Located in Wixom, Michigan, just west of Detroit, Mahr Inc.’s newest Midwest Regional Customer Center recently celebrated its grand opening. Mahr’s President, CEO, and VP of Sales, America, Brett Green offered some industry insight and thoughts on the company’s new facilities.

“These customer centers will play a key role as we continue to roll out a regional structure focusing on being local to our customers,” Green says.

With a portfolio of more than 16,000 products, not every Mahr device is relevant to every location. “We made a decision based on what each region looks like, along with its culture, in determining where to open customer service centers,” Green explains. “We have a facility in Erlanger, Kentucky, that has been open for about 10 years. There’s one in Cypress California. We recently opened one in Greenville, South Carolina, and with the addition of this location, we now have one that is close for our Canadian customers. In addition, we have a partner we are collaborating with for a facility in the Pacific Northwest.”

Advanced manufacturing industries have strict quality guidelines for everything. By having facilities closer to customers, Mahr can help them learn the range of inspection tools available.

“Some customers may only know Mahr instruments at the end of the production line in a controlled environment such as an inspection room,” Green notes. “Connecting with customers in regional facilities enables us to educate them about what’s available and find the right approach for their production process.”

PHOTOS: BOSTON SICENTIFIC

Parkinson’s disease (PD), a neurodegenerative disorder affecting millions of people worldwide, causes muscle stiffness, slow movements, and tremors, making everyday tasks difficult to perform. Although there is no known cure, various treatments make PD more manageable, including deep brain stimulation (DBS) therapy, which delivers mild electrical stimulation to specific regions in the brain through implants powered by an implantable pulse generator (IPG) that sits inside the chest. Therapies improve PD symptoms, but do not slow or stop disease progression, making it imperative to have options to adjust treatments as the disease worsens. As with any fixed surgical implant, changing DBS treatment parameters – such as simulating different areas of the brain – can be difficult.

“The progression of PD necessitates a therapy that can evolve with the patient,” says Dr. Francisco Ponce, director of the Barrow Center of Neuromodulation in Phoenix, Arizona.

Cochlear-implant-inspired approach

To deliver a solution that improves patient comfort and enables physicians to easily adjust treatment as a patient’s symptoms change or progress, Boston Scientific looked to cochlear implant technology for inspiration, implants that regenerate hearing and teach users to identify different sounds, voices, and music. Engineers at Boston Scientific strived to create a similar product that would target specific locations and produce specific levels of stimulation in the brain. The company released the Vercise Primary Cell (PC) and Vercise Gevia DBS systems, featuring the Vercise Cartesia directional lead. The systems, with development spanning back to 2004, allow physicians to control the range, shape, position, and direction of electrical stimulation.

“This type of stimulator is described by some as a brain pacemaker,” says Rafael Carbunaru, vice president of research and design at Boston Scientific. “However, the heart doesn’t require the same finesse as the brain, as it simply contracts in a particular sequence. The brain is different because each fiber may be carrying different information. You need to be careful where you stimulate because 1mm difference right or wrong can have a significant impact on the patient.”

To give neurologists better control of the shape and size of the stimulation field, Vercise directional DBS systems use eight individually controlled electrodes on each lead, providing stimulation adaptable to impedance changes within the brain.

“With the brain you want to stimulate the right target,” Carbunaru says. “And this stimulation has to be maintained over time.”

These requirements are addressed by:

Electrodes – Cartesia directional leads allow current to be delivered in any direction around the lead.

Electricity – Current directed to each of eight contact points within the lead enables a stimulation shape that matches the target area. Multiple independent current control (MICC) independently manages how much current flows on each electrode.

Software – STIMVIEW technology developed by Boston Scientific allows neurologists and physicians to view the stimulation field being created on a screen, allowing them to easily match the shape of the stimulation field with the target region in the brain.

