Top Tool

Submitted by Duane Kari, Sales Manager

Top Tool is trading places with the Boston Red Sox this week. While the BoSox are in Minnesota to take on the Twins at Target Field, we've headed to New England for BIOMEDevice Boston. Where we will hope to at least accomplish a Fenway Park drive-by to celebrate the stadium's 100th birthday.

You, however, can visit BIOMEDevice from the comfort of your own smart phone. During the last few MD&M tradeshows, Top Tool has taken part in the inevitable transition to “online everything” by posting a mobile version of our exhibits in Fort Worth, San Jose and Minneapolis. And we've gone mobile for the Boston show as well. To tour BIOMEDevice exhibitors and other event features in Boston, download the app here. And then search for Top Tool in booth #840.

In addition to checking out the mobile digital version of the Top Tool exhibit in Boston, I invite you to visit our newly expanded website for content focused on what we do – and how we do it – for medical device and life science clients. Click here to see the new information.

The expanded web content includes a pair of new features designed to demonstrate the role of precision micro stamping in leading-edge, health-related applications. The first is an interactive illustration that provides examples of stamping solutions in a range of applications. From neural electro stimulation to surgical staples and ingestible-sensor technology. Just click on the “examples” circle near the top of the page.

Top Tool also produced a brief video focused specifically on complex precision stamping solutions for medical micro manufacturing. Click here to go directly to the video.

Other features on the new Medical/Life Sciences section take a look at R&D, Precious Metals/Exotic Materials, Control Plans/Risk Management, and FDA Regulation/Validation. There is also a brief case history related breakthrough cardiac care technology.

Thanks for visiting Top Tool . . . online or on your phone.

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Posted by Dave Kari, Director of Wire EDM

"Begin with the end in mind” is the central theme in why work holding deserves early, high-priority consideration when it comes to wire EDMing complex micro parts.

The wire – especially a .00078in. wire – gets all the attention. But how to firmly (yet delicately) hold a micro part is one of the biggest challenges that can come between a high-precision, highly complex design and a small-wire EDM center uniquely qualified to cut the part. If realizing the designer’s intent is what points to wire EDMing as the micromanufacturing solution, then work holding often is where everything must begin. It’s the first place to get creative and inventive whenever an elegantly engineered micro part comes through the door.

In this case, that means getting creative about a part management concept (the fixture) sufficient to hold a component with a footprint smaller than 1mm. The part specification can also include multiple, complex features down to 100µm. And tolerances as tight as tight as 13µm, or one-sixth the thickness of notebook paper.

Equally important when it comes to wire EDMing complex micro parts, especially for use in an application like an implantable medical device, the material can be ultrathin. Whether the stock is Platinum Iridium, MP35N, or Nitinol.

Ultrathin is a relative term because it tends to be defined as the leanest dimension at which a wire EDM manufacturer can cut metal precisely. Not long ago, 0.01in. was the smallest dimension for something labeled ultrathin. Then 0.005in became the unofficial definition. But there’s a good chance you’ll hear a design engineer say that 0.005in. is “still pretty thick."

The most sophisticated ultrathin capability today involves wire EDMing complex micro parts at thicknesses down to 0.0015in.

In Top Tool’s experience with complex precision parts, the fixture or other holding device for a micro component almost always must be custom-designed and custom-built. Unlike work holding options for larger components, there is no single fixture solution with the flexibility to do the job across a range of micro scenarios. Micro projects are inherently more complex. The more unique the micro part, the more unique the fixture and work holding solution.

"Beginning with the end in mind” leads to the proper emphasis on work holding. And how you hold a micro component certainly drives a better part. Robust part management frequently has been the difference when a previous approach did not succeed.

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Posted by Marty Cavegn, Sales Engineer

Precision micro stamping doesn’t get enough credit for getting along with others. Other manufacturing methods, that is.

Stamping and laser cutting? There have been some classic partnerships.

Stamping and wire EDM? They go together like Batman and Robin.

Stamping, like every manufacturing approach, has limitations. But what if stamping can deliver 80% of the solution? That’s when collaboration can make sense. Where stamping – as the primary operation – takes out cost, holds ultra-tight tolerances and guarantees repeatability. While a different, secondary technique meets the rest of the requirements.

