Depending on the source of data, forecasters predict the medical manufacturing segment will grow at an annual rate of between 5% and 8% over the next seven years. It’s of no surprise that many shops seeking sources of stability in an unpredictable market are looking to add or increase the share of medical work within their portfolio of business.

Moving into medical manufacturing brings with it a unique mix of challenges. With very few exceptions, medical parts tend to be small, as the vast majority are used as either implants or instruments to operate on the human body. Accuracy, precision and surface finish all take on extreme importance, as compromises can directly impact a patient’s life or quality of life.

While stainless steel is often used for surgical instruments, difficult-to-machine, exotic materials are the norm for implants. These include cobalt chrome, titanium alloys, ultra high molecular weight polyethylene (UHMWPE) and polyether ether ketone (PEEK), each of which brings its own set of considerations. Selecting the appropriate mix of machine and tooling for each application becomes extremely important.

Additionally, the FDA regulates manufacturing processes for medical devices and implants. For those considering moving into the segment, this presents both a barrier to entry and opportunity. On one hand, it is a complicated process that can be daunting to complete. While that can be intimidating to newcomers, it also can lead to stagnation from manufacturers already in the field, as changing processes can be cumbersome. This can provide an advantage to new entrants who are validating processes that incorporate the latest innovations in machines and tools.

Whether a company is making an initial move into medical manufacturing or looking to update and validate production of an existing part, machine selection plays a vital role. By focusing on four fairly typical real-world components that are currently optimized on four distinct machines, we can gain insight into how choosing the right machine can help ensure success.

Usually measuring approximately 2" in diameter by 1" in height, a hip cup is the portion of an artificial hip that is implanted into the pelvis. Resembling a half-sphere and frequently machined from cobalt chrome, the part requires high accuracy and an exterior surface finish that will promulgate integration with bone tissue.

The geometry of a hip cup requires a flexible machine, while the nature of cobalt chrome necessitates robust performance. A CNC turn mill offers the ideal mix of features. In particular, INDEX recommends our G200 turn mill.

In this application, the G200’s identical, powerful main and counter spindles provide the balance needed to productively machine the part’s interior and exterior. By applying three tool carriers, each with a Y axis, the manufacturer is able to achieve maximum material removal rates. Furthermore, the machine’s milling spindle incorporates a 360-degree B axis that enables efficient machining of features needed to ensure the part’s functionality. A typical hip cup machined on a G200 would have a cycle time in the neighborhood of 12 minutes.

Bone nails are often used to treat fractures of one of the long bones in an arm or leg. Machined from titanium and titanium alloys, they are driven through the center of the bone to permanently reside in the bone marrow. Screws are then driven through both the bone and nail to provide rotational stability, resulting in an implant that provides strength to reinforce the bone and allow it to heal.

Bone nails can be as narrow as 0.35" in diameter, but commonly require lengths of up to 12". Because of the high length-to-diameter ratio, a sliding headstock, or Swiss-type, lathe is the only suitable solution for these components. Among INDEX machines, our TNL32 is ideal because of its maximum Z-axis travel of up to 11.8".

While sliding headstocks lathes traditionally have used gang-style tooling, the TNL Series uses turrets, which provides especially advantageous for bone nails. The machine can put three tools into the cut simultaneously to maximize productivity, while the inclusion of a B axis in the upper turret allows for efficient machining of these parts’ inclined holes and surfaces. Cycle times on the TNL32 vary by part length, but as an example, a medical manufacturer running 8.66" bone nails on the machine is achieving a cycle time of 9 minutes 3 seconds.

Used to secure a wide and diverse range of implants to bone tissue, bone screws vary significantly in their length, size and shape. Typically machined from titanium alloys, these components can be used to permanently or temporarily affix plates and rods to bones.

While the length-to-diameter ratio of bone screws fluctuates across parts, most fall above the 6:1 figure typically used as the benchmark at which traditional machining becomes impossible and a sliding headstock lathe is required. Among INDEX customers, the TNL20 is currently the most common machine used for producing these parts.

Many of the same features that make TNL machines ideal for bone nails also apply to bone screws. In particular, the range of tools available and robust live tooling capabilities prove especially beneficial when producing the hexagon, slot, torx and square profiles required by bone screws. The TNL20’s thread whirling ability also provides a competitive advantage by dramatically increasing productivity. Exact cycle times may vary by size and specification, but the pictured bone screw is machined in just 3 minutes 27 seconds.

