Michael Barbella, Managing Editor10.01.21
The world is shrinking.
Globalization and technological advancements have closed economic and political gaps between countries, creating a more integrated (but not necessarily equal) society. Revolutionary innovations in transportation and communication have compressed space and time, engendering a borderless world where globetrotting is as easy and common as a trip to the corner market.
The digital revolution has truly transformed the world and its inhabitants: The internet—and subsequent rise of the 24/7 news cycle—has given humankind a front row seat to history and instant fingertip access to a boundless data repository. Moreover, handheld devices with more computing power than the mainframe aboard Apollo 11 (moon rocket) have made science fiction-like instant communication a stark reality.
“Is the world still flat? Are you crazy? It’s like, flatter than ever,” political commentator/author Thomas L. Friedman told Center for China & Globalization Founder/President Wang Huiyao last summer via videoconference.
“Remember, when I wrote ‘The World is Flat [A Brief History of the Twenty First Century]’ in 2004, Facebook didn’t exist, Twitter was still a sound, the Cloud was still in the sky. 4G was like a parking place. Big data was a rap star and Skype was a typo. All of those things came after I wrote ‘The World is Flat.’ We have never connected more different nodes than we have today, and we’ve never greased the connection—sped up the connection—between those nodes more than we have today. When you connect so many nodes and then speed up the connection between those nodes and take the buffers out, you get fragility. When I wrote ‘The World is Flat,’ many people wrote books to say, it’s not flat, it’s spiky, it’s lumpy, it’s curved, it’s bumpy. All those books are wrong. The world is flatter than ever.”
Flatter, smarter, and more interdependent, actually. The world in 2004 was less fluent, less collaborative, and far less networked, lacking the outsourcing, data sharing, and open sourcing habits that have spawned astounding technological advancements in science, computing, and healthcare.
Those advancements, nurtured by the ever-shrinking world, have perhaps had the most profound impact on the latter sector. Chronic conditions, for example, can now be monitored remotely in real-time through wearables, Bluetooth-enabled devices, and Cloud servers. Similarly, virtual doctor’s visits are possible (and popular, thanks to COVID-19) per online video conferencing tools like Zoom, Google Meet, Microsoft Teams, and Slack.
Not surprisingly, the flatter world that Friedman has written extensively about is evident in healthcare, too. There are fewer acute-care hospitals now than there were 17 years ago, more ambulatory care services, and significantly more networks linking companies, products, patients, and markets. Medical equipment has shrunk as well: Pacemakers that were once worn externally around the neck have been reduced to the size of a multivitamin (Medtronic plc’s Micra). Swallowable (“pill”) cameras can record images of the GI tract, while implantable loop recorders—smaller than a pack of chewing gum—record ECG data that helps doctors identify abnormal heart rhythms.
Moreover, Stanford University engineers are developing a self-propelled medical device small enough to fit through blood vessels for potential drug delivery applications, analyses, and/or blood clot or plaque removal. And Swiss researchers discovered a way to navigate electronic devices smaller than a human hair inside blood vessels.
Such diminutive devices require even more miniscule parts, the likes of which are best manufactured though micromolding. The technique is capable of producing finished components with wall thicknesses from 0.001 inches and mold core diameters less than 0.002 inches and weighing as little as 0.0001 grams.
Medical Product Outsourcing spent the last few weeks researching micromolding’s latest trends, challenges, regulatory requirements, and potential evolution over the next five years. The magazine spoke with more than a half-dozen industry experts, including:
Maggie Beauregard, quality manager; Sherry Bekier, account manager; Jared Cicio, molding/production manager; Patrick Haney, R&D engineer; Gary Hulecki, executive vice president; Kyle Kolb, tooling supervisor; and Lindsay Mann, sales/marketing director at MTD Micro Molding, a Charleton, Mass.-based micro medical manufacturer of ultra-precision molded components.
Donna Bibber, vice president of Business Development; and Brent Hahn, sales/marketing director at Isometric Micro Molding Inc., a vertically integrated micromolding company based in New Richmond, Wis.
Kenny Freitag, sales manager-Specialty Molding and Medical Tubing, at Spectrum Plastics Group, an Alpharetta, Ga.-based manufacturer of critical polymer-based components and devices for medical and other markets.
Scott Herbert, founder and president of Rapidwerks Inc., a Pleasanton, Calif.-based precision micromolder.
Aaron Johnson, vice president of marketing and customer strategy at Accumold, a high-tech manufacturer of precision micro, small, and lead frame injection-molded plastic components headquartered in Ankeny, Iowa.
Dave Moyak, general manager; and Tom Moyak, director, Business and Engineering, at Matrix Tool Inc., a full-service thermoplastic injection mold building and molding company based in Fairview, Pa.
Steve Raiken, president of RenyMed, a full-service medical injection molder based in Baldwin Park, Calif.
Raghu Vadlamudi, chief research and technology director at Donatelle, a New Brighton, Minn.-based firm providing medical device design, development, and contract manufacturing services. Its micromolding processes can achieve tight tolerances and create components that weigh less than 1 mg.
Michael Barbella: What are the latest trends in micromolding technology and services?
Donna Bibber and Brent Hahn: CT scanned component and assembly data, full factorials of combinations of number of cavities, lots, material lot to lot variation, and building these assemblies with all of these combinations and CT scanning these results in STL files of utmost importance to clinical trial data, visual recognition of variation, and innovation for new and improved products and processes of the future.
Kenny Freitag: Companies are designing new products that feature miniaturization, high precision, and tight tolerances, all of which require micromolding. This is especially true for small parts in the life sciences and medical device industries, including implantables. Customers are also asking for new exotic, highly engineered materials rather than standard thermoplastics, especially for high-temperature applications. As features get smaller and smaller, Spectrum continuously improves its system controls and technologies to enable even greater control over shot size, measuring systems, and equipment monitors.
