Speakers and Presentation Topics

(listed alphabetically, by speaker’s last name)

Next-generation cochlear implants: recent developments and emerging trends
Hongsoo Choi, PhD
Associate Professor
Daegu Gyeongbuk Institute of Science and Technology (DGIST)

Cochlear implants (CIs) are currently the most common solutions for sensorineural hearing loss caused by damage to hair cells in the cochlea. The damage usually results from the loss of the hair cells in the organ of Corti, which is on the basilar membrane. Hair cells are specialized mechanoreceptors that convert the mechanical movement of the basilar membrane into an electrochemical signal to stimulate the auditory nerve. CIs mimic the passive frequency selectivity and the acoustic-electrical energy conversion of the cochlea to stimulate the auditory nerve by an artificial electrical signal. In this presentation, an overview of the current CIs and the latest development for next generation CIs will be provided. Micro-acoustic sensors and microelectrode arrays are the key enabling technologies to overcome the limitations of current CIs. Biomimetic artificial basilar membranes are acoustic sensors to mimic the function of the cochlea. Finally, future perspectives of CIs for fully implantable hearing aids will be discussed.

Biography: Dr. Hongsoo Choi is an Associate Professor at the Department of Robotics Engineering and Co-Director of the DGIST-ETH Microrobot Research Center at DGIST. He received his MS (2003) and PhD (2007) degrees from the School of Mechanical and Materials Engineering at Washington State University. He received several awards from many conferences including Rising Star Award (2014) from the International Society of 3M-NANO and Best Poster Award (2015) from The Korean Society of Medical and Biological Engineering. His research areas are biomedical microrobots for targeted therapeutics, MEMS-based devices for biomedical applications, especially piezoelectric devices such as piezoelectric micromachined ultrasound transducers (pMUT) and artificial cochlea using piezoelectric sensors.


Powering medical sensors and devices: comparative review of available energy sources
Gary Johnson
Director of Sales
Ilika

The rapid development of sensing devices for wireless body area networks (WBANs) is opening opportunities for continuous health monitoring and more proactive patient health management. Trends towards miniaturization are allowing the deployment of more efficient sensors and devices for implantable devices (cardiac, neuro-stimulators), drug delivery, epidermic electronic patches, ophthalmic, or orthodontics applications. Powering these devices autonomously is critical with requirements for long life, high reliability, high energy density, and safety placed on the energy source. In this presentation, a comparative review of available energy sources will be given, including conventional batteries, supercapacitors, and solid state batteries (including our product roadmap of small footprint solid state batteries). Additionally, the power sources suitability will be discussed in terms of size, safety, and electrical requirements for various use cases. Recharging mechanisms will be evaluated depending on their relevance, including RF, ultrasound, or NFC and, when available, harvested energy from human heat, vibration (such as heart movements), or solar energy.

Biography: Gary Johnson joined Ilika as Director of Sales in 2016 and is responsible for establishing strategies and partnerships for Ilika’s solid state battery IP in the USA. Gary holds a degree in Electrical Engineering from the University of Minnesota. He developed strong technical experience in low power electronics used in implantable and body-worn medical devices working for NanoAmp Solutions, AMI Semiconductor and Texas Instruments. Gary also has experience with MEMS technology and IP licensing from his time working for IMT and UBM TechInsights. Gary is currently focusing on the value solid state batteries bring to the medical device market


Rebuilding the senses: current and future developments in neuroprosthetics
Alexis Karandrea, PhD
Technology Analyst
IDTechEx

Neuroprosthetics is a growing field that has the potential to re-engineer a patient’s lost sense of sight and sound. While technology for cochlear implants has been around for decades, continued innovation in this area generates new devices with increased functionality. Additionally, cochlear implants have served as the basis for the field of retinal implants. Implanted into the eye to replace a patient’s lost rod and cone cells, these implants transduce visual information to the remaining nerve cells in the retina to be sent to the brain. Efforts to generate MEMS devices with long-term biocompatibility may further translate into bionic limbs that are integrated with, and provide tactile sensory feedback through a patient’s own nervous system. This talk will detail themes and trends in the development of each sub-segment of neuroprosthetics, highlight specific concerns that should be considered in developing these devices, and forecast the projected growth and prospective adoption of these medical devices over the next decade. The talk will also provide an overview of the leading commercial and R&D efforts in this field, including the recently funded startups.

Biography: Alexis Karandrea is a Technology Analyst for IDTechEx, specializing in the field of biotechnology. Alexis holds her PhD degree in the Medical Sciences and MSc in Biotechnology from the University of South Florida. After completing her MSc she was employed by Magellan Bioscience, a drug discovery company specializing in marine microbial extracts. There she worked on a biotransformation project in addition to the curation of their compound libraries. Upon completing her doctorate, she worked in the technology transfer office for Moffitt Cancer Center. At Moffitt, she assisted in the commercialization of multiple technologies such as cancer therapies, diagnostics, and medical devices. Currently at IDTechEx, Alexis has a special focus on neuroprosthetics. She regularly interviews key companies in developing fields to perform detailed assessments on the current state of emerging technologies. From this research, she identifies trends and generates market forecasts for the prospective adoption of these new and innovative medical devices.


Design challenges and strategies for ingestible sensors
Andrew Kelly
IC/Systems Architect
Cactus Semiconductor

Experts estimate that 50% of patients do not take medicines as prescribed, and this lack of adherence is the root cause of billions of dollars of medical costs. Recent technological progress with ingestible sensors promises to address the medication adherence problem and revolutionize the way we manage medications. Due to the extraordinary method for powering these ingestible devices, the application-specific integrated circuit (ASIC) at the heart of the sensor requires a creative custom design approach. The primary design challenges include requirements for a high-integrity communication link to support billions of unique serial numbers, running on an ultra-low voltage, high-impedance supply, and in a high-loss environment – all in an extremely miniaturized form-factor. Other challenges include managing the conflicting high-quality and reliability requirements of medical devices with the manufacturability, supply continuity, and ultra-low cost requirements of a high-volume product. This presentation will summarize these design challenges, as well as highlight the strategies that can be used to address them.

Biography: Andrew Kelly is an IC/Systems Architect at Cactus Semiconductor Inc. in Chandler, Arizona. Prior to joining Cactus Semiconductor, he was a Senior Principal IC Design Engineer at the Medtronic Microelectronics Center. Over the past 30 years, he has defined and designed dozens of full custom mixed-signal ICs for a wide range of portable and implantable medical devices such as glucose meters, hearing aids, neuro-stimulators, drug infusion pumps, bio sensors, orthopedic sensors, and cardiac pacemakers.


Physiological analytics for preventative health care and consumer wearables
Ilkka Korhonen, PhD
VP Technologies
Firstbeat Technologies

Novel wearable sensors enable continuous and unobtrusive monitoring of various physiological parameters such as, heart rate, motion, respiration, SpO2, and blood pressure. These sensors create vast amounts of highly complex personal data, which often remains under-utilized and poorly understood by the users and ignored by their care providers. To make the data valuable it needs to be transformed into actionable knowledge of physiological and behavioral status of the user. This talk will review the recent progress in the physiological parameters produced by the wearable sensors and related analytics challenges. The talk will especially focus on the state-of-the-art techniques, as well as opportunities for physiological and behavioral analytics being developed to manage the sensor data explosion. Some examples of benefits gained by advanced physiological analytics in sports and wellness will be presented. This talk will also provide an overview of companies and organizations working on analytics technologies and recent notable R&D efforts.

Biography: Dr. Ilkka Korhonen has more than 25 years experience in health technology, wearable physiological monitoring, algorithms and sensing technology, related scientific research, and product and business development. His vision is to bring health technologies for consumers and patients into their everyday life, making consumer the primary user of the health technology and health information. He is also an Adjunct Professor of Personal Health Informatics at Tampere University of Technology. Earlier, he held various research positions as a professor or principal scientist, as well as having been a co-founder and CTO of an optical heart rate pioneering company, PulseOn. He has more than 200 scientific publications, several patents, and has given invited lectures in numerous scientific and business forums.


Hybrid plastic-based MEMS devices for biomedical applications
Dorian Liepmann, PhD
Professor
University of California, Berkeley

Originally the development of microfluidic MEMS devices was based entirely on silicon. The close coupling between electronics and fluid control would provide new platforms for advanced biomedical applications. It was assumed that large production volumes would reduce the cost of the silicon-based devices enough so that they could be used for single-use medical applications. Unfortunately, this has not happened and silicon MEMS are too expensive (~$0.05/mm2) to be disposable. As a result, we have refocused our bioMEMS research to use plastics, made using 3-D printing and hot-embossing. The talk will describe how we can imbed microelectrodes in plastic devices. Early applications include cell cytometry, lysis, and electroporation. CMOS chips and graphene–based sensors can also be incorporated into the plastic microfluidic devices and connected to the electronic interconnects, thus making biomedical sensors with increased functionality possible. The second project involves a needle-free, microjet-based drug delivery system for oral delivery of protein drugs that we fabricate using 3-D printing. The “pill” uses a solid-to-gas phase change to generate high internal pressure to create a liquid jet that can penetrate mucosal layers inside the cheek or in the intestine.

Biography: Dorian Liepmann is a professor in the Departments of Bioengineering and Mechanical Engineering at UC Berkeley and Co-Director of the Berkeley Sensor and Actuator Center (BSAC). Professor Liepmann has been a faculty member for more than 22 years. He was Chair of the Dept. of Bioengineering from 2004 to 2010 and held the Lester John and Lynne Dewar Distinguished Professorship in Bioengineering from 2001 to 2005. His research interests include bioMEMS, microfluid dynamics, experimental biofluid dynamics, hemodynamics associated with valvular heart disease and other cardiac and arterial flows. Prior to joining the faculty at the University of California, Berkeley, Professor Liepmann had ten years of industrial research experience at the Jet Propulsion Labs and the Institute for Non-Linear Science at UC San Diego. Professor Liepmann received his PhD in 1990 from the University of California, San Diego in Applied Mechanics.


Micro and nanoelectrode arrays and their role in advancing human health
Swaminathan Rajaraman, PhD
Assistant Professor
University of Central Florida

Cellular function and response has been a significant subject of human fascination since time immemorial and a major field of study that has improved the understanding of the mechanics of the human body. Specifically, the functioning of electrically active (electrogenic) cells is of particular interest as these cells control several important physiological functions such as visualization, locomotion, and activities of key organs in the human body. Micro and nanoelectrode arrays serve as the primary interface for signal transduction with electrogenic cells and in conjunction with CMOS electronics, mechanics and software are enabling instrumentation that will result in actively and passively manipulating these cells either in a dish, in a wearable or in an implantable setting. These efforts to engage with electrically active cells are bringing major advances in human health areas of drug discovery, diagnostics, therapeutics, prosthetics, environmental sensing and implantable devices. This talk will provide an overview of the latest developments with micro and nanoelectrode arrays using in medical applications.

Biography: Swaminathan Rajaraman received his BS degree in Electronics Engineering from Bharathidasan University (Trichy, India), his MS degree in Electrical Engineering from the University of Cincinnati (Cincinnati, OH) and his PhD degree in Electrical Engineering from the Georgia Institute of Technology (Atlanta, GA) in 1998, 2001 and 2009 respectively. He has worked in industry with Analog Devices Micromachined Products Division (MPD) in Cambridge, MA, and CardioMEMS (now Abbott Labs) in Atlanta, GA, on optical MEMS micromirrors and MEMS pressure sensors for congestive heart failure. He is further a co-founder of Axion BioSystems, the industry leader in high-throughput microelectrode array (MEA) technology. Dr. Rajaraman returned to academia in 2016 and is currently an Assistant Professor at the University of Central Florida (Orlando, FL). His current research interests include in-vitro and in-vivo micro and nanoelectrode arrays, micro and nanofabrication on novel biological substrates, microneedles, flexible electronics devices, microtweezers, micro-TAS, nanobiosensors and implantable MEMS devices.


