Officials from the Ceratizit Group announced the planned acquisition of the Komet Group, as of Oct. 12, 2017. The transaction is still subject to the approval of the antitrust authorities. Together, Ceratizit and Komet will become one of the top five global players in the international cutting tools market. Its more than 9,000 employees at 34 production sites worldwide will enable manufacturing and delivery of products in close proximity to customers.
Mitutoyo puts metrology tools in students’ hands
Mitutoyo America Corp. donated Digimatic calipers and micrometers to students in the Engineering Technology Program at Northern Illinois University (NIU) in DeKalb, Illinois. Combining theoretical education with industry-based, hands-on opportunities, the technology program is preparing the next generation of engineers and technologists.
Matt Dye, president of Mitutoyo America Corp., told students, “What a great opportunity you have here. You’re seeing a lot of the same equipment that’s being used on the shop floor today. Take it all in.”
While donating the products he shared with the group that he was in a similar program in college and understanding how things get made correctly has provided him with many opportunities throughout his career.
Donald R. Peterson, Ph.D., dean of the College of Engineering and Engineering Technology at NIU, added, “Metrology is important, even for those in R&D. This class is essential in any type of engineering.”
Mitutoyo has a long-standing relationship with NIU. In 2008, Mitutoyo established the Mitutoyo Metrology Laboratory on the campus to provide hands-on, educational experience for technology and engineering undergraduate students. As one of the best-equipped educational metrology laboratories in the country, it includes gage blocks, micrometers, coordinate measuring machines (CMMs), laser scanning micrometers, and form measuring equipment.
After a week of recall services on my car with substandard or omitted repairs, and trouble with a new cell phone that wouldn’t work, I’m irritated. None of these issues were harmful or life-threatening, but they were time-consuming, frustrating, and caused me to question the quality of these products I invest in and rely upon each day.
I’m looking for a perfect world that has perfect products with no quality flaws at all. In it, every product purchased will work perfectly on the first try. In this perfect world, there is no such thing as a product recall, the need to buy extended manufacturers’ warranties, or spending time going back to the retailer to have faulty products repaired or exchanged. There would be no cybersecurity hacks or need for patching operating system vulnerabilities. Not only would this perfect world elate consumers, it would also be perfect for original equipment manufacturers (OEMs) and their suppliers.
While perfection doesn’t exist, the quality of medical devices and equipment continues to be an area that receives plenty of attention. In 2011, the U.S. Food and Drug Administration (FDA) Office of Regulatory Affairs, along with the Center for Devices and Radiological Health (CDRH), launched the Case for Quality. This came about following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. Root causes for the most frequently seen product recalls were:
- Design – 31%
- Manufacturing – 24%
- Suppliers – 14%
- Post-production – 12%
Armed with the knowledge of where quality issues occur most often, to reduce the number of recalls, FDA officials suggested implementing:
- Design control
- Quality management systems
- Inspection and global harmonization
- Unique device identification
- Process control
- Documentation control procedures
Quality must be the driving principle in what any company does. While a quality management system is important in an organization’s policies, procedures, and practices, it is only as good as it is implemented, believed in, and adhered to; that must start from the top down. In addition to companies investing in the right quality systems, product lifecycle management software platforms, complementary efforts such as the Medical Device Single Audit Program and the unique device identification are driving companies toward a cohesive, quality standard.
While medical devices and equipment are designed and manufactured to make people’s lives better, when a recall occurs it ends up as an expense to the manufacturer, a burden to patients and/or medical practitioners and facilities, and, in some instances, can be life-threatening. I’d be interested in learning the steps your company is taking to ensure quality is instilled from start to finish.
The emPOWER Ankle is a complex active prosthetic foot and ankle solution that replaces muscle and tendon function, supporting users with additional energy while they walk. Because of the devices’ complexity, even slight changes to the product or documentation result in large amounts of paper documentation, which must be manually compiled and routed for review and approval. With a major re-design project on the horizon, BionX Medical Technologies Inc.’s engineers began evaluation solutions to replace the paper-based document control and change the control system that was becoming unmanageable.
Company officials wanted an electronic product lifecycle management (PLM) system that would efficiently manage a multi-level product structure/bill of material (BOM) and engineering change orders, with the ability to expand into other electronic records management such as training records, corrective and preventive actions (CAPA)/quality issues, and supplier management. The system had to meet the FDA 21 CFR Part 11 compliance requirements for electronic records and electronic signatures.
“We went through a discovery process during the course of several months, evaluating about five different solutions,” says Rick Smith, Sr. director, quality & regulatory, BionX Medical Technologies. “The system needed to be flexible, without being overly complex, with a fairly intuitive administrative interface. Pricing and ongoing licensing costs were also a factor, given our small size and limited resources. A matrix of requirements was created and the different solutions were ranked on how well they solved our particular needs, and Omnify Empower PLM was our choice.”
