About Bill Hanlon, PhD & Scott Thiel, MBA, MT (ASCP)

Dr. Hanlon, Vice President and Head of Global Regulatory Affairs at Covance Drug Development, leads a group of 165 regulatory professionals advising clients on global, regional and local regulatory strategy associated with study design and regulatory agency interactions as well as drug development programs. The group provides a range of regulatory services for the creation and submission of regulatory documents in support of clinical trials, regulatory agency meetings and marketing applications. Scott Thiel, Associate Director at Navigant Consulting, Inc., has nearly 30 years of experience in the medical device, health information technology and in-vitro diagnostics industries. He assists clients with product development and commercialization, medical device software and connectivity (including consumer electronics interfaces), regulatory strategy and compliance, auditing, labeling and promotional material review, and quality system assessment, creation, and remediation.

Validation: A Key Stage in Mobile Health Development

To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Developmentcrucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market, ensuring that patients and providers can rely on the output to make appropriate medical decisions.

Mobile health apps offer functions ranging from data collection to running algorithms, and underlying all of those features is the need for a quality system. To show that their product is reliable, developers need to take a variety of measurements, confirm that data transmission and analysis work correctly and test the app on multiple devices. Continue reading

Developing a Successful Regulatory Strategy for Mobile Health Devices and Applications

For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The Covance Mobile Health Blogguidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas.

To make progress in this rapidly changing field, companies need to find a way to work within the regulations while encouraging creative development. Consulting with experts and the FDA, considering key design issues, taking precautionary quality measures and assessing global requirements will increase the chances that a company can bring a safe and successful mobile health device and/or app to market.

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