Isolation of circulating tumor cells for next generation cancer diagnostics
Viktor Shkolnikov, PhD
Senior Research Scientist
HP Labs

One major cause of cancer-associated mortality is tumor metastasis, which is caused by circulating tumor cells – cells that detach from the primary tumor, travel through the blood stream, and give rise to tumors in new locations. These cells carry with them lots of valuable information such as insights about the abnormal pathways in the parent tumor and hints about locations for where these traveling cells will be most pre-adapted. If these cells can be successfully isolated, this information can be turned into actionable clinical decisions regarding the patient's therapy. Since these cells are isolated from the blood (i.e. via liquid biopsy), they can be sampled more often than traditional biopsies. Such liquid biopsies promise more frequent, relevant, and up-to-date information on the patient's condition, including response to treatment. This talk will present challenges and current methods for isolating and analyzing circulating tumor cells, review methods currently under development, provide an overview of commercialized systems, and briefly touch on our work related to this topic.

Biography: Viktor Shkolnikov leads a team of scientists and engineers at HP labs to develop novel microfluidic and electrokinetic technology for solving valuable diagnostics problems, such as minimally invasive diagnosis of cancer (a project he conceived and began). His interests and expertise are at the interface between medicine and fluid mechanics (and the associated physics, chemistry, and engineering) and he constantly seeks ways of how these can be leveraged to alleviate pain and improve health. Viktor Shkolnikov received his PhD, MS, and BS degrees all in Mechanical Engineering and all from Stanford University.


Ultra-low power implantable inertial MEMS sensors
Mark da Silva, PhD
Engineering Manager, High Performance Sensors
Analog Devices

Implantable sensors continue to be used in research and real-world medical products to measure motion, temperature, force and pressure within the human body. Recent developments in MEMS sensor technology, coupled with advancements in ultra-low power signal processing, have opened new application areas for implanted motion sensors. Motion sensors implanted into limbs can now provide real time visualization of the body to help surgery, patient recovery, and long-term improvements in ambulation. Similar sensors implanted in the back can assist in spinal cord stimulation for advanced treatment of chronic pain. These sensors, along with the more well-known motion sensors for cardiac rhythm management (rate responsive therapy), continue to grow in terms of range of patient therapies offered based on available patient motion information. Robust, relatively inexpensive, ultra-low power, and reliable implantable sensors hold great promise for advancement of medical procedures, health management, and therapy for aging populations. Body area networks with implanted sensors, analogous to wearable sensors may be commonplace soon as advances in data processing enable medical professionals to offer more help improve patients’ lives.

Biography: Since 2008, Dr. Mark da Silva has been at Analog Devices where he is responsible for new product development of MEMS high performance inertial sensor products for healthcare and industrial markets. In the decade prior to joining ADI, Dr. da Silva led MEMS technology development services at Coventor and Exponent. Prior to joining industry, Dr. da Silva was a post-doctoral fellow and lecturer at the University of Maryland, focused on understanding the behavior of polymeric thin-films for medical applications. He has a MS and a PhD in Mechanical Engineering from The Johns Hopkins University and an undergraduate degree in Aeronautical Engineering from the Indian Institute of Technology (IIT), Bombay. Current interests include technology and product development in the areas of micro and nano ultra-low power sensing systems.


Development of a sensor-enabled wearable medical device for orthotics and prosthetics
Ellen Su
CEO and Co-founder
Wellinks

Patient compliance is notoriously low within orthotics and prosthetics (O&P), leading to more pain, lower quality of life, longer recovery times, and increased risk of surgery. Wearables that can measure brace compliance and fit can help doctors adjust and tailor treatment to individuals and make more informed treatment decisions. The O&P industry, however, is more used to working with plaster and plastic than sensors and electronics, which compounds the challenges faced by companies bringing devices to a regulated market. This talk will explore some of the new technologies coming to market in orthotics and prosthetics, as well as additional opportunities for sensor-based technologies. We will also discuss the specific case of using sensors in scoliosis braces to prevent surgery, including the challenges of in-house product development and lessons learned from launching our own sensor-enabled wearable medical device in the O&P industry.

Biography: Ellen Su is the CEO and Co-founder of Wellinks, a company developing devices to improve treatment for musculoskeletal conditions via monitoring and feedback. She received her B.A. from Yale University and has experience in product design and mechanical engineering. Wellinks is based out of New Haven, CT, and will be launching their first product in the fall with a team of 3 full time employees. E llen has led the process of raising funding through both investors and non-dilutive sources in order to fund and launch their first product.


Power management strategies for medical implants
Bill Von Novak
Principal Engineer/Manager
Qualcomm Technologies

Medical implants require power to operate – from microwatts to watts in some cases. This power is traditionally sourced by primary batteries, and they can provide power from months to years. However, new applications require more energy than primary batteries can reliably deliver, and changing batteries in medical implants can often lead to risk of infection in compromised patients. More recently, medical device manufacturers have turned to wireless power sources in combination with secondary (rechargeable) batteries to power medical implants. This allows longer implant life without surgical intervention, and also enables applications with higher average power draws. In some cases, managing both wireless charging and secondary battery energy storage can be difficult. Varying voltages, thermal concerns due to inefficiencies, and requirements for startup at zero state of charge can combine to make the job of a power designer a difficult one. In addition, maintenance and safety requirements on batteries add additional constraints to any such design. This talk will discuss power management strategies and designs for medical implants and give a few examples of such designs.

Biography: Bill Von Novak has been at Qualcomm Technologies since 1994, when he worked on early CDMA base stations and handsets.Since then, he has been working in the field of power management and wireless power transmission, and now leads the wireless power group at Qualcomm.He spearheaded the formation of the AirFuel Alliance and has remained active in that organization. He has 141 issued patents in almost a dozen countries, most covering wireless power transmission.


Microfabricated intradermal biosensors: recent trends, developments, and applications
Joshua Windmiller, PhD
CTO
Biolinq

It is widely recognized that true value in the emergent wearable sensors domain will be unlocked by extending electrophysiological sensing paradigms to electrochemical methods aiming to provide insight into the wearer's biochemistry. This talk will discuss academic and industrial efforts that are aimed at the development of a front end for the digital health ecosystem – non-invasive, skin applied electrochemical biosensors that are able to quantify relevant metabolomic, electrolytic, hormonal, and neurochemical information in a real-time and continuous fashion with clinical accuracy. Armed with this actionable information, the wearer is now empowered to assess the causality associated with how their daily lifestyle choices – diet, exercise, sleep patterns, stress management – affect their overall metabolic health. Various approaches facilitating non-invasive biochemical sensing in physiological fluids will be introduced and discussed, including a survey of several microfabrication techniques that are leveraged to manufacture these microdevices.

Biography: Dr. Joshua Windmiller is an internationally-recognized expert in electrochemical biosensor technology. His PhD research, funded by a Powell Foundation fellowship, focused on the development of printed biosensors, bioelectronics, and biofuel cells. He has published over 50 manuscripts in peer-reviewed journals and conference proceedings, and has eighteen US patents issued or pending. Dr. Windmiller, a Gordon Fellow, NIH SHIFT awardee, and two-time NIH Lab-to-Marketplace awardee is the recipient of the Printed Electronics USA 2010 Academic R&D award for his developments in textile-based printed bioelectronics. He completed a postdoctoral fellowship in the Laboratory for NanoBioElectronics at UCSD in 2013, where he was supported by the von Liebig Center for Entrepreneurism and led a commercialization grant sponsored by the Department of Energy. For his successful product development activities leading to the commercialization of novel printed bioelectronic paradigms, he received the Printed Electronics USA 2014 Product Development award. He currently serves as the CTO of Biolinq, a startup that he co-founded, devoted to the development of the novel biosensing modalities he has invented for application in the personal wellness and healthcare domains


MEMS and sensor grants at NIH: a how-to guide
Michael Wolfson, PhD
Program Director
National Institutes of Health (NIH)

In the last five years, the National Institutes of Health (NIH) has had a cumulative budget of around $150B. In this introduction to medical device development at NIH, we will provide an overview of the United States’ largest biomedical funding agency, give examples of how NIH sponsors technology development, and present a mini-grantsmanship seminar on how new investigators can work with NIH. The talk will give a snapshot of the standard investigator-initiated grant types, such as R01, R21, and introduce the audience to a few special initiatives: the BRAIN Initiative, SPARC, and bioengineering research grants. A description of the NIH peer review process will be provided, with advice on common problems. The talk will close with examples of ongoing projects involving MEMS and sensors, and their impact on unmet medical needs from fields as diverse as brain-computer interfaces, rehabilitation engineering, and study of organ function.

Biography: Dr. Michael Wolfson joined the National Institute of Biomedical Imaging and Bioengineering (NIBIB) in 2016 as a Program Director in the Division of Discovery Science and Technology. He has programmatic oversight of discovery and applied research grants, with emphasis on implantable and assistive medical devices. Mike received a ScB degree in electrical engineering from Brown University and a PhD degree in electrical engineering from Cornell University. He is a Senior Member of the IEEE and a member of the Society for Neuroscience. Mike specializes in performing characterization, analysis, and integration of novel biologic and microscale systems within commercial, small business, and academic R&D environments. His expertise spans multiple disciplines and covers emerging domains, such as bio-, micro-, and nano-system technologies. From 2000 through 2009, Mike was involved in several ventures to develop microsystems technologies for commercial applications. From 2009 through 2016, he was a subject matter expert in DARPA's Microsystems Technology Office and Biological Technologies Office, supporting MEMS and neuro-technology programs. During this period, Mike consulted for several other organizations, including GlaxoSmithKline and the Bionics Institute. He brings to NIBIB substantial experience developing and managing translational neurotechnology R&D portfolios, with particular emphasis on system design principles. Mike has been instrumental in DARPA's RE-NET, HAPTIX, ElectRx, and NESD programs, as well as the GSK Innovation Challenge. He has also provided mentorship to over a dozen recipients of the DARPA Young Faculty Award.


Technology Showcase Presenters

(listed alphabetically, by company name)

Sanjay Shinde
Sr. Manager
Canon USA

Jason Alexander
Business Development Manager
IMRA

Ian Campbell
CEO
OnScale

Julia Brueckner
Application Scientist
Quantum Analytics

Carlos Stahr
Regional Sales Manager
Silex Microsystems


Startup Showcase Presenters

(listed alphabetically, by company name)

Andrew Chang
CTO
Lumo BodyTech

Mark Webb
Senior Nanofab Process Engineer
Mekonos

Ben Bazor
Director of R&D
TacSense

Ray Lin
Electrical Engineer
VenoSense

Sameh Sarhan
CEO
Xtrava


Past Speakers

Many thanks to our speakers from Medical MEMS 2016.

Changing cancer outcomes: an overview of single cell analysis technologies
John Butler
President and CEO
Quantumcyte

The field of single cell analysis and its role in basic life sciences research and diagnostics is ongoing and exciting with many new and different technologies being developed to study the basic unit of life. A diversity of devices have been created to do single cell sample prep for genomic and proteomic applications, sub-cellular visualization, as well as, to target cells with specific peturbagens for computational biology experiments and diagnostics. Recently, technologies have been developed to measure disease cell population responses at the single cell level in an attempt to predict patient outcome from drug therapy ex-vivo. In this talk, we will be reviewing the many different technologies for doing single cell research and outlining their key technical benefits, as well as, how they fit into the continuum of single cell research. We will conclude the discussion by reviewing a variety of recent work examples using single cell approaches for predicting patient responses to chemotherapy.

