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Exhibitor In-Booth Presentations 
Wednesday, June 12 - 9:15 am - 10:00 am and 12:00 pm - 2:00 pm  |  Thursday, June 13 - 9:15 am - 10:00 am


New for 2019 and at the suggestion of OMTEC’s Advisory Board, nine exhibiting companies have been selected to deliver a 15-minute, in-booth presentation. Your existing and potentially new partners intend to grow your knowledge and emphasize the ways in which they can help you and your company.

Wednesday, June 12


When: 9:15 am | WhereSurface Dynamics, Booth #216

Residual Powder Removal from Additively Manufactured Complex Porous Structures - A More Efficient Technology
Speaker: Mukesh Kumar, Ph.D., Global Technology Director, Surface Dynamics/Eurocoating SpA

One of the main issues related to the generation of highly intricate porous structures produced by Additive Manufacturing (AM) techniques is the proper removal of residual trapped powder – a byproduct of the manufacturing steps. The orthopedic community is well aware that the in vivo release of such fine metal powder, post implantation, will result in third-body wear, osteolysis and tissue necrosis. Among the most common cleaning methods are wet ultrasounds, air blowing, blasting, water jet and etching. All of these methods are limited in their ability to remove and quantify the powder entrapped in the complex part of the geometry.
Eurocoating has developed the XClean® procedure, a proprietary technique that allows for very fast and complete removal of semi-sintered or loosely attached metal powder by means of a mechanical agitation method, without the risk of damaging the part. Experiments have demonstrated that with the XClean® treatment, up to three times more of trapped powder can be removed compared to the well-accepted ultrasonic cleaning method. The effectiveness of this process has been verified by a pool of mechanical tests in order to demonstrate that there is not damage to treated samples. Test methods included static shear, compression, tensile and taber. This talk will compare and describe the results of such a cleaning method.


When: 9:40 am | Where: Carpenter Technology Corp., Booth #234
Quantification of Nickel-Ions released by Carpenter BioDur®-Cobalt and Stainless Alloys Under Physiologically Relevant Wear Conditions 
Speaker: Gaurav Lalwani, Applications Development Engineer - Medical, Carpenter Technology 

According to CDRH, ~12% to 15% of the general population in the U.S. is sensitive to nickel (NI), and exposure to Ni ions released from normal wear of medical implants can lead to adverse side effects. With a heightened awareness of the effects of NI toxicity in medical devices, there is a focus on quantifying the amount of Ni ions released from medically-relevant Ni-rich alloys. While there are no standards currently governing the permissible amounts of Ni in an alloy system, an FDA guidance document issued on August 18, 2015, titled “Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems,” recommends quantifying NI ion release from devices containing NI-rich alloys under physiologically relevant conditions of implant wear.

The US Pharmacopeia (USP) suggests a permissible daily exposure (PDE) for NI as a metallic impurity in drug products to be 0.5 µg/kg/day. Carpenter Technology has conducted an independent study to quantify Ni ions released from the following Cobalt based alloys: Cartech BioDur® CCM, CarTech BioDur® Low Ni-CCM, Cartech BioDur® 316LS and Cartech BioDur 108 (Low Ni Stainless). These products are extensively used in orthopedic and trauma applications. Pin-on-disc and 4-point bend testing was performed on samples with surface finish mimicking end-use medical devices using a novel test setup that allows for in vitro NI ion release measurements during mechanical loading. This type of testing closely mimics physiologic conditions and captures both the initial bolus release of NI along with longer-term NI ion release profile in vitro. Nickel ions captured in a suitable low volume reservoir are quantified using inductively coupled plasma optical emission spectrometry (ICP-OES). The results compare the potential impact of using Low-Ni variants of Cobalt based and stainless alloys versus the use of conventional products for Ni-sensitive population.


When: 9:40 am | WhereSchütte Corporation, Booth #347
Mastering the Challenges of Manufacturing Medical Components 
Speaker: Thomas Simmich, Sales and Technical Engineer, Schütte Corporation 

Manufacturing companies whose core business it is to provide the highest quality medical products such as drills, reamers, rasps, broaches and implants are facing challenges such as reducing cost and finding qualified people.

