This is the unedited transcript for webinar: Challenges & Emerging Solutions through Micro Molding.
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Hello, everyone! Thank you for attending today’s webinar: Challenges & Emerging Solutions through Micro Molding. I’m your host, Nic Abraham, Managing Editor of Medical Design and Outsource Magazine. Thank you for joining us today!
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Let me give you a little bit about this speaker and then I’ll turn the microphone over to him. Brian Matachun joined MTD Micro Molding in 2008, leading and developing it’s customer oriented technical sales force. Brian has nearly 20 years of business management, polymer development, and plastic processing expertise. He uses his extensive experience and education in plastic engineering to lead MTD’s dedicated sales force. With that, let’s start! Brian, the mic is yours!
Thank you for the introduction, Nic, and thank you all for taking the time out of your day to learn more about micro molding. As you all know all too well, the medical industry is constantly changing. It takes constant innovation to stay on top of it. That’s why MTD is committed to solving complex problems to help our [inaudible 00:03:05] bring higher quality medical device components to market before their competitors. We’ve been doing it since 1972 and have become a recognized leader in our field but to us leadership means more responsibility. It inspires us to drive ourselves even harder to design and produce more effective solutions for our partners.
How do we do that? It’s fairly simple. Our focus is 100% on micro, 100% focus on medical, 100% in house micro tooling, and 100% of all micro molding occurs in our certified class A cleanrooms. We are privately housed and driven by desire to be the first and be the best and helping our customers do the same with our products. We are continuously investing in new technology. 10% of our revenue goes towards internal science project where we require new sales techniques and knowledge to stay ahead of the curve. As a note, MTD now has 2 new molding cells, a graphite [inaudible 00:04:04] and a CMM for our tooling division on order.
From a quality standpoint, we are ISO 9001-2008 certified and will be 13485 registered in July of this year. MTD was also named 2015 Processor of the Year finalist based on factors like financial performance, quality, customer relations, and technological innovations.
The first order of business is to qualify what a micro molding component is and MTD does this simply by asking a few questions for our clients:
1. Does your part fit a 1 inch by 1 inch square?
2. Does your design require one or more of these following features, such as: do you have wall stocks in the range of .002 to .004? Does it require edge and corner radi less than .001? Do you have the aspect rations in the range of 250-1? Or perhaps a small hole in the range of .002 as well? Is your part weight so low that you can measure or make 520 parts from a single [inaudible 00:05:06] of plastic?
All of these features can be accomplished and generally recognized by the industry as being micro and requiring specialized tools. Something to remember is that a part does not need to be microscopic in order to be considered a micro part. This has been proven to be one of the greatest myths of our industry today. In many instances micro features on a part you can see with the naked eye require more specialized tools and techniques than what is required to create a microscopic part with simple geometry. Some of the most difficult parts to manufacture are larger parts with micro features.
Since micro molding is the core of MTD’s business, we’ve patented to develop a complete new set of tools for us to be successful over the past 43 years. These are what we refer to as our Six Sciences which were by our clients as a roadmap to success. There’s a proven track record that when these steps our embraced, our clients tend to yield better long term results both with part functionality and speed to market. Each of these sciences can be a discussion all unto themselves however with time not being our side today let’s cover each one of these 4000 foot level.
Micro material science is where everything begins. In micro molding subjecting materials to unusually high sheer forces while relying on close tolerance temperature monitoring. Better knowledge of the material [inaudible 00:06:24], whether it be plummet grapling, peak, or an absorbable material is absolutely essential to success.
Next is using material selection as a qualifier for what micro part design is feasible for you. Understanding and knowing what can be pulled up versus what can be manufactured in production volume is the key to being successful. In a simple word, it’s reproducability. Micro-tooling capabilities is something we hold very dear to MTD. We design build and maintain 100% of all tools in house. Our clients approach MTD when they are seeking high resolution features as the devices and components are miniaturized. The mold is definitely our enabler to produce these highly unique parts.