Biography: Mr. John Butler has over 20 years of experience working in the biotech industry in basic research and development, process development and operations, and manufacturing for non-regulated (ISO) and regulated (GMP) companies. He was instrumental in the development of several high throughput drug discovery technologies, two DNA microarray technologies, the development of novel high throughput DNA synthesis technologies and processes, and drove process improvements for a $250 million per year DNA synthesis facility. In March of 2011, Mr. Butler decided to start Quantumcyte with a desire to help people with rare, untreatable cancers. He started this effort to help his wife, who was diagnosed with a rare cancer, and found that the concept could help others. He incubated the concept with Dr. Ron Davis at The Stanford Genome Technology Center where he established the processes for the surface tension array technology that is the foundation of the concept.


The fusion of wearable sensors and medical diagnostics: tools vs. toys
Baabi Das
President and Co-Founder
Zansors

The introduction of consumer wearable sensors has increased awareness and acceptance of wearable technologies. Consumers and patients are now curious and demanding medical diagnostics device in smaller, cheaper, user-friendly platforms and packages. Can the fusion of wearable sensors and medical diagnostics transform the lives of consumers/patients? Will these next-generation sensor products be tools or toys? In this talk, key questions and case studies applying medical diagnostics to wearable sensors and vice versa will be presented. Are wearable sensor companies ready to conduct Institutional Review Board approved clinical studies and publish peer-reviewed data and results? How can wearable sensors firms learn from medical diagnostics companies who apply quality systems to their product development roadmaps? Can wearable sensors handle complex biological samples? Wearable sensor products are using wireless technology, telemedicine, and mobile cloud systems; how can these fuse with medical diagnostics at the home? Medical diagnostics have a hitherto standardized protocol for biomarker discovery, but can wearable sensors capture new signals and open paths to new biomarker discovery and monitoring protocols. The upcoming product launches for sensors will delight or disappoint depending on whether we are launching low-end prototypes or high-quality products: Tools vs. toys.

Biography: Baabi Das is the President and Co-Founder of Zansors. He graduated with a BA and an MBA from the University of Michigan in Ann Arbor. He has been working to commercialize technology platforms from the e-learning, molecular medicine diagnostics, and aerospace industries for the past 15 years at leading firms like Sylvan Learning, Lockheed Martin, and Becton Dickinson (BD). In the education space, he has integrated e-learning platforms with content from top universities. In aerospace, he helped to build and assemble advanced technology parts for jet engines and rotorcraft. In healthcare, he worked to commercialize multiplex biomarker panels including establishing regulatory (FDA) and reimbursement strategies for reference laboratory tests based on molecular medicine. In addition, he developed new business segments in personalized medicine (pharmacogenomics) using microarrays and microfluidics platforms based on single nucleotide polymorphisms (SNPs). Currently at Zansors, he is working on commercializing wearable biosensors and apps for mobile health. He is leading the management and product development for wearable sensors and point-of-care technologies which rely on biosensors, bioengineering and embedded algorithms.


Medical MEMS and smart fabrics: opportunities, trends, and developments
Lloyd Green
Director, Engagement Marketing
IEEE Standards Association

Healthcare is rapidly evolving to support patients’ preference towards home healthcare monitoring and basic ailment diagnosis. Such innovative approaches result in decreased costs associated with hospital visits. Together, these factors are driving the use of MEMS technology across the medical equipment field to be more patient-centric and focused. MEMS and sensors play a critical role in addressing the need for miniaturized and portable devices that can capture vital information and that aid in providing rapid and accurate diagnosis of diseases. Add into the equation the idea of smart fabrics, whereby the role of piezo-electronics, conductive materials, and wireless technologies, advance beyond the typical concept of wearables. Smart fabrics are capable of interacting with their users, as well as track and communicate vital sign information. This presentation will address the convergence of MEMS and sensor devices with smart fabrics in the medical field, as well as the innovative solutions enabled by them that can accelerate telemedicine.

Biography: Lloyd Green is Director of Engagement Marketing and Creative Community Services for the IEEE. In this role Lloyd is responsible for developing, promoting and supporting conformity assessment activities based on IEEE standards. He brings a wealth of technology related experience in the areas of strategic marketing, corporate communications, market intelligence, business development and product marketing. Lloyd has been a frequent speaker for the IEEE Standards Association (IEEE-SA) regarding conformity assessment initiatives on areas including, power, timing and synchronization and mobile device image quality. Previously, Lloyd was Director of Marketing and Customer Support at Juniper Networks where he was responsible for Juniper's line of highly accurate end-to-end timing and synchronization solutions, which addressed the mobile backhaul and femto market. Prior to Juniper Networks, Lloyd held technical, marketing and business development roles at Altamar Networks, Network Equipment Technologies (N.E.T) and British Telecom International (BTI). Lloyd holds a BS in Telecommunications from the South East London Technical College.


Microfluidics for diagnostics: a 40-year tale of hype and commercialization
Erol Harvey, PhD
CEO
MiniFAB

It was the late 1970s when some of the pioneering commercial work using microfluidics was conducted by researchers at ICI Winnington research lab in the UK. Yet only recently have we begun to see the emergence of high volume applications enabled by the microfluidics technology. It was not technical difficulties that slowed this process down, but rather a complex set of mismatches. For example, the poorly utilized materials and manufacturing methods combined with the slow growth rate of the commercial market for these disruptive devices. Microfluidics was also one of the first fields of academic research to be dominated by the "patent-before-publishing" dogma, yet in retrospect it is unclear whether this helped or hindered the rate of commercialization. As the market starts to grow, it is those business models with optimal integrated design and manufacturing strategies that will succeed, as well as those that seek to exploit the data generated by these lab-on-a-chip devices. This talk will provide an overview of the commercial history of microfluidics for diagnostics applications, the current status, and emerging trends for the near future. The talk will also include some key market statistics, cost trends, as well as highlights of some of the leading technology companies in this segment.

Biography: Dr. Erol Harvey is co-founder and CEO of MiniFAB, a developer and manufacturer of lab-on-a-chip diagnostic devices. Started in 2002, MiniFAB currently manufactures millions of nano-precise plastic medical diagnostic devices each year for clients around the world. With a PhD in Plasma and Laser Physics from Monash University, he spent time in Oxford, UK before returning to Australia. Erol has been involved in the commercialization of micro and nano technologies for more than 20 years and has global experience in working in and with major multinationals, start-ups and SMEs, universities, as well as government research labs. He is a Fellow of the Australian Academy of Technological Sciences and Engineering (ATSE), and has served on many Government Councils and Advisory Boards. In 2011, MiniFAB was awarded the inaugural "Enabling Technology Company of the Year" and in recognition of achievements in entrepreneurship in emerging technology in 2012, Dr. Harvey was awarded Enabling Technology Entrepreneur of the Year by the Victorian Government Manufacturing Hall of Fame.


Microfluidic product development: a systems approach for rapid prototyping
Leanna Levine, PhD
President and CEO
ALine

Complexity in microfluidics product development originates in the requirement to integrate and optimize the functional performance of a variety of dissimilar components that are coupled together in close proximity. It involves a combination of biological and materials science, as well as mechanical and potentially optical engineering to create a robust product solution. Any product that performs tests and measurements is fundamentally an information producing system. The quality of the information depends critically on how well each of its disparate components are harmonized to become "more than the sum of the parts". This talk will provide a general methodology on how to evaluate microfluidic modules, and then how integrate them to achieve robust interfaces such as between the cartridge and the instrument as well as the materials and the reagents. The presentation will also provide a comprehensive overview of currently available rapid prototyping tools and techniques for microfluidic devices, which allow quick exploration of the material and device geometry space, as well as integration of cartridge clamping to a modular instrument platform with pneumatic and thermal control. The talk will provide an overview of the risk elements, which need to be considered when engineering a microfluidic cartridge. Lessons learned through this early integration lower risks in the commercial instrument development, while achieving proof-of-principle with a lot of real data supporting the viability of moving to commercialization.

Biography: Dr. Leanna Levine, founder of ALine, Inc. is an entrepreneur, technologist, and inventor. She founded ALine in 2003, and conceived and developed ALine's unique and proprietary fabrication platform that permits rapid prototyping and volume manufacture of highly functional microfluidic and lab-on-chip devices. Under her leadership, the company has developed instrumentation and a unique tool box of functions that have seen commercial application for single-use products. ALine has created a disposable design strategy that can be generally applied for a variety of multiplexed, quantitative diagnostic or field-portable tests. Prior to founding ALine, Dr. Levine was involved in the development of bioanalytical technology to support life science research while part of Monsanto's corporate R&D where her lab lead the industry in the application of fluorescence polarization for high throughput screening of enzyme targets, now an industry standard detection method in fluorescent plate readers. In 1998 she joined Spectrum Laboratories as Director of Manufacturing and Product Development. During her tenure at Spectrum she developed a novel fiber-in-fiber spinning method for hollow fiber membranes. Her unique combination of scientific research skills and manufacturing expertise has played a significant role in creating a bridge from research innovations into viable product opportunities. Dr. Levine earned her PhD at Washington University, St. Louis (1986), and her BS in Biochemistry and BA in German from the University of Missouri, Columbia, MO (1982). In 2003, she was a visiting scholar at the UCLA Anderson School of Business. In 2000, she was the chair of the Gordon Conference on Bioanalytical Sensors. She is the co-author on a dozen publications and several patents.


Laboratory developed tests (LDTs): understanding FDA's current proposed regulations
Richard Montagna, PhD, FACB
Senior Vice President for Scientific and Clinical Affairs
Rheonix

Early embodiments of laboratory-developed tests (LDTs) were simple tests performed by individual laboratories that maintained a close relationship with the requesting physician. Due to the proximity of the lab to the requestor and the ability to directly communicate results, FDA was willing to exercise "enforcement discretion" and therefore not assume a direct regulatory role. Since 2010, however, FDA has signaled that it planned to dramatically expand its regulatory oversight of LDTs. FDA's primary rationale was that LDTs have become much more complex and that thousands of samples are shipped daily throughout the US for testing by remote laboratories. In October 2015 FDA released two draft guidance documents outlining its plans to implement a risk-based enforcement of some LDTs. Battle lines have been drawn between the FDA and CLIA laboratories and many laboratory associations. The talk will describe the current state of affairs and how Rheonix is working with the FDA to provide microfluidic based systems that will allow laboratories to remain compliant with the changing regulatory landscape.

Biography: Dr. Richard Montagna is the Senior Vice President for Scientific and Clinical Affairs at Rheonix, Inc., holds a PhD in Molecular Biology and is a Fellow of the National Academy of Clinical Biochemistry. He is also an Adjunct Professor at Cornell University in the Department of Biological and Environmental Engineering. He has won over $8 million of grant funding as Principal Investigator, published 44 peer-reviewed scientific papers and has led the commercialization of over 40 biotech products, including FDA approved diagnostics. In 1988 he testified before President Reagan's AIDS commission regarding the prevalence of HTLV-1 antibodies in the US blood supply, urging the commission to mandate nationwide blood screening, which was implemented within one year. In 2008 he was nominated for the National Research Initiative Discovery Award in recognition of work using nanostructures for the direct detection in of prions in serum.


