The Illinois Science + Technology Park started with the former corporate headquarters of pharmaceutical giant G.D. Searle. The community of scientists, inventors, and innovators work from basic research through commercialization of medical devices, nanotechnology, bioscience, and emerging technologies.
Ann Arbor, Michigan-based EZset LLC has selected Hi-Speed Corp. in Thousand Oaks, California, as its exclusive West Coast manufacturer’s representative for high-precision, German-built tool-presetting machines. Hi-Speed has representatives throughout California, Arizona, Nevada, Washington, Oregon, Utah, Idaho, and Montana.
EZset tool presetting machines use an advanced vision system and image-processing software to measure cutting tools to meet accurate machining needs. Manufacturing organizations gain a rise in final-part quality and process efficiency, including extended tool life. Four models are available with a variety of measurement ranges and image-processing variations: ICbasic, IC1, IC2, and IC3. www.ezset.info/home; www.hispeedcorp.com
CNC Software’s 250,000th installation of Mastercam
CNC Software Inc.’s Mastercam software has become the first CAD/CAM software to reach 250,000 installations worldwide. The 250,000th seat was purchased by Roding Automobile GmbH, a division of Stangl & Co. GmbH Prezisionstechnik, a precision manufacturing company in Germany. www.stangl-kulzer.de/home-en www.mastercam.com IMTS 2018 Booth #133340
Tsugami/Rem Sales’ 40th anniversary
Since the start of the Tsugami/Rem Sales partnership in 1978, Rem Sales has been the exclusive source for Precision Tsugami CNC machine tools across North America. Headquartered in Windsor, Connecticut, Tsugami/Rem Sales, a division of Morris Group Inc., provides machine tools and engineering expertise through distributors and two technical centers in Fullerton, California; and Roselle, Illinois.
Tsugami/Rem Sales and Morris Group Inc. offer solutions such as the whirling unit for thread cutting and the Tsugami LaserSwiss machine line.
Rem Sales is celebrating its 40th year with Tsugami by adding to its engineering and project management staff – Swiss and universal product managers – adding new machine offerings to the market such as the Tsugami M08J, and integrating new technology options to Swiss-type machines including the MachineMetrics Remote Health platform for customer support and service. www.remsales.com IMTS 2018 Booth #339410
GF Machining Solutions expands distributorship
GF Machining Solutions has named Applied Machine Solutions Inc. (AMSI) its exclusive distributor and representative in Georgia and Alabama as of June 1, 2018 – expanding ASMI’s current territory of Florida.
This partnership with AMSI brings a wealth of industry experience, along with a large support team in the field and from its Ball Ground, Georgia, administrative office and show room. AMSI also has locally based equipment, tooling and consumables staff in coverage areas and continues to expand its service and support throughout the Southeast.
AMSI will represent GF Machining Solutions’ milling, EDM, and 3D laser texturing equipment along with its automation systems, parts, and consumables. www.gfms.com IMTS 2018 Booth #338754
Industry appointments
Index Corp. has hired three employees to its North American team. Jim May joined the company’s senior leadership team as marketing manager and will be replacing Gary Jones, who plans to retire in early 2019. Rachael Davenport joined as an application engineer, and Josh Julian joined as a project coordinator. www.indextraub.com IMTS 2018 Booth #338136
Giovanni Zunino has been appointed president of Prima Power Laserdyne, succeeding Terry VanderWert who retired.
Prima Power Division CEO Ezzio Basso says, “Mr. Zunino will continue Prima Power Laserdyne’s track record of strong global growth. He brings an extensive and successful career track record to the company that will ensure our technology position continues to grow in both domestic and international markets.”
During his 20-year career, Zunino held positions in platform management, program management, sales and marketing, proposal management, purchasing, and general management in the U.S., Italy, and France. www.primapowerlaserdyne.com IMTS 2018 Booth #236756
Methods Machine Tools Inc. has appointed company President Jerry Rex as president and CEO. Also, Dale Hedberg has been promoted to vice president of operations. Hedberg will be responsible for all of Methods’ operations including production, shipping/receiving, inside sales, trade shows, and continuous improvement. www.methodsmachine.com IMTS 2018 Booth #339119
Jim MayGiovanni ZuninoRachel DavenportJerry RexJosh JulianDale Hedberg
More than 25 years ago, an article in the MIT Sloan Management Review (tinyurl.com/y8azhv6p) looked at how Western manufacturers were using new techniques and technologies to improve manufacturing in response to international competitive pressures:
Two dominant manufacturing strategies have emerged. One is the just-in-time (JIT) manufacturing system… The other is the computer-integrated manufacturing (CIM) approach.
