WAMIII - Virtual Talk Series

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WAMIII Virtual Talk Series

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us.

Upcoming Sessions

WAMIII Virtual Series – Session 9
TBD

Wearable Computing Systems based on Body Sensor Networks: State-of-the-Art and Future Research Challenges
Prof. Giancarlo Fortino, University of Calabria, Italy

This session will discuss the state-of-the-art of currently available wearable computing systems based on Body Sensor Networks (BSNs). It will focus on the main results achieved in the SPINE project, led by Prof. Fortino’s research group, in terms of defined models, methodology, algorithms and real prototypes (e.g. activity/gesture recognition systems, fall detection systems, mobile ECG processing systems, elbow/knee rehabilitation systems, emotion recognition systems, etc.). The session will also enumerate and discuss future research challenges along with possible solutions in such an exciting research domain.


+ Read Speaker Bio

Giancarlo Fortino (SM’12) is Full Professor of Computer Engineering at the Dept. of Informatics, Modeling, Electronics and Systems (DIMES) of the University of Calabria (Unical), Rende (CS), Italy. He has a Ph. D. degree and Laurea (MSc+BSc) degree in Computer Engineering from Unical. He is High-end Foreign Expert of China (term 2015-2018), Adjunct and Guest Professor at the Wuhan University of Technology (China), High-end Expert of HUST (China), CAS PIFI Visiting Scientist at Shenzhen (2019-2021), and Associated Senior Research Fellow at the Italian National Research Council - ICAR Institute. He is the director of the SPEME (Smart, Pervasive and Mobile Systems Engineering) Lab at DIMES, Unical and co-director of two joint-labs on IoT technologies established with Wuhan University of Technology and Shanghai Maritime University, respectively.

He is co-founder and CEO of SenSysCal S.r.l., a spin-off of Unical, developing innovative IoT-based systems for e-health and domotics. He is the Chair of the IEEE SMC Italian Chapter, Member-at-large of the IEEE SMCS BoG, Member of the IEEE Press Board of Directors, and founding chair of the IEEE SMC Technical Committee on “Interactive and Wearable Computing and Devices”.

Sessions on Demand

 

 

WAMIII Virtual Series – Session 1 on Demand
26 March 2020 11AM - 12PM ET

Blockchain and smart contract security in practice
Dr. Sebastian Banescu, Senior Research Engineer, Quantstamp

Blockchain and DLT-based applications are often assumed to be secure by design, and by using such technologies one can effortlessly secure the application they are building. However, this is far from the truth. Numerous vulnerability types may be present in such applications, e.g. reentrancy, front running, time manipulation, access control, arithmetic issues, etc. In this webinar we will take an example based approach to learning about vulnerabilities in blockchain applications. More importantly, we will discuss best practices about how to detect such vulnerabilities and minimize the impact of a hack.


+ Read Speaker Bio

Dr. Sebastian Banescu is a senior research engineer at Quantstamp, a crypto native start-up based in San Francisco, that provides world class blockchain security and enterprise solutions. He holds a Ph.D. in Computer Science with an emphasis on software security from the Technical University of Munich in Germany. Previously he graduated with honors from the Information Security Technologies track of the Eindhoven University of Technology in the Netherlands. His research spans across several areas of computer security such as reverse engineering, malware detection, software protection and privacy. Before joining Quantstamp, Sebastian worked as a security engineer at Philips and BMW.

 

 

WAMIII Virtual Series – Session 2 on Demand
27 March 2020 11AM - 12PM ET

The Knowledge Model
Ron Schilling, Director CEO Coach, EchoPixel and Histolix

The Knowledge Model is a framework for thinking. It is focused on increasing the interoperability driven enterprise to achieve increased patient outcomes. Knowledge, comprised of cognitive and intuitive factors requires balance as noted in the quote by Albert Einstein, "The intuitive mind is a sacred gift and the cognitive mind is a faithful servant. We have created a society that honors the servant and has forgotten the gift.” With appropriate balance, significant gains in patient outcomes have been demonstrated.


