Hannah Simpson usually favors certain words in her cancer recovery discussions.

The most prized figures of speech include “miracle,” “God,” “blessed,” and “divine Providence.”

It’s not surprising that Simpson uses such nouns to describe her survival—she is, after all, a bona fide medical anomaly. Statistically speaking, Simpson shouldn’t exist: She’s had two glioblastomas (brain tumors) surgically removed, losing almost all her right frontal lobe—down to the ventricle—in the process. Yet she’s had no paralysis or cognitive deficits from the sacrifice.

Simpson is 15 years removed from her first glioblastoma (GBM)surgery, affording her membership to an exclusive patient group for long-term brain cancer survivors. GBM’s median survival rate is 14.6 months, according to Glioblastoma Research Organization data, and only 6.8% of patients live five years past their diagnosis.

“How have I survived this surgery and this diagnosis (glioblastoma)?” Simpson asks in an autobiographical summary of her cancer journey, posted on the Glioblastoma Foundation website. “I believe God has granted abundant miracles.”

It certainly seems that way: Simpson learned of her first glioblastoma after suffering a grand mal seizure. Fortunately (miraculously?) the egg-sized tumor was located in front of the brain’s motor cortex—a prime spot for easy removal with minimal risk of long-term physical side effects, according to Simpson’s surgeons.

Also supporting the first tumor’s easy removal was the fact that its tissue (blessedly?) was easily distinguishable from brain tissue, a rarity in glioblastoma cases.

Another rarity was Simpson’s swift recovery from both GBM procedures. Within weeks of her 2009 surgery, she regained full strength and full movement on her left side and was cleared from all therapies (speech, occupational, and physical). Likewise, only Simpson’s multi-tasking and motor planning skills were slightly affected by her 2019 surgery and chemotherapy/radiation regimen.

Simpson remained cancer-free as of January 2022, and thankfully (God’s will?), is being monitored biannually for possible recurrence.

“I continue to beat the odds. I believe my non-standard care (multi- drug chemotherapy and hyperbaric oxygen treatments immediately before radiation sessions) and my faith are the main contributing factors,” Simpson wrote in her Glioblastoma Foundation post. “As I continue my fight, I know there are no guarantees…this has been a season and process laced with God’s miracles and Divine Providence.”

Unfortunately, miracles and Divine Providence are about the best options for long-term brain cancer survival. Patients face a 17% two-year survival rate, and there is no life expectancy data beyond five years.

Thus, patients like Simpson are left to hope for a miracle.

Such divine interventions, however, could soon find support from mortal science. U.S. researchers currently are crafting solutions to not only sense and treat cancer, but also to test therapeutics in-vitro.

A multi-institutional research team, for example, is under contract with the Advanced Research Projects Agency for health to develop and test a tiny device that can sense cancer-associated inflammatory markers and autonomously deliver immunotherapy. The 1-centimeter-wide implant will house living engineered cells that both synthesize and deliver therapies when needed.

Brigham and Women’s Hospital researchers, meanwhile, are testing a glioma treatment device its creators hope will provide valuable insight on pharmaceutical therapies. About the size and shape of a grain of rice, the device is used during standard brain surgery to determine the impact of various drugs on glioblastomas.

During its two- to three-hour visit within the brain, the implant administers tiny doses of up to 20 drugs into the tumor. The device is removed during the procedure and the surrounding (tumor) tissue is sent to a lab for analysis, ultimately providing scientists with previously unparalleled insight into pharmacologic impacts on the tumor microenvironment.

Withstanding and traversing such an environment requires a device that is durable, flexible, and most importantly, small enough to infiltrate the brain’s diminutive domain. Producing such a product would be unimaginable without micromolding, a highly specialized manufacturing process that generates extremely small, high-precision thermoplastic parts and components with micron tolerances. Through micromolding, medical components can be created to assume microgram proportions.

Or in the glioblastoma implant’s case, millimeter proportions.

