mHealth for Medical Device Manufacturers, Washington DC, 3-4 February 2016

MedTech Intelligence mHealth for Medical Device Manufacturers

MedTechIntelligence have renamed their Washington DC Medical Device Summit as mHealth for Medical Device Manufacturers and will be bringing together a very interesting selection of speakers/topics that highlight how the spotlight is turning on the mHealth opportunity now that Apple (with it’s $200B cash stockpile) is on a very public medical device industry hiring spree.

Click here to register to attend/virtually attend the event ($1,795/$1,595 discount).

Keynote topics will include:
  • The Evolving World of Health Care and the Role of mHealth
  • The emerging world of connected and data-driven health care
  • Opportunities for providing improved care while containing costs
  • How mobile apps and connected health affect the medical device industry
  • Business models, new players and partners, and novel opportunities
  • User-driven product development
  • Contrasts to conventional medical device development processes
  • The FDA Regulatory Framework
  • FDA regulations and guidance documents pertaining to mHealth
  • Office of Device Evaluation experience with mobile app and other mHealth premarket submissions
  • Linking medical devices to Electronic Medical Records (EMR)
  • EU and other OUS regulations and expectations
  • Premarket Risk Assessment Modifications
  • Continuous risk reevaluation from R&D through design to production
  • Non-FDA Regulatory Oversight
  • FDA position on cybersecurity
  • FBI and other government agency security concerns and activities
  • HITECH Act and other breach reporting requirements
  • Evolving Delivery Systems and Payment Models
  • U.S. Government Position and Regulations on Security
  • Practical Approaches to Cybersecurity – Balancing Accessibility vs. Privacy, Data vs. Security
  • Product development cybersecurity considerations
  • Cybersecurity in postmarket surveillance

Speakers will include:

Paul Campbell, Senior Advisor, Amplify Public Affairs Ed Dougherty, Principal, Dentons
Chuck Farlow, Program Director Regulatory Affairs, Medtronic
Nicole Gardner, VP, IBM Global Business Services
Cindy Gillespie, Principal, Dentons
Tina Grande, SVP Policy, Healthcare Leadership Council
Nancy Green, Healthcare Strategy & Thought Leadership, Verizon
Andrew Harrison,VP & Regulatory Counsel, Regulatory Compliance Associates
Louis Jacques MD,  ADVI (former Director, Coverage & Analysis Group, CMS)
Robert Jarrin, Senior Director Government Affairs, Qualcomm
Diane Johnson, Senior Director Strategic Regulatory, MD&D, Johnson & Johnson
Michelle Jump, Principal Regulatory Affairs Specialist, Stryker
Bernhard Kappe, CEO, Pathfinder Software
Craig Kennedy, CEO, Moleculight
Thomas Maeder, Conference Director, MedTech Intelligence
Steve McPhilliamy, Partner, Insight Product Development
Colin Morgan, Head of Global Product Security, Johnson & Johnson
Bakul Patel, Assoc Dir for Digital Health, CDRH
Linda Ricci, Division of Cardiovascular Devices, ODE, CDRH
John Riggi, Cyber Outreach Section Chief, Cyber Division, FBI
Suzanne Schwartz MD, Director, Emergency Preparedness/Operations and Medical Countermeasures, CDRH
Eric Soederberg, President, Sunrise Labs
Robin Strongin, President & CEO, Amplify Public Affairs
Doug Woodruff, Head of Quality and Regulatory, Philips Healthcare
Diane Wurzburger, Executive QA/RA US & Canada, GE Healthcare

Related mHealthInsight blog posts:

Watch the mHealth Symposium from the 2015 World Diabetes Congress (1 hr CPD accredited video)

Watch the Mobile First Clinical Trials presentation from the 2015 Mobile Clinical Trials Congress (1 hr video)

Find a mHealth event to attend in 2016

My Mobile is just as much part of my medical device set up as the FDA approved device it monitors

An introduction to mHealth opportunities for the Medical Device industry

mHealth Lesson for Medical Device Manufacturers: Clever doesn’t beat Connected

Mobile Health Devices – will Patients actually use them

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The Corporate Blog of 3G Doctor
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