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MEPTEC& SMTA PRESENT Microelectronics Packaging & Test Engineering Council Surface Mount Technology Association A S P E C I A L T WO - D AY T E C H N I C A L S Y M P O S I U M Participating Companies: 3M Electronic Solutions Arthur Jonath Associates Dyconex AG Ito Corporation Kyzen Corporation mc10 Incorporated Medtronic Microelectronics Center PackageMate, Inc. Plexus Specialty Coating Systems St. Jude Medical Universal Instruments Corporation U.S. Army Research Laboratory Zarlink Semiconductor Inc. 2011 Medical Electronics Symposium / Day Two Vital Technologies for Health Wednesday September 28th Arizona State University • Tempe Campus • Tempe, Arizona In Association With Corporate Sponsors Association Sponsors
Transcript
Page 1: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEPTEC&SMTAPRESENTMicroelectronics Packaging & Test Engineering Council Surface Mount Technology Association

A S P E C I A L T W O - D A Y T E C H N I C A L S Y M P O S I U M

Participating Companies:

• 3M Electronic Solutions• Arthur Jonath Associates• Dyconex AG • Ito Corporation • Kyzen Corporation • mc10 Incorporated• Medtronic Microelectronics Center

• PackageMate, Inc. • Plexus• Specialty Coating Systems• St. Jude Medical• Universal Instruments Corporation • U.S. Army Research Laboratory• Zarlink Semiconductor Inc.

2011Medical ElectronicsSymposium / Day TwoVital Technologies for Health

Wednesday September 28thArizona State University • Tempe Campus • Tempe, Arizona

In Association With

Corporate Sponsors Association Sponsors

Page 2: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

DAY 2 - MORNING AGENDA

7:15 am Registration Opens 8:15 am Welcome and Introduction 8:30 am – 9:00 am Keynote: Leveraging ARL Technologies Toward High Performance

Body Sensor Networks for Soldier Healthy Stephen Kilpatrick, U.S. Army Research Laboratory

Session 5: Materials and Design at the Board and Systems Levels Session Chair: Don Banks, St. Jude Medical 9:00 am – 9:30 am Substrates for Medical Implantable Applications

Marc Hauer, Ph.D., Dyconex AG, Bassersdorf, Switzerland, an MST Company

9:30 am – 10:00 am Conformal Electronics for Natural Integration with the Human Body

Ben Schalatka, Ph.D., mc10

10:00 am – 10:30 am Emerging Materials and Miniaturization of Electronics 3M’s Long

Fine Pitch Flexible Circuits, A Novel Alternative to Stranded Cable Nate Kreutter, 3M Electronic Solutions

10:30 am – 11:00 am Break Session 6: Systems Assembly & Manufacturing Session Leader: Randy Crutchfield, Medtronic Microelectronics Center 11:00 am – 11:30 am Printed Circuit Board Design for Cleaning Medical Assemblies

Mike Bixenman, BBA, Kyzen Corporation

11:30 am – 12:00 pm Using Anisotropic Conductive Adhesives in Advanced Medical

Applications Peter J. Opdahl, Ito Corporation

12:00 pm – 12:30 pm Parylene’s Expanding Use in Emerging Technologies

Richard Molin, Specialty Coating Systems 12:30 pm – 1:30 pm Lunch

Page 3: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

DAY 2 - AFTERNOON AGENDA Session 7: Product Reliability and Testing Methodology Session Leader: Dale Lee, Plexus 1:30 pm – 2:00 pm Field Return Failure Analysis of Implantable Medical Devices

Mauri Sutton, Medtronic

2:00 pm – 2:30 pm PCB Pad Cratering: Long Term Risks for High Reliability Devices

Denis Barbini, Ph.D., Universal Instruments Corporation

2:30 pm – 3:00 pm The 8 Disciplines Problem Solving Process - Application to a

Medical Device Arthur Jonath, Ph.D. and Fred Khorasani, Ph.D., Arthur Jonath & Associates

3:00 pm – 3:30 pm Break Session 8: Medical Electronics System-Level Product Applications Session Leader: Ron Molnar, PackageMate, Inc. 3:30 pm – 4:00 pm RF Telemetry for Medical Implants

Kirk Snodgrass, Medtronic, Inc.

4:00 pm – 4:30 pm “Disappearing Die” – The TIPS project Martin McHugh, Zarlink Semiconductor

4:30 pm – 5:00 pm A 3D Body Position Tacking System with an Infrared Sensor and a

Pressure Mat Jianli Zheng, Ph.D, Medtronic

Page 4: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

KEYNOTE PRESENTATION

Leveraging ARL Technologies Toward High-Performance Body Sensor Networks for Soldier Health