Patrick Haney: The medical industry recognizes that devices and components can and should be miniaturized. As a result, we are seeing a higher increase in clients that are interested in converting a device that was previously manufactured using a different method and/or and completely different non-polymeric material. As the micro medical device industry continues to grow, medical OEMs are beginning to realize the potential and capabilities of micro injection molding and their engineering and design teams are testing the boundaries on things like overall size, pharmaceutical incorporation, overmolding capabilities, mechanical ability, etc.
Scott Herbert: Smaller, quicker, faster equipment; more automation, less handling, more vision system inspection inline.
Gary Hulecki: Utilization of robots, advanced vision systems, and software allows contract manufacturers to save time and cost while providing customers with accurate, complex assemblies or packaging solutions.
Aaron Johnson: Traditional tool building for short-run prototype parts can be prohibitive by speed and cost. New developments with 3D printing, like with Fabrica Group’s high precision Fabrica 2.0 printer, can complement micro molded R&D efforts and help get new products to market faster.
Dave Moyak: Part miniaturization is a constant trend in nearly every market segment in industry. In a drive to squeeze as much technology into an ever-shrinking footprint, OEMs are looking to suppliers that can help in every phase of the product life cycle. The margin for error is less than razor thin. With so little room for error, a lean manufacturing culture is critical to success in micromolding. At Matrix we constantly re-evaluate our entire cradle-to-grave process with a focus on continuous improvement and waste reduction. As an engineering-driven company, we are intentional in our actions to simplify our solutions to everyday challenges. We accomplish this through the application of a fundamentally sound engineering approach we call “The Matrix Way.”
Steve Raiken: Micro molding has become much more mainstream as tool making and machine technology has improved. Micro surgical, micro electronics, drone technologies, and new personal care products are all relying on engineered micro molded parts.
Raghu Vadlamudi: Some of the latest trends include innovative material handling techniques to minimize over-drying, and automated manufacturing work cells to handle parts with minimal weight (sub milligram range). Molding machine manufacturers are rising up to the challenges of providing equipment with small shot capacities to improve process consistency.
Barbella: What are customers demanding or expecting of their micro molded products and have these demands/expectations changed in recent years?
Bibber and Hahn: The ability to mold smaller and smaller parts in overall size as well as micro features and/or tight tolerances on 5” or smaller parts. Furthermore, Industry 4.0 and ISO 21CFR Part 11 compliance is trending for micro molding technology due to pharma and drug delivery data and process control. Data, changes to process, and analysis of automated, collected data will contribute to next-generation products.
Sherry Bekier: The demands witnessed over the past few years include the need for cost reduction plans, faster lead times, and more value-add activities. Also, the pandemic has caused the medical device field to be more careful with funding/budgets and having to deal with unexpected price increases and shortages of materials is a challenge for all parties involved. To remain competitive, value-added solutions are key. This includes assembly work, final packaging, and managing the outsourcing of other services for our customers. This all results in an easier, more cost effective, single source solution for manufacturing our customer’s micro medical devices.
Jared Cicio: There is a consistent increase in demand for more smaller dimensions and flash tolerances on molded parts. These have always been important features for any micro molded part, but tighter tolerances are requiring us to continue to explore and create new methods and procedures for machining our molds, molding our parts, and even how we fixture, inspect, and measure parts. A few years ago, we would typically see flash tolerances around .004”-.005” on drawings. We now typically see .002”-.003 maximum. This forces us to look at mold construction and molding parameters differently because our tools need to be built “tighter” to create parts that are “model-like” in quality. CT scanning of parts to check for internal features or voids is becoming more of the norm as well, which is a service we offer in-house to get real-time data and feedback.
Freitag: Customers want precision and accuracy. They seek molders that will share their deep knowledge and experience about material science and molding technologies during the design for manufacturing (DFM) process to make their designs better and easier to produce. They expect us to find solutions to their toughest design challenges—smaller parts, advanced materials, improved functionality, tighter tolerances, improved outcomes, and even regulatory assistance. Speed is also in the highest demand—both in manufacturing the product and getting it to market—so vertically integrated services are always an added benefit for customers.
Johnson: Speed to market has long been a desire of the industry. Competitive pressure, even in the medical device industry, is also a key driver for many OEMs. The continued growth towards miniaturization has only increased this demand. And of course, quality expectations are never less than perfect.
Dave Moyak: Smaller, faster, lighter, better. With traditional plastic parts, the end point is a known destination—using widely known and accepted manufacturing practices. With micromolded parts, it’s more of a journey. What we know and can accomplish today is a significant percentage better than what we could do five years ago and we’ll say the same thing five years from now. The end point keeps moving because of the advancements in design, tooling, machinery and knowledge. We have over a dozen plastics and mechanical engineers on staff. Matrix Tool typically completes over 100 continuous improvement projects per year. Many of these KPI projects directly improve some aspect of our micro tooling or micromolding capabilities. Innovation and improvement are goalposts that will continue to move by both us and our customers. It’s a never-ending journey.
Raiken: Customers are looking for suppliers with a higher level of expertise, experience, and confidence in micro part and tooling design.
Barbella: Please discuss the challenges and complexities involved in micromolding tooling design. How can these challenges be overcome?
Bibber and Hahn: Since the mold is the enabler to micromolding, this is an extremely important component of a PFMEA, which Isometric developed called Microns Matter.® The Microns Matter® method breaks down the tolerances such that our mold is built to 20 percent or less of the tolerance to leave the remaining 80 percent of the tolerance to be taken up with molding process, gage R&R, material lot to lot variation, and material drying. The reason for a robust mold design/fabrication plan is two-fold.
First, if the part tolerances are 16 microns and the Cpk is 1.33, the mold needs to be built to 4-micron tolerance to be capable. Missing this important step in the risk mitigation plan results in tolerance stack-up errors later in the project, where costs are exacerbated and cannot be afforded by medial and drug delivery device OEMs. Second, the mold maintenance, dimensional monitoring and control are key to holding the Cpk over the full depreciation schedule of the mold. When this maintenance is completed by the very same journey mold makers that fabricated it, this addresses again the overall Cpk and reduces stack-up errors.
