Talk about model employees.

Such workers are a rarity these days, as low unemployment, generational shifts, skills shortages, entrepreneurialism, and a gig economy make it difficult—if not nearly impossible—to find good talent.
GE Healthcare, however, beat the odds with one of its more recent hires.

YuMi joined the multinational firm roughly 12 months ago, and henceforth has never been late for a shift, never complained about management (or co-workers), and has never asked for a raise. YuMi also has never taken time off.

Perhaps most impressive though, is YuMi’s impeccable performance record: She’s logged more than 2,100 hours on the factory floor without incident.

If only all workers were more like YuMi.

They certainly could be, though they’d lack integrity, communication skills, critical thinking abilities, and creativity.

Basically, they’d be devoid of a personality, like YuMi.

Like most robots.

Technically, YuMi is a cobot—an artificially intelligent droid that interacts with people (robots, contrarily, are autonomous machines requiring no human interaction). YuMi “works” on a prototype assembly line at GE Healthcare’s Helsinki, Finland, facility, which makes patient monitors and gas measurement modules used in ventilators and anesthesia delivery solutions.

Developed by global technology firm ABB, YuMi was designed specifically for small parts assembly. GE Healthcare chose the IRB 14050 single-arm YuMi to help build an advanced battery component for a new product prototype because it was better at spreading glue than its human counterparts.

“We needed to add a gluing step to the assembly process that was extremely difficult to carry out manually,” Teemu Äärynen, advanced manufacturing engineering program leader for GE Healthcare, Finland, said in a case study posted on ABB’s website. “A cobot solution was the ideal way to automate this task, and we were able to program the cobot for prototype assembly very quickly.”

YuMi is a one-armed version of its dual-armed sister (the IRB 1400 YuMi cobot), born in 2015. It was intended to closely and safely interact with people and help reduce entry barriers for potential new cobot users, especially small- and medium-sized enterprises, according to ABB.

Such barriers need to fall to accommodate the surge in medical device developers pursuing flexible, reliable, and creative manufacturing options. Automation—via cobots (and robots)—is becoming a standard industry solution as medtech products become ever smaller and more customized.

Besides streamlining the production process and maximizing output, cobots and robots can help the medtech sector achieve smart manufacturing solutions that prioritize fundamental value propositions like digital validation practices, compliance management, big data analysis, and cost mitigation.

Cobots and robots are just one of many solutions to which medtech companies are turning to improve their manufacturing processes. Medical Product Outsourcing embarked on a fact-finding mission over the last few weeks to discover other methods manufacturers are using to enhance their assembly and automation processes. The magazine spoke to various experts, including:

• Henry Chou, product marketing specialist at Chieftek Precision USA, a manufacturer of linear motion components for medical and surgical devices.
• Benedikt A. Hoell, R&D director; and Leonard P. Zuba, vice president of sales; at Raumedic Inc., a Mills River, N.C.-based manufacturer of polymer components and systems for the medical device and pharmaceutical industries.
• Hadi Lalani, vice president; and Luis Valdez, engineering manager; at Applied Manufacturing Technologies Inc., an Anaheim, Calif.-headquartered manufacturer of automated and semi-automated custom machines and robotic part handling systems.
• John McGrane, marketing communications manager at Acme Manufacturing, a maker/provider of robotic finishing systems and precision centerless grinding machines. The company is based in Auburn Hills, Mich.
• Craig Occhiato, field segment manager, Micro, at Burkert, a global manufacturer of measurement and control systems for liquids and gases.
• Doug Swanson, president of Swanson-Erie Corporation, an automation solutions provider for various industries. The Erie, Pa.-based firm provides specialized tooling and machine solutions for automatic assembly, processing, and inspection.
• John Wuschner, vice president of Engineering and Quality for Kahle Automation, a worldwide supplier of high-speed automation and process equipment for the medical device, pharmaceutical, and healthcare industries.

Michael Barbella: What current trends are shaping the medical device assembly and automation sector?

Henry Chou: The current trends are more towards [manufacturing] automation and [device] miniaturization.

Hadi Lalani and Luis Valdez: Some current trends in medical device assembly are process improvement; cost reduction; the use of automation, including artificial intelligence, vision inspection systems, robotics, and machine learning.

