Thank you to the companies that submitted in-booth presentation abstracts. While the abstracts listed on this page were not chosen by our Advisory Board for the in-booth presentation lineup, we wanted to share their expertise and knowledge in the event that they have an answer to your needs. Their abstracts are presented below, as well as links to learn more about each company.
Additive manufacturing of titanium medical devices usually means Laser Powder Bed Fusion (L-PBF) of Ti-6Al-4V Grade 5 or Grade 23. Despite the lower strength, pure titanium (CP Ti, Commercially Pure Titanium) has some interesting properties that can be beneficial for certain applications when it is processed through additive manufacturing. A first topic that will be addressed is the required post-processing: is a heat treatment like annealing or hot isostatic pressing (HIP) required to obtain certain mechanical properties compliant with industry standards? And secondly, can the dynamic mechanical properties of pure titanium lattice structures match those of identical structures made out of Ti-6Al-4V? If you want to learn all about these unique properties and find out if L-PBF of pure titanium can be a worthy alternative for Ti-6Al-4V, or would like to understand how pure titanium can help you save production time and costs, then don’t miss this presentation.
Nitinol is a shape memory alloy used in medical applications: cardio or cerebrovascular stents, staples, instruments, etc. It can either present a shape memory effect (SME) activated by temperature, or a superelastic effect (SE) with recoverable strains about 10x higher than conventional alloys. These specific properties are useful to insert and deploy devices during surgery and to provide an active function to the implant.
Conventional shaping of Nitinol is tricky, as it is hard to machine. The achievable geometries are thus derived from tubes, wires or sheets, limiting its extensive use. These limitations can be overcome with 3D printing, allowing geometric complexity and mass customization. Nonetheless, laser powder-bed fusion of Nitinol is challenging as the alloy is prone to cracking, oxidation and SME behavior shift. This presentation reviews a study in which the process was optimized along with post-processing to obtain functional 4D Nitinol staples. A promising perspective for innovative 4D devices.
Simply meeting the ASTM requirements of a coating is like saying that a car “meets” the minimum crash test requirements. Does that give you the confidence to drive that car?
Mechanical requirements of a hip implant are not the same as the knee, shoulder, etc. Understanding the anatomical performance requirements and the ability to optimize the coating design will change an implant from “meeting” the requirements to “best in class” performance, both at the time of surgery and throughout the critical healing period.
Learn from Ph.D. coating scientists about the performance requirements of each major anatomical area and the important design and process factors that will optimize the coating performance for the specific implant application.
The use of adhesives is rising as chemists develop adhesives that adhere better to a wider variety of substrates, cure in less rigorous conditions, resist higher temperatures, show longer pot lives and provide improved durability. Using adhesives requires securing the bonded components during the curing phase, usually under pressure. Adhesive users face the challenge of removing excess cured adhesive from metal bonding or holding fixtures used to apply this pressure. The excess adhesive on bonding fixtures can limit fixture life and introduce potential variations into the bonding process. Removing excess adhesive helps ensure optimal, consistent outcomes. Reliability is even more vital in performance-critical bonding scenarios, such as structural performance or regulated medical devices requiring process validation. Scott Schewe from EP Biotech, a well-known medical device materials expert, will present his findings in evaluating durable release coating options.
Final cleaning and packaging are gaining more importance. OEMs have recognized that older machines cannot fulfill the new FDA and EU MDR regulations. Specific parts made in additive manufacturing, holes and cannulas need new technologies such as vacuum-pulse pressure cleaning. Learn about the need for and role of future-oriented turnkey cleaning solutions, including cleanroom and packaging systems.
Drag finishing and robotic grinding and polishing were the predominant finishing processes for joint replacement implants over the last decade, and have replaced most manual finishing. Implant manufacturers are keen to reduce per-piece cost and labor, and deliver absolute process repeatability.
Drag finishing technology has evolved as a surface finishing solution, significantly reducing processing time. Integration of robotics allows for targeted treatment of specific areas of an implant. Automation eliminates labor and delivers highly repeatable output. Intelligent process controls and monitoring systems track data, analyze process parameters and guide the operators and supervisors to take action before the process or the equipment fails.
You will gain a basic understanding of the technologies and their application for the finishing of joint replacement implants. Learn how to improve product quality, reduce process costs, reduce reliance on labor and capture process knowledge.
Wool felt is highly effective for the mechanical polishing of hard materials, and has been revered by experts for centuries. Wool felt is used for polishing medical devices in the form of polishing pads, wheels, belts and bobs (mandrel-mounted rotary tools).
FDA suggests that materials used in the manufacturing of medical devices should not contain animal-derived ingredients. Wool can be used with documentation of risk mitigation, but wool is an animal-derived material, and polishing involves contact with the device.
Spartan developed and patented synthetic fiber media products that exceed the capabilities of wool felt and do not contain animal-derived ingredients. Tools made with HP (High Performance) media finish metals faster and more accurately, saving time. Impregnation of abrasives such as diamond eliminates the need and mess of bar compounds — polishing processes are cleaner, and automation is much simpler. FDA’s position and Spartan’s ADI-free HP media and Durotex will be presented.
The sacroiliac joint (SIJ) is a diarthrodial joint comprising the sacrum and the ilium and serves multiple functions. The SIJ functions as the anatomic pathway to join the spine to the pelvis, and aids in transmitting the vertical forces from the spine to the pelvis and lower extremities. An overview of SIJ biomechanics will be presented to better understand the complex forces and kinematics of the SIJ. Additionally, critical evaluation of fixation systems for long-term stabilization and fusion of the degenerative SIJ is crucial to ensure that the implant systems are safe and provide the necessary integrity to achieve fusion and improved patient outcomes. Therefore, knowledge of the SIJ biomechanics combined with an understanding of the benefits and risks with fixation systems used for SIJ stabilization can provide insight into the development of viable and clinically relevant test strategies for the evaluation of implant integrity.
Companies worldwide face a potential challenge to manage complaints and report adverse events to the respective health agencies, like FDA and EU MDR, electronically. They must constantly adhere to the changes in regulations, pull all the information related to the adverse event that may reside in the enterprise systems, such as PLM, ERP, CRM etc., and validate the inputs before submission. Sconce’s ThingWorx Regulatory Hub App helps companies report the adverse events to health agencies by seamlessly integrating with PLM systems such as Windchill and other enterprise systems as required. The App also tracks the submission process until the acknowledgments are received to close the process loop. The GUI is user-friendly and will be regularly updated to keep on track with the regulatory changes mandated by health agencies. Since the application seamlessly integrates with enterprise systems, manual inputs can be reduced, saving end-users time and increasing reporting accuracy.
For decades, the orthopedic industry has been trying to reduce the cost of inventory (estimated to be 8% of revenues) through better forecasting and management. There is now a way to reduce that cost by 75% or more.
The solution involves a suite of technologies that enable the cost-effective manufacture of a set of implants that are size-specific to the patient and delivered within the surgery scheduling window. This approach benefits all stakeholders: the surgeon and care facility gain efficiency through reduced inventory management and needed storage space; the OEM can reduce the amount and cost of inventory placed in the field, and their sales representatives can reduce the time spent on non-productive logistics tasks.
The SITES Medical and Mach Medical presentation will cover details regarding the technologies involved, additional details of the stakeholder benefits, including estimates of cost savings and implementation strategies.