Presented by

Stephen Kilpatrick, Ph.D. Senior Electronics Engineer

U.S. Army Research Laboratory

The U.S. Army Research Laboratory is the Army’s corporate laboratory, with a mission to provide the underpinning science, technology, and analysis that enable full-spectrum operations. Its Sensors and Electron Devices Directorate (SEDD), Electronics and RF Division, conducts innovative basic and applied research to provide the Army with affordable enabling technology in electronic/radio frequency (RF) sensing and advanced electronic device technologies, nanoelectronics, micro-autonomous technologies, and novel micropower. We describe plans for a new effort which seeks to leverage several of our core technologies to create novel Body Sensor Networks (BSN) which could provide a new level of health monitoring for soldiers in-training and in-theatre. While great strides have been made in developing wireless BSNs in recent years, they still generally suffer from large form factors, unsustainable power consumption for long-term applications, poor reliability and security, and body incompatibility. Future wireless BSNs for the soldier will likely need to be ultralow-power or self-powered; high-performance; autonomous; reliable; frequency adaptable; highly flexible, conformable, and stretchable where necessary; rugged; unobtrusive and noninvasive; and private and secure with efficient and robust protocols and no unwanted interferences. ARL has developed a strong portfolio of technologies in wireless RF communications, compact antennas, flexible graphene nanoelectronics, ultralow-power devices, energy harvesting and supercapacitor-based energy storage, MEMS/NEMS, and reversible adhesives, just to name a few. This endeavor combines and expands these competencies to develop novel RF sensor network technologies which meet the stringent health-monitoring needs and operational scenarios which pertain to our nation’s warfighters.

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MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Session 5

Materials and Design at the Board and Systems Levels Session Leader: Don Banks, St. Jude Medical

Materials are a key element in enabling efficient medical electronic device design, development and production. Materials utilization at the board and systems levels may be a combination of leveraging known capabilities with the specific needs of products as critical as implantable applications. Substrate, board and flex designs have gained increasingly more functionality to support applications where high density and small size are factors. The electrical, thermal and mechanical characteristics of flexible and rigid materials can allow novel applications and high reliability.

Page 6: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Session 6

Systems Assembly & Manufacturing Session Leader: Randy Crutchfield, Medtronic Microelectronics Center

The design, packaging, materials and component development efforts for medical electronics come together in system manufacturing. As miniaturization and other enabling technologies move forward, the demand for higher yields, no rework, and ever increasing quality requirements at the systems assembly level are driving improvements in Design for Manufacture and Assembly (DFMA). Incorporation of DFMA techniques complements the assembly strategy, whether captive our outsourced, and emphasizes the need for enhanced communication between design and assembly groups.

Page 7: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Session 7

Product Reliability and Testing Methodology Session Leader: Dale Lee, Plexus

Medical electronic products, diagnostics and the associated therapies, focus on medical electronic product reliability and safety is fundamental at both the corporate quality and government regulatory levels. Internet access to information and of course the media have brought the needs for product safety and reliability into the open, from sourcing of material to development and assembly testing to final product. Corporations and the consumers themselves have played an active role in monitoring and reporting product safety information, with focus also on impact to the environment. New developments in medical technology continue to raise the bar on requirements for testing, qualification and certification, with state-of-the-art technology leading the way in preparation and documentation of the newest quality and reliability standards.

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MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Session 8

Medical Electronics System-Level Product Applications Session Leader: Ron Molnar, PackageMate, Inc.

The rapidly aging population in developed countries together with the need for basic healthcare in underdeveloped countries is quickly becoming a challenge for the healthcare industry. Providing access to high quality, affordable, and accessible health care, anywhere and anytime without increasing costs is now a bigger challenge than ever. As the industry moves toward patient-focused solutions, more emphasis is being placed on home healthcare devices that are smaller, lower cost, and simpler to operate. New products thrive on convergence, connectivity, image processing, integrated services, analog and mixed signal processing, data mining, and analysis

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MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Substrates for Medical Implantable Applications Marc Hauer, Ph.D., Dyconex AG, Bassersdorf, Switzerland, an MST Company

The substrate is the backbone of an electronic medical implantable device. It has a direct impact on achievable form factors, interacts directly with the assembly process and is crucial for the performance and reliability of the device. The ideal substrate allows a direct interconnect with all components, reducing the number of interconnects and thereby improving reliability, reducing cost and minimizing volume. To achieve this goal, the substrate should be able to reach geometrically all necessary locations and should provide a versatile surface finish which is compatible with assembly processes. The substrate is a significant contributor to the volume of an electronic hybrid. Reducing the size of the substrate contributes thereby directly to the overall volume of the implant. The minimum surface area of a substrate is often driven by component requirements, which need to find a place within the electronic hybrid. A volume reduction of the substrate can thereby often occur only by decreasing the thickness of the substrate. This reduction needs to take certain electrical requirements into account, (i.e. breakdown voltage, RF performance) which may impact the choice from available materials. In many cases, the form factor of an implantable device, in combination with the number of components, does not allow for a single rigid substrate. The interconnect between different assembly surfaces can be optimized by using flexible substrates with a dedicated bend zones. These bend zones avoid the use of additional interconnects, simplifying the entire product. The vertical interconnects within a substrate are, besides the interconnections with the components on the surface, the most critical feature with regards to the overall reliability of the device. Thinner substrates shorten these vertical interconnects, which lowers mechanical stress during thermal cycling and improves the reliability of the substrate. Last, but not least, the availability of materials for implant applications is very often restricted. The use of most materials is only possible with a careful selection of suppliers with the right indemnifications in place.

