This presentation offers a profound exploration of Digital Anatomy Printing (DAP) and its transformative impact on orthopedic care. The narrative unfolds through the real-life experience of our Executive Vice President, Jay Dinsmore, who utilized Dinsmore’s DAP services to create and present a model of his own spine to his spinal surgeon following a car and snowboarding accident.

Introduction to DAP:

• Define and highlight the significance of DAP 
• Explore the potential for patient-specific models 

Realizing Efficiency and Cost Savings:

• Illustrate how DAP streamlines surgical planning
• Emphasize cost-effectiveness through optimized pre-surgical visualization

The Jay Dinsmore Case Study:

• Delve into Jay Dinsmore’s experience with DAP
• Showcase how DAP enhances communication between patients and surgeons

Outlining the Benefits:

• Enhanced surgical precision: DAP facilitates precise pre-operative planning.
• Improved patient communication

ADDMAN Booth #544
Speaker: Jay Dinsmore, Executive Vice President

Metal Craft innovatively combines human-centric manufacturing with automation to address workforce demand and cost reduction. Focused on low- to mid-volume production, it tackles challenges in the medical device industry, especially in orthopedic instrumentation with high-mix/low-volume demands, ushering in sustainable and efficient manufacturing. 

Utilizing a combination of standard principles and best practices, automation is expanded from high-volume production to everyday manufacturing. Through collaborative automation, we facilitate a smooth interaction between human workers and automated systems. 

Focused collaborative automation includes auto loading systems, streamlined material handling and lights-out manufacturing, enabling autonomous facility operation for peak productivity. Patent-pending processes, standardized tooling, programming templates and monitoring mechanisms simplify operations, providing workers with intuitive tools.

Metal Craft Machine & Engineering Booth #314
Speaker: Corey Fouquette, Engineering Manager

Among the various metals used for orthopedic devices, high-performance stainless steels are some of the most widely used when it comes to medical implants and surgical tools. Medical OEM design engineers select these materials for the combination of corrosion resistance, biocompatibility, and mechanical properties. However, due to developments in surgical procedures, production techniques and changing regulatory requirements, the demand for improved materials has arrived. 

In our presentation, we will discuss recent developments in: 

• Cobalt-restricted materials to support EU MDR compliance 
• Novel processing pathways and new product offerings to combat residual stresses
• A new-to-world, high strength martensitic material  
• Gold standards in high strength, biocompatible materials and the specifications
• Market expectations and what’s on the horizon of metallic medical implants and instrumentation

Carpenter Technology Booth #405
Speaker: Raymond DeFrain, Manager of Regional Metallurgy & Medical SME

This presentation aims to bridge the knowledge gap of orthopedic packaging professionals as it pertains to the Usability and Human Factors requirements of ISO 11607-1:2019. We’ll address common orthopedic packaging systems and the process of aseptic opening and transferring to a mock sterile field, as well as techniques of aseptic presentation and how a healthcare professional determines which one to use.

Learning Objectives:

• Provide attendees with real-world insights into the interaction between healthcare workers and the process of aseptic presentation of common orthopedic packaging systems through an interactive (and fun) walkthrough.
• Teach aseptic presentation techniques and terminology, and provide insights as to how a healthcare professional determines what technique to use on a particular product/packaging system.
• Call to action on incorporating usability elements into the design phase.

Packaging Compliance Labs Booth #740
Speaker: Matt TerBush, Director of Packaging Innovations

ClorDiSys’ chlorine dioxide (CD) gas is an EPA-registered sterilant that is non-carcinogenic, non-explosive and is an ambient temperature process. This presentation will cover the benefits and uses of CD. It is the sterilization method that is the closest alternative to ethylene oxide (EO) in terms of efficacy. Yet, it lacks many of the negative attributes of EO, such as its status as a carcinogen, harmful residues, and heated, lengthy process. CD gas has a yellow-green color, allowing a spectrophotometer to accurately measure concentration and provide close monitoring. Cycle times are short, ranging from four to six hours on average, from pre-conditioning through aeration. Since it is non-explosive, CD sterilization can be conducted in-house. This reduces sterilization and shipping costs, as well as overall time in the supply chain. Residuals are benign, resulting in only the ions chlorate, chlorite and chloride, commonly non-detectable. Sterilization can be completed with product in sterile barrier systems, unit cartons or shipper boxes.

ClorDiSys Booth #723
Speaker: Emily Lorcheim, Project Manager

As the global population ages, the demand for orthopedic surgery is increasing, leading to a rise in implant-associated infections. These infections pose a significant challenge, potentially resulting in complications such as revision surgery, limb amputation or patient mortality. The global surge in antimicrobial resistance (AMR) further complicates treatment with antibiotics. Therefore, there is an urgent need to explore non-antibiotic strategies to address implant-associated infections.

CAM Bioceramics is actively designing innovative antimicrobial implant materials using calcium phosphates (CaPs) within the DARTBAC project. This consortium, funded by the Dutch NOW, aims to provide effective tools to combat AMR in the healthcare sector. CAM will present the latest findings on these materials at OMTEC 2024.