Some current trends in the automation sector:

• Re-shoring of manufacturing
• Increased focus on cybersecurity
• Traditional vs. additive manufacturing
• Importance of predictive maintenance
• Sustainable and environmentally responsible business practices

John McGrane: Customer processes are changing, they are making improvements to their castings and coming to us to assist with the final part finishing processes. We are seeing that new parts are requiring fewer finishing processes, and less work to finish the parts. Instead of six operations, we might only need two for some applications.

The overall manufacturing process has improved and there have been advancements in vision and part inspection. There is a move away from optical comparators to CMMs and 3D scanning technology to improve part quality, improve employee safety, and refocus the workforce.

Craig Occhiato: In POC [point-of-care] diagnostic devices we see pressure to move faster through the design and manufacturing process.

John Wuschner: During and as we exited the pandemic, we’ve seen an increase in the demand for syringes and needles with low dead space as manufacturers geared up to support the vaccination campaigns and use the vials to maximum efficiency. We have also seen a renewed emphasis on having the capacity to produce medical devices within a country’s borders to reduce the risk of supply chain reliance on foreign sources during desperate times. Government programs throughout the globe, similar to the BARDA program in the U.S., channeled millions of dollars in support of this endeavor, and not surprisingly, changed the financial analysis of many manufacturers, resulting in a robust period for our industry over the last two years.

Leonard P. Zuba: Although not necessarily a new trend, customization continues to drive innovation. Optimizing tactile device operation may depend on material choice and part geometry, but the consistency of operating the device will certainly be enhanced by some level of automation.

Barbella: What factors are driving the need for automation in medical devices?

Chou: The need for speed, repeatability, and skilled personnel in other areas.

Lalani and Valdez: There are several factors that drive the need for automation in medical devices: process improvements, cost reduction, reduced worker fatigue, increase in throughput, quality improvement, big data, managing data for manufacturing, and generating accurate metrics.

McGrane: Automation has become the answer to solve labor shortages and ensure quality parts. The repeatability of robots is unmatched.

Occhiato: COVID-19 POC is still driving demand for POC devices, and that continues to drive automation. For fluid handling, the challenges are the same—smaller volumes, higher accuracy, and lower cost.

Wuschner: The disposable nature of so many common medical devices will often lead to automation of the assembly for the sole reason of supporting the supply chain effectively. Labor cost savings will of course always be a factor, and also process capability can be better controlled. Tubing sets, for example, are a traditionally labor-intensive product difficult to automate and have often been produced in lower labor markets, but the quality of the output highly depends on the experience of the assembly technician and is subject to many more noise variables. Automating processes like solvent bonding, coiling, and taping can yield higher outputs in terms of product quality in addition to pieces per person-hour, and for these reasons we have seen an increase in RFQs in this area.

Zuba: Although automation is commonly associated with higher volume applications and cost reduction, it is also driven by requirements for tighter tolerances, miniaturization, and the current tight labor market.

Barbella: How has the increasing penchant for disposable devices affected medical device assembly systems?

Benedict A. Hoell: The disposable market historically has been a very cost-driven market. Today’s economy, which has been heavily impacted by labor shortages, inflation, and supply-chain disruptions has posed additional challenges to suppliers and manufacturers of disposable devices to remain competitive and a reliable source. Automation, therefore, is becoming even more important for medical device assembly systems, as it will enable manufacturers to provide customers with a reliable product supply, both on time and with consistent quality.

Lalani and Valdez: The increasing penchant for disposable devices has affected medical device assembly systems in the following ways:

• An emphasis on environmentally friendly manufacturing process.
• Since products are single-use disposable devices, there is now an emphasis in product manufacturing efficiency and lower costs.
• Reducing machine product waste.
• Safe recycling of disposable devices.

Occhiato: Devices using disposables are not new, but we are seeing an increase in projects to pneumatically move and control fluids in disposable cartridges for medical device analyzers and POC devices.

Wuschner: As disposable device volumes increase, so does the need for more efficient automation, and with that come design considerations. Machine efficiency can be greatly improved by designing the components with automation in mind. Fast-cure adhesives that are easily dispensed (or components designed with integral fastening), design of components for more robust feeding, material selection for bonding, etc. all play a part in the uptime and yield of the equipment.