Micro molding is not molding small parts with macro molding techniques and tools, the influence of material residues, time in the barrel, the shot weight, the proximity of high masses to open areas, heating and cooling of the mold, the force required during injection, adding inspection to the process to accept or reject immediately and so-forth are all dramatically different for micro. Micro sized parts do not lend themselves to touch, whether by a probe or by hand so all measurements must be made by highly sensitive optical systems. Assimilar to metrology, handling and assembling or package micro sized is far more challenging. The solutions are different than those employed in making macro sized parts. Every machine at MTD has a custom end of arm tool made just for your part, there is not a single part at MTD that is simply ejected into a bin and allowed to free fall. As you can see, micro and macro require a different set of skills in order to be successful.
As was stated earlier, it all starts with the material. One of the most common questions we always field is what materials are suitable for micro molding? The simple answer is that all thermoplastic materials are suitable for micro molding but what the determining factor that usually comes up is that your geometry will drive what material is suitable for your design. Essentially, what makes MTD special is our in depth experience with all of these materials both thermoplastic and bioabsorbable. The reason we are so well versed in the given materials edge of success and failure is that we’ve designed unique characterization techniques to evaluate the materials under the micro molding process. We want to encourage our clients to engage MTD as early as possible to avoid any of those false positives or false negatives.
The first step in the process is always focusing on the material and establishing what is required for material preparation pre-molding. Process development starts long before a customers tool is ready and even before it starts being manufactured. A lot of bioabsorbable materials, exotic materials, and custom blends come to the door with minimal or no data so we can discover this for ourselves with testing. Once we establish where we think we should be with the process conditions, we use our in house [inaudible 00:09:25] micro technology tools.
The first one is micro-fill. This utilizes a spiral mold at collected temperatures so we can run several injection velocities and record peak pressure, transfer pressure, and flow lines. From that we can determine how sheer sensitive the material is. Depending on the part geometry, it will also let us know what kind of speed we can expect to use to be successful when filling unique geometries.
The second is our micro-flow. Using a thickness plaque that ranges from .002 to .009 we can see the effect of reduced wall section on flow line. Running through multiple injection velocities while measure flow line we can determine what wall thicknesses are realistic for a certain material. In the event we discover that we cannot fill a given thickness, we can always adjust machine parameters. Just like any adjustments, there are limitations though.
Lastly, are micro-runner studies. This is a tool that has a rationing runner system that varies in diameter and aids in determining the minimum runner size required to fill the volume of your part. This is to help us size a runner assistant to adequately mold the product without sacrificing material. This is extremely important for expensive material that may be in the range of $3000 up to $1000 per kilogram. For instance, one of the most expensive materials we mold at MTD to date is approximately $1,000,000 per kilogram. These technologies coupled with extreme conditioning control allow us to use conventional runner systems to produce upwards of 10000 shots per pound of material. When we hear another vendor struggling with consistency, it is clear that the importance of control instance factors was not likely understood nor practiced.
MTD is globally known as a leader in premier tooling shot from micro molds. As stated earlier, it is our ability to create higher resolution features as medical devises get smaller and smaller. When MTD receives a design, it is our responsibility to use every tool in our toolbox to design a mold and come up with a solution to provide that client that perfect match to their model. At MTD our work piece accuracy target is 40 to 1,000,000. What I mean by work piece accuracy though is what the actually part comes out of the machine looking like and not what the actual machine is specified to do. This is what separates MTD from other shops. We may both have plan going in but MTD has exact execution.
It is always nice when we see drawings that have tip radi less than .001 because if that is truly what the client needs, MTD is the only person in the world who can do this because of our Sarix 3D EDM technology. This is a very unique piece of equipment that creates cavity geometry by following a tool path similar to CNC milling but the major difference is that the end mill is actually an electrode that can as small as 5 microns. Simply just imagine the [inaudible 00:12:28] of the geometry and the cavity.