+ Read Speaker Bio

Ron Schilling - started at RCA Labs as part of the team developing CMOS. Then went to Motorola where, as marketing director for the 6800 microprocessor, took on Intel’s 8080, resulting in being #2 in the industry. Made a big jump to the medical industry at GE when the CT scanner was born. As the 1st marketing director, launched in US, formed a Joint Venture with Yokogawa in Japan, placed 1st scanner in China, with GE ultimately became #1 worldwide. As head of GE Strategic Planning and Business Development, got GE into MRI. Then became President of MRI at Diasonics, becoming #2 worldwide behind GE. Diasonics MRI was later acquired by Toshiba, and I became Senior Vice President for Toshiba America Medical Systems. I then became co-founder of EchoPixel to create Interactive Mixed Reality technology for achieving major gains in Patient Outcomes. Presently serving as Director CEO Coach at both EchoPixel and Histolix, providing leadership technology in Digital Pathology.

 

 

WAMIII Virtual Series – Session 3
01 April 2020 11AM - 12PM ET

Cracking the Code on Medication Adherence with an Ingestible Sensor
Erick Buffkin, etectRX 

etectRx will discuss the recently FDA-cleared ID-Cap system for tracking medication adherence as an application of ingestible sensors. The session will also describe the technology platform upon which the system is built - eBurst.


+ Read Speaker Bio

Eric has a passion for new ventures, new technologies, product design and development. He is a serial entrepreneur, having launched technology, product, and services companies in the technology and healthtech sector. Over the course of his thirty years in technology ventures, Eric has been instrumental in establishing industry standards for networking the digital home. These standards have ultimately influenced how we all enjoy digital media, access information, and manage our homes with connected devices.

Eric is currently Senior VP, R&D/Operations for etectRx Inc., a healthcare technology company creating a platform for digital pills and other ingestible sensors.

Eric is committed to enabling and empowering new entrepreneurs. He is an angel investor and mentor to new technology companies in his community of Gainesville, Florida and a constant promoter of the power of the innovation economy. He holds a bachelor’s degree in electrical engineering from the University of Florida and an MBA from Rollins College.

On a personal note, Eric is married with three children. He is a lifelong resident of Florida and a dedicated fisherman, boater, and outdoorsman. When he is not offshore somewhere on his boat, you can reach him at the Innovation Hub or through LinkedIn.

 

 

WAMIII Virtual Series – Session 4
03 April 2020 11AM - 12PM ET

Overview of Medical Device Communication Test Methods and the NIST Test Framework
John J. Garguilo, Supervisory Computer Scientist, National Institute of Standards and Technology (NIST)

NIST Computer Scientist John J. Garguilo will provide an overview of activities regarding medical device communication landscape, standards development, and domain development efforts to effect safe, semantically reliable, and verifiable data communications (primarily) from the medical device point-of-care to the healthcare “enterprise”. Mr. Garguilo will discuss several prominent and current standards activities and medical device domain development efforts to produce common “device profiles” derived from high-impact use cases and via the NIST Test Framework - a set of test tools leading to standards-based test instances. Such tooling advances the level of rigor and provides a “single source of truth” based on Health Level Seven (HL7.org) messaging standards and the IEEE SA (standards.ieee.org) medical device communication nomenclature and domain information models. Mr. Garguilo will also provide an overview of the freely and publicly available NIST Test Framework components which contribute to common use and device conformance leading to interoperability.


+ Read Speaker Bio

John J. Garguilo is a supervisory computer scientist at the National Institute of Standards and Technology (NIST) of the United States Department of Commerce. John’s the Group Leader of the Systems Interoperability Group and leader of the Semantic Interoperability of Medical Devices (SIMD) project focused on medical device communication research and testing and aimed at enabling the adoption of medical device communication standards by acute, point-of- care, and personal health medical device manufacturers.

John currently serves as the Health Level Seven (HL7) Healthcare Device Working Group Co- Chair and over a decade as the test lead as well as six years as the Technical Committee Co-chair for the Integrating the Healthcare Enterprise – Patient Care Device (IHE-PCD) domain. John is also serving an elected two-year term as the Secretary of the IEEE 11073 Medical Device Communications Point of Care (PoCD) working group. John’s focus over the past fourteen years has been on developing conformance test tooling in support of standardization of medical device information exchange and working with device standard and Standards Development Organizations (including HL7 V2 and ISO/IEEE 11073). His work includes testing and promoting adoption of standards for medical device communications throughout the healthcare enterprise as well as integrating it into the electronic health record. John works and is closely engaged with medical device experts within the HL7, IHE-PCD domain, and ISO/IEEE Healthcare Devices and Personal Health Devices working groups. John also leads the HL7 message validation test tooling effort and development of an industry adopted harmonized medical device terminology database containing ISO/IEEE 11073 terminology.