CAM Bioceramics Booth #133
Speaker: Giuseppe Cama, Head of R&D

Advancements in additive manufacturing (AM) have helped expand innovation in orthopedic device design, including use of complex lattice features to further promote bone integration. In keeping pace with the increasing use of AM, FDA has requested supplementary information for 3D-printed device 510(k) submissions — data that they don’t traditionally ask for when reviewing machined products. Accordingly, anticipating regulatory considerations early in the planning process can help avoid pitfalls and maximize the potential for a streamlined project.

This presentation summarizes our experience working with FDA regarding AM orthopedic device 510(k)s, both as a consultant clearing submissions for clients and as a contract manufacturer fabricating the associated prototype, V&V and production parts. Key topics will include test sample strategies, process controls/validation and production monitoring.

SpiTrex Orthopedics Booth #341
Speaker: Jeff Brittan, Vice President of Product Realization

Trackinbox is a connected, subscription-free sterilization tray for orthopedics designed to endure extreme autoclave conditions. More than a sterilization container, this customizable solution allows medical device companies to efficiently track and account for surgical kits, addressing a major challenge in the orthopedic industry. 

Leveraging a cloud-based dashboard, Trackinbox relies on daily geolocation pings to offer asset tracking of surgical kits on the go. This enhances accountability across stakeholders, from sales reps to hospitals to ASCs. 

Facilitated by Intech’s expert tray designers, Trackinbox is crafted to store and organize your most valuable assets, ensuring that your devices are available and sterile in the O.R. when needed. Capable of withstanding sterilization cycles, it’s built for durability without recurring fees, making it a cost-effective solution.

Intech Medical Booth #605
Speaker: Francois Samson, Strategic Marketing Director

Elos Medtech’s pioneering innovation introduces surface hardening of Titanium (Ti) as a transformative solution for wear-exposed implant parts. The newly patented thermochemical process significantly enhances the durability of Ti parts of any grade and geometry, maintaining a metallic luster without a brittle surface, deformation or changes in dimensional and topographical features. Rigorous mechanical testing of wear and tribocorrosion demonstrate superior performance over CoCr alloys. This revolutionizing technology holds the potential to enhance biocompatibility and sustainability compared to conventionally used CoCr alloys, ushering in a future of novel, surface hardened and wear-resistant Ti materials.

The session introduces the innovation and shows the latest performance results of surface hardened Ti against relevant industry standards for the first time. Join us to witness the transformative advancements in orthopedics.

Elos Medtech Booth #415
Speaker: Magnus Grüner, Ph.D. Student, Elos Medtech

This presentation will review the fundamental considerations when changing from or adding technology to what is initially used in product validation, supporting the use of new technologies. With three available radiation technologies (E Beam, x-ray and gamma), it is common to look at alternative options to meet critical and growing needs in capacity, as well as which is best for individual product needs. This brief discussion will focus on changes from gamma to x-ray, why x-ray is an important tool in maintaining the need for sterilization capacity for medical devices into the future, minimum expectations in testing/assessment for a transfer of an established sterilization dose, transfer of a maximum allowable dose, and considerations of the change to a different irradiator with regard to product qualification (PQ) mapping and assessment of activation.

STERIS Booth #807
Speaker: Betty Howard, Radiation TechTeam Manager

The medical device industry is constantly examining new technologies to accomplish three primary goals: improve clinical outcomes, improve surgical techniques and lower expenses. Increasingly, the contract manufacturer drives innovation. Experienced surface technology providers are now faced with the difficult task of prioritizing these technologies. As patient populations change and potential complications become increasingly unacceptable, is it possible for surface technologies to improve? Surfaces designed to be more durable, assist with infection prevention, eliminate allergy concerns and offer improved bone growth are constantly under evaluation. Additive manufactured porous surfaces, plasma spray, bio-active nanostructures and anodized technologies all offer surgical teams great options to address clinical challenges. CMO teams must be able to design, manufacture and most importantly, offer new versions of these clinically valued products.

Lincotek Medical Booth #543
Speaker: Brandon Miller, Business Development Manager

3D-printing of bioactive ceramics like hydroxyapatite for medical devices is an exciting new technology. It can produce complex geometries that are impossible through conventional manufacturing. However, there are considerable barriers to entry. Developing prototypes or performing small-scale preliminary testing requires huge investment and specialized expertise.

To help orthopedic device manufacturers explore this new frontier of healing technologies, Himed has created a new contract research lab — the Bioceramics Center of Excellence (BCOE) — to conduct rapid R&D of calcium phosphate technology through bioink composition and material enhancements.

This presentation will highlight how the BCOE can reduce barriers for companies that are exploring bioceramic solutions like 3D printing. It covers:

• Reducing risk by outsourcing prototypes
• Material parameters to meet manufacturers’ design goals
• Iterative design and preliminary testing
• Refining process and parameters for scale-up manufacturing

Himed Booth #247
Speaker: Esther Valliant, Biomaterials Research Scientist