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Texture Analysis
Conference in August
sandvik.com/medical
Sandvik medical manufacturing facilities deliver millions of components every year.
In the production of orthopedic implants and instruments, you want to be sure to get to market rapidly and efficiently with an innovative product. As one of the largest manufacturers in the field, and a world leader in machining, cutting tools and new materials development, Sandvik can give you greater competitiveness. We have an extensive range of capabilities including materials development, machining, investment casting, forging, powder technology and
surface modifications. We will support you to add value to your product, identify the optimum method of manufacture as well as customize machining and tooling programs. Represented in more than 130 countries, Sandvik has a proven record in supporting medical device manufacturers in meeting key commer- cial objectives with our advanced materials science, rapid prototyping and manufacturing efficiency. We work in focused teams drawing on global resources and can respond to the urgent need for a quick turnaround, equally meeting the demands of a worldwide launch.
Editorial Staff Eileen De Guire
Editor eileen.deguire@
Joanne Miller Production Manager
asminternational.org
Carolina, Chair
Ray Harshbarger Walter Reed Army Medical Center
Sebastien Henry Porex
endorsement of any of the publication’s content.
Sales Staff Kelly Thomas, CEM.CMP
National Account Manager Materials Park, Ohio
tel: 440/338-1733 e-mail: kelly.thomas@ asminternational.org
ADVANCED MATERIALS & PROCESSES/JULY 2009 37
JULY 2009
On the Cover Jarvik Heart is developing a scaled-down version of the Jarvik 2000 left-ventricular assist device, specialized for use in young children, with the support of a $5 million grant from the National Institutes of Health (NIH). At about the size of a AA battery, the pump will be used to treat children as young as three to five years. A tinier model — about half that size — will be developed for newborns and infants. For more information: www.jarvikheart.com
A publication of ASM International 9639 Kinsman Road
Materials Park, OH 44073 Tel: 440/338-5151; Fax: 440/338-4634
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pediatric Jarvik heart
burnishing
in August
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Where’s the News? The dilemma – How relevant is the news section in a quarterly publication?
Some of the best news stories could be as old as 3 months, and by the time they are published they are more history than news. The solution – ASM has developed two outlets for distributing relevant news in a timely manner.
The MPMD eNewsletter began publishing in January 2009. To receive this free electronic newsletter, visit http://asm.asminternational.org/asm/n.asp. ASM is also very pleased to offer daily news via our website Newswire. ASM editors cull the news daily and choose the most important materials news stories for your industry.
The MPMD Newswire can be viewed at the ASM MPMD Resource page at http://asmcommunity.asminternational.org/portal/site/www/MPMD/. Let us know what you think!
Wire-cut electric discharge machining provides the precision machining and surface finish required to fabricate bearings for a pediatric heart pump device.
Harry Moser GF AgieCharmilles Lincolnshire, Ill.
For manufacturers of sensitive, life-saving medical devices, the easiest means of production is rarely possible. Jarvik Heart, Inc. (New York, N.Y.), for example, pursues the best solution for
fabrication, which lead to the recent installation of a GF AgieCharmilles wire electric discharge machining (EDM) unit for manufacture of components for its pediatric ventricular assist device.
Dr. Robert Jarvik possesses over thirty years of experience in the field of medical device design and production. Working with a team of researchers at the Univer- sity of Utah in the 1970’s, he developed the Jarvik-7, the world’s first total artificial heart designed to provide life- long support. Since 1987, he has continued his efforts to develop devices for people with severe heart failure at a facility occupying four floors of a building in Manhattan.
In April 2004, Jarvik Heart was awarded a $5 million contract from the National Institutes of Health (NIH). The goal was to develop a miniaturized version of the highly successful Jarvik 2000 VAD (Ventricular Assist De- vice) for use in children and infants with congenital heart defects. At present, children with such conditions face extremely dire odds.
There is a cumulative 50% mortality rate for the multiple operations necessary in the first two years of life for children with some of the more serious heart defects. After that, only one in ten children receive a donor heart. Additionally, those lucky few may spend years waiting, with a reduced quality of life due to liver damage, fluid build-up in the abdomen and other associated complica- tions. The development of a permanent VAD will have tremendously positive effects on these children born with the cards stacked against them.
