A Medical Device Molding Meet-Up

Medical device manufacturing requires significant precision, repeatability, and regulatory compliance, putting molding services and technology at the front of successful production operations. Manufacturers are under growing pressure to deliver high-quality components faster, more efficiently, and at greater scale. Advances in injection molding technologies, automation, cleanroom processing, tooling design, and material science are transforming how medical technologies are developed and produced, from disposable consumables to complex diagnostic and surgical devices.

To gain more insights about the trends, challenges, and innovations impacting this sector, MPO spoke to a dozen industry experts in molding services and equipment. Topics range from micro molding and multi-shot molding to validation requirements, sector growth prospects, and smart manufacturing processes. The experts draw on experience in engineering, manufacturing, quality assurance, and equipment development to discuss the technologies and strategies helping organizations to improve consistency, reduce waste, maintain compliance, and accelerate time to market.

• Jarrod Aydelott, director, global tooling and molding, Aptyx
• Travis Carter, process engineering manager, Kaysun Corp.
• David Gonzalez, VP of engineering, Cinova Medical
• Brunson Parish, director of technology development, MRPC
• Scott Herbert, founder and president, Rapidwerks
• Kevin Hutts, sales representative, Kaysun Corp.
• Simon Kassas, VP of sales, Rx, and medical device, Currier Plastics
• Lindsay Mann, director of commercial strategy, MTD Micro Molding
• Rob Morin, VP of sales and marketing, PDC
• Bob Reeves, VP of operations, Kaysun Corp.
• Michael Sanford, chief commercial officer, ANA Global
• Ray Scherer, global engineering manager, Aptyx
• Jim Schoeplein, business development manager, Broadway USA
• Michael Tucci, CEO, Micro Technologies
• Jenna Vogel, business development engineer, Kaysun Corp. 

Sam Brusco: How have expectations from medical device OEMs evolved in recent years?

David Gonzalez: Over the past several years, medical device OEM expectations have increased significantly and broadened across regulatory, operational, and technical dimensions. Heightened regulatory scrutiny, market pressures, digitalization, and disruptions to global supply chains have reshaped what OEMs require, pushing expectations well beyond traditional cost, quality, and delivery metrics.

Scott Herbert: OEMs expect a full partner vs. a vendor. They look for design for manufacturability (DFM) upfront, material selection guidance (biocompatibility and performance), and regulatory awareness (ISO 13485, traceability, validation support). There’s also a zero-defect mindset, meaning not just having quality systems but real-time quality assurance with cavity-level monitoring and SPC tied to CTQs. OEMs also look for electronic device history records (eDHR) integration.

Speed and flexibility are always key. Faster prototyping leads to bridge tooling for production. Always necessary is the ability to scale from pilot to millions without a redesign. Transparency and traceability are also important, with full lot traceability down to resin batch and cavity. OEMs also seek data access (not just reports), and cleanroom and automation as a baseline. Automation is no longer a differentiator—it’s expected.

Kevin Hutts: Medical OEMs increasingly seek suppliers that are vertically integrated. For injection molders, this true one-stop shop approach means everything from early design support (DfM analysis, tooling strategy, material selection) and automation, through value-added services like assembly, welding, heat staking, and identification and labeling. Consolidating suppliers and manufacturing steps reduces logistics and handling, lowers contamination risk, controls costs, and delivers higher quality outcomes.

Quality and regulatory requirements continue to grow around documentation, traceability, and formal process validation (IQ/OQ/PQ). Certifications like MedAccred Plastics accreditation and ISO 13485 have become meaningful differentiators in injection molding partner selection. There’s also a persistent push to accelerate timelines without sacrificing quality, whether through faster prototypes, bridge tooling and quick-turn molds, or running tooling, validation, and automation in parallel.

