As medical device designs continue to evolve, more molded products and parts are entering the market. Laser-based surgical tools, micro-implants, and bioresorbable technologies are just some of the innovative technologies being molded. Fabricating smaller and more complex medical devices requires extensive experience and high precision from molders. Molders must also have thorough knowledge of material behavior, particularly for advanced materials. Medical device makers want to work with molders dedicated to manufacturing medical products, or else dedicate a large portion of their business to medical manufacturing.

Rather than focusing on one or two process aspects, many medical molders collaborate with medical device customers. They may offer services including design, prototype development, guidance on design for manufacturing (DFM), material selection, and full production. It’s become practice for molders to successfully manage all elements in the process from design to regulatory support.

Parts are also becoming small enough that sometimes a full production run can be held in one hand. Small parts require a molder strong in 2-shot, multi-component, or electronically integrated parts. Medical device manufacturers constantly design more products needing overmolding or insert molding to combine materials—plastic, metal, rubber, or thin, flexible surface electrodes—to create unique physical properties or specific surfaces or textures.

To gain more insights about this medical manufacturing mainstay, MPO spoke with 11 medical molding experts over the past few weeks:

• Don Bonitati, director, medical device market, at Minnesota Rubber & Plastics, a Minneapolis, Minn.-based provider of material compound development, engineering design, and manufacturing of custom molded elastomeric and thermoplastic components and assemblies.
• Ethan Bruyn, manufacturing technology leader at Medbio Inc., a Grand Rapids, Mich.-based cleanroom injection molder of plastic components for the medical and biotechnology industries.
• Stephen Costa, senior director, plastics engineering and technology, at Jabil, a St. Petersburg, Fla.-based manufacturing solutions provider to a variety of industries.
• Donald DeLeire, director of medical device at SMC Ltd., a Somerset, Wis.-based contract manufacturer of single-use and disposable medical devices.
• Cory Heckman, senior injection molding manager at Raumedic, a Mills River, N.C.-based manufacturer of tubing, molded parts, catheters, and modules for medical technology.
• Scott Herbert, founder and president of Rapidwerks Inc., a Pleasanton, Calif.-based precision micromolder.
• Jason Middleton, VP of sales and development at Ray Products Co. Inc., an Ontario, Calif.-based 3D thermoformed plastic parts manufacturer.
• Rey Obnamia, VP of technology & regulatory and operating partner at IRP Medical, a San Clemente, Calif.-based provider of elastomeric solutions.
• Thomas Taylor, president and CEO of Foxx Life Sciences, a Salem, N.H.-based manufacturer of tubing, bag, bottle, flask and carboy assemblies, filtration, fluid management, laboratory safety products, and glassware for the research, biotech, and pharmaceutical industries.
• Ashley Turrell, director of strategy at Natech Plastics, a Ronkonkoma, N.Y.-based manufacturer of plastic injection-molded components.
• Marc Weinmann, president of VEM Medical, a Clovis, Calif.-based based provider of medical mold tooling and cleanroom injection molding.

Sam Brusco: What latest advances in molding technologies/supporting technologies have you invested in, and what are they making possible for medical manufacturing?

Don Bonitati: We’ve invested in advanced injection molding presses and vision inspection machines in our global facilities. In the last year alone, our Litchfield, Minn., operation brought six new injection molding presses online and added two high-speed automated vision inspection systems to further advance our capabilities. Additionally, we are bringing online a new ISO Class 8 cleanroom that will support COVID-19 efforts on a critical customer project, as well as expanding existing ISO Class 7 & 8 cleanroom capacity.

Ethan Bruyn: We’ve been pushing the ‘Industry 4.0’ mindset, trying to integrate as much as possible into our molding machines’ controllers—hot runner controllers, temperature control units, cavity/melt temperature monitoring, integrated robots, and automation.

We were the first in the U.S. to test and successfully use Euromap 82.2, a communication protocol between HRCs and molding machines, which has had significant benefits. We launched multiple, high-volume programs with the complete Priamus Fill Control System, allowing miniscule fill time deviations by constantly monitoring the melt front location in all cavities. One variable setting us apart from most molding companies is we’ve teamed up with a molding machine manufacturer (Arburg) that we feel continues to push medical molding limits. Doing so also enables our team to become the expert when using their controller and allows us to utilize it at 100 percent.

