In-Booth Presentations & Honorable Mentions

Custom Automation & Workholding for Scalable Medical Device Manufacturing

Ahaus Tool & Engineering – Booth 755

Medical device manufacturers face growing pressure to increase throughput, maintain tight tolerances and reduce reliance on manual labor while ensuring precision, consistency, and compliance with strict regulatory standards. In regulated environments, automation paired with validated fixturing improves traceability and process control. Modular and flexible fixturing solutions also allow manufacturers to adapt quickly to design changes and low-to-medium production volumes common in medical manufacturing. Overall, fixturing and automation increase production efficiency, enhance product quality, and reduce operator dependency.

This presentation explores how custom automation and CNC workholding can be designed together to support scalable medical device manufacturing. Attendees will learn how integrated fixturing, palletization, and automation strategies enable unattended machining, improve consistency, and deliver measurable returns through higher spindle utilization, reduced downtime, and predictable output.

Accelerate Launches & Minimize Costs: Manufacturer of Record & Kitting

Avalign Technologies, Inc. – Booth 847

For OEMs who manage multiple projects with limited internal resources, outsourcing can help balance workloads and allow internal teams to focus on strategic priorities. A reliable CDMO partner can function as an extension of your organization, enabling OEMs to commercialize more programs without adding internal resources. 

When serving as the Manufacturer of Record (MoR), Avalign Technologies assumes responsibility for design, development, and regulatory compliance, utilizing customer design inputs. Combined with outsourced kitting, this approach can reduce duplicate inspections, improve working capital efficiency, enable more projects, and relieve constrained engineering and operations resources. 

Attendees will learn practical ROI considerations and lessons from real programs. As a trusted CDMO, Avalign can manufacture, source, kit, and hold complete instrument sets, enabling inventory flexibility and a scalable one-stop supplier model that supports faster, more predictable launches.  

Security You Can Prove: Reducing Risk in Medical Device Innovation

DornerWorks, LLC – Booth 1312

Medical devices are more connected, software-driven, and exposed than ever, with risks of failure, breaches, and unintended behavior rising. As attack surfaces grow, traditional “patch-and-protect” approaches to safety and cybersecurity are falling short. A new generation of provably correct system architectures embeds safety and security into the foundation of device operation, ensuring systems behave as intended under fault or attack.  

By leveraging formally verified components and memory-safe software practices, organizations can achieve guarantees of correct behavior, including robust process isolation and elimination of entire classes of software defects. Beyond stronger security, these approaches reduce maintenance burden by minimizing latent bugs and simplifying updates over the device lifecycle. This session explores how provable security reduces development risk, accelerates time to market, lowers long-term cost, and increases confidence in next-generation medical systems. 

VitaGlass™ Bioactive Glass Ceramic: A Next-Generation Bioactive Coating

DSM-Firmenich Biomedical – Booth 900

As orthopedic OEMs expand cementless fixation into more complex patient populations, implant surface performance must support reliable fixation and early healing without compromising manufacturability. VitaGlass™ Bioactive Glass Ceramic is designed to accelerate mineralization, enhance wettability, and add protective potential to cementless arthroplasty.1 

VitaGlass™ demonstrates full surface mineralization in 24 hours1, one week faster than hydroxyapatite, while retaining proven bioactivity and antimicrobial potential, even after post-processing above 500°C2. The material is fully compatible with plasma spray and blend formulations, enabling integration into established coating workflows. 

This presentation will explore osteostimulation for faster, stronger healing, manufacturing readiness, and scalability considerations, helping OEMs unlock new markets and expand their portfolio with breakthrough technology—because everyday counts when healing begins.1,2 

1,2 Data on file 

Microbiology as a Competitive Advantage in Accelerating MedTech

EXALTA – Booth 1221

Microbiology sits at the intersection of patient safety, regulatory rigor, and time-to-market. As FDA expectations evolve and EU-MDR requirements intensify, the way that microbiology is integrated into product development directly shapes launch timelines, regulatory confidence, and commercialization outcomes. 

This session explores how treating microbiology as an integrated development discipline — embedded alongside product development, regulatory, and manufacturing — can materially accelerate medtech programs without compromising safety or compliance. Dr. Dan Hickey will share how in-house microbiology expertise, supported by ISO 17025-accredited capabilities and real-world MDR manufacturing experience, enables earlier insight, tighter development loops, and stronger regulatory readiness, helping medical device companies bring breakthrough innovations to market on compressed, more predictable timelines. 

