Sensors for Medical Device and Implantable Applications

 

医療機器や埋め込み型機器の応用分野に対応するセンサー
適切な設計と統合によるより良い患者予後の実現

センサー技術の進歩により、医療の世界で革命的な変化が起きています。急速に発展しつつあるこの市場では、新たなセンサーの開発企業が競争力を高めるための方策や既存のメーカーが新型のセンサーを自社の機器に統合する方法、企業が直面する課題や回避すべき陥穽、成功が見込める設計や実装などが重要なテーマとして浮上しています。医療分野のセンサーに焦点を絞り込んだこのカンファレンスプログラムでは、各種のセンサーを医療機器に組み込む際に直面する課題をより良い形で克服する方法などが紹介されます。

12月10日(火)

7:30 am Registration and Morning Coffee

全体セッション

8:20 Chairperson's Remarks

Christopher Hartshorn, PhD, Program Director, Cancer Treatment & Diagnosis, National Institutes of Health; National Cancer Institute

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, HP 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

Lisa Diamond, CEO, Pinpoint Science LLC

  • Where can access to biosensor solutions save lives in the developing world?
  • How can novel biosensor technologies contribute to fighting emerging pandemic threats?
  • What new tools can be offered to consumers to monitor and diagnose their own health status?
  • How do we best handle data collected from connected biosensors, protecting patient privacy while informing public health agencies?
  • What new applications for biosensors are needed in veterinary medicine, agriculture and food safety? 

Table 2: Power Solutions for Miniaturized Implants

Robert Rubino, Senior Director, Research and Development, Integer

  • How can we improve power technology to make powered implants smaller and more convenient?
  • What wireless power solutions are available?
  • What new battery and capacitor solutions are available that enable smaller devices?
  • What are the technical hurdles that these new technologies need to overcome and how do we get there?

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

  • What advantages are offered by Application Specific Integrated Circuits (ASICs)?
  • What are the primary challenges associated with an ASIC-based design?
  • What are the most common applications that justify the challenges of an ASIC-based design?
  • How do you approach the system/circuit partition when developing an ASIC-based design?
  • What factors should be considered when deciding to either work with an ASIC supplier or develop an ASIC in-house?
  • What are the most important factors when selecting an ASIC supplier?

Table 4: Overcoming the Challenges to Bringing Medical Devices to The Market

David DiPaola, Managing Director, DiPaola Consulting

  • What were your biggest challenges bringing a medical device to market and what solutions did you implement?  
  • How were you able to expedite the FDA approval process and when in the development did you get the FDA involved?  
  • How do you recommend shorting the time to market for a medical device?  
  • What issues did you face in pilot production that were not identified in in the development stage and what steps did you take to address this?
  • How did you incorporate manufacturing, test and dimensional measurement requirements into your design up front?  What tools did you use?  

Table 5: Advanced Materials

Stacey Standridge, PhD, Deputy Director, National Nanotechnology Coordination Office

  • What advanced materials are you working with?
  • What specific performance, cost, or other benefits are you targeting with these materials?
  • What are the bottlenecks in deploying advanced materials in devices (e.g., technical performance, manufacturing scale, reproducibility, integration, standards, financial considerations)
  • What are potential mechanisms to address these bottlenecks?
  • What lessons can be learned from prior technologies in evolution of scale, reproducibility, and quality control? Are there any new challenges that are unique to your advanced material?

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?

次世代のウェアラブルセンサーと埋め込み型センサー

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.

Advancements in continuous glucose monitoring (CGM)- non-adjunctive use and zero calibrations- have been transformative for diabetes patients. Latest sensor technology and algorithms have resulted in sub-ten Mean Average Relative Differences (MARDs). However, there are some remaining difficult physiology related discrepancies. Complexity of immune responses, foreign body responses, patient to patient differences, and patch adhesion are causing inaccuracies. Drug-eluting sensors, multi-sensing elements, and 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

The early days of Connected-Care R&D could not overcome necessary efficacy and safety requirements in sufficient time to live up to the hype for medical use. 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

12:30 Sponsored Presentation: Title to be Announced

1:00 Enjoy Lunch on Your Own

次世代のウェアラブルセンサーと埋め込み型センサー (続き)

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 Customer behind the Customer/Sensor Design for Patient Usability

Grant Hughes, Co-Founder & Chief Strategy Officer, FocusMotion Health

In designing and implementing solutions, tech companies want to show off their bright shiny data, yet often forget the technology sophistication of the end user: the patient. Machine learning and millions of data points don't matter if we can't engage the patient or if we can't provide usable, actionable data for the surgeon or the hospital. How do we design to serve both customers?