Simon Kassas: Expectations have evolved from a narrow focus on cost, quality, and compliance to a strategic and integrated partnership model, where key suppliers contribute across the full product lifecycle, from design and engineering through regulatory support, manufacturing, and commercialization. OEMs seek partners that bring higher levels of innovation, integration of software, connectivity, and advanced materials, while prioritizing total value and patient outcomes over simple cost reduction. OEMs’ supply chain strategies are shifting toward greater resilience and flexibility, with increased emphasis on nearshoring and risk mitigation. Regulatory requirements have become more complex and continuous, demanding proactive expertise rather than reactive compliance, while speed-to-market pressures have intensified despite growing products and regulatory complexity driving the need for agile development and specialized capabilities. In parallel, the rise of decentralized, patient-centric care models and less invasive medical and drug delivery applications is pushing OEMs to expect solutions that extend beyond traditional hospital settings. 

Lindsay Mann: Speed-to-market has always been a pressure point for medical device OEMs. That’s not new. What has changed is how customers think about achieving it.

The conversation has shifted from “Can you produce this?” to “How can we optimize this?” DFM discussions that once happened after tooling was already underway are now taking place during early-stage design reviews, where they can reduce costly iterations. Customers ask more strategic questions, including how to reduce complexity without sacrificing functionality, how to optimize cavitation and minimize material waste, and how to create a scalable path to production. That level of collaboration needs deep technical expertise and a commitment to serving as a problem-solving partner from feasibility through validated production.

Rob Morin: For years, the industry focused heavily on global supply chains optimized around labor costs, manufacturing scale, and the lowest landed cost. That model worked well when predictability and efficiency were the primary objectives. Today, however, the conversation has changed significantly.

Over the last several years, medical device OEMs have had to navigate supply chain disruptions, transportation instability, geopolitical tensions, inflationary pressures, and shifting regulatory expectations. At the same time, devices themselves have become more advanced, more compact, and more complex to manufacture. As a result, OEM expectations for molding suppliers have evolved beyond traditional measures of quality, cost, and delivery.

OEMs now seek manufacturing partners who can contribute much earlier in the development process and support programs from concept through commercialization. In many cases, molders are expected to participate in discussions on material selection, DFM reviews, automation planning, validation strategy, and long-term scalability assessments. The relationship has become far more collaborative than transactional.

One of the biggest changes is the shift toward regionally balanced supply chains. During the pandemic, many companies discovered how vulnerable highly fragmented global sourcing models could become when transportation networks slowed, borders tightened, or key suppliers experienced interruptions. Those lessons continue to influence sourcing decisions.

Brunson Parish: Medical device OEMs place a greater emphasis on early-stage collaboration than ever before. Increasingly, customers are looking to manufacturing partners not just for execution, but for engineering insight during the development phase—particularly around product design enhancements that improve manufacturability. This is where Design for Manufacturability (DFM) plays a critical role. By engaging early, we help identify potential challenges and opportunities related to material selection and process scalability before production begins. OEMs also rely more on guidance around primary materials and performance-equivalent alternatives, especially as supply chain dynamics and material availability continue to evolve. Expectations have shifted toward more strategic partnerships—where manufacturers contribute upfront expertise to improve quality, reduce risk, and accelerate time-to-market.

Michael Sanford: We see an industry shift beyond simple robotic assistance toward autonomous, closed-loop systems that use AI for real-time self-correction. The application of predictive control is providing near zero-defect repeatability essential for the medical device industry. In addition, the associated digital validation stream that comes from the application of AI closed-loop systems can provide relevant data for regulatory compliance.

Ray Scherer: OEM expectations have shifted toward speed, predictability, and earlier partnership. Molding is no longer viewed as a downstream step. Customers expect input on materials, tooling, and manufacturability much earlier to reduce risk and compress timelines.

There is also a greater demand for insight. It is not enough to meet spec. OEMs want to understand how and why a part performs, especially with complex geometries and advanced materials. That is driving more integrated approaches that combine simulation, molding, and advanced inspection to accelerate development and avoid late-stage surprises.

Jim Schoeplein: As a mold builder, and often a third‑party supplier to OEMs, we see a deliberate shift toward greater OEM technical oversight of mold design. This has driven better alignment with OEM technical expectations, while also impacting overall timelines. The intent from OEM teams is to introduce technical improvements, supported by increased awareness and deeper involvement throughout the development process.