We can change out injection units, from a 17-ton machine up to 359-ton machines, in less than an hour to give us flexibility for different materials and/or shot sizes. We can remotely monitor our machines to see if they are running or not and exactly what’s going on in the process. We can also evaluate the last cycle’s fill time to peak cavity pressure of a job that ran months ago.

Stephen Costa: Jabil’s molding business has been investing in new equipment for precision small/micromolded parts.

Donald DeLeire: SMC invested in in-mold cavity pressure transducers from both Kistler and RJG. We’ve also invested heavily in new high-precision electric molding machines across our plants. These investments have increased capacity and lead to improved quality and lead times. 3D printing for rapid prototyping and component manufacturing are available options.

Cory Heckman: By investing in automation at the injection molding presses, we added the capability to produce multi-material, multi-component products simultaneously. This reduces lead time and cost for the customer. Furthermore, our program to enable real-time press monitoring with smartphone access will increase uptime and productivity.

Scott Herbert: There are a wide range of advancements in micromolding and injection molding. Highly engineered materials are pushing limits and improving part structural strength and stability. The other side is material control, specifically the volume of material that allows controlling the fill in the tiniest of cavities. 

Jason Middleton: There’s a need in the medical market for part repeatability in medium to large sizes with UL 94 V0 flame-rated, FDA approved, and chemical/impact-resistant material solutions. Pressure forming is ideal because it satisfies mid-volume plastic enclosure demand.

Our capabilities let us provide highly cosmetic and durable solutions that are alternatives to larger part injection molding with low- to mid-volume needs. The part complexity has recently increased tremendously due to 6-axis robotic routers and aluminum tooling that allows for part-to-part and run-to-run repeatability, as well as mold texturing and undercut features.

Rey Obnamia: We continue to invest in advanced mold designs at higher cavitation, molding machines with advanced process controls and monitoring, full automation for the entire molding cycle that includes visual, and dimensional inspection through packaging.

Thomas Taylor: Molding equipment continues to advance in all electric machines with the latest technology, including magnetic platen and quick-change tooling fixtures.

Ashley Turrell: First is our integration of co-bots into molding workcells. Utilizing co-bots adds various benefits for our team and clients, including eliminating unnecessary labor and human error, while simultaneously increasing our process’s quality and consistency. This ultimately leads to better quality parts and reduced costs for clients.

We recently invested in filling and sealing stations for diagnostics clients. We can now mold their diagnostic devices, assemble them, and, fill them with liquid, foil seal diagnostics parts, appropriately package and ship to clients, all in-house. This helps shrink what’s usually a complicated supply chain, while also mitigating additional costs associated with contracting these services to vendors. Because this process occurs at one New York facility, we control the complete process and ensure quality standards are met at each manufacturing and assembly stage.

We registered with the FDA and installed a Class 8 cleanroom to assemble and package medical devices. We qualified the process using a design of experiments to characterize a full processing window and developed a training program for operators working with the cleanroom equipment.

Marc Weinmann: Over the past few years, we’ve seen an increasing number of projects making use of 3D steel printing technology. With this technology, we can achieve lower cycle times and depending on the part, better part quality due to cooling. It’s often a high upfront investment but will pay off in part manufacturing. Over the years we’ve trained our staff how to adapt their design according to this technology.

Sam Brusco: How do you ensure molding remains competitive with other manufacturing technologies (e.g., CNC hybrid machining, additive manufacturing, etc.)?

Bonitati: Our technology roadmap has outlined a path to bring on board the latest equipment technologies to improve on the quality and reliability for product performance. We continue to push the boundaries with the latest molding and post-processing equipment to support industry demands for smaller, tighter tolerance components for minimally invasive procedures, diabetes, point-of-care diagnostics, and the wearable markets.

