Advances, Opportunities and Innovative Solutions for Consumer and Clinical Wireless Medical Devices

Transcription

1 BIOMEDevice San Jose Conference: Wireless Medical Device December 2-3, 2015 San Jose Convention Center Advances, Opportunities and Innovative Solutions for Consumer and Clinical Wireless Medical Devices Day 1: Wireless Medical Device for Consumer Use Keynote Presentation 9:00am - 9:30am 9:00am 9:30am Changing Psychology with Technology: Engaging Users to Adopt mhealth Long-term Can you design behavior change? Everybody wants change but nobody wants TO change what it will take from technology to see long-term adoption of digital health Is mhealth the answer? Discovering how the consumerization of healthcare affecting values-based healthcare delivery Digging deeper into gamification tools that increase user engagement and produce positive outcomes is this the Holy Grail? Bill Saltzstein, President, CODE BLUE CONSULTING Break Chairperson: Bill Saltzstein, President, CODE BLUE CONSULTING Trust Me, I m a (Digital) Doctor 9:45am 11:45am 9:45am 10:20am Power to The People: Next-Generation Wearables, Mobile Applications & At- Home Devices for DIY Healthcare An overview of the current market and hot trends in DIY healthcare Understanding the capabilities consumers need from connected health

2 Exploring preventive diagnostic tools that mitigate the onset of health problems Developing solutions for the treatment and management of chronic disease through mobile devices, applications, and wearables Lois Drapin, Senior Vice President, New Health Markets, KOGNITO & Chief Executive Officer, The Drapin Group LLC. 10:20am 10:55am Revolutionizing Point of Care with Remote Healthcare Solutions How can wireless medical devices enable remote medical care and lower healthcare cost? Examining the possible risks with dependence on home devices and remote monitoring systems Discussing mhealth at the point of care for better Electronic Medical Record (EMR) data transmission and management Lance Myers, Ph. D., Chief Technology Officer, SENTRIAN 10:55am 11:30am An Innovative Design Approach for Wellness-Integrated Medical Technology How will hybrid clinical/consumer devices and applications continue to transform care delivery? Key factors that you will want to consider when jumping into product design for a wellness-integrated health solution How do you design engaging user interfaces for a variety of end-users, including patient/provider needs? Sonya Kim, M.D., Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS 11:30am Q&A Ask The Experts 11:45am Facilitator: Bill Saltzstein, President, CODE BLUE CONSULTING Speakers: Lois Drapin, Senior Vice President, New Health Markets, KOGNITO & Chief Executive Officer, The Drapin Group LLC. Lance Myers, Ph. D., Chief Technology Officer, SENTRIAN Sonya Kim, M.D., Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS Lunch Chairperson: Sonya Kim, M.D., Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS

3 Going to Market: Reimbursement & Regulation 1:00pm 2:30pm 1:00pm - 1:30pm Joining the Medical Device Club: Getting Accepted for Reimbursement Strategizing how to get financial return on your medical technology Pre-market planning: How to integrate the key reimbursement criteria into your business plan and product development road map Post-market planning: How to integrate the key reimbursement criteria into your business method when you re already at market Designing digital health devices that can produce reliable data that evidences improved health outcomes and lowered healthcare costs Examining the reimbursement landscape for 2016 and beyond 1:30pm 2:15pm Panel Session Regulation 101 for Connected Health in 2020 Listen in on regulatory experts clarifying the new regulatory guidance in the digital health space and get an in-depth understanding of FDA and FCC s role in the market approval process. In this panel session, these experts will share their insight on risk analysis, what to consider when preparing for PMA and 510(k) submissions, compliance requirements for Medical Device Data Systems (MDDS), and more. Moderator: Sonya Kim, M.D., Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS Panelist: Chris Danek, Independent Consultant & (formerly) Chief Executive Officer, ATHEROMED Ryan Minarovich, Partner and Co-Founder, THE TENZING GROUP Michelle Jump, Principal Regulatory Affairs Specialist, STRYKER Arezou Azar, Ph.D., Regulatory Affairs Leader, Software & Systems, PROTEUS DIGITAL HEALTH, INC. Q&A 2:15pm - 2:30pm Facilitator: Sonya Kim, M.D., Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS Speakers: Leslie Stephens, Director, Health Economics, ABBOTT VASCULAR Chris Danek, Independent Consultant & (formerly) Chief Executive Officer, ATHEROMED Ryan Minarovich, J.D., Partner and Co-Founder, THE TENZING GROUP Michelle Jump, Principal Regulatory Affairs Specialist, STRYKER Arezou Azar, Ph.D., Regulatory Affairs Leader, Software & Systems, PROTEUS DIGITAL HEALTH, INC. Break

