As of 7/28/15 Listed alphabetically by last name Heterogeneous Integration of Isotachophoresis on a Bioflexible Electronic Device

types of capacitor construction and effects on power loss and power dissipation. Outline ways to manage power loss, with emphasis on the capacitors Equivalent Series Resistance (ESR). Review the key elements for modeling the capacitor by applying S2P files for impedance calculations. Substrate Technology Enabling The Next Generation Implantable Devices Marc Hauer, Dyconex AG Today, the substrate is the electronic backbone of an electronic medical implantable device. It provides the electrical connection between the different components and acts, in many cases, also as a mechanical carrier. Flexible substrates have demonstrated the support for miniaturization of implantable electronic devices by simplifying interconnects, improving the reliability of the overall system and providing direct access to the different connection planes (i.e. battery, feedthrough ...) inside a device. The available interconnect density of the substrate has been increased to a level where the size of the electronic module is primarily driven by the size of components, electrical requirements (i.e. cross talk, HF requirements, resistivity, ..) and manufacturing process limitations. To support the integration needed for the next generation’s substrates more functionality can be transferred into the packages which reduces the floor space on the substrate and thereby reduces the overall size. Another concept could be the integration of a higher functionality into the substrate. Embedding of components has demonstrated to be a valid option. This option has the drawback that a higher complexity and higher added values are introduced in an early stage of the manufacturing process. Both factors tend to increase the overall manufacturing cost of a device. An alternative concept for flexible substrates to support the miniaturization of devices is being used by other size driven markets. Here ultradense packages are built using flip chip die which are folded on top of each other. Last but not least the combination of thin film processes with conventional PCB technology may allow new opportunities inside an implantable medical device. A Platform Development Strategy for Implantable Neurostimulator Devices Andrew Kelly, Cactus Semiconductor, Inc. As researchers identify new therapies for neuromodulation, the industry faces a challenge for commercialization. Before a commercialization effort can begin, a proof of concept (POC) device is required to establish the safety and efficacy of a device and therapy. Ideally, a POC device must be implantable and must produce the same therapy in the same form factor as the commercial device. A substantial custom hardware development is often required to create the POC. As such, device developers require investment to support the POC development, while investors require a good POC before committing to the funding. A platform development strategy can result in an implantable device to deliver the required therapy in a similar form factor with a reduced cost and schedule compared to a full custom approach. This presentation introduces platform technologies that combine semicustom mechanical hardware from CIRTEC Medical Systems with an electrical hardware platform based on a Cactus Semiconductor ASIC. The presentation concludes with a summary of a neurostimulation device development based on the platform strategy. Miniaturization of Cochlear Implants Kurt Koester, Advanced Bionics This talk will cover the trend towards the miniaturization of medical devices by reviewing the history and experience in the cochlear implant field and discuss some of the challenges that size reduction imposes on the design of active implantable devices. To successfully achieve miniaturization targets, it is generally necessary to simultaneously decrease the size of hermetic packaging and the electronics and component payload inside the device. Other aspects of the cochlear implant application, e.g., head-level device placement, designing systems with implantable and body worn components, and covering the pediatric and adult use-cases make device miniaturization desirable. However, these issues drive different designs considerations, test requirements, device characterization, and longevity expectations relative to other active implantable devices and these issues will also be discussed. vBloc Neurometabolic Therapy: Pioneering Micro-electroceutical Treatment of Metabolic Disease Mark Knudson, EnteroMedica Inc. The concept of treating disease with electroceuticals – using electrons instead of molecules, has gained currency in recent years within the medical, scientific and engineering communities. Early success has come with the application of microelectronic techniques to up-regulating neuromodulation implants, or neurostimulators. Neurostimulation is the therapeutic activation of the nervous system utilizing a pulsed waveform delivered by microelectrodes. A majority of the work being done in the electroceuticals arena has focused on this form of neuromodulation which seeks to increase neurophysiologic activity using low frequency, low amplitude electrical pulse trains. To date this technology has been utilized in the treatment of a number of conditions including hearing loss, epilepsy, pain, and abnormal heart rhythms, to list a few. EnteroMedics’ approach is different from these previous electroceutical neuromodulation devices. vBloc Neurometabolic Therapy has pioneered the blocking part of the neuromodulation spectrum. Rather than increasing neural signals, this therapy interrupts them using a unique algorithm with high frequency, low amplitude waveforms that lead to the blocking of the neurophysiologic transmission on the axon, putting vBloc Neurometabolic Therapy in a neuromodulation category all its own, neuroblocking. Obesity and metabolic disease are an ideal first target for this therapy. By blocking the signals between the gut organs and the brain rather than altering the anatomy, we are offering people with metabolic disease and obesity an option they have not had before – a minimally-invasive, non-anatomy altering solution. vBloc therapy works by controlling hunger