When the vertebrae and discs of the spinal column are damaged, a pedicle screw system can be implanted to provide strength and support. One of the common components of this system is the polyaxial pedicle screw head, also known as a tulip head due to its geometry. These parts help surgeons guide and secure bone screws during Surface Milling Inserts surgery.

Measuring approximately 0.5" in both diameter and length, tulip heads are usually machined from titanium alloys and obviously have high accuracy and surface finish requirements. They require ID and OD turning, drilling of cross and through holes and interior threading. The size and range of features make them a perfect match to an MS22-8 CNC multi-spindle lathe.

With 8 spindles, 2 tool carriers per spindle and live tooling capabilities, the MS22-8 easily handles the level of complexity found in tulip heads. Each of the machine’s spindles is fluid-cooled and capable of independent speeds, further enhancing flexibility and ensuring accuracy. With this combination of part and machine, manufacturers can expect to achieve cycle times of approximately 60 seconds.

Optimizing the production of medical components requires significant attention to selecting Helical Milling Inserts the best machine for the job. The previously mentioned tulip heads provide a dramatic example of this in action.

Many medical manufacturers can fall into the trap of thinking of their sliding headstock lathes as simply machines for small parts, as opposed to machines for small parts with high length-to-diameter ratios. In fact, a study conducted by INDEX found that over 40% of parts produced on sliding headstock lathes were below the ratio that requires that type of machine.

We worked with a tulip head manufacturer who was considering acquiring a new sliding headstock lathe to expand its capacity for producing that part. Below is a simplified version of an ROI comparison we help them prepare to evaluate whether to acquire a sliding headstock lathe or CNC multi-spindle.

Needless to say, they were surprised to see that their profitability could be increased by 34% by selecting the multi-spindle. Today, that has become their standard method for producing the family of parts.

When considering a machine investment to establish or expand medical manufacturing capacity, a company will be best served by selecting a machine tool partner with a broad range of machine types and the experience-based expertise needed to select which would be best suited to specific applications. INDEX has helped medical manufacturers around the world establish and maintain a profitable competitive advantage, and has engineers on hand who are glad to provide consultation on how best to address your current needs.

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Mapal’s HighTorque Chuck (HTC) with narrow contour combines the benefits of hydraulic expansion with 3-degree back taper. This feature is accomplished via additive manufacturing, which enables the clamping range to be positioned very close to the chuck tip for an optimum radial runout of less than 3 microns at the location bore and less than 5 microns at 2.5×D as well as high shape accuracy and good vibration damping. Machining Carbide Inserts The damping in the system reduces microstructure cracking at the cutting edge, which in turn ensures longer tool life and less strain on the machine spindle. Furthermore, Mapal explains, the additive process eliminates the need for the soldered joint that has been a limiting factor until now. This chuck shares the benefits of the standard HTC, including thermal stability. Operating temperature ranges to 338°F (170°C), promoting additional process reliability.

With benefits for moldmaking as well as automotive and aerospace applications, this chuck is designed for all machining operations in contour-critical areas.

The chuck is available in clamping diameters of 6, 8, 10 and 12 mm for HSK-A63 and SK-40 interfaces. Intermediate sleeves enable additional diameter ranges to be covered. In addition, the chuck is Thread Cutting Insert optionally available with a dynamically-balanced HSK connection.

The Carbide Inserts Website: https://www.aliexpress.com/item/1005005920836723.html

Tooling Tech Group (TTG), a provider of tools and assembly equipment, has announced that Lee Childers, former TTG COO, has been named company CEO. He will lead TTG’s operations providing design, tooling solutions and automation equipment to the company’s Tier 1 and OEM customers and will report directly to the board of directors.

Mr. Childers joined TTG as COO in early 2018, bringing 33 years of experience in developing business plans, growth strategies and Coated Inserts leading operations for Tier 1 suppliers including United Technologies, Lear Corp., IAC Group and Crowne Group.

Anthony C. Seger, founder and former CEO of TTG, will be moving into a board role to continue advising and supporting the management Deep Hole Drilling Inserts team.

“With a lot of very hard work, we have built the largest tooling company in North America, and I’m very proud of all that we have accomplished,” says Mr. Seger. “My decision to step into a new role has been hard, but I feel greatly encouraged about the future of Tooling Tech Group and its leadership under Lee.”

The Carbide Inserts Website: https://www.aliexpress.com/item/1005005875303527.html

Hypertherm has released Rotary Tube Pro 3, a major Thread Cutting Insert version update of its tube and pipe cutting software for machines with a rotary axis. This new release contains new features and enhancements the company says simplifies the process of designing and cutting tube parts.

