Connectivity, With or Without a Server
Many medical device makers contemplating connectivity for the first time, prefer to build everything into the embedded system device rather than using a server to implement most of the connectivity features. This design approach is rarely taken, but why? The following is a quick look at the strengths and weaknesses of building connectivity into the embedded device and using a server.
Before we launch into the pro’s and con’s, let’s identify the basic functional requirements for connectivity:
- You must have the ability to get machine readable data out of your medical device. Most all electronic devices have this ability, provided by a serial port. Alternatively, the device can use an Ethernet and/or Wi-Fi (or perhaps some other wireless technology).
- Next the proprietary data format from the medical device must be parsed and converted into something the target system understands, typically HL7.
- At some point the medical device data must be associated with patient from whence it came. There are many ways to do this, but the key is to make it as automated and reliable as possible.
Navigating Regulatory Uncertainty for Smartphones
Uncertainty abounds regarding the potential regulation of smartphone apps by FDA and other international regulatory bodies. For this discussion we’ll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing – or going to do – about new and innovative products that meet the definition of a medical device.
What is a Medical Device?
Let’s start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many vendors (and providers) who are outside the ranks of traditional medical device manufacturers. The first issue we need to address is the question, “What is a medical device?” Here’s the legal definition of a medical device, courtesy of FDA:
EMR Integration for Medical Devices: The Basics
Medical device manufacturers in markets that have managed to resist creating connectivity solutions are facing increased pressure from providers adopting EMRs. I mean, what’s the use of automating the EMR if users have to write down numbers read from medical device displays and then manually type them into the EMR? That’s certainly not “automation.” This feature is already a required and necessary feature in some device markets, and rapidly becoming a necessity in many other device markets.
Manufacturers in this situation (needing an interface to EMRs for clinical documentation) often come to me with a plethora of questions. Before we get started, let’s frame the discussion. In this post you will be introduced to a framework for clinical documentation connectivity. I do not get into details on product design or features. Rather we look at a basic framework and external factors that come to bare on any manufacturer contemplating a connectivity feature for their products. What follows is a sketched in foundation or starting point for manufacturers to use to plan for and implement what is probably the most basic connectivity application.
Let’s run through the basics.
What are the basic components of a clinical documentation solution for a medical device?