CIM links islands of automation, information, and advanced flexible production technologies throughout the company. Sounds a lot like Industry 4.0.
The article considers both systems’ impact on organizations, noting they share the idea that reduced system throughput time is key to improving manufacturing productivity. But there is one caution from the authors:
CIM implies many assumptions about the capabilities of information and flexible manufacturing technology as well as the outcomes of its usage… we believe that researchers and manufacturing managers should rethink the use of advanced technologies.
Wait, they suggested not investing in advanced technologies? Not completely:
It could be more productive to redesign the organizational structure before implementing available technology than to hope the technology will bring about manufacturing effectiveness. Investments in flexible technologies should then be considered as a last resort and used to handle variability that cannot be reduced through more efficient means.
This immediately made me think of IMTS 2018, because 25 years after this article, CIM is booming, only it’s progressed, been refined, and is referred to as Industry 4.0. Originating under a German government program promoting computerization of manufacturing, Industry 4.0 calls for creating smart factories through enterprise-wide automation, which can allow for development of new business models that may contribute to new ways of interaction across the entire supply chain.
With Costa Rica’s medical manufacturing market booming, manufacturer Okay Industries needed a competitive edge, something it achieved by becoming the first company in Latin America to invest in Tornos’ Swiss Nano capabilities.
“Our operation in Costa Rica has been growing steadily since we started in 2012. Costa Rica has a growing medical sector with many original equipment manufacturers (OEMs) here, so our Alajuela site positions us to collaborate closely with them and serve their needs,” the division’s general manager, Mario Chaves says. “Additionally, Costa Rica has an excellent pool of talent, from engineers to machinists, because we have a lot of good technical schools.”
A new level of precision
Adding the Swiss Nano was part of an investment strategy to continue going beyond the ordinary to meet its customers’ needs.
“Our Tornos SwissNano is part of our expansion project. We recently won two new, very good projects demanding an increased equipment investment,” Chaves says.
One of those projects is producing a 1.5mm x 1.5mm medical device used in breast cancer surgery. This requires taking precision manufacturing expertise to a new level.
“The SwissNano has already exceeded our expectations by demonstrating very good stability on the required part dimensions,” Chaves says. “In the perfect scenario, we will have some additional capacity with our SwissNano to win additional high-precision projects that we know exist.”
Moreover, the SwissNano, one of the most precise machines in today’s market, helps Okay Industries demonstrate value to potential customers. And that supports the company’s vision.
“Okay Industries will be the most trusted partner of custom-engineered precision components and assemblies by combining our 100-years-plus foundation in tooling expertise, our leadership in innovation, and our employees’ commitment to excellence.”
Getting started
Already experienced with Tornos’ Swiss GT 26 equipped with a gear hobbing device, Okay Industries turned to Tornos when officials decided to invest in a high-precision, Swiss-type lathe.
“With the Swiss GT 26, we are able to produce a plastic gear for a medical device and we have been able to cut our cycle times on specific parts by more than 50%,” Chaves says. “It was the performance of the Swiss GT 26 that led us to look at the SwissNano.”
Chaves explains how the SwissNano extends Okay Industries’ machining expertise to a nano-precision level with its ability to load and unload < 3mm diameter bar stock. Advanced ergonomics allow machine operators to have the guide bush in front of them, and it shares the TISIS common interface with the Swiss GT 26.
Mario Chaves, GM of Okay Industries Costa Rica, and Kendrick Miranda sales representative of Mayprod in Costa Rica, in front of the Tornos SwissNano.
Technology’s cutting edge
Mayprod, located in San Salvador, El Salvador, is Tornos’ exclusive Central American distributor, priding itself on supplying first-class machine tools, accessories, service, and technical support.
Founded in 1987 by Carlos Huezo Sr., Mayprod has 30 employees and serves El Salvador, Guatemala, Costa Rica, and Nicaragua. The founder’s vision of bringing modern, computer-numerical control (CNC) technology to Central America continues, says his son and Mayprod operational manager Carlos A. Huezo.
