Saturday, September 26, 2009

Medtronic's Remote Programming Patent, 1st commentary

I mentioned in my earlier entry that I plan to focus on the recently granted patent of Medtronics, "Conditional requirements for remote medical device programming" (US Patent # 7,565,197). I have started my analysis of this patent and have found it extremely rich with respect to defining remote programming and it's future.

For those not familiar with remote programming and how it fits in the medical device industry, a brief primer. First, medical devices are implanted machines designed to provide support to a patient with a specific medical condition, such as heart failure, irregular heart beats, diabetes, etc. The more well-known implantable devices include pacemakers, defibrillators and drug pumps.

Second, significant advancements in implants have been made over the last decade. These are small computers with communications capabilities, including the capability to communicate using a radio, wireless, connection. Implants can transmit significant amounts of data.

Third, patients with implanted devices are generally provided a home-monitoring unit that communicates with the implanted device. This communication has largely been one-way, that is, the implanted device sends its data to the home monitoring unit that in turn uploads the data to a central repository (a large, centralized computer system) managed by the device manufacturer. The central repository provides the device managers the ability to review (using a Web connection) the uploaded device data to determine if the patient has had any medically significant episodes (such as a shock delivered by the defibrillator to restart the patient's heart) and to determine if any of the settings on the device require adjustment.

Finally, often times patients may have more than one device. Patients with implanted medical devices often have more than one significant medical problem that requires the intense management provided by implantable devices.

Medical devices have a significant limitation, battery size and life. The medical device requires power to enable it to deliver the prescribed therapy to the patient and (particularly when wireless communications are used) enable the device to transmit data. Conceivably, remote programming will require even more power. I shall discuss the power issue in a later posting.

As I mentioned earlier, the communication has largely been one way, from the device to the central repository. And, the information is data, not programming instructions. Remote programming adds a significant dimension to the patient device management.

Today, patients must travel to their device manager's clinic every time their implanted device requires an update. That update could include something as simple as changing in the way that their device operates to updating the software (firmware) in their device. Remote programming makes it possible to perform all the updates remotely - in the field - that today requires a visit to the clinic. It also provides the capability for finer control over a patient's device or devices.

This implications of this patent are significant. Although there is only 1 primary claim and 32 claims total, I believe that this patent can be considered broad. How Medtronics plans to defend or profit from it is anyone's guess. Nevertheless, this patent is worth further exploration and speculation. My next post will be my first examination of the technical specifics of this patent.

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