John holds a Master’s degree from the Johns Hopkins University, Baltimore, Maryland and Undergraduate degree from the State University of New York, Potsdam, both in computer science. John has extensive experience over the past 30 years working on and managing software systems to support research, testing, automating work flow applications, data communications, and electronic commerce.

 

 

WAMIII Virtual Series – Session 5
03 April 2020 12PM - 1PM ET

TIPPSS for Connected Healthcare - Trust, Identity, Privacy, Protection, Safety, Security
Florence Hudson, Founder and CEO, FDHint

The increasingly connected healthcare world including clinical Internet of Things (IoT) devices is creating great opportunity for improved data sharing, better access to information, and deployment of devices to extend and improve healthcare. There is also increased risk. We will discuss the challenges in Trust, Identity, Privacy, Protection, Safety and Security of devices, data, and patients, and the standards efforts working to address these issues. 


+ Read Speaker Bio

Florence Hudson is the founder and CEO of FDHint, an advanced technology and diversity & inclusion consulting firm. She is Interim Executive Director of the Northeast Big Data Innovation Hub at Columbia University, and Special Advisor for the NSF Cybersecurity Center of Excellence at Indiana University. She is Chair of the IEEE standards working group on Clinical IoT data and device interoperability with TIPPSS, and on the IEEE Engineering in Medicine and Biology Standards Committee. She serves on advisory boards at Princeton University, Cal Poly San Luis Obispo, Stony Brook University, and Blockchain for Healthcare Today. Former IBM Vice President and Chief Technology Officer, and Internet2 Senior Vice President and Chief Innovation Officer, she began her career as an aerospace engineer at Grumman and NASA. Her education includes a Bachelors Degree in Aerospace and Mechanical Engineering from Princeton University, and Executive Education at Columbia University and Harvard University Graduate Schools of Business.

WAMIII Virtual Series – Session 6
16 April 2020 12PM - 1PM ET

Unique Device Identification (UDI) Across The Device Landscape
Terrie Reed, Principal, Reed McCullough LLC
Ken Fuchs, Sr., Standards Consultant, Draeger Medical Systems, Inc

This session will discuss the current status of the US and Global UDI System, how UDI continues to be integrated into public policy, software applications, data and device communication standards to enhance data used for supply chain, clinical and regulatory decision making.  In 2013 the FDA published the UDI regulation requiring device manufacturers to apply a unique device identifier to the label of most medical devices and to submit data to the FDA’s Global Unique Device Identification Database. AccessGUDID, the public portal for GUDID, contains over 2.5 million device model records.  Vendors are beginning to take advantage of this global identifier, scanning the UDI to reduce patient exposure to expired and recalled product and to monitor long term outcomes.  While there is no specific requirement that UDI be integrated into personal health or point of care devices, it is clear that in order to better track use of these devices,  UDI data must  flow smoothly from these devices to consuming applications this needs to be accomplished.  Fortunately, standards from ISO/IEEE 11073 and IHE PCD are already well positioned for this eventuality and will be discussed.


+ Read Terrie Reed's Bio

Terrie Reed, the former FDA Associate Director of Informatics and Senior Advisor for UDI adoption, has over 20 years of healthcare information management and systems engineering experience.  As FDA Associate Director of Informatics Ms. Reed led the cross-disciplinary UDI team that established the initial UDI regulatory policy, designed and rolled out resources now used by software developers, supply chain professionals, clinicians, researchers, manufacturers and regulators as a means to transform the tracking of device-related patient procedure information. Later, as FDA Senior Advisor for UDI adoption, Ms. Reed collaborated across stakeholder groups advocating for UDI to be included in health IT standards to support the scanning of UDI and use of data in AccessGUDID by both manufacturers and healthcare workers. Ms. Reed has also used feedback from innovative pilots and first adopters to inform regulatory strategies impacting the overall UDI system. Now, in her role as an independent consultant, Terrie is excited to advise organizations that seek to achieve the original vision of the UDI system including preventing harm and empowering patients to make more informed care choices by giving them access to timely and accurate UDI-based device information.


+ Read Ken Fuchs' Bio

Ken is currently the Sr. Standards Consultant at Draeger Medical Systems, Inc. a manufacturer of electronic medical devices including patient monitoring, ventilation, anesthesia and warming therapy systems.

Ken is currently responsible for coordination of Drager Medical Systems’ participation in US and International standards development activities. He is also personally active in medical device clinical as well as interoperability related standards.  He currently serves as the chair of the IEEE 11073 Standards Committee (SC) for medical device communication, he co-chairs the AAMI MP working group for multi-parameter patient monitors, is Secretary for the IEEE P2733 SC and is involved in a number of other standards development efforts in ISO, IHE, HL7 and AAMI.

