Top Tool

By Duane Kari, Sales Manager

If you never been to one of these shows? They are one-stop resources for product development professionals, featuring the latest advances in precision manufacturing, quality tooling, wire EDM machining, networking . . . and much more.

Top Tool will be exhibiting with over 25 years of experience in servicing the medical, defense, electronics, energy, and other high-tech industries. Co-creating best in class micro solutions with designers, engineers and strategic sourcing specialists with the common objective of managing risk while driving business value.

R&D. Top Tool thrives on R&D-stage challenges. We understand how R&D innovation can create solutions with value-chain impact.

Precious Metals, Exotic Materials. We manufacture critical medical device components stamped from ultra-thin precious metals and exotic materials. At thicknesses down to 0.0015in.

Risk Management. Managing risk is critical to achieving the potential in medical device innovation. Top Tool helps device makers dial down risk while keeping the target outcome in reach.

FDA Regulation. An extensive history in medical device regulation equips Top Tool to support FDA compliance while leveraging the miniaturization, materials and complexity that drive product innovation

Innovation Starts with You… Now would be a good time to plan your event at: http://visitors2.eventgenie.com/mobileappanaheim

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Marty Cavegn-Sales Engineer

Just went out to a Wire EDM manufacture’s website to get the tolerance capability of their best wire machine. The published accuracy is ±.000040" or 1 micro meter. If you have 20 tolerances in between a punch and a die, this gives a potential error of ±.0008".  That is more error than allowed for building a near zero clearance die.  Thus, if you look purely at the numbers, the best machine in the world can't make a complex die correct out of the chute.

This situation has been around for centuries.  It wasn't until the dawn of the 20th century, when Henry Ford created the assembly line and parts tolerances, that this was a problem.  Prior to the assembly line, everything was made by fitting the pieces together.  The folks that were best at it were called craftsmen.  Top Tool relies on both our equipment and craftsmanship to make tools.  Anyone can go buy the best wire machine, not anyone can make the stamping dies that Top Tool does.

So yes, under a microscope the die components are not perfect, and maybe even a little less perfect than planned.  That doesn't mean there are egregious errors in the design.  There is slight micron level variation in the parts which is normal.  Our skilled internal staff is able to understand the form fit & function.  The less skilled staff on the outside might not be able to.  As a good partner, Top Tool takes the responsibility to improve the die with custom craftsmanship, to make it more easily repaired by less skilled individuals during the entire life of the tool.

I don't want to sound like a cheer leader, but what happens here is really impressive.  I know because I have bought parts from a lot of folks that fail to stand behind their tooling.  I also worked in other high tech industries where precision was important and tolerances alone could not guarantee functional parts.  You often rely on the law of averages, and sometimes when the variables (big tool, deep entry, small clearances for thin materials, multiple WEDM machines used in fabrication, etc.) and tolerances stack up against you, you typically redo something to compensate. - “you get what you pay for.”

Hope that helps clarify a little about tool & die building?

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By Duane Kari, Sales Manager

Top Tool is exhibiting in Silicon Valley this week. The Bay Area is home to numerous biomedical device companies and continues to be a center for health care innovation and digital technologies. This year’s Biomedevice show promises to highlight emerging technologies, provide advice on taking device ideas to market, and offer networking opportunities for medical device professionals

Likewise Minnesota has a similar High Tech region poised to develop and accelerate Innovation; located in the heart of Minnesota’s Medical Alley, Top Tool Company collaborates with medical device designers, engineers and strategic sourcing specialists on micro component solutions.

Recently The Minnesota High Tech Association (MHTA) has named precision micro stamping manufacturer Top Tool Company a finalist, along with 3M and Seagate Technolgy, in the Advanced Manufacturing category for the 2012 Tekne Awards. The award honors technological advancement in manufacturing. The program reinforces Minnesota’s place as one of the most competitive and technologically advanced regions in the world. A full list of finalists is available online at http://www.tekneawards.org/finalists

Presented by the MHTA, the Tekne Awards honor those who play a significant role in discovering new technologies that educate, improve lifestyles, and impact the lives and futures of people living in Minnesota and all over the world.

 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 “digital everything” by posting a mobile version of our exhibits in Boston and Minneapolis. And we are mobile for the San Jose show as well. You can download the app here:

http://www.canontradeshows.com/expo/biomed12/index.html

While at the show please be our guest in Booth #213.

Click here: https://www.compusystems.com/servlet/ar?evt_uid=584  

For complimentary admission, use promo code BZ

To preview the conversation, check the Top Tool website for a wide range of precision metal stamping discussions, including:

ü  Is precision stamping is strategic, relevant for micro components?