Freitag: Probably the biggest challenge is miniaturizing parts and duplicating them in a high-volume production and manufacturing environment. It is absolutely imperative to create robust and repeatable processes for mircomolding parts. Mold designs evolve as materials evolve. Miniaturization creates challenges with understanding material flow and shear, for example. Automation can certainly improve micromolding efficiency, but only if unit volumes are high enough. Tooling is very complex, so there is a real issue with finding tooling shops and vendors with skilled personnel.
Herbert: Tool complexity can be a long conversation, while today’s challenges are multifaceted. From EDM sinker or wire work all have a role in the fabrication and challenges. Depending on the application, small pins or holes seem to be a challenge as well. Holding a pin steady, while often referred to as molding around a noodle, can be a challenge and difficult—i.e., how to hold a pin and how to mold a variety of plastics around the pin without disturbing it or moving it. Disturbing its location or concentricity is often a challenge to any experienced micromolder.
Johnson: Nothing is as simple as it seems, especially with micromolding. The smaller, more complex, or the tighter the tolerances, the greater the challenge can be for tool design and processing. At Accumold, we walk each project through our DfMM—design for micro molding—process. It’s a must for any micro molding project to be successful.
Kyle Kolb: Size and space constraints are usually the biggest challenges. These affect everything from gating, ejection, seal off angles, to draft. The best way to work through these challenges is to complete a very thorough DFM process, almost always creating a solid model tooling split that will very closely reflect what you would want to see in steel. How well you navigate the DFM process will drive how easy or difficult the tool design phase can be. During the DFM process, getting the challenges on the table, whether it is radii vs. sharp, draft vs. no draft, or ejector/parting line/gate locations, will dictate how we go about designing the tool. We may have already dreamed up how the design will go, assuming some concessions can be made, but what if the parting line we thought of passes through a critical surface? We have to be able to adapt the tool design to ensure the client receives molded parts that function per their product design intent. Another thing we must keep in mind is wall aspect ratios as they relate to material selection. Can the material be changed to achieve to geometry or does the geometry have to be changed based upon the material? For example, we cannot mold PEEK as long and thin as we can polypropylene.
Tom Moyak: It is commonplace in the injection molding industry—if not startlingly surprising—to see how many critical decisions are made, impacting very large sums of money simply because that’s the way things have always been done. For right or wrong, what’s been good enough has sufficed for much of the industry for decades. With such little room for error, micromolding success truly requires the use of fundamentally sound and logical decisions at every step of the process. There has to be a focus on waste reduction through the application of 5S lean manufacturing principles. This is especially true with the foundation of any advanced micromolding part, which is creating a sound tool design.
Some critical aspects of mold design for micromolding include maximizing mold alignment, minimizing mold mass and minimizing flow lengths with tighter cavity spacing. You must also use creative, balanced layouts, and design the mold to accurately create robust details that can handle the micro-features and micro-gates inherent to the nature of these products. IMMs for micromolding rarely have enough daylight for hot runner systems, nor is the error introduced by these systems helpful towards consistently creating parts of the highest quality. Getting away from old school thinking allows micro molders to realize they may be able to design a mold that is simpler while accomplishing more with less.
One of our recent successes involves convincing a top 10 Fortune company to let us tackle a very high-profile program of theirs using “The Matrix Way.” They originally requested that we quote a 16-cavity mold with a hot runner system and other technology for a micro-featured, delicate product. Knowing the material they selected wasn’t optimal and what they requested had a very high probability of failure, we suggested alternative materials.
But more importantly, we were only willing to quote our completely unique “out of the box” solution. It took some convincing, but our unique eight-cavity all cold-runner solution provided more throughput with less waste than they had estimated for their 16-cavity hot runner solution. The tool we designed and built was simpler and required a much lower capital investment. It had the added bonus of a greatly reduced cycle time and smaller runner sizing while greatly improving part quality and consistency. It was a win-win for all and a real eye-opener for our customer, and especially their customer.
Raiken: The main challenge is to eliminate as much of a cold runner as possible so that the control of the injection molding machine delivery system/shut off nozzles are maximized. Part handling post molding can become a big issue and requires a new way of part handling. In addition, air evacuation from the tooling is a high priority.
Vadlamudi: Designing tools might not be that challenging with the CAD packages that are available, but it is tough to machine the micro features in the molds with conventional machining techniques. These challenges can be overcome by understanding the type of equipment or the process to employ in machining these features. Mold cavities can be manufactured with micro laser and EDM technologies.
Barbella: What regulatory requirements/changes have impacted medtech micromolding and how?
Maggie Beauregard: The European Union’s Medical Device Regulation officially went into effect this past May. These new regulatory requirements will continue to change the medical device world for those both located in the European Union and also those wishing to market their devices there. With new requirements covering almost all aspects of device regulations from lifecycle traceability requirements, updated post-market surveillance reporting requirements, new labeling requirements for Class III and Implantable devices, and even changes to how devices are classified, device manufacturers will need to pay close attention to these changes.
Bibber and Hahn: The impact a molder has on a medical OEM’s submission has increased. Isometric supports our customer’s filings by creating a plan for each component or assembly. There are many aspects, but the most impactful has been incorporating CT scan data into the OEM’s submissions.
Johnson: Anyone working in the medtech space will eventually feel the regulatory impact on the industry—even if you’re a tier II or II supplier. And certainly, the closer you are to a finished good, the higher the impact. In addition, the recent changes to the ISO 13485 quality system management have challenged organizations to rise to the occasion as well. The process to be a qualified supplier to medtech companies is not getting easier.
Today’s suppliers must have a robust QMS to meet the demand.
Raiken: As with all medical devices, FDA is now very watchful for patient safety. ISO 13485 and excellent clean room molding systems are standard.
