Ranica Arrowsmith, Associate Editor07.22.14
Proof of concept. This is the driver behind any kind of prototyping—medical devices included. And this means it isn’t good enough to merely produce an example of dimensions. While rapid prototyping—a.k.a., 3-D printing—is a good method for showing OEM clients what their device might look like in terms of size and shape, it doesn’t quite cut it when it comes to demonstrating whether a design concept will actually work as expected. Will a certain material really stand up to use in the real world? Even aesthetics are important—will the chosen design be visually attractive?
Prototyping is an essential stage of the design phase. By materializing a design concept, contract manufacturing organizations can shorten the design and development phase, because OEM clients can see exactly how their device will look and function ahead of time and make any needed adjustments. Designers can ask new questions about the function of a device with a physical example in front of them, and envision more possible uses, including unintended, for the device. Appropriate prototyping goes a long way to minimize changes late in the design stage.
Because prototype devices are not under any regulatory obligation (as they are not going to be used in tests or trials), contract manufacturing organizations (CMOs) have the freedom to quickly put together examples in in-house shops without the pressure of clean-room manufacturing and other considerations important for in-human use devices. Though sometimes, early stage, small-run devices made for clinical trials are called “prototype” devices, this term is misleading. Such devices are better called “pilot” devices, and often are created so that OEMs can move quickly into clinical trials to speed the regulatory approval or clearance process.
However, as Angel Domingo, director of quality and regulatory services for Irvine, Calif.-based Pro-Dex Inc., maker of powered solutions for medical and other markets, told Medical Product Outsourcing, “Anticipating regulatory requirements for specific intended uses and regulatory markets can feed into the prototype design, so determining a regulatory strategy early on is important.
“Some prototypes may be representative of units to be used in verification and validation (V&V) activities,” she continued. “To ensure regulatory/compliance needs are considered, adequate prototype quantities should be considered to represent statistically valid quantities in those studies. Further, prototype materials for V&V activities may need to be compliant to RoHS (Restriction of Hazardous Substances Directive), WEEE (Waste Electrical and Electronic Equipment Directive), REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and Conflict Minerals regulations.”
Every year, manufacturing and prototyping methods get better and faster, pushed by OEMs wanting devices on the market faster and faster in order to be more competitive and profitable. But as Jared Sunday, director of engineering for Ci Medical Technologies Inc. (formerly Classic Industries, a Latrobe, Pa.-based injection-molded components manufacturer for medical, pharmaceutical and healthcare applications), told MPO, “The old saying of ‘quality, speed or cost: you get to pick two of three’ is not applicable anymore. Trends and demand to remain competitive, continue to push the envelope to deliver all three of these goals.”
Especially now, 3-D printing is increasingly becoming the process more often associated with “quick and easy.” With more patents on 3-D printing technologies expiring, many last year and this year, 3-D printing machines and printers are easily acquired and cheap. Any CMO can have one in house, and unlike a mold, for instance, one printer can suffice to make any shape and design.
However, as Sunday suggests, CMOs and OEMs need not be beholden to speed and convenience alone when it is eminently possible now to achieve low cost and speed, as well as quality.
“Three-D printing offers a quick product for a reasonable cost without the need for capital tooling expense,” Sunday explained.
“Three-D printing is often used for components of quantities under 50. These components offer rapid delivery of parts for form examination and marketing evaluation. This can be done without the added cost and lead time associated with design, construction, and sampling of traditional prototype tooling where a mold is needed to be built. However, 3-D printing does have its limitations. Printed parts often are not suited for functional testing due to differences in resultant material properties. The surfaces are often rougher to the touch and appearance than components that are injection molded. This limits the ability to utilize the 3-D components for functional, fit, or reliability testing. Three-D components are also not as dimensionally accurate. A good 3-D printed part is very useful for early on in the development cycle. The disadvantage occurs if the parts produced from a printing operation are expected to be used for more than the current technology allows.”
Stu Gallant, vice president of engineering and product development for Pro-Dex, told MPO that while rapid prototyping can provide fast turnaround, this method outputs components that lack in robustness and overall quality. “Rapid (1-2 week) small runs of plastic components are now also readily available,” he added.
Ultimately, prototypes should offer a device maker insight into how a device looks, works, and is made. This is why prototyping using the intended manufacturing process is the most ideal scenario.
