Wednesday, December 2, 2015

9:00 am - 9:30 am

Wednesday, December 2, 2015
9:00am - 9:30am

  • 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

Wednesday, December 2, 2015
9:00am - 9:30am

  • Understanding the current market, hot trends in the industry, and getting an overview of what’s next in the medical device industry
  • The integration of novel technology with consumer-centered design
  • Discovering old and new challenges in healthcare innovation – what problems still need solutions and how can you capitalize on unmet needs?

Wallace Wu, Vice President of Software Products and Asian Affairs, MISFIT WEARABLES

9:45 am - 4:00 pm

Wednesday, December 2, 2015
9:45am - 4:00pm

Phase 1: Establishing Your Company
Chairperson: Joanna Nathan, Founder, ENVENTURE & Director of Product Development, SARANAS

9:45am - 10:15am
Jump Starting Your Startup Protection: The Ultimate Startup Survival Guide

  • Overview of patent eligibility, litigation trends and realities, and maximizing the value of your intellectual property
  • Establishing your niche and protecting your company’s competitive edge to avoid the common fate of 90% failure rate before reaching profitability
  • Considering cost-effective solutions in acquiring proper protection

Joel Harris, Senior Director of Intellectual Property, INCUBE LABS

10:15am - 10:45am
Team Work Makes Dream Work: Building the Best Team That Delivers and That Investors Love

  • Assessing which jobs to outsource and which to bring in-house so it makes sense for your budget and business model
  • Exploring experience and credibility you should have in your leadership team – board, advisors, and senior management – to attract investors  
  • What should you expect as the team changes with company growth and success
  • What happens when things go wrong - where you really learn if you have the right team

Michael Weickert, Chief Executive Officer, SONESCENECE, INC & Chief Executive Officer, S.E.A. MEDICAL SYSTEMS, INC

10:45am - 11:30am
Panel Session: Zero to Hero Startup Success: Highly Innovative Approaches & Execution

These startups have become the change they wanted to see in the medical device industry. Hear from an exclusive panel of pioneers as they candidly discuss their innovations, trials and errors, risk management, funding strategies, and the decisions that catapulted them into commercialization.

*Speakers record selfie video of 3 things they think made them successful, play as introduction to panel.

Joanna Nathan, Founder, ENVENTURE & Director of Product Development , SARANAS

Ravi Kuppuraj, Chief Executive Officer, MED TECH STARTUP
Tom Ross, Chief Operating Officer, PONTIS ORTHOPAEDICS
Jim McGough, Co-Founder, EDGEONE MEDICAL
Rodney Brenneman, Chief Executive Officer, ROX MEDICAL
Kathryn Stecco, Co-Founder and Chief Medical Officer, PANTHERA MEDTECH

11:30am - 11:45am
Q&A: Ask The Experts

11:45am - 1:00pm

Phase 2: Developing a Successful Business Model
Chairperson: Jim McGough, Co-Founder, EDGEONE MEDICAL

1:00pm - 1:25pm
Fireside Chat: Playing By The Rules: Navigating The Regulation Pathway

  • Clarifying FDA’s standards, expectations, where the rules can or can’t bend, and what to keep in mind for 2016
  • Reviewing  510(k), de novo, PMA submissions, and understanding what’s expected to change in the approval process
  • How can you position your company for successful market approval? What are the important things to consider before diving into product development, and pivoting your process after the dive?

Frank Pokrop, Director Quality and Regulatory Affairs, CAREFUSION INC
Plamena Entcheva-Dimitrov, PhD, RAC, Founder and Principal Consultant, PREFERRED REGULATORY CONSULTING

1:25pm – 1:55pm
Panel Session:Taking a Preemptive Approach to Strategizing for Reimbursement

This panel of industry thought leaders will debate the best strategies to design innovative medical devices that improve health outcomes AND lower healthcare costs. It is imperative that product developers have a strategy for obtaining reimbursement on the market, so don’t miss this opportunity to gain critical insights on how to integrate the key reimbursement criteria into your business plan and product development road map, which will help you improve your chances of market adoption and payer approval down the road.

Carla Brenner, Founder, HEALTHTECH WOMEN

Sanjeev Saxena, Chief Executive Officer, POC MEDICAL SYSTEMS
Machelle Shields, Healthcare Policy and Compliance Advisor, BUTLER SNOW
Marijke Annis, Founder, RUCKUS PARTNERS, INC.
Matthew Diamond, MD, PhD, Medical Director, MISFIT WEARABLES

1:55pm - 2:30pm
Coaching & Collaboration Spotlight Session

During this interactive brainstorming session, the room will be divided into five areas (each area led by a program Speaker) labeled ‘Regulatory,’ ‘Reimbursement,’ ‘Going-to-Market,’ ‘M&A,’ and ‘Funding’ to provide you the opportunity to dig deeper on each subject, network on a more personal level, and activate intimate conversations in order to find solutions to your company’s biggest challenges.