“The ability to bring the lab right to the patient unlocks so much potential…” Pier Paolo Peruzzi, assistant professor in BWH and Harvard Medical School’s Department of Neurosurgery, said last fall upon publication of pilot clinical trial results. “We’re optimistic that this is a new generation approach for personalized medicine.”

Medical Product Outsourcing consulted nearly a dozen experts over the last several weeks to better understand micromolding’s role in personalized medicine and the medical device industry in general. Participating in the conversation were:

• Maggie Beauregard, quality manager; Jared Cicio, molding/production manager; Patrick Haney, R&D engineer; Dave Klein, senior process engineer; Lindsay Mann, sales/marketing director; and Cheyenne Stack, account manager at MTD Micro Molding, a Charlton, Mass.-based micro medical manufacturer of ultra-precision molded components
• Brent Hahn, senior vice president; and Vijay Kudchadkar, director of Plastics Engineering at New Richmond, Wis.-headquartered Isometric Micro Molding, a Nissha Medical Technologies company.
• Brian Jimenez, business development manager at AdvanTech Plastics LLC, a full-service plastic injection molding firm in Woodstock, Ill.
• Charles Klann, director of Engineering, Saint-Gobain Medical, a Solon, Ohio-based designer, developer, and manufacturer of custom medical components and engineered systems for medical devices.
• Robert Morin, sales and marketing vice president at PDC (Plastic Design Company), a Scottsdale, Ariz.-headquartered specialty manufacturing company that provides precision injection molding and value-added assembly services to the medical device and life sciences industries.
• Dominykas Turčinskas, commercial manager at Micromolds, a Lithuanian provider of plastic injection molding services.

Michael Barbella: Please discuss the trends and challenges in medical device micromolding. Have these trends and challenges changed in recent years?

Patrick Haney: Challenges in medical device micromolding remain significant, as they always have. The field is continually pushing the boundaries of what’s possible, with increasingly complex micro designs requiring more than just mold creation and molding services. Many devices now demand extensive material research and close collaboration between product designers and mold designers. Customers turn to their molders to explore what can be achieved and to ensure their critical design features are realized, resulting in a highly detailed and collaborative process. As more customers recognize the potential for miniaturizing their designs, they increasingly rely on molding suppliers to bring these innovations to life. This growing interest in micromolding highlights the need for education and guidance. Molders are now expected to provide more insight into the capabilities of micromolding, helping clients understand its potential and develop optimized molding strategies for their projects.

Lindsay Mann: Advancements in wearable health technologies and implants continue to push the need for smaller, more complex devices and components. Micromolding is the optimal manufacturing method to manufacture these tiny plastic parts in the highest quality and high volumes, in a cost efficient manner.

Brent Hahn: Without a doubt, the size and scale of parts and features continue to be smaller and smaller with tighter tolerances. The biggest challenge we see at Isometric Micro Molding is being able to successfully micro mold in extreme high volume and high cavitation. The higher the cavitation, the exponentially more difficult it is to hold 1.33 Cpk requirements. Building robust molds, executing and maintaining micron-sized vents, manufacturing micro features/parts quickly, and controlling part handling and static, all while holding tight tolerances and thin walls without flash and/or short shots are all necessary to accommodate these high-volume requirements.

Vijay Kudchadkar: The field of medical device micromolding has seen substantial progress and emerging challenges. Manufacturers are driving innovation with increasingly smaller components with challenging features requiring tighter tolerances and thinner walls. This trend demands precision and expertise in sub-micron precision tooling and micro molding.

Additionally, there is a shift in manufacturing, with OEMs transitioning from traditional methods like machining and extrusion to micro injection molding. However, micro molding these parts presents significant challenges since they weren’t necessarily designed to be injection molded. Another trend is the consolidation of multi-part assemblies into single components using 2-shot micro molding. While this approach reduces component count and enhances reliability, it adds complexity to the manufacturing process, requiring ultra-precision 2-shot tooling and molding.

