Tuesday, December 10
7:30 am Registration and Morning Coffee
8:20 Chairperson's Remarks
Stacey Standridge, PhD, Deputy Director, National Nanotechnology Coordination Office
8:30 Wear, implant and analyze: sensors and the future of chronic care
Rafael Carbunaru, PhD, Vice President R&D, Boston Scientific
As rates of chronic disease climb, so do opportunities for wearable and implantable solutions to help manage them. Core technology and sensor improvements; integration into healthcare systems; robust security; and personalized experience could all speed adoption. This talk will address current market and opportunities, and include examples of using wearables, sensors and analytics in a proof-of-concept clinical study and life-saving AI for chronic disease applications.
9:00 Regulatory Considerations during Mobile Medical App Development for Commercial and Clinical Trial Use
Mike Benecky, Senior Director, Global Regulatory Affairs in Precision and Digital Medicine, GlaxoSmithKline
Mobile medical apps are defined as medical devices from their intended use. Mobile medical app regulation is health risk-based to balance patient safety and barriers to technological innovation. Medical device patient risk analysis is a critical prerequisite prior to sensor/app inclusion within a clinical trial. Key components of quality management systems for mobile medical apps include: software requirements/specifications, user acceptance testing, software postmarket surveillance, software version control and medical device adverse event reporting.
9:30 Nanotechnology, MEMS, Microfluidics for Health 4.0 Hypermobility
Anita Rogacs, PhD, Head of Life Sciences Strategy and R&D, Hewlett Packard Labs
New imperatives of healthcare are focusing on prevention, personalization of diagnostics and treatment, and democratization, including access to everyone, anywhere, anytime at a low cost. The technology convergence in medicine is enabled by the powerful
combination of microelectronics, microfluidics, advanced (bio)-chemistry, distributed network, and data analytics.
10:00 Networking Coffee Break
10:30 Roundtable Discussions
Roundtable discussions are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic. Each topic is led by a moderator who ensures focused conversation around the key issues of that topic. Attendees choose to join a specific group.
TABLE 1: How Biosensors Can Address Global Health Challenges
Table 2: Power Solutions for Miniaturized Implants
Robert Rubino, Senior Director, Research and Development, Integer
Table 3: Mixed-Signal Application Specific Integrated Circuits (ASICs): Advantages, Challenges, Justification, and Strategies
Andrew Kelly, BSEE, Director of Applications Engineering, Semiconductor Division, Cirtec Medical
Table 4: Overcoming the Challenges to Bringing Medical Devices to The Market
David DiPaola, Managing Director, DiPaola Consulting
Table 5: Advanced Materials
Stacey Standridge, PhD, Deputy Director, National Nanotechnology Coordination Office
Table 6: Sensors for Collaborative or Autonomous Systems: Challenges and Considerations
Tom Calef, CTO, Activ Surgical
- What industries are exploring such systems and what can be learned from them?
- What sensor types and circuit architectures are well-suited for such systems?
- What factors should be considered when deciding to either work with a sensor supplier or develop in-house?
- What are current user-acceptance or regulatory/compliance challenges and successful case studies for overcoming them?
- How is data being collected, stored, and used in today’s learning models? What are the best practices for specific industries?
- What is required for these systems to take the next “big leap” into Level 3 autonomous behavior or beyond?
11:15 Transition to Sessions
11:25 Chairperson's Remarks
Nick Van Helleputte, PhD, R&D Manager Biomedical Circuits & Systems, imec
11:30 Faults in Continuous Glucose Monitors: Cause, Effect, and Potential Solutions
Disha B. Sheth, PhD, Sr Staff Scientist, Manager, DexCom Inc.
The advancements in continuous glucose monitoring (CGM)- non-adjunctive use and zero calibrations- have been transformative in the life of
patients with diabetes. Latest sensor technology and algorithms have resulted in sub-ten Mean Average Relative Differences (MARDs). However, there are some physiology related discrepancies that have been difficult to
crack. Complexity of immune responses, foreign body responses, patient to patient differences, patch adhesion are a few causes of inaccuracies especially during early and late wear periods in CGMs. Drug eluting sensors, multi-sensing
elements, self-learning algorithms are some of the potential solutions to these faults.
12:00 pm Connected-care and Companion Diagnostics using Cloth-Based Nanotechnology: From R&D to Clinical Utility to Commercialization
Venk Varadan, Co-Founder and CEO, Nanowear
From the inception of “Digital Health” over a decade ago, the connected-care and Digital Diagnostics showed immense promise in coupling static EHR data, existing devices and therapeutics with daily dynamic data captured from the body. But the industry quickly learned that R&D and product build could not overcome necessary efficacy and safety requirements in sufficient time to live up to the hype for medical use, while technology focused on consumer use instead. After nearly ten years, there are specific technologies, products, and therapeutic areas that have emerged from this challenging phase of R&D, proving their value clinically and improving patient lives from the comfort of their own home
Gordon Bell, Vice President of Marketing, Energous Corporation
12:45 Enjoy Lunch on Your Own
1:55 Chairperson's Remarks
Nick Van Helleputte, PhD, R&D Manager, Biomedical Circuits & Systems, imec
2:00 Non-Invasive Biochemical Sensing: Breakthrough for Precision Medicine
Gavi Begtrup, PhD, CEO, Eccrine Systems, Inc.