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MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Conformal Electronics for Natural Integration with the Human Body

Roozbeh Ghaffari, Ph.D., mc10 mc10 develops and will describe a new generation of thin, conformal electronics technology that endures bending, twisting, and stretching without sacrificing performance. A key aspect of this technology is the ability to achieve these desirable form factors while using traditional, wafer-based, high-performance semiconductors. All dominant forms of electronics and optoelectronics exist exclusively in planar layouts on the flat surfaces of rigid, brittle semiconductor wafers or glass plates. Although these largely two dimensional (2D) configurations are well suited for many existing applications, they are intrinsically incompatible with a diverse set of envisioned systems. A prime example of this incompatibility is the class of medical devices requiring intimate contact with human tissue, as planar electronics cannot naturally conform to the soft, curvilinear surfaces of living organisms. This presentation will describe the approaches that allow for electronics to embody extreme form factors such as 400% expansion and packages that match the elastic modulus of human skin. Two specific use cases shall be explored that require these novel features. The first use case is a medical device used to treat a trial fibrillation in which electronics are embedded on the surface of a balloon catheter. This product expands up to 400% inside the heart in order to make conformal contact with the pulmonary vein and ablate the cardiac tissue. In order to ensure the surgery has been performed adequately, however, a separate catheter is currently required to measure the electrical pathways inside the heart, which leads to longer treatment times and decreases safety. mc10’s approaches allow for a single product with the necessary sensors embedded in the balloon and expanding as necessary. The second use case describes the vision of wearable devices capable of monitoring and tracking physiological parameters. “Wearable” electronics typically consist of rather cumbersome, rigid components strapped to a user; however, the ideal solution is ‘invisible’ to the wearer and does not infringe on a user’s mobility or comfort. mc10’s platform and approaches allow us to come closer to the ideal solution but challenges still exist. This use case shall describe the challenges associated with creating truly wearable electronics such as packaging, electronic design, power, and I/O.

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MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Emerging Materials and Miniaturization of Electronics 3M’s Long Fine Pitch Flexible Circuits, A Novel Alternative to Stranded Cable

Nate Kreutter, 3M Electronic Solutions Digital ultrasound imaging modalities such as Intracardiac Echocardiography (ICE) and Transesophageal Imaging have created a new challenge in microelectronic packaging. These applications are unique in that the imaging instruments must be able to navigate though an artery to the heart for (ICE) or down the esophagus as in to image the heart or digestive track. Nature’s physical constraint of the human artery has set the limit to maximum size of the catheter electrical conduit that carries the signal lines to accommodate both functions of energizing the imaging device and receiving data to create an image. Real-time imaging and diagnostics compound the challenge by increasing the number of signal lines required. Miniaturization as we know it in the electronics world takes an object like a printed circuit board reconstructs it by reducing the size of the components , routing layers or by integration of components there by reducing its size in all 3 dimensions. The unique challenge in this case is to miniaturize, by reducing the width and height of the conductors and interconnect interfaces but keep the length of the conductors sufficiently long to transverse the human body and in the ICE case that could be over 2 meters. In addition to the miniaturization challenge the catheter and its contents must be highly flexible and the conductors electrically must be easily terminated to the imaging component reliably by mass termination techniques. Also the conductors and polymer must be thin enough to allow stacking and the trace to trace pitch small enough to accommodate the large number of traces on a single plane in this construct. A key attribute that makes the application possible is a continuous non-interrupted conductor traveling from one end of the probe to the other with only junctions at each end for termination. Advancement in 3M flexible circuit manufacturing have made it possible to construct multiple strands of ultra fine pitch traces at a pitch of (50um lines and spaces) over 2 meters long with conductors less than 12um thick in copper on a 25um adhesiveness polymer base thus enabling new design options for imaging devices. 3M Flexible Circuit Foundry continues to pioneer new technologies to enable circuit designers greater design freedom and functionality.

Page 12: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Printed Circuit Board Design for Cleaning Medical Assemblies Mike Bixenman, Kyzen Corporation

Medical Electronic innovations are providing higher functionality encased in miniaturized designs. To achieve this level of functionality, bottom termination components are used to improve speed and performance. QFNs, LGAs, passives and even power components have shifted their contacts to the bottom of the package. These bottom termination components provide good electrical and thermal performance using shorter signal traces. Published research reports that reliability issues are a concern when building devices with these miniaturized components. Thermal cycling, mechanical cycling, and the potential for dendritic growth concern designers. The elimination of leads may reduce solder joint strengths. As package sizes shrink, there is also a concern with the mismatch in the coefficients of thermal expansion between the alloy, silicon, board laminate and plastic molding. Large component area, multiple I/Os, and low standoff heights can combine to trap flux under bottom termination components. There are reports that no-clean flux residues may leave behind high levels of weak organic acids above the maximum 150µg/in2. Processes using water soluble flux also raise reliability concerns due to these residues being trapped under the component gaps. The purpose of this research is to evaluate the impacts of PCB design on cleanability of the final assembly using modified board designs. Designed experiments will be used to correlate cleaning performance using an aqueous based chemical assisted cleaning process. Attendees will learn how to control the soldering process residue flow and component location to improve cleaning performance.

