Medical Minitec 2018

(subject to change)


8:00 AM
Begin with Welcome, Introductions, Announcements and Review of Program and Sponsors & Exhibitors


8:30 AM
Materials for Medical Applications
Vipul Dave, Johnson & Johnson
Development of novel polymer systems has led to several innovations that have profoundly influenced the future of medicine. Polymers are widely used in many medical devices for short-term and long-term applications and the properties of these materials must be tailored for the intended use. There is always a need to modify existing materials or develop new materials to meet the challenging demands of new medical devices. The presentation will provide an overview of the selection criteria of materials that are used for medical applications, and examples will include materials that are used in cardiovascular, orthopedic, surgical and drug delivery devices.
9:00 AM
A Uniform and Unbiased Method for Testing the Chemical Resistance of Plastics in Medical Luer Connectors
Isaac Platte, Covestro
Medical Luer connector seal using the mechanical advantage of threaded collars to press a conical projection into a mating conical hole. The high hoop stresses generated can reduce the ability of plastic female to resist harsh medical liquids, such as disinfectants or drug solutions. Covestro has developed a test method proven to evaluate the chemical resistance of female Luers immersed in these liquids while being subjected to a range of sealing force. The method eliminates variability caused by Luer design or material friction and greatly reduces the number of samples required to establish a rank of chemical resistance.
9:30 AM
Product Design Differences Between Plastic and LSR
Rick Finnie, M.R. Mold & Engineering
This presentation will outline the differences in designing products for silicone injection molding vs. plastic injection molding. Learn why some design issues make a product unmanufacturable and a slight variation of the design can make all the difference.
10:00 AM
Morning break
10:30 AM
Stability of Polyurethanes in Cardiac Applications
Ajay Padsalgikar, Abbott (SJM)
Biological stability of polyurethanes is an important property for the integrity of device functionality especially for long term implantable devices. The biostability of polyurethane materials has been a subject of intense research over the years and various methodologies have been used to predict and assess this property. Accelerated in vitro testing has been used to isolate degradation mechanisms and predict clinical performance of biomaterials. However, validation that in vitro methods reproduce in vivo degradation is critical to the selection of appropriate tests. High temperature has been one of variables proposed as a method to accelerate degradation. Correlation of such data to in vivo performance is poor for polyurethanes due to the impact of temperature on microstructure. This review looks at the mechanism of polyurethane degradation and the appropriateness of different methods that have been used by researchers.
11:00 AM
Anti-counterfeiting Features in Medical Devices
Christian Herrild, Teel Plastics
Counterfeit medical devices are a major problem in some markets, especially with the rise of production and consumption in countries with historic counterfeiting issues. Counterfeit devices can damage the reputation of a medical device OEM and cause lost sales, but more critically they can be harmful to patients. While there are many technologies and techniques that can be used to help prevent counterfeiting or detect counterfeit devices, device manufacturers need an understanding of the market dynamics for counterfeit goods and the behaviors of companies making counterfeit devices to know how best to protect their products. The market dynamics for counterfeiting and some anti-counterfeiting technologies will be reviewed.
11:30 AM
Assessing Potential Health Risks of Polymers Used in Wearable Devices
“Chip” Kurt Breitenkamp, Exponent
The market for wearable medical devices continues to grow based on the introduction of fast, lightweight technology with improved ability to analyze and rapidly communicate patient vital signs and, in the future, changes in sweat and blood chemistry. One common trait of wearable devices, including wearable medical devices, is long-duration contact on the skin. Since most devices are constructed using many types of synthetic polymers, there has been increased awareness of how plastic device housings, adhesives, coatings, among other materials, may impact the user's health over time during use. In this presentation, we will discuss how analytical methods and literature-based toxicological risk assessments can be used to understand the potential toxicity of extractable and leachable compounds from wearable devices in simulated end-use scenarios. We will describe common leachable compounds we’ve identified during our testing of wearables and potential risk mitigation strategies to employ during device development.
Q & A
12:00 PM
Lunch Break