Michael Tucci: Expectations from OEMs are being reshaped by a combination of compressed product development timelines, increasing regulatory complexity, and internal resource constraints. Simply put, OEMs are under more pressure to launch faster, with less margin for error, and fewer internal resources to manage every phase of development. As a result, they no longer have the luxury of overseeing a fragmented, disconnected, and sequential plastics development—holding their suppliers’ hands from design to tooling to production. Instead, they rely on suppliers who can take responsibility for moving programs forward quickly, taking ownership of more of the process, and getting it right the first time.

This drives earlier engagement in the development process, where suppliers are expected to contribute expertise in material selection, DFM, and prototyping to accelerate decisions and reduce iteration cycles. At the same time, there’s a clear shift toward suppliers taking greater ownership of outcomes, including tooling, process development, and full component or assembly quality—spanning everything from incoming material control to system-level validation and material transparency. In this environment, the traditional model of handing off development between multiple stakeholders is becoming a bottleneck. OEMs are increasingly looking for solutions that streamline the entire plastics lifecycle—reducing friction, compressing timelines, and improving execution.

Brusco: What recent innovations in molding technology are having the biggest impact on medical manufacturing?

Jarrod Aydelott: The biggest impact is coming from the combination of advanced materials processing and full-part inspection. We are molding more high-performance and filled materials, which enable metal-to-plastic conversion but also introduce complexity in shrink, warpage, and shape control. Moldflow allows us to predict how materials will behave, and CT scanning gives a complete, non-destructive view of the part, both internally and externally, to validate those predictions.

Instead of relying on limited data points, we can see the entire geometry and identify issues like porosity or deformation much earlier in the process. That speed to insight is what is really changing development timelines. That level of insight is especially important for components used in robotic and minimally invasive systems, where small dimensional changes can directly impact motion and overall device performance. As components get smaller and more complex, the ability to see and understand the full part early is what enables speed without sacrificing quality.

Travis Carter: AI-powered process monitoring and inspection are having the biggest impact right now. Systems like RJG CoPilot represent a meaningful leap forward, using advanced analytics and adaptive alarm bands to detect and correct process deviations in real time, helping ensure every shot meets specification. Paired with The Hub (a centralized data management platform), these technologies enable comprehensive traceability and historical data analysis that are particularly valuable for regulated medical applications.

Complementing these advancements, digital shop floor platforms such as DELMIAWorks Shopworks play a critical role in connecting people, processes, and data. By standardizing workflows, enabling real-time data capture, and providing visibility into production performance, these systems ensure that high-quality data feeds into SPC and process control strategies.

These innovations strengthen Statistical Process Control (SPC) with Cpk/Ppk analysis, giving real-time visibility into process capability and early warning of variation—critical for medical programs where consistency is non-negotiable. For medical manufacturers, the result is improved quality consistency, stronger traceability for audits and complaints, and greater production predictability.

Gonzalez: Medical molding operations increasingly leverage advanced automation and digital integration to strengthen quality, compliance, and operational resilience. This includes use of robotics to minimize human variability and contamination risk; vision‑based inspection to ensure consistent, real‑time quality assurance; automated packaging within controlled environments to safeguard product integrity; and comprehensive traceability at the lot, cavity, and timestamp level to enable rapid investigation, regulatory readiness, and lifecycle risk management.

We are actively advancing our digitalization strategy through the development of a novel, data‑driven molding platform. This system is designed to enable real‑time part quality monitoring combined with intelligent, self‑adjusting machine capabilities. By continuously analyzing process data and making automated adjustments, we aim to ensure true part‑to‑part quality repeatability, strengthen process robustness, and further reduce manufacturing risk across the product lifecycle.

Herbert: Micro molding is arguably the number one driver. Sub ±10-micron tolerances are becoming standard. It enables neurovascular, ophthalmic, and microfluidics and requires advanced tooling (micro venting, high polish) and specialized resins (COC/COP, PEEK, LCP). In-line metrology and closed-loop processing are also making an impact. It features cavity pressure and temperature sensors, real-time adjustments during the shot, and digital twins to stabilize Cp/Cpk pre-PPAP.

Overmolding and multi-material integration combine rigid and soft-touch (TPE, LSR) and drives ergonomics, patient safety, and device usability. Hybrid manufacturing is emerging, which combines injection molding and additive manufacturing for inserts, tooling, and prototyping. Smart molding features AI to optimize cycle parameters in real time, with machine vision catching defects instantly.

