the equipment as well. The process and the equipment and personnel available to produce a specific are a large determining factor in the type of automation a producer should implement.

How long does it take to see ROI on automation solutions?

Warren: There is not one answer to this question. The ROI depends on multiple factors such as the current costs, the product margins and the automation complexity.  With that said, I remember the first time I implemented a robotic process into a previously manual line when I was a General Manager. I had estimated a 1.5-year payback, and as my first foray in to automation was concerned for the success of the project.  The project paid back far faster, because, once the process was automated, we saw all the hidden costs and inefficiencies that were eliminated. As business leaders we have a responsibility to ensure the ROI meets expectations, but we should encourage our teams to quantify all the tangible and intangible gains of such projects.

Hatzis: Speed of ROI depends on the scope of the solution, which is why most projects take a minimum viable product (MVP) approach to show ROI early (2-6 months) and then scale out. Determining ROI and how to metric it is an important step in creating any capital project around continuous improvement because it frames success for both the producer and their selected vendors in clear terms.