Today’s non-invasive electronic health patches perform conventional measures like heart activity and body motion, while the medical field awaits continuous wearable sensing of chemical information like that found in blood draws. All this is now rapidly changing as sweat biosensing is targeting a first killer application in medication monitoring, enabling precision dosing through non-invasive, direct measurement of individual drug response.
2:30 The Sensor Journey: from Idea to Algorithm to Complete Patient Recovery Platform
Cavan Canavan, Co-Founder & CEO, FocusMotion Health
Being cutting edge can mean being beyond initial applicability. We’ll have an honest discussion about FocusMotion’s inception to market fit failure to market fit success after leaving its initial thesis behind and embracing
healthcare opportunities and a more vertical approach – learnings include: prototyping, data collection, patient-centered design, and endurance.
3:00 FEATURED PRESENTATION: Advancing Continuous Glucose Monitoring Sensor Development with Machine Learning
Elaine Gee, PhD, Senior Principal Algorithm Development Engineer - Artificial Intelligence, Diabetes R&D, Medtronic
A wearable continuous glucose monitoring sensor relies on an algorithm to convert sensor electrochemical signals into sensor glucose for the user. Development of a safe and reliable CGM requires large datasets to support sensor glucose algorithm development, optimization, and evaluation. Here we discuss using machine learning to leverage high-quality, time-dependent signals to improve sensor glucose accuracy in creating the next-generation CGM sensor.
3:30 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Tutorials
6:00 Welcome Reception in the Exhibit Hall with Poster Viewing
7:00 End of Day
Wednesday, December 11
8:00 am Registration and Morning Coffee
8:20 Chairperson's Remarks
Robert Rubino, Senior Director, Research and Development, Integer
8:30 Dexcom's Continuous Glucose Monitoring (CGM) Technology and Its Impact on Diabetes Management, Artificial Pancreas, & Digital Health Systems
Peter Simpson, Vice President of Sensor R&D and Advanced Technology, Dexcom
Recent advances in continuous glucose monitoring (CGM) technology have significantly increased its usability and impact on diabetes management. CGM's are now widely reimbursed and are rapidly becoming the standard of care for
all people on intensive insulin therapy.
This presentation will provide an overview of Dexcom's CGM sensor technology, its use in digital health and artificial pancreas systems and a preview of our future products.
9:00 Objective Measures for Clinical Assessment and Precise Understanding of Disease Progression
Christopher Hartshorn, PhD, Program Director, Cancer Treatment & Diagnosis, National Institutes of Health; National Cancer Institute
Cancer patients disconnected from resource intensive cancer centers face challenges beyond simply the disease they are dealing with. These patient populations include both ones in rural communities as well as populations whom have access hindered via disability, transportation or time. This limited access to the care system also presents a problem for clinical teams involved in caring for and assessing patient status and therapeutic response. Connected health solutions (i.e., autonomous or interactive devices and mobile apps that deliver health data to the user and / or clinical team) have been increasing in use, gradually over the last decade, yet very few have reached the maturity needed for cancer-specific, clinically relevant applications. Moreover, the next generation of these tools goes beyond contextual and vital sign measurement (e.g., physical sensors) into passive wireless measures for systemic molecular characterization (e.g., continual biomolecular measurements from interstitial fluid, sweat) and assessment of local biology (e.g., implantable biosensors). Ultimately, these passive sensing platforms of ‘digital biomarkers’ will afford clinicians 1) more objective metrics of response to therapeutics; 2) control and auto-reporting of symptoms and their fluctuations; 3) monitoring of side-effects of experimental or standard of care therapies; and 4) more ecologically valid clinical endpoints, all decreasing assessment burden via increased continuity of physiological measurement sampling and patient context, outside of the standard clinical visit. This talk will look at various efforts across the National Institutes of Health attempting to enable more objective measures for out-of-clinic patient-specific assessment and longitudinal understanding of disease progression in large cohorts.
9:30 Wearable Electrochemical Sensors – Recent Advances
Joseph Wang, Distinguished
Professor & Chair, Nanoengineering, University of California, San Diego
This presentation will discuss recent developments in the field of wearable electrochemical sensors integrated directly on the epidermis or within the mouth for various non-invasive biomedical monitoring applications. Particular attention will be given to non-invasive monitoring of metabolites and electrolytes using flexible amperometric and potentiometric sensors, respectively, along with related materials, energy and integration considerations. The preparation and characterization of such wearable electrochemical sensors will be described, along with their current status and future prospects, and challenges.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
10:30 Roundtable Discussions
Roundtable discussions are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.