Page 13: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Using Anisotropic Conductive Adhesives in Advanced Medical Applications

Peter J. Opdahl, Ito Corporation Anisotropic Conductive Adhesives, or ACAs, have been a standard part of the packaging engineer’s toolkit in consumer electronics for decades. Typically used as films (ACFs), but increasingly available also as pastes (ACPs), these materials have become used in a number of medical applications such as digital X-ray amplifier packages and ultrasound imaging where a high number of I/Os and a high density interconnect is required for success. This paper will provide concrete examples of how ACAs are currently used in packages exceeding 4000 I/Os and at pitches of <0.050mm. We will use these examples to discuss the technical advantages and limitations of ACAs, including assembly yields, electrical performance, mechanical performance, and reliability considerations. We will also look at the business case for ACAs by discussing the capital investment required to implement the technology in both R&D and manufacturing settings, and the typical material and assembly costs seen when using ACAs in a production environment.

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MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Parylene’s Expanding Use in Emerging Technologies Richard Molin, Specialty Coating Systems

As great strides continue to be achieved in the pursuit of bringing life-enhancing technologies to the market, the materials of construction and their integration into such devices can largely determine the success of any given platform. Advances in medical electronics regularly challenge the capabilities of many materials, be it in terms of their mechanical, thermal, electrical or environmental protection behaviors, and while many biocompatible materials provide one or more of the desired qualities, very few can meet all target properties required. One material that often stands out among the best candidates is Parylene. Although for decades Parylene has remained a mainstay in conformal coatings for medical devices, its growing use in early stages of device development is becoming more common, providing for opportunities to be used as a bulk material as well as a protective coating. These opportunities often present themselves in new light as the result of advances made in the areas of adhesion, pattern delineation and thermal properties. Presented will be a selection of emerging medical technologies that require the desired properties of Parylene such as flexibility, biocompatibility and pattern ability. Recent advances in Parylene technology will be reviewed in light of these devices; advances that have aided in the facilitation of its selection as a key material. The technologies reviewed include retinal prostheses and biological sensors for pressure and thermal measurement. In addition, ground breaking work is underway to utilize carbon nanotube (CNT) technology, which can significantly benefit from the use of Parylene, either as a flexible substrate material, as a passivation layer for CNT active components, or as binding media for the CNT structures themselves. Parylene has provided great benefit to many medical electronic devices over the years as a thin, biocompatible, protective coating. In addition to this primary use, its employment in new and novel ways is evident in emerging device technologies, leading to the expectation that it will continue to grow as a material option to satisfy needs that few alternate materials can.

Page 15: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

Field Return Failure Analysis of Implantable Medical Devices Mauri Sutton, Medtronic

This presentation will deliver an overview of some of the requirements, techniques, and future challenges of performing failure analysis on implantable medical devices. More specifically, Implantable Pulse Generators (IPG’s), and Implantable Cardioverter Defibrillator’s (ICD’s) will be the focus. As a medical device manufacturer, we are obligated to investigate field failures and do so in a timely manner. Therefore we are tasked with root cause analysis, in the shortest amount of time which is often contradictory. One inherent challenge lies in the fact that we have to analyze failures on devices that were designed to never be opened. Oftentimes, some preliminary analysis can be accomplished without breaking the seal, but the most comprehensive analysis requires destructive measures. This introduces the risk of damaging the samples and/or having the fault clear with no ability to reintroduce the failure. With the risk in mind, mechanical and chemical deprocessing techniques are employed. These, along with state of the art technology including X-ray, photon emission microscopy, thermal emission microscopy, micro probing, acoustic microscopy, cross-sectioning, electrical testing, micro circuit editing, scanning electron microscopy, elemental analysis and others, we are often able to start with a “faulty device” and isolate a root cause to a discrete component or an Integrated Circuit (IC). Further analysis often reveals failures within the discrete components or to the sub-micron level on an IC. A needle found in a haystack. An overview and some examples of these techniques will be presented.