For nearly four years, Dr. Jarvik and his team worked to reduce the size of the Jarvik 2000 to the point where it would be suitable for pediatric use. Unfortunately, small designs lead to a host of problems.
“We found that we could not just shrink the existing design,” says Dr. Jarvik. “With a smaller pump, we con- tinually had problems with thrombus (clot) formation within the device. This was a severe problem, as it would eventually lead to premature pump failure. A small thrombus would form around the bearings and cause enough friction to stop the rotor from spinning. The tiny motors don’t have enough torque to overcome this binding force.”
Late in 2007, Dr. Jarvik made a breakthrough in the de-
sign of a pediatric VAD that involved a redesign of the bearings used in the pump. Mathematical modeling and prototype testing suggested that the solution had been found, and the question became how best to machine the component. The machining task would require several sharp angles, and levels of accuracy and surface finish exceeding the capabilities of Jarvik Heart’s existing equipment. Because of the VDM’s size and other requirements, the part needed to be machined on a wire EDM.
After investigation and tests with several EDM manufacturers, Jarvik Heart chose the AC Classic V2 from GF AgieCharmilles. The machine features the IPG-V gener- ator that increases pulses’ shape factor while shortening the pulse duration, allowing it to obtain high accuracy and surface finish. These areas are also bolstered by the machine’s unique toroids that activate during taper cutting, which increases the wire tensile force.
“The AC Classic V2 delivered the precision and surface finish demanded by the part,” says Dr. Jarvik. “We have to hold steep angles within a 0.016º tolerance, while having the machine provide surface finish of around 0.15 μm. It’s a demanding application and we couldn’t do it without the innovations found in GF AgieCharmilles’ wire EDM.”
While developed for infants, the new design has potential ramifications for all those who suffer from life threatening heart disease. To be effective, the pediatric VAD needed to be able to increase its output to match the growing body of its host. In an infant, it would require operation at 20,000 rpm to achieve the necessary blood
38 ADVANCED MATERIALS & PROCESSES/JULY 2009
2 Electric Discharge Machining of Pediatric Heart Pump
APPLICATION NOTE
www.HeraeusMedicalComponents.com
flow. As that child grows, the pump’s rpm increases to drive a greater amount of blood. Initial evaluation of the new design indicates that the pump is capable of maintaining 70,000 rpm, pumping enough blood for an adult. Due to its much smaller size, the new pump could considerably reduce the risks and com- plexity of the surgery necessary to implant a VAD.
“The new model holds tremendous promise,” says Dr. Jarvik. “The fit of the bearings is so perfect that the amplitude of radial vibrations possible is on the order of 10 to 20 millionths of an inch. When the pump is running at 70,000 rpm underwater, it is nearly silent and you can hold it and feel practically no vibration.”
The pediatric VAD will soon be used in its first animal implants followed by a long period of clinical trials. As with all medical devices, full acceptance and in- tegration of the product will be a lengthy process due to regulatory hurdles.
“Each improvement to the design of a VAD becomes somewhat more difficult,” explains Dr. Jarvik. “Once we had a device that proved effective for two years, people then wanted one that would last for five. Once we cleared that hurdle, people wanted one that would last for ten. And once one model receives those results, the regulatory bodies want every model to achieve those results. In effect, each success we achieve lengthens the time it will take to develop our next improvement.”
EDM basics The electric discharge machining
process involves submerging two con- ductive materials (the electrode and the workpiece) in an insulating liquid, and connecting them to a current source that is switched on and off. When the current is switched on, an electric voltage builds
between the two parts; when the parts are brought together, the voltage is dis- charged and a spark jumps across. Where it strikes, the metal is heated and melts. Many such sparks spray non-simultaneously, one after the other, and gradually shape the desired form in the piece of metal. Several hundred thousand such sparks must fly per second for efficient EDM. The electrode wire can be inclined, thus making it possible to make parts with a taper or with different profiles at the top and bottom. The wire is usually made of brass or stratified copper, and has a diameter between 0.02 and 0.33 mm.