From dream to reality: microfluidic based cancer diagnostics using simple blood samples
Rolf Muller, PhD
CEO
BioFluidica

Novel biomarkers from blood samples (liquid biopsies) will revolutionize the world of diagnostics. The existence of these biomarkers, including circulating tumor cells (CTCs), cell free DNA (cfDNA), exosomes, and their clinical relevance, have been known for many years and the knowledge is rapidly increasing. The problem with these important disease indicators is their extreme low abundance in the blood stream. For example, the occurrence of CTCs that were shed by a cancerous tumor or diseased tissue is one cell in a background of more than 5,000,000 white blood cells and 9,000,000,000 red blood cells. Current technology is either not sensitive enough, lacks purity, or does not allow manufacturability and scalability to reach clinical relevance. Novel solutions and devices developed by several companies are overcoming this problem by using microfluidic and MEMS technologies. This talk will briefly discuss how cancer is diagnosed now and, more specifically, how cancer is currently diagnosed through blood tests. From there, most of the talk will provide a comprehensive overview of existing R&D efforts and commercial technologies and tools to diagnose cancer through blood tests using microfluidic and other micro/MEMS technologies, as well as existing challenges and problems with these approaches. The talk will also discuss future directions, roadmaps, and emerging trends for this class of diagnostic technologies and devices.

Biography: Rolf Muller is a biotechnology leader combining science and business knowledge to build and grow successful technology companies that further healthcare and the field of personalized medicine. He has structured and guided highly efficient multi-disciplinary research and commercial teams through funding, product development, and successful product launch into global markets. Prior to joining BioFluidica he was the Founder and President of Biomatrica, which he developed from an idea to be a global leader in biopreservation technologies for diagnostic and health care companies. Over the last 16 years, he has been involved in analyzing markets and developing strategies to position biotechnologies to maximize value. He has interacted with most of the major pharma and biotechnology companies to obtain funded development contracts, joint projects, and partnerships. In addition to successfully raising capital from investors, he also raised non-dilutive capital from CDC, NCI, NIH, DARPA, In-Q-Tel and DOD. He obtained his PhD in biochemistry from the Pasteur Institute in Paris, France.


MEMS in medical devices: the time is now
Igino Padovani
Business Development Manager
Robert Bosch

The recent trends in healthcare present a new set of demands for the healthcare providers, the reimbursement system, and the medical devices makers. This presentation will discuss how these demands drive tangible growth opportunities for the leading MEMS manufacturers. With 25 years of history, the MEMS industry carries a formidable set of competences, which is well-suited to address the new needs of the healthcare system. Some examples will be described through specific case studies in technology R&D, product development and quality management. The case studies will revolve around new medical devices such as a lab-on-a chip (LOC) for rapid molecular diagnostics and a breathalyzer for early detection of respiratory conditions. While the technological capabilities of the MEMS industry offer significant benefits for medical devices, a set of challenges have historically prevented large-scale impact in this area. These challenges include sustainability of R&D expenses and development of new channels to revenues. The current trends in diagnostics, telemedicine and patient monitoring have the characteristics to allow MEMS players to overcome these challenges and play a significant role in the medical market.

Biography: Mr. Igino Padovani is Business Development Manager for Vital Sensors at Robert Bosch LLC in Palo Alto, CA. He has a long history in MEMS and biosensors product development and product definition. His mission at Bosch is to generate new business opportunities and to develop strategic partnerships in health and wellbeing areas. Prior to Bosch, he was product definer for Maxim Integrated in San Jose, CA, working on biosensors for consumer and medical markets. At Maxim, Mr. Padovani was also a founding member of the sensing solutions business unit and he was instrumental in building and marketing the MEMS product line from ground up. Before Maxim, Mr. Padovani worked in MEMS R&D at STMicroelectronics in Cornaredo, Italy, where he developed the microphone product line in partnership with OMRON, JP. Mr. Padovani holds seventeen patents and patent applications and has a Master's degree in Electrical Engineering from Politecnico di Milano, Italy.


Practical aspects of integrating MEMS into clinical diagnostics instruments
Bruce Richardson
President and CEO
Accel Biotech

MEMS and related lab-on-a-chip technology are enabling clinical laboratory instrumentation to progress on a miniaturization path. The desire for miniaturization in this space has several drivers including implementation of point-of-care devices, cost saving on expensive reagents and the prospect of multiplexing, i.e. parallel analysis of different biomarkers in a single sample. DNA sequencing and droplet digital PCR are key molecular diagnostic applications also driving the use of chip-based sensors. New MEMS technology may represent breakthrough capability, but require significant downstream development to be incorporated in a working instrument. Focusing on system development, this talk will explore the numerous challenges of integrating MEMS into a complete lab instrument. Challenges include creating a disposable package around the sensor, fluidic interfaces, bubble formation, cost and handling of reagents, sample preparation requirements, constraints imposed with optical detection and regulatory requirements. Case studies will be used as examples of good and bad practices to get to market quickly.

Biography: Accel Biotech CEO Bruce Richardson started the company in 2007, bringing three decades of innovative design and management experience to the organization. Bruce is named on 40 patents and has worked in the medical device, life science instrumentation and biotechnology industries. He is an established industry expert on overcoming technical challenges and delivering products that succeed in the marketplace. Bruce has previously worked at BC Tech, Lathrop, and Arcturus Engineering on leading and managing the development of products. His experience spans optics, electronics, lasers, mechanical design and much more. He is an alumni of the University of California, Berkeley.


Trends and applications of MEMS in monitoring and diagnostic devices for low-resource settings
Sona Shah
CEO
Neopenda

With design considerations driven by severe limitations such as power, cost, and size, MEMS enabled technologies are increasingly relevant in the development of medical innovations for low-resource settings. From monitoring fetal heart rate during labor to diagnosing malaria in remote locations, the need for inexpensive and portable devices is growing. Tuberculosis, malaria, and HIV/AIDS are consistently amongst the leading causes of death in the developing world. Diagnostic tests for these conditions are often expensive and cumbersome, and may take several days to return results. Researchers and innovators often turn to microfluidic or microelectronic solutions as mechanisms to create sensitive and specific diagnostic and monitoring devices that can be used in even the most severely resource-limited settings. There are challenges associated with these devices, however, as the field is only recently growing and it is often difficult to balance advanced technology with cost constraints. This talk will provide an overview of the current trends and applications of MEMS based technology solutions for the developing world.

Biography: Sona Shah is co-founder and CEO of Neopenda, a global health startup working to reduce newborn mortality in low-resource settings. Neopenda is developing a neonatal vital signs monitor for use in clinical settings to help nurses efficiently and effectively detect when a neonate is in distress. Sona is currently pursuing her Masters in Biomedical Engineering at Columbia University and has a BS in Chemical Engineering from Georgia Tech. She has experience working in the developing world as a teacher and as an engineer, where she first discovered her passion for global health. Sona has also spent several years working in the pharmaceutical industry.


Machine learning and sensors for improved medical care
Kevin Shaw, PhD
CTO and Co-Founder
Algorithmic Intuition

The world of medicine is fundamentally about sensing the needs of the patient. In earlier days this could only be done directly in the presence of a medical professional while in their office. Now however, we have sensors that can gauge a patient's condition as they go about their life. Sensors can track cardiac events, respiration rates, food intake, sleep, pill taking, social interaction and daily activity wherever they may be. But how is a medical professional to "boil down" this torrent of data, including days' or weeks' worth of measurements in any meaningful way? Now we are beginning to see the required advances in software tools and algorithms to handle this data. Machine learning, deep neural networks and artificial intelligence are some of the tools being used to pre-process and flag data, so that medical professionals can either be shown only important events or be alerted as they are happening. And, even beyond this, we are seeing the ability to predict and anticipate disease state progression in ways never before possible. In this talk, we will discuss some of the recent applications of machine learning for medical sensing. We will explain what machine learning is, why it is so powerful, and what it can and can't do. Next, we will look at the powerful new combinations of sensors that are being developed. And finally, we will look forward to some of the expected advancements coming down the road.

Biography: Dr. Kevin A. Shaw has 25 years of experience working in the field of MEMS and sensors. Currently he is CTO and co-founder at Algorithmic Intuition, where machine learning algorithms are used with sensors to provide insight in wellness and medical products. Dr. Shaw has five degrees including a doctorate in MEMS from Cornell University and a Masters in business from Stanford Graduate School of Business. In the 90s, he founded his first company (Ironwood Technology, which was later acquired). He next joined Kionix where he designed MEMS inertial sensors while working to bring up a 150mm semiconductor fabrication facility. Kionix was acquired by Rohm Semiconductor in 2000 for $233 million. He later joined Sensor Platforms to build algorithms for MEMS sensors and became CTO in 2009. Sensor Platforms was acquired in 2014 by Audience, Inc. Dr. Shaw has 30 US patents in MEMS, sensors and algorithms.


Fabrication processes and materials for medical MEMS
Brian Stephenson
President and COO
Tronics MEMS

As medical technologies continue to show significant improvements to meet the high levels of requirements driven by the healthcare industry, more and more startups and traditional medical device manufacturers are switching from traditional technologies to nano and microsystems to enhance existing product performance or provide new features. While this transition opens up a lot of opportunity for manufacturers of MEMS devices, it also presents new challenges in addition to the existing development and commercialization challenges inherent in MEMS. These new devices require materials, integration and processing method changes to be able to meet the requirements of the healthcare market. Substrate and thin film materials consisting of polymers, glass, and ceramics are common and must be merged with existing materials and processes. Thin films using platinum, titanium, and new processes utilizing graphene and carbon nanotubes (CNTs) are becoming more common. Adding non-traditional process capabilities such as enzyme fixing, fluid handling, and sterilization processes on the same production line as the MEMS devices themselves is desired due to the tight integration of these processes to front-end manufacturing and have significant implications for the overall performance of the device. This talk will provide an overview of considerations for manufacturers moving into the medical device domain. The talk will also discuss additional challenges including familiarization with new quality standards and requirements, FDA approval processes, and increased documentation and traceability responsibilities through all phases of development and manufacturing.

Biography: Brian Stephenson has over 23 years of experience in the high volume semiconductor and MEMS industries. He began his career with Texas Instruments in Houston, Texas as a process engineer. Next, he developed and put into production the first oxide and tungsten CMP processes within STMicroelectronics. Brian then joined WaferTech (a subsidiary of TSMC) where he started up and transferred 0.18um CMOS processes for STI, oxide and tungsten CMP processing in addition to managing the CVD/metal deposition equipment engineering group. Brian also spent four years as the Director of US Applications Development with Ebara Technologies, Inc., managing development and field support teams for advanced (90nm node) 300mm copper and fixed abrasive planarization processes. After Ebara, Brian re-joined STMicroelectronics in Dallas, Texas as an engineering manager where his team worked on several MEMS technologies, from microfluidic devices such as inkjet print-heads to biomedical devices, including lab-on-chip and glucose sensors. In 2008, Brian partnered with Tronics Microsystems in France to found Tronics MEMS, Inc. in Richardson, Texas to continue to serve the custom MEMS development and manufacturing market. Brian holds a Bachelor's degree in Engineering Physics from Southwestern Oklahoma State University.


Next generation sample enrichment and detection capabilities using microfluidic and nanofluidic interfaces
Aaron Timperman, PhD
Director of Research
University of Notre Dame

Many bioanalytical analyses involve a search for rare targets amongst a complex background that require low limits of detection and high selectivity. Microfluidic or lab-on-a-chip (LOC) systems are generally well suited for such analyses and their suitability further increases as sample volume decreases. As channels are further decreased in size to the nanochannel regime, new transport processes and physics are encountered. One very important change is the role of surface charge, which continually increases as the channel's critical dimension decreases. This unique behavior can be used to enhance the functionality of microfluidic LOC systems to provide effective means for sample enrichment, detection, and unique separations. Electrophoretic sample enrichment schemes can provide sample enrichment of 1000-fold in a few minutes to greatly enhance the ability to detect trace-level targets. Nanopore detection systems provide exquisite sensitivity with the simplicity and compact format of electrochemical detection systems. These unique characteristics are providing motivation for their continued incorporation into commercial microfluidic systems. This talk will provide an overview of the most notable recent R&D efforts and advances in this technology area, as well as examples of use cases and applications in commercialized systems.