*Chairperson will call ‘time’ every seven minutes to help facilitate movement and keep the conversations flowing. Everyone should bring their business cards.

Jim McGough, Co-Founder, EDGEONE MEDICAL

Phase 3: Strategizing For Funding
Chairperson: James Bell, formerly Chief Executive Officer of MOBILIZER, INC & Entrepreneur in Residence of ZEROTO510 MEDICAL DEVICE ACCELERATOR

2:45pm – 3:20pm
Panel Session: Analyzing the Market From the Investor’s Perspective

Investment experts debate the challenges and opportunities facing entrepreneurs in this insightful panel discussion, allowing you to see the industry from their point of view.
In this session, you will hear about their assessment process and how to properly identify the appropriate funding source for your company (including alternative investment routes like crowd funding). This panel will unveil what you can expect from the constantly evolving investment world, how best to pitch fundable products, and useful tactics in securing seed investment.

Faz Bashi, Chair, Digital Health and Sciences, LIFE SCIENCE ANGELS & Board Member, Chair of Collaboration, ANGEL CAPITAL ASSOCIATION

Lindy Fishburne, Executive Director, Breakout Labs, THIEL FOUNDATION
Talat Imran, Co-Founder, VENTUREHEALTH & Vice President, INCUBE LABS
Cliff Wright, formerly Chief Executive Officer, CENTERVUE, INC & Life Science Entrepreneur in Residence, THE ANGELS’ FORUM
Karen Drexler, Founding Member, ASTIA ANGELS

3:20pm - 4:00 pm
Rapid-Fire Pitch Competition

Ten startups will each have the opportunity to present their one-minute elevator pitch to a panel of investors to gain invaluable feedback on their pitch and a chance to secure investment.

*Submission deadline for startups: November 20th, 2015 – For more information, email

James Bell, formerly Chief Executive Officer of MOBILIZER, INC & Entrepreneur in Residence of ZEROTO510 MEDICAL DEVICE ACCELERATOR

Faz Bashi, Chair, Digital Health and Sciences, LIFE SCIENCE ANGELS & Board Member, Chair of Collaboration, ANGEL CAPITAL ASSOCIATION
Lindy Fishburne, Executive Director, Breakout Labs, THIEL FOUNDATION
Talat Imran, Co-Founder, VENTUREHEALTH & Vice President , INCUBE LABS
Cliff Wright, (formerly) Chief Executive Officer, CENTERVUE, INC & Life Science Entrepreneur in Residence, THE ANGELS’ FORUM
Karen Drexler, Founding Member, ASTIA ANGELS
Lissa Goldenstein, Co-Founder, AUXOGYN INC.

Conference Adjourns

Wednesday, December 2, 2015
9:45 am - 4:00 pm

Trust Me, I’m a (Digital) Doctor
Chairperson: Bill Saltzstein,

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
  • 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.
Scott Reese,Executive, PUBLICIS & Executive, RAZORFISH HEALTH

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
  • Collecting data is easy – how do you make sense of vast reams of data?

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., MBA, Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS

11:30am - 11:45am
Q&A: Ask The Experts


Going to Market: Reimbursement & Regulation
Chairperson: Sonya Kim, M.D.,
Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS

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

Michael F. Arrigo, Chief Executive Officer, NO WORLD BORDERS

1:30pm - 2:15pm
Regulation 101 for Connected Health in 2020

Listen in on experts discussing regulatory strategies in connected health, clarifying FDA regulatory guidance in the digital health space, and get an in-depth understanding of tactics to optimize the development process in a regulated environment. In this panel session, these experts will share their insight on medical device software lifecycle processes (IEC62304), including agile and hybrid development approaches, risk analysis, what to consider when preparing for PMA and 510(k) submissions, compliance requirements for Medical Device Data Systems (MDDS), and more.

Sonya Kim, M.D., Chief Executive Officer and Founder, ONE CARING TEAM & Founder, BEST MD HOUSE CALLS

Chris Danek,
Medical Device Entrepreneur and Advisor & Co-Founder, ATHEROMED (PHILLIPS HEALTHCARE)
Ryan Minarovich, Partner and Co-Founder, THE TENZING GROUP
Arezou Azar, Ph.D., Regulatory Affairs Leader, Software & Systems, PROTEUS DIGITAL HEALTH, INC.

