Contract manufacturers, job shops, and original equipment manufacturers (OEMs) in the medical device industry require improvements to productivity processes to stay competitive. And, medical part manufacturing poses a variety of challenges, as high-precision parts incorporate a range of full 5-axis moves.

For example, highly precise complex parts used to fix bones are rarely composed of straight or square shapes, instead involving contours for functionality and aesthetics. Implants benefiting from advanced machine technology include bone plates and screws, femoral heads and acetabular cups for hip replacements, and parts for knee and spine implants. Components can range from just less than 1" to more than 10" long and are typically machined from high-performance titanium and stainless steels alloys, as well as medical plastics such as PEEK.

Growth from a surge in customers, along with a more diversified customer base, increases the pressure to raise output while controlling manufacturing costs. More often than not, the answer comes from advanced, all-in-one, productivity-enhancing machining systems that provide integrated productivity-boosting packages with high-speed spindles, multiple-pallet automation, full 5-axis positioning, and user-friendly controls.

Case in point

For one medical shop, advanced machining systems were critical to increasing productivity. The shop machined implants with 5-axis machining centers with 15,000rpm to 20,000rpm spindles, trunnion table 5-axis capability, and two-pallet automation. However, a surge of incoming work and a desire to optimize existing jobs forced the shop to consider machining platforms with higher rpm spindles, smaller footprints, and more pallets. Mikron HSM 400U LP machining centers from Lincolnshire, Illinois-based GF Machining Solutions provided solutions.

The shop now has three Mikron HSM 400U LP machines with 42,000rpm HSK-E40 spindles, tilt-table trunnion 5-axis capabilities, 220° of B-axis rotation, Heidenhain iTNC 530 controllers, and rotary automation systems with 18 workholding pallets. The machines occupy two-thirds of the floor space, weigh less, and have larger work envelopes than the previous machines.

Vector spindles on the machines deliver consistent surface finishes and part details, while reducing machining time for semi-finishing and finishing. With high dynamics and 1.7g acceleration, the machines reduce non-cut time and maximize spindle utilization. Liquid-cooled, linear direct-drive motor technology allows short setting times and high dynamic rigidity of the attitude control. The linear direct drive with central oil lubrication reduces friction-induced wear and ensures long-term precision.

To orient complex, contoured parts such as bone plates for drilling, threading, and surfacing, medical shops often use 3+2, 5-axis positioning techniques. The Mikron axes rotate up to 200rpm, reducing positioning time when compared with trunnion-table 5-axis machines.

Fast workpiece positioning is critical for medical parts that have 20 to 30 threaded holes. When each hole requires machining a flat, a counterbore, a through-hole, and a thread, small amounts of extra speed in B-axis rotation results in long-term cycle time reductions. With higher spindle speeds and faster 5-axis part positioning, the Mikron mills reduce cycle times 20% to 30%.

To optimize application of the Mikron machines’ pallet systems, some medical shops fit pallets with a tombstone that can hold multiple similar parts, enabling consistent tool packages and eliminating the need to change fixtures. This approach ensures lights-out operation between shifts without loading, unloading, or removing fixtures.

With the machines’ Heidenhain controls, operators can perform edits at the machine in the conversational mode saving programming time and minimizing delays.

Automation’s advantage

Cost savings through automation are also changing the way medical contract manufacturers look at machine tool purchases. Machine tools with pallet changing or bar feeding capability can provide maximum versatility and productivity. Such integrated automation allows manufacturers to be competitive and get the most out of their equipment and skilled workforce.

A concurrent benefit is flexibility. For the medical shop with the Mikron HSM 400U LPs, typical job lot sizes range from 10-to-300 pieces, yet it often receives five-piece orders as well. The machines make setups for these jobs fast and accurate, while their pallet changers boost efficiency for the shop’s legacy products.

The shop proves out and validates small batches of prototype parts, then when repeat orders come in, program and fixturing are ready to begin production.

With tolerances around 0.0005" and surface finishes such that post-machining, finishing operations on medical parts must be limited to only deburring of complicated double- or triple-lead threads. Part precision and quality are crucial in machining processes. In addition, this minimizes the need for hand finishing, significantly reducing the possibility that a part will be scrapped due to inconsistent manual processing.

High-speed machining techniques contribute to manufacturing quality, efficiency, and cost control, allowing medical contract manufacturers, such as the one using the Mikron HSM 400U LPs, to replace custom tools with lower-cost, off-the-shelf tools. Rather than roughing a part, creating a contour with a form tool, and then finishing with other tools, the shop applies one roughing tool and one finishing tool to complete a part.