“Rapid prototyping is typically performed on a ‘best effort’ basis,” said Jack Daugherty, director of operations for Xact Spec Industries LLC, a precision machining and deep-hole drilling company based in Chagrin Falls, Ohio. “And although it begins to paint the picture for the manufacturing and part-specific requirements, short runs of a device allow you to dial in a process and begin learning manufacturing lessons related to tool life, required speeds and feeds, tool holding and fixtures that will help make the transition to manufacturing smoother.”
Finding the Right Fit
One way of addressing the problem of rough surfaces in prototyped devices is stereolithography (SLA), which is in fact one of the pioneer methods of 3-D printing, patented in 1986 and introduced in 1988. The method and apparatus makes solid objects by laying down layers of an ultraviolet curable material. The original patent, filed by Charles W. Hull, describes a concentrated beam of ultraviolet light focused onto the surface of a vat filled with liquid photopolymer, a plastic that changes properties when exposed to light. The light beam draws the object onto the surface of the liquid layer by layer, using polymerization or cross-linking to create a solid. Stereolithography is a rapid process, and components often can be made in a day—however, it historically has proven to be an expensive method of prototyping. Photo-curable resins have in the past ranged from $80 to $120 per liter, and the cost of SLA machines has ranged from $100,000 to more than $500,000. Recently, though, newly piqued interest in the technology (and the fact that the patent expired in 2006) has spurred the creation of drastically cheaper SLA machines such as the Ilios HD by OS-RC ($4,000), the Form 1 by Formlabs ($3,300), and many others. There also has been a drastic reduction in the cost of photo-curable resins, with U.S.-based providers such as MakerJuice Labs offering materials as low as $40 per liter and European based providers such as spot-A Materials offering materials for 68 euros (approximately $91) per liter. SLA is advantageous when surface finish and overall appearance straight from the machine is the most important factor in the prototype. The process provides smoother surface finishes than many other 3-D printing methods. However, like with other 3-D printing methods, prototypes made with SLA will not stand up to demanding performance. Stereolithographed devices will look like they are supposed to, but they will not work like the finished device is intended to, and neither is it made like the final device is intended to be made.
Stereolithography is but one of the methods a company such as Ci Medical technologies can offer its clients.
“Ci Medical Technologies utilizes many methods of prototyping to provide our customers with appropriate components for evaluation and testing,” Sunday said. “We are able to tailor the method and result of the prototype effort to match specific form,
fit, and functional requirements at any specific stage in the development process. This can be targeted to focus on functional needs, sales and marketing requirements, and speed to market goals. We have successfully utilized 3-D printing, stereolithography, cast tooling, stock machining, hand-loaded semi-automatic tooling, quick turn aluminum tooling, fully automatic aluminum tooling, and rapid constructed tool steel tooling.”
Finding the right fit for a client is key. Cast tooling prototyping, for instance, can be vital in the design process for devices whose end manufacturing process will be die-cast tooling. As stated above, prototyping enables flaws and design fixes to be addressed early on in the design process, saving money down the line. In the case of die-cast components, flaws found too late can bring the costs into the six-figure range, as replacing tools can be very expensive. According to Armstrong RM, an East Syracuse, N.Y.-based rapid manufacturing company, 75 percent of production dies require rework ranging from simple modifications to a major overhaul. Additional costs can include shorter tool life and late delivery of the product to the marketplace. At a minimum, a three-month delay in introducing the product to market means a loss of sales and a potential loss of market share that may be hard to recover. Appropriate use of today’s prototyping technologies can help manufacturers avoid these needless added costs and uncomfortable situations.
Stereolithography has its part to play in tandem with prototyping methods such as cast tooling. In prototype plaster mold casting, for instance, an SLA master model is replicated into silicone rubber and used as a reusable master pattern for a single-use plaster mold. Although this process is limited to low-melt alloys such as aluminum and zinc, this process can be used to make quick prototype parts as well as low volume production parts. This low-cost “soft” tooling approach (so-called because the die is made of a soft material such as rubber) usually costs about 10 percent of production die cost. It allows for quick and easy modifications to part geometry, and that ease of geometry modification facilitates design refinement.
The Value of Proof of Concept
“Faster and more precise, low-cost molding capabilities along with new varieties of casting and materials are contributing to more realistic prototypes and manufacturing methods,” Pro-Dex’s Gallant said, stressing how valuable it is to have prototypes that are as close as possible to the final product. “Multi-axis CNC machines with more sophisticated programming capabilities also enhance speed.”
