Category Archives: Medical Devices

Medical Devices

The Reality of EMR Integration for Medical Devices

Tim provides a good starting point for understanding this in EMR Integration for Medical Devices: The Basics. What this highlights of course is that getting data from a medical device into an EMR is a lot harder than it should … Continue reading

Posted in EMR, Interoperability, Medical Devices | 1 Comment

Personal Healthcare Products: This is what the future looks like.

I’m jealous of companies that get to produce diagnostic medical devices without having to go through the FDA 510(k) process. For example, the iHealth BP3 blood pressure monitor is a high-tech looking device with a  free Apple application: Hopefully they’re using … Continue reading

Posted in FDA, Medical Devices | Tagged | 2 Comments

Medical Devices and the Cloud

The article Is Cloud the tomorrow of Medical Devices Industry? includes some of the challenges — regulatory, privacy, security etc. — faced by manufacturers trying to manage medical device data in the cloud. You can’t disagree with this statement: The success of … Continue reading

Posted in Cloud Computing, EMR, Interoperability, Medical Devices | 2 Comments

The Cardiocam: Physiological Monitoring via Webcam

Today’s New York Times Magazine The Year in Ideas: 10th Anniversary Special features the MIT Cardiocam: Cardiocam is a low-cost, non-contact technology for measurement of physiological signals using a basic digital imaging device such as a Webcam. The ability to perform … Continue reading

Posted in Medical Devices, Technology | Tagged | Leave a comment

Second Annual Medical Device Connectivity Conference

This year’s Medical Device Connectivity Conference is being held Sept. 28-29, 2010 in San Diego. From the press release Tim Gee says: The only conference devoted to the topic of medical device connectivity, the program will offer a unique opportunity … Continue reading

Posted in Interoperability, Medical Devices | Tagged , | Leave a comment

A Threat Analysis of Networked Medical Devices

Here’s an interesting analysis of security threats within a Windows-based hospital network for embedded medical devices: A threat analysis of critical patient monitoring medical devices. The threat models are fairly complex and clearly a product of wider enterprise network IT … Continue reading

Posted in HIPAA, Medical Devices, Microsoft | Tagged , | 2 Comments

ISO 62304: The Harmonized Standard for Medical Device Software Development

The FDA approved ISO 62304 as a recognized software development standard in 2009. Developing Medical Device Software to ISO 62304 gives a nice overview. Besides providing a globally accepted development process one of the other practical components is the assignment … Continue reading

Posted in FDA, Medical Devices, Software Quality | Tagged | 7 Comments

The Software Quality Balancing Act

Andrew Dallas’s article Caution: V&V May Be Hazardous to Software Quality touches on a number of good points regarding software quality best practices. Medical device software development V&V (also see here) and the documentation that goes with it have substantial … Continue reading

Posted in Agile, FDA, Medical Devices, Software Quality | Tagged , | 1 Comment

The Challenges of Developing Software for Medical Devices

Developing Software for Medical Devices – Interview with SterlingTech gives a good overview of the challenges that especially face young medical device companies. In particular (my emphasis): Make sure that your company has a good solid Quality System as it … Continue reading

Posted in FDA, Medical Devices, Programming, Software Quality, Tools | Tagged , | Leave a comment

The BCI X Prize

As announced at a recent MIT workshop: The BCI X PRIZE: This Time It’s Inner Space: The Brain-Computer Interface (BCI) X PRIZE will reward nothing less than a team that provides vision to the blind, new bodies to disabled people, … Continue reading

Posted in EEG, HCI, Medical Devices, Technology | Tagged , | Leave a comment