This hybrid or blended approach is sometimes called 80/20. The actual percentages vary, but stamping is always accountable for the high side of the equation.

One example: using a fine end mill to create a channel by hogging out material (primary operation) and then finishing off with laser cutting as the only way to add a hinge hole and slot.

Grinding or cutting away material is a subtractive method that’s more time consuming and costly than stamping’s “near-net shape” approach. The laser operation might be a non-negotiable operation due to the geometries and critical features. But using stamping as the primary operation – to create the channel blank – could eliminate as much as 90% of the overall cost.

I’ve seen it work the other way as well. An OEM specified stamping as the manufacturing method, but experienced quality problems because holding tolerances across multiple bends is a stamping limitation. Each bend adds more tolerance. The designers were trying to accomplish a single critical feature beyond the capability of a pure stamping operation. Machining was an option, of course. But at a cost 80% higher than stamping. Better to achieve 80-90% of the end result through stamping, and then use a secondary operation for the challenging detail.

Precision metal stamping is producing features, geometries and tolerances that were unthinkable just a few years ago. In the case of micro manufacturing, we’re talking about parts 2 mm (.080in) and less. Likewise, the dimensions on an individual feature can be as small as one-tenth of a millimeter (.004in). Tolerances may be as tight as 0.01mm (.0004in). And the work frequently involves handling ultrathin materials – not to mention precious metal alloys – down to 0.013 mm (.0005in).

Stamping generally is up to the micro task. But even if the part is not a pure stamping candidate, there likely is good reason to find a way to work out a stamping-led hybrid solution.

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Posted by Duane Kari, Sales Manager

Why does an engineer turn to micro stamping to make a platinum pacemaker electrode? A stainless surgical staple. Or an ingestible microchip for wireless health monitoring? It comes down to what's physically possible at the micromanufacturing level. In some cases, precision micro stamping is the only way to hold and manipulate a micro part.

Consider a medical device component with a footprint smaller than two millimeters. The spec includes multiple, complex features down to one-tenth of a millimeter (100 microns). Some tolerances are as tight as 13 microns. That's one-sixth the thickness of notebook paper.

And the part must be made from ultra-thin Platinum Iridium. Or MP35N. Maybe even Niobium.

Precision metal stamping in millimeters and microns is not for everyone. But this is where it gets interesting for Top Tool.

Much of what’s possible at the top end of precision micro stamping wasn’t imagined a few years ago. But the most sophisticated form of micro stamping is helping medical device and other health sciences innovators move their new products to market.

Top Tool collaborates with customers to design, develop and manufacture complex precision micro component solutions for a wide range of medical device and health sciences applications. From neuro stimulation and vascular surgery, to treatments for hearing, diabetes and sleep disorders.

Our full-range capability includes engineering services, in-house design and die construction, rapid prototyping, long-term development support, qualification runs and full-scale production.

We manufacture critical components – featuring complex geometries and tight tolerances (down to .001in) – stamped from ultra-thin, exotic materials and precious metals. Ultrathin precision metal stamping involves producing parts at thicknesses down to 0.0015in.

A high-end micro stamping specialist can accomplish results you might not expect. That should be welcome news for designers and engineers working on product miniaturization. No one is making bigger. But speed, precision, productivity and cost containment – the well-known characteristics of metal stamping – are always in style when it comes to product engineering and design.

Collaborating with a micro stamping component supplier at the high end of the specialty can lead your micromanufacturing in new, productive and breakthrough directions.

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Posted by Marty Cavegn, Sales Engineer

Top Tool enthusiastically presents at several well-done tradeshows and expositions specific to medical device and health sciences manufacturing. Without question, the shows are among the best sources of insight into customer challenges in precision micromanufacturing. This space can't capture all the compelling in-booth discussions, but here are a few observations from last week's MD&M West in Anaheim.

I've also linked to previous Top Tool blog posts related to the topic at-hand.