Brian Jimenez: AdvanTech has seen a trend in micromolding gears for medical devices. Innovation demands more efficient and compact designs. This requires improvements to gear design so they can be more compact while robust, and capable of producing more capacity. The challenge in doing so for injection molding lies in the space needed to accommodate.
Charles Klann: A recent trend in micromolding has been the introduction of micro-sensor technology and incorporating them into devices.  his has added to the complexity of tool design and construction.

Robert Morin: In recent years, the trends in medical device micromolding have shifted significantly. One of the most notable changes is the increased demand for miniaturization. As devices become smaller and more complex, the need for micromolded components that can deliver high performance in limited spaces has surged. This has pushed the boundaries of traditional molding techniques, requiring advancements in both machinery and materials. However, with these advancements come challenges. Precision is paramount in micromolding; even the slightest deviation can result in a defective product. The tolerance levels for micromolded parts are incredibly tight, often measured in microns. This requires manufacturers to invest in cutting-edge technology and quality control measures to ensure that each component meets the stringent standards expected by the medical industry.

Another challenge is the increasing complexity of designs. As devices become more sophisticated, the parts that make them up are also becoming more intricate. This complexity can lead to higher rejection rates during production, increasing costs and lead times. Manufacturers must constantly refine their processes to address these issues, balancing the need for precision with the realities of production.

Dominykas Turčinskas: The ongoing trend of miniaturization in medical devices demands increasingly smaller and more complex components. This has pushed the boundaries of micromolding, where tolerances of a few microns are now the norm. Innovations in microfluidics and implantable devices further drive this need. Medical micromolding is moving beyond conventional thermoplastics to advanced materials like bioresorbable polymers, PEEK (polyether ether ketone) and other biopolymers. What we notice at Micromolds is that more and more materials have to work with hydrogels together creating a one unique system, especially in OoC devices. With current technologies it seems that everything can be manufactured at low volumes, thus the most challenging thing becomes scaling with assurance of consistency, reproducibility, and traceability. In recent years the biggest change we’ve noticed is that regulatory expectations have evolved, thus demanding more robust process validation and documentation. This has placed a greater emphasis on data-driven manufacturing.

Barbella: What are customers commonly demanding or expecting from their micromolded parts?

Haney: From our perspective, there is a high level of urgency in medical device development right now, so timing is more critical it seems. There is a need for fast and accurate decision making and collaboration. This urgency translates to the molder and there is no room to iterate or deviate—the customer is depending on the development and manufacturing plan to work to meet their product timeline requirements. Customers’ needs for components and micro devices are more scientific and specific than before. As a result, the demand for material science expertise is higher and they depend on their selected molder for that.

Mann: Customers are increasingly seeking the best solutions for their product design needs, which involves not only understanding but also aligning with their unique program goals. This could include providing expert guidance on materials, optimizing design for manufacturability (DFM), exploring cost-saving opportunities, or partnering with a top-tier micromolding provider. More than ever, they are looking to forge strategic relationships with molders who can help them meet tight deadlines and elevate the quality of their next-generation designs by leveraging the molder’s specialized expertise.

Cheyenne Stack: Customers expect excellence in micromolding across several key areas. They expect high quality parts free of defects that precisely meet their specifications.

Additionally, they look for valuable design for manufacturability (DFM) feedback from micromolding experts to ensure parts are optimized for injection molding efficiency. Customers also seek a reliable and trustworthy molding partner capable of delivering the precision needed for complex medical devices. As projects progress through process development, customers rely on MTD’s expertise to understand and address the phenomena that arise, tackling any challenges promptly. They value transparent communication throughout the project to ensure a smooth and successful outcome.

