Exponential increases in demand for the next generation of clinical diagnostic, monitoring and measuring sensors for applications in implantable and wearable devices have created new commercial market opportunities with explosive growth potential. Low
cost materials and advances in nano and micro fabrication techniques within the manufacturing process have led to significant increases in the commercialization of biological and chemical sensors for healthcare applications. This conference track
will examine the latest advancements in research, engineering and manufacturing and will provide attendees with the state-of-the-art in biosensors commercialization for healthcare.
Final Agenda
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Tuesday, December 5
7:30 am Registration and Morning Coffee
8:25 Chairperson’s Opening Remarks
Ahmed Busnaina, Ph.D., Director, National Science Foundation Nanoscale Science and Engineering Center Northeastern University
8:30 Precision Health and Integrated Diagnostics (PHIND): A Vision for the Future
Ryan Spitler, Ph.D., Deputy Director, Precision Health and Integrated Diagnostics Center, Stanford University School of Medicine
This presentation will describe the vision of precision health and integrated diagnostics (PHIND), which will use data from health monitoring devices and other sources to predict and prevent adverse health outcomes. Based on lifelong learning, customized
approaches for the types of monitoring and intervals of surveillance can be adjusted on a continual and individual basis. These capabilities will work towards keeping individuals healthy for as long as possible and if necessary enable interventions
at the earliest possible point.
9:00 The National Nanotechnology Coordination Office and Support for Nanosensors for Health, Safety, the Environment and Sustainability
Stacey Standridge, Acting Chief of Staff, National Nanotechnology Coordination Office, National Nanotechnology Initiative
The National Nanotechnology Coordination Office (NNCO) supports multiple efforts by National Nanotechnology Initiative member agencies to advance the development and commercialization of nanotechnology enabled sensors for health, safety, the environment,
and sustainability. This presentation will provide an overview of NNCO activities related to nanosensor development and resources and support for sensor development by NNI agencies.
9:30 Microscale pH Modulation on Demand: A Platform for Tuning Biological Reactions in Microenvironment
Young Shik Shin, Ph.D., Senior Research Scientist, Robert Bosch Research and Technology Center/Stanford Genome Technology Center
pH plays important roles in a broad range of biological functions such as protein-protein interactions, enzymatic activity, chemical reactivity, and molecular assembly. Here, we introduce an electrochemical platform that can generate spatially well-defined
regions of different pH within an aqueous solution. pH of each microenvironment can be dynamically controlled by oxidizing/reducing an electrochemical additive, quinone, with patterned indium tin oxide electrodes on the substrate. Optical transparency
of the underlying glass substrate and electrodes allows the platform to function as a drop-in replacement for bioassays that employ optical readout. In our present design, multiple electrodes in each reaction chamber generate up to 10 different pH
regions so that one experiment or assay can test several pH conditions simultaneously, or multiple assays optimized at different pH values can be run in the same batch without the need for changing buffers or using multiple reaction chambers.
10:00 Networking Coffee Break
10:30 FEATURED PRESENTATION: Advanced Diagnostics in Endoscopy for Different Imaging Modalities
George Duval, Principal R&D Engineer, Boston Scientific
In this this talk I will present challenges associated with diagnostics and monitoring for Crohn’s Disease, an Inflammatory Bowel Disease using the current endoscopic severity indexing and highlight various industry and academic research that
is indicating better ways to quantify this scoring with various imaging techniques.
11:00 Opportunities for Improvements in Non-Invasive Monitors for Newborn Medicine
Jagjit Teji, M.D., Attending Neonatologist, Pediatrics Division of Neonatology, Ann and Robert H. Lurie Children’s Hospital of Chicago
About 500,000 babies out of 4 million in the USA and 1 out of 8, in 135 million worldwide are delivered worldwide prematurely. They require Neonatal Intensive Care for achieving highest potential in growth and development. Currently, Giraffe Isollete,
an incubator, is the only device made for the babies and every few years some improvements are made on the existing one. It is cumbersome using devices made for adult population but that is all we have. The devices should be made for and used
for the babies and children. Non-invasive monitoring and management with sensors could have potential here.
11:30 Electrochemical Imaging in 3D Multicellular Tumor Tissue
Miklos Gratzl, Ph.D., Professor, Case Western Reserve University
To make drug development more effective, integration of efficient in vitro testing in 3D multicellular tumor models after successful testing in monolayers and before preclinical studies is required. We are developing an approach that makes is
possible to produce large numbers of identical multicellular model tumors for serial testing fast and inexpensive. The approach also allows for high throughput screening of the 3D constructs in a multidimensional experimental space. This includes
electrochemical imaging of hypoxia, an important factor in therapy failure, inside these models possible for the first time.