Barbella: Is there a limit to how small a micro molded part can be?
Bibber and Hahn: The short answer is yes, and it is dependent on many variables such as material selection, gate size and location, and mold design robustness. Having said that, our smallest molded part was over 1,000 parts per plastic pellet. Parts that are hundreds of parts to a single pellet are moldable, but there’s a limit as to the number of cavities that can be pellet split and still be moldable in scale. This is known on a case-by-case basis; however, generally speaking this extreme is rarely more than 4-cavities while other micro molded parts can be 16, 32, or even 64 cavities.
Herbert: Without a doubt there is, everyone wants to be able to push the limits. However, reality is with conventional molding machines (micro), you have an ability to control volume. There is a maximum and a minimum within that volume. The question is how do you control this volume and to what degree. Making one part is not so challenging making the same part in volume is.
Johnson: Sure, but I’m not sure we’ve hit that yet. One of the smallest parts a customer has asked us to produce has its longest dimension at only 800 microns. We’ve also produced features on micro parts that are sub-micron in size. Yes, there will be a limit, but we’re always up for a challenge.
Dave Moyak: What is considered an “acceptable flash” specification of 0.002”-0.003” for a conventional molded part is actually the size of many micro part features. Individual micro parts are routinely fractions of a resin pellet. But regardless of the size of the plastic part, successful manufacturing always comes down to three basics: a good tool, a good machine, and a good process. Micromolding has continued to stretch the capabilities of the resin suppliers, tool machinery, and injection molding machine OEMs. Equipment manufacturers are constantly creating solutions to the micro paradigm. Many companies, such as Matrix, still have to modify even the best equipment in this field to meet the challenges of the tools we produce and the molds we run. Eventually these modifications become part of the mainstream offerings of the equipment suppliers. Necessity truly drives innovation.
Raiken: The parts may be too small to handle post molding—any amount of static will cause the smallest micro parts to become “sticky” and will cling to anything, even in a glass jar.
Vadlamudi: The limit to a micromolded part comes from the equipment that’s needed to build the molds and mold the parts. In addition to the equipment capabilities, the need for knowledgeable and skilled personnel is of paramount importance. Donatelle currently manufactures parts with 100 micron thickness that weigh less than a tenth of a milligram.
Barbella: How might the medtech micromolding industry evolve over the next five years?
Bibber and Hahn: Molding, 3D micro printing, material development, and miniaturized devices are a high growth niche business. It will be important for micro molders and automated micro assemblers like Isometric to continue to focus on moving the decimal points to the right in terms of part size, tolerance, wall thickness, and feature size.
Retaining skilled talent will continue to be important to innovation. Isometric has < 1 percent employee turnover in the 31-year history of the company. The basis of Isometric’s core values will continue to be important factors in our ability to retain these skill sets and employees to ensure future success.
Adding surface finishes, incorporating biomimicry of hydrophobic and hydrophilic surfaces, and other surface treatments such as plasma and corona treatments will enhance the physical bond strength and performance of miniaturized devices of the future. It’s common for technical and engineering-focused companies to get side-tracked on “the shiny stuff”; however, to truly grow, partnerships with key customers and fulfilling their needs is the heart of what provides continued growth and prosperity.
Cicio: It’s difficult to predict how the industry may evolve over the next five years but it is safe to say that customers are going to continue to expect tighter and tighter tolerances, which will continue to push manufacturers like MTD to stay on the cutting edge of technology for toolmaking and molding methods. Today, customers are prioritizing contract manufacturers that can be full-service suppliers and we will continue to see more customers seeking this service where they can look to us to be their one-stop-shop to take them from molding all the way to final packaging.
Freitag: Parts will continue to become smaller and more complex, challenging the limits of molding technologies. Materials will be developed that are specifically for micromolding processes that have greater functionality and can hold tighter tolerances. Ultimately, the Internet of things will allow the integration of sensor technologies, machine-to-machine communication, artificial intelligence, and cloud-based platforms to become integrated into micromolding systems, maximize production quality and efficiency and reduce operational costs and downtime. Different manufacturing technologies (machining, lasers, additive manufacturing, and molding) are also being combined in creative ways to create “hybrid equipment” where these technologies can complement each other in making a part.
Herbert: I see tooling being the biggest affected over the coming years. “Get Small”—as we say—will be the driving factor in tool fabrication.
Hulecki: We will see new lighter, stronger, reinforced polymers available for medical devices. This can replace metal implants as a more cost-effective and repeatable solution.
Johnson: As the demand for medtech devices to do more in the same space, or more in less, increases, the interest in micromolding will follow accordingly. At the same time, the desire for OEMs to reduce the supply-chain management costs will compete for attention. Those challenged with the design and development of next-generation products will have to navigate partners that can truly meet their needs. As nice as it would be, it’s doubtful a one-stop-shop can do it all. A careful selection of integrated partners, like a micromolder, will be needed.
Lindsay Mann: The micro injection molding market continues to grow, estimated to be about a $1.5 billion market within five years. Converting delivery and testing methods once done in a doctor’s office to ones that can be done at home require novel designs of existing and improving technologies to make these procedures simple, repeatable, painless, and reliable. Complex, smaller plastic devices that include overmolded sensors/delicate substrates are generally needed for these devices and require advanced micro injection molding to create.
As digitization of miniaturized devices continues, we will continue molding around/over/through batteries, PCBs, and delicate substrates that perform important data transmission jobs. This will apply to many markets and applications. Protecting these substrates is crucial and encapsulating them with micro overmolding is an effective and feasible solution.
Raiken: Personalhome healthcare devices and wearables that associate with smartphones will become much more mainstream.
Vadlamudi: There will be advancements in material handling equipment and in processing equipment with smaller shot capacities (to obtain consistency from shot to shot). There will also be developments in materials which will allow molding thinner wall sections. Molding equipment with integrated with robots and inspection systems will become commonplace in the medtech micromolding industry.