Engineers designed both systems to maximize device lifespan and usability. The Vercise Gevia system uses a rechargeable battery with at least a 15-year lifespan. The Vercise PC system’s battery, although not rechargeable, should last approximately four and a half years using typical settings. Data collected on the first Vercise system in the U.S., which won FDA approval in late 2017, shows that patients treated with the system had a 49.2% improvement in symptoms.

Developing, upgrading technology

The Vercise PC and Vercise Gevia DBS systems include mechanical, electrical, and software aspects which constantly change as technology advances. This requires Boston Scientific to work on future generations of technology while they develop and launch the first versions of these systems.

“Boston Scientific has created an environment where we can have a strong, safe manufacturing procedure that is reliable but also has the flexibility to advance,” Carbunaru says.

As advancements appear, engineers upgrade the devices’ capabilities to match – making electronics and mechanical packaging smaller, improving power supplies, and adding software capabilities. Computer modeling and in vitro studies ensure upgrades work and produce efficient results. The Vercise directional DBS systems are currently being used in clinical studies such as the global DBS post-market registry and DIRECT-DBS, a study that evaluates the effectiveness of directional leads used to treat PD.

Material science is also important, as implants must be biocompatible and interface well with body tissue. This can be a long process, as the devices are designed to last at least 15 years and therefore must be capable of long-term biocompatibility.

For future iterations of their DBS systems, Boston Scientific hopes to one day develop a closed-loop Vercise system, a feat that has not yet been possible due to the need for a sensitive, specific signal.

“Our vision is for the systems to become smarter, more autonomous, and more natural as a neural prosthesis,” Carbunaru adds.

Boston Scientific
http://www.bostonscientific.com

About the author: Mara Bahmer is the editorial intern for Today’s Medical Developments, Today’s Motor Vehicles, and Aerospace Manufacturing and Design.

Flawless. Precise. Intricate. Detailed. With no right or wrong answer, what do those words bring to mind? For some it may conjure up images of a beautiful art masterpiece, others may picture a brilliant-cut diamond, and yes, some may envision medical devices and equipment. A large MRI machine wouldn’t come to mind, but how about a dental implant, a femoral stem, a bone screw, or microstent?

The aging population together with increasing life expectancy represent some of the top drivers for the industry – from implants to wheelchairs, MRI machines, and everything in-between – but demand for smaller, less intrusive devices continues to push the boundaries of design and manufacture. As those boundaries get pushed, the challenge to produce smaller components to fit into smaller places means manufacturing to tighter tolerances and looking at different technologies. There are a lot of examples throughout this issue.

This month’s Medical Innovations section highlights Swiss researchers who produced a 0.05mm x 0.50mm microstent with highly detailed structures measuring 100µm in diameter. While not ready for real-world application, these stents are 40x smaller than any manufactured to date.

The researchers use heat from a laser beam to cut a three-dimensional template – 3D negative – into a micro-mold layer that can be dissolved with a solvent. They then fill the negative with a shape-memory polymer and set the structure using ultraviolet (UV) light. Finally, they dissolve the template in a solvent bath and the three-dimensional stent is finished.

It’s the stent’s shape-memory properties that give it its fourth dimension. Even if the material is deformed, it remembers its original shape and returns to this shape when warm. The extra dimension generated the process’ name – indirect 4D printing. Pediatric surgeon Gaston De Bernardis explains how this would work to address urinary tract constrictions in gestating fetuses. First compressed, the stent can be pushed through the affected area and once in place, it returns to its original shape, widening the constricted area of the urinary tract.

However, in utero surgery on gestating fetuses is not the only place small devices are needed. What about those living with Parkinson’s disease? Deep brain stimulation (DBS) implantable devices, such as Boston Scientific’s Vercise directional DBS, deliver mild electrical stimulation to specific regions in the brain through implants powered by an implantable pulse generator (IPG) inside the person’s chest. And everything in the systems needs to be small, as Boston Scientific’s Vercise uses eight individually controlled electrodes on each lead to better manage the stimulation field.