Straight Annealed Nitinol Bar–Considerations & Applications for Orthopedics 

Fort Wayne Metals – Booth 725

Nitinol was first discovered in 1959 in the Naval Ordinance Lab in White Oak, Maryland. Since that time its use has continued to grow, and today it is widely used in neuro and cardiovascular applications for its unique superelastic and shape memory properties. However, this alloy has seen more limited use in the orthopedic setting. This presentation will provide an overview of nitinol’s unique properties with a special focus on straight annealed nitinol bar and some common applications for this product form in orthopedics today. It will detail important parameters for specifying nitinol for your projects, common test methodologies, and the design window they enable. Fort Wayne Metals capabilities relating to nitinol bar will also be shared. 

Techniques to Enhance the Bioactivity of Polyetheretherketone

Himed – Booth 522

Polyetheretherketone (PEEK) is a thermoplastic polymer that is appealing for biomedical orthopedic applications due to its bone-like mechanical properties, chemical stability, and radiolucency. However, its practical use is significantly limited by its hydrophobic nature and inability to integrate directly with bone tissue. 

In this presentation, I will address how to overcome functional barriers by reviewing the significant benefits of PEEK in orthopedic applications involving hard tissue. Additionally, I will explore techniques aimed to enhance biocompatibility to ensure optimal device performance via: 

• Modifying the surface texture 

• Applying a bioactive surface coating of hydroxyapatite 

• Incorporating bioactive materials into PEEK to create a composite material

This overview presentation is designed for OEMs engaged in the design of orthopedic devices, encompassing personnel from purchasing, quality, operations, and executive levels. 

A Fresh Approach to Ordering Prototype Complex Instruments

Hipp & Son – Booth 1347

Hipp & Son’s Online Configurator is making it faster, clearer, and far less resource-intensive for developers or sourcing experts to order complex instrument prototypes.

Instead of lengthy email chains and manual RFQs, users follow a guided process: register, upload a complete assembly, select material, lead time, and finishing—and receive an instant, automatic quote. That means quicker feasibility checks, faster internal approvals, and a reliable basis for budgeting from the start. 

The real customer value is predictability and risk reduction. Once the order is placed, Hipp & Son takes over the critical execution steps—adapting the data set for metal 3D printing and handling manufacturing and post-processing (e.g., grinding, hardening, assembly, finishing, labeling). Customers get a finished prototype designed to “get the maximum out of your design,” without coordinating multiple suppliers. 

State-of-the-Art Precision with Fiber Laser Cutting Technology

Instrumental Machine and Development – Booth 1151

Instrumental Machine and Development is a contract manufacturer based in Warsaw, Indiana, specializing in orthopedic instrumentation for OEMs in the orthopedic industry. As the 2025 Kosciusko County Business of the Year, our company is recognized for its commitment to quality, reliability, and on-time delivery.  

Instrumental Machine and Development helps solve manufacturing challenges by providing precise, efficient production solutions that meet the demanding standards of the orthopedic market. With one of the few state-of-the-art laser cutting machines in our region and a wide range of in-house capabilities, from prototyping through large-scale production runs, the company offers flexibility, speed, and consistency. By combining advanced technology with hands-on expertise, Instrumental Machine and Development serves as a trusted manufacturing partner for orthopedic innovators. 

Black by Design: Biocompatible Additive Manufacturing for Single-Use Devices

Lifestyle Medical – Additive Division – Booth 1309

Single-use orthopedic instruments are increasingly adopted to reduce reprocessing burden and streamline logistics. Many polymer additive solutions rely on post-build dye steps to achieve black coloration, adding cost, variability, and risk. This session explores how intrinsically black, biocompatible ALM PA950HD enables stronger design-for-additive strategies for disposable orthopedic instruments. By integrating color at the material level, manufacturers eliminate dye steps, reduce variability, and improve consistency. Drawing from real-world orthopedic experience, we will cover material selection, design considerations, regulatory implications, and efficiencies gained by simplifying post-processing. Attendees will compare undyed Nylon 12 parts, dyed Nylon 12 parts, and vapor-smoothed PA950HD components to evaluate finish, feel, and consistency. OEMs will leave with guidance for simplifying manufacturing while maintaining performance and compliance. 

Bridging Prototype to Production with Fast, Flexible Manufacturing

Lifestyle Medical – Manufacturing Division – Booth 1309

Medical device teams must move fast without compromising quality. Whether supporting early innovators or established OEMs launching line extensions, the challenge is the same: deliver human-use devices quickly and correctly. 

This presentation outlines a manufacturing model built to bridge the gap between prototyping and high-volume production. Lifestyle Medical Manufacturing delivers two-week lead times, efficient small-batch builds, and early Design for Manufacturability collaboration to maintain momentum through pilot, clinical, and early commercialization phases. By avoiding oversized commitments and long queues, teams can build tens to hundreds of units at full medical quality standards. With dedicated capacity, streamlined workflows, and experienced machinists, speed and quality coexist. The result: fewer surprises, fewer deviations, and devices built right the first time. 