ü  Emerging materials, from Nitinol to wovens like Delrin, Kapton and Gortex

ü  Six Critical Factors in Precision Micro Stamping

ü  The R&D-stage solution to fast, streamlined prototyping

ü  Why Platinum is not for every component manufacturer

ü  ”Design for stamping manufacturability” cuts lifecycle costs

Top Tool manufactures high-precision, micro and micro-miniature components – featuring complex geometries and tight tolerances – stamped from ultrathin, exotic materials and precious metals. Medical device makers rely on our deep, specialized experience taking on the unique challenges that accompany designing, engineering and manufacturing intricate small parts for their latest innovations. See you at the show.

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Presented by the MHTA, the Tekne Awards honor those who play a significant role in discovering new technologies that educate, improve lifestyles, and impact the lives and futures of people living in Minnesota and all over the world. The program reinforces Minnesota’s place as one of the most competitive and technologically advanced regions in the world. A full list of finalists is available online at http://www.tekneawards.org/finalists

Here’s our story, envision a micro part only 2 millimeters in size. Or smaller. With multiple, complex features down to 100 microns. And tolerances as tight as 13 microns.

R&D. Top Tool thrives on R&D-stage challenges. We understandhow R&D innovation can create solutions with value-chain impact.

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Posted by Ted Huot, Engineering Lead

Medical device advances that feature aggressive miniaturization challenge manufacturing’s best production methods. Precision micro stamping is up to the task . . .  if you’re current on what’s possible. In the following Q&A, Top Tool Engineering Lead Ted Huot distinguishes the relatively new micro specialty from its old-school heritage.

Is the medical device sector still discovering what micro stamping can accomplish?

Ted: Many discussions – often during tradeshows – begin with someone saying, “Really? That’s a stamping?” A device engineer looks at a micro medical part example that’s only 2mm long. Yet it includes a dozen bends, shapes and forms. Not to mention very complex geometries and features down to 100 microns. Or tolerances as tight as 13 microns.

All of that is possible, yet machining methods seem to get more attention. Why?

Ted: Certain manufacturing habits die hard. Stamping used to mean blanking out non-complicated, flat-profile parts. It was automatic to hand over anything even slightly complex to machining. Today, by comparison, we collaborate – as early as the R&D stage – on engineering and design parts to leverage what only stamping can do.  The intricate, ultra-precise micro stamping that delivers medical-caliber quality is drastically different. “Forming” is a more descriptive term. It’s not only piercing or cutting edges. A stamping solution can also bend, draw, shave, coin and skive.

Can micro stamping truly keep pace with medical device complexity?

Ted: Stamping actually is an even better fit as complexity increases. The more that’s going on in a micro part, the more you want to stamp that component. The variability inherent in a machining operation, or several operations, increases the potential to make parts at least minimally different each time. Making 10,000 parts with a validated, “smart” tool – often using in-die sensors tied to press controls – means every complex piece is identical.

How does complexity impact the way a stamping supplier removes variation?

Ted: Working on medical device challenges frequently represents new manufacturing territory. So part qualification is critical. But suppliers define this element of risk management differently. Passing first article inspection by making five parts to the print does not validate tooling and confirm the best possible approach to production.Rigorous part qualification and analysis begins at concept and design, stays in place through all stages of manufacturing, and finishes with follow-up in post-production.

What precision micro stamping capability still surprises medical OEMs?

Ted: A lot of what’s possible in high-end micro stamping wasn’t imagined even a few years ago. So it’s almost always the combination of precision, accuracy and complexity that’s possible in a micro component footprint. A 13-micron tolerance is one-sixth the thickness of notebook paper. It’s possible to store 5,000 micro-miniature parts in one-half of a prescription medication bottle that looks like gold dust or platinum flakes. Micro stamping gets it done. All the way down to the μm level.

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Posted by Duane Kari, Sales Manager

Top Tool regularly works with customers on challenges related to producing complex components that have – in the beginning – no clear (and realistic) manufacturing solution. It requires being comfortable with lots of questions and open issues at the start of a project.

Here are some examples:

Solved Persistent Failure Issues. Quality problems with a fragile and micro medical device component nagged the OEM during attempts with multiple suppliers, including stamping contractors. The solution didn’t surface until part-failure “forensics” diagnosed deformation created because the nickel-based material – at vulnerable dimensions – was not robust enough to withstand heat treatment.

The answer was a new, in-die material handling strategy to hold multiple ultra-thin .0015in. features stable during heat treatment. Re-engineering for manufacturability produced features selectively reinforced with extra material removed during a secondary, post-heat operation.