CNC, or computer numerical control, is the automation of machine tools operated by precisely programmed commands encoded on a storage medium, as opposed to controlled manually via hand wheels or levers, or mechanically automated. Multi-axis machining is a manufacturing process where computer numerical control tools that move in four or more ways are used to manufacture parts out of metal of other materials by milling away excess materials (subtractive manufacturing) by water jetting or laser cutting. Typical CNC tools support translation of the controlling software program in three axes.
Pro-Dex makes powered surgical devices that have to withstand harsh environments, such as arthroscopy handpieces and other orthopedic surgical devices. For this reason, the company provides proof of concept at stage two of its six-stage product development process. Proof of concept occurs immediately after the first stage—determining feasibility of project—and then is followed by process design and process development, design verification and validation, product transfer and release, and post-production evaluation. Providing proof of concept using the intended end-manufacturing process so early on greatly reduces the risk of time wasted later on fixing unforeseen issues. CNC machining, because it is software dependent, can be altered and customized relatively easily, and therefore is a valuable asset in prototyping.
For its part, Xact Spec has five-axis CNC turning lathes, which can produce components up to 16 x 40 inches in complex alloys such as stainless steel, Monel, Inconel and titanium. For small components, Xact Spec’s Citizen model A32 machine for Swiss machining has seven-axis capabilities for complex turning and milling, and can produce parts as small as 0.050 inches in length.
There are two types of screw machines: Turret and Swiss. The Turret-type mounts the material on a vertical ram which works into the lathe. The Swiss type, named after its place of origin where watchmakers used it for precision components, mounts the workpiece on a rotary slide. As its etymology suggests, the Swiss screw machine is better at more precise work. CNC Swiss screw machines are capable of rotating a part at up to 10,000 revolutions per minute at an accuracy level of 0.0002 to 0.0005 inches.
Xact Spec offers prototyping services with a focus on quick turnaround and cost containment—according to Xact Spec, it does not charge a premium for prototyping. In most cases, it offers prototypes for the same price as production quantities.
“Prototypes are processed on the same equipment that will be utilized in the production environment, allowing us to prove concept of design as well as manufacturability of the part in the same process,” Xact Spec’s Daugherty told MPO.
Avalon Laboratories LLC is a medical device manufacturer in Compton, Calif., that makes surgical and minimally invasive devices. The company provides both proof of concept and rapid prototyping to its clients. The company’s expertise lies in its polymer solution casting technology, which uses liquid polymers throughout the manufacturing process resulting in specialized designs unobtainable by extrusion technology. This technology offers the ability to add multiple components, varying wall thickness or diameter along the length of the device. With polymer solution casting the process provides the ability to embed components in virtually any configuration. Because this process is unique to Avalon, proof-of-concept prototyping is one of the company’s most important methods of demonstrating to clients exactly how this manufacturing process will benefit their device.
“A proof of concept takes into consideration the application and dimensional specifications to determine what in-house materials and molds are available to provide the customer a prototype that shows that the component, device and/or assembly will work as needed in the same material as the final product,” Market Development Manager Ronelle Decker and Senior Sales Manager Kelly Hartwell explained to MPO. “A notable advantage of polymer solution casting is that the total manufacturing cost for both prototyping and production volumes are frequently less than conventional technologies. This cost benefit results from the use of relatively inexpensive molds coupled with the scalability and adaptability of the manufacturing line. As a result, new products and processes are readily developed and implemented, facilitating cost-effective creation of very feature-rich and complex catheters.”
Prototyping for the Future
The high-precision methods that CNC Swiss screw machines offer, even at the prototyping stage, are part of a larger trend of the demand for better and more accurate prototyping methods early on in the design stage.
“The biggest trend we have observed is the need to continually improve machining and machinist capabilities to meet the ever tightening tolerances being demanded by our customers,” Xact’s Daugherty said.
As Ci Medical’s Sunday said, clients no longer are willing to sacrifice quality, speed or cost for the sake of a good prototype. CMOs now are expected to deliver on all three to keep their business.
