2nd SoCalBio Digital Health Conference

2018 Who Should Attend?

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 group

Thanks to Sponsors

www.SoCalBioDH.com

2nd 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

#SoCalBioDH

The SoCalBio Digital Health Conference is an annual event organized by the Southern California Biomedical Council (SoCalBio), the trade association of the bioscience and health industries in the Greater Los Angeles region. The conference showcases Southern California innovators and provides a forum for key providers, payers, entrepreneurs, and investors to share how digital innovations can improve the delivery of care at lower costs. In its second year, this SoCalBio conference will focus on smart wearables, particularly medical-grade devices and related solutions. The event will highlight how wearables — including devices based on Southern California innovations — are on track to become a new modality in the interaction between patients and healthcare providers. Topics to be covered: What makes the wearables market tick: consumer vs. medical

grade wearables. Wearables hot-spots: growth drivers and investment trends. Wearable innovations: current & future applications. Who are the innovators in Los Angeles and Southern California. Innovation adoption, chronic disease care and population aging. Regulatory, cybersecurity and privacy challenges.

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Conference Agenda

8:00 Welcoming Remarks

8:05 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 Break

Research by MarketsandMarkets indicates that “The wearable medical devices market is expected to reach USD 14.41 Billion by 2022 from USD 6.22 Billion in 2017, at a CAGR of 18.3%. “

The growth of the market is attributed to the technological advances in medical devices, increasing penetration of smartphone-based healthcare apps compatible with wearable devices, and increasing awareness of the benefits of physical fitness.

2nd SoCalBio Digital Health Conference 3

8:55 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 • Jens Paetau , Practice Lead at NextFlex, California Manufacturing Technology

Consulting (CMTC) • Chris Thierfelder, former Executive from Halyard / Digital Health Consultant

9:55 Break

10:00 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 Break

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11:00 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 Networking luncheon

12:45 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

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1:45 Break 2:00 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)

3:00 Break

3:05 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

4:05 Break

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4:10 Panel Discussion:

Consumer Adoption & Reimbursement

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:

• Scott Witt, President, Witt Venture Development

Panelists:

• Patrick Bertagna, President & CEO, GTX

• Soeren Mattke, PhD, Director, USC Center for Improving Chronic Illness Care

• Ayman Salem, MD, President & CEO, iKioo

• 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

5:10 Final Remarks by Panel Moderators:

Where to Go from Here?

Building a Sustainable Digital Health Economy in Greater Los Angeles

5:30 Concluding Reception:

Meet the Speakers

6:30 Conference Adjourns