Medical Device Mobile Apps Conference Agenda

Medical Device Mobile Apps: What Needs FDA Approval
An FDAnews Virtual Conference
Thursday, Aug. 30, 2012 • 10:00 a.m. – 4:00 p.m. EDT

10:00 a.m. – 10:15 a.m.

Introduction to the Virtual Conference

10:15 a.m. – 11:15 a.m.

Top Trends Driving the Industry Towards Adoption of Mobile Apps for Medical Device Connectivity and Remote Healthcare
The market is flooded with medical device and health-related apps – many of them harmless, but some of them potentially dangerous and in need of regulation. Recently, the FDA noted it's not just about cool software or making something useful. Compliant app developers must understand the risks and the intentions of the devices they create.

This presentation will focus on the top trends influencing the development of apps and provide a regulatory and strategic pathway for potential app developers.

Attendees will learn:

  • What constitutes a medical mobile app and the role of apps in medical device systems
  • The evolution of hardware platforms and exploring market segmentation
  • The key drivers for growth in mobile apps in medical applications
  • Challenges and barriers to market entry for a medical device manufacturer

Tim Gee, Principal, Medical Connectivity Consulting

11:15 a.m. – 11:30 a.m.


11:30 a.m. – 12:30 p.m.

Successful FDA Approval Case Study: Designing, Developing and Commercializing an FDA-Approved Mobile Medical Application
On September 26, 2011, Calgary Scientific received clearance from the FDA to market its medical imaging application, ResolutionMD™ Mobile, as a mobile diagnostic application. This initial FDA clearance applied to versions of the solution running on Apple® iPhone® and iPad® devices. The company also obtained ISO 13485/9001 and CE Mark certifications and four FDA 510(k) clearances. This presentation will detail the who, what, where, when and how of securing a successful FDA approval.

Attendees will learn:

  • How to obtain FDA clearance — identifying and addressing the safety and effectiveness criteria
  • The issues that impact design, usability and end-user implementation
  • Different factors that went into creating and designing a mobile device user interface
  • How to become a strategic supplier — using an app to leverage your company strategy

Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific

12:30 p.m. – 1:30 p.m.


1:30 p.m. – 2:30 p.m.

What Does the FDA Consider a Regulated App? Understanding the FDA’s Current Comments, Draft Guidance, “Enforcement Discretion” and Definition of Accessories
The medical device industry wants the FDA to clarify the issue of intended use, which focuses on the difference between wellness and health apps. As the industry awaits the FDA’s proposed rule, what can developers do now to understand if their product falls under the FDA regulatory radar? Plus, how is the FDA using their “enforcement discretion” regarding products that might not meet the recent draft guidance criteria but nevertheless be considered a medical device under FDA regulations. Brad Thompson — one of the industry’s leading attorneys and strategists for medical device apps — leads you step-by-step through what the FDA expects from you. You can’t miss this presentation!

Attendees will learn:

  • How to decipher the general parameters of the scope of FDA regulation of mobile medical apps
  • What the FDA means when it uses the words “health” versus “wellness”
  • The FDA’s concept of intended use — is clarification needed?
  • Accessories, accessories, accessories: What are accessories and which accessories does FDA regulate?
  • When the FDA regulates decision-support software found in a mobile apps

Brad Thompson, Member, Epstein Becker & Green; General Counsel, mHealth Regulatory Coalition

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 3:45 p.m.

Mobile Medical Applications in the Clinical Setting — Simplifying Device Connectivity, Developing Point of Care Consolidation of Device Alarms, Health and Status and Improving Process Control and Workflow Automation
Clinical operations is the combination of many systems, including: people, information systems, medical devices and, most importantly, the patient. Designing any part of a system without an understanding of how it will be used within the system will cause unintended consequences. Designing safety into the system is key to preventing adverse events and can be done by analyzing processes and workflow, and designing in interlocks where mistakes could occur. This presentation will focus on the intersection of traditional and emerging medical devices and how they connect and operate in the real-world settings of hospitals and medical research centers.

Attendees will learn:

  • Examples of current mobile medical applications and the impact they currently have in the clinical environment
  • What functional and nonfunctional requirements should be considered to have a safe and effective mobile environment
  • Where the future of mobile medical apps is moving. How will the FDA, devicemakers and clinical organizations work together to best serve patients?

Tracy Rausch, Chief Technical Officer, DocBox

3:45 p.m. – 4:00 p.m.

Closing Comments and Adjournment