Strategies for Developing Mobile Medical Apps for Patient-interactive Medical Devices

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October 3, 2016

To manage chronic medical conditions, real-time monitoring of disease-specific physiologic metrics is becoming an important part of standard of care, and smartphone technology is making it possible. Existing smartphone interfacing devices now record health parameters and metrics on diseases such as diabetes, cancer, respiratory diseases, heart failure, sleep disorders and more. Even microscopic sensors are emerging, with bioengineering innovations for continuous blood glucose monitoring and for detection of gastric and other cancers.

The environment in which these medical monitoring systems work has been referred to as the mobile ecosystem and includes the medical device developers, medical devices, smartphone interfaces, operating systems and software, wireless service providers and most importantly, the end users.

The complexity of this environment mandates an understanding of the regulatory considerations not only for the medical device, but also the smartphone interface with the end user. That interface includes the smartphone software, known as a mobile medical application (MMA). Human factors and usability engineering are critical parts of the product development and evaluation process, and as a result, there are a number of recently updated regulatory guidance documents. In this paper, we explore the concept-to-market product development pathway for medical devices with MMAs, using the following as examples:
• A Class 3 continuous glucose monitor (CGM) system with an MMA interface,
indicated for insulin-dependent diabetes
• A Class 2 MMA diabetes management device that offers pharmacy and reimbursement benefits

This paper will explore at a high level the regulatory guidance documents for the device system and MMA interface development, and will support a smooth progression through concept, development and market approval.

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