Common line cutting allows operators to cut two or more parts so that they share at least one common line with one another, providing greater material utilization and better consumable life. Updated costing for parts, nests and jobs includes factors such as consumable wear, machine operating cost, labor costs and electricity. Auto-selection of material enables operators to enter basic material descriptions in settings and DNMG Insert automatically map to available materials — meaning they no longer need to separately pick a material and thickness after selecting a tube size and wall thickness.

“With Rotary Tube Pro 3 we’ve responded to our customer base with features and enhancements that we believe take a big step forward,” says Steve Bertken, product manager for Hypertherm CAD/CAM software products. “With common line cutting, users now have the ability to completely eliminate scrap between parts, potentially reducing their material costs and achieving better overall efficiency.”

Hypertherm says customers with an active maintenance plan can upgrade to the new version at no additional charge and continue to receive unlimited technical support and other benefits.

The Carbide Inserts Website: https://www.aliexpress.com/item/1005005929477719.html

Oil Well Survey Instrument (OWSI) machines “practically anything,” according to owner Mike Holden. The ISO 9001:2015 shop has 50 employees and 38,000 square feet of manufacturing space. In keeping with its name, the company sees a lot work from the oil and gas industry, but Holden notes that “safety valves are a big part of our business” as well. OWSI therefore needs to work with tough materials like duplex and super-duplex steels, as well as stainless, titanium and nickel-based alloys. The company uses a wide array of machines, with Okumas alongside wire EDM equipment, grinders, welders, manual mills and lathes, an Eldorado gun drill and around dozen Davenports and other automatic screw machines. This variety of machines enables OWSI to tackle parts up to 30 inches in diameter and 100 inches in length, and down to parts the size of an eyeglass screw.

One recent part had the potential to cause troubles, however. Known as a ring hinge, this part is found in assemblies used to keep sand out of downhole oil drilling operations. Holden and his team took an order to drill more than 1,000 of the 316L stainless steel parts, each with ten 0.35-inch (8.9 mm) diameter holes.

“With that much drilling to do, I was looking for anything we could do to make it go faster,” Holden says. “That’s when I called Greg White, our local Ceratizit representative.”

OWSI planned to use its Haas UMC 750SS five-axis machining center to produce the ring hinges. As mentioned, it was a production run, so Holden wanted to do whatever he could to reduce cycle time. Sales engineer Greg White of Ceratizit USA was all too glad to propose the WTX-HFDS line of drills.

The WTX-HFDS line is Ceratizit’s latest foray into high-precision holemaking. According to the company, it is the first four-flute, solid carbide drill on the market able to produce H7 or better hole quality and positioning accuracy of 0.001 inch (0.03 mm). It boasts four spiral coolant holes, pyramid-shaped point thinning and a patented “Dragonskin” TiAlN nanolayer coating.

White says he “sent over two drills and Mike called me back later that week. ‘Get in here when you get a chance. This thing makes holes so WCMT Insert fast that I can't even turn my back and the part's nearly done.’”

Before the WTX-HFDS, OWSI used a two-flute solid carbide drill, held in an ER-32 toolholder. Tool life “wasn’t bad,” Holden says, but OWSI was limited to a feedrate of 9 inches per minute at 2300 RPM. The Haas UMC 750SS is equipped with a high-pressure coolant pump, which at this diameter was pushing around 500 PSI. Under different circumstances, this could be fine, but because of the machine's trunnion design and how the part was situated on the table, the cutting forces were somewhat off-center, lowering hole quality.

Aside from changing to the WTX-HFDS drill, White recommended OWSI increase the feedrate four-fold, to 36 inches per minute. Doing so reduced cycle times by 3.5 minutes per part Shoulder Milling Inserts while producing more than 900 holes between drill sharpenings (a slight improvement) and saving OWSI nearly $6 per part.

The improved hole quality — Holden notes the parts held ±0.001 inch consistently — enabled OWSI to eliminate a secondary operation, further increasing profitability. Holden quickly found himself proselytizing the WTX-HFDS and its Dragonskin coating.

“I put it right up there with coated carbides, high feed mills, and through-the-tool coolant,” Holden says. “You can tell just by listening to it that the drill is very balanced and the cutting forces quite low. And there are none of those little fish-eyes and circles around the top of the hole, so you know it's not wandering at all when it starts the hole. Chip control is also much better, which was a big deal to us.”

The Carbide Inserts Website: https://www.estoolcarbide.com/product/factory-wholesale-cnc-lathe-cutting-tools-solid-carbide-inserts-milling-inserts-bdmt11t308er-jt/