1.  "We expect better material management from our stamping supplier." A micro stamping provider should add significant value to supply chain effectiveness through precise, cost-efficient raw material managmenet. Especially in the case of precious metals and exotic materials. (Related blogs here and here)  

2.  It’s a small (micro) world. More and more, the medical industry is following the international standard of measurement in millimeters. Previously, you frequently heard references to “thousandths of an inch.” That’s less and less the case now. Most discussions on precision and complexity are in millimeters. (Related blog here)

3.  “Wow, never even thought about die cutting it. You can do that?” It’s one of the most encouraging things we hear. And the answer frequently is “yes.” We got the question again at MD&M West in connection with our experience working with mesh and fibers. (Related blog here)

4.  “Someone is making it now, but struggling with the 0.1524mm thickness.” The combination of difficult material, complexity and ultra-thin components can put micro stamping to the test. A challenge we welcome, of course. (Related blog here)

5.  A glimpse into applications intersecting with micro stamping. Frequent booth discussions on stainless steel surgical tools, many categories of health monitoring, and catheter-based treatments or therapies. (Related blog here)

6.  What method has an inside track on repeating patterns and volume? We discussed a number of projects requiring a component solution that deals efficiently and precisely with repeating patterns. In other words, how to provide parts – typically for reel-to-reel or continuous feed automation – with multiple small, repeated features. (Related blog here)

Finally, micro stamping is even gaining validation among competitive methodologies. Everyone in the Top Tool booth agrees there was noticeable interest from contract manufacturing suppliers who seem to be evaluating the addition of micro stamping capability to enhance their existing medical device component capability. Obviously, we think they are extremely wise to notice the stamping value-add.

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Posted by Duane Kari, Sales Manager

"Micro component solutions don't always arrive gift-wrapped." It's a topic that's sure to come up in the Top Tool booth at MD&M West in Anaheim Feb. 14-15.

Finding the most accurate, cost-efficient way to make complex micro parts for medical OEMs routinely tests the limits of precision manufacturing. Especially with specifications like micron-level dimensions, complex geometries, ultra-tight tolerances and exotic materials. That’s why risk-taking – and risk management – also must be routine.

As a contract micro stamping manufacturer with more than 25 years of experience supporting medical device makers, we always look forward to talking shop at the MD&M conferences. Especially when the conversation gets around to R&D-stage challenges that include the need for specialized experience designing, engineering and manufacturing intricate and complex micro parts. We always leave MD&M shows with new insights from great conversations with designers, engineers and strategic sourcing specialists.

Risk is a common factor when you need to solve manufacturability challenges that come with features as small as 1/10th of a millimeter. Or tolerances down to 1.5 microns. On critical components stamped from platinum. Top Tool understands how to work at the development stage. Our medical device experience includes developing micro manufacturing solutions for:

- Neuro-stimulation
- Deep brain stimulation
- Dental implants, systems
- Hearing aids
- Diabetes monitoring
- Cardiovascular stimulation
- Cardiac pacing, defibrillation
- Anastomosis
- Sleep apnea
- Blood filtration
- Laboratory filtration

FDA regulation and manufacturing validation is another frequent MD&M topic for medical device manufacturers who need to push the limits of micro component design and engineering while complying with stringent requirements. With a long history in the highly regulated medical device industry, we understand how to work with specialty materials and properties that drive innovation. This includes experience in the unique characteristics of thin materials (down to .0005in.) ranging from gold, silver and platinum to Nitinol, Titanium and MP35N.

Micro-level complexity points toward high-end precision stamping to streamline, simplify, reduce cost and enable the highest-possible quality. This can be especially true within medical device development and manufacturing, where materials and manufacturing account for at least one-third of an OEM’s cost to move a product from concept to selection by a physician. Our tested and proven R&D capability includes programs and systems critical to aligning product development with cost-saving “design for manufacturability.”

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Posted by Dave Kari, Director of EDM

The amazingly delicate medical component prototype is only 1.3 mm wide. So it's equally amazing that it requires 142 separate hits by the tool – all of them performed within a few square millimeters – to precision micro stamp the coining, forms, features, bends and bevels included in each stainless steel part.

