For the last several years I have become intimately familiar with the medical device industry and the large volumes of data created by medical devices. My role has been in developing and promoting clinical solutions consisting of medical device integration and enterprise patient monitoring. Over the next few months I will add my thoughts on the growing trend and awareness of medical device data and analytics. Sorry but there is no proprietary information here.
Is innovation possible?
The regulations and quality system requirements imposed on makers of FDA guided medical devices makes it very difficult to innovate. Every 510(k) submission has to have predicate devices and fit into one category or another. Software based products are given the same scrutiny as hardware devices. The rising trend of wearable devices (such as FitBit) are placing people's health in their own hands. Can this trend influence the medical device market?
One thing I have learned is there is limited commonality between medical devices in terms of data generated. A whole business was invented to connect and extract data from these devices and make this data accessible, primarily for hospital IT iniatives to feed their EMR and quality for federal reimbursements related to meaningful use. Since most medical devices are designed to last for years, a large percentage of hospital devices still in use today were never designed to be networked and even more importantly, the data generated by these devices (or not generated in many cases) needs careful evaluation and validation.
Medical devices monitor patients for specific conditions, and are designed to alarm at any sign of deviation from set/predetermined limits. This alarming concept stems from basic liability issues, however it has brought about a huge problem in healthcare known as alarm fatigue. Devices need to be more contextually sophisticated and be able to input and output usable data for actual human beings to interpret, as well as have the ability to interact with other devices for patient (and clinician) sensitivity and context.