Further in the discussion, one of the common misnomers in micro molding is when our client asks us to produce a rapid prototype of what the industry would call a soft tool. Soft tooling is not suitable for micro for a few different reasons; one being that all cavity geometry at MTD is done via EDM which in essence does not really care if the substance is hardened steel or soft aluminum. Most importantly, aluminum does not hold up to the pressures that the mold will experience during the micro molding process which could be in excess of 50000 PSI or greater of injection pressure.
Once the mold is complete it is very important to perform installation qualifications on one of MTD’s technologically advanced micro molding cells. Because MTD warranties most of it’s tooling for one million cycles, it is our responsibility to make sure it is functioning properly when mounted in the press. Our machines utilize screw over plunging designs which is different than a conventional molding machine in which a screw does 4 basic functions: melt, feed, convey, and inject the polymer. In MTD’s case, the screw only melts, feeds, and injects the polymer into the plunger cavity. This has several advantages but the most basic are controlling resistance time at high heat and not sharing all of the materials in the barrel for every single shot as you would commonly do for conventional molding.
Investing in top of the line equipment makes the job easier and more efficient for our process engineering team to develop the widest process window possible. Dependable and accurate equipment is essentials when working with such small numbers. As a matter of fact, our machines have plunger resolution of .03 millimeters. This means that 25% of the diameter of a human hair on position is the difference between a full shot, short shot, or a flat shot. By implementing in line inspections systems, we are able to verify the absence or presence of details down to one ten thousandths. This allows our clients the peace of mind that every part is 100% inspected and corrected.
Another line of defense that we employee is RUG ed Art that speeds the visual inspection up and can tighten the window on how a cavity is packed, sort from good and bad as well, and predict dimensions. We have developed the software for micro components where it can actually predict what a dimension will be by assessing how cavity pressures impact particular dimensions.
Although each micro manufacturing cell is considered autonomous, MTD must also depend on proper quality assurance techniques that come in the form of micro metrology and testing. MTD product realization methodology resembles what you would normally find in the medical industry following a standard IQ, OQ, PQ but because of the typical part type, end type tolerances we have adapted our processes and tools to focus on perfecting the measuring system earlier on in your project. For custom fixturing and non contact OGP measurement programs are created and validated in house for each part. Anyone can measure a part with a rubber ruler and I assure you MTD sees this all too often. We always proof our measurement system for all critical dimensions with the gauge R & R. There is high confidence that the data we provide for the customer is valid and captured with accuracy. One statement of clarification caution is our gauge R & R does not tell you that the part is within specification. What it does tell you however is that your measurement system can accurately and consistently measure the part.
Now that we know the six sciences, have discussed some of these in more detail, and created boundaries for a what a micro molded part can tend to, we can now talk about what this geometry has allowed our clients to further their designs beyond their imagination. As you may readily see that which is possible is fairly exceptional and MDT’s offering of wall thicknesses down to .002, aspect rations of 250:1, employing zero draft designs, and tip radi of 5 microns have changed the game for markets like endoscopy, drug delivery, and laparoscopy. MDT can now insert tiny [inaudible 00:16:51], delicate electronics, or simply join 2 percision components that otherwise would have been assembled from high risk manual fashions. Medical device companies are requiring higher tolerance components for more client specific therapies and treatments. This is found in some products for radiation directing [inaudible 00:17:11] therapy as well as quantitative care drug delivery. The growth in market acceptance of bioabsorbable polymers throughout the body have leveraged MDT’s unique set of skills for their current and next generation devices.
So now, let’s go to 3 case studies where the pitfalls we have noted in prior slides were highlighted by our client and how challenges were overcome by the emergence of MDT’s micro molding technology. This slide up here is a 3d comparison of a 3D printed prototype to a mold built by MDT. For some very low quantity applications, such as personalized medical implants, 3D printing has reportedly been used as a limited run production technology. It is natural that the successes experienced by those using the method in the macro world would inspire similar experimentation in the micro world as well. The dilemma for most development engineers is in determining whether the short delivery time and low cost sample of a 3D printed part outweigh the disadvantages of potential loss of critical micro feature definition, reduced material choices, and possibly the loss of the ability to functionally test. To clarify the dilemma in terms of feature definition, the quick visual comparison of the two parts shown in the bottom left illustrates this.