Kassas: Medical manufacturing is advancing rapidly, with innovations in molding technology focused on improving precision, performance, and patient adoption and safety. In response, we continue to invest in advanced capabilities to support increasingly complex and highly regulated applications. Core technologies such as medical injection molding and micro molding enable the production of highly intricate components with extremely tight tolerances, supporting the ongoing trend toward miniaturization and device complexity. In addition, over-molding and multi-material molding allow for enhanced functionality and integration, often reducing downstream assembly. Our ability to perform both injection molding and blow molding within controlled cleanroom environments further ensures the highest standards of quality, contamination control, and regulatory compliance for critical healthcare applications. Coupled with advancements in automation, process monitoring, and validation, these innovations enable greater consistency, scalability, and speed. 

Mann: The most significant shift is in metrology. The emergence of hybrid systems that combine CT, vision, CMM, and AI into a unified inspection workflow is especially impactful. MTD is the first micromolding like ours to invest in Bruker’s optical 3D metrology system, capable of nanometer-level precision. This technology enables inspection of parts smaller than 1 mm, including internal geometries, overmolded interfaces, and surface finishes, with a level of confidence that changes how design reviews, first article inspections, and validation are approached.

At the micro scale, measurement capability is essential. Without it, validation and commercialization become impossible. Advanced metrology is no longer just a quality checkpoint. It is a strategic process development tool that helps refine designs and troubleshoot assemblies earlier, when changes are easier and more cost-effective.

Morin: As device complexity continues to increase, advances in molding technology play an increasingly important role in supporting product development. Micro molding has become important as components continue to shrink in size while performance expectations increase. Many modern devices require extremely small features, thin walls, and highly repeatable tolerances that were difficult to achieve consistently only a few years ago.

Multi-material molding and liquid silicone rubber technologies allow engineers to integrate more functionality directly into molded components. Over-molding techniques are helping combine rigid and flexible materials into compact assemblies while reducing secondary operations and simplifying assembly processes.

Parish: We have extensive experience molding thermoplastics, silicone, and synthetic elastomers. As a result, a significant portion of what we manufacture involves combining these materials into a single component or assembly. Recent innovations that enable multi-material molding—such as overmolding and chemical bonding—are having a major impact by enhancing device performance while simplifying manufacturing processes. Advances in self-bonding LSRs, open-air plasma treatment, multi-material molding machines, and multi-component shuttle molding have expanded the range of possibilities, allowing manufacturers to produce increasingly complex, high-performance medical devices with greater efficiency and reliability.

Schoeplein: Recent innovations such as conformal cooling, enabled through 3D‑printed mold components, along with highly sophisticated simulation software, have significantly improved predictive deformation and dimensional analysis. In addition, the use of CT scanning and 3D color mapping has increased accuracy while reducing metrology lead times.

Tucci: The largest impact comes from the convergence of processes that were traditionally separate. Molding is no longer a standalone step—it’s becoming part of an integrated manufacturing system. Advancements in robotics and automation allow molders to add more secondary processes at the press without paying for multiple work centers. At the same time, 3D-printed steel tooling inserts have been changing product performance to enable organic pathways for cooling that’s virtually impossible to manufacture with traditional technologies. That turns into increasingly complex geometries for designers that can be molded for advanced products—at reduced costs due to accelerated cooling. We also see a shift toward enabling molded components to now encapsulate “smart-ready” features such as PCB boards and sensors, bringing a new set of challenges to over-molding. 

Brusco: What device categories are driving the most growth?

Gonzalez: Several medical device categories are driving the majority of current and near‑term market growth, reflecting shifts toward less invasive care, chronic disease management, digital health, and home‑based treatment. Based on recent market analyses and adoption trends, the following categories stand out as the most influential growth engines. The strongest growth is occurring at the intersection of miniaturization, minimally invasive care, digital connectivity, and home‑based treatment.

Herbert: Minimally invasive devices like catheters, endoscopic tools, and neurovascular devices are the largest technical drivers. These require micro features, tight tolerances, and advanced materials. Drug delivery also has a large volume with recurring revenue due to strong growth in chronic disease and home care. These include autoinjectors, pens, and wearable injectors. 