Schütte, a machine tool builder based in Cologne, Germany, has served the grinding market since 1919. The company has tailored solutions based on demands in scale of quantity of our customers and their production requirements, whether it be simple or complex drills, reamers, rasps or freeform surfaces. Schütte will perform an in-booth presentation of the latest developments in flexible part handling automation solutions combined with the specially developed SIGSpro software for medical drills, rasps and reamers. This software boasts an in-built CAD CAM functionality to create freeform surface-oriented parts such as femoral knee implants by combining grinding, milling and abrasive belting functions all in one setup. SIGSpro offers offline programming and simulation to reduce developing effort from its earliest stages of quoting and bidding on projects to optimizing applications to keep overall production cost down.

The Schütte WU335 linear grinder’s unique selling points are many, not least of which is the highly dynamic linear drive technology that is outstanding in terms of accuracy and repeatability. Schütte’s patented automatic wheel and tool magazines that change the wheel pack and coolant manifold simultaneously come in configurations of 5,12 or 24 places. There are also automatic wheel and tool measuring probes ensuring that the program starts out with accurate tool dimensions and workpiece locations. The WU335 also offers wheel dressing options to accommodate extended periods of unattended production. Another important USP is Schütte’s special support slides X1 and X2, enabling the function of both a steady rest and tailstock at once. Additionally, these X-slides act as programmable NC axes.


When: 12:40 pm | Where: In'Tech Medical, Booth #535
Innovate How You Operate with Wayvio 
Speaker: Francois Samson, Sales Engineer and Marketing Manager, In'Tech Medical 

Imagine a technology platform that turns virtually any medical device into a self-monitoring smart tool. Imagine a cost-effective and reliable way to monitor and manage your fleet of instruments within a tight regulatory framework.
In today’s supply chain, when surgical kits are deployed to the field, we too often go by the old motto that “no news is good news” and try to correlate tray rotation with implant consumption, assuming that kits are handled and manipulated within the realm of conditions they were designed to be used in. But what if the tray contains shock-sensitive devices such as navigational arrays, cameras or torque limiting devices? How about putting these devices through arbitrary recalibration cycles, simply because you don’t know how & when they're being used. Leveraging its expertise in silicone overmolding and smart design of cases & trays, In’Tech Medical finally has the solution you’ve been looking for: Wayvio®.

Thanks to the technology’s data-powered app and RFID-enabled devices, you will have the right tools in hand to keep your supply chain optimized and connected, ensuring that your medical devices are not only safe to use–but in the right place at the right time. Relying on various sensors and RFID technology, Wayvio turns virtually any medical device into a self-monitoring smart tool. From the Board Room to the Operating Room, Wayvio helps all actors within the supply chain optimize logistics, drive down cost and ultimately improve patient outcomes by providing engineering teams with dependable field data, such as sterilization or torque-click counts, for informed decision making throughout a medical device’s lifecycle. As such, Wayvio is more than just another asset management tagging solution for tracking. By “extracting” data from the field, Wayvio provides a manageable and seamless automated solution throughout the supply chain, from manufacturer to point of care.


When: 1:05 pm | Where: STERIS Applied Sterilization Technologies, Booth #823
Key Considerations in Selecting and Optimizing a Sterilization Process for Orthopedic Implants
Speaker: Betty Howard, Radiation TechTeam Manager, Steris Corporation

This presentation offers a review of the critical areas needed to develop a successful sterilization process for orthopedic implants. The discussion will focus on irradiation modalities (E beam, gamma and x-ray), including the role of material selection and product design and options for setting a dose range that assures the required Sterility Assurance Level per current AAMI/ISO standards is met during the routine production process. Additional discussion will focus on commonly used microbiology tests in dose setting and documentation of delivered dose (dosimetry) to assure that the requested dose range is delivered throughout the product load during routine production (dose mapping).

 


When: 1:30 pm | Where: Lowell, Inc., Booth #748
Matching Supplier Data with Customer Data for Inspection Reduction Initiatives

Speaker: Edward Jaeck, Vice President of Strategic Growth and Business Development, Lowell, Inc. 

Metrology-matching aligns two measurement and inspection systems with each other, and is an underused but essential process for medical device OEMs that want to master the art of supply chain management. Adopting this process can help ensure consistent product results across your suppliers, enable dock-to-stock practices and save you money.