Bruyn: Automation is a must. The cost of direct labor is constantly rising and automation is our answer to achieve the repeatability medical customers want. We’ve been able to significantly lower automation costs by creating flexible automation systems we can use on multiple programs. We’ve invested in a team of automation engineers and technicians to design, build, and support all our automation.

CNC machining and additive manufacturing have their time and place, but aren’t the most viable options for most items in the quoting pipeline. They either can’t meet the volume requirements, or result in reduced structural part properties. We still have both of these in-house, however, and use them for the occasional low-volume job.

Costa: Injection molding will always be more competitive and cost-effective for high volume, high precision manufactured parts. The cycle time to produce a part by machining or additive manufacturing takes much longer and can’t obtain the same surface finishes or tight tolerances as precision injection molding. (This is especially true for optical parts.) Available material grade selections are also far greater for injection molding than additive manufacturing or machining, which may limit applications.

DeLeire: We invest in multi-axis robots for part load and part extraction to reduce dependence on adding labor to scale up new jobs. Investments in multi-axis machining centers in our tooling and automation areas has reduced lead-time and cost on component builds.

Heckman: Competitive technologies to molding are often great ways to augment and improve our own molding process. For example: We adopted 3D printing of mold inserts, shortening our prototyping cycle, and enabling us to test aspects of the manufacturing and quality process before the final tool is made, saving time.

Herbert: As a business owner/entrepreneur you constantly have to push the envelope, ensuring you’re ahead of the technology curve and that you remain on top. Otherwise, you’ll be left behind: Consider the mantra of “every day is a school day.” EDM technology is consistently pushing the envelope, with smaller wires and faster burn times while improving accuracy. 

Middleton: The market today is challenging us to be much more than a thermoformer. However, technology and innovation are what drive us to continue to grow. Utilizing the latest pressure forming equipment, including six-axis robotic routers for secondary operations, we’re well equipped to meet customers’ needs and complexities as a complete partner. To do this, we add capabilities for assemblies like sheet metal to plastic parts to help reduce the time for our OEMs at their assembly line.

Obnamia: We continue to keep up with new and improved elastomers, additive manufacturing for true LSR as it becomes available, and finding suitable applications to our manufacturing processes. We try to stay with or ahead of what medical OEMs do with technology to support their programs.

Taylor: Molding competitive analysis is always driven by volumes and materials. Molding remains the king of technologies for the appropriate volumes.

Turrell: Molding holds an inherent advantage over many other technologies at higher volumes because it can achieve high quality at high speed for complex parts. We have incorporated Scientific Molding principles into our mold qualification process to ensure it remains capable and stable over the long term.

Weinmann: We stay competitive by investing in the right technologies—automation and less manual interaction in every process step is the goal. The increased investment in 3D printed steel parts with conformal cooling for medical molds is part of our roadmap. Next, we plan to add another 5-axis CNC milling center. In 2019 we started seeing the huge benefit of our 5-axis milling center at VEM Europe, and we’re equipping other operations with these machines.

Brusco: What do OEMs look for when choosing a medical molder? Why do they seek out your company specifically?

Bonitati: They look for a partner that will work closely with them early in development while offering solutions supporting innovative and revolutionary changes in the products they bring to market. Whether an improvement to an existing product or new design concept, technology leaders look for cutting-edge materials and capabilities that will set them apart from competition, to improve patients’ lives and reduce trauma during procedures for faster recovery times.

We offer technical support with our Advanced Materials Group (AMG) for selection, development, and analysis of custom material formulations. We also offer product design support from FEA modeling, mold flow, and DFM expertise to optimizing product design and material selection in the early development stages.

Bruyn: We can support a diverse variety of projects: low-volume, insert-molding with complex shut-offs, or high-volume manufacturing producing tens of millions of parts a year. We’re also a one stop shop. We have a passion for technology and a lot of personnel to support most anything thrown at us.