Barbella: What are some of the more challenging aspects of medical device assembly and automation?

Chou: The challenging aspects arise from finding the necessary components to make your machines, some of which are available from only a few companies.

Hoell: There are a variety of challenges that manufacturers are facing. Some of them are driven by external factors such as the state of the economy or supply chains, others are driven by product design and complexity. Therefore, it is immensely important to focus on a good planning phase for any assembly or automation project early in the development cycle. Some product designs may not be suitable for full automation and may require manual labor. A good design for assembly analysis will be key to identify potentials and make sure that the eventual product will be a success.

Lalani and Valdez: Some of the most challenging aspects of medical device assembly and automation are the initial design review (plan for future or additional processes), review of best practices for process control, planned intervals for preventive maintenance, and the manufacturing of specialized tools (both modular and custom).

McGrane: Costs are being reduced with abrasive media life management, and newer technology is allowing parts to be closer to a finished good, requiring reduced finishing processes. Other challenges are reducing scrap, employee turnover, safety, increased throughput, defining a new standard quality of part, and parts subject to human error being verified as quality.

Occhiato: As medical devices move toward point-of-care, home-based and wearables, adding more sensors (smart sensors) is necessary for safety to monitor the process and/or the patient. Some fluid automation challenges we overcome is dosing and measuring lower volumes, leak and bubble detection, and measuring analytics like pH and conductivity.

Doug Swanson: The current disruption and uncertainty within the supply chain of critical materials and components, particularly electrical and controls related, coupled with prolonged end user action, is prophesized to be detrimental to the ability of (all) automation suppliers to do their job on a timely basis, and at the lowest cost. In some ways, it’s reminiscent of the prelude to the mid-1970s. It’s dangerous to postpone decision-making. It predictably drives up cost, slows and makes uncertain program success, stifles innovation, and discourages the most talented, making them susceptible to other professional pursuits.

Wuschner: Miniaturization of components to support wearable devices and handheld analyzers is common and has generated increased pressure on component and automation suppliers. For example, what was once allowable flash is no longer tolerable. Feeders now require higher precision tooling since small variations in a track are now a larger percentage of the total component size and more easily cause jams.

We recently delivered a machine to assemble extremely small needle assemblies. The cannula were oriented radially and press-fit into a roughly 5.0-mm square cube, glued, and cured at a rate of 450 ppm. The cannula are 18G x 6mm long and even the cannula manufacturer had trouble handling the material. None of the existing feeding and handling methods worked effectively at this short length. To meet this challenge, we created a new method of feeding and orienting that was specific to this particular cannula. A separate development took place to determine the most practical method for press-fitting the cannula that would prevent blockage, since the ID flow is very critical in the final application.

Old paradigms had to be set aside and extensive development was undertaken to first singulate from bulk, then orient axially, and finally radially. A pilot system was developed to prove the development on a larger scale first, then the production line was built and is now operational on the customer’s floor.

Higher-precision tooling and components also require changes from the customer regarding their approach to training on the equipment as well as the skill level of the support personnel. As machines become more sophisticated, machine technicians must become more system-oriented in their approach to troubleshooting. The diagnostic tools they will use require a higher level of understanding and the solutions a more delicate approach. Manufacturers should be investing in early STEM programs in their local areas as well as trade-schools and apprenticeships in the same way the machine tool industry once did.

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

Chou: Industry 4.0 would allow manufacturers to increase productivity by lowering guesswork on stock and other necessary items by having a real or near real-time status updates.

McGrane: Industry 4.0 allows manufacturers to track machine productivity and part quality. It provides them with the capability to meet production demands, understand where quality improvements are needed, and reduce bottlenecks.

Quality parts—there’s more data provided on a knee than with automated finishing methods. Manufacturers can now see where part quality issues might arise. Vision and inspection of parts has helped improve this. Industry 4.0 technologies also provides confidence and integrity to doctors that the parts being installed are quality and can be trusted.

Wuschner: The building blocks are already here. Each manufacturer has to perform an analysis of their products, processes, and operations to determine if the implementation will generate the added value. For the technologies to yield the most benefits, this may mean more than connected equipment. It could also mean product/process design changes to support the efficiencies expected, and the design control and validation costs associated with that all have to be factored into the analysis.