4 Chairperson: Lance Myers, Ph. D., Chief Technology Officer, SENTRIAN All About That Data 2:45pm 4:00pm 2:45pm 3:15pm Patient Privacy & Data Security in the Cloud Communication Age Our technology is advancing faster than we can protect it. How can we keep up with the cloud communication age and build sustainable data protection? Understanding FDA s evolving guidelines and standards to address cyber security How is HIPAA playing an increasingly pervasive role in health data management? Advances in safely transmitting data to healthcare applications and protecting data on mobile devices from cyber attacks Redefining the concept of privacy to protect the patient while utilizing health data for treatment and outcomes Steve Abrahamson, Director, Product Security Engineering, GE HEALTHCARE 3:15pm 4:00 pm Panel Session The Future of Consumer-Generated Health Data: Breaking Away from Dark Data to Deliver Clinical Value Join the conversation about mhealth data integration and management how can you make consumer-generated data relevant to medical care and aid clinical decisions? These thought leaders will discuss the future of consumer devices delivering quantifiable health outcomes, strategies to improve Big Data analytics for clinical value, shedding light on dark data and the potential security risks of cloud-enabled solutions. Moderator: Stephanie Kute, Ph.D., Manager of Advanced Analytics and Health Research, BATTELLE Panelist: Kimberlie Cerrone, Chief Executive Officer, TIATROS INC. Rochelle Pleskow, (formerly) Chief Healthcare Informatics Officer, HEWLETT-PACKARD Steve Abrahamson, Director, Product Security Engineering, GE HEALTHCARE 4:00pm Conference Adjourns Day 2: Wireless Medical Device for Clinical Use Keynote Presentation 9:00am - 9:30am 9:00am 9:30am How the Healthcare Crisis is Triggering the Opportunity to Move Beyond Niche Device Problem Solving Defining the healthcare crisis and how technology can be used to create long-

5 term change No more niche problem-solving: Evaluating the wireless technology market opportunities to tackle the bigger picture Joe Flower, Chief Executive Officer, THE CHANGE PROJECT, INC. Break Chairperson: Jonathan Honiball, Senior Director, Customer Research, PACIFIC CONSULTING GROUP Keeping Up With The Digital Revolution 9:45am 11:45am 9:45am 10:15am Pinpointing the Technology Barrier That s Holding Future Hostage Looking at the latest trends in wireless technology, advancements being made, and what capabilities physicians still need Examples of disruptive technology and innovation for consumer devices and what s preventing them from getting into hospitals around the world Assessing the hurdles for sensor development and cognition technology that need to be resolved for the next generation of products to get to market Analyzing the failures of mhealth devices past and present Upkar Dhaliwal, System Architect, FUTURE WIRELESS TECHNOLOGIES 10:15am 10:45am Smarter Healthcare with Internet of YOU Medical Device Technology What s next for machine-to-machine communication in the hospital ecosystem? Big Data and machine learning for empowering patients: How can the Internet of Things improve patient experience and advance medical care? Developing IoT in home devices to accelerate remote healthcare Discovering IoT vulnerabilities at the device, application, data quality, and network level How IoT will take us to the next level of personalized medicine David E. Albert, M.D., Founder and Chief Medical Officer, ALIVECOR 10:45am 11:30am Panel Session Consumer Design-Thinking + Medical Design-Thinking = Successful Products for Widespread Adoption So many solutions, not enough problems to solve between innovative technology and usability, what should be your priority in the product design cycle? How do you achieve an all-in-one interface using consumer-design principles and clinical application objectives? Designing products that are easy to train, maximize user engagement, and fosters

