Medical devices, such as glucometers, often use software to show, compare, store and analyze the data that they collect.
our experiences with medical device software
We have developed software for new medical devices and written their FDA 510k software documentation. We have also created patient and physician portals to display medical device data, and integrated medical device data into electronic medical records.
Some common medical devices that we have created software for in the past are:
- activity monitors
- blood pressure cuffs
- digital cameras (diagnostic quality)
- home medical tests (digital)
- pill bottles
- pulse oximeters
- range of motion detectors / Nintendo wii
- specialty thermometers
- weight scales
Additionally, we have created these types of medical device software:
- electronic log book
- Microsoft HealthVault integration
- patient portals
- physician portals
- remote monitoring data repository
overview of medical device software
Medical devices, such as glucometers, often use software to show, compare, store and analyze the data for patients and healthcare providers on a PC or mobile phone. This data is a key component of disease management, and telemedicine/connected health.
The goal of using medical devices to capture and transmit their data to healthcare providers is to bridge the huge time and data gap between office visits. This way, healthcare providers can intervene before someone becomes seriously ill and needs hospitalization. Studies have shown that it is much easier (and less expensive) to keep someone well than to help them after they are ill.
Also, this medical device data is useful in the healthcare provider’s electronic medical record for that patient, so that it can be found easily in the future. We work with medical device manufacturers to develop software to simplify the integration between their devices and electronic medical records. For healthcare providers, we have helped them integrate information from specific medical devices into their existing data repositories or have helped them create a new data repository to manage that data.
When our software is included as part of a device, we follow the FDA processes to create the medical device software and its associated 510k documentation to make it easy for our customers to get it approved. We have created documentation templates to make the FDA 510k device software approval process as simple as possible.