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

12月11日(水)

8:00 am Registration and Morning Coffee

全体セッション

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 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

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, 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

  • How do you decide what to prioritize?
  • Continuous improvement in sensitivity and specificity

Table 2: Best Practices for AI, IoT, etc

Aminat Adebiyi, PhD, Research Staff Member,Biomedical IoT and Applied Analytics, IBM

  • We hear about what’s worked at conferences, but what about what hasn’t worked?
  • What standards do we like? What don’t we like?

Table 3: The Small Business Innovation Research (SBIR) program and Small Business Technology Transfer (STTR)

Dr. Juan Figueroa, Puerto Rico Science and Technology Trust

  • When was the first time you heard about SBIR/STTR? What are the similarities and differences from what you heard today?
  • Are you aware of any SBIR/STTR award winner? Are you aware of a company with a potential for >$1M equity free and hold on to IP? Why wouldn’t you invest in it/them? Why would you invest in it/them? 
  • Are you afraid the federal government will take the IP? 
  • Are you afraid the grantees (contractors) do not have the experience to move the company forward? 
  • Do you have a horror story about an SBIR/STTR company? A positive story? What went wrong? What went right?
  • What do you want to hear to make you look favorably towards investing in an SBIR/STTR grantee?  

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

  • What will next generation physiological monitoring sensors and systems look like?
  • What technologies will need to be developed to enable continuous (e.g., wearable) monitoring of additional, medically relevant, vital signs?
  • Can raw data from existing sensors be used to infer other vital parameters using AI / ML approaches?
  • Would there be a net gain from the consumerization of these new sensing modalities (cost versus benefit of resulting follow up / treatment)?
  • What are the risks to the end-user, and can we think of approaches to mitigate them?

Table 5: Considerations for use of Sensor-measured Digital Endpoints during Drug Clinical Development

Mike Benecky, Senior Director, Global Regulatory Affairs in Precision and Digital Medicine, GlaxoSmithKline

  • What further work needs to done to establish an  “off-the-shelf” 510k cleared sensor device as a Digital Clinical Outcome Measure in a Pivotal Drug Study?
  • What added value do digital sensors bring to the drug clinical development process?
  • What are the regulatory challenges during utilization of a novel digital endpoint during a registrational drug clinical trial?
  • What therapeutic areas appear most fertile for use of digital endpoints during drug clinical development

医療用センサーと消費者向けセンサー

11:25 Chairperson's Remarks

Joshua Windmiller, PhD, MSc, Co-Founder & CTO, Biolinq, Inc.

PANEL DISCUSSION

11:30 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 tradeoffs between these two sensor classes as the panelists tackle this dilemma.

Panelists:

Tom Calef, CTO, Activ Surgical

YuFeng Yvonne Chan, MD, PhD, Associate Professor & Director Digital Health, Genetics & Genomic Sciences & Emergency Medicine, Icahn School of Medicine at Mount Sinai

Debbie Chen, PhD, Founder & CEO, Hydrostasis, Inc.

12:30 pm Sponsored Presentation (Opportunity Available)

1:00 Enjoy Lunch on Your Own

摂取型センサーと挿入型センサー

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 - 125,000 lives and over $500 billion annually in the US alone.  Poor patient adherence to prescriptions dominate that expense and current ineffective mitigation efforts do not address the fundamental root cause - the gap between physician expectation and patient behavior.  The Proteus digital-medicine platform integrates medication with hardware, software, analytics and services to close that critical loop.

2:30 Advancing Diagnostics in Endoscopy: Quantifying Inflammation through Perfusion Sensing

George Duval, Principal Engineer, Endoscopy R&D, Boston Scientific Corp.

Inflammation is the root of a lot of digestive diseases like Ulcerative Colitis, Barrett’s Esophagus, and more. With today’s tools, gastroenterologists using direct visual observations are very subjective to interpretation. 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. 

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

10:30 Roundtable Discussions

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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