Ken’s background has focused on networking, connectivity and system architectures at various point of care medical devices companies including Draeger Medical Systems, Siemens Medical Solutions, Mindray Medical and the non-profit Center for Medical Interoperability.

 

 

WAMIII Virtual Series – Session 7
17 April 2020 12PM - 1PM ET

Self-Powered Wearable Devices and Sensing Systems from the ASSIST ERC
Adam Curry, Innovation Ecosystem Director, Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST)

ASSIST is an NSF engineering research center (ERC) based at NCSU that is advancing self-powered and low-powered wearable devices and sensing systems. Application spaces include health & wellness, IoT, manufacturing, automobiles, and agriculture. The Center includes faculty and student researchers from 8 universities, along with representatives from over 25 member companies. Research follows 4 thrusts: 1) energy harvesting and storage; 2) low-power physiological, biochemical, and environmental sensing; 3) low-power electronics and radios; and 4) integration and testing. Adam will give an overview of the Center and highlight a few mature technologies developed at the Center, including a self-powered shirt transmitting electrocardiogram (ECG) wirelessly in real-time; low-power wrist-worn heart rate, environmental, and biochemical sensors; and sweat sampling and sensing technologies.
 
Learning Objectives:
1.     Gain exposure to technologies enabling self-powered sensing systems
2.     Understand applications enabled by self-powered sensing systems
3.     Become familiar with opportunities to engage with ASSIST 


+ Read Adam Curry's Bio

Adam Curry manages industry relations and promotes technology commercialization at ASSIST. Adam's background includes 11 years in scientific research at Becton, Dickinson & Co., where he developed diagnostic instrumentation and smart technologies for drug administration, health records, and supply chain. Adam holds a PhD in Biomedical Engineering from Duke University and MS and BS degrees in Mechanical Engineering from NC State University.

WAMIII Virtual Series – Session 8
30 April 2020 12PM - 1PM ET

What Medical Device Vendors Can Learn From Past Cybersecurity Vulnerability Disclosures
Vidya Murthy, MedCrypt
Kate Schneiderman, Marketing Analyst, MedCrypt

In 2016, the United States Food and Drug Administration (FDA) released a guidance document entitled Post-Market Management of Cybersecurity in Medical Devices, in which the FDA makes several recommendations to medical device vendors and healthcare delivery organizations on how to manage the cybersecurity risk that connected medical devices introduce. One of the recommendations is for device vendors to participate in “threat sharing”, in which information about security vulnerabilities is shared with the medical device community via Information Sharing Anal- ysis Organizations (ISAO). Two of the presumed benefits of threat sharing are that 1) industry stakeholders have the information necessary to minimize their cybersecurity risk and 2) other medical device vendors can use this information to prevent their products from having the same or similar vulnerabilities.  Assessing medical device vulnerabilities disclosed, we will discuss trends in vulnerability disclosures, status of the current regulatory environment and best practices identified to be proactively secure. 


+ Read Vidya Murthy's Bio

Vidya is fascinated by the impact of cybersecurity on the healthcare space.  Beginning her career in consulting, she realized a passion for healthcare and worked for global medical device manufacturer Becton Dickinson. She has since joined MedCrypt, a company focused on bringing cybersecurity leading practices to medical device manufacturers. Vidya holds an MBA from the Wharton School. 


+ Read Kate Schneiderman's Bio

Kate is a Marketing Analyst passionate about technology’s impact on society. Prior to joining MedCrypt, Kate helped establish the AI for Social Good program at Intel.

Supporting Partners

Registration

Note:  When you register for the Series you get access to the recorded sessions. You'll receive a weekly email announcing new sessions for the week, links to ALL recorded sessions and you will receive reminder emails (24 hour and 30 minutes) prior to each session.

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us. Participation in these sessions includes the following:

  1. Hearing global expert perspectives (from every corner of the world) on the technical and regulatory challenges and viable clinical applications of wireless medical devices on, in around the patients.
  2. Learning, sharing ideas and building consensus for development of solutions to address challenges impeding trust and adoption of these technologies for diagnosing, monitoring and treating patients.
  3. Access to a platform without geographic bounds enabling a global community of progressive thinkers with common initiatives to harmonize recommendations and form collaboratives to drive solutions through the development of technical and data standards.

Register Now