Avoided Locked-In Higher Costs. Evaluating stamping during R&D can avoid validating a machining protocol that inflates lifecycle costs unnecessarily. Especially in the case of high-priced precious metals. In this micro medical challenge – stamping flat stock to form bends, folds and other complex features – instead of cutting down raw platinum stock – stamping reduced the per-piece cost of a component to less than half of the original $20 machined version.

Stamping’s capability to fabricate precious metal components using significantly less precious metal drove a significant portion of the cost reduction. But the streamlined approach also replaced a specified laser-etching operation incorporated into the stamping process.

Delivered As Designed. The price point for an intricate critical component in an advanced health sensing technology eliminated manufacture by machining. From a cost perspective, stamping was the only viable approach. But the development-stage OEM had approached multiple stamping suppliers without identifying a source able to produce the part through metalforming.

The principle issue was a conflict between a critical-function component . . . and the ability to stamp the part as engineered and drawn. Bridging the gap required experience with complex challenges and the engineering capacity to re-design for stamping manufacturability while retaining functionality.

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Posted by Marty Cavegn, Sales Engineer

In a recent ranked list of preferred fabrication methods (for medical components), molding outpaced the next most popular approach by a 2-to-1 margin. We can confidently assume that cost effectiveness is the main attraction. But plastic also has its limits, of course. A key piece of functionality or performance often requires a material property – like tensile strength, wear-surface durability, strength-to-size ratio or a surface for welding – that plastic molded components alone can’t supply.

When those types of requirements indicate that metal is the solution, precision stamping and forming makes the approach viable by delivering parts per dollar instead of dollars per part. There is a lot of precedent for replacing a $3 machined or laser-cut part with a precision stamped component at 25 cents per unit. That’s especially true if you can optimize for stamping and forming manufacturability during the R&D or prototyping stages.

Keep in mind, however, that the solution does not have to be a single-method approach. At Top Tool, the specialty is precision metal stamping. But Job #1 is to provide customers with answers to component manufacturability. We frequently are involved in “never-been-done” projects – especially at the micro manufacturing level – that require collaboration with other fabrication methods.

Which is why, in some cases, the answer is a “hybrid” or combination technique. Assemblies that merge stamped components and plastic overmolding are an example. In fact, I think overmolding is an underutilized approach. Molding and stamping both meet the “parts per dollar” outcome that volume manufacturing must deliver. Together they provide the functional performance of metal and the complex geometry fit of a molded part. It’s an effective – and cost efficient – combination of form, fit and function.

Top Tool is about stamping and forming, so here’s a last thought that heads things back in the direction of metal as the viable option. The overmold-and-metal stamping hybrid provides even more potential for demanding projects when you consider that the door to benefitting from emerging and exotic materials – and doing it cost effectively – is opening wider all the time. Nitinol, for example, provides better elasticity than plastic, but with much higher strength. As a result, designers have definite and accelerating plans to exploit its functionality, versatility and durability. The key manufacturing issue – from the perspectives of cost, productivity and precision – has been how to manipulate the material. Stamping and tooling advances that are keeping pace with new materials have been successful resolving difficulties that accompany properties like durability and abrasiveness.

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Posted by Mark Erickson, President

At this writing, I’ve been in my new role at Top Tool for two months. I’m still in the ramp-up stage, and it’s clear there’s a lot to experience and learn. But it also means I come in contact – almost daily – with aspects of the company, our customers and our team that make “getting started” very motivational. After almost 30 years in metal stamping, I don’t mind admitting it’s fun to learn some new tricks.

I’m happy to see, for example, the high number of Top Tool relationships that are “design-for-manufacturability” collaborations and partnerships rather than basic, arm’s-length customer/vendor purchasing transactions.

What does a design-for-manufacturability collaboration look like? Here are three examples of involving precision metal stamping design and engineering early – well in advance of the final print – as a way to optimize cost, quality and performance.

1. Focus on what is critical. Generally, 70-80% of a product’s cost is locked-in by the time the design is complete. At the component part level, every design-stage feature or dimension steers a part toward a manufacturing approach or method. Typically, a few key features or dimensions are critical, but a significant number are non-critical. Looking at manufacturability can drive design modifications that optimize for “critical,” but prevent “non-critical” from increasing cost or risking quality unnecessarily.

2. Integrate the supply chain. Manufacturability can be a missed opportunity when supply chain relationships occur in silos. One example: assemblies that merge stamped components and plastic over molding. A non-integrated approach looks at molding and stamping as separate, unconnected elements. Because the molder develops its approach independent of the best way to stamp the metal component, the stamping options can be constrained to solutions that “fit the mold.”  A design-for-manufacturability approach, by comparison, puts the OEM in the same room with the stamping supplier and the molder . . . early in the design stage.