Now, while the smart, customizable knee orthosis featured on our cover this month isn’t tiny, combining mechanical design elements with embedded electronics – microcontrollers, sensors, radio frequency (RF) connectivity – forms smart parts that enable customized products.

As medical manufacturers continue to push the envelope on how small devices can go, advancements such as memory materials open up more opportunities. So give it time, parts will continue to get smaller.

Elizabeth Engler Modic, Editor
emodic@gie.net

In-house CNC tool grinding is becoming increasingly attractive to manufacturers who use a sizable volume of tooling. Driven by environmental responsibility and the need to reduce overall tooling cost, reconditioning generally costs less than replacement and resharpening typically costs less than half of producing a new tool. Endmills can be reground at least three times, making the numbers even more compelling.

Tool service providers typically offer a high-quality, high-precision, resharpened tool aimed to perform nearly as well as original manufacturers’ specifications. But when is it more attractive to in-source tool resharpening?

In addition to lowering costs, a large tool consumer could gain flexibility and reduce turnaround time by bringing reconditioning in-house. It’s not just about tool cost but also the cost of production downtime if the right tool isn’t available when needed. Also, machine shops can run into overly long regrinding times, especially when using unusual geometries. And, a machine shop can carry less inventory as back up if handling reconditioning in-house.

Today’s CNC tool grinders are easier to use, but tools are more complex. ANCA technology automates mixed batch regrinding so the process is easy and effective, but, a company new to tool grinding must consider expenses. In addition to investing in a tool and cutter grinder – which can easily be $300,000 – in-house grinding also requires grinding wheels, workholding, coolant, utilities, floor space, the operator, and a CNC tool measuring machine.

Economics

In-house regrinding will depend on the utilization of a tool and cutter grinder. To objectively approach the question, first determine the hourly rate of the investment – this includes the cost of depreciation, interest, floor space, energy, maintenance, and consumables. The cost of the operator will come into the equation based on a one-, two-, or three-shift operation and if the machine has the capabilities to run unmanned.

Based on the hourly rate and estimated cycle time per reground tool, a manufacturer will be able to compare the base cost of in-house resharpening opposed to outsourced services.

Once you have a cost comparison, evaluate soft factors:

• Cost of spares to maintain production during tool regrind
• Outsourced resharpening cost per tool × the number of spindles
• Lost production costs with turnaround/waiting times
• Tool quality
• Other processes, edge preparation, coating
• Service, shipping costs

Automation

To automatically pre-set the regrinding process, ANCA and Zoller integrated solutions offer reliable, error-free data transfer, which also includes the wear of the tool measured. Regrinding parameters can be allocated to a corresponding pallet location when a tool loader is used. Once the tool is picked up by the loader and presented to the workholding, ANCA Auto Tool Measurement (ATM) digitizes the tool. The cycle measures the most commonly required parameters for most tool types.

A mixed batch of tools can be automatically loaded for regrinding. ANCA Loadermate software can group the tools by tool type, required regrinding operations, and in-feeds based on the wear factor, setting up a mixed batch of tools for unmanned operation.

A variety of automated regrinding solutions for mixed batches are available – collet loading (tool and collet are getting changed together) or collet changing combined with radio-frequency identification (RFID).

With RFID, information is recorded at the programming station and the tool is coupled with the RFID tag.

The machine picks up the tool and RFID tag, scans the RFID, and automatically calls up the grinding program. The RFID is parked while the tool gets loaded and reground.

With the ANCA RFID solution, customers can randomly load tools into a loader pallet, creating an individual program for each tool. The tool position inside the pallet can be swapped with another tool at any time if a tool needs resharpened in a hurry.

Tool and cutter grinders can run regrinding with an operator or unmanned. The duration of unmanned machining is dependent on the type of loader and the pallet capacity.

ANCA
https://www.anca.com