As recently as five years ago this complex key micro component in a coming medical miniaturization milestone could exist in the designer’s mind, but not in a surgeon’s hands.

The difference-maker today at Top Tool is one of the very few .00078in. wire electronic discharge machining (EDM) systems online in U.S. manufacturing. Not only does it possess the .00078in. capability, it also features a dual spool capability to cut using different size wires.

Using EDM with a small wire is the only approach to succeed at a .021in. x .013in. punch used to pierce a micro-sized opening in the prototype component. This component is possible only because the wire is small enough to cut a virtually undetectable .002in. radius.

At these millimeter and micron levels, the cutting process is always on the edge between controlled and uncontrolled. Or stable versus unstable. The “razor’s edge” metaphor isn’t remotely close to representing the small window – a narrow range of acceptable conditions – where “the small wire” does its work. You would have to get inside small-wire EDM to really see what happens during this non-conventional ma-chining process. It’s about a different level of material removal.

So think small as you submerge into the die electric water tank. You make your way into the collection tube. That’s where micro flecks of degraded wire and burnt (cut away) material debris – “swarf” in machin-ing terms – are washed along like river bottom gravel in a stream of takeaway water. But not all of the micro debris is as harmless as gravel. The biggest pieces might as well be very large boulders.

On an EDM with a larger, more typical wire diameter, the system is not precise enough to detect or be disrupted by the boulder problem. By the time a larger wire senses the boulder, it would be too late. But the .00078in. wire, with its sophisticated sensors, is so algorithmically powerful it can sense being nudged off the programmed path. In the worst case scenario – without maintenance to remove the debris – the boulder-size flecks are even large enough to break the wire.

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Posted by Duane Kari, Sales Manager

One approach to technology innovation revolves around the effectiveness that can result from duplicating a property – like a form or a shape – already found in Nature. The inference being that Nature has a proven knack for evolving some of the purest, most elegant and productive design engineering to be found.

The Egyptians in 2500 B.C. used the 400-volt electrical shock from catfish for pain relief. In other words, nerve stimulation. Today’s version of Nature’s solution is the science of neural electro stimulation or neuromodulation. Biocompatible, implantable devices using electrodes – manufactured from the platinum group metals (PGM) – for the treatment or correction of everything from hearing loss and cardiac rhythm management to deep brain stimulation for lessening debilitation from Parkinson’s Disease.

Actually, the nerve tissue interface in neural stimulation today depends on a microelectrode. The innovation objective is to downsize the electricity delivery method by fabricating the smallest-possible electrode to precision-target nerve tissue. The ultimate goal – being pursued through nano engineering – is stimulation at the cell or molecular level.

In the meantime, advanced materials – like a platinum iridium alloy – are key to optimizing neural electro stimulation. Platinum is the current optimal choice for its biocompatibility, non-corrosion inertness, durability and electrical conductivity. Combined in an alloy with iridium, electrodes become even more resistant to chemical reaction in the body.

Iridium is one of the rarest elements in the earth’s crust. Gold is 40 times more abundant, for example. Only about 3 tons of iridium is produced annually.

When it comes to part fabrication, the ability to work in a PGM is equally rare. Especially in the stamping realm. Very few suppliers claim to stamp micro components from PGM. Even fewer truly specialize in platinum and platinum alloys. Most contract manufacturers won’t touch the material. And it’s very possible that a supplier willing to work with the material doesn’t fully understand the complexity, challenge and unique risk management required.

A significant percentage of Top Tool business is toolmaking and stamping production for very small parts manufactured from very expensive precious metals like platinum. We have worked in the material – most frequently with medical device OEMs – for more than a decade. After 10-plus years of learning and refining, we’ve developed and fine-tuned systems and processes for getting more from each ounce of material than less qualified, less tested parts suppliers.

One Top Tool approach is development of a proprietary material spec used when we procure PGM materials. All precious metals are not created equal. They act and behave differently. Off-the-shelf PGM sufficient for machining does not have custom mechanical properties (tensile strength, hardness, etc.) present in a proprietary blend developed specifically to optimize precision stamping. Top Tool’s customized spec for platinum is optimized to control consistency above and beyond usual requirements.