Wearables and diagnostics like biosensors, ECG monitors, and patches require overmolding, miniaturization, and aesthetic/comfort requirements. Infection control is driving demand for disposable and single-use devices like syringes, cartridges, and diagnostic consumables. Microfluidics and lab-on-chip devices are a fast-growing niche as well. They are high precision and low volume, but demonstrate high value.

Kassas: Minimally invasive solutions continue to expand as they reduce patient trauma, shorten recovery times, and lower overall healthcare costs. Drug delivery devices, including autoinjectors, on-body delivery systems, and inhalation platforms, are seeing rapid growth alongside the rise of biologics, as well as new molecule discoveries such as GLP-1 therapies and the innovatively repurposing existing molecules for safer, more effective, and less invasive patient applications. In addition, wearable and connected devices enable remote monitoring and support the shift toward decentralized, patient-centric care. Across these categories, there is increasing demand for miniaturization, precision, and integration of advanced materials and electronics. 

Mann: The growth in this area is closely tied to the rise of smart medical devices, including sensors, electronics, and implants that store data or function as surgical markers within the body. As these components become smaller and more sophisticated, protecting them without increasing device size becomes increasingly important, and over-molding proves to be an effective solution.

For many customers, the capability is still surprising. Sensitive electronics can be over-molded without damage, and the process can improve overall device functionality. Fully encapsulating substrates like PCBs, sensors, and transponders replaces manual epoxy application with a repeatable, scalable manufacturing process capable of achieving tighter tolerances and creating watertight or hermetic seals while maintaining an ultra-thin over-mold profile.

Morin: Minimally invasive and catheter-based devices remain a major area of expansion as healthcare providers continue shifting toward procedures that reduce patient recovery times and improve outcomes. Growth in robotic-assisted surgery, electrophysiology, neurovascular therapies, and advanced interventional devices is increasing demand for molded components with smaller geometries, tighter tolerances, and increasingly complex designs.

Drug delivery is also seeing significant investment. Wearable injectors, on-body delivery systems, polymer based primary containers, and connected delivery devices are all creating demand for more sophisticated molding solutions. Many of these products require a combination of precision molding, fluid management, assembly integration, and highly specialized material expertise.

Diagnostics and microfluidics also continue to grow, particularly in point-of-care applications and lab automation systems. Demand for disposable cartridges, microfluidic chips, precision plates, and optical-grade consumables has increased substantially over the last several years. These products often require high-cavitation tooling, micro molding capabilities, automated inspection systems, and extremely consistent process control.

Parish: We see strong growth in several key categories, particularly implantable drug delivery systems, blood management and filtration devices, and robotic-assisted surgical technologies.

Scherer: Minimally invasive and robotic-assisted devices are driving significant growth, along with wearables and drug delivery systems. Across all of these areas, we are seeing increasing demand for smaller, more complex components with tight tolerances.

A strong example is precision-molded gears. These are critical sub-components that enable controlled motion in robotic surgical systems, minimally invasive instruments, and wearable or drug delivery devices. Many of these applications are shifting from metal to engineered and filled polymers to reduce weight, improve manufacturability, and lower cost at scale.

What this means in practice is less margin for error. Small variations in material behavior or geometry can directly impact performance, so getting molding, tooling, and inspection right early is essential to avoid delays and ensure consistent production.

Schoeplein: The drug delivery market has experienced significant growth in recent years. The rapid expansion of GLP-1 therapies, self-injection devices, and auto-injectors have driven major capital investments and multi-million-dollar expansions within the contract manufacturing sector.

Advancements in smart glucose monitoring systems—especially those that integrate with wearable insulin pumps—have greatly improved quality of life for diabetic patients. While it is unfortunate that chronic disease and weight loss trends are major growth drivers, they have undeniably accelerated innovation and expansion across the medical OEM landscape.

Tucci: Minimally invasive devices—particularly single-use devices and consumables—are driving the most consistent growth. Moreover, we are seeing an increasing demand for “smart” devices that have embedded sensors, increased wire management, and PCB integration. These products sit at the intersection of precision, volume, and cost pressure. They require tight tolerances and repeatability but also demand aggressive pricing and rapid ramp-up. That combination is forcing a rethink of how products are designed and industrialized, with greater emphasis on integrated processes, automation, and designing for manufacturability from the outset.