There are two EDM processes, die- sinking EDM and wire-cut EDM. In the case of die-sinking EDM, the desired shape is formed in the workpiece with a three-dimensional electrode. The wire- cut EDM system, such as that used to fabricate the Jarvik VAD, cuts the metal with a special metal wire electrode that travels along a pre-programmed path. By changing the movements of the upper and lower wire guides, angled or conical surfaces can be produced to the highest accuracy and with the finest surface finish.
Modern EDM equipment is character- ized by high cutting speeds, highly efficient automation, and interlinking and storage of very long and recurring machining cycles. And thanks to electronic monitoring and fully automated correc- tion of the EDM process, no supervision is required. The process lends itself well to fabrication of components with tight dimensional tolerances and low surface roughness. MPMD
For more information: Harry Moser, GF AgieCharmilles, 560 Bond Street; Lincolnshire, IL, 60069; tel.: 847-726-2 975; [email protected]; www.agiecharmilles.com.
Jarvik Heart relies on the AC Classic V2 to hold steep angles within a 0.016º tolerance while maintaining surface quality and accuracy.
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Texture analysis to quantify properties such as firmness, adhesiveness, cohesiveness, tackiness, swelling/absorption, and more complements traditional mechanical testing for characterization of medical devices.
Angele Sjong, Ph.D. Sjong Consulting LLC Boulder, Colorado
Texture analysis, which has long been used by the pharmaceutical, food and cosmetic industries, is increasingly used to evaluate properties of medical devices. Texture analysis refers
to properties such as firmness, adhesiveness, cohesiveness, tackiness, swelling/absorption, in addition to relaxation behavior, fatigue, and brittleness. For many of these tests, standard methods lag behind product development. Regulatory agencies including the FDA have used the TA.XTPlus Texture Analyzer to evaluate medical devices. In addition, the patent literature increasingly relies on texture analysis to validate claims.
In this article, Marc Johnson from Texture Technolo- gies is interviewed and discusses the TA.XTPlus Texture Analyzer developed by Stable Micro Systems. In its most basic configuration, the instrument, with load cells ranging between 750 g and 50 kg, resembles the common low-force tensile tester. The range of tests that the instrument can conduct with relatively short set-up times is markedly different in part because of the flexible software. Mr. Johnson describes how the TA.XTPlus is used in the medical device industry as well as how other industries, such cosmetic and food, have used the instrument over the years.
AS: What can a person do with this instrument that they cannot do with common low-force testing equipment? MJ: Two major differences are the flexibility of the instrument and the ease with which it can be programmed to test the custom attributes companies design into their products. The same instrument can be used in compression or tension, for very small or very large test distances, and for extremely small or high forces. The instrument’s flexibility makes it equally suited for testing fibers that are only 50 microns thick to metered dose inhalers to device keypads and switches.
Instrument purchases are allocated in budgets for specific research problems, however, once those problems are solved, what becomes of the instrument? Problems evolve, and test instruments need to evolve as well. For example, a lab may have eight or nine people using the instrument to evaluate a variety of properties such as fracture behavior, tack, relaxation, snapping, long-term fatigue, etc. In today’s economy clients appreciate instruments that can accomplish a wide variety of testing objectives; flexible programmability allows an instrument to be used for many purposes.
The crosshead of the Texture Analyzer moves up and down in 1 micron increments, a very precise resolution. A typical increment for other instruments is in the 2.5 - 10 micron range. The instrument can accommodate relatively fast (40 mm sec-1) or slow (0.01 mm sec-1) crosshead speeds. Variable crosshead speeds at small increments is important for adhesive evaluations. For example, at slow speeds polymer chains can be disentangled rather than ruptured, so it excellent for measuring creep and shear properties of adhesives or gel coatings.
Most laboratories that purchase a texture analyzer already have mechanical testing instruments such as In- strons for running standardized tests. The texture analyzer complements those standard instruments’ capabilities because it is designed to test custom attributes for which standards typically do not exist. For measurements conducted per ASTM methods, the standard instruments are very good.
AS: How is the TA.XTPlus used in the medical device industry? MJ: It’s a pretty broad range, depending on the medical device, which can have both active and passive functions. The TA.XTPlus is very commonly used to test membranes and switches, where force/distance/time measurements can be correlated with voltage. For example, many foams and gaskets have impedance characteristics.