The first step of inspection matching for OEMs is to master your internal metrology development, guaranteeing that you can measure all critical features with validated test methods. Then, you are ready to engage suppliers and share your proven test methods with them. The supplier may be able to use the test method and algorithms as they are, or may need to build a custom program to validate their measurements against yours. After testing and reviewing the data, you’ll understand where your systems align or differ, and can outline next steps to work toward the ultimate goal – having supplier data match the OEM data.


Thursday, June 13


When: 9:15 am | Where: FMI Instrumed, Booth #734
Additive Manufacturing Orthopedic Implants: How to Think about Design and Process 
Speaker: Jelle ten Kate, Msc., FMI Instrumed

Additive manufacturing (AM) has gained traction in orthopedics, so why isn’t it a plug-and-play technology yet? While AM has existed for years, mass implementation takes longer than most expect because AM requires a different approach to design and comprehensive knowledge of the entire process. This presentation will review ways that AM can add value and save time and money vs. conventional manufacturing techniques when design and process are properly planned and executed.

AM requires important design rules. The technology adds or melts layers. Therefore, there is a limit on the angle for overhanging surfaces. Engineers must think about the build orientation. In the event that large overhanging surfaces can’t be prevented, support material (SM) is needed. This material will support the layers on top of this SM and also function as a heat sink. Residual stresses occur due to rapid heating and cooling. SM can transfer this heat to the build platform and make sure that the part doesn’t deform or crack. The full AM process must be taken into account. Parts made by AM undergo more process steps than those that are traditionally manufactured. SM has to be removed, parts have to be clamped for milling and if required, marking is needed. Designing for the whole process chain has a high-added value.

Consistent part quality needs to be confirmed through validation of the whole AM process. Speeding up the implementation of AM requires more than just attention to manufacturing. The whole process chain has to be taken into account. While this way of thinking takes more time up front in the commercialization process, it allows for proper AM execution and will save time and money in the end.


When: 9:40 am | WhereFOBA Laser Marking & Engraving, Booth #827
MOSAIC™: The Fixture-less Laser Marking Technology

Speaker: Faycal Benayad-Cherif Ph.D., Business Manager Software, FOBA Laser Marking & Engraving 

FOBA MOSAIC™, a patent-pending innovation, uses a unique concept based on through-the-lens vision combined with the tiling of images. The exceptional image simulates a top-down view from inside the laser with an imaging field as large as the laser marking area. The top-down view is critical, as it eliminates perspective effects that are known to be a major source of distortion with regard to accurately laser marking medical devices. Within less than a second, instruments or implants placed under the laser marker, in any orientation or position, are marked accordingly and accurately. When marking either machine or human readable traceability contents, such as the UDI (Unique Device Identifier), medical device manufacturers benefit from this novelty: As laser marking runs practically fixture-less, there is no need for the manufacturing, the design, the production or the maintenance of industrial fixtures which translates into significant cost savings. A faster and more consistent production throughput means another contribution to efficiency and robust traceability. Parts can be marked accurately regardless of their placement under the laser. Additionally, the laser marking process is easy to set up and significantly easier to use, even for untrained operators.


When: 9:40 am | Where: CAM Bioceramics, Booth #252
Manufacturing and Chemical, Physical and Biological Characterization of Innovative CaP-Based Materials for Bone Repair

Speaker: Giuseppe Cama, Senior Scientist, CAM Bioceramics 

CAM Bioceramics is an ISO 13485:2016 Certified Dutch medical device company with more than 20 years of experience in designing, developing and manufacturing medical grade calcium phosphate (CaP) materials. R&D activities are principally focused on product design and the manufacturing process of innovative and effective solutions for bone treatment and prevention of bone infection. This 15-minute talk will present research activities related to the manufacturing of innovative calcium phosphate bone cement characterized by pores of a size suitable for vascularization and bone ingrowth. Cement formulation, manufacturing steps and chemical, physical and biological properties will be discussed together with the description of a device designed for cement component mixing and extrusion.

Furthermore, insight will be presented about recent development of micron-sized CaP particles characterized by properties tailored to be used alone or in combination with polymers for additive manufacturing. In these regards, the efforts made in order to achieve desired calcium phosphate particle features suitable for producing 3D scaffolds with a tailored geometry will be shared. The talk will underscore the critical steps for bringing the idea designed in the lab to the clinic...from a science and then from a regulatory perspective.