Biography: Dr. Timperman has enjoyed working across a number of disciplines throughout this his career and his research have included activities of chemistry, biology, engineering, health sciences, and oceanography. While obtaining his PhD in Analytical Chemistry at the University of Illinois, he gained experience with capillary electrophoresis, optical detection, and instrument design. Following his graduate work, he broadened his expertise with post-docs in chemical oceanography at the University of South Florida, and proteomics at the University of Washington. His first faculty position was in the Department of Chemistry at West Virginia University where he focused on the development of microfluidic systems for proteome analysis, developing novel nanofluidic/microfluidic approaches to sample enrichment and a novel microfluidic separation called traveling-wave electrophoresis. After 11 years at the WVU, he moved to ERDC-CERL, a US Army Corps of Engineers lab in Champaign, Illinois to strengthen a program broadly aimed at biosensing. In the summer of 2015, he moved to the University of Notre Dame as Research Director of the Advanced Diagnostics and Therapeutics Initiative and to join the faculty of the Department of Chemistry and Biochemistry, where his current research interests are at the interface of microfluidics, proteomics, and microbiology.


Next-generation point-of-care testing: clinical needs, technologies and opportunities
Ping Wang, PhD
Director, Clinical Chemistry, Pathology and Genomic Medicine
Houston Methodist Hospital

Next-generation diagnostic point-of-care technologies (POCT) are emerging. Many of these technologies feature potential applications of nanotechnology, microfluidics and sensors that are compatible with mobile phones and wearable electronics, enabling more rapid sample preparation, ease of access to diagnostics, and more seamless data transmission. The challenges lie in how to bridge these novel technologies with current clinical needs, how to interpret the health data generated, and how to translate the technology and data into improved patient outcomes. Partnerships between clinicians, laboratorians, scientists and entrepreneurs are essential in order to meet the challenges. This presentation will review current clinical diagnostic needs from a clinical laboratory perspective, trends and promises of next-generation POCT, and discuss opportunities and strategies needed to realize these promises. Some novel POCT technologies being developed in the speaker's lab will also be discussed. The goal of the presentation is to spark discussions, collaborations and partnerships with stakeholders in academia and industry.

Biography: Dr. Ping Wang is currently the Medical Director of Clinical Chemistry at Houston Methodist Hospital and Associate Professor of Pathology and Laboratory Medicine at Weill Cornell Medical College. She chairs the POCT committee at the Houston Methodist Hospital Health System. She is also Director of the ComACC-accredited Postdoctoral Fellowship Program at Houston Methodist Hospital. Dr. Wang is board certified in Clinical Chemistry, Molecular Diagnostics and Toxicological Chemistry by American Board of Clinical Chemistry, for which she currently serves as Vice President and Chair of Examination Committee. She is a fellow of the National Academy of Clinical Biochemistry. She has published over 60 peer-reviewed papers, abstracts and book chapters. Besides clinical service and teaching, Dr. Wang's current research interests focus on translating novel research and start-up findings into clinical diagnostic tools. She is principal investigator of several NIH grants focusing on novel point-of-care diagnostic devices, and actively collaborates with major diagnostic companies as well as start-up ventures to develop next-generation tools.


Breath analysis: new potential for personalized non-invasive health diagnostics
Konstantin Zamuruyev
Research Engineer
University of California, Davis

Exhaled breath analysis is a new emerging field expected to advance personalized non-invasive health diagnostics. Exhaled breath contains a complex mixture of compounds including CO2, NO, inorganic compounds such as ammonia, volatile organic compounds (VOCs), and non-volatile compounds trapped in aerosols. This mixture reflects the concentrations of the various constituents at the alveolar-blood interface. Some compounds may reflect the exogenous “exposome” from the surrounding air. Other breath constituents are produced endogenously by the body during normal physiological processes, and their concentration shifts can reflect disease or disorder processes. Finally, microorganisms in the respiratory tract proliferate and can produce unique metabolite signatures to the pathogen species. By capturing and analyzing the constituents in exhaled breath, we can gain insight into the patient’s health status. Currently, breath samples are usually analyzed for metabolite content using commercial bench-top mass spectrometers. Ultimately, as new MEMS-based mobile detection technologies are developed, we envision breath testing to be performed directly at the point-of-care. This presentation is targeted to give an overview of the latest research in this field, available commercial instruments, and methods for health diagnostic with breath analysis.

Biography: Konstantin Zamuruyev is a graduate researcher at the Bioinstrumentation and BioMEMS Laboratory at the University of California Davis. He is a lead engineer to develop portable platforms for breath collection. Konstantin completed a number of research projects on hardware design and optimization of the methodology for breath collection with human and animal subjects. His experience in MEMS and microfabrication allows him to work on transferring optimized bench-top health-diagnostic platforms into microscale systems that are targeted to find applications in personalized mobile medicine and environmental exposome monitoring. His particular research interests are in microfluidics, liquid, and gas analysis systems. He is a recipient of a scholarship from National Institute of Environmental Health Sciences (2011-2014) and a training grant from Center for Comparative Respiratory Biology and Medicine (2014-2016).


(2016 sponsor presentations, listed by sponsorship level)

Platinum Sponsor

MEMS manufacturing: serving the biotech industry by enabling innovative biomedical devices
Christophe Lemaire
Senior Account Manager
Silex Microsystems

Smaller, lower power, real-time monitoring, wearable or implantable, and scalable, are increasingly desirable attributes that define the trends shaping the life sciences and biomedical products industry. These trends drive the need for MEMS-based structures and devices of ever smaller scale, greater precision and/or complexity, for new materials, as well as for sophisticated, yet robust and repeatable manufacturing processes. MEMS technology has been used in genomics, proteomics and molecular diagnostics for several years, enabling advances in DNA sequencing, point-of-care diagnostics and therapeutics. More recently, bioMEMS are transforming the way drugs are being delivered, and enabling breakthroughs in tissue engineering. As MEMS foundries expand their services and capabilities to meet the demands of these emerging applications, they are also faced with, and must overcome, new challenges. Silex Microsystems, the world’s #1 pure play MEMS foundry, has served the biotech industry for over 15 years. With unmatched MEMS process engineering expertise and state-of-the-art equipment and capabilities in its Class 1-10 200mm fab, Silex is more than ever committed to bringing innovative and cost effective MEMS manufacturing solutions to biomedical devices companies.

Biography: Christophe Lemaire is Senior Account Manager at Silex Microsystems AB, the world’s leading pure-play MEMS foundry. His primary responsibility is to provide the technical and commercial interface between established and prospective customers, and Silex’ MEMS process development and manufacturing organizations. In addition to the bio-medical markets, his accounts are found in many areas of application, including consumer, industrial, telecommunications and photonics. Christophe has over 25 years of business development, marketing, and sales experience in the semiconductor manufacturing business. Prior to joining Silex, Christophe was the main driving force behind the consumer markets’ early adoption of Analog Devices’ successful line of MEMS inertial sensors in a variety of portable devices. While at Analog Devices, Christophe led global marketing and business development initiatives for several of the company’s mixed-signal product lines. Previously, he held a marketing engineering role at Precision Monolithics. Christophe started his career as Systems Design Engineer at Groupe Tekelec, in Paris, France. Christophe holds a BS in Electrical Engineering from École Supérieure de Technologie Électronique, Paris, France, and an MBA from the University of San Francisco.


Program Sponsor

MEMS manufacturing for biomedical device companies
Jessica Gomez
CEO
Rogue Valley Microdevices

Bringing a new MEMS-based biomedical device to market presents numerous challenges, not the least of which is moving from the design phase to pilot production for the critical MEMS component technology. What should biomedical device innovators expect from their foundry relationship? With a roster of commercially successful customers in microfluidics, lab-on-chip platforms and other biomedical devices, precision MEMS foundry Rogue Valley Microdevices offers custom design services with an eye toward manufacturability. The company’s design-for-manufacturing program encompasses the most essential steps in the manufacturing process: design review, process development, process optimization, cost reduction in preparation for volume production, and establishment of second source suppliers. Learning about foundry engagement before diving in spares you from potentially expensive and time-consuming mistakes, leaving you more prepared and ready to collaborate with your ideal partner.

Biography: As founder and CEO of Rogue Valley Microdevices, Jessica Gomez has created a world-class precision MEMS foundry in the heart of Southern Oregon. Integral to her role as CEO, Ms. Gomez practices a business philosophy of offering best-in-class process technology and R&D expertise to customers. Prior to founding Rogue Valley Microdevices in 2003, Ms. Gomez gained her experience in semiconductor processing and production management through positions at Standard Microsystems Corporation, Integrated Micromachines and Xponent Photonics.


(2016 Technology Showcase speakers – listed alphabetically, by company name)

nCapsulate freeform packaging for medical MEMS: delivering system benefits by shaping the package to the application needs
Oliver Maiwald
CEO
Sencio

nCapsulate provides the ultimate packaging solution. Capable of embedding electronic and mechanical systems together, it enables unique integration possibilities resulting in a wealth of benefits and cost savings for manufacturers. Sencio’s plastic encapsulation for MEMS and sensors is a cost-effective process with a number of benefits. It allows the sensor surface of the system to be partially exposed to the environment while protecting the embedded sensor and interconnections (wires) against destructive elements, including stress and hazardous gases and fluids. This functional packaging is highly versatile, and is compatible with technologies from exposed die molding to multi-die packaging SiP (System in Package), among many others. nCapsulate enables complete freedom of package shape, or freeform encapsulation. The package can be accurately shaped to the exact requirements of the application.

Biography: After developing DECT hardware and software applications at Höft & Wessel, Oliver began his semiconductor career at National Semiconductor as a product application engineer. Here he gained both technical and customer expertise, working on everything from RF and software to full applications. He then went into product marketing at Dialog Semiconductor, where he led efforts to integrate DECT into Internet access devices, invented DECT ULE and took part in DECT standardizations at ETSI. Oliver started to lead Sencio on March 1, 2014. Oliver holds a Master’s degree in telecommunication engineering from the University of Hannover in Germany.


Evaluating the integrity of medical MEMS devices
Ginny Ho
Automation Prospect Specialist
Sonoscan

For many years acoustic microscopy (AM) techniques have been utilized to evaluate the quality of the bond between materials, especially for microelectronic devices. AM has been established as one of the few techniques within SEMI MS8-0309 - GUIDE TO EVALUATING HERMETICITY OF MEMS PACKAGES that can provide reliability and quality control data for MEMS hermetic seals. However, little has been done to determine the minimum seal width required to ensure long-term MEMS package hermeticity based on the permeability of the various seal materials. C-SAM® techniques and methods are non-destructive analyses that provide data on how well a cap or lid is bonded to the cavity package, the actual width and thickness of the seal material, plus any voids embedded within the seal. The same techniques used to inspect cavity seals is utilized for the inspection of lab-on-chip channel seals and constrictions. The brief presentation by Sonoscan will include background on C-SAM inspection techniques and how they can be used for various medical MEMS applications.

Biography: Ginny Ho joined Sonoscan in April 2005 as an applications engineer and worked closely with customers on acoustic evaluation and fault detection involving both electronic component packages and other highly integrated parts. In 2007, she was appointed as Regional Sales Manager for China/Hong Kong to oversee and coordinate sales and product support for that region. In 2015, Ms. Ho returned to the U.S. to use her experience to assist the company with their automated inspection system sales and took on the role of Automation Prospect Specialist. Her previous professional experience is in test and measurement applications, marketing and sales. She received her Master’s Degree in Computer Science from Roosevelt University and her BS in Testing and Measurement Technology and Automation Control from Chongqing University. In her spare time she enjoys traveling, reading and music.