Page 16: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

PCB Pad Cratering: Long Term Risks for High Reliability Devices Denis Barbini, Ph.D., Universal Instruments Corporation

Solder failures alone no longer define the reliability of devices. Often the PCB itself will mechanically fail under the connecting pad, known as pad cratering, and result in a loss of device functionality. We typically blame stiffer solders due to Pb-Free implementation, but the fact is that even industries exempt from RoHS are dealing with pad cratering issues. The root cause can be traced to the PCB laminate materials which have largely transitioned to Pb-Free compatible systems. These materials have been adapted into SnPb products because they otherwise satisfy all data-sheet requirements for Tg, Dk, etc. Yet, these laminates are often weaker and more brittle than traditional materials used in historical SnPb assemblies and they cannot withstand the same levels of stress from electrical test, transportation and field stresses. Most work in understanding pad cratering has thus far focused on "catastrophic" failure, which can be defined as a complete failure in a single stress event such as a bend or drop. We use PCB strain as a metric to define limits before failure occurs. However, an even more severe risk may be associated with latent defects as a result of a manufacturing stress which causes a partial crack under the pad. These partial cracks can go largely undetected since they do not cause functional failures of the devices. Once subjected to field stresses though, these cracks can quickly propagate and result in very early failures. In high reliability, mission critical applications such as certain safety and medical devices, we must define the failure population by the early failures. Latent defects due to partial pad craters can significantly reduce the lifetime of a device, and data has shown that the acceleration factors between pristine and damaged samples do not scale. This presentation will highlight the issue of pad cratering from a latent defect perspective, and provide a mechanistic approach at assessing risk associated with various initial damage levels.

Page 17: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

The 8 Disciplines Problem Solving Process Application to a Medical Device

Arthur Jonath, Ph.D. and Fred Khorasani, Ph.D., Arthur Jonath & Associates The concept of problem solving is an old one; every one of us solves problems every day. A scientific approach to problem solving was created to deal with the complexity of problems associated with the industrial revolution. This approach was taught in some fields to researchers, scientists and engineers, but mostly had been left to individuals. A few decades ago, to increase problem solving efficiency, some companies started teaching standardized team methods to their employees. One successful problem solving methodology, the “8 Disciplines” (8D), first standardized by the U.S. Government during the manufacturing frenzy of the Second World War, gained adherents wherever multi-step manufacturing lines and product failure modes span a variety of technical expertise. The auto and semiconductor industries have long experience with 8D; practitioners in pharmaceuticals, medical devices and information technology are not far behind. There are different approaches to problem solving; which is the right one? The answer is that all successful approaches are logical, and there cannot be only one approach to solving every type of problem. When solving a particular problem, nothing should replace a person’s thinking. The solvers should be willing and able to modify methods to fit the problem at hand rather than force-feed the problem to the approach. While its genesis focused on manufacturing, it is being applied throughout the enterprise, from design to customer service and everywhere in between. The 8D Problem Solving Process is used to identify, contain, correct and eliminate problems. The method is useful in product and process improvement. We will present an overview of the 8D process, along with actual applications to an electronic pain control patch, in order to discuss the best ways to leverage its power.

Page 18: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

RF Telemetry for Medical Implants

Kirk Snodgrass, Medtronic, Inc. As electronics for medical implants get more and more capable, effective, reliable telemetry from implant-to-doctor programmer and implant-to-implant becomes ever more vital. The medical professional needs to instruct the implant and prescribe operating modes and therapies, and the implant needs to make real-time reports of its sensory findings and status. The range of this communication needs to great enough to move the programmer out of the sterile field of the operating room and yet not so far as to present a security concern for the patient. MICS and MEDS are two communications bands that have been set aside by international telecommunications regulators for medical implants. The bands are near 400 MHz, which is a good compromise for reduced rf tissue losses, and it provides bandwidth in a relatively unoccupied bit of spectrum. MICS (Medical Implant Communications System) is primarily intended for implant-to-programmer links, while MEDS (Medical Data System) adds implant-to-implant and transmit-only capability. These can be combined into "body area networks" where remote sensors can provide input to a central implant to optimize therapies, or report the progression of degenerative diseases to the medical professional for preemptive treatment.

Page 19: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH “Disappearing Die” – The TIPS project

Piers Tremlett, Zarlink Semiconductor This presentation will discuss Zarlink’s involvement in the TIPS project which has created micro electronic packages that can typically increase the density of medical sub systems by a factor of 4. The project has created ultra thin packages (ultra thinned silicon embedded in a thin substrate) and has developed the technologies for integrating these packages into a stack. The packaging has utilized various PCB and wafer scale type technologies rather than conventional IC packaging For “in or on body” medical devices, there is a strategic imperative to derive more functionality (to deliver better patient therapy) from a smaller and lighter device (more discrete and comfortable for patients). This translates into three mantras that drive the electronic design of active medical devices - miniaturization, wireless communication and low/no power requirements (as typified in recent announcements of projects that are investigating revolutionary leadless pacemakers). The TIPS program sets out to tackle the problem of miniaturization for next generation “in or on body” medical devices or sub-systems. To meet this objective, the project has produced three demonstrators: a hearing aid memory stack, an implantable radio module and an ICD sub system module. Each type of product requires high functionality in a miniaturized form.