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:55 Chairperson’s Remarks
Stacey Standridge, Acting Chief of Staff, National Nanotechnology Coordination Office, National Nanotechnology Initiative
2:00 Integrated Microfluidic Platform for Rapid Antimicrobial Susceptibility Testing and Bacterial Growth Analysis
Tania Konry, Ph.D., Assistant Professor, Department of Pharmaceutical Sciences, Northeastern University
The rapid emergence of antibiotic resistance presents an alarming challenge for management; it is now increasingly likely that many patients will be treated with inactive therapy, leading to adverse outcomes. Here, a novel technology called ScanDrop
that incorporates a bead-based assay and microfluidics device will address the shortcomings of current diagnostic technologies. As conceived, ScanDrop provides ultrafast (< 20 min), highly sensitive, direct-from-patient sample diagnostics
for UTI pathogens without the need for culture pre-amplification, and provides AST results within 15 min of specimen acquisition. In this proposal, we aim to further develop and validate the previously developed and patented ScanDrop technology.
In the proposed aims the team of bioengineers working with microbiologists with extensive expertise in clinical and basic microbiology and diagnostic method evaluation will first validate detection assays for specific pathogens; second, integrate
a novel droplet co-encapsulation technology previously developed by the Konry lab to deliver bacterial viability reagents into each droplet for susceptibility testing; third, incorporate these assays within ScanDrop allowing for optical interrogation
of nanoliter reaction volumes and merging with antimicrobial droplets for AST.
2:30 Home Monitoring of Disease Progression in Patients
Ramiro Ribeiro, M.D., Ph.D., Senior Medical Director, Head of mHealth, Head R&D, Acucela, Inc.
Patients with retinal diseases such as neovascular AMD require frequent follow-up in the physician’s office as delayed treatment results in irreversible vision loss. These often expensive visits are a major burden for the often elderly patient
population, their caregiver, but also physicians. Home monitoring of disease progression allows following patients more tightly and bringing them into the clinic for treatment on a timely basis. Recent advancements in retinal imaging technologies
will be discussed that allow for the development of home monitoring devices and systems.
3:00 Non-Invasive Continuous Blood Glucose Monitoring Using Microwaves: Human Clinical Trial Results
Heungjae Choi, Ph.D., Ser Cymru Research Fellow, School of Engineering, Cardiff University
Diabetes population is rapidly rising and a truly non-invasive and accurate continuous blood glucose monitoring sensor is considered as the holy-grail of diabetes research. In this talk, state-of-the-art minimally-invasive continuous glucose monitoring
techniques will be reviewed and the design and performance evaluation of a microwave-based non-invasive continuous blood glucose monitor will be presented. A clinical trial involving 24 human subjects with and without diabetes was carried
out to prove the accuracy and repeatability of the proposed system, showing mean absolute relative difference (MARD) of 12.5% for all 24 subjects.
3:30 Refreshment Break in the Exhibit Hall with Poster Viewing
4:15 PANEL DISCUSSION: From the Bench to Production - Overcoming the Challenges of Sensor Development through Advanced Micro and Nanoscale Manufacturing Methods for Healthcare Applications
Moderator: Ahmed Busnaina, Ph.D., Director, National Science Foundation Nanoscale Science and Engineering Center Northeastern University
Panelists: Luther Lindler, Ph.D., Senior Scientist (ST), Biological Programs, Chemical and Biological Defense Division Science and Technology Directorate, U.S. Department of Homeland Security
Additional Panelists to be Announced
Invention at the nanoscale promises to revolutionize novel bio-sensors for pathogen detection and monitoring of a large number of biomarkers. Utilization of nanoscale printing technology that creates a novel biosensor platform for real-time pathogen
monitoring and for wearable sensors to monitor physiologic state. Join our panel of experts as they discuss the latest micro and nanoscale methods for manufacturing the next generation of biosensors.
5:15 Welcome Reception in the Exhibit Hall with Poster Viewing
6:15 End of Day
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Wednesday, December 6
8:00 am Roundtable Discussions with Continental Breakfast
Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from
their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
TABLE 1: Bridging the Divide: Transitioning Wearable and Implantable Biosensors to Clinical Applications
Moderator: Joshua Windmiller, Ph.D., CTO & Founder, Biolinq Technologies, Inc.
- Why is there a lack of clinical-grade wearable or implantable biosensor products, despite the proliferation of innovations in the biosensors domain?
- What are the key challenges that need to be overcome to make biosensors viable for practical applications?
- What are key drivers of adoption of biosensors in the marketplace?
