Sensors for Medical Device and Implantable Applications

Advances in sensor technology are revolutionizing healthcare. Patient outcomes and standardization of care continue to benefit from smarter and more connected medical devices that provide real-time patient monitoring and device performance data. Unlike in other fields, medical device sensors require additional design considerations and performance metrics, particularly those used in surgical or implantable devices. These extra challenges, coupled with regulatory requirements, necessitate sophisticated designs and special considerations. In this rapidly advancing market, how can new sensor developers compete and how can existing manufacturers incorporate sensors into their devices? What are challenges and pitfalls to avoid, and what successful designs and implementations can be learned from? At Cambridge Innovation Institute's Sensors for Medical and Implantable Applications program, attendees will learn how to better overcome the challenges of incorporating sensors into medical devices.

Tuesday, December 10

7:30 am Registration and Morning Coffee

Plenary Session

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

Lisa Diamond

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

Next-Generation Wearable and Implantable Sensors

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

Next-Generation Wearable and Implantable Sensors (Cont.)

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.

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

Plenary Session

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

Clinical vs. Consumer Sensors

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

Ingestible & Insertable Sensors

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

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