Page 20: A SPECIAL T WO -DAY TECHNICAL SYMPOSIUM 2011meptec.org/Resources/2011 Medical Proceedings - Day Two.pdf · 2013. 3. 27. · • Arthur Jonath Associates • Dyconex AG • Ito Corporation

MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

A 3D Body Position Tacking System with an Infrared

Sensor and a Pressure Mat Jianli Zheng, Ph.D, Medtronic

3D body position tracking system is proven to be very useful in sports medicine and patient balance study. A 3D position tracking system has been demonstrated to provide 3D position data referenced to the coordinate system based on the two heel positions. A pressure mat (pressure sensor array) is used to indentify the two heel positions of the patient and establish the reference coordinate system based on the 2D pressure scan data. Reflective beads (markers) are mounted on the body locations to be tracked and an infrared 3D position sensor is used to acquire the 3D position data. The 3D data directly from the sensor output are referenced to the sensor coordinate system. To make the data independent on the sensor position, a reference tool consists 4 reflective beads with a defined geometry is used to provide a reference coordinate system. A calibration procedure is required to build the relationship between the pressure mat coordinate system and the reference coordinate system such that data can be transformed to the pressure mat coordinate system via the reference then further transformed to the heel coordinate system. Calibration is performed by first placing the reference tool at the origin of the pressure mat with axis aligned and taking the position (representing orientations) and quaternion (representing rotation) data of the reference relative to the sensor by the 3D position sensor. Without moving the sensor, the reference tool is then moved to the final fixed location and another position and quaternion data set is acquired for the reference tool. Based on the two data sets, an orthogonal rotation matrix can be established to represent relationship between the final reference coordinate system and pressure mat coordinate system. Once calibration is finished, the sensor can be freely moved such that both reference tool and tracking beads can be easily captured in the same view. Both pressure mat and 3D position sensor are interfaced with computer through USB connection with data acquisition and processing software developed in LabVIEW. With two beads mounted on the knees of the patient, the system successfully demonstrated the capability of acquiring and processing the two knee position data continuously with sampling period about 0.1 second (currently limited by the speed of the driver). With a careful calibration, the relative accuracy of the tracking data is about 1mm and absolute accuracy is about 5mm, limited by the resolution of the pressure mat. The real-time data with time stamps for each data point can be captured and stored with a defined time period for further analysis. The system is capable of tracking up to 32 markers simultaneously.

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MEDICAL ELECTRONICS SYMPOSIUM VITAL TECHNOLOGIES FOR HEALTH

BIOGRAPHIES

SYMPOSIUM CO-CHAIRS AND SESSION CHAIRS Dale Lee is a DFX Process Engineer with Plexus Corporation primarily involved with DFX analysis and definition/correlation of design, process, legislative and tooling impacts on assembly processes and manufacturing yields. Dale has been involved in surface mount design, package and process development and production for over 20 years in various technical and managerial positions. These activities have included research, development and implementation of advanced manufacturing technologies and interconnect techniques, design and development of CSP and BGA packages, PCB and PCBA support, DFX analysis of flex and rigid PCB/PCBA’s including supply chain, process qualification and new process introduction for domestic and foreign low, medium and high volume production applications. Dale is an active member of the SMTA and served on the Board of Directors. Ronald J. Molnar is currently the Executive Director of AZ Tech Direct, LLC, an electronics resource network, offering consulting services in the electronics industry. He is an industry veteran and has enjoyed a distinguished career in the fields of Optoelectronics, ASIC, Bipolar Logic & Memory, Contract IC Assembly and Test, Equipment Automation, Sales Representation, and Consulting over the last 35 years. He’s held VP of Engineering positions with Amkor Technology, Abpac, and Tiros. Mr. Molnar has traveled extensively and worked with numerous offshore IC assembly facilities and suppliers across Asia. He has been awarded 3 patents and has written many articles and technical papers. He is an active member of IEEE, IMAPS, SMTA, and MEPTEC industry groups. He received his BSEE from U.C. Berkeley in 1973. SESSION CHAIRS Randy Crutchfield received his MSEE from Arizona State University, BSEE from Northern Arizona University, and AAS from Glendale Community College. Randy has worked at McDonnell Douglas Helicopter developing engineering flight simulators, at the CalComp division of Lockheed Martin as Hardware Engineering Manager, and at Intel Corp as Staff Hardware Engineer. He has been with Medtronic since 2001 at the Tempe Campus. At Medtronic Randy is a Senior Principal Product Engineer responsible for hybrid development and product engineering for implantable medical devices. He is a member of the Medtronic Tempe Technical Guild and is a Designer for Six Sigma (DFSS) Black Belt. Randy is a holder of two patents with another three applications filed at the US Patent Office. He has published several posters within Medtronic and has also been published in the Society of Photo-Optical Instrumentation Engineers Journal. His technical affiliations include the Institute of Electrical and Electronic Engineers (IEEE) and the Surface Mount Technology Association (SMTA). Randy lives with his wife and youngest daughter in Scottsdale. He is a private pilot and enjoys flying with the Phoenix Flyers club. He also enjoys reading, running, and spending time at his cabin in northern Arizona. Donald Banks has more than 25 years experience in electronic packaging and substrate technologies at IBM, Motorola, W.L. Gore, 3M and most recently with St. Jude Medical. At St. Jude Medical in Sylmar, California, Don is a Hardware Development Manager in the company’s Cardiac Rhythm Management Division. His responsibilities include printed circuit board products and processes for hybrid microelectronic assemblies in support of the company’s pacemaker and implantable cardiac defibrillator devices. Don also participates in strategic technology, process development and cost reduction activities.

