SoCalBio Digital Health Conference
Medical Grade Wearables:
Innovation, Market Opportunities, and Regulatory Challenges
Hotel Maya
700 Queensway Dr, Long Beach, CA 90802
November 9, 2018 — 8:00 am – 6:30 pm
Agenda
8:00 am
Welcoming Remarks
8:15 am
Opening Presentations by Rob Greenberg, Alfred Mann Foundation & Ahmed Enany, SoCalBio:
LA Built the Foundations of Medical Wearables
- NASA, JPL and the First Digital Health Wearable Built by Space Labs Medical to Detect Astronauts Vital Signs Wirelessly.
- When Medical Meets Digital, A Tribute to Alfred Mann and his Technological Contributions that Helped Enable the Medical Wearable, Insertable, Implantable Device Market:
- Power Generation
- Sensor Technologies
- Miniaturization
- Bi-Directional Telemetry Using Wireless
- Digitization of Medical Devices
- Medtronic Presentation about the MiniMed 670G Platform of Managing Diabetes, a breakthrough technology that builds on Mann’s legacy.
8:45 am
Break
8:55 am
Panel Discussion:
Trends in the Wearables’ Markets and Technologies
Do wearables matter? Wearables have a checkered history. There were a lot of promises that they would be able to detect and mitigate health problems rather than just simply relay health data. That hasn’t really happened in a big way. The use cases are sparse. Now, there is some renewed interest in wearables that the Apple Watch has been approved by the FDA. We are seeing more and more startups trying to use sensors as a gateway into health data collection and clinical care. Wearables can be used in clinical trials to collect real work data, and health systems understand that monitoring devices can create efficiency. But, what is required to bring wearables into the mainstream of healthcare. Do we see trends indicating that we are moving in this direction?
Introductory Presentation:
- Stuart Karten, President & CEO, Karten Design
Panelists:
- Samir Chatterjee, PhD, Fletcher Jones Professor of Design, Technology and Management, Center for Information Systems and Technology, Claremont Graduate University
- Ron Goldberg, President & CEO, IsoWalk
- Katherine Lewinter, MD, Pediatric Pulmonology, Children’s Hospital Los Angeles
- Chris Thierfelder, former executive from Halyard / Digital Health Consultant
9:55 am
Break
10:00 am
Southern California Wearable Device Showcase I:
Wearables for Wellness
- Adela Health (Smart Shirt to Train and Strengthen Back Muscles for Good Posture and Healthy Spine Naturally)
- Eyedaptic (Simulated Natural Vision Eyewear for Age-Related Macular Degeneration)
- Life Beat (A Music-Based Treatment Platform, Helping People Reach Emotional Balance and Reduce Stress Levels)
- Micro Medical Devices (Wearable for Visual Field Analysis)
10:55 am
Break
11:00 am
Southern California Wearable Device Showcase II:
Remote Monitoring & Elderly Care
- GTX (miniaturized Global Positioning System Tracking Technology for Monitoring the Elderly and People with Dementia)
- Visus Technology (Motion Analytics and Home Health for Improved Clinical Outcomes)
- Wytcote Technologies (IoT Platform for Elderly Care)
- Senseer (Smart Microsensing Platform Technology for Remote Monitoring to Guide Evidence-based Treatment)
Hospital Workflow:
- Tagnos (Clinical Logistics Automation Platform that Combines Real-Time Patient, Staff and Asset Data with AI to Optimize Operational Workflows)
12:05 pm
Networking Luncheon:
Luncheon Panel Discussion:
Partnering to Build the Future of Wearables in Clinical Research and Healthcare Delivery
As the commercial and scientific potential of wearable devices in medicine becomes clearer, both tech titans and scores of digital health start-ups are vying for some of the action. This presents bioscience companies with new potential opportunities for partnering to integrate wearables into their offerings and make sense out of the data generated. This may help in boosting their value propositions and strengthening their competitiveness. But challenges also abound. This luncheon discussion will explore how partnering can increase the potential of mobile and wearable technologies in transforming drug and device development as well as improving healthcare delivery.