For gel coatings that cure on stents, the cohesion/adhesion and friction properties are measured with the TA.XTPlus instrument. The force required to pull a coating off the substrate can be measured. We do a lot of
Texture Analysis of Medical Devices
The instrument set up for a gel burst test. The inset shows the gel’s deformation during the test.
6 testing with films and microspheres. Measuring the resilience of a gel bead is very relevant to drug-coated stents (see Figure 2). A lot of catheter[Ref. 1] and stent tests including friction, shear, tack, peel, and deflection are done with our instrument. The instrument can even be programmed to apply forces comparable to blood pressure, comparable to a heart pump. Researchers can change testing parameters to mimic high/low blood pressure and heart rate changes, and blood clot and coagulation tests (adhesion/cohesion) can be conducted.
For cyclic testing of active implants such as di- aphragms, pumps, and switches, it may not be desirable to collect force and distance data for all 50,000 cycles. The data acquisition feature can easily be turned off for selected intervals. For example, we conducted fatigue tests in a water bath on a tooth implant post and cap. In 1.5 hours we were able to bond and debond the implant 14,400 cycles.
Another example of a difficult test that is well-suited to a texture analyzer is measuring the adhesion of a very specific, narrow (1 mm) concentric drug-delivery component in a transdermal patch with many other concentric adhesive, drug-delivery sections.
AS: Many companies already have peel testers. For standard peel tests, aren’t these sufficient? MJ: For measuring peel strength, the standard peel testers work well. However, the peel testers do not work as well when the quality of the peel is important. For example, a highly jagged peel force-distance curve is an indication of poor peel quality. The quality of peel is very important for a number of industries including medical devices.
AS: For what type of tests does the FDA use the TA.XTPlus Texture Analyzer? MJ: The FDA has the instrument in several of their labs including its Division of Pharmaceutical Analysis. They use it to conduct independent standard and non-standard testing on a variety of products, and to verify measurements provided by companies. The FDA has published papers using data for the metered dose inhaler generated with the TA.XTPlus, and it has used it to create tests for evaluating transdermal drug deliver systems.
AS: When buying a texture analyzer for medical device testing, what are the key considerations? MJ: The biggest one is how limited are the expected uses going to be? If you have three shifts per day of peel tests, and only peel tests, you may not need the instrument’s flexibility, although the durability may be attractive. The instrument is very rugged, which adds to the initial cost (approximately $25,000, including software and training), however, for many of our customers, the ruggedness of the instrument is well worth the price. On the other hand, one of the highest costs associated with a new instrument is training, and any instrument needs to be both easy to learn and flexible enough for a wide range of potential applications. That is where SMS’ intuitive Exponent software pays off. It is so easy to learn that training costs are nominal at best.
AS: Out of curiosity, what is the difference between mechanical testing a potato chip and a french fry? MJ: There are no standards for these types of food texture tests. The main question is, how does the customer perceive value and is your product worth the value? With
many foods such as potato chips and french fries, customers have very strong expectations. One of the challenges of the food industry is to test the product consis- tent with the consumer’s experience of the product. For example, if the product is cut with the teeth, the test is different than that for a product that is chewed like meat where there is compression and springback to consider. In the case of potato chips, crispiness is measured on the first bite and crunchiness is measured on the second bite. Does it emit sound and how much? Crispiness is a simple puncture test and evaluation of the slope of the force. Consumers have an extraordinary ability to distinguish between degrees of crispiness because they can discern very fine differences in stiffness. Consumers instinctively know the rate of increase of force very well. However, they are not as sensitive to the magnitude of force.
French fries are much more difficult to test than potato chips since they are not at equilibrium when they are eaten. There is only a 4-5 minutes window when they are eaten, and the starches change dramatically over time, affecting properties. There is always a broad distribution of texture in the batch arising from differences in starch content, position in the fryer (oil content), etc. The chal- lenge is testing enough french fries in a time-tempera- ture window that correlates with a precise consumer judg- ment. We can simultaneously measure sound and track it with force and distance. For french fries, we use a puncture probe and not a three-point bend test.