Costa: The competitive and regulatory demands on OEMs require them to work with injection molders that can bring the right environment, equipment, engineering materials, and employees to manufacturing. These “Four E’s” encompass important evaluative criteria by which medical device manufacturers identify and measure their prospective partners among molders and other plastics processors. The criteria are as follows:

• Environment: Cleanrooms and non-cleanrooms, and quality and regulatory requirements such as cGMP, ISO 13485, ISO 9001, and lot traceability.
• Equipment: Injection molding machinery, molds, robotics and assembly automation.
• Engineering Materials: Non-commodity plastics with challenging process requirements. Includes supply lot controls, USP Class VI, BSE/TSE, and 10993 compliance.
• Employees: Highly skilled people who work with technically advanced molds, equipment, and processes supporting complex mold and assembly validations.

DeLeire: OEMs prefer molders who can participate in all phases of development from concept, prototype, DFM, pilot, and production—in addition to having in-house capability to manage the project from concept through validation. Our customers choose us because we can bring subject matter experts in tooling, injection molding processing, automation, and validation to all phases of the project lifecycle.

Heckman: Molded products are always part of a greater whole. We find customers come to us because we bring other ways to add value. We have decades of expertise not only in injection molding, but in compounding, extrusion, design for manufacturability, and assembly. A customer can bring us as much of the project as they want, reducing the number of vendors in the mix. This enhances the probability that all components will work together correctly at the end of the project.

Herbert: Medical OEMs search us out because of our ability to react. We have the technical expertise to perform. Micromolding is no easy task; it’s technical in nature and very precise regarding fabrication and material control of material. OEMs know this and seek this expertise. 

Middleton: OEMs look for partners that can accomplish the job correctly, the first time, on time, and at the best price. As a full-service custom thermoforming company, we’ve earned a reputation for providing customers with quality, precision, and dependability, over seven decades.

We also believe in continuously investing in the most innovative technology. We use 6-axis robotic routers and 3D coordinate measurement systems inside our 48,000 square-foot, ISO 9001:2015-certified manufacturing facility for advanced vacuum forming and pressure forming.

We’re on the West Coast, so we interact with large medical device design firms, OEMs, and contract manufacturers. We also work with startups, providing initial design and concept review, often with education on process capabilities. Whether a startup or a Fortune 500 company using pressure forming, we’re comfortable pushing process boundaries. We’ve always found creative and unique ways to connect with the medical device community—at a trade show, lunch and learn, facility tour, webinar, or a Zoom design review. As experts, we help OEMs discover the best fit for their project, even outside the pressure forming realm.

Obnamia: OEMs seek a medical molder who can transform seamlessly from prototype stage to initial production to full-scale high-volume production of millions of parts as rapid as possible, in a cost-effective fashion, where each stage of scaling up transitions without production delays and continues assurance of supply, quality, and customer experience. This is why OEMs approach us to be their supplier of choice. 

Taylor: The number one item for choosing a molder is trust and transparency. The molder and OEM must be partners vs. customer and supplier to be successful. Molders underestimate the importance of the relationship and communication. It isn’t just price and capabilities—I would rather have a molder I can trust vs. a molder I can’t with more capabilities. After being on both sides over the past 33 years, this is the key to success.

Turrell: We typically hear they choose molders based on responsiveness, industry-specific certifications, industry experience, manufacturing capabilities, values, and reputation. 

Companies seek us out because we specialize in partnering with medical device companies and innovative medical startups. We have an engineering team guiding clients from design through final assembly, all the time paired with one project manager that sees the complete project through. Our extensive medical device and diagnostic experience comforts clients because they know they’re working with a team that truly understands their needs and can help proactively find and mitigate risks.

Medical companies also appreciate our quality management system. We’re certified ISO 9001, ISO 13485, and FDA-registered. Knowing we meet these rigorous quality standards gives clients peace of mind. Our whiteroom manufacturing space and class 8 cleanroom also intrigues current and potential clients. These spaces are critical for medical device production.

Weinmann: Most OEMs look for long-term partners that produce and give significant feedback on the product and production process. Many medical customers came to us with a product, but without a solid plan of how to assemble and test it. A task force made up of VEM staff and the OEM then began to analyze each process. There’s always a constructive knowledge exchange among the team that leads to successful production, assembly, and testing.