The software offers the ability to work solely with electronic documentation rather than maintaining paper records. BionX research and development (R&D) group gained the ability to approve changes electronically and remotely, along with the increased visibility into product design and development.
The company chose to implement Omnify Empower PLM in stages. They began with document control, change control, and validation of 21 CFR Part 11 compliance. Shortly after, they executed Training Management. Next, they managed supplier qualification documentation and linked their qualified suppliers to specific parts by implementing Supplier Management.
The company is in the process of adding Service Objects to maintain device history records, service records, and Quality/CAPA for non-conforming material.
“The Omnify Empower implementation has been extremely useful during business reviews with external parties. Information regarding testing, design, suppliers, marketing material, and training can be accessed in real-time, in a clear and presentable manner,” Smith says. “Several external reviewers have commented on how useful that has been; particularly helpful with our recent ISO 13485 re-certification.”
BionX Medical Technologies Inc.
Nearly every day, from one of its seven nationwide manufacturing facilities, Wilbert Plastic Services ships a crucial part or assembly. That plastic piece may be a magnetic resonance or computed tomography cover, carefully designed and then thermoformed.
Headquartered in Belmont, North Carolina, with multiple manufacturing locations nationwide, Wilbert has weathered the recession, facility closures, new openings, and employee base growth to more than 1,400 as the company shows little sign of stopping. For the past 15 years, the company has served the medical market as one of more than a dozen industries for which the company has created plastic parts and assemblies for more than a half-century.
Wilbert Plastic Services’ achievements in the medical market are significant to the brand as are two of its manufacturing facilities – White Bear Lake, Minnesota, and Belmont.
Selecting the process
Wilbert’s designers and engineers help customers select the best process during a project’s initial stage – thermoforming or injection molding, two processes that yield different, but dependable results. For 90% of medical industry products produced, thermoforming fits the job.
In thermoforming, an already-created plastic sheet is heated until the sheet becomes pliable. The heated sheet is then formed into the desired object using a mold, then trimmed and cooled.
Compared to other processes, such as injection molding, thermoforming offers customers increased design flexibility, better performance, and stress-free molding.
“Thermoforming offers advantages such as recyclables, and better quality and consistency, and one thermoform tool can outlast the life of any program, delivering surface quality without paint and with serviceability,” says Randy Kress, Wilbert’s sales director for thermoforming.
Kress notes that while thermoforming extends to many industries, it is often used for magnetic resonance (MR) and computed tomography (CT) machine covers because they are traditionally lower volume. This, coupled with capital investment and the process’ ability to combine multiple parts into one, often makes thermoforming the go-to choice for medical customers.
However, it takes an experienced design and engineering team to guide customers toward the proper process, and much of Wilbert’s current medical work reaching the industry as a final product started as designs one or two years ago.
Long before launch, Wilbert collaborates with customers to ensure thermoformed pieces are as perfect as possible from the drawing board.
“Today’s MR/CT covers include design work from Wilbert for manufacturability as well as changes to optimize material content and reduce cost and design of all fixtures, ensuring product quality and repeatability,” Kress notes.
These covers also incorporate fastening systems that hide all mechanical fasteners, a step beyond plastics. Cost savings are implemented throughout, as is tooling that incorporates undercuts. This results in rolled edges hidden from view, creating design freedom not typically achievable with thermoforming.
Other value-added components produced, created, and assembled by the Wilbert team for MR/CT enclosures include wire harnesses, lighting, paint, lasers, internal shielding, and kitting, rounding out a finished product before it reaches the customer. The collaboration results in a superior product and customer loyalty.
“We’re a make-to-order business,” says Wilbert CEO Greg M. Botner. “Customers appreciate our high-quality products and reputation, both of which were built during decades of work. We’ve invested heavily in developing these aspects of our business and consistently produce plastic parts that they can depend on.”
That dependability has helped the company grow, Kress says, noting “Our medical business has grown by increasing content with current customers and adding new customers who are leaders in their market space. Changes in material offerings have allowed us to offer product enhancements not available by processes other than thermoforming.”
Kress attributes the company’s ability to excel in serving the medical plastics market to the various enhancements available today, such as A surfaces, co-extruded appliques, and high-quality color films or color monolithic sheets.
“Wilbert’s advancements in tooling design allow us to thermoform products that historically couldn’t be produced in thermoforming. In addition, our in-house fixture designs allow us to incorporate hundreds of components into our assemblies without jeopardizing quality.”
Kress notes that the company’s medical field capabilities far exceed plastics, as engineers regularly incorporate multiple processes, materials, and components into high-level assemblies, such as electronic carts or incubators for medical use.
Shipping between 500,000 to 600,000 parts and assemblies daily from its seven plants, Wilbert engineers work to guide all clients from design to a finished piece.
“Our products are not available on store shelves or online,” Botner says. “These products and assemblies are individually designed with customer goals at the forefront. We’re an essential part of what makes a better product.”
Wilbert Plastic Services