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At W.L. Gore and Associates in Eau Claire, Wisconsin, Don led assembly development and provided engineering support for flip chip and wire bond substrates. He established a microelectronics packaging laboratory to provide customers with product integrity information. His team defined fatigue failure modes and optimized design features for assembly and reliability robustness. When the Gore facility was acquired by 3M in October, 2000, Don transitioned to a technical marketing role defining new business opportunities. He also served as project manager on next-generation flip chip carrier and wafer level test board product launches. At Motorola in Austin, Texas Don was an engineering manager in a packaging process development group. Key projects included die bond, over molding, BGA ball attach, rework, and cleaning processes for wire bond and flip chip components. At IBM in Austin, Texas and in Endicott, New York, he was a technical contributor, bringing new electronic packaging technologies to IBM’s manufacturing sites and OEM customers. The group qualified IBM’s first ceramic BGA packages. Don has a BS in Metallurgical Engineering from Montana Tech and an MS in Metallurgical Engineering and Materials Science from University of Notre Dame. Over the years, Don has been an active participant in technical organizations including iNEMI, ECTC and SMTA. DAY 2 KEYNOTE SPEAKER Stephen Kilpatrick, Ph.D., is a Senior Electronics Engineer at the U.S. Army Research Laboratory in Adelphi, MD, where he is a member of the Electronics Technology Branch within the Sensors and Electron Devices Directorate (SEDD). Stephen holds a B.A. in Physics and an M.S and Ph.D. in Materials Science & Engineering. His doctoral research at Lehigh University focused on novel oxidation behavior in SiGe alloys. Prior to assuming his present position, he worked for IBM Microelectronics Division as the program manager for lead-free C4 (wafer-bumping) R&D, and helped develop several SiGe BiCMOS technologies. He has also been a researcher at the Princeton University Plasma Physics Laboratory in the areas of edge plasma diagnostics and plasma-materials interactions for nuclear fusion reactors. Since joining ARL in 2003, he has conducted research on graphene nanoelectronic devices, energy-harvesting nanostructures, and the use of carbon nanotube arrays for chemical sensing and for thermal management in high power-density electronic devices. He holds seven patents and several applications, has authored or co-authored more than 70 archival journal publications and one book chapter, and given over 60 conference presentations. PRESENTERS Denis Barbini, Ph.D., is the Director of Business Development for the Advanced Process Laboratory division of UIC. He received his doctorate in chemistry from Binghamton University. The focus of his work is the evaluation of electronics assembly materials in conjunction with emerging technologies in order to develop solutions for high yielding assembly processes and high reliability products. Mike Bixenman, DBA., is one of the joint founders and CTO of Kyzen Corporation. He is an active researcher and innovator in the precision cleaning field. Mike chaired the IPC Cleaning & Alternatives Handbook, IPC Stencil Cleaning Handbook, and two IPC/SMTA Cleaning and Conformal Coating Conferences. Mike has published over 100 technical papers and received a number of awards in his field of expertise. Mike holds four earned degrees, including a Doctorate of Business Administration from the University Of Phoenix School of Advanced Studies. Roozbeh Ghaffari, Ph.D., is co-Founder, Senior Program Manager at MC10 Inc where he is leading development of medical applications. Dr. Ghaffari holds S.B. and M.Eng. degrees in Bio-Electrical Engineering from MIT and a Ph.D. from the Harvard-MIT Division of Health Sciences and Technology. Marc Hauer, Ph.D., is R&D Manager and Engineering Manager at Dyconex. As Engineering Manager he is responsible for medical implantable and hi-reliability products. In his previous functions he was an application and product engineer. Marc holds a Ph.D. in Laser material processing from the Swiss Federal Institute of Technology in Zürich (ETH) and is the author of 18 scientific papers Arthur Jonath, Ph.D., earned BS and MS degrees in Engineering at MIT, and obtained a Ph.D. in Materials Sciences at Stanford University. He spent the first half of his career in research at the Lockheed Palo Alto Research Laboratories and as VP, Reliability & Quality Assurance for VLSI Technology. He has served as Director, CEO or Technical Advisory board member on several start-ups. In addition to his