Structured glass wafers for MEMS packaging improvement
Ryosuke Kanai
Market Development Manager
TECNISCO

We are " TECNISCO, LTD.", a processing supplier for glass products used in MEMS and glass microfluidics for DNA sequencing and chemical manufacturing, based in Tokyo, Japan. We can provide the 4 following advantages by undertaking several processes (cutting, grinding, polishing, metalizing, and bonding as a one-stop solution partner: 1) maintaining the stability of product quality, 2) shortening the lead time, 3) providing better cost-performance products and services, and 4) solving customers’ problems by crossing our technologies and developing original products. We support design and manufacturing for your MEMS packaging as a solution partner.

Biography: Mr. Ryosuke Kanai is a Market Development Manager at the Global Marketing Division of TECNISCO, LTD. Ryosuke has over 9 years of successful sales and marketing experience, directing sales and business development, and 6 years of mechanical design and engineering experiences. He is involved with 3 new products’ development: a glass chip for DNA sequencing, an implantable device for medical devices and an insulation type of heatsink for high power laser diodes. He received 1 internal award, and has 1 pending patent. He creates the new business opportunity by contacts not only inside but also outside the company.


(2015 speakers – listed alphabetically, by speaker’s last name)

Medical wearables and value driven medical care: an overview of emerging business models
Mark Blatt, MD
Worldwide Medical Director
Intel

The business and reimbursement climate in the USA (and worldwide) is rapidly changing from volume driven fee-for-service to payment models that are driven by the value of the outcomes. This change is facilitated by the availability and deployment of medical wearable in large-scale healthcare applications. In order for such deployments to be successful they must fulfill certain business and technical requirements. They must address meaningful business use cases (e.g. patient safety, health and wellness, avoided readmissions, chronic disease management) that offer competitive advantages over more traditional care models. They must be easy to use, yet highly secure; solve personalized problems yet be highly scalable; be both easy to manage and cost effective. Does your wearable solution fit these criteria? How do you turn your components and systems into a viable business model? This talk will focus on how your medical wearable solution can be deployed, at scale, to help solve real world business problems in today's healthcare industry.

Biography: Dr. Mark Blatt joined Intel in 2000 working in the New Business Group. He is currently Worldwide Medical Director, Enterprise Solution Sales, in the Sales and Marketing Group. He has a particular interest in integrated care delivery, mobile point of care, secure computing and the emergence of cloud computing services. Prior to joining Intel, Dr. Blatt was the managing partner of a five-provider group in family practice. He is a graduate of Albany Medical College (MD) and Yale University (MBA). Dr. Blatt currently serves on the Board of Directors for the Clinical Groupware Collaborative, and Bryan University. He is a member of the IEEE Medical Technology Policy Committee, the American Telemedicine Association, HIMSS, a lifetime member of the American Academy of Family Physicians, and a diplomat of the American Board of Family Practice (1982-2010).


The future of wearables: from a fitness accessory to an essential clinical tool
Uli Chettipally, MD, MPH
Emergency Physician
Kaiser Permanente

According to IHS, the worldwide market for sensors in wearables will expand to 466 million units in 2019. Wearable devices themselves will increase to 135 million shipments, three times the current number. This rapid growth in the market is exciting. Even more exciting to watch is the transition of wearables from a health and fitness accessory into a clinically useful tool; a tool that will be able to predict, diagnose and monitor disease processes. This talk will discuss: (1) the hurdles that need to be crossed to take advantage of this market opportunity, (2) the market forces and healthcare environmental factors that help with this transition, (3) the suggested path in this transition into a more clinical health care market, (4) the changes in the regulatory framework that is occurring in anticipation of this growth, and (5) the potential of partnerships among various stakeholders to leverage diverse strengths.

Biography: Dr. Uli Chettipally is an emergency physician, researcher and an innovator with 20+ years of experience in patient care, clinical research and technology innovation. He is the co-founder and CTO of CREST Network, a consortium of emergency physicians and researchers at Kaiser Permanente, a large integrated health care delivery system in Northern California. He is also the co-founder of the San Francisco Bay Area Chapter of Society of Physician Entrepreneurs (SoPE), a non-profit that brings information, innovation and inspiration to healthcare entrepreneurs. He is a thought leader, strategist and an advisor for several projects. He is spearheading several technological innovations involving mobile healthcare, clinical decision support, knowledge translation, big data and shared decision making tools that will take us into the next generation of advances in disease prevention, risk stratification and outcomes based intervention.


Bending technology: a surgeon's perspective on wearable devices
Sanat Dixit, MD
Co-Founder and Chief Medical Officer
Octovis

The recent crop of wearable consumer devices has generated tremendous interest and spurred application development for a host of industries, including healthcare. For individual physicians, the enterprise level introduction of new technologies can be a mixed blessing. The allure of innovation is quickly mitigated by the constraints of unfamiliar hardware and archaic software, often leading to inefficiency, disengagement and frustration. Physicians, as critical stakeholders in the healthcare continuum, often have little input on technology development, integration and adoption, yet they end up being the primary end-users. This presentation will touch upon the perspectives of the end-user, explore models on how to more optimally approach wearable technology integration into the healthcare space, and offer specific use case scenarios designed to enhance both workflow and engagement.

Biography: Dr. Sanat Dixit is a board certified neurosurgeon specializing in cerebrovascular surgery. He is a co-founder of Octovis, a Nashville based healthcare company developing integrated workflow solutions for healthcare that incorporate wearable devices in the care cycle. Dr. Dixit was born in Lucknow, India and moved to the US in 1973. He completed his undergraduate studies at Case Western Reserve University in Biology and English. He earned his Doctor of Medicine degree at SUNY Stony Brook and completed his neurosurgical training at Pennsylvania State University's M.S. Hershey Medical Center. Following this, Dr. Dixit completed a two-year fellowship in cerebrovascular and neuro-interventional surgery at the prestigious Semmes Murphey Clinic where he stayed on as faculty through 2006. In 2012, he earned a Master's in Business Administration from Vanderbilt University. An active clinician, he maintains a thriving practice in Nashville, Tennessee. He is a Fellow of the American College of Surgeons and Diplomate of the American Board of Neurological Surgeons.


Wearable sensors and big data computing for mobile health: monitoring to interventions
Emre Ertin, PhD
Associate Professor
Ohio State University

Recent advances in wearable sensing and mobile computing have given researchers the ability to collect unprecedented amounts of data about everything from biology to behavior that can explain and improve people's health status. Day-to-day data from wearable sensors allows for better and more personalized decisions in regard to health care and management. Specifically, real-time monitoring can optimize care delivery via delivering just-in-time mobile health interventions. However, there still exist a multitude of challenges to implement mobile health systems. First, while wearable sensors provide a large, noisy, and complex data stream about the many facets of a patient's life and health, there is still a gaping need for a computational engine that can transform sensor data into sets of useful bio-markers readily interpretable by clinicians. Second, the lack of mathematical models of human health and behavior and its interactions with the environment makes the intervention design a challenging task. Third, wearable sensors have to be designed to blend into people's daily life routine while providing information on physiology and behavior. This talk will describe recent progress in wearable sensing and computing to address these challenges, including behavior inference from multi-mode physiological sensors, models of stress, illicit drug usage, smoking and design of wearable UWB sensors for contactless measurement of heart and lung motion and pulmonary edama which has the potential to dramatically expand the scale of physiological data we can obtain in the field while minimizing the burden to participants.

Biography: Emre Ertin is a research associate professor with the Department of Electrical and Computer Engineering at the Ohio State University. He received his BS degree in Electrical Engineering and Physics from Bogazici University, Turkey, in 1992, his MSc degree in Telecommunication and Signal Processing from Imperial College, United Kingdom, in 1993, and his PhD degree in Electrical Engineering from the Ohio State University in 1999. From 1999 to 2002 he was with the Core Technology Group at Battelle Memorial Institute. At Ohio State he served as principal investigator on AFRL, ARL, DARPA, NRL, and NIH funded projects on novel sensor concepts with applications to radar sensing and mobile health. He developed reference designs for software defined radar systems that enable both MIMO radar and RF bio-sensing research under the AFOSR Discovery Challenge Trust program. For DARPA's Knowledge Enhanced Compressive Measurement program, he designed wideband radar sensors with deep sub-Nyquist receiver structures and led RF bio-sensor development under NSF support. He is an investigator with the Davis Heart and Lung Research Institute at the Ohio State University and serves as the Sensor Platform Technologist for the recently awarded NIH Center of Excellence in Mobile Sensor Data-to-Knowledge (MD2K) that develops big data solutions to quantify physical, biological, behavioral, social, and environmental factors that contribute to health and wellness in daily life.


Non-invasive wearable transdermal microsystems for continuous monitoring of bioanalytes
Anand Gadre, PhD
Director, Nanofabrication Research Facility
University of California, Merced

This talk will provide a review of breakthrough technologies focused on the non-invasive wearable microsystems for health monitoring applications. Such sensor systems have the potential to provide new sources of physiological information through interaction with a variety of body fluids, such as saliva, sweat and interstitial fluids (ISF). These body fluids have been used for non-invasive detection of inherited metabolic disease, organ failure, and drug efficacy. However, most of the activity in this field has focused on non-invasive glucose sensors in connection to efficient diabetes management. Of these, electrochemical sensors have gained a dominant role in clinical diagnostics owing to their high performance, portability and low cost. Therefore, this talk will focus on the recent developments in wearable electrochemical non-invasive micro/nanoscale sensors for diabetic monitoring. It is expected that such wearable non-invasive sensors will bring many exciting opportunities for continuously monitoring the human body across a broad range of bio-medical and fitness applications.

Biography: Dr. Anand Gadre graduated with his BS and MS degrees in Applied Physics from the University of Mumbai. Anand completed his doctorate from the Institute of Chemical Technology (ICT), India. In 2001, Anand joined University of Maryland as a Postdoctoral Fellow and later worked as Research Associate in the Nanoscience and Microtechnology Laboratory (GNuLab) at Georgetown University. In 2004, Anand joined the State University of New York at Albany as an Assistant Professor of Nanobioscience, and later was promoted as an Associate Professor with tenure. Anand earned his MBA degree from the University at Albany in 2009. In 2011 Anand joined as the Director of a Core Nanofabrication and Stem Cell Research Facility at the University of California, Merced, where he is currently pursuing his research in nanobiotechnology. Anand has published several peer-reviewed papers, co-authored book chapters, and served as a referee for several national and international journals.


Wearables for Parkinson's disease: validating sensors and apps for targeted clinical applications
Joseph Giuffrida, PhD
President and Principal Investigator
Great Lakes NeuroTechnologies

Parkinson's disease impacts quality of life for millions of people globally. Symptoms include tremor, slowed movements, stiffness, freezing, and gait abnormalities. Therapies to control symptoms can cause side effects of wild, irregular movements. Measuring symptoms and side effects, which fluctuate daily, is critical for optimizing patient care and clinical trials. Fluctuating symptoms and mobility deficits associated with Parkinson's create a targeted market for wearable sensors and telemedicine. While motion sensors are now common in wearables and mobile devices, gross movement measures do not provide a direct measure of Parkinson's features, as each symptom has very distinct features. Important details in assessing Parkinson's lie in protocol design, positioning and sensitivity of sensors, and clinically validated algorithms. This ensures targeted Parkinson's symptoms can be differentiated from daily activities that may mask or mimic those symptoms. Finally, balancing the tradeoff of data sensitivity versus user compliance represents critical constraints for targeted medical applications.