Hahn and Kudchadkar: Customers demand micromolded parts that are smaller, more complex, and have tighter tolerances while expecting production volumes in the millions or billions annually with a Cpk of 1.33 or higher. Traditional tooling tolerances of ±0.0002” (5 microns) or even 0.0001” (2.5 microns) are no longer sufficient. Medical OEMs now require sub-micron precision tooling at competitive prices. Customers also expect 100% of parts to meet specifications, that the manufacturer have a plan to account for all variables, including ultra-precision tooling and the maintenance of that tooling, a processing window that will accommodate lot-to-lot resin variation, part handling that doesn’t create damage or scrap, and an environment that controls static and other debris-causing issues, all while delivering on time.

Jimenez: Customers demand precision on their dimensions with tolerances usually being within ±0.001”. We’ve even seen requirements be within ±0.0005” in critical areas. The reason being is the micromolded parts will usually assemble with other mating parts and to ensure fit, form, and function work properly, the dimensions need to be spot on.

Klann: Customers expectations have increased with respect to part quality and performance capabilities. Having a technically sound process is critical and the ability to share with customers performance capability is crucial.

Morin: Customers in the medical device industry have always expected excellence, but their demands have evolved alongside technological advancements. Today, there is a growing expectation for micromolded parts that not only meet functional requirements but also provide added value in terms of durability, biocompatibility, and cost-effectiveness. For example, customers often require components that can withstand sterilization processes without compromising their structural integrity or performance. Additionally, there is an increasing demand for parts made from advanced materials that are not only safe for use in the body but also compatible with other materials used in the device. Meeting these demands requires a deep understanding of material science and a commitment to ongoing research and development.

Turčinskas: Customers seek high precision with micron-level tolerances, consistent quality across production, material biocompatibility for medical applications, and quick turnaround times from prototyping to production.

Barbella: What role, if any, is AI (artificial intelligence) playing in micromolding?

Jared Cicio: Here at MTD, we have been working on options to best-utilize AI to help our business and our customers. We embarked on a project with a company that specializes in using AI and is teaching us how to more efficiently “prompt” software to get the responses we are seeking, quickly and accurately. If you can provide the system with the proper data and teach it how to decipher that dataset, the possibilities are limitless. This process has changed processes that used to be hands-on and slow-moving into ones that can executed in seconds with AI.

We continue to integrate molding machine output data with metrology part inspection data to discover correlations between molding machine outputs and quality (visually and dimensionally) of micromolded parts. AI will be utilized to better predict machine maintenance or even mold component wear as well.

Haney: AI can significantly advance both the complexity and speed of solving theoretical engineering problems by integrating real-world micromolding results with theoretical models. By using AI to analyze discrepancies between theoretical predictions and actual outcomes, we can validate or refine micromolding theories. This process helps increase the accuracy and predictability of micromolding, reducing uncertainties and accelerating development timelines for new projects. In particular, AI can be used to adjust mathematical models to better predict micromolding phenomena. This includes refining our understanding of material behavior at the micro scale, micromolding rheology, morphology, and viscoelastic properties. By leveraging AI in these areas, we can enhance the precision of our micromolding processes and improve the efficiency of development efforts.

Hahn: Enhanced analysis of data and trends benefits not only the micro molding, but the customer and patients. Isometric has world-class assembly automation that incorporates AI into our in-line part testing and optical measurements to create the highest level of confidence that parts are meeting specification. Automation is allowing us to assemble these extremely fine parts without creating damage or bioburden. It also eliminates the human factor which statistically has proven to be only 80% accurate, as well as the eliminating the need to ship parts outside of the U.S. to low-cost areas of the world for assembly.

Jimenez: AI has had a significant impact on the generative design aspect for many of our customers. AI does play a role with quality assurance; programming vision systems for defect detection, and even monitoring pressures during molding. Through various sensors, if certain parameters are not met during injection the software can isolate that part for further visual inspections such as shorts, warpage, sink, etc.

Klann: The area of AI is developing fast and will soon become prevalent in micromolding technology.

Morin: Artificial intelligence is beginning to transform micromolding, offering new opportunities for innovation and efficiency. AI-powered systems can analyze vast amounts of data from the molding process, identifying patterns and trends that may not be apparent to human operators. This enables manufacturers to optimize their processes, reduce waste, and improve the overall quality of their products. Moreover, AI can be used to predict potential issues before they arise, allowing for proactive maintenance and reducing the likelihood of production delays. As AI technology advances, its role in micromolding is likely to expand, offering even greater potential for improving precision and efficiency.