The answer to whether 3D printing will be sufficient or whether a part must be hard tooled might become clear once the need for micro sized features is determined. Are they desirable or are they critical for function? The same is true for the number of parts required. Is the need limited to a handful of parts or will thousands of parts be needed? The physical, mechanical, and electrical property of the material is also a concern. This component [inaudible 00:19:07] clip has a dynamic end that must open and close without failure while the teeth or stares that we call them are a design feature to mitigate the migration of the clip off of the vessel. On both accounts 3D printing was not favorable because it could not be made on the at home material and the resolution of the teeth exhibited poor tissue performance. This being said, however, MTD does strongly believe that developments in 3D printing that are occurring at a rapid pace will eventually nurture the design and development of micro prototypes.
The next case study began with our clients desire to create a bioabsorbable part. The way they approached the challenge was sensible; before they invested in molding a bio-material, they wanted to find a reasonable thermoplastic surrogate material that could tell them whether or not they could have a likelihood for success with a bioabsorbable. The surrogate material was identified as polycarbonate and when they built the mold and tried to run product, the initial mold could not fill the part properly. The next fold for the molder was trying a host of other polymers. Perhaps polycarbonate was not the best material choice. The results proved that the molder could not fill the part in any material. The closest they got was using a high flow acrylic which is pictured in the top black and white photo.
The LDM eventually came to MTD and after we analyzed the test from the other vendor it was clear that the first vendor approached the mold construction very similar to a macro part. This resulted in excessive gas traps throughout the entire perimeter of the tack. With MTD’s micro fill technology as we explained earlier and the understanding of the material during the micro process, we knew we had to approach micro perspective and obviously build it differently. Weeks later (approximately 4 weeks), our first shot looked exactly the drawing you see there. That’s what we’re up to today when we are in full production mode producing over 170,000 parts per week and we have been able to pass down a cost save of 38% to the customer over 4 years.
The path we encourage our clients to take when they are starting a challenging R & D project is to always start at proof of concept and scale the program using the following steps:
Step 1. Prove the design is viable.
Step 2. Create a prototype mold that can sustain early production.
Step 3. Maximize cavitation based on what you learn from that prototype tool.
Step 4. Build production cavities at maximum cavitation to reduce costs and then possibly multiple molds to achieve your volume requirements.
This next case study looks into one of the most rapidly growing field that MTD is exposed to today. That is personal delivery of pharmaceuticals. An injectable drug delivery systems company was struggling with the traditional manufacturing methods for it’s device. The process included a series of high risk, cumbersome steps and mainly assembled 4 micro components. Cost concerns were a factor and these steps required having an entire room of people assembling components at one time. MTD was approached by the client to build a single cavity mold that proved our technology could be used here. After a few months of mold-fill analysis and collaboration, the successful micro molding of this device eliminated the risky assembly and provided our client a long term cost on model that was scaling to nearly 50,000,000 units per year. Traditional manufacturing methods for the development of cannulas have used the peak forming process of converting tubing. Next generation products will likely follow the new advances that MTD’s tooling expertise has allowed. If you were to look at the micro tooling and molding industry today, MTD is the only company who is producing components with these nearly impossible geometries.
As we close out here, I’d like to cover what makes MTD so special. If you can really remember just a few points from this discussion, I would hope that these are the ones that you will remember. We are always asked the simple question: who was your competition? The response that most companies would give is that we don’t have any competition. The following is a list of why this is particularly true for MTD’s case.
*First, there is no other molder in the world that focuses solely on micro molding. It is always a subdivision of their larger macro molding company.
*Next, we are the only micro molder that we know of in the entire world that focuses solely on the medical device market place. Others may use automotive, electronics, and other consumer products to fill in the void.