In the cosmetics world, consumers have a very fine ability to discern tackiness. So you’re really measuring cohesive force. We can quantify the relative amounts of adhesive/cohesive failure. MPMD
Reference 1. D.S. Jones, C.P. Garvin, S.P. Gorman, Relationship between biomedical catheter surface properties and lu- bricity as determined using texture analysis and multiple regression analysis. Biomaterials, 25, p. 1421-1428, 2004.
For more information: Angele Sjong, Sjong Consulting LLC, PMB #324, 2525 Arapahoe Ave., Ste. E4, Boulder, CO, 80302; tel.: 650/799-4170; [email protected].
Marc Johnson, Texture Technologies Corp., 6 Patton Drive, Hamilton, MA, 01982; tel.: 978/468-9969; marcj@ texturetechnologies.com; www.texturetechnologies.com.
Fig. 2 — Typical exponent curve produced from the measuring the resilience of a polymer gel bead.
Doug Hornbach* Lambda Technologies Cincinnati, Ohio
Low plasticity burnishing is a surface enhancement method that produces a deep layer of compressive residual stress with
minimal cold working. It is a flexible process, capable of being implemented with a wide variety of CNC machine tools. The benefits of compressive residual stresses to boost fatigue strength in metallic components have long been recognized. Achieving deep compression with low cold work reduces relaxation of the protective compressive layer either thermally during exposures at service temperatures, or mechanically due to overload or impact.
This article describes how the technology can be applied to improve fatigue life of implanted total hip prosthesis systems.
Hip implants Implanted total hip prosthesis (THP)
systems are subjected to a spectrum of cyclic loading from normal day-to-day activities. Chances of high cycle fatigue failure increase with patient size and level of activity.
Modular THP construction has be- come more widely applied because it gives the surgeon the opportunity to in- teroperatively choose the proper size prosthesis, and offers flexibility in treating a wide spectrum of hip defects and patient anatomies. Modular systems are typically held together by means of a tapered interlock.
However, fretting can take place along the contact of the taper junction because of small displacements between the two connected subcomponents. Surface micro-cracks from fretting damage can cause a significant reduction to the high cycle fatigue strength of the THP.
To counter this possibility and raise fatigue strength, low plasticity burnishing can be applied. A product-specific LPB process was developed and applied to the modular neck taper junction of a Ti- *Member of ASM International
6Al-4V THP, as shown in Fig. 1. LPB produced a compressive residual stress field with an improved surface finish. High- cycle-fatigue tests demonstrated com- plete elimination of fretting fatigue failures in the processed area of the taper junction, as well as a substantial increase in overall THP fatigue strength.
The design of the compressive residual stress field of the hip stem was based on finite element modeling. The model served to estimate both the in-service applied stresses and the LPB residual stresses in the neck stem segment.
To test the design, forces were applied to the femoral head to simulate the loads sustained during fatigue testing. Residual stress results measured by X-ray diffraction on LPB processed neck segments were then placed in the FE model to accurately simulate the compression imparted by the LPB process.
High cycle fatigue tests were performed on untreatedand LPB treated neck segments in accordance with ISO standards 7206-4 and 7206-8. LPB improved the fatigue strength of the hip stem greater than 40% and increased the life by over 100X. The LPB process com- pletely eliminated fatigue failures from the treated neck taper region. MPMD
For more information: Karen Buffington, Lambda Technologies Inc., 5521 Fair Lane, Cincinnati, OH 45227; 513/561- 0883; [email protected]; www.lambdatechs.com.
Low-plasticity burnishing improves fatigue strength
Area pprotected wwith low pplasticity
burnishing ((LPB)
Fig. 1 — This diagram shows a THP titanium neck segment, metaphyseal (cut away), and femoral stem.
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his year’s conference and exposition continue the traditions of excellence and innovation in presenting the state-of-the-art in biomaterials science and engineering for medical devices used to repair, replace, and regenerate tissues and structures of the human body.
Organized by recognized leaders in the ma-
terials for medical devices field, the three day event offers eleven sessions, a plenary program with two keynote speakers, a poster session, and ample time for networking.