“Trends and demand to remain competitive, continue to push the envelope to deliver all three of these goals,” Sunday said. “High-quality molds that can be built and validated quickly for a low cost are what separate one injection molder from the next. The challenge to deliver all three can be accomplished by examining current and emerging technologies. Previous barriers are being eliminated every day through the use of technology. In order to remain competitive as an engineering service provider and injection molder, we must stay on the forefront of these to bring value and speed to our customers.”
Prototyping is an essential stage of the design phase. By materializing a design concept, contract manufacturing organizations can shorten the design and development phase, because OEM clients can see exactly how their device will look and function ahead of time and make any needed adjustments. Designers can ask new questions about the function of a device with a physical example in front of them, and envision more possible uses, including unintended, for the device. Appropriate prototyping goes a long way to minimize changes late in the design stage.
Because prototype devices are not under any regulatory obligation (as they are not going to be used in tests or trials), contract manufacturing organizations (CMOs) have the freedom to quickly put together examples in in-house shops without the pressure of clean-room manufacturing and other considerations important for in-human use devices. Though sometimes, early stage, small-run devices made for clinical trials are called “prototype” devices, this term is misleading. Such devices are better called “pilot” devices, and often are created so that OEMs can move quickly into clinical trials to speed the regulatory approval or clearance process.
However, as Angel Domingo, director of quality and regulatory services for Irvine, Calif.-based Pro-Dex Inc., maker of powered solutions for medical and other markets, told Medical Product Outsourcing, “Anticipating regulatory requirements for specific intended uses and regulatory markets can feed into the prototype design, so determining a regulatory strategy early on is important.
“Some prototypes may be representative of units to be used in verification and validation (V&V) activities,” she continued. “To ensure regulatory/compliance needs are considered, adequate prototype quantities should be considered to represent statistically valid quantities in those studies. Further, prototype materials for V&V activities may need to be compliant to RoHS (Restriction of Hazardous Substances Directive), WEEE (Waste Electrical and Electronic Equipment Directive), REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and Conflict Minerals regulations.”
Every year, manufacturing and prototyping methods get better and faster, pushed by OEMs wanting devices on the market faster and faster in order to be more competitive and profitable. But as Jared Sunday, director of engineering for Ci Medical Technologies Inc. (formerly Classic Industries, a Latrobe, Pa.-based injection-molded components manufacturer for medical, pharmaceutical and healthcare applications), told MPO, “The old saying of ‘quality, speed or cost: you get to pick two of three’ is not applicable anymore. Trends and demand to remain competitive, continue to push the envelope to deliver all three of these goals.”
Especially now, 3-D printing is increasingly becoming the process more often associated with “quick and easy.” With more patents on 3-D printing technologies expiring, many last year and this year, 3-D printing machines and printers are easily acquired and cheap. Any CMO can have one in house, and unlike a mold, for instance, one printer can suffice to make any shape and design.
However, as Sunday suggests, CMOs and OEMs need not be beholden to speed and convenience alone when it is eminently possible now to achieve low cost and speed, as well as quality.
“Three-D printing offers a quick product for a reasonable cost without the need for capital tooling expense,” Sunday explained.
“Three-D printing is often used for components of quantities under 50. These components offer rapid delivery of parts for form examination and marketing evaluation. This can be done without the added cost and lead time associated with design, construction, and sampling of traditional prototype tooling where a mold is needed to be built. However, 3-D printing does have its limitations. Printed parts often are not suited for functional testing due to differences in resultant material properties. The surfaces are often rougher to the touch and appearance than components that are injection molded. This limits the ability to utilize the 3-D components for functional, fit, or reliability testing. Three-D components are also not as dimensionally accurate. A good 3-D printed part is very useful for early on in the development cycle. The disadvantage occurs if the parts produced from a printing operation are expected to be used for more than the current technology allows.”
Stu Gallant, vice president of engineering and product development for Pro-Dex, told MPO that while rapid prototyping can provide fast turnaround, this method outputs components that lack in robustness and overall quality. “Rapid (1-2 week) small runs of plastic components are now also readily available,” he added.
Ultimately, prototypes should offer a device maker insight into how a device looks, works, and is made. This is why prototyping using the intended manufacturing process is the most ideal scenario.
“Rapid prototyping is typically performed on a ‘best effort’ basis,” said Jack Daugherty, director of operations for Xact Spec Industries LLC, a precision machining and deep-hole drilling company based in Chagrin Falls, Ohio. “And although it begins to paint the picture for the manufacturing and part-specific requirements, short runs of a device allow you to dial in a process and begin learning manufacturing lessons related to tool life, required speeds and feeds, tool holding and fixtures that will help make the transition to manufacturing smoother.”