Globalization and technological advancements have closed economic and political gaps between countries, creating a more integrated (but not necessarily equal) society. Revolutionary innovations in transportation and communication have compressed space and time, engendering a borderless world where globetrotting is as easy and common as a trip to the corner market.
The digital revolution has truly transformed the world and its inhabitants: The internet—and subsequent rise of the 24/7 news cycle—has given humankind a front row seat to history and instant fingertip access to a boundless data repository. Moreover, handheld devices with more computing power than the mainframe aboard Apollo 11 (moon rocket) have made science fiction-like instant communication a stark reality.
“Is the world still flat? Are you crazy? It’s like, flatter than ever,” political commentator/author Thomas L. Friedman told Center for China & Globalization Founder/President Wang Huiyao last summer via videoconference.
“Remember, when I wrote ‘The World is Flat [A Brief History of the Twenty First Century]’ in 2004, Facebook didn’t exist, Twitter was still a sound, the Cloud was still in the sky. 4G was like a parking place. Big data was a rap star and Skype was a typo. All of those things came after I wrote ‘The World is Flat.’ We have never connected more different nodes than we have today, and we’ve never greased the connection—sped up the connection—between those nodes more than we have today. When you connect so many nodes and then speed up the connection between those nodes and take the buffers out, you get fragility. When I wrote ‘The World is Flat,’ many people wrote books to say, it’s not flat, it’s spiky, it’s lumpy, it’s curved, it’s bumpy. All those books are wrong. The world is flatter than ever.”
Flatter, smarter, and more interdependent, actually. The world in 2004 was less fluent, less collaborative, and far less networked, lacking the outsourcing, data sharing, and open sourcing habits that have spawned astounding technological advancements in science, computing, and healthcare.
Those advancements, nurtured by the ever-shrinking world, have perhaps had the most profound impact on the latter sector. Chronic conditions, for example, can now be monitored remotely in real-time through wearables, Bluetooth-enabled devices, and Cloud servers. Similarly, virtual doctor’s visits are possible (and popular, thanks to COVID-19) per online video conferencing tools like Zoom, Google Meet, Microsoft Teams, and Slack.
Not surprisingly, the flatter world that Friedman has written extensively about is evident in healthcare, too. There are fewer acute-care hospitals now than there were 17 years ago, more ambulatory care services, and significantly more networks linking companies, products, patients, and markets. Medical equipment has shrunk as well: Pacemakers that were once worn externally around the neck have been reduced to the size of a multivitamin (Medtronic plc’s Micra). Swallowable (“pill”) cameras can record images of the GI tract, while implantable loop recorders—smaller than a pack of chewing gum—record ECG data that helps doctors identify abnormal heart rhythms.
Moreover, Stanford University engineers are developing a self-propelled medical device small enough to fit through blood vessels for potential drug delivery applications, analyses, and/or blood clot or plaque removal. And Swiss researchers discovered a way to navigate electronic devices smaller than a human hair inside blood vessels.
Such diminutive devices require even more miniscule parts, the likes of which are best manufactured though micromolding. The technique is capable of producing finished components with wall thicknesses from 0.001 inches and mold core diameters less than 0.002 inches and weighing as little as 0.0001 grams.
Medical Product Outsourcing spent the last few weeks researching micromolding’s latest trends, challenges, regulatory requirements, and potential evolution over the next five years. The magazine spoke with more than a half-dozen industry experts, including:
Maggie Beauregard, quality manager; Sherry Bekier, account manager; Jared Cicio, molding/production manager; Patrick Haney, R&D engineer; Gary Hulecki, executive vice president; Kyle Kolb, tooling supervisor; and Lindsay Mann, sales/marketing director at MTD Micro Molding, a Charleton, Mass.-based micro medical manufacturer of ultra-precision molded components.
Donna Bibber, vice president of Business Development; and Brent Hahn, sales/marketing director at Isometric Micro Molding Inc., a vertically integrated micromolding company based in New Richmond, Wis.
Kenny Freitag, sales manager-Specialty Molding and Medical Tubing, at Spectrum Plastics Group, an Alpharetta, Ga.-based manufacturer of critical polymer-based components and devices for medical and other markets.
Scott Herbert, founder and president of Rapidwerks Inc., a Pleasanton, Calif.-based precision micromolder.
Aaron Johnson, vice president of marketing and customer strategy at Accumold, a high-tech manufacturer of precision micro, small, and lead frame injection-molded plastic components headquartered in Ankeny, Iowa.
Dave Moyak, general manager; and Tom Moyak, director, Business and Engineering, at Matrix Tool Inc., a full-service thermoplastic injection mold building and molding company based in Fairview, Pa.
Steve Raiken, president of RenyMed, a full-service medical injection molder based in Baldwin Park, Calif.
Raghu Vadlamudi, chief research and technology director at Donatelle, a New Brighton, Minn.-based firm providing medical device design, development, and contract manufacturing services. Its micromolding processes can achieve tight tolerances and create components that weigh less than 1 mg.
Michael Barbella: What are the latest trends in micromolding technology and services?
Donna Bibber and Brent Hahn: CT scanned component and assembly data, full factorials of combinations of number of cavities, lots, material lot to lot variation, and building these assemblies with all of these combinations and CT scanning these results in STL files of utmost importance to clinical trial data, visual recognition of variation, and innovation for new and improved products and processes of the future.
Kenny Freitag: Companies are designing new products that feature miniaturization, high precision, and tight tolerances, all of which require micromolding. This is especially true for small parts in the life sciences and medical device industries, including implantables. Customers are also asking for new exotic, highly engineered materials rather than standard thermoplastics, especially for high-temperature applications. As features get smaller and smaller, Spectrum continuously improves its system controls and technologies to enable even greater control over shot size, measuring systems, and equipment monitors.