Patient-Specific Implants Overcoming the Complexity of Custom Manufacturing 

Mikron Corp. Monroe – Booth 1310

The rise of patient-specific implants (PSIs) is transforming medical device manufacturing, replacing standardized solutions with anatomically precise designs that improve fit, recovery, and outcomes. However, customization introduces significant production complexity.  

PSIs require high-precision machining of difficult materials such as Grade 5 titanium and cobalt-chrome, often featuring intricate geometries and organic shapes produced in “batch size one” environments. 

Success demands flexible manufacturing cells, advanced CAD/CAM integration to convert imaging data into toolpaths, specialized tooling for abrasive alloys, and stable, validated processes that ensure quality and cost efficiency. 

As personalized care expands, the convergence of surgical data, digital engineering, and precision machining becomes essential to scaling patient-specific solutions. 

Beyond the eQMS: The Rise of Audit Intelligence

Monica Burt and Associates, LLC – Booth 710

For decades, the medical device industry has digitized everything—except for the audit. We moved SOPs to the cloud, yet our most critical risk-sensing mechanism remains analog: one human, one checklist, one subjective opinion. This creates an “Intelligence Gap.” Your eQMS stores data but doesn’t understand it. It cannot read thousands of pages of supplier documentation to predict risk or normalize findings across global sites. 

In this session, Monica Burt introduces Audit Intelligence—the next evolution of quality. Unlike tools that simply digitize the clipboard, Audit Intelligence uses NLP to ingest and analyze unstructured quality data at scale. 

Attendees will learn: 

• The Evolution: Why the “Digital Checklist” was only a half-step
• The Mechanics: How AI maps text to ISO 13485 clauses toidentifyrisk without bias 
• The New Standard: Moving from reactive auditing to predictive monitoring

Join us to see why the future isn’t gathering more data—it’s understanding the data you already have 

Predicting Disruption: Using Audit Intelligence to Secure Your Supply Chain

Monica Burt and Associates, LLC – Booth 710

For a Supply Chain Leader, a quality finding isn’t just a compliance issue—it is the leading indicator of a future backorder. Yet, most supply chain teams have zero visibility into this data until the line goes down. 

We rely on snapshot audits conducted once every two years, leaving us blind to vendor health for the other 729 days. In a fragile global market, this lack of visibility is a strategic vulnerability. 

Audit Intelligence bridges the gap between Quality and Supply Chain. By using AI to continuously analyze supplier documentation, we turn static audit reports into dynamic risk signals. 

In this session, we will cover: 

• The “Precursor Signals”: How to spot the early warning signs of vendor failure months before a shipment is missed
• Vendor Risk Management 2.0: Moving from “annual assessments” to “continuous monitoring” without adding headcount
• The Data Bridge: How to finally integrate quality data into your supply chain planning

Stop reacting to disruptions. Start predicting. 

Automated Grinding and Polishing of Hip Implants and Medical Drills

Monnier + Zahner – Booth 960

As endoprosthesis implants continue to increase quality of life and biomedical material technologies advance, so must the manufacturing processes. A new level of quality is possible with Monnier + Zahner model M682 modular grinding and polishing machine. This machine gives ultimate control of force, time, temperature, position, or any combination thereof. Equally impressive is the Model M683, our third generation of rotary transfer grinding machine for medical drills and other round tools. This innovative machine uses 20+ CNC axes to index parts through five stations, each working simultaneously to grind critical features. This new offering increases flexibility and size of drill that can be run with cycle times that are 1/5th of the traditional grinding machine. Both machines have been designed around automation, which can be expanded to include AGV / AMR for maximum autonomy. 

UHMWPE Crosslinking Optimization in E-beam by Virtual Dose Mapping

NextBeam – Booth 1061

Electron beam crosslinking of UHMWPE has advantages in terms of processing speed, economics, and less time spent in an ozone-rich oxidizing environment, with the main challenge being uniformity of dose distribution throughout the material compared to X-ray or gamma.  

This presentation describes dose distribution studies performed with RayXpert virtual dose mapping software, physical dosimetry, and trans-vinyl index (TVI) to optimize the dose distribution of common rectangular and round geometries of UHMWPE in electron beam. 

A Playbook for Post-Acquisition Sourcing Efficiency

Paperless Parts – Booth 621

M&A is often justified by efficiency. But for sourcing teams, acquisitions can initially create the opposite: more parts, more systems, more RFQ pathways, and a larger, more fragmented supplier base. That complexity often shows up downstream as duplicated RFQs, inconsistent requirements, supplier fatigue, and missed opportunities to leverage the combined portfolio. In this talk, learn a pragmatic framework for finding sourcing synergies after an acquisition.  