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group consulting practice, he currently serves as interim COO and Board Member respectively on two technical start-up companies in Silicon Valley and is on the School of Engineering Advisory Board, Stanford University. Fred Khorasani, Ph.D., Principal AJA, is a management consultant and industrial statistician. He received his Ph.D. in Statistics from Kansas State University. His academic experience includes associate professor of statistics, Head of the Statistics Department and Associate Dean of the School of Mathematics and Computer Science. He followed that working in the semiconductor industry for Fairchild, Signetics and Intel. He has helped clients such as Samsung, Applied Materials, Sandia National Laboratories, Hewlett-Packard, Schlumberger and Johnson & Johnson apply his concepts in Statistical Thinking to solve a wide variety of technical and business problems. Nate Kreutter is an Advanced Product Development Specialist for 3M. Nate has worked for 3M for 27 years. He has a B.S degree in Physics. During his employment at 3M Nate spent most of his career working on various electronic Engineering projects revolving around flex circuit processes, design and application engineering. Martin McHugh is responsible for developing international multi-disciplinary collaborations focusing on the research and development of technologies that enable the next generation of small self powered medical devices. This has included Zarlink’s involvement in a number of high profile EU collaborations under the FP 6&7 programs. Martin led the successful research and design of an in-body microgenerator, which harvests energy from the heartbeat to help power implanted medical devices, other projects have focused on the development of flexible packaging techniques to support the design of less obtrusive implanted medical devices. Martin sits on the Industrial Advisory Board at Cardiff University's School of Engineering and the Advisory Board for MediWales, an industry group that represents the needs of industry to government and health authorities. Richard Molin joined Specialty Coating Systems in 2000 from the semiconductor industry, and works with internal and external customers to develop Parylene coating solutions in a variety of disciplines. He holds a B.S. in Materials Science and Engineering and an MBA in Technology Management. With 25 years of experience in product and process development, his current focus is on advanced materials and processes for Parylene technology. Peter Opdahl is President of Ito Corporation and runs Ito Group, a worldwide network of subsidiaries and partnerships that cover the major manufacturing areas of Japan, China, Southeast Asia, India, Europe, and the Americas. He spends a great deal of his time in the area of display and high-density board interconnects, specifically those that involve the use of Anisotropic Conductive Film. Beginning in 1999, Peter began running a highly successful series of Seminars on ACF design and use. The Seminar has now been given over 40 times and has graduates at companies and research institutes worldwide. Peter was raised in the United States but has now lived for fourteen years in Japan. He has a BS degree from Georgetown University in Political Science (no joke) as well as a Masters of International Business Management from the Thunderbird School of Global Management. He also spent two years at Waseda University in Tokyo on a post-graduate research fellowship given by the Japanese Ministry of Education. He speaks, reads, and writes fluent Japanese, and knows just enough Chinese to get into trouble. Kirk Snodgrass has 40 years of experience in RF design engineering. In addition to medical electronics, he has worked in avionics, radar, space borne, military, and data communications. For the past six years, he has been a Product Engineer on RF telemetry applications at Medtronic, Inc. These operate in the MICS and MEDS bands near 400 MHz. Mauri Sutton is a Senior Product Analysis Engineer at Medtronic (Tempe, Arizona Campus) working primarily in analysis of Field Returned devices including Implantable Cardioverter-Defibrillators (ICD’s) and Implantable Pulse Generators (IPG’s). After four years of service in the U.S. Navy, Mauri began his career in Microelectronics in 1993 at Motorola (Semiconductor Products Sector) and has worked for on Semiconductor and Freescale Semiconductor. His roles have included Integrated Circuit Manufacturing, Process Engineering, Yield Enhancement, and electrical and physical Failure Analysis at the IC level and system level. Mauri holds a B.S. from Arizona State University and an MBA (Technology Management) from University of Phoenix.

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Jianli Zheng, Ph.D. is a Senior Principal Test Engineer with Medtronic. He is responsible for developing test solutions for medical devices at Medtronic Tempe Campus. Prior to Medtronic, he had seven years of experience as college professor, and held various positions in industries including research scientist in the areas of fiber-optic sensors and optical spectroscopy, and design engineer for optical amplifiers in telecommunication industry. He is the co-author of two books in sensor technologies and optical measurements and has published more than 20 research papers as leading author or co-coauthor. He holds a Ph.D. degree of Electrical Engineering from Old Dominion University.

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About MEPTEC

MEPTEC (MicroElectronics Packaging and Test Engineering Council) is a trade association of semiconductor suppli-ers, manufacturers, and vendors concerned exclusively with packaging, assembly, and testing, and is committed to enhancing the competitiveness of the back-end portion of the semiconductor industry. Since its inception over 30 years ago, MEPTEC has provided a forum for semiconductor packaging and test professionals to learn and exchange ideas that relate to packaging, assembly, test and handling. Through our monthly luncheons, and one-day sympo-siums, and an Advisory Board consisting of individuals from all segments of the semiconductor industry, MEPTEC continuously strives to improve and elevate the roles of assembly and test professionals in the industry. For more information about MEPTEC events and membership visit www.meptec.org.

About SMTA

The SMTA (Surface Mount Technology Association) membership is an international network of professionals who build skills, share practical experience and develop solutions in electronic assembly technologies, including micro-systems, emerging technologies, and related business operations. For more information about SMTA events and membership visit www.smta.org.

PO Box 222, Medicine Park, OK 73557Tel: 650-714-1570 www.meptec.org

5200 Willson Road, Suite 215, Edina, MN 55424Tel: 952-920-7682

www.smta.org


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