Jenna Vogel: Drug delivery is driving the most significant growth, particularly autoinjectors, insulin pens, inhalers, and wearable injectors. The rising prevalence of chronic diseases combined with a broader shift toward patient self-administration and home-based care underpin the trend. Surgical and reusable device programs remain steady as well, particularly where over-molding, tight tolerances, or complex assembly are involved.

These need high precision, consistent part performance, and tight regulatory compliance, putting capable injection molders at the center of the design and manufacturing conversation.

Brusco: How are you applying automation, AI, or digital monitoring in molding processes?

Aydelott: Automation is foundational for consistency, repeatability, and cost control, especially in high-volume medical manufacturing. Increased use of press-side automation reduces labor dependency, improves consistency, and helps maintain cost competitiveness. On the digital side, we are using simulation, inspection, and AI-driven tools to create a more data-driven process. Moldflow allows us to predict material behavior and optimize tooling before we cut steel, while CT scanning gives us a complete view of the molded part to validate those predictions quickly.

We are also applying AI to help analyze and process data, standardize workflows, and accelerate decision-making, particularly in NPI. These tools improve efficiency, reduce variability in how work is executed, and help teams move faster with more consistent outcomes. Together, this combination reduces trial and error, shortens validation cycles, and helps move from design to production with greater speed and confidence.

Gonzalez: We apply automation and digital technologies pragmatically across most molding operations, not as “AI for AI’s sake,” but as targeted tools to improve process consistency, reduce scrap, and shorten validation and qualification cycles. In practice, this philosophy translates into disciplined automation, robust process monitoring, and selective use of advanced analytics where they deliver measurable, repeatable value.

Building on this foundation, we are currently advancing an AI‑based R&D initiative focused on the next generation of injection molding control. The objective of this novel technology is to develop an autonomous molding system capable of predicting potential quality deviations and automatically correcting process parameters before defects occur. By leveraging real‑time process data, historical performance trends, and advanced modeling techniques, this effort aims to move beyond reactive control toward truly predictive and preventive process management.

Herbert: Leaders are using lights-out capable cells, or close to it. They feature robotic part removal, inspection, and packaging, as well as cleanroom-integrated automation.

Kassas: We leverage automation across its manufacturing operations to ensure consistency, efficiency, and the highest levels of quality. From molding and assembly through packaging, automated systems enable repeatable, high-precision production at scale while reducing variability and improving throughput. We have implemented real-time monitoring of machine performance and critical testing equipment to provide greater visibility, control, and process reliability across operations.

Building on this foundation, we are also advancing our manufacturing capabilities utilizing an AI-driven vibration monitoring system across key equipment. This predictive technology will identify potential machines wear or failure, enabling proactive intervention before issues occur. As a result, we reduce unplanned downtime, mitigate operational risk, and ensure more consistent, uninterrupted production. 

Mann: Automation and advanced software are reshaping inspection and process control in development and production environments. Intelligent vision systems enable more effective inline inspection by identifying defects in real time, reducing variability, and accelerating data analysis without compromising accuracy.

On the CT side, modern systems combine high-performance hardware with automated measurement workflows to identify defects, evaluate internal geometries, and generate inspection reports with minimal operator involvement. As CT technology moves closer to the production floor, non-destructive validation is no longer limited to R&D. Integrating in-house CT into production transforms inspection of internal features into a repeatable process-control step rather than a specialized exercise, significantly expanding what can be achieved within the tight tolerances required for micro molding.

Morin: Automation is becoming more important throughout the industry. In many high-precision applications, automated systems are now essential for maintaining consistency and repeatability. Robotic handling, automated assembly, in-line inspection systems, and closed-loop process monitoring are becoming standard features in many advanced molding operations.

There is also growing interest in digital manufacturing tools and data-driven process monitoring. While AI is still in the early stages of adoption across much of the industry, manufacturers are beginning to use advanced analytics to improve process stability, identify maintenance issues earlier, and reduce variability. In many cases, the greatest value today comes from improved visibility into the molding process itself through cavity pressure monitoring, statistical process control, and real-time production analytics.