Barbella: What factors should be considered in choosing an automation or assembly partner?

Chou: Reliability, availability, and accountability.

Lalani and Valdez: Chose suppliers with specific areas of expertise—i.e., subject matter experts. And pick a partner that is open to new ideas and is not against looking into current and/or old problems.

McGrane: When looking at automation, it is important to understand the partner’s track record, what they are known for, what types of projects they can do successfully and have running in the field, and how long they have been in business for. Another consideration is whether the partner is RIA-certified and can ensure that proper safety measures are being taken to reduce liability. Also of importance is ISO certifications and other certifications that might be required by the customer. Does the integrator comply with their requirements? The ecosystem of the partner is crucial as well—who are they working with and who will be able to support the customer? Automation systems involve many partnerships; choosing the right integrator is also choosing their network of partners to ensure a successful project.

Occhiato: With today’s unemployment issues and supply chain shortages, I would look for a financially sound partner that can provide the following internal resources:

• Manufactures a majority of their products from raw materials
• Has experienced staff capable to design and manufacture products
• Has quality products and processes
• Available building space

Swanson: Consideration in choosing an assembly/automation partner is manifold, but remains basic. The recognition of a true partner relationship goes in both directions. And, such a combination includes competence, durability, demonstration of technical achievement, and currency of management teams from the vendor’s side. Equally important, the same attributes must be questioned from the buyer’s side. Can they address the myriad of questions to be asked on a timely basis? Do they have the back up of top management? Lastly, are funds available on a timely basis for the specific program?

Wuschner: Ideally, manufacturers should be looking for a partner that has experience building automation for similar products. Very often, there are solutions already available and tested and for which the experienced automation company has a proven capability. Additionally, when dealing with medical device products, having a partner who can perform a full IQ/OQ validation package can save a great deal of time and resources once the machine is installed. The company’s technology portfolio should have a wide range of options to draw upon with a resource capacity (people and floor space) to support multiple projects at a time. Depending on the size of the project, manufacturers should also consider whether the project is the right size for the companies being considered, so there is no concern for cash flow throughout the project (smaller companies doing large-scale projects) or excessive overhead (larger companies doing small-scale projects). They should also take care that all the companies under consideration are similar in size, so that the relative overhead costs will be similar when comparing pricing options.

Zuba: A discerning customer should look for partners with demonstrated technical prowess and a collaborative approach to product development. A global footprint is usually beneficial for international companies but is often also valuable for smaller organizations as they scale operations and/or expand markets.

Barbella: How might medical device assembly and automation evolve over the next half-decade?

Hoell: Assembly and automation will continue to grow in importance, especially for contract manufacturers as OEMs are likely to further consolidate supply chains. The more vertically integrated contract manufacturing partners are, the better they will be suited for a successful partnership with an OEM. Specifically, this will require the ability to assemble more and more complex devices or sub-assemblies and maintain a reliable product supply. Automation is only one way for many to succeed, but certainly one that has already proven to be a viable option either for actual manufacturing or for quality inspections.

Lalani and Valdez: Smart machines—quality, consist data, etc., big data (managing data specifically for manufacturing), best practices, active participation of all stakeholders, and enhanced cybersecurity.

McGrane: A change in implant materials. Media/abrasives will continue to advance, creating new ways to finish parts. Auto-generated robot paths will be able to finish the part without the need for extensive robot programming.

Swanson: In forecasting the future of medical device mechanization/automation, several factors stand out:

• Increasing reduction within the qualified medical components automation suppliers: the big ones get bigger and more costly, opening the way for lesser funded spinoffs.
• Greater standardization of basic machine platforms and tooling (e.g., robots) resources.
• Improved functionality, but longer lead times for all electronics contained in machines, at least for controls and data recording/reporting needs.
• Infrastructure(s) limitations.

Wuschner: I think in the short-term, we will continue to see growth of automated capacity in areas that support medical countermeasures, principally against pandemic influenza and emerging diseases. Governments are still putting money towards this. Along with that market growth, non-traditional markets for automation (lower volume, high complexity products) continue to be pressured to reduce cost and increase throughput. Look to see some technical boundaries pushed over the next few years as these difficult to automate projects come along. The companies who are willing to support DFA redesigns are the ones who will get there first with the least pain.