and changing a patient’s relationship with food. This presentation will address the development of vBloc Neurometabolic Therapy from scientific concept through a January 2015 FDA approval and its relationship to future trends in this fast-growing field. Electronic Component Supply Chain Management for Medical Implantable Devices: Synergy of Business, Technical, and Quality for Risk Mitigation Quinn Krekorian, Micro Systems Engineering, Inc. The implantable medical electronics market requires the evolution of supply chain management to meet the unique challenges of medical electronics manufacturing: Low volume, long life cycles, zero defect tolerance etc. A cross functional supply chain management philosophy is required to account for the variable conditions and complexity of components across the entire product lifecycle from concept through end of life. This presentation seeks to introduce the significant role supply chain management plays in balancing the business climate and risks associated with electronics manufacturing in the medical implantable market. The resulting philosophy of a cross functional supply chain management team approach to supplier selection, supplier performance monitoring, and risk mitigation strategies will be described. The staffing, skill set requirements and inventory strategies employed by cross functional supply chain management teams required to ensure high integrity throughout the supply chain will be described. The Utilization of Technology Building Blocks to Construct Novel Flexible Circuits for Medical Electronics Nate Kreutter, 3M Company Electronics are being utilized in the medical arena to image, diagnose, sense, monitor, stimulate or provide therapy to enhance modern heath care. The medical applications that use electronics in or on the human body are extensive. A partial list would include diagnostic test strips, cochlear implants, hearing aids, pace makers, defibrillators, neuro stimulators and catheter imaging systems. New applications and a higher level of sensing or data gathering increases the demand for miniaturization, higher routing density and the need for more components both active and passive. Increasingly the electronic circuits need to be flexible enough to bend, twist and fold where needed and rigid in specific areas to accommodate connectors and ICs and other components. As the requirements increase for a higher level of functionality in a fixed space, so do the challenges for electronic packaging. Designs require the placement of more features and components into a smaller footprint as well as understanding the biocompatibility of materials and how to process them. There are a number of building blocks that can address these challenges for medical electronics which include material options, new equipment and new processing methods. Today we can build unique structures that would have been difficult years ago. For example, we can select an advanced photo imageable polymer to protect circuitry that was formed with laser direct imaging with ultratight registration from one metal layer to another. This enables the creation of very small micro vias to interconnect layers thereby increasing the circuit routing density to new increased levels. Building circuits that not only meet the requirement of the specification but also taking into consideration the manufacturability, connectivity and ease of assembly is key to success. 3M continues to pioneer new technologies to enable circuit designers greater design freedom and functionality to address emerging needs in medical electronics. Development of a Sensor System to Measure Lumbar Spinal Fusion Deborah Munro, University of Portland Lumbar fusion is one of the fastest growing areas of orthopaedic surgery. An incision is made over the lumbar region of the spine and metal bracing is applied bilaterally to the posterior of the verterbrae. This bracing provides initial mechanical stiffness until bone growth, stimulated by a bone growth factor, encapsulates the spinal instrumentation and eliminates motion between the two lumbar vertebrae. After lumbar fusion surgery, rehabilitation takes several months, and determination of fusion is complicated by the presence of the titanium rods and screws and the orientations at which radiographs can be taken on patients. In addition, the bony fusion process occurs in stages, and the early stages are not mineralized bone and are thus not visible on a radiograph. However, fusion occurs much sooner than is predicted by radiographs and could be measured with a sensor. Back motion induces a bending moment in the spinal rod; that bending could be measured as a strain. This strain would initially be large, but it would decrease over time as the bone growth provided additional fixation. After some period of time, the strain would minimize at a lower value and remain relatively constant. By periodically sampling the strain electronically, a curve could be generated, showing the onset of rigid fixation. Resistive and capacitive strain sensors were mounted to a spinal rod and tested under physiologically appropriate bending on lumbar sheep spines. Initial results show that when the sensor is under load, the output voltage of the sensor correspondingly changes in magnitude, indicating that a change in extension and flexion of the rod results in a measurable change in output voltage and that these results are repeatable. Simulated fusion tests show there is also a correlation between strain and fusion mass growth that can predict solid bony fusion. A Use Condition Based Peck Model for Temperature, Humidity and Bias Tests for the Medical Electronics Industry Rema Nair, St. Jude Medical The JEDEC or Military standards propose using 85% relative humidity and a temperature of 85C along with bias for accelerating various growth mechanisms such as electromigration and corrosion. The Peck model is the most widely accepted reliability model for a temperature, humidity and bias test. In our experience, we have found that the standard test conditions are not suitable for acceleration in implanted device use conditions. This paper will describe an adapted Peck model that has been used for screening and characterizing various failure growth mechanisms more effectively than