Ariel Vizcaino's List: Health care

• Also impacted by the MDDS rule are “secondary” alarm notification vendors and vendors providing surveillance and/or data integration of medical device data with data from other sources.
• in remote monitoring there are 3 market segments: sensors, gateway and information management system. The “product” is a system made up of all three.

• A defining piece of medical device regulations are the marketing claims or intended use for the device.
• Apple’s description (intended use) of their prototypical blood pressure device started out as an unregulated device. This is one used solely by the patient for their own use for health and wellness (aka the fitness market). As soon as the Apple presenter mentioned that, “users could send their blood pressure data to a physician,” the system became a medical device — in this case, because the data is used for diagnosis.
• LifeScan told me, “Our goal is to make diabetes management as seamless as possible for patients, so that it’s easy to integrate into patient’s lifestyles.” The One Touch demo was a proof of concept showing the potential capabilities offered by the iPhone (which were pretty impressive). While LifeScan plans to have an offering for the iPhone in the future, Dave noted that, “the combination of the One Touch glucometer, software and the iPhone represent what the FDA defines as a medical device.” Further, he noted that an application of this kind would include electronic patient identifiable data, and would have to meet HIPAA requirements.
• Chronic disease management is dependent on patient’s self management. Chronic diseases like COPD, CHF, and diabetes, need data from multiple sources: diet information, weight, blood pressure, SpO2, and other parameters.
• Besides the obvous limitations (insufficient battery life, small hard to read displays, size and weight), perhaps the biggest barrier for point of care compuating devices is selecting the right applications and designing a good user interface. Charting in the EMR is not a good application for a hand held device (this is why C5 tablets ride around as computers on wheels). But messaging like alarm notification is a great application, as is voice, and certain workflow automation applications like patient flow and perhaps meds administration.

  • Point of care computing device
• If you’re targeting clinicians and the point of care, you’re going to end up having to meet some regulatory requirements and do some engineering to fine tune your product.

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