Registration is open! Advance discounts apply through July 10. Website: www.asminternational.org/meddevices
MPMD 2009: Materials Innovations for Medical Devices
“MPMD ’09 is sure to provide
excellent opportunities to
healthcare delivery.”
SPECIAL EVENTS Keynote Addresses - Monday Poster Session - Tuesday
TECHNICAL SESSIONS Bioactive/Biomimetric Surface and Drug Delivery Systems / Surface Engineering of Medical Devices
Biostability and Biocompatibility of Medical Devices
Corrosion, Fatigue and Durability of Medical Devices
Effect of Materials on Treatment and Surgical Techniques
Fabrication Processes for Medical Devices
Materials R&D
Materials R&D/Fabrication
EXPOSITION August 11-12
Visit the expo floor to speak with vendors about the latest in materials and processing technologies
available in the market.
Full expo details: www.asminternational.org/meddevices
Booth Company
313 Admedes Schuessler 301 Anomet Products, Inc. 213 Aspen Research Corporation 105 ATI (Allegheny Technologies, Inc.) 105 ATI Allegheny Ludlum 105 ATI Allvac 105 ATI Engineered Products 105 ATI Wah Chang 209 Carpenter Technology Corporation 204 Ensinger 207 GeoCorp Inc. 109 Heracus Medical Components 101 IMR Test Labs 113 Materials Evaluation and Engineering, Inc. 201 Minitubes 205 Proto Mfg. Inc.
PLENARY PROGRAM KEYNOTE SPEAKERS
Robert S. Schwartz, M.D. The Biocompatibility of Intravascular Devices –
The New Paradigm
Wear and Corrosion Products In Tissues From Failed Metal-On-Metal Total Hips
Dr. Patricia A. Campbell, Orthopaedic Hospital / UCLA, Los Angeles, CA; Fabrizio Billi, Orthopaedic Hospital / UCLA, Los Angeles, CA; and Battenberg Andrew, Or- thopaedic Hospital / UCLA, Los Angeles, CA
The Effects of Heat Treatment, Surface Condition and Strain On Nickel-Leaching Rates and Corrosion Performance In Nitinol Wires
Dr. Audrey A. Fasching, Memry Corporation, Bethel, CT; Esra Kus, Exponent, Menlo Park, CA; and Bradley A. James, Exponent, Menlo Park, CA
Considerations in the Design of Modular Neck Femoral Implants
Mr. Justin Hertzler, Zimmer, Inc, Warsaw, IN and Steven Humphrey, Zimmer, Inc, Warsaw, IN
Simulated Tissue-Implant Interaction In a Minimally Invasive Mitral Valve Repair Procedure
Dr. Milton DeHarrera Edwards, Lifesciences LLC, Irvine, CA and Dr. Wei Sun, University of Connecticut, Storrs, CT
An Introduction to a New Family of Palladium Based Medical Alloys
Dr. Peter M. Hale, Deringer-Ney Inc., Bloomfield, CT; Dr. Edward F. Smith, Deringer-Ney Inc., Bloomfield, CT; and Mr. Arthur S. Klein, Deringer-Ney Inc., Bloomfield, CT
The Physical Properties of a Novel Porous Titanium In-growth Material
Dr. Naomi Murray Stryker, Orthopaedics, Mahwah, NJ; G. Kulesha, Stryker Orthopaedics, Mahwah, NJ; J. Muth
Stryker Orthopaedics, Mahwah, NJ; C. Ngo, Stryker Orthopaedics, Mahwah, NJ; and S. Murray, Stryker Orthopaedics, Mahwah, NJ
Outcomes In the Treatment of Benign Bone Lesions Using An Engineered Bioceramic
Dr. Steven Gitelis, Rush University Medical Center, Chicago, IL
Strength and Fatigue Improvement of Metastable Beta Titanium Alloys by Boron Additions and Equal Channel Angular Extrusion Processing
Prof. Shankar Sastry, Washington Uni- versity, St. Louis, MO and Gian A. Colombo, Washington University, St. Louis, MO
Characterization of ASTM F2066 Grade Alpha Plus Beta Ti-15Molybdenum
Mr. Scott Williamson, University of Mis- sissippi Medical Center, Jackson, MS; Dr. David J. Bryan, ATI Allvac, Monroe, NC; Michael Roach, University of Mississippi Medical Center, Jackson, MS; Lyle Zardiackas, University of Mississippi Medical Center, Jackson, MS; and Mr. Howard Freese, ATI Allvac, Monroe, NC
“Our technical program will bring together diverse researchers with the common goal of understanding the materials and clinical effects on the performance of new and current medical devices.” Jeremy L. Gilbert, Ph.D. Program Chair
SELECTED PRESENTATIONS A brief selection of the talks that will be presented at the conference:
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AUGUST 8 – SUNDAY Drug Delivery Technology Jim Arps, Ph.D., SurModics, Inc. and Klaus Wormuth, Ph.D., SurModics, Inc.