“Metalworking in Central America today is still dominated by manual machines. Costa Rica, with its growing medical device manufacturing sector, is the exception,” Huezo says. “Our biggest products are conventional lathes, and our customers know that we specialize in machine tools, so they return to us again and again. At the same time, customers are realizing the importance of CNC technology and with Tornos’ advanced Swiss-type lathe technology, we can provide it to them.”
With the global population aging and technology diffusion paving the way to increased miniaturization, medical device manufacturing is flourishing in Costa Rica.
With the SwissNano’s high thermal stability and rigidity, Okay Industries can deliver the uncompromising precision levels its customers demand.
“Having access to such technology – along with Mayprod’s unparalleled machine tool industry expertise and commitment to top-notch service throughout the machine’s life cycle – appeals to customers,” Huezo adds. “We put a lot of emphasis on post-sales service and technical support, and this truly differentiates us from other machine tool distributors in our market.”
Impressive results
“In our first part runs on the SwissNano, the results were very impressive, with virtually no variation between the first part and the 200th part,” Chaves says. He emphasizes that the TISIS programming software, Tornos’ Industry 4.0 portal, makes it easy for machine operators to manage the Swiss GT 26 and the SwissNano.
“One of the chief reasons I joined the Okay Industries family was President Jason Howey’s focus on and interest in people,” Chaves says. “The human side is the most important part of the company. We focus on hiring and developing good citizens.”
A bright future
Chaves sees a bright future for Okay Industries’ Costa Rica operation and for its collaboration with Tornos.
“There are a lot of opportunities for Tornos and our company. Tornos has very good equipment. In fact, when we were at Tornos headquarters in Moutier, Switzerland for the commissioning of our SwissNano, I was very impressed with the Tornos MultiSwiss,” Chaves explains. “I can actually picture this machine on our workshop floor. I don’t have a project yet to justify the purchase of a MultiSwiss, but we are looking for one.”
Meanwhile, Tornos solutions help keep Okay Medical and Precision Components Manufacturing and its 65-strong workforce on track to achieve its vision.
Nearly all manufacturers (92%) say product quality defines success in the eyes of their customers, and half of them define success by their ability to meet on-time deliveries, according to a recent IQMS survey.
Savvy medical device manufacturers rely on key metrics to define unique, individualized roadmaps for enterprise-wide compliance and quality goals. The highest performing companies realize that nearly all of their systems constantly contribute data regarding quality and compliance. However, that wealth of information must meet a complex web of demands.
Compliance tracking and reporting for the U.S. Food and Drug Administration (FDA), Code of Federal Regulations (CFR), and International Standards Organization (ISO) 9001 standards often require several different systems.
FDA 21 CFR Part 820 regulations require the maintenance of a complete device history record based on tracking each batch, lot, or unit to demonstrate that every device has been produced in accordance with the Device Master Record (DMR). Staying in compliance with 21 CFR Part 820 requirements makes it possible for manufacturers to attain Current Good Manufacturing Practice (CGMP) compliance as well.
Meanwhile, supply chains are increasingly the life blood of every medical device manufacturer, accentuated by these companies’ need to integrate technologies outside their areas of expertise. This further complicates the ability to manage high quality and compliance standards, as companies need insights not only throughout their own facilities but across their ecosystems.
To ensure quality management and compliance systems stay synchronized with supply chain, production, fulfillment, and service systems, it’s important to understand:
How medical device manufacturers are aggregating key performance indicators (KPIs) for greater insights
The role of these insights in how shop floor decisions drive top floor results
The use of overall equipment effectiveness (OEE) to track use and performance of production machines and other assets
Metrics, KPIs
A common challenge is taking a strategic view of the world of data and identifying which KPIs are suitable. KPIs should determine if a business’ performance measures are red, yellow, or green.
Comprehensive dashboards can aggregate metrics across an entire product life cycle, from pre-market to post-market, communicating the status of suppliers, quality, plant output, shipments, and customer feedback. The hidden value of this data is in understanding the correlations that exist between the data sets to help identify something previously unknown.
In a 2018 study by Accenture, 79% of executives agreed that organizations are basing their most critical systems and strategies on data, yet many have not invested in the capabilities to verify its validity. By developing data intelligence to ensure veracity, integrity, and quality, companies can establish, implement, and enforce standards for data provenance, context, and integrity.