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Posted by Gary Hartmann, Vice President of Operations

Today’s answers to “what’s possible next?” continue to impress. Especially when it comes to packing dramatically increased capability and productivity into a significantly smaller footprint.

One of my favorite “productivity-in-a-small-package” innovations is the sleek, six-inch-tall Lily Impeller. The “Lily,” which can mix a 20-million gallon water reservoir to inhibit bacteria growth, is capable of replacing an energy-guzzling circulating system that stands three stories tall and has the circumference of a California Redwood.

Start with something three stories tall, and take it down to six inches high? That’s miniaturization to the max. Enabled, no doubt, by lots of positive thinking. There’s definitely lots of math and high-test engineering going on there. But it also required some serious optimism – during the research and development process – to move from “blue sky” to blueprint.

Being optimistic made me think about New Year resolutions, which are about seeing the possibilities. The same holds true when you’re in the business of helping customers find ways to design, engineer and manufacture critical components becoming more complex while they get smaller.

Looking back on R&D-stage projects that challenged us during 2011 – ranging from platinum parts for implantable medical devices to critical components for advanced weapon systems – I noticed two types of (positive) thinking that consistently help us collaborate with designers, engineers and purchasing specialists. Especially when it comes to “what’s possible next?” in precision complex micro components.

To stay optimistic about precision micro stamping solutions that can pack “more” into “smaller,” Top Tool resolves to:

Make friends with risk.

Look at complexity as an opportunity. Not a threat.

Answers to micromanufacturing challenges at the µm level don’t arrive giftwrapped. Getting to “what’s possible” always requires dealing with risk and complexity.

Happy New Year from Top Tool. And best wishes for a 2012 that’s full of positive thinking.

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Posted by Duane Kari, Sales Manager

Greetings from BIOMEDevice in San Jose. I’m very comfortable in Minnesota’s Medical Alley. Even during winter. But I can’t deny looking forward to a few December days in Northern California. Especially while talking with medical device designers, engineers and sourcing specialists about quality, cost and time-to-market solutions that micro component stamping can contribute throughout a project cycle.

I recently came across a technology provider’s “Faster to the Future” tagline, which also happens to describe the ultimate benefit that complex precision micro stamping must deliver. Especially in the innovation-driven medical device and health products space. That's where Top Tool specializes in parts solutions for everything from spinal, neuro and cardio applications . . . to surgical items and treatments for hearing, diabetes and sleep disorders.

Actually, I’d expand the tagline and call our promise Faster to the Future . . . With Less Drama and No Surprises. There is a lot that goes into that deliverable. If I had to boil it down to a few factors critical to outcome-driven, strategic progress for medical and health OEMs, I’d start with three ways that the Top Tool micro stamping approach succeeds at removing or minimizing drama and surprises.

1. Development-stage risk assessment designed to drive long-term, final outcomes. Especially when it comes to the tension between what is sufficient early . . . and the approach that will also stand up in production. It’s not necessarily wise – while trying to shrink schedules and costs – to dumb down the prototype build. Which means starting bare and trying to do with as little as possible. Top Tool begins with a vision of the optimized, “perfect world” build. And then works to dilute that standard as little as possible. Largely through previous experience with what is unique to medical device and health products scenarios.

2. Experience that creates accurate expectations around lead times. Lengthy product development timeframes are a fact of life in the medical device and health products space. A vendor that is focused only on profiting at prototype – vs taking on the project for the long-term – has no incentive to work backward from the final solution. Top Tool actively pursues the medical and health category, knowing that it requires patience. And often our own R&D-phase investment in developing a tool that facilitates efficient, effective progress though unique, demanding circumstances like FDA regulation.

3. Critical operating procedures and systems which are anything but standard outside of the medical category. The OEM’s design and engineering expertise is product/solution innovation that advances patient treatment. Our job is to worry about, fill in and implement lots of fine details – like process control systems – that are critical but not necessarily obvious. Every medical device-related RFQ automatically triggers Top Tool to apply and build-in a wide range of systems and processes that can’t be left out of the project.

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