*Thirdly, from a tooling perspective, to our knowledge today we are the most experience micro molder who utilizes Sarix 3D EDM technology to create cavity detail.
*Then if we look at a few of our guiding stars (and what I mean by this is these following three metrics guide us year over year and reset them and we remeasure them every year) 90% of our projects are completed on time. Simply stated, you get parts in hand when they are promised to you.
Now, the next to speak for themselves:
*20% of our successes have been failures by others.
*30% of our successes have actually been no quoted by the industry. This means your project may have circled every potential micro molder in the world and MTD is the only vendor that saw your design and believed it could be done. Combining these last 2 statistics: 50% of our business every year is working on a project that is nearly improbable.
Well, I think everyone for their time today. I hope you all learned a little more about the micro molding market for medical device as well as MTD’s unique skill set. Right now, I’d like to pass along the question and answers along to Nic.
All right. Thank you, Brian. Great presentation!
So, we are going to move along and wrap up with a few questions from our audience. The first question we have is: I heard you say the max footprint for a micro part is 1 inch by 1 inch, how does that correlate to over molding?
Over molding is one of the things that some people do get confused with today. When we talk about 1 inch by 1 inch square, we are always talking about the business area that we are actually working with. So today MTD does combine catheter components that may be 3 feet, 4 feet, or 5 feet long but the actual over molded area that we are working with fits in that 1 inch by 1 inch square. The actual component may not be 1 inch by 1 inch but again repeating, as long as that working area fits in that space.
All right. Awesome!
The next question we have is: you mentioned in house testing, what type of testing can you perform at your MTD micro molding facility?
From a testing capability stand point, we have tinsel testing. Being a tool shop, we are able to create custom fixtures and jigs that go on the tinsel machine to evaluate your component in a dynamic fashion or again, if it’s a fastener we can do tinsel testing. We have differential scanning caliber imagery, known as DSC, which allows us to look at a glass transition temperature of the material as well as the percent of crystalinity. Which is why a good deal of what we mold is in the bioabsorbable space and heat components because peak… your properties of that finished peak component are related back to the percent of crystalinity and the molded component, we want to be able to test that.
We also have inherent viscosity testing which we use not only in the bioabsorbable space but other materials where we’re looking at molecular weight or tension in the post molded product. Because like I said, the micro molding process tends to be a very violent process. Again, 50000 PSI of injection pressure that you’re delivering in .01 seconds. It’s imperative that you’re not burning the material. What we look at from MTD’s perspective is if it’s going to be an incoming criteria or release criteria or critical test for you to perform on incoming inspections or for an approval of validation, we want to be able to test that if possible in house while we’re creating that process window. It only makes sense to do it then.
Okay. Thanks, Brian. We have another question here. What is the tightest tolerance you can hold?
What we’ve successfully completed today from a gauge R & R perspective, it all relates back to that, is we’ve gotten down to plus or minus two tenths to have a passing gauge R & R. Is every component, every feature, every dimension capable of holding that? No because that relates back to a lot of different things in terms of where we’re taking the dimension such as having a plus or minus .2 tolerance on a dimension that you have to take from a .003 radius would be nearly impossible. Color of the component has a lot to play into that. Is it a straight through hole that we’re looking at? Is there a read in edge? A lot plays into that but again like we said- it’s removing those or identifying those critical areas or tolerances early on and then performing that gauge R & R to understand that.
One additional thing that we go through will all of our projects and we see some highly tolerance components or highly tolerant drawings is we will go through a process where we call red, yellow, green. That is where our tooling and molding people will take your drawing and we highlight it red, yellow, or green. Green meaning there are no issues with what we see there. Yellow, when we look at that, we’re saying okay we might have a problem in the dimensionals but we go ahead and create that automated routine. Red quite frankly is something that MTD has never been able to achieve or seen in 43 years so it’s definitely a big stop sign. It’s allowing our clients the understanding in the upfront prior to purchase order where the challenges lie. Not sitting at the table after purchase order is being placed then telling our client “no we can’t hit that radius, that dead sharp you wanted? No it needs to be .003.” As we like to call it, we play cards hands up.