6 longer term-usage Moderator: Prat Ganapathy, Design Lead, IDEO Andrew Atwell, Principal, SAMSUNG OPEN INNOVATION CENTER Josh Stein, Chief Executive Officer and Co-Founder, ADHERETECH Steve McPhilliamy, Partner, INSIGHT PRODUCT DEVELOPMENT & Executive Director, INSIGHT ACCELERATOR LABS Jonathan Honiball, Senior Director, Customer Research, PACIFIC CONSULTING GROUP 11:30am Q&A 11:45am Facilitator: Prat Ganapathy, Design Lead, IDEO Upkar Dhaliwal, System Architect, FUTURE WIRELESS TECHNOLOGIES David E. Albert, M.D., Founder and Chief Medical Officer, ALIVECOR Andrew Atwell, Principal, SAMSUNG OPEN INNOVATION CENTER Josh Stein, Chief Executive Officer and Co-Founder, ADHERETECH Steve McPhilliamy, Partner, INSIGHT PRODUCT DEVELOPMENT & Executive Director, INSIGHT ACCELERATOR LABS Jonathan Honiball, Senior Director, Customer Research, PACIFIC CONSULTING GROUP Lunch Chairperson: Andrew Atwell, Principal, SAMSUNG OPEN INNOVATION CENTER Uberization of Medical Technology 1:00pm 2:30pm 1:00 pm 1:30 pm A Creative Approach for a Better Power Source: What s Next in Battery Technology Closing in on opportunities for power from energy harvesting to wirelessly recharging Examining advancements in battery technology and how they will aid low-energy medical devices Exploring next-generation biocompatible housing for batteries how do you make them smaller while keeping them safe for patients? How do you extend the life cycle of batteries, achieve long distance power, and improve reliability? Steve Majerus, Investigator, ADVANCED PLATFORM TECHNOLOGY CENTER 1:30pm - 2:00pm Designing Smartphones and Tablets Into Medical Devices

7 Defining goals, requirements, compliance to standards (IEC-6061, etc.), and the submission/approval process Software design life - understanding distribution, control, support, and security How do you choose a software platform and operating system that s right for you? Getting insight on risk assessment and management Jim Turner, Program Manager, Software Engineering Group Manager, SUNRISE LABS 2:00pm - 2:30pm Case Study Healthcare On Demand: Disruptive Technologies & Innovative Solutions in Digital Health TBD Nick Desai, Founder and Chief Executive Officer, HEAL & (formerly) Chief Executive Officer, FITORBIT Chairperson: Prat Ganapathy, Design Lead, IDEO Break Building The Unified Platform 2:45pm 4:00pm 2:45pm 3:15pm Creating the Ultimate Digital Platform for Efficient Data Management & Accessibility Building data organization solutions for physicians to quickly access patient data and make clinical decisions You asked for data and now you ve got too much of it how do you manage the data stream to filter what s superfluous versus what s valuable? Examining the value chain of data to lower healthcare cost, demonstrate the value of wireless technology, and improve population health Kimberlie Cerrone, Chief Executive Officer, TIATROS INC. 3:15pm - 4:00 pm Panel Session The Future of Hospital & Medical Device Interoperability What it will take to achieve a seamless flow of information Brainstorming solutions to standardize electronic health record information across different systems for efficient medical care Understanding the Agencies involvement - progress being made in efforts to establish clear rules for health IT and what to expect from HIPAA guidelines Looking beyond EMR/EHR what lies ahead in interoperability for medical devices and equipment capturing health information with clinical value

8 Moderator: Kimberlie Cerrone, Chief Executive Officer, TIATROS INC. Panelist: Dan Pettus, Vice President, CAREFUSION Gregg A. Jackson, Principal Consultant, GERSHON MEDTECH Melissa Masters, Director of Electrical, Software and Systems Engineering, BATTELLE Jeff Brandt, Manager, Technical Architecture Mobility, ACCENTURE 4:00pm Conference Adjourns