with the standard acceleration conditions. The new test conditions, their rationale and their application to use will be discussed in detail. Implementing New Technology in Audible Alarms to Decrease Size, Decrease Power, and Increase Functionality Daniel O'Brien, Mallory Sonalert Products, Inc. Although Mallory's audible alarms are considered single components to medical equipment designers, they are actually complex electromechanical assemblies which include complex circuitry and power supplies. Mallory has identified three technology tracks to apply to audible alarms to decrease the size, decrease the power requirements, and increase functionality. The audience will not only hear about future developments with audible alarms, but will hear how about the process of implementing new technology which can be applied more broadly to medical equipment. Specifically, the audience will hear about 1. Mallory's efforts to utilize wireless technology not only to severe the physical connection between the alarm, external power supply, & controller, but to increase functionality at the same time. 2. Mallory's efforts to utilize advanced circuit design and manufacturing techniques to provide a smaller audible alarm footprint. 3. Mallory's efforts to increase the functionality of a piezoelectric type alarm which can meet the complex sound requirements of IEC6060118 and has a 10 times power reduction over alarms using speakers (which enables the new alarm to be used with super capacitor backup power systems). Cost, Size and Energy Efficiency Through 3D Silicon Integration Fayçal Mounaim and Guillaume Raimbault, IPDiA Today’s goal is to miniaturize medical implants in order to simplify surgical procedures and to optimize the costs of such treatments. In the meantime, these implantable devices target a longer operating lifetime and have to be smarter, still being as reliable as the previous ones. Consequently the miniaturization and efficiency of energy storage in such implants are becoming key points during the design phase One way to cope with these new requests is to benefit from the latest silicon technologies to design 3D components and assemblies. IPDiA in Caen (France) is the world leader of integration of capacitors and other passive components using the inherent strengths of silicium. IPDiA already designed and is delivering products to the top leaders in medical electronics. These cooperations result in smaller and particularly more reliable integrated electronic devices with an increased performance in stability and power consumption. We will present today’s state-of-the-art of that technology and the projected developments for the coming 4 years. The presentation will focus on the benefits for healthcare as well as the experiences of our client/partners and how it is re-defining design rules of the implantable devices. Electronic Assemblies & Devices for the Medical Industry: Cleaning & Material Compatibility Challenges Jagar Patel, M.S. Ch.E., ZESTRON Americas Within the medical industry, electronic parts and medical devices must meet the highest quality standards as failure is not an option. Whether one is manufacturing electronic assemblies or devices, precision cleaning of flux and/or metal processing residues is of utmost importance, without adversely affecting material compatibility. For electronic assemblies, residues, either ionic or nonionic, must be fully removed. Partially removed or untouched residues can lead to component and product failure resulting from electrochemical migration, dendritic growth and electrical leakage currents. Regarding medical devices, contamination from the manufacturing processes such as electropolish solution, coolants, paraffin lubricants, and soda blast residues must be completely removed in order to meet the required cleanliness standards. Within this presentation, two case studies are presented detailing the challenges presented and solutions offered to two manufacturers, one producing Class 3 electronic assemblies and another medical devices. Case Study 1: A global electronics contract manufacturer had a requirement to identify and qualify a cleaning process capable of removing combinations of NoClean, lead free, leaded paste, and liquid flux residues utilizing industry approved test coupons. Using IPCB24 and IPCB25 test coupons, the test protocol included identifying an aqueous cleaning agent, confirming compatibility with existing equipment and components, establishing cleaning process parameters, and verifying cleanliness results using IPC standards. Wave systems and reflow ovens were used to solder the coupons with multiple types of solder pastes and wave fluxes. The coupons were cleaned using an aqueous cleaning agent and spray in air cleaning equipment. Case study 2: A global medical products manufacturer sought an environmentally friendly alternative to their current acidic cleaning process. In addition to meeting the cleaning requirements, the alternative cleaning process required a greater level of process control as well as be compatibility with the materials currently used. In the case of the electronics manufacturer, the authors were able to identify and quantify the critical parameters impacting cleanliness for Class 3 assemblies components utilizing numerous IPC assessment standards. For the medical device manufacturer, a cleaning process was identified meeting their cleanliness process control and compatibility requirements. Integrated Collaborative Design Optimization of Molecular Diagnostic Analytical Instrumentation System Thomas Ray, Plexus Corporation Medical diagnostic instrumentation systems today require the integration of advanced electronics, microfluidics and disposables containing biohazardous materials, with traditional fixed instrumentation systems. These designs require an interface between the disposable microfluidic cartridge and diagnostic instrumentation system where achieving precise alignment tolerances are critical to operational success. This presentation will discuss the allocation of tolerances, innovative design alternatives and assembly processes/tooling utilized to resolve electromechanical positional and electrical requirements. Soft Electronics for the Human Body John Rogers, Ph.D., University of