3. Different thinking creates new ideas. Our customers are experts at what they want their products to do. Top Tool is at the table to help determine the best way to make our precision metal component work in the product. I’ve already observed that powerful results – from R&D breakthroughs to long-term product life-cycle impacts – get a boost from making design-for-manufacturability principles available to a customer’s design and engineering discussions. With some insight into what optimized precision stamping is uniquely qualified to accomplish, new ideas inevitably start to flow around the OEM table.

Regular customer/supplier interactions happen every day and usually don’t give the supply chain an opportunity to think creatively. Early involvement and collaboration can have a positive effect on cost, quality and manufacturability.

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Posted by Sue Ryan, Vice President Finance

In more and more cases, when stamping comes onboard "early" in the design or R&D process it means getting integrated at a design-for-manufacturability stage. "What is the most efficient and effective way to design and fabricate this part so it functions this way?" That's when the connection to a supplier is a strategic, value-adding collaboration and not just a basic transaction.

Materials procurement and management falls somewhere between the same two points. Is the capability about basic transactions? Or can a supplier collaborate further upstream, where there is potential for your supply chain to add strategic value?

Consider the constant challenge in forecasting. The economic downturn of the past several years clearly added complications. But the same is holding true for the road coming back. The uneven recovery keeps the pressure on to find new, creative and measurable ways to minimize or avoid risk. Supply chain, as always, is a target-rich environment for leveraging opportunities to relocate as much risk as possible beyond your own walls.

High-end materials logistics lets you trust risk management to the supplier. The skill sets range from capabilities in Lean Cost Performance Index (CPI) and full lot traceability, to web-based order management and sourcing proprietary precious metals.

Here's an example: An uncommon, custom blend of nickel silver -- available only through a European supplier -- might have a 12-week lead time. An OEM customer can source the material, but will wrestle with daily price fluctuations in order to manage price variation. And the material is too expensive – particularly at high volume – to park it in inventory or compile safety stock.

The answer might be a three bin Kanban managed by the metal stamping supplier. Just-in-time replenishment scheduling tells the supply chain what to produce, when to produce, and how much to produce. One bin supplying the OEM factory. One bin being filled during stamping production. And the buffer bin, in between stamping and the OEM, ready for the factory floor. A supplier using this three-bin material management system can put parts on the customer’s receiving dock within three days of getting the re-supply signal from OEM operations.

It's the difference between arm's length transactions . . . and collaborations that reflect your strategy.

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Posted by Duane Kari, Sales Manager

It may not have the drama of a presidential election poll, but a survey on the Medical Design Technology (MDT) homepage makes me think about hitting the campaign trail. To pump up the popularity of precision stamping within the medical device segment.

MDT asked the question: Which fabrication process do you use most often for medical device components?

Readers replied and generated these results:
      Molding 42.34%
      Machining 21.77%
      Extrusion 9.68%
      Other 6.05%
      Pressure/Thermoforming 5.65%
      Photoetching 5.65%
      Stamping 4.84%
      Casting 4.03%

Given a wide-ranging, all-inclusive category like “medical device components,” you don’t expect stamping to compete with molding for the top spot. But I can confidently say that micro stamping, in particular, is well positioned to improve how frequently it is a medical device solution. Ongoing miniaturization is driving new challenges in making complex components – particularly critical medical electronic parts – that depend on the repeatable, cost-efficient quality that’s unique to stamping.

Predictably, a climb in the medical device survey will result from some of the machining vote moving over to the stamping column. Actually, that transfer is already happening. The frequency of stamping today (at 4.84%) likely reflects an increase from where the method would’ve ranked in earlier polls. Much of what happens in high-end stamping today wasn’t imagined just five years ago.

Top Tool, for example, is collaborating with a leading global innovator on futuristic cardiac care that requires a level of complex and precise micro fabrication that machining can’t produce.
Medical device scientists and engineers were challenging the limits to treating a common, life-threatening aspect of cardiac intervention. At the same, time, Top Tool had been bringing the quality, cost and efficiency of stamping to micro component projects. Particularly in the area of implantable medical devices using components made platinum and other precious or exotic materials.

In another example, the decision to evaluate micro stamping during the R&D stage avoided validating a machining approach that would have inflated lifecycle costs unnecessarily. Top Tool developed a solution to stamp flat stock to form bends, folds and other complex features – instead of cutting down raw platinum stock. As a result, stamping reduced the per-piece cost of a component to less than half of the original $20 machined version.

High-end micro stamping is delivering the ultra-tight tolerances and micron-level precision that medical device designers need to achieve in order to move their health-improving breakthroughs from concept to reality. That’s going to be good for several points of improvement in future surveys.

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