How can you create a consolidated view of the combined product portfolio? What’s the best way to standardize RFQ intake? How can you more intentionally route work to the right suppliers based on capability, capacity, and performance? You’ll also see how Paperless Parts helps OEMs operationalize this approach to reduce noise for suppliers and accelerate quoting while improving control and consistency. 

Understanding a Medical Device Cyber Attack: An Inside Look

Plante Moran – 318

Manufacturing companies face a unique cybersecurity threat landscape due to the convergence of modern enterprise networks and connected OT (Operational Technology) and IoT (Internet of Things) devices, such as medical devices. This convergence expands the attack surface and allows cyber incidents to move from network systems into production environments and devices, potentially causing downtime or safety risks. 

Attackers rarely focus on a medical device alone. Instead, they take advantage of weaknesses in the surrounding hospital or manufacturing environment, such as poor network segmentation, legacy systems, weak credentials, or insecure remote access. Once inside the environment, they may monitor activity, disrupt operations, or compromise device behavior and data. This session illustrates a typical attack path and highlights the types of vulnerabilities that can be exploited to demonstrate the associated risks, as well as best practices to mitigate these risks. 

Replace PFAS in Your Sealing Stack While You Still Control the Timeline

Precision Associates, Inc. – Booth 529

Per and polyfluoroalkyl substances (PFAS) are built into countless orthopedic and medical device gaskets, seals and O-rings, and the rules around them are tightening fast. As PFAS come under pressure, reliable replacements must be found without sacrificing performance. This session, led by Brad Kadue, President of Precision Associates, a leading American manufacturer of high performance custom rubber sealing solutions, links global PFAS regulation with credible paths forward for medical device designers and materials teams.  

Using real sealing configurations, Brad will map upcoming restrictions to specific materials, show which PFAS-containing elastomers are most exposed, and where PFAS-free solutions can work. Attendees will leave with a practical framework connecting regulation timelines, material selection, validation processes, and documentation opportunities so that they can plan future designs with confidence, streamline requalification, manage cost, and avoid future disruption. 

Solar Atmospheres: Precision Vacuum Heat Treating for the Medical Industry

Solar Atmospheres – Booth 429

Solar Atmospheres is a quality-driven commercial heat treater specializing in vacuum processing that produces clean, bright components with minimal distortion—performance characteristics critical to medical applications. With more than 40 years of experience, Solar has earned numerous corporate prime approvals by consistently meeting stringent quality and compliance requirements. Many medical processing standards originate from the aerospace industry, where Solar has maintained long-standing compliance and technical expertise. 

Medical manufacturing presents complex material challenges, and Solar Atmospheres delivers engineered solutions through advanced vacuum heat treating. Our capabilities support a wide range of medical components, including stents, catheterization wires, implantable electrical stimulation devices, joint implants, and other critical hardware. Solar Atmospheres continues to support the evolving demands of the medical device industry. 

X-Ray as a Complement or Alternative Technology for Med Device Manufacturing

STERIS AST – Booth 117

Ionizing Radiation, such as gamma, electron beam and X-ray, is globally recognized for its use for terminal sterilization and modification of materials in healthcare products. This presentation will review key considerations for transitioning between photon technologies commonly used in orthopedics. It will cover associated benefits, risk assessment requirements, and recent advances reflected in ISO 11137-1:2025 and AAMI TIR 17:2024 that support technology change. The presentation will also highlight recent expansions in U.S. processing capacity, demonstrating how photon technologies can complement existing operations and strengthen long-term business continuity planning 

Development of High Strength, High Ductility Cobalt Chrome Bar

Zapp Precision Metals – Booth 1338

Spinal rod systems require materials that combine high strength with exceptional ductility to enable forming while maintaining mechanical integrity. Zapp has developed an advanced manufacturing process to produce high-elongation cobalt–chromium (CoCr) bar, in a warm-worked condition that possesses mechanical properties that are specifically optimized for spinal rod applications. Through a closely controlled warm-working process, Zapp is capable of producing 3.0 mm – 6.0 mm diameter, ASTM F1537 Alloy 1 bar with elongation values greater than 25%, significantly exceeding typical elongation values of warm-worked CoCr bar. This unique balance of properties delivers superb formability without compromising mechanical strength. The enhanced ductility also reduces the risk of metallurgical compromise during fabrication and end use. The specially developed CoCr bar meets the demanding requirements of the ASTM, ISO and UNS standards while providing a robust material solution for next-generation spinal fixation systems requiring both strength and ductility.