To enter the rapidly growing mobile health space, companies must overcome the 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.
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.
In the validation stage, the product is given to representative users to test whether it performs as expected. Typically, the developers need to check if the measurements agree with those obtained using a traditional approach, such as an approved blood pressure device. A wide range of values should be tested to ensure that the new product reliably reproduces the results of the existing product; for example, if the app measures glucose, the comparisons should be performed across a variety of patients with different blood glucose levels.
Depending on the intended use, the precision requirements may vary. Some apps measure weight, which is an important factor to track in patients with congestive heart failure (CHF). If the company claims that the app will help physicians monitor CHF, the requirements will likely be more stringent than if the app is a general-purpose weight scale.
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 body mass index (BMI) calculation-developers must check that the software generates the correct result.
Finally, the product needs to be usable. That is, the patient must be able to understand how to perform functions such as entering data, establishing Bluetooth connections and downloading results. If instructions are available in multiple languages, the text will need to be translated back and forth multiple times to ensure that the meaning has not been altered.
Developers may face some challenges testing their product on multiple devices. If the app is intended for use across different operating systems, the company will need to confirm that the product meets the required standards on each OS. Many patients will frequently upgrade their phones, and the app should be stable enough to provide consistent information across each person's history.
Covance'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.