Finding the Right Fit
One way of addressing the problem of rough surfaces in prototyped devices is stereolithography (SLA), which is in fact one of the pioneer methods of 3-D printing, patented in 1986 and introduced in 1988. The method and apparatus makes solid objects by laying down layers of an ultraviolet curable material. The original patent, filed by Charles W. Hull, describes a concentrated beam of ultraviolet light focused onto the surface of a vat filled with liquid photopolymer, a plastic that changes properties when exposed to light. The light beam draws the object onto the surface of the liquid layer by layer, using polymerization or cross-linking to create a solid. Stereolithography is a rapid process, and components often can be made in a day—however, it historically has proven to be an expensive method of prototyping. Photo-curable resins have in the past ranged from $80 to $120 per liter, and the cost of SLA machines has ranged from $100,000 to more than $500,000. Recently, though, newly piqued interest in the technology (and the fact that the patent expired in 2006) has spurred the creation of drastically cheaper SLA machines such as the Ilios HD by OS-RC ($4,000), the Form 1 by Formlabs ($3,300), and many others. There also has been a drastic reduction in the cost of photo-curable resins, with U.S.-based providers such as MakerJuice Labs offering materials as low as $40 per liter and European based providers such as spot-A Materials offering materials for 68 euros (approximately $91) per liter. SLA is advantageous when surface finish and overall appearance straight from the machine is the most important factor in the prototype. The process provides smoother surface finishes than many other 3-D printing methods. However, like with other 3-D printing methods, prototypes made with SLA will not stand up to demanding performance. Stereolithographed devices will look like they are supposed to, but they will not work like the finished device is intended to, and neither is it made like the final device is intended to be made.
Stereolithography is but one of the methods a company such as Ci Medical technologies can offer its clients.
“Ci Medical Technologies utilizes many methods of prototyping to provide our customers with appropriate components for evaluation and testing,” Sunday said. “We are able to tailor the method and result of the prototype effort to match specific form,
fit, and functional requirements at any specific stage in the development process. This can be targeted to focus on functional needs, sales and marketing requirements, and speed to market goals. We have successfully utilized 3-D printing, stereolithography, cast tooling, stock machining, hand-loaded semi-automatic tooling, quick turn aluminum tooling, fully automatic aluminum tooling, and rapid constructed tool steel tooling.”
Finding the right fit for a client is key. Cast tooling prototyping, for instance, can be vital in the design process for devices whose end manufacturing process will be die-cast tooling. As stated above, prototyping enables flaws and design fixes to be addressed early on in the design process, saving money down the line. In the case of die-cast components, flaws found too late can bring the costs into the six-figure range, as replacing tools can be very expensive. According to Armstrong RM, an East Syracuse, N.Y.-based rapid manufacturing company, 75 percent of production dies require rework ranging from simple modifications to a major overhaul. Additional costs can include shorter tool life and late delivery of the product to the marketplace. At a minimum, a three-month delay in introducing the product to market means a loss of sales and a potential loss of market share that may be hard to recover. Appropriate use of today’s prototyping technologies can help manufacturers avoid these needless added costs and uncomfortable situations.
Stereolithography has its part to play in tandem with prototyping methods such as cast tooling. In prototype plaster mold casting, for instance, an SLA master model is replicated into silicone rubber and used as a reusable master pattern for a single-use plaster mold. Although this process is limited to low-melt alloys such as aluminum and zinc, this process can be used to make quick prototype parts as well as low volume production parts. This low-cost “soft” tooling approach (so-called because the die is made of a soft material such as rubber) usually costs about 10 percent of production die cost. It allows for quick and easy modifications to part geometry, and that ease of geometry modification facilitates design refinement.
The Value of Proof of Concept
“Faster and more precise, low-cost molding capabilities along with new varieties of casting and materials are contributing to more realistic prototypes and manufacturing methods,” Pro-Dex’s Gallant said, stressing how valuable it is to have prototypes that are as close as possible to the final product. “Multi-axis CNC machines with more sophisticated programming capabilities also enhance speed.”