Parish: Our approach is centered on designing highly automated, integrated manufacturing cells from the outset. Automation not only reduces repetitive tasks and allows our team members to focus on higher-value work, but it also plays a critical role in driving consistency, quality, and scalability—especially within cleanroom environments.

We continue to invest in advanced molding cells that incorporate automation, in-line inspection, and real-time process monitoring. Today’s equipment is increasingly intelligent, enabling us to apply logic that allows systems to communicate seamlessly across the cell. Rather than operating as standalone pieces of equipment, our work cells function as connected, cross-functional systems that can self-monitor, identify variation, and make adjustments in real time. This level of integration—combined with digital monitoring and data-driven decision-making—helps improve efficiency, reduce waste, and ensure the high level of process control required for medical device manufacturing.

Sanford: We have been foot-forward in our thinking our thinking around AI. We view the accumulation of data and the leveraging of a secure environment for analysis to be our highest return area. A specific use case is the tracking of setting history and results with equipment to optimize starting parameters and reduce the change-over times (think using AI to supercharge a traditional SMED approach). The accumulation of data and knowledge within these models can help create a foundation for generating digital twins which move AI use upstream—aiding in accelerating pre-production and validation activities.

Bob Reeves: Our AI journey builds on seven years of Industry 4.0 groundwork that has touched every department in the organization. Today, we have three distinct technology tracks running in parallel, combining AI-driven process control with connected digital manufacturing systems.

The most significant is our transition to RJG CoPilot and The Hub. CoPilot is an AI-powered process monitoring system that uses adaptive alarm bands and advanced analytics to identify and correct process deviations in real time, going well beyond the capabilities of our previous eDart system. The Hub works alongside CoPilot to centralize production data, enabling real-time visibility, historical traceability, and integration with our ERP/MRP systems. We purchased our first five CoPilot systems in mid-2024, with additional units planned through 2030.

The second is intelligent monitoring built into our new granulator systems, which continuously track blade wear and performance. By leveraging data-driven insights, the system can identify early signs of degradation before it impacts regrind quality or increases energy consumption, enabling more proactive maintenance and improved process stability.

The third, and most operationally impactful for our customers, is our DELMIAWorks ShopWorks digital shop floor platform. Shopworks plays a critical role in standardizing execution and ensuring accurate, real-time data collection across our molding operations. It integrates automatic scrap entry, SPC charting, and control plan execution into a single interface, while providing operators with electronic work instructions, set-up sheets, and process logs at the point of use. By connecting shop floor activity directly to our ERP/MRP systems, Shopworks strengthens traceability, reduces manual entry errors, and provides a reliable data foundation that supports our broader AI and continuous improvement initiatives.

Schoeplein: Automation, AI, and digital monitoring are all key contributors to reduced costs, improved production speed, and greater process consistency. Human operators naturally experience variability—good days and bad days—which is simply the reality of any workforce.

Automation and AI help remove that variability by ensuring consistent execution and enabling predictive maintenance based on historical performance data. Digital monitoring allows manufacturers to identify trends and detect potential issues before they result in downtime or quality concerns, leading to more reliable and efficient operations.

Tucci: Many of the underlying technologies have existed for years but AI is beginning to fundamentally change how molding processes are understood and controlled. Advanced simulation is becoming standard but the real shift is happening through convergence of real-time sensor data, machine feedback, high-speed 3D scanning, and significantly increased data processing capabilities.

For the first time, we are approaching a state where the entire molding process—from machine behavior to full part geometry—can be monitored, analyzed, and adjusted in near real time. This moves process control from reactive to predictive, and increasingly toward autonomous optimization.

As these systems mature, we will see a step change in performance—higher consistency, faster process development, and continuous improvement happening during production, not after the fact. The trajectory is clear: a closed-loop manufacturing environment that is constantly refining itself, with variability systematically reduced at every level.

In that context, the limiting factor will increasingly shift from technology to human intervention. The opportunity—and challenge—will be designing systems where data-driven decision-making augments or replaces manual adjustments, putting us on a very real path toward near-perfect process control.