What to Consider When Developing a Connected Medical Device

The explosion of the Internet of Things (IoT) is transforming the patient experience in remote clinical monitoring, chronic disease management, preventative care, and assisted living. What factors do you need to think about what building a connected medical device? With over 30 years of experience in product, Joe St. Onge, Program Manager and HW Group Leader at Sunrise Labs, discussed some critical factors to consider when building a connected medical device.

1.) Define what the device is going to do. This seems rather basic, but too many times people do things simply because they can. You need to define what the device is going to do, what data you're going to collect, what you signals you're going to analyze, what accuracy is required based upon whether the device is a wellness or medical device, etc.

2.) Know the market. You need to understand the current state of the market. Is it highly competitive? Is there room for a new competitor? There is a proliferation of wearable, connected medical and wellness devices on the market. There are close to twenty different wellness devices competing with each other not only based on ability to track your health, but also on simplicity and style. Your claims may define your product as a medical device in the eyes of the FDA, if so, you need to perform specific tasks as part of product development and file information on the product to the FDA for clearance before going to market.

3.) Know the user. During the development process, it's critical to determine who the target user is and create detailed use cases for the device.

4.) Decide what the device looks like and how it will be worn. What the device looks like and how it's worn are very important. Fitness trackers, for example, are designed to measure your heart rate while exercising or your respiration rate while you sleep. You don't want to design a bulky device with the potential to disrupt your sleep or your workout. Simiarily, the underlying components, like the size of the battery or sensors of the device are important to consider as they could influence the size or shape of the finished product.

5.) How is the device connected. You need to determine if the device requires a full-time connection to the cloud or if it's intermittent. There are a variety of means to connect to the internet, like a cabled connection (Ethernet or USB) or wireless connection (WiFi, Zigbee, or Bluetooth).

6.) Evaluate cybersecurity risks. You can never be totally secure, especially with the added component of wireless connectivity. It's important to perform an assessment that addresses the potential cyber risks and their level of impact on the user. At Sunrise, we can provide a comprehensive hazard and risk assessment to determine cybersecurity risks and how they will be mitigated.

Watch Sunrise's latest video about our experience in product development for connected devices