A quality auditor checks the NC/CA levels for an X-ray manufacturing center.
Shop floor/top floor
Shop floor decisions are based on data and information presented in real-time through human-machine interfaces (HMIs), overhead process screens, and mobile devices. To strike a balance between product and customer requirements, shop floor decisions need to be based on accurate, verified data.
The key is to avoid extremes to sustain in-control processes. Low-yield/high-cost products that exceed all requirements and high-yield/low-cost products that miss requirements both fail to meet top floor desired results. Displaying accurate information provides the correct action at the correct time based on factors such as environmental conditions, customer demand, raw material lot variances, time of day, and continuous runtime hours.
Variables can be evaluated to determine what information should be included when making shop floor decisions to optimize process controls. Insights from aggregating data may appear to be complex because much of this kind of data analysis has never been done on an on-going basis since most companies have lacked the necessary tools or resources. The correlations help to shape changes to shop floor decisions and set internal expectations based on customer expectations.
Using OEE
Because quality and on-time delivery are critical to medical device manufacturers’ success, OEE is important in evaluating production machines and other assets. OEE is a calculation comprised of several different variables multiplied together to get an overall value in an easy-to-use number. It’s calculated by the formula of availability x performance x quality, three key strategic, operational process metrics. OEE values can quickly be compared to communicate an overall plant utilization rate and then be split into production areas, production lines, and individual metrics. When OEE data is analyzed across different production areas, it offers new insights and correlations.
Another potential source of insight can come from comparing OEE values to production plans of scheduled products. Specific products consistently have a better OEE value than others, so the planning department can better optimize scheduling to maximize resources and results. That new knowledge can be used by quality and process engineers, as well as research and development professionals, to determine what is driving the OEE to improve effectiveness on other lines.
5 key metrics
1. Corrective action – Automated corrective and preventive action (CAPA) management streamlines traditional manual and paper-based processes, such as approvals and escalation. Quality management system (QMS) software facilitates identification of root causes faster and communicates them to the organization – a critical component for realizing continuous improvements in processes, as well as optimizing OEE throughout time.
2. Complaints – Are complaints being addressed quickly? Data should be turned around efficiently to improve product quality. Metrics to monitor include the number of open complaints, the average time they spend open, and the number of overdue complaints.
3. Audit findings – Were external and internal audits effective? Leading indicators can be developed from audits – on-time completion rates for scheduled audits, number of major noncompliances, the percentage of high-risk noncompliance instances, recurring problems, and time to closure for corrective action requests.
4. Medical device reporting (MDR) – What percentage of MDRs are being submitted to the FDA on time, and what is the total number of MDRs submitted? Automating MDR reporting and tracking product quality are essential for complying with 21 CFR Part 11.
5. Nonconformance – Metrics should include the number and percentage of nonconformance instances closed within 60 days to identify patterns in recurring nonconformance instances by type. QMS can be used to ensure that out-of-specification conditions are automatically detected and communicated, providing real-time visibility into what is happening. One of the key metrics commonly used for tracking this aspect of quality is nonconformance/correction action (NC/CA). During a quality audit, auditors will check NC/CA levels and closed case rates.
A technician completing OEE calculations on production machinery.
Proper reporting
OEE can explain why one or all five metrics are out of compliance, since all of these variables are closely interrelated and, to some degree, dependent on each other. Operational excellence requires balancing quality, asset performance, operations, and environmental health and safety (EHS) management. A poorly performing compliance indicator will impact quality and productivity, which can become a cascading problem that leads to disastrous results. Production assets operating outside normal parameters due to malfunctions, misalignment, or outright failure cannot be expected to produce goods that meet quality specifications.
With the systems in place analyzing OEE, medical device manufacturers can take advantage of the technology to track other metrics. These include perfect order performance, percentage of products in compliance, and cost of quality, providing manufacturers further insights into how to ensure that their product quality excels.
About the authors Anthony Parise is a medical device product strategist at EtQ, a provider of quality and compliance management solutions and can be reached at aparise@etq.com.Louis Columbus is a principal at manufacturing enterprise resource planning company IQMS and can be reached at lcolumbus@iqms.com.
Elizabeth Engler Modic