TABLE 2: Health Monitoring
Moderator: Ryan Spitler, Ph.D., Deputy Director, Precision Health and Integrated Diagnostics Center, Stanford University School of Medicine
- Wearables/activity trackers
- Passive monitoring
- Strategies for better adoption
- Biomarkers
- Predictive Data Analytics
TABLE 3: Using Wearable Devices for Healthcare
Moderator: Mark Buccini, Director, Business Unit Strategy, Texas InstrumentsPatient willingness.
- Passive and semi-active fitness trackers are common place, but what about high quality patient bio data?
- There is still significant resistance by some to engage with the technology.
- Battery-life issues. The majority of trackers today need to be charged. But medical grade devices must be capable of operating for weeks or months without needing a charge, especially with elderly or restricted patients.
- Security and privacy. As with any medical technology, there are security and privacy concerns with data that may be transmitted wireless. How can this data be protected? Protected from hacking?
TABLE 4: Next Generation Implantables
Moderator: Bill von Novak, Principal Engineer, Qualcomm
- What medical needs in the patient population today cannot be addressed without medical implants?
- How does more rapid/frequent availability of patient data change the current treatment paradigm?
- How will data security issues affect the acceptance of medical implants?
8:55 Chairperson’s Opening Remarks
Charles Young, Ph.D., Principal Professional Staff, Chief Scientist, Applied Biology Group, Asymmetric Operations Sector, The Johns Hopkins University Applied Physics Laboratory
9:00 Towards New Avenues in Minimally-Invasive Intracutaneous Electrochemical Biosensing
Joshua Windmiller, Ph.D., CTO & Founder, Biolinq Technologies, Inc.
This talk highlights the development of a novel class of minimally-invasive electrochemical biosensors that facilitate the quantification of relevant metabolomic, ionic, and neurochemical information residing in the viable epidermis in a continuous,
real-time fashion. Fabricated through manufacturing processes that are scalable, cost-effective, and highly precise, these novel biosensing modalities seek to bridge the gap between analytical-grade instrumentation typically found in the hospital
laboratory and user requirements for unobtrusive, low-profile, skin-applied devices able to deliver timely, actionable information using existing wirelessly-enabled wearable and mobile platforms.
9:30 Objective Measures for Clinical Assessment and Precise Understanding of Disease Progression - Webcast Presentation
Christopher M. Hartshorn, Ph.D., Program Manager, Office of Cancer Nanotechnology Research, National Cancer
Institute
The rapid adoption of wearable and external sensing platforms since 2015, by the consumer health market, have begun to pave the way for similar platforms to act as objective measures for continuous, out of clinic cancer research and patient assessment.
This talk will look at various efforts across the National Institutes of Health attempting to enable more objective measures for out-of-clinic assessment and understanding disease progression, more precisely in time and context.
10:00 Printed Batteries Enabling Wearable to Unawarable
Rajan Kumar, CEO and Founder, Ocella LLC
Humans are in contact with textiles the vast majority of their lives, but we have yet to see an approximate level of incorporation of sensor & electronics in textiles as in we have seen in our homes, cars, televisions, and wearable devices.
By integrating electronics, including IOT devices, into textiles, the E-textile segment promises to bring the integrated world even closer to its human users. With such integration, E-textiles have the likely potential to reshape the way we
interact with computing systems, from touchscreens in mobile devices, to an intimate body contact and continuous monitoring of our bodies. Unfortunately, smart clothing currently inhibited by non-conforming, bulky, rigid batteries that require
valuable space, weight and time-consuming mounting. We need cheaper, conformal, and simple electronics to enable this future of ubiquitous computing.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
11:15 Droplet-Based Microfluidic Detection of Pathogens and Indicator Organisms Based on Growth Characteristics in Selective and Differential Growth Media
Charles Young, Ph.D., Principal Professional Staff, Chief Scientist, Applied Biology Group, Asymmetric Operations Sector, The Johns Hopkins University Applied Physics Laboratory
Even with the advent of rapid molecular and immunological detection methods in environmental and clinical laboratories, there are many instances where growth and isolation of the organism is necessary to confirm results of rapid methods, determine
whether the organisms are living or dead, or for follow-on analysis. In this presentation, we will describe our current efforts to apply a rapid, droplet-based microfluidic method for the growth-based differential detection and isolation of
microbes in as little as 4 hours.
11:45 Regulatory Considerations for Commercialization of Medical Devices - Webcast Presentation
Orlando Lopez, Ph.D., Program Director, National Institute of Dental and Craniofacial Research (NIDCR); Formerly Biomedical Engineer, Lead Regulatory Reviewer, Office of Device Evaluation, FDA
Discussion of the FDA regulatory process and associated considerations for taking a new medical device to market. Specific emphasis will be given to performance testing considerations needed to demonstrate safety and effectiveness of sensor-based
devices.
12:15 pm End of Biological and Chemical Sensors for Healthcare Applications
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