2:15pm - 2:30pm

2:30pm - 2:45pm

All About That Data
Chairperson: Lance Myers, Ph. D.,
Chief Technology Officer, SENTRIAN

2:45pm - 3:30 pm
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.

Stephanie Kute, Ph.D., Manager of Advanced Analytics and Health Research, BATTELLE

Kimberlie Cerrone, Chief Executive Officer, TIATROS INC.
Russ Haight, Regional Director of Operations, Evolution Health, ENVISION HEALTHCARE
Michael Murray, Director, Product Development Security, GE HEALTHCARE

3:30pm - 4:00pm
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

Michael Murray, Director, Product Development Security, GE HEALTHCARE

Conference Adjourns

10:45 am - 3:15 pm

Wednesday, December 2, 2015

10:45am - 11:30am
Wearables: Adding Meaning To Mobile Experience With Haptics

In today's society, mobile devices are no longer second screen. Whether at home or on the go, people consume most of their entertainment content on mobile devices. As wearables continue to grow in popularity, wearable content becomes an imperative connection point for brands and consumers. David Birnbaum will discuss his four principles for designing touch-enabled content for wearables.

Advancement in wearable technology presents an opportunity for designers and developers to employ touch feedback and better engage users and offer richer entertainment experiences.

David Birnbaum, Design Director, IMMERSION CORPORATION

11:45am - 12:30pm
Wearables: Smart Clocking Techniques Extend Battery Life Of Wearables

This presentation will provide an overview of the clock architecture schemes and low power wireless protocols deployed in cloud connected wearables. It introduces the concept of ultra-small, micro-power high-accuracy clock sources that can be leveraged to reduce device footprint while conserving power to extend battery life.

Jehangir Parvereshi, Sr. Manager, CE, SITIME


2:30pm - 3:15pm
Wearables: Assessing Market Opportunity In Medical Wearables

Learn to assess product viability for medical wearables

Julien Penders, Co-Founder & CEO, BLOOM TECHNOLOGIES

Thursday, December 3, 2015

10:00 am - 4:00 pm

Thursday, December 3, 2015
10:00 am - 4:00 pm

Improve your ability to deliver great design by learning and practicing key elements of the IDEO design process. IDEO, the global design and innovation firm, has a history of delivering impactful, compelling, human-centered design to the world of medical and consumer products. IDEO will lead a fully interactive design workshop allowing the participants to flex their creative muscles and learn how to brainstorm novel and creative solutions, and quickly prototype experiments to test concepts. The workshop will use case studies of existing products on the market to describe the steps and tools of the design process.

9:00 am - 9:30 am

Thursday, December 3, 2015
9:00am - 9:30am

  • Defining the “healthcare crisis” and how technology can be used to create long-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.

9:45 am - 4:00 pm

Keeping Up With The Digital Revolution
9:45 am - 4:00 pm

Chairperson: Jonathan Honiball, Senior Director, Customer Research, PACIFIC CONSULTING GROUP

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
Healthcare Organizations & Medical Device Manufacturers: The Nexus Responsibility for Security

Currently, the FDA is provides security recommendations for medical device manufacturing and clinical use. However, ensuring that security from attack is something that manufacturers and hospitals are struggling with at this time. Hospitals expect a device secure from attack to be delivered to them and maintained in that state. Manufacturers, on the other hand, place heavy emphasis on hospital policies to ensure the security of their devices – sometimes to the point of building little, if any, meaningful security into their devices. This intersection, where each entity expects the other to “manage” the security of the medical device , creates a high-risk environment where security has a high chance of “falling through the cracks”. This is particularly exacerbated in the case of wireless devices. This talk will address this vulnerable intersection, provide real-world examples, and offer practical steps that both hospitals and medical device manufacturers can implement to reduce the emerging security risks in this area.

Chana O’Leary, Senior Security Consultant, TUV RHEINLAND

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 longer term-usage

Prat Ganapathy, Design Lead, IDEO

Andrew Atwell,
Josh Stein,
Chief Executive Officer and Co-Founder, ADHERETECH
Steve McPhilliamy,
Jonathan Honiball,
Senior Director, Customer Research, PACIFIC CONSULTING GROUP

11:30am - 11:45am


Uberization of Medical Technology

1:00pm - 1:30pm
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?