Biography: Dr. Joe Giuffrida received his PhD in Biomedical Engineering from Case Western Reserve University in 2004. His background focuses on movement disorders with extensive experience in clinical research, new technology development, and commercialization of medical devices. He has successfully secured and executed over $15 million dollars in programs funded by the National Institutes of Health and authored many scholarly publications and scientific presentations. Dr. Giuffrida is currently president and principal investigator at Great Lakes NeuroTechnologies, leading the company's growth through research, engineering, sales and marketing, manufacturing, and administrative teams. He has led global product launches of several wireless medical devices including Kinesia technology to assess Parkinson's disease using wearable sensors, mobile apps, and web applications for telemedicine, clinical trials, and programming deep brain stimulation. His teams have worked to validate the technology in over sixty publications, with domestic and international medical device certifications, and intellectual property for sensor-based Parkinson's assessment.


Sensing technologies for early identification of diabetic foot ulcers
David Goodman, MD, MSE
Co-founder and CEO
FeetFirst

Diabetes is the leading non-traumatic cause of lower extremity amputations in the US. Many people with longstanding diabetes experience nerve damage that results in loss of sensation in the feet, predisposing them to diabetic foot ulcers. These ulcers typically develop insidiously as people at risk have no way to identify the subtle changes that occur in the progression of a foot ulcer until it is obvious and usually advanced to the point that heroic measures (i.e invasive and expensive) are needed to save the foot, if it can be saved at all. Over the years, a variety of non-invasive technologies have been employed in an effort to develop a biomarker that can easily and reliably identify subtle and early changes in the foot that can trigger low cost interventions to prevent a foot ulcer from developing. This talk is focused on a review of these approaches and how they can be incorporated into the digital health ecosystem. Sensing technologies to be highlighted include pressure and thermal mapping as well as hyperspectral, near infrared, colorimetric and visible RGB photographic imaging.

Biography: David is the co-founder and CEO of FeetFirst, a digital health startup that is committed to making diabetic foot ulcers a thing of the past. Starting with co-inventing many of the early innovations in pulse oximetry and then later in remote disease management and now in digital health, David has been fortunate throughout his career to have positively impacted countless people around the world while delivering substantial returns to investors through innovations that he helped to invent. David's energies are now devoted to combining his expertise in biomedical sensing with the basic building blocks of digital health to create novel and scalable non-invasive biomarkers that enable better health at home as well as in the doctor's office. David holds a BAS in applied science and bioengineering and a MSE in bioengineering from the University of Pennsylvania. David also received an MD cum laude from Harvard Medical School and the Harvard-MIT Division of Health Sciences and Technology. David completed his internship at the University of California, San Francisco (UCSF) in the Department of Medicine. He holds 18 issued and 4 pending US patents and maintains clinical practices in California and Hawaii.


Soft electronics: strategy for future wearable devices
Jae-Woong Jeong, PhD
Assistant Professor
University of Colorado, Boulder

Conventional medical devices that interfaced with our body were rigid and bulky. Biological organs and systems, by contrast, are soft, elastic and curved. Recent research and development initiatives have established the materials and manufacturing foundations for a new class of soft electronics and optoelectronic devices that overcome this fundamental mismatch in mechanics and form. These technologies enable ergonomic, non-invasive integration of sensors and actuators, directly with human body, in ways that are impossible with conventional hard, planar device technologies. This talk will review recent advances in soft electronics and materials that can be applied for advanced healthcare in wearable forms. The talk will also introduce our research on "skin-like" epidermal devices that can be integrated with the skin in a way that yields intimate, conformal contact at the electronics-skin interface. Finally, potential applications of soft wearable electronics will be discussed.

Biography: Jae-Woong Jeong received his BS degree from the University of Texas at Austin in 2005, and his MS and PhD degrees from Stanford University in 2008 and 2012, respectively, all in electrical engineering. From 2012 to 2014, he worked as a postdoctoral research associate in Frederick Seitz Materials Research Laboratory, Beckman Institute for Advanced Science and Technology at the University of Illinois at Urbana-Champaign. Dr. Jeong is currently an Assistant Professor of Electrical, Computer, and Energy Engineering at University of Colorado, Boulder. His research interests are in developing flexible/stretchable bio-integrated devices, MEMS technology, and photonic microsystems for various biomedical applications including advanced health monitoring, human-machine interfaces, and drug delivery.


Heartbeat analytics: wearable sensors and applications
Joni Kettunen, PhD
CEO
Firstbeat Technologies

Heartbeat sensing is one of the emerging trends in wearables. Heartbeat is a physiological measure and as such provides access to human physiology and health. What can we learn from such data? One of the much discussed pathways is heart rate variability, which can be used for measuring stress and recovery. Heartbeat data is also related to physical condition, fitness, effects of exercise, sleep quality and metabolic processes. Different types of heartbeat sensors differ in accuracy, but they also enable different types of use cases. We will discuss different sensor types, such as ECG and PPG. Heartbeat is a physiological signal and the nature of such data should be taken into account in product planning, testing and validation. Heartbeat data, as derived from a wearable device, is complex and its interpretation requires understanding of the underlying biological dynamics. We will discuss the potential of heartbeat analytics to produce meaningful and physiologically valid metrics for health, wellbeing and sports.

Biography: Dr. Joni Kettunen is the co-founder and CEO of Firstbeat Technologies, a Finnish physiological analytics company. Kettunen received his PhD in 1999 from the University of Helsinki on heart rate variability based modeling of physiological stress. At Firstbeat, Kettunen leads a team of 40 physiologists, data scientists and software engineers specialized in physiological modeling. He has led Firstbeat into a leading heartbeat analytics company, working within preventive health care industry, with hundreds of elite sports teams, and having produced analytics for millions of consumer products.


Reliability standards and test methods for wearable medical devices
John McNulty, PhD
Principal Engineer
Exponent

The wearable medical electronics market is expanding rapidly due to the evolution and miniaturization of sensor technologies. Unfortunately, many qualification standards used in industry are either not medically-specific or fail to address new technologies and concerns. This presentation will address gaps in existing standards and relevant test methods for wearable medical devices in the following areas: biocompatibility/biostability in the context of skin irritation and key irritant materials besides nickel; dermal injury arising from single or multiple fault conditions that cause resistive heating; corrosion as typically evaluated for implanted devices but also subject to exposure to sweat and other liquids; adhesion of devices to skin as well as within multi-layer assemblies; and RF performance in the context of radiation emissions and immunity as well as "wireless coexistence" with other wearable or implantable medical devices.

Biography: Dr. John McNulty is a Principal Engineer in Exponent's Materials and Corrosion Engineering practice, where he has worked since 2009. He chairs the iNEMI working group on reliability standards for implantable medical electronic devices, and is a participant in the working group focused on wearable/portable medical electronic devices. His areas of specialization include failure analysis of components and systems, reliability testing and analysis, and electronic/opto-electronic packaging and assembly. He received a PhD in Materials Engineering from UC Santa Barbara and a BS in Materials Science and Engineering from UC Berkeley. He is a licensed Professional Engineer and a Certified Reliability Engineer.


MEMS technology: key innovation driver for wearable medical devices
Mehran Mehregany, PhD
Director, Case School of Engineering San Diego
Case Western Reserve University

Use of sensor-enabled wearable wireless health solutions to monitor the health condition of chronic disease patients is key to the quality of life of the patient and to reduction of cost of health care - by keeping the patient out of the hospital and emergency rooms. Chronic diseases account for 75%+ of the US health care expenditures. Monitoring for early intervention is key to avoiding long-term adverse outcomes for those at risk of developing chronic diseases. This presentation will elaborate on the important role that MEMS sensors play in enabling wearable, health monitoring solutions. Capturing data is the key to such solutions, which requires sensors of various modalities. MEMS sensors have the advantages of miniaturization, integration and batch fabrication - driving size, performance and cost advantages.

Biography: Mehran Mehregany received his PhD in Electrical Engineering from Massachusetts Institute of Technology in 1990, when he joined Case Western Reserve University. Mehregany founded the Case School of Engineering San Diego in July 2007, and its Wireless Health and Wearable Computing programs in 2011 and 2014, respectively. He is the Director of Case School of Engineering San Diego and Goodrich Professor of Engineering Innovation. Mehregany has over 360 publications describing his work (including a recent textbook on wireless health), holds 20 U.S. patents, is the recipient of a number of awards/honors and has founded several technology startups. His research interests are sensors, micro/nano-electro-mechanical systems, silicon carbide technology and microsystems, wearables and wireless health.


Low-power MEMS piezoelectric ultrasound transducers
Corina Nistorica, PhD
Principal Engineer
FUJIFILM Dimatix

Piezoelectric micromachined transducers are a novel approach for the construction of miniaturized, low-power portable ultrasound imaging systems and catheter transducer arrays. Here we report on the performance of a 3D MEMS ultrasound transducer. High performance PZNT film is implemented in 3D dome-shaped structures, which form the basic resonating cells of the transducer. Such domes having various dimensions and various resonant frequencies are built into a parallel network of resonators taking advantage of overlapping frequency spectra of multiple resonators similar to a high order linear filter. Additionally, low voltage operation of 5V to 20V, compatible with CMOS integration and low impedance (less than 50 ohms) are also demonstrated. Such a transducer can be incorporated in miniaturized low-power medical imaging and therapeutic systems.

Biography: Dr. Corina Nistorica is a Principal Engineer at FUJIFILM Dimatix, Inc and her focus is MEMS Ultrasound Transducers. Previously she has developed solutions for MEMS based storage technology on ferroelectric media as part of the Probe Storage Project at Seagate Technology. She has also worked on thermal MEMS actuators and studied tribology and hard coatings for MEMS devices at Zyvex Corporation. She has worked on MEMS gyroscopes based on piezoelectric film and on advanced electrical testing and physical characterization of MEMS devices as well as failure analysis.


A review of wearable sensors and actuators used for rehabilitation
Hyung-Soon Park, PhD
Associate Professor
Korea Advanced Institute of Science and Technology (KAIST)

With improvements in medicine in the last few decades, people are living longer, but with multiple, often complex, health conditions. From an epidemiological standpoint, the cohort of "baby boomers" in the developed countries is now reaching an age at which they will begin to severely stress the health care system. There is now an urgent need for improving health care systems for our aging society. For those having physical impairments from neurological disease or musculoskeletal problems, rehabilitation is a cornerstone for restoring body functions for daily activities such as manual tasks and walking. Accurate and reliable assessment, as well as proper physical therapy, are key factors for successful rehabilitation. As another example, robotic devices equipped with wearable sensors and actuators have been developed for intelligent rehabilitation. Additionally, this talk will discuss specific solutions based on wearable sensors and actuators used for hand rehabilitation. Finally, the presentation will provide examples of how wearable sensors are applied for reliable assessment of spasticity which is essential for effective rehabilitation.

Biography: Hyung-Soon Park received his PhD degree in mechanical engineering from KAIST (Daejeon, Korea) in 2004. From 2004 to 2009, he worked as a research associate and a research scientist with the Sensory Motor Performance Program at the Rehabilitation Institute in Chicago, Illinois. From 2009 to 2013, he was a staff scientist with Rehabilitation Medicine Department at the National Institutes of Health (NIH) in Bethesda, Maryland. Dr. Park is now an Associate Professor at the Mechanical Engineering Department, Korea Advanced Institute of Science and Technology (KAIST) in Daejeon, Korea. His current research interest focuses mainly on application of robotics and control technology for effective neuro-rehabilitation, and the study of neuromuscular impairments post brain injuries.