1:00 PM
Precision Compounding via Twin Screw Extruders for Medical Products
Charlie Martin, Leistritz
Developed almost 100 years ago for natural rubber/plastics applications, processes via twin screw extrusion (TSE) are used to continuously compound cutting-edge plastics formulations for medical device and drug delivery systems. There are many mixing devices, but it has become evident why TSE processing offers significant advantages as compared to other manufacturing techniques. The well-characterized nature of the TSE process lends itself to ease of scale-up and process optimization, while also affording the benefits of continuous manufacturing. A comparison of the similarities and differences for a plastics format TSE and “GMP” class configuration will be presented.
1:30 PM
Increasing Efficiency in Design and Validation of Plastic Parts Using CT Scanning
Melissa Butrie, 3D Proscan
CT scanning is being used for various industrial applications and enabling significant improvements in terms of process efficiency. It allows customers to perform defect analysis non-destructively, compare manufactured parts to CAD models or other parts, execute first article inspections and validations in less time, and reverse engineer models from legacy parts. Examples of real world scenarios, including a time and cost comparison for various dimensional inspection methods and a brief overview of the reverse engineering process, will be given. Some of the ways in which CT scanning ties into Additive Manufacturing will also be discussed.
2:00 PM
Process Monitoring and Control Systems as Basic Building Blocks for the 4th Industrial Revolution
Marcel Fenner, Priamus
The use of cavity pressure and cavity temperature signals to monitor and control the injection molding process is state of the art in the production of technically sophisticated injection molded parts. The 4th industrial revolution is opening up untold possibilities in the automation of administrative, technical and planning processes. Such control systems are an ideal source of data of the highest relevance and information density. Depending on the target to be achieved information from many different machines and devices can be collected and analyzed. Some examples are dryers, mold temperature controllers, hot runner controllers, robots, molds, injection molding machines and any other machine or devices with network capability. Specific gains of such systems can be a faster recognition of quality trends and correcting it accordingly, traceability, remote monitoring and controlling or the data is the base for better production planning.
2:30 PM
Afternoon Break
3:00 PM
Proven Methods to Reduced Process Development, Inspection & In-Process Inspection Times for Injection Molding of Medical Device Components
Suhas Kulkarni, Fimmtech
Over the last several years, the requirements for medical products has changed in two ways. First the required volume of production has increased some components and assemblies by a significant amount and second, the products have become much more complicated with tighter tolerances and requirements. All this has led to increased developmental times, increased mold cavitation, increased inspection and increased costs. Understanding the molding parameters and performing a Designed Experiment (DOE) based on the molding factors can significantly reduce times and costs for development. The talk will present proven ways with some case studies and provide a road map that one could easily implement on their next project.
3:30 PM
A New Injection Moldable, Medical Grade HMWPE for Implant Applications
Steve Kurtz, Exponent
We present the properties of a new polyolefin medical grade, GUR® 1001, which is a linear HMWPE that can be injection molded. Properties will be compared with GUR® 1020 UHMWPE. Biocompatibility data will be presented as well as an injection molding processing guideline. It will be shown that, despite its still relatively high molecular weight, injection molding of GUR®1001 can be performed without degrading the material. Resulting properties of molded parts are comparable to compression molded parts of GUR® 1001. Furthermore, e-beam irradiation at different dosages has been performed to analyze property changes. Due to its lower molecular weight, the mechanical properties of GUR® 1001 do not reach the same level of as UHMWPE, but in certain medical applications the extraordinary wear resistance and impact strength are not required to the extent UHMW-PE grades offer.
4:00 PM
3D Printed Prototype Parts out of Production Material
Kai Wender, Arburg
Rapid Prototyped parts through Freeforming capabilities with exactly the material that the part will be produced in mass production. Discussion on how this technology works and how it can help to quickly go through the Prototype stage and convert the generated information into the final product. Further we will review the capability of Freeforming and individualizing mass produced parts quickly in very unique ways.
4:30 PM
Summary, Closing Remarks
4:45 PM —
6:00 PM
Networking Reception