1:30pm - 2:00pm
Designing Smartphones and Tablets Into Medical Devices

  • 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

Doug Halperin, Director of Operations, Western Region, SUNRISE LABS

2:00pm - 2:30pm
Healthcare On Demand: Disruptive Technologies & Innovative Solutions in Digital Health

  • Three kids, a nanny, a dog, a cat and a goldfish – challenges and stories from the front-line of on-demand house call medicine
  • Can you deliver quality, convenience AND value in healthcare?  How the home makes that happen
  • The unique challenges of starting and scaling a medical practice that exists in the ether 
  • How wireless medical devices are making in-home care more comprehensive, more accurate, more timely and more effective than even a doctors’ offices
  • What’s next – is the doctor’s office really obsolete?  

Nick Desai, Founder and Chief Executive Officer, HEAL & (formerly) Chief Executive Officer, FITORBIT

2:30pm - 2:45pm

Building The Unified Platform
Chairperson: Prat Ganapathy,
Design Lead, IDEO

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 – IoT a paradigm shift in medicine interoperability, connecting millions of medical devices to the ecosystem and capturing health information with clinical value 

Kimberlie Cerrone, Chief Executive Officer, TIATROS INC.

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

Conference Adjourns

9:45 am - 4:15 pm

Thursday, December 3, 2015

9:45am - 10:30am
The Challenges Of Developing A Wearable Heartrate Monitor For Swimmers

Designing and developing a wearable fitness device for swimmers which is submersible, and measures heartrate from the swimmer's head, is challenging, but not impossible. An experienced multifaceted team of industrial designers, electrical designers, mechanical designers, and specialists in thermal management, materials, molding, and rapid prototyping collaborated to solve a series of tough problems over the development process. Solutions often required tradeoffs and compromise across the disciplines, and resulted in an optimally configured design. This presentation will outline the unique challenges that were faced throughout the development process and the solutions employed.

Don't underestimate the development efforts when developing a highly integrated product like a wearable fitness device. It is critical to consider the multiple disciplines in tandem such as mechanical, electrical, and industrial design especially true if the product has unique design constraints such as rugged user environments.

Andy Grunes, Director, AAVID CORPORATION
Hind Hobeika, Founder, INSTABEAT INC

10:45am – 11:30am
Technology and Fashion Awaken the Soul of the Shoe

This talk will cover wearables with regards to the integration of fashion and technology. First we will explore the fashion industry, as a global business system for designing, producing and distributing clothing and accessories.
Second we will cover advanced technologies used to build wearable fashion with code samples of sensors capturing physiological data. The talk will culminate by showing how these two industries will co-evolve and the different forms these collaborations can take. Their growth will now come from radically new products that combine the best that two industries can offer (i.e. Google Glass, Project Jacquard & Soli).

Understanding of wearable devices as a fusion of contemporary fashion and advanced technology. 
Detailed overview of existing products and code samples of sensors capturing physiological data.
Insider view on collaboration with a fashion company. Production, marketing and distribution issues the wearable devices manufacturers are facing in fashion and technology industries.

Siamak Ashrafi, CTO, ZOEWEAR
Elena Philipova, International Fashion Industry Consultant

11:45am - 12:30pm
Hiding The Internet And The Thing: A Look At Designing A Connected Experience Where The Technology Fades Away

It's time for the power of connected technology to move beyond the kitsch of blinking lights and into its proper place, as a linchpin of customer experience. We will explore how brands and retailers can simultaneously take advantage of this technology while making it fade into the background for a seamless customer experience. We'll discuss the transformative power of utilizing wearable connected devices and relevant technologies to help identify guests, vision systems that help ensure the systems see them with clarity, cloud based systems to help connect the user with the event long after the event is over.

Andy will discuss what's driving this trend, where we think the world of wearables is going, and share a prototype that explores practical applications for brands and retailers to apply to their businesses. These practical applications help develop emotional connections with consumers, resulting in increased shopping cart size and willingness to recommend a product or experience.

Andy Austin, Director, Experience Technology, CBX


3:30pm - 4:15pm
Going Beyond Wearables: Ingestible Sensors

As diseases mutate and evolve, so should the practices and medicines used to diagnose and treat them. Some innovative companies, like Proteus Digital Health, have begun to integrate medicines that treat chronic conditions with mobile technology via ingestible sensors.

Proteus Digital Health wanted to guarantee that their digital health feedback system worked properly from one device, network and OS to the next while ensuring that the ingestible device functioned as intended inside a patient's body. In this presentation, Sanket Mehta will highlight the real-world challenges of creating and quality-assuring a completely new segment of digitized and mobilized healthcare.

In this presentation, Sanket Mehta will discuss developing and quality-assuring a revolutionary digital health feedback system. From ideation and development to testing and monitoring, Sanket will highlight the real-world challenges of creating and quality-assuring a completely new segment of digitized and mobilized healthcare.

Sanket Mehta, Account Manager, INFOSTRETCH CORPORATION