CNC, or computer numerical control, is the automation of machine tools operated by precisely programmed commands encoded on a storage medium, as opposed to controlled manually via hand wheels or levers, or mechanically automated. Multi-axis machining is a manufacturing process where computer numerical control tools that move in four or more ways are used to manufacture parts out of metal of other materials by milling away excess materials (subtractive manufacturing) by water jetting or laser cutting. Typical CNC tools support translation of the controlling software program in three axes.
Pro-Dex makes powered surgical devices that have to withstand harsh environments, such as arthroscopy handpieces and other orthopedic surgical devices. For this reason, the company provides proof of concept at stage two of its six-stage product development process. Proof of concept occurs immediately after the first stage—determining feasibility of project—and then is followed by process design and process development, design verification and validation, product transfer and release, and post-production evaluation. Providing proof of concept using the intended end-manufacturing process so early on greatly reduces the risk of time wasted later on fixing unforeseen issues. CNC machining, because it is software dependent, can be altered and customized relatively easily, and therefore is a valuable asset in prototyping.
For its part, Xact Spec has five-axis CNC turning lathes, which can produce components up to 16 x 40 inches in complex alloys such as stainless steel, Monel, Inconel and titanium. For small components, Xact Spec’s Citizen model A32 machine for Swiss machining has seven-axis capabilities for complex turning and milling, and can produce parts as small as 0.050 inches in length.
There are two types of screw machines: Turret and Swiss. The Turret-type mounts the material on a vertical ram which works into the lathe. The Swiss type, named after its place of origin where watchmakers used it for precision components, mounts the workpiece on a rotary slide. As its etymology suggests, the Swiss screw machine is better at more precise work. CNC Swiss screw machines are capable of rotating a part at up to 10,000 revolutions per minute at an accuracy level of 0.0002 to 0.0005 inches.
Xact Spec offers prototyping services with a focus on quick turnaround and cost containment—according to Xact Spec, it does not charge a premium for prototyping. In most cases, it offers prototypes for the same price as production quantities.
“Prototypes are processed on the same equipment that will be utilized in the production environment, allowing us to prove concept of design as well as manufacturability of the part in the same process,” Xact Spec’s Daugherty told MPO.
Avalon Laboratories LLC is a medical device manufacturer in Compton, Calif., that makes surgical and minimally invasive devices. The company provides both proof of concept and rapid prototyping to its clients. The company’s expertise lies in its polymer solution casting technology, which uses liquid polymers throughout the manufacturing process resulting in specialized designs unobtainable by extrusion technology. This technology offers the ability to add multiple components, varying wall thickness or diameter along the length of the device. With polymer solution casting the process provides the ability to embed components in virtually any configuration. Because this process is unique to Avalon, proof-of-concept prototyping is one of the company’s most important methods of demonstrating to clients exactly how this manufacturing process will benefit their device.
“A proof of concept takes into consideration the application and dimensional specifications to determine what in-house materials and molds are available to provide the customer a prototype that shows that the component, device and/or assembly will work as needed in the same material as the final product,” Market Development Manager Ronelle Decker and Senior Sales Manager Kelly Hartwell explained to MPO. “A notable advantage of polymer solution casting is that the total manufacturing cost for both prototyping and production volumes are frequently less than conventional technologies. This cost benefit results from the use of relatively inexpensive molds coupled with the scalability and adaptability of the manufacturing line. As a result, new products and processes are readily developed and implemented, facilitating cost-effective creation of very feature-rich and complex catheters.”
Prototyping for the Future
The high-precision methods that CNC Swiss screw machines offer, even at the prototyping stage, are part of a larger trend of the demand for better and more accurate prototyping methods early on in the design stage.
“The biggest trend we have observed is the need to continually improve machining and machinist capabilities to meet the ever tightening tolerances being demanded by our customers,” Xact’s Daugherty said.
As Ci Medical’s Sunday said, clients no longer are willing to sacrifice quality, speed or cost for the sake of a good prototype. CMOs now are expected to deliver on all three to keep their business.
“Trends and demand to remain competitive, continue to push the envelope to deliver all three of these goals,” Sunday said. “High-quality molds that can be built and validated quickly for a low cost are what separate one injection molder from the next. The challenge to deliver all three can be accomplished by examining current and emerging technologies. Previous barriers are being eliminated every day through the use of technology. In order to remain competitive as an engineering service provider and injection molder, we must stay on the forefront of these to bring value and speed to our customers.”