No two projects are alike; OEMs know this and seek an experienced, creative, and hands-on medical molder that can accept any challenge. With VEM Medical many OEMs found that and continue working closely with us.

Brusco: What medical device material advances are impacting or challenging molding processes, and how?

Bonitati: Processing aids are one of the biggest impacting *factors challenging medical device products. More often customers require an elastomer to comply with ISO 10993 biocompatibility guidelines. This is the case when a product contacts skin or blood, or is part of a short- or long-term implant. Many common additives in materials aren’t ISO 10993 compliant; however, those same additives allow reliable and consistent processing of these materials. These processes may include molding, flash removal handling, and packaging.

The benefits of working with a supplier who can formulate custom compounds is adjustments may be made to materials to remove processing aids that don’t meet biocompatibility requirements, and replace them with alternate processing aid. Trade-offs can range from limitation to process options, additional automation require for demolding, special handling, and packaging requirements. We work closely with customers on design considerations and performance requirements when making these changes. The challenge is balancing design inputs with the optimal process, while offering a competitive solution.

Bruyn: Parts are getting smaller, thinner, and more complicated. Many OEMs are also seeking to convert from reusable stainless steel components to disposable, plastic devices. Resins like PEEK and/or Radel are specified in these cases. High-melt-temp resins pose difficulties to toolmakers and molders, given the effects of high temperatures on the tool components.  We also aim to learn more apt prediction in designing tools for high thermal expansion, and ensure these parts properly eject from the tools.

Many customers are in the diagnostic realm—human contact with those parts is prohibited. This requirement forces use of automation, cavity separation, and continual monitoring of the molding process and the mold to ensure startup parts and/or anomalous cycles are rejected, in order to continue production even if one or more tool cavities is damaged.

There are challenges simply due to the OEM’s constraints to require biocompatible, even when the choice isn’t optimal for the part’s geometry. We can request alternatives (and often do), but program timing or costs sometimes limit using an easier-to-process resin.

Costa: Demand for high precision, high-quality low-pressure molding (LPM) applications that encapsulate complex electronics is growing. New medical grade LPM materials are being developed to meet these new applications. Other direct molded encapsulation methods are being developed for embedded electronics. 

DeLeire: Continued use of clear and soft-touch materials. Advances in prototyping and short-run production opens the door for many materials. The challenge continues to be investing adequate time during development to ensure items are scalable.

Heckman: Sustainable and biodegradable materials are certainly on the horizon. We recently worked with a well-known U.S. medical device company to help them switch to a plant-based pigment in a part we produce for them. Over time, this will turn into a major industry topic.

Herbert: It’s not just today, it’s been here for a long time: “Smaller and smaller, tighter and tighter tolerances. How small can you go! We need better!”

Middleton: Color matching, additives that can include anti-microbial resistance, lower material minimums, and reduced time to market continue to drive innovations that provoke successful OEM product launches. Materials from SEKISUI/KYDEX (specifically the KYDEX product line) continue to be forward-thinking, allowing us to also bring end-of-life recycled capability by eliminating the need for paint.

With their ability to match material in colors, including metallic, our customers can now state plastics used on their medical instruments can be recycled, which not all molding processes support. Most medical OEMs are at a low-mid volume quantity; SEKISUI/KYDEX supports our and our OEMs’ needs, especially during these challenging times.

Obnamia: Cost-effective, high liquid volume silicone, micromolded critical-to-function components and overmolding silicone on complex plastic, metal, rubber, or flex circuit substrate designs. High-end LSR injection mold designs with full automation (part demolding to in-line inspection, cavity separation to product packaging) can achieve this, unless post-cure or assembly are needed.

Taylor: Supply chain and resins are the biggest challenge in the industry today. Second is the availability of qualified technical people with experience running molding equipment. We need to do more to promote industry within the younger generation. 

Weinmann: The increased use of silicone parts, made with liquid silicone rubber. This can be a challenge for many molders as the material has incredibly low viscosity compared to other plastic materials. Precision on medical molds is even more important to handle that.

Brusco: Where is molding for medical manufacturing headed? What’s coming in the next few years?