Turčinskas: We are still in the abstract use of AI for manufacturing-related operations because true micromolding is hard to simulate and is more of a niche technology. That means AI tools must be specially developed for our use. However, AI enormously helps us in management and client support. Also, our Fanuc molding and CNC machines have AI control functions that help us optimize for better precision and repeatability but these are not core changes in technology—rather, they are improvements.

Barbella: What recent innovations in micromolding and supporting technologies has your company invested in and why? What new capabilities do these advancements enable?

Cicio: We are constantly making investments in new technologies that will increase our capabilities. One example is high powered inline inspection equipment being implemented into our molding cells that do not sacrifice cycle time. Custom-designed vision systems with light filters and high-powered ring lights provide high-contrast, high-resolution images along with defect detecting software that quickly and efficiently inspects all cavities to determine pass/fail part designation, all within validated cycle times.

Hahn: Isometric Micro Molding is not a traditional molding company. We are constantly pushing the boundaries of miniaturization, micromolding, and precision assembly to support our customers. Examples include 400:1 aspect ratio thin wall molding, needles with 3-micron sharps in thermoplastics, PEEK and bioresorbables, and ±1.5 micron assembly positional accuracy. Isometric has been at the forefront of manufacturing miniaturization solutions, focusing not only on individual components but on the entire device. Our recent innovations and investments support early-stage R&D, to help overcome potential challenges quickly. Our solutions range from 3D printed components and 3D printed molds, to enhanced Design for Manufacturing (DfM) and Design for Assembly (DfA), as well as comprehensive statistical analysis and assembly stack-up for the complete device. Leveraging our extensive expertise in resins honed through the use of our proprietary micro test bars has allowed us to seamlessly integrate higher viscosity resins with our customers’ preferred part geometries. Our cutting-edge innovations also feature micro rotational platens, ultra-precise two-shot molding, and automated epoxy dispensing with an accuracy of ±1 nanoliter.

Jimenez: We have replaced several of our hydraulic press for new all-electric presses. There are several advantages to all-electric. The first being cleaner molding environment, which is significant in the medical device industry, especially if it requires cleanroom molding. They are energy efficient and the reduction in power consumption is a cost savings that can be passed over to the customer. There are also improvements with repeatability. All-electric presses will reproduce the same energy, speeds, and force each shot allowing for a tighter control and accuracy which is crucial to meet the tight tolerance demand.

Klann: We have invested in new capabilities with respect to surface modifications to molded parts.  This technology will enhance part characteristics and other part performance features. We feel these new technologies will assist customers to meet their design needs for micromolded parts.

Morin: To stay ahead in the competitive micromolding market, companies must continually invest in new technologies and capabilities. Recent innovations in micro molding have focused on improving the precision and scalability of the process, enabling the production of even smaller and more complex components. For example, advancements in micro-injection molding machines have allowed for greater control over the molding process, resulting in higher-quality parts with fewer defects. Additionally, the development of new materials, such as bioresorbable polymers, has opened up new possibilities for medical devices that can be safely absorbed by the body after use. These investments not only enhance a company’s ability to meet current market demands but also position them to take advantage of emerging trends and opportunities in the future.

Turčinskas: Since we now experience a booming market of microfluidics—LoC (lab-on-a-chip) and OoC (organ-on-a-chip)—we invest both in HR and R&D as well as hardware for bonding techniques. Clients who seek to transfer from PDMS chips to plastic and scale their production require vendors to provide full service, which includes not only molding their devices but also bonding them with films or in sandwich layers. The process is very delicate and sensitive to environmental changes. We have had some great achievements too—we successfully bonded PMMA (polymethyl methacrylate) to PMMA chips ,which is usually not an easy thing to do.