This course discusses the material issues involved in localized drug delivery from implantable devices. Medical Device Design Validation and Failure Analysis Brad James, Ph.D., P.E., Exponent Failure Analysis Assoc.
Fracture, fatigue, stress analysis, and corrosion design validation approaches are examined, and real-world medical device design validations are reviewed. Nitinol for Medical Devices Alan Pelton, Ph.D., Nitinol Devices and Components
Nitinol’s unique properties are very dependent upon alloy composition and processing. In this course, you will learn what affects Nitinol’s properties, how to control them, and how its unique properties can be applied in medical devices.
AUGUST 9 – SUNDAY Biological Testing Methods for Combination Devices Nicholas P. Ziats, Ph.D., Case Western Reserve University
This course provides an overview of analyses of ex- plants, tests and assays that can be performed when evaluating functional requirements for advanced medical devices, including combination devices.
Biomedical Microdevices: An Introduction to BioMEMS Colin K. Drummond, Ph.D., Case Western Reserve University
This one-day course will provide an overview of Bio- MEMS technology and the principal engineering, materials, and clinical challenges in BioMEMS development today. Stainless Steels, Cobalt-Chrome and Titanium Alloys for Medical Devices Phillip J. Andersen, Ph.D., Andersen Metallurgical LLC
The class provides a broad background into key as- pects of the properties of these alloys, their mechanical properties and corrosion behavior. Methods used to pro- duce these materials are discussed and the relationship between processing choices and resultant properties are presented. Characterization of Medical Device Materials with Atomic Force and Confocal Raman Microscopies Greg Haugstad, Ph.D., University of Minnesota and Jinping Dong, Ph.D., University of Minnesota
This short course introduces two powerful analytical techniques that are increasingly applied to biomedical materials characterization over spatial scales ranging from hundreds of microns to nanometers: atomic force microscopy (AFM, and related methods) and confocal Raman microscopy (CRM).
ONSITE PRE-CONFERENCE COURSES Extend your knowledge and attend MPMD Education Short Courses.
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xMechanical
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17025:2005(E)
Conference & Exposition August 8-12, 2009 Hilton Minneapolis – Minneapolis MN USA MPMD is the only medical devices conference that brings together materials scientists and engineers, metallurgists, product designers, researchers and clinicians. From cardiovascular, neurological and pulmonary devices to orthopaedics and dental appliances – we’ve got the technical programming to help prepare you to lead the industry in innovation.
Keynotes:
Robert S. Schwartz, MD Minneapolis Heart Institute Foundation The Biocompatibility of Intravascular Devices –The New Paradigm
Featured Technical Sessions: • Corrosion, Fatigue and Durability
of Medical Devices • Nanotechnology • Materials R&D • Effects of Materials on Surgical
Techniques • Modeling • Regulatory Affairs Relative to
Materials • Biostability and Biocompatibility
of Medical Devices • Fabrication
Make the most of the conference and register for a pre-conference seminar.
Exposition: August 11 11 a.m. - 7 p.m. Networking lunch on the show floor
Evening networking reception August 12 9 a.m. - Noon
Plan now to be a part of the expo.
Contact [email protected] or 440.338.1733 to reserve your exhibit, advertising or sponsorship.
Get the industry information you need to lead the industry in innovation. Register for MPMD today at www.asminternational.org/meddevices.
Group Discounts Available!
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