All right. Awesome! So another attendee would like to know what brand of molding machine do you use?
Very simple. We use Sodick, twenty ton Sodick machines. The one difference is we like to say we buy a twenty ton Sodick machine, [inaudible 00:31:06] plunger, but we then customize the machine. It’s a full customization where we could put anywhere from $500-$650,000 dollars worth of additional things into it that combine close temperature monitoring as I mentioned earlier on. All the machines have robots and automation. All the machines have at least one camera on them for part recognition… actually, sorry, let me rephrase that, every machine has at least 2 cameras on them. They are very customized when they are all done.
All right. Great. We have another question. What is the thinnest wall that can be molded for cannula and what is the longest limb for cannula?
Yes, so of what we have done to date one of the thinnest walls is roughly .002. The longest flow line is 4.5 thousandths one inch long but for cannulas they’re usually roughly in the 4 to 5 thousandths range in terms of wall. In what is very unique at MTD is that we have those cannulas you saw prior to that where they have that dead sharp tip on them so it’s the ability to have that tip in our tooling capabilities so… let me start over.
So, from a tooling perspective, it is our ability and expertise and precision and all this wonderful things that our toolmakers do every day of that week. That pin needs to sit in that pilot hole, shut off, not allow flash, and vent. Just imagine what you are trying to do when we talk about placement of that pin and splitting tenths to get it to do exactly what it should do. It’s pretty amazing. In a nutshell, it goes back to your material selection and the material will then drive what can be done, what is possible in terms of thinnest walls and dimensional tolerancy.
All right, Brian. This next question is kind of long so let me know if you need me to repeat it. It reads:
How well do scientific molding principles translate to micro molding when it seems the runner is so much larger than the part with the injection time so short?
I’m going… as I chuckle here.. sorry, I’m not going to go out on a limb and try to answer that question for you. I’m not a master molder by any stretch, I don’t use the techniques in our place but I would love to take that answer and pass it along to our master molders and have them respond directly to you.
All right. Awesome! Let’s do one or two more here.
What is 3D EDM milling?
What it is is it combines two different technologies. For everyone who is familiar with high speed C & C milling and some of the limitations of it, what that is is that one of the limitations that Sarix machine overcomes is that when you do C & C milling the geometry you are able to impart to your sub-straight is predicated upon the size of your end mill because it’s a touching method, you are actually taking a .005 end mill and biting into that sub-straight and removing material in that fashion.
EDM on the other hand removes steel (we’ll say) in the form of using the field of electricity around the electrode. The electrode is never really touching the piece of steel, it’s the field of electricity around it. What Sarix combines is that you have an… again you program the machine, so you have an end mill but the end mill against a piece of hardened steel or whatever, it’s an electrode that then creates cavity geometry using and cutting with that field of electricity. What we are able to do since it’s not contact is create extremely small end mills down to 5 microns to create very crisp and small geometries.
I hope that helps. It’s very unique but I urge you to go look at Sarix S- A- R- I- X and see the technology they are employing. It is is pretty amazing. It cuts very similar to an XL length if you look at it. You would remove a layer of steel and then what happens is the actual cutting bit will then go into the, step down, into the piece of steel and create it’s next layer or remove steel in the next layer. What it’s doing is it’s removing millionths of steel and every time it steps down it steps down in sub-micron increments. Pretty amazing piece of technology.
All right. Thanks, Brian! Well, we are going to wrap up here. Once again, you can find this webcast and it will be available at medicaldesignandoutsourcing.com. One final message: please follow us, Medical Design and Outsourcing, on Facebook and Twitter. This concludes our presentation. I would like to thank everyone for attending and please enjoy the rest of your day!
Thank you very much, Nic. Thank you everyone as well. Bye now!