Moderator:
- Joseph Boystak, Managing Partner, Health2047 Capital Partners
Panelists:
- Steven Bowers, Assistant Director, Product Assurance and Security Legal, Intel Corporation
- John Donello, VP, Research Pharmacology, Allergan
- Bethany Grant, Director R&D, Digital Product Engineering, Johnson & Johnson
Break
Southern California Wearable Device Showcase III:
Wearables Targeting Medical Conditions
- QT Medical (Compact, Digital, and Wireless ECG That Works with Mobile Devices)
- Pressao Medical (Smart Wearables for Treating Pre-Hypertension)
- StimAire (Wireless Neurostimulation Wearable to Treat Sleep Apnea)
- Expy Health (Platform for Orthopedic Surgery Recovery)
- Allevion Therapeutics (Smart Wearables for Treating Essential Tremors)
- Flint Rehabilitation Devices (Wearables for Clinic and at-Home Therapy After Stroke, Spinal Cord Injury, or Traumatic Brain Injury)
Break
Panel Discussion:
Regulatory Challenges and Strategies for Wearable Medical Technology
Despite their promise, most wearables have been developed to serve the young, well-to-do, fitness-oriented users, and self-quantification enthusiasts. The transition of wearables from direct-to-consumer novelties to health devices requires passing the rigorous FDA regulatory processes for product approval or clearance. The purpose of these processes is to ensure that the type and quality of data generated are both relevant and applicable in a clinical setting. This panel will discuss current FDA approaches in regulating mHealth and wearables, and how and when your technology might encounter regulatory scrutiny.
Moderator:
- Peter Blaisdell, PhD, Chair, SoCalBio Innovation Catalyst Program
Panelists:
- Shep Bentley, President, Bentley Biomedical Regulatory Consultants
- Sugato De, M.S., Principal Consultant, PAREXEL International
- Phil Johnson, Senior Principal, Quality & Compliance Services, IQVIA
- Raju Joshi, Managing Partner, Clinical Partners Group, LLC
Break
4:10 pm
Panel Discussion:
Consumer Adoption, Reimbursement, Privacy, Who Owns the Data
Even if wearables pass strict FDA scrutiny, the ability to drive adoption in the healthcare system depends on who is paying for them. This panel will explore when the patients themselves can pay for wearables. The role of government – through the Centers for Medicare & Medicaid Services (CMS) – will be discussed. CMS has recently released new payment rules that may give mHealth technology a better shot at reimbursement. This is an important step in driving medical wearable implementation in healthcare settings where patients are either reluctant or cannot afford wearable technologies. This panel will also discuss when health insurers cover the cost of health wearables as part of an emerging market of employers looking for healthy workers.
Moderator:
- Ayman Salem, MD, President & CEO, iKioo
Panelists:
- Patrick Bertagna, President & CEO, GTX
- Soeren Mattke, PhD, Director, USC Center for Improving Chronic Illness Care
- Stacey Schepens Niemiec PhD, Assistant Professor of Research, USC Chan Division of Occupational Science and Occupational Therapy
- Philip van Allen, Graduate Media Design, Art Center
Final Remarks by Panel Moderators:
Where to Go from Here?
Building a Sustainable Digital Health Economy in Greater Los Angeles
Concluding Reception:
Meet the Speakers
Conference Adjourns
Who Attends
- Medical device developers
- Component manufacturers
- Information technology providers
- Information security professionals
- Digital health investors
- Providers & Payers
- Pharmaceutical/OTC manufacturers
- Research organizations, universities, institutes
- Public sector
- Clinical/contract research organizations (CROs)
- Associations & advocacy groups
About SoCalBio
Southern California Biomedical Council (SoCalBio) is a nonprofit, member-supported trade association that serves the biotech, medtech, IVD and digital health communities in the six counties that comprise the Greater Los Angeles region (Los Angeles, Orange, Ventura, Santa Barbara, Riverside and San Bernardino). SoCalBio is actively promoting digital health as a vibrant and fast-growing component of the Los Angeles “health and wellness” economy. Find information about SoCalBio at: www.socalbio.org.