Patrick Haney: The medical industry recognizes that devices and components can and should be miniaturized. As a result, we are seeing a higher increase in clients that are interested in converting a device that was previously manufactured using a different method and/or and completely different non-polymeric material. As the micro medical device industry continues to grow, medical OEMs are beginning to realize the potential and capabilities of micro injection molding and their engineering and design teams are testing the boundaries on things like overall size, pharmaceutical incorporation, overmolding capabilities, mechanical ability, etc.
Scott Herbert: Smaller, quicker, faster equipment; more automation, less handling, more vision system inspection inline.
Gary Hulecki: Utilization of robots, advanced vision systems, and software allows contract manufacturers to save time and cost while providing customers with accurate, complex assemblies or packaging solutions.
Aaron Johnson: Traditional tool building for short-run prototype parts can be prohibitive by speed and cost. New developments with 3D printing, like with Fabrica Group’s high precision Fabrica 2.0 printer, can complement micro molded R&D efforts and help get new products to market faster.
Dave Moyak: Part miniaturization is a constant trend in nearly every market segment in industry. In a drive to squeeze as much technology into an ever-shrinking footprint, OEMs are looking to suppliers that can help in every phase of the product life cycle. The margin for error is less than razor thin. With so little room for error, a lean manufacturing culture is critical to success in micromolding. At Matrix we constantly re-evaluate our entire cradle-to-grave process with a focus on continuous improvement and waste reduction. As an engineering-driven company, we are intentional in our actions to simplify our solutions to everyday challenges. We accomplish this through the application of a fundamentally sound engineering approach we call “The Matrix Way.”
Steve Raiken: Micro molding has become much more mainstream as tool making and machine technology has improved. Micro surgical, micro electronics, drone technologies, and new personal care products are all relying on engineered micro molded parts.
Raghu Vadlamudi: Some of the latest trends include innovative material handling techniques to minimize over-drying, and automated manufacturing work cells to handle parts with minimal weight (sub milligram range). Molding machine manufacturers are rising up to the challenges of providing equipment with small shot capacities to improve process consistency.
Barbella: What are customers demanding or expecting of their micro molded products and have these demands/expectations changed in recent years?
Bibber and Hahn: The ability to mold smaller and smaller parts in overall size as well as micro features and/or tight tolerances on 5” or smaller parts. Furthermore, Industry 4.0 and ISO 21CFR Part 11 compliance is trending for micro molding technology due to pharma and drug delivery data and process control. Data, changes to process, and analysis of automated, collected data will contribute to next-generation products.
Sherry Bekier: The demands witnessed over the past few years include the need for cost reduction plans, faster lead times, and more value-add activities. Also, the pandemic has caused the medical device field to be more careful with funding/budgets and having to deal with unexpected price increases and shortages of materials is a challenge for all parties involved. To remain competitive, value-added solutions are key. This includes assembly work, final packaging, and managing the outsourcing of other services for our customers. This all results in an easier, more cost effective, single source solution for manufacturing our customer’s micro medical devices.
Jared Cicio: There is a consistent increase in demand for more smaller dimensions and flash tolerances on molded parts. These have always been important features for any micro molded part, but tighter tolerances are requiring us to continue to explore and create new methods and procedures for machining our molds, molding our parts, and even how we fixture, inspect, and measure parts. A few years ago, we would typically see flash tolerances around .004”-.005” on drawings. We now typically see .002”-.003 maximum. This forces us to look at mold construction and molding parameters differently because our tools need to be built “tighter” to create parts that are “model-like” in quality. CT scanning of parts to check for internal features or voids is becoming more of the norm as well, which is a service we offer in-house to get real-time data and feedback.
Freitag: Customers want precision and accuracy. They seek molders that will share their deep knowledge and experience about material science and molding technologies during the design for manufacturing (DFM) process to make their designs better and easier to produce. They expect us to find solutions to their toughest design challenges—smaller parts, advanced materials, improved functionality, tighter tolerances, improved outcomes, and even regulatory assistance. Speed is also in the highest demand—both in manufacturing the product and getting it to market—so vertically integrated services are always an added benefit for customers.
Johnson: Speed to market has long been a desire of the industry. Competitive pressure, even in the medical device industry, is also a key driver for many OEMs. The continued growth towards miniaturization has only increased this demand. And of course, quality expectations are never less than perfect.
Dave Moyak: Smaller, faster, lighter, better. With traditional plastic parts, the end point is a known destination—using widely known and accepted manufacturing practices. With micromolded parts, it’s more of a journey. What we know and can accomplish today is a significant percentage better than what we could do five years ago and we’ll say the same thing five years from now. The end point keeps moving because of the advancements in design, tooling, machinery and knowledge. We have over a dozen plastics and mechanical engineers on staff. Matrix Tool typically completes over 100 continuous improvement projects per year. Many of these KPI projects directly improve some aspect of our micro tooling or micromolding capabilities. Innovation and improvement are goalposts that will continue to move by both us and our customers. It’s a never-ending journey.
Raiken: Customers are looking for suppliers with a higher level of expertise, experience, and confidence in micro part and tooling design.
Barbella: Please discuss the challenges and complexities involved in micromolding tooling design. How can these challenges be overcome?
Bibber and Hahn: Since the mold is the enabler to micromolding, this is an extremely important component of a PFMEA, which Isometric developed called Microns Matter.® The Microns Matter® method breaks down the tolerances such that our mold is built to 20 percent or less of the tolerance to leave the remaining 80 percent of the tolerance to be taken up with molding process, gage R&R, material lot to lot variation, and material drying. The reason for a robust mold design/fabrication plan is two-fold.
First, if the part tolerances are 16 microns and the Cpk is 1.33, the mold needs to be built to 4-micron tolerance to be capable. Missing this important step in the risk mitigation plan results in tolerance stack-up errors later in the project, where costs are exacerbated and cannot be afforded by medial and drug delivery device OEMs. Second, the mold maintenance, dimensional monitoring and control are key to holding the Cpk over the full depreciation schedule of the mold. When this maintenance is completed by the very same journey mold makers that fabricated it, this addresses again the overall Cpk and reduces stack-up errors.