Bonitati: We offer technical support with our Advanced Materials Group (AMG) for selection, development, and analysis of custom material formulations. We also offer product design support from FEA modeling, mold flow, and DFM expertise to optimize product design and material selection in the early development stages. Our on-premise advance materials lab is fully equipped with state-of-the-art compounding and analytical equipment capable of sampling and testing multiple chemistries for medical applications ensuring scalability of all R&D materials.

We will continue to see limits being pushed concerning material performance requirements, drug compatibility, biocompatibility, and impermeability. Seal interactions with chemistry is an industry need for improved extraction and leachate performance. For example, our AMG team is expanding our portfolio of materials that meet demanding diagnostic and diabetes market requirements.

Bruyn: One significant change is the evolution of the smart molding machine. More predictive maintenance on the machine and molds helps us predetermine and notify the correct personnel when a motor begins to fail or a latch lock starts to dry up. Along with this is closed-loop molding, where the machine adapts for material variation and makes changes needed to achieve the same part over and over again.

Automation will become an essential part of manufacturing. Using protocols like OPC-UA communication will continue to be a big push in integration. The more useful data one person has available, the more they can continue to learn from a process and make improvements.

Costa: Medical manufacturing continues to see further part miniaturization. Parts in wearable medical device assemblies demand smaller sizes, and this trend will continue. Smart devices with embedded electronics will also be the norm in the next few years. Medical device manufacturers must be cognizant of the intrinsic challenges and costs imposed. Without investing in the proper environment, advanced equipment, engineering/material processing knowledge, and highly skilled employees, device manufacturers may find themselves ill-equipped to meet OEM needs.

DeLeire: Continued use of molders who can integrate many types of manufacturing processes to provide molded parts and offer value-add solutions including full device assembly. In addition, utilizing vendors who have the expertise to provide fully automated solutions for high-volume applications, but also lower cost solutions in lower cost countries for projects that may have lower volumes.

Heckman: Political tensions around the world, as well as the COVID pandemic, have brought the vulnerabilities incurred by offshoring into sharp focus. To bring strategic manufacturing back within our borders without driving up costs, it will be necessary that the industry be open to new technologies and new ways of working. We can add value and increase productivity by adopting technologies that carry out secondary processes right at the molding press, rather than offline.

Herbert: There will be more opportunities for those willing to bridge the gap; providing a more diverse offering is key. Make the customer happy! Consider the mantra: “change is enviable.”

Middleton: With a renewed focus on core supplier and technology alignment, pressure forming will have a critical seat at the table of new product design, development, and deployment. Medical device complexity will continue to increase—engineers and product designers from hi-tech environments like Google, Apple, and Tesla entering the medical device marketplace and utilizing their experience will further accelerate the medical device market.

Obnamia: Medical molding is heading for further miniaturization of rubber parts, which become more difficult to produce when they’re co- or over-molded with other substrates. Advanced controls and AI continues to be smarter. Advanced technologies like material choices with added properties, injection mold designs at much higher cavitation, full automation, and vision inspection systems will make complex medical molding seem easier.

Taylor: More molding will be done in North America; the trend is bringing molding and manufacturing back to the U.S. and our neighbors. We just added four more class 7 cleanrooms and 75 percent of our branded product is produced and assembled in the U.S. (over 90 percent in North America). Our customers appreciate that commitment to local service and “Made in America” initiative.

Turrell: Medical manufacturing continues “breaking the rules” for what’s possible. Each new part geometry brings unique challenges. Features get smaller, tolerances grow tighter, and quantities of those components are rising. The level of accuracy and precision we can hit shrinks and tightens, and we must maintain optimal Cpk (process capability index) over longer runs. We’ve made parts with 20-micron features—if those features are off by too many microns, the device won’t work. We anticipate this trend to keep extending.

Weinmann: Advances in technology make room for new applications and production processes. At the same time, the need for medical devices in general is increasing, as it becomes more accessible for a larger portion of the global population. Notably, there are many companies moving production out of China into India, Mexico, South East Asia, and Eastern Europe. We are well positioned for this upcoming change.