Maintaining independence: can wearable technology help older people remain mobile and live independent lives?
Brenda Reginatto
Research Lead
Insight Centre for Data Analytics
University College Dublin

How could older people live their lives independently for as long as possible without costly care? How could we ensure no older person would ever have a fall? How could we guarantee people maintain enough physical ability to continue doing the things they love when they are 80, 90 or 100 years old? The proportion of global population aged 60+ will double by 2050, while the number of people aged 80+ will almost quadruple. These demographic changes will cause a profound impact on the prevalence of chronic conditions and demand for long-term care. Ensuring older people can remain mobile and able to care for themselves for as long as possible is critical to families and welfare systems. Recent advances in wearable sensors, data analytics, machine learning and robotics can contribute to breakthroughs in increased mobility. Relevant challenges remain in terms of cost, product design and usability, and sustainable business models centered on self-care.

Biography: Brenda Reginatto is the Research Lead at the Insight Centre for Data Analytics in University College Dublin. She researches the application of wearable computing and machine learning in improving mobility assessment for older people. Brenda also works as consultant and advisor to health technology start-ups. She has an MSc in Gerontology from King's College London and has worked extensively with falls prevention and long term care. Brenda is passionate about creating technology products to support independent living amongst older people. She can be found on Twitter at @b_reginatto.


Smart textile garments: the new frontier of continuous ECG monitoring
Dov Rubin, PhD
VP Marketing and Business Development
HealthWatch Technologies

Recent breakthroughs in textile technology now enable continuous monitoring of electrocardiogram (ECG) signals. Just how is this achieved? Are all textile and wearables claiming to sense ECGs capable of diagnosing a heart attack? Our personal health should intuitively be monitored by personal smart devices, but is there a market demand for continuous monitoring? This talk will examine the current ECG marketplace, and discuss the technical challenges of sensing ECG signals from clothing as well as getting the signals to the physician in real-time when every second counts. The presentation will also cover the economics, lucrative market segments, business drivers, and competitive landscape to show that not all wearables are created equal. Attendees will also be able to view, in a live presentation, a wearable textile with heart-sensing electrodes.

Biography: Dr. Dov Rubin is an expert in non-invasive medical technologies and is currently Senior Vice President of Marketing and Business Development at HealthWatch, a med-tech startup developing innovative textile, ECG-sensing garments for around-the-clock patient monitoring. Dr. Rubin developed the first transcutaneous oxygen sensor, as well as the first microprocessor based patient ventilator with Puritan Bennett. He was also co-founder of NDS (listed on NASDAQ), the leading supplier of secure digital TV entertainment delivery to over 140 million viewers, which he started in 1988 along with News Corporation's Rupert Murdoch. NDS was earning $650 million in annual revenues and was acquired by Cisco for $4 billion. More recently, Dr. Rubin was President and CEO of Itamar Medical, a publicly traded company (listed on TASE), which developed state-of-the-art biomedical products involved in non-invasive, early detection of heart disease and obstructive sleep apnea. Dr. Rubin has a PhD in Biomedical Engineering from the University of Southern California and MSc from Case Western Reserve University.


The latest trends, challenges and opportunities in wearable sleep monitoring technology
Leslie Ruoff, RST, RPSGT
Sleep Core Director
VA Medical Center

Sleep is essential for restoring our minds and bodies, but millions suffer from poor sleep due to their environment, unhealthy behaviors, or illness. Many of these people are unaware that these issues prevent them from obtaining restorative sleep. Clinical sleep studies are expensive and typically only produce a single night of data that is collected in an unfamiliar setting. New advances in sensor and wearable technology can track sleep in our home environments for extended periods of time and can also educate and motivate us to improve our patterns and behaviors that we may otherwise overlook. With an increasing number of devices on the market claiming to track and improve sleep, it is imperative to assess the accuracy of the information they provide. This talk will provide an overview of the current sleep devices and sensors, their limitations when compared to the traditional "gold standard" measures, and emerging opportunities. The talk will also introduce the science of sleep and what changes our bodies encounter in a typical night.

Biography: Leslie Ruoff is the Sleep Core Director for the Stress and Health Research program, affiliated with the San Francisco VA Medical Center and the Northern California Institute for Research and Education. Leslie has over a decade of experience in sleep medicine and pharmaceutical research. In 2010, she was appointed to establish and lead an internal and centralized support system for Department of Defense (DoD) and National Institutes of Health (NIH) funded studies exploring the relationships between sleep, circadian rhythms, sleep deprivation and cognitive functioning in PTSD, insomnia, pain, and neurodegenerative diseases. Leslie actively consults and collaborates with numerous primary investigators across multiple institutions and disciplines to integrate biometric data collection into research protocols, including a recent study seeking to validate a consumer wearable device reporting sleep patterns. Adopting validated, consumer wearable technologies is quickly becoming integral to implementing more affordable and robust studies. She welcomes new sensor technologies to enhance public sleep health literacy.


Driving cost-effective obesity care delivery with wearable technologies
Shingai Samudzi
Founder and CEO
ProjectVision

The healthcare industry transition towards a consumer-oriented service experience greatly incentivizes providers to leverage wearable applications as a source for gathering data about consumers on a daily basis, rather than just during (infrequent) patient visits or after emergency events. For example, a marketplace full of available data ultimately allows care providers to move away from "one size fits all" approaches to obesity management, instead deploying clinical resources in direct response to emerging needs among the population of patients served within the health system. The most relevant wearables in the obesity management space are those that have developed best practices around integrating wearable devices into the daily health patterns of users in key age groups that have been the most resistant to adoption. These best practices not only help patients reduce mortality risk through sustained behavior change, but also help care providers improve understanding of the pathologies behind obesity.

Biography: A decision science graduate from Carnegie Mellon University, Shingai has a passion for leveraging data and algorithms to support business and public policy decisions. Within healthcare, he has had formative experiences with medical informatics and health system architecture working first at Cerner Corporation and subsequently at Kaiser Permanente. At both, he has managed large, multi-facility implementations of EMR integrations and patient experience services (such as remote video interpreter services). Over this same period, he was introduced to concepts such as Human Centered Design that lead him to experiment with combining qualitative and quantitative research methods for healthcare product development projects. A fitness enthusiast himself, Shingai has a strong belief that "quantified self" is a key part of the future of a consumer-driven healthcare market. Shingai founded ProjectVision in the spring of 2014 to execute his vision of cost-effective healthcare that is responsive to both individual and population health needs.


Wearable sensors for greater visibility into dynamic phenotype
David Shaywitz, MD, PhD
Chief Medical Officer
DNAnexus

A key premise of precision medicine, and of the Precision Medicine Initiative, is that the integration of rich genomic and phenotypic information can improve care, inspire science, and drive the development of novel therapeutics. Wearable sensors, a foundational technology of digital health, can provide greater visibility into dynamic phenotype, and complement and dramatically extend the comparatively static and episodic information typically available from the electronic medical record. The increasingly granular assessment of real-world physiology is expected to enable refined patient segmentation, and help define the underlying molecular networks -- though this ambition remains largely unrealized. Examples of efforts to integrate clinically-relevant dynamic phenotype with molecular biology in areas such as metabolism and respiratory will be examined. The potential application of other types of sensors, such as those assessing interpersonal interactions and degree of connectivity, will also be reviewed. Potential limitations, as represented by the pulmonary artery catheter experience, will also be discussed.

Biography: Dr. Shaywitz (Twitter: @dshaywitz) is chief medical officer of DNAnexus, a Bay Area company that provides a cloud-based enterprise platform for the management of genomic and other healthcare data. Dr. Shaywitz received his MD/PhD from Harvard and MIT, and trained in internal medicine and endocrinology at MGH. He gained subsequent experience in the Department of Experimental Medicine at Merck, the healthcare practice of the Boston Consulting Group, and at Theravance. He writes extensively about medical innovation, and is co-author, with Lisa Suennen, of "Tech Tonics: Can Passionate Entrepreneurs Heal Healthcare With Technology?" In 2015, they launched "Tech Tonics: The Podcast," focused on "the people and passions at the intersection of technology and health." Dr. Shaywitz is a co-founder of the MGH/MIT Center for Assessment Technology and Continuous Health (CATCH) program focused on integrating rich phenotypic assessment with genetic information to guide clinical care and inspire fundamental research.


Mass adoption of wearable medical devices: the role of health insurance companies
Omid Toloui, MPH
Digital Health Strategist

Digital health and wearable medical devices aimed at promoting wellness or managing chronic illnesses have become smaller, cheaper and more effective. However, their adoption in the traditional healthcare marketplace has not reached its inevitable tipping point. This presentation will explore the role that health insurance companies (i.e., payers), the largest purchasers of healthcare goods and services, will play in the mainstream adoption and rapid growth of wearable medical devices. While these devices show great promise and should be attractive to an industry aimed at managing risk, they also present unique challenges. We will examine recent advancements in the use of digital health devices by insurance companies and explore emerging reimbursement models. We will also reflect on other established markets and products to help predict the future, and identify factors that can lead to the wide-scale acceptance of wearable medical devices within the healthcare sector.

Biography: Omid Toloui is focused on advancing the digital health revolution. He is passionate about finding solutions at the intersection of healthcare, technology and design that engage individuals in understanding and proactively managing their health. Currently, Omid is Senior Director of Product Management at Altegra Health where he is responsible for managing and marketing solutions that marry data analytics and technology to educate patients on their conditions, ensure timely care and improve health outcomes. Previously, Omid directed Sinaiko Healthcare Consulting's strategic analytics practice. As a management consultant, he specialized in projects spanning multiple disciplines requiring a thorough understanding of the healthcare marketplace, strategy and the challenges facing patients, providers, payers and investors. Omid monitors and writes about emerging digital health and wearable technologies, consumer and market trends and is an avid self-quantifier. He earned his Master of Public Health degree in Health Services Management, Bachelor of Science degree in Psychobiology and Minor in Italian from UCLA, and is currently pursuing his second Master's degree at UCLA.


Call for Speakers

If you’d like to participate as a speaker, please call Dr. Mike Pinelis at 734-277-3599 or send a brief email with your proposed presentation topic to mike@memsjournal.com. All speakers will receive a complimentary pass to the conference.

Conference scope includes topics related to medical MEMS sensors and electronics, such as:

  • Diagnostics: portable assaying and sample preparation of blood, urine, cells, tissues, and bodily fluids. For example, microfluidic and lab-on-a-chip devices to diagnose diseases in portable instruments and smaller sized benchtop systems.
  • Medical wearables: application trends, business and economic drivers, case studies, challenges, and opportunities.
  • Drug delivery systems: both transdermal and implanted techniques; for example, micro needles that provide convenience and precisely measured amounts of dispensed drugs. Smart, MEMS-based drug delivery systems also enable continual drug delivery monitoring and improve patient compliance.
  • Digital health: wireless devices, body area networks, online services, genomics, and personal genetic information.
  • R&D tools: biological arrays and assays to understand the response of cell in vitro to a variety of chemical, thermal and mechanical stimuli.
  • Surgery and minimally invasive procedures: micro surgical tools as well as neural stimulation and measurement electrodes.
  • Health screening: preventive monitoring such as early detection of cancer through consumer, over-the-counter devices that are to be used on a day-to-day basis.
  • Individualized treatment: integration of diagnostics with therapy and treatment on portable, smart lab-on-a-chip devices; for example, treatment specifically based on the exact disease variation as well as the patient genotype and current health factors.
  • Worldwide healthcare trends: market drivers, demographic factors, government policy effects.
  • Business aspects: fundraising, reimbursement, technology transfer, regulatory compliance, company formation, recruiting, and market research.