Freitag: Probably the biggest challenge is miniaturizing parts and duplicating them in a high-volume production and manufacturing environment. It is absolutely imperative to create robust and repeatable processes for mircomolding parts. Mold designs evolve as materials evolve. Miniaturization creates challenges with understanding material flow and shear, for example. Automation can certainly improve micromolding efficiency, but only if unit volumes are high enough. Tooling is very complex, so there is a real issue with finding tooling shops and vendors with skilled personnel.
Herbert: Tool complexity can be a long conversation, while today’s challenges are multifaceted. From EDM sinker or wire work all have a role in the fabrication and challenges. Depending on the application, small pins or holes seem to be a challenge as well. Holding a pin steady, while often referred to as molding around a noodle, can be a challenge and difficult—i.e., how to hold a pin and how to mold a variety of plastics around the pin without disturbing it or moving it. Disturbing its location or concentricity is often a challenge to any experienced micromolder.
Johnson: Nothing is as simple as it seems, especially with micromolding. The smaller, more complex, or the tighter the tolerances, the greater the challenge can be for tool design and processing. At Accumold, we walk each project through our DfMM—design for micro molding—process. It’s a must for any micro molding project to be successful.
Kyle Kolb: Size and space constraints are usually the biggest challenges. These affect everything from gating, ejection, seal off angles, to draft. The best way to work through these challenges is to complete a very thorough DFM process, almost always creating a solid model tooling split that will very closely reflect what you would want to see in steel. How well you navigate the DFM process will drive how easy or difficult the tool design phase can be. During the DFM process, getting the challenges on the table, whether it is radii vs. sharp, draft vs. no draft, or ejector/parting line/gate locations, will dictate how we go about designing the tool. We may have already dreamed up how the design will go, assuming some concessions can be made, but what if the parting line we thought of passes through a critical surface? We have to be able to adapt the tool design to ensure the client receives molded parts that function per their product design intent. Another thing we must keep in mind is wall aspect ratios as they relate to material selection. Can the material be changed to achieve to geometry or does the geometry have to be changed based upon the material? For example, we cannot mold PEEK as long and thin as we can polypropylene.
Tom Moyak: It is commonplace in the injection molding industry—if not startlingly surprising—to see how many critical decisions are made, impacting very large sums of money simply because that’s the way things have always been done. For right or wrong, what’s been good enough has sufficed for much of the industry for decades. With such little room for error, micromolding success truly requires the use of fundamentally sound and logical decisions at every step of the process. There has to be a focus on waste reduction through the application of 5S lean manufacturing principles. This is especially true with the foundation of any advanced micromolding part, which is creating a sound tool design.
Some critical aspects of mold design for micromolding include maximizing mold alignment, minimizing mold mass and minimizing flow lengths with tighter cavity spacing. You must also use creative, balanced layouts, and design the mold to accurately create robust details that can handle the micro-features and micro-gates inherent to the nature of these products. IMMs for micromolding rarely have enough daylight for hot runner systems, nor is the error introduced by these systems helpful towards consistently creating parts of the highest quality. Getting away from old school thinking allows micro molders to realize they may be able to design a mold that is simpler while accomplishing more with less.
One of our recent successes involves convincing a top 10 Fortune company to let us tackle a very high-profile program of theirs using “The Matrix Way.” They originally requested that we quote a 16-cavity mold with a hot runner system and other technology for a micro-featured, delicate product. Knowing the material they selected wasn’t optimal and what they requested had a very high probability of failure, we suggested alternative materials.
But more importantly, we were only willing to quote our completely unique “out of the box” solution. It took some convincing, but our unique eight-cavity all cold-runner solution provided more throughput with less waste than they had estimated for their 16-cavity hot runner solution. The tool we designed and built was simpler and required a much lower capital investment. It had the added bonus of a greatly reduced cycle time and smaller runner sizing while greatly improving part quality and consistency. It was a win-win for all and a real eye-opener for our customer, and especially their customer.
Raiken: The main challenge is to eliminate as much of a cold runner as possible so that the control of the injection molding machine delivery system/shut off nozzles are maximized. Part handling post molding can become a big issue and requires a new way of part handling. In addition, air evacuation from the tooling is a high priority.
Vadlamudi: Designing tools might not be that challenging with the CAD packages that are available, but it is tough to machine the micro features in the molds with conventional machining techniques. These challenges can be overcome by understanding the type of equipment or the process to employ in machining these features. Mold cavities can be manufactured with micro laser and EDM technologies.
Barbella: What regulatory requirements/changes have impacted medtech micromolding and how?
Maggie Beauregard: The European Union’s Medical Device Regulation officially went into effect this past May. These new regulatory requirements will continue to change the medical device world for those both located in the European Union and also those wishing to market their devices there. With new requirements covering almost all aspects of device regulations from lifecycle traceability requirements, updated post-market surveillance reporting requirements, new labeling requirements for Class III and Implantable devices, and even changes to how devices are classified, device manufacturers will need to pay close attention to these changes.
Bibber and Hahn: The impact a molder has on a medical OEM’s submission has increased. Isometric supports our customer’s filings by creating a plan for each component or assembly. There are many aspects, but the most impactful has been incorporating CT scan data into the OEM’s submissions.
Johnson: Anyone working in the medtech space will eventually feel the regulatory impact on the industry—even if you’re a tier II or II supplier. And certainly, the closer you are to a finished good, the higher the impact. In addition, the recent changes to the ISO 13485 quality system management have challenged organizations to rise to the occasion as well. The process to be a qualified supplier to medtech companies is not getting easier.
Today’s suppliers must have a robust QMS to meet the demand.
Raiken: As with all medical devices, FDA is now very watchful for patient safety. ISO 13485 and excellent clean room molding systems are standard.
