要进入快速增长的移动健康空间，公司必须克服
crucial 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.
移动与传统保健品
Before validation, engineers must perform verification. These tests ensure that the product has met the requirements for features and functionality. For example, a company might build an app that allows patients aged 12 to 80 to monitor their blood pressure with a certain precision. The developers must then confirm, among other things, that the cuff fits the range of arm circumferences for those ages and passes lab tests for accuracy.
在验证阶段，产品被给予代表用户来测试它是否按预期执行。通常，开发人员需要检查测量是否与使用传统方法获得的那些，例如经批准的血压装置。应测试各种值，以确保新产品可靠地再现现有产品的结果;例如，如果应用程序测量葡萄糖，则应在各种不同血糖水平的患者中进行比较。
Depending on the intended use, the precision requirements may vary. Some apps measure weight, which is an important factor to track in patients with充血性心力衰竭（CHF）。如果公司声称该应用程序将有助于医生监控CHF，则要求可能比应用程序是通用权重规定的要求更严格。
强大的数据传输和分析
Developers also need to show that data transmission and analysis work as expected. Many apps send data from the mobile device to the cloud, and that process must be tracked to confirm that the information is not altered along the way. Similarly, if an app allows the user to plug an electromechanical device into a phone, the company will need to confirm that the physical connection is robust. And if the app runs algorithms on the data—such as a体重指数（BMI）计算开发人员必须检查软件是否生成正确的结果。
最后，产品需要使用。也就是说，患者必须能够了解如何执行诸如进入数据的功能，建立蓝牙连接和下载结果。如果有多种语言提供指示，则需要多次转换文本以确保含义尚未被更改。
Cross-Device Testing
开发人员可能面临一些在多个设备上测试其产品的挑战。如果应用程序旨在用于不同的操作系统，该公司将需要确认产品在每个操作系统上符合所需的标准。许多患者经常升级他们的手机，该应用程序应该足够稳定，以便在每个人的历史中提供一致的信息。
景’s Mobile Health Solutions include regulatory consulting and validation services to help biopharmaceutical and technology companies succeed in the fast-growing mobile health field. With partners such as Navigant, which has specialized expertise in medical device regulations, we can ensure that clients identify the right pathways for validation, registration and approval.