Each topic is led by a moderator who ensures focused conversation around the key issues of that topic. Attendees choose to join a specific group.
Table 1: Miniaturization for Chemical and Biological Detection
Cory Bernhards, PhD, Research Microbiologist, CBR, Defense Threat Reduction Agency
Table 2: Best Practices for AI, IoT, etc
Aminat Adebiyi, PhD, Research Staff Member,Biomedical IoT and Applied Analytics, IBM
Table 3: The Small Business Innovation Research (SBIR) program and Small Business Technology Transfer (STTR)
Juan Figueroa, PhD, Entrepreneurship Advisor and Associated Researcher, Puerto Rico Science and Technology Trust
Table 4: Non-Invasive Physiological Monitoring Beyond Activity, PPG, RR and ECG - Adding More Medically Relevant Vital Signs
Ashish V. Pattekar, Principal Scientist, PARC, a Xerox Company
Table 5: Overcoming the Pitfalls to Sensor Commercialization
Roger H Grace, President, Roger Grace Assoc
11:15 Transition to Sessions
11:25 Chairperson's Remarks
Joshua Windmiller, PhD, MSc, Co-Founder & CTO, Biolinq, Inc.
11:30 PANEL DISCUSSION: The Medical Sensor Technologist's Dilemma - Clinical or Consumer Sensor
Panel Moderator:
Joshua Windmiller, PhD, MSc, Co-Founder & CTO, Biolinq, Inc.
Patient outcomes and standardization of care continue to benefit from smarter and sensor-enabled medical devices that provide real-time patient monitoring and device performance data. The challenge is selecting the right sensor, including deciding between consumer or clinical-grade sensors. This panel will evaluate the trade offs between these two sensor classes as the panelists tackle this dilemma.
Panelists:
Tom Calef, CTO, Activ Surgical
Debbie Chen, PhD, Founder & CEO, Hydrostasis, Inc.
Anita Rogacs, PhD, Head of Life Sciences Strategy and R&D, Hewlett Packard Labs
Megan Little, Sr Engineering Manager, Mechanical R&D, Medtronic Diabetes
12:30 pm Enjoy Lunch on Your Own
1:55 Chairperson's Remarks
Joshua Windmiller, PhD, MSc, Co-Founder & CTO, Biolinq, Inc.
2:00 Turning on the Lights - Improving Outcomes and Increasing Access with Digital Medicines
Jeremy Frank, PhD, Senior Vice President Digital Medicine, Digital Medicine, Proteus Digital Health
The cost of sub-optimal pharmacotherapy is immense, both in terms of human lives lost (125,000 annually in US) and financial burden on healthcare systems (over $500 billion in US alone). Poor patient adherence to prescriptions
drive a significant portion of that expense but current approaches taken to control costs have been ineffective or, worse, counter-productive. For certain diseases, access to life-saving medication is restricted in certain
patient populations based on the uninformed assumption that those people will be unable to adhere to a particular drug regimen. Such sweeping, ineffective policies can be eliminated by surfacing the information necessary
to correctly identify patients that are struggling with adherence and provide them with the support they need to stay on therapy. The Proteus digital-medicine platform integrates medication with hardware, software, analytics
and services to deliver that exact information and has had significant impact in every disease area it has been applied to. In this talk, Jeremy will provide insights into this digital-medicines category and associated pipeline
of products in development and commercialization.
2:30 Advancing Diagnostics in Endoscopy: Quantifying Inflammation through Perfusion Sensing
George Duval, Principal Engineer, Endoscopy R&D, Boston Scientific Corp.
Inflammation is at the root of a lot of digestive diseases like Ulcerative Colitis, Crohn’s Disease, Barrett’s Esophagus, Gastroenteritis and more. With today’s tools, gastroenterologists are limited in diagnosing the progression of inflammation beyond visual observations which are very subjective to interpretation. Blood tests and pathologies take time. The desire to quantify inflammation objectively during an examination could mean improved patient outcomes and procedures. We have been researching a variety of sensing technologies that show promise in quantifying inflammation. This talk will focus on in vivo perfusion sensing for inflammatory bowel diseases and how it can help stricture management.
3:00 Ingestible and Insertable Technology for Advanced Monitoring of the GI System
Nick Van Helleputte, PhD, R&D Manager, Biomedical Circuits & Systems, imec
Globally metabolic health is dropping at an alarming rate. The human gastro-intestinal system is a very complex system and actually rather accessible, certainly considering recent technological advances in sensing and miniaturization. This talk will focus on technological innovations needed to provide a holistic view of the human GI system in the form of ingestibles or minimally invasive insertables.
3:30 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Tutorials
6:00 End of Day