Barbella: Is there a limit to how small a micro molded part can be?
Bibber and Hahn: The short answer is yes, and it is dependent on many variables such as material selection, gate size and location, and mold design robustness. Having said that, our smallest molded part was over 1,000 parts per plastic pellet. Parts that are hundreds of parts to a single pellet are moldable, but there’s a limit as to the number of cavities that can be pellet split and still be moldable in scale. This is known on a case-by-case basis; however, generally speaking this extreme is rarely more than 4-cavities while other micro molded parts can be 16, 32, or even 64 cavities.
Herbert: Without a doubt there is, everyone wants to be able to push the limits. However, reality is with conventional molding machines (micro), you have an ability to control volume. There is a maximum and a minimum within that volume. The question is how do you control this volume and to what degree. Making one part is not so challenging making the same part in volume is.
Johnson: Sure, but I’m not sure we’ve hit that yet. One of the smallest parts a customer has asked us to produce has its longest dimension at only 800 microns. We’ve also produced features on micro parts that are sub-micron in size. Yes, there will be a limit, but we’re always up for a challenge.
Dave Moyak: What is considered an “acceptable flash” specification of 0.002”-0.003” for a conventional molded part is actually the size of many micro part features. Individual micro parts are routinely fractions of a resin pellet. But regardless of the size of the plastic part, successful manufacturing always comes down to three basics: a good tool, a good machine, and a good process. Micromolding has continued to stretch the capabilities of the resin suppliers, tool machinery, and injection molding machine OEMs. Equipment manufacturers are constantly creating solutions to the micro paradigm. Many companies, such as Matrix, still have to modify even the best equipment in this field to meet the challenges of the tools we produce and the molds we run. Eventually these modifications become part of the mainstream offerings of the equipment suppliers. Necessity truly drives innovation.
Raiken: The parts may be too small to handle post molding—any amount of static will cause the smallest micro parts to become “sticky” and will cling to anything, even in a glass jar.
Vadlamudi: The limit to a micromolded part comes from the equipment that’s needed to build the molds and mold the parts. In addition to the equipment capabilities, the need for knowledgeable and skilled personnel is of paramount importance. Donatelle currently manufactures parts with 100 micron thickness that weigh less than a tenth of a milligram.
Barbella: How might the medtech micromolding industry evolve over the next five years?
Bibber and Hahn: Molding, 3D micro printing, material development, and miniaturized devices are a high growth niche business. It will be important for micro molders and automated micro assemblers like Isometric to continue to focus on moving the decimal points to the right in terms of part size, tolerance, wall thickness, and feature size.
Retaining skilled talent will continue to be important to innovation. Isometric has < 1 percent employee turnover in the 31-year history of the company. The basis of Isometric’s core values will continue to be important factors in our ability to retain these skill sets and employees to ensure future success.
Adding surface finishes, incorporating biomimicry of hydrophobic and hydrophilic surfaces, and other surface treatments such as plasma and corona treatments will enhance the physical bond strength and performance of miniaturized devices of the future. It’s common for technical and engineering-focused companies to get side-tracked on “the shiny stuff”; however, to truly grow, partnerships with key customers and fulfilling their needs is the heart of what provides continued growth and prosperity.
Cicio: It’s difficult to predict how the industry may evolve over the next five years but it is safe to say that customers are going to continue to expect tighter and tighter tolerances, which will continue to push manufacturers like MTD to stay on the cutting edge of technology for toolmaking and molding methods. Today, customers are prioritizing contract manufacturers that can be full-service suppliers and we will continue to see more customers seeking this service where they can look to us to be their one-stop-shop to take them from molding all the way to final packaging.
Freitag: Parts will continue to become smaller and more complex, challenging the limits of molding technologies. Materials will be developed that are specifically for micromolding processes that have greater functionality and can hold tighter tolerances. Ultimately, the Internet of things will allow the integration of sensor technologies, machine-to-machine communication, artificial intelligence, and cloud-based platforms to become integrated into micromolding systems, maximize production quality and efficiency and reduce operational costs and downtime. Different manufacturing technologies (machining, lasers, additive manufacturing, and molding) are also being combined in creative ways to create “hybrid equipment” where these technologies can complement each other in making a part.
Herbert: I see tooling being the biggest affected over the coming years. “Get Small”—as we say—will be the driving factor in tool fabrication.
Hulecki: We will see new lighter, stronger, reinforced polymers available for medical devices. This can replace metal implants as a more cost-effective and repeatable solution.
Johnson: As the demand for medtech devices to do more in the same space, or more in less, increases, the interest in micromolding will follow accordingly. At the same time, the desire for OEMs to reduce the supply-chain management costs will compete for attention. Those challenged with the design and development of next-generation products will have to navigate partners that can truly meet their needs. As nice as it would be, it’s doubtful a one-stop-shop can do it all. A careful selection of integrated partners, like a micromolder, will be needed.
Lindsay Mann: The micro injection molding market continues to grow, estimated to be about a $1.5 billion market within five years. Converting delivery and testing methods once done in a doctor’s office to ones that can be done at home require novel designs of existing and improving technologies to make these procedures simple, repeatable, painless, and reliable. Complex, smaller plastic devices that include overmolded sensors/delicate substrates are generally needed for these devices and require advanced micro injection molding to create.
As digitization of miniaturized devices continues, we will continue molding around/over/through batteries, PCBs, and delicate substrates that perform important data transmission jobs. This will apply to many markets and applications. Protecting these substrates is crucial and encapsulating them with micro overmolding is an effective and feasible solution.
Raiken: Personalhome healthcare devices and wearables that associate with smartphones will become much more mainstream.
Vadlamudi: There will be advancements in material handling equipment and in processing equipment with smaller shot capacities (to obtain consistency from shot to shot). There will also be developments in materials which will allow molding thinner wall sections. Molding equipment with integrated with robots and inspection systems will become commonplace in the medtech micromolding industry.