Medical parts contract manufacturing demands a level of responsibility beyond that of general machining. Start-to-finish control is crucial because medical parts must be perfect. Medical contract manufacturers purchase certified raw material and bring the parts to their final dimensions, completing first piece, in-process, and final inspections, certifying that a part is ready for human use. Customers rely on the manufacturers’ process control and team to provide consistent products. Investment in the right machining technology helps medical contract manufacturers deliver quality products on time.

GF Machining Solutions LLC

www.gfms.com/us

Medtronic to reach $39.9 billion estimated

In vitro diagnostics (IVD) to reach $70.8 billion in estimated sales

Roche to lead IVD segment at $12.8 billion estimated

Johnson & Johnson leads orthopedics with 24.1% market share

Neurology

fastest growing segment forecast CAGR of 7.6%

Fastest growing device areas

• In vitro diagnostics (IVD)
• Cardiology
• Diagnostic imaging
• Orthopedics
• Ophthalmics
• IGeneral & plastic surgery
• Endoscopy
• Drug delivery
• Dental
• Wound management

By 2020

$34 billion medtech R&D spending

Top R&D companies

• Medtronic
• Johnson & Johnson
• Siemens
• Roche
• Philips
• Abbott Laboratories
• Boston Scientific
• General Electric
• Stryker
• St. Jude Medical

Source: www.evaluateresearch.com

Linear AMS’ online, automated rapid quoting, model building

Linear AMS and its online tool Rapid Quote offers an interactive service where users upload 3D CAD models, explore design iterations, and build cost models for metal additive manufacturing (AM).

Uploading CAD model to Linear AMS through Rapid Quote allows users to adjust models as needed with automated and accurate cost quotes for each iteration, speeding rework. Configuring alternatives with cost information expands options and can save hours if not days in eliminating guesswork.

The ability to highlight concerns on the CAD model allows a range of design considerations before production starts. Then, the same CAD file powers the Linear AMS metal AM equipment, streamlining design through production, including process traceability and material selection. www.linearams.com

Manufacturing has grown little since mid-2014. Five million manufacturing jobs have been lost since the start of the 21st century. U.S. manufacturing hit a cyclical bottom in June 2009, and a 21% increase in output since then has been accompanied by only a 5% increase in manufacturing employment. February 2010 was the low point in manufacturing employment, with the job count rising 7.2% since then, indicating that employment recovery lags far behind the cyclical norm following past recessions. That’s the news from a June 2016 Congressional Research Services (CRS) report by Marc Levinson, section research manager.

But there really is some good news in manufacturing, especially medical. According to the Bureau of Labor Statistics (BLS), even as overall manufacturing employment fell during the last two decades, the number of workers employed in manufacturing medical equipment and supplies grew 8%, with many positions requiring individuals with advanced degrees. A high school diploma is no longer a ticket to the factory floor. The CRS report states that between 2000 and 2015, the number of manufacturing workers with graduate degrees increased by 32%. Demand for workers with associate degrees in academic fields level rose 17%, as the number of manufacturing workers without degrees beyond high school fell by one-third.

The need is for educated workers trained and ready to work in the automated, technically advanced factories of today. And, as one reader recently responded about my editorial in the Nov/Dec 2016 issue, “As far as I am concerned, we do not have a skill shortage. What we have is a VISION shortage. Right here in the good old USA we have plenty of people. Potential skilled workers to design, build, and service automation equipment.”

However, there’s another part of the manufacturing equation coming into play and that has to do with what counts as manufacturing. Mark Mills, senior fellow at the Manhattan Institute, states that the size of the manufacturing sector at 12% share of gross domestic product (GDP) is underestimated – that it’s an artifact of how government accounts for business activities, not how businesses operate or what they do. He notes that it’s likely twice as large, stating that if the final assembly of products takes place in a warehouse – part of manufacturing – those employees are counted by BLS as services, contributing to skewed data for the strength and contribution to manufacturing.

Even if data isn’t fully representative of manufacturing’s strengths, what’s clear is the need for companies and workers to have a vision to embrace and make the most of today’s advancements. The materials, technologies, and machines, along with Big Data and the Industrial Internet of Things (IIoT) are all playing a role in the changing face of manufacturing. Growth in manufacturing productivity is possible, but it will take vision and investment in workers, automation, and its future.

What is your vision to grown, invest, and stay on the leading edge of manufacturing excellence? Drop me a line at emodic@gie.net to let me know. ~Elizabeth