Illinois Recent advances in materials science and mechanical engineering enable construction of high performance optical and electronic microsystems that can flex, bend, fold and stretch, with ability to accommodate large (>>1%) strain deformation with a purely elastic mechanics. Such technologies can be integrated intimately and non-invasively with the surfaces of important organ systems in the human body. This talk summarizes fundamental and applied aspects of three recent examples that address currently unmet clinical needs: (1) 'skin-like', wearable electronics for continuous, clinical quality measurements of health status, (2) high resolution mapping systems capable of resolving fast, transient behaviors in brain activity, and (3) soft sensors and stimulators for advanced forms of cardiac electrotherapy. Automation of Flex Substrate Electronics Final Assembly: “Mechanized Origami” John Roos, Micro Systems Engineering, Inc. High packaging density medical electronics design and assembly is enabled by the use of flexible substrates. Repeatable, precise and controlled folding of these assemblies is a critical factor to enable the needed quality and reliability of the circuits. Flexible substrates allow for folding and interleaving SMT component topographies to reduce volume as well as making 3D interconnects between mixed format components such as batteries, high voltage caps, feedthroughs and mechanical frames. The primary manufacturing challenge is handling the flexible substrate through surface mount assembly and especially final assembly. As evidenced by existing product architectures the final assembly challenge is typically resolved by reverting to manual methods. This paper presents a case study where major elements of the final assembly of defibrillator electronics have been fully automated. Automation has been enabled by early codevelopment of device level mechanical architecture, components and manufacturing methods. The automation approach is implemented incrementally in manufacturing to enable product roadmap schedules and minimize investment risk. Medical & Healthcare: What are the Opportunities for MEMS and Sensors? Benjamin Roussel, Yole Developpement New technologies have the ability to transform HealthCare globally: enable early diagnostic through new detection modalities, increase treatment efficiency with targeted drug delivery, allow functions replacements through smart implants surgery... Due to tremendous potential of the applications, the medical and healthcare market are nowadays considered by most electronics and semiconductors suppliers as a new growth opportunity. The potential is huge, ranging from high value/high margin medical devices to health consumer products for wellness and fitness. As part of this market, Wearable electronics is a significantly growing market, mainly driven by smart watches. Many products are already on the market, measuring physical and physiological parameters, which are transferred to a base station (typically a mobile phone). Added value is then created by specific “smart” applications. To feed these applications with data, the demand for all types of so-called bio-sensors is significantly increasing and affecting the way the sensor industry is organized. Pressure sensors, IR sensors, microfluidic chips, chemical and gas sensors are just few examples. Yole Développement will provide an overview of the applications and the challenges industry will face to enter this market. Advancing Neuromodulation Through Development of Advanced Research Tools Erik Scott, Medtronic LLC A complete neurostimulation system consisting of a reusable, four channel, fully implantable rechargeable neurostimulator (INS), recharger and wireless controller has been designed, built and used chronically in animals. The purpose of this system is to enable acute and chronic research with stimulation codes and patterns in rodents and large animals, as a means to understand the underlying neuroscience principles responsible for neuromodulation therapy, as well as to explore improved outcomes for existing therapies and identify potential new opportunities. A key functional feature is the ability to generate electrical stimulation pulses of arbitrary shape and at high repeat rates. The total volume of the INS is 3cc including the rechargeable battery, stimulation system and low volume lead connector block. The battery is recharged using transcutaneous induction, and wireless telemetry operates at a distance of up to 60 cm to enable untethered, real time program updates. Medical High Density Interconnects: An Evidence Based Approach Ravi Subrahmanyan, Micro Systems Engineering, Inc. Substrate interconnects for medical implants or other high reliability applications need to have repeatable processes and demonstrated reliability based on a mechanistic approach. A meaningful product reliability monitoring methodology has been proposed that provides objective evidence of a printed circuit board performance in real application situations. Leveraging a design specific Interconnect Stress Test (IST) and realistic use conditions for assembly, test, shipping and handling, a mechanistic and statistical methodology has been used to quantify the reliability of vertical microvia interconnects. IST test runs on numerous samples were performed to evaluate differences of process parameters, material selection and via geometry. It was demonstrated that via reliability could be improved by an order of magnitude through revisiting the critical processes and materials. IST testing and large volume hot testing was applied to show statistical evidence of improvements. The Design Challenges for Home Use Medical Devices Greg Thompson, Sanmina Corporation, Medical Division The presentation will cover the challenges that are encountered when taking traditional medical devices and implementing them for the home use environment. The clinical setting is a very controlled environment – this is not true of the home environment. Challenges exist due to foreign substances and rough handling (liquids/dirt/dust, bugs/pests, drop/shock and expected misuse, etc.. Challenges also exist due to use by undertrained users – and users that don’t want to admit if the device has experienced accidental abuse.