When granting regulatory approvals for medical devices, both IEC 62366 and the FDA have emphasized the importance of applying human factors and user-centered design activities to the development process to ensure medical device safety and improve usability. The development of mobile medical apps (MMAs) is no exception. Developers of an MMA aren’t just building another Angry Birds or Candy Crush app, they are building a medical device in the form of a mobile app that keeps up with a user’s health, perhaps even diagnosing symptoms and preparing users for unforeseen medical emergencies. Read the whole thing here.
With the increasing occurrences of high-profiles security breaches including identity theft, phishing scams and hacking attempts on internet users not to mention the news of NSA surveillance, we’ve all become very aware that we need to keep our information safe. As more complicated Internet-connected appliances evolve into the Internet of Things, embedded device security has become critical to a product’s viability.
The first thing you must determine prior to starting your project is whether or not it will be considered a medical device. According to the FDA, “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” A bed pan is considered a medical device, however the Fitbit is not – so it’s important to find out how your product will be classified. Is there any potential for harm? Are there any safety risks are involved?