Category Archives: Medical Devices

Medical Devices

Medical Devices in Home Health Care

Posted on August 10, 2008 by Bob

If a company like Intel gets involved you know that providing home health screening devices must be a big opportunity. Intel Health Guide is designed to be a comprehensive home monitoring service. In-home patient device. An online interface allowing clinicians … Continue reading →

Posted in Medical Devices, PHR, Technology | 4 Comments

Digital Devices and EHRs: the ROI

Posted on July 28, 2008 by Bob

Here’s a piece that provides a quick analysis of the ROI of having vital signs and ECG devices connected to an EMR: Digital Devices and EHRs — Perfect Together The right way to do it: Electronic transfer of patient information … Continue reading →

Posted in EMR, Medical Devices | 1 Comment

More Software Forensics and Why Analogies Suck

Posted on July 1, 2008 by Bob

There’s a recent article in the Baltimore Sun called Flaws in medical coding can kill which just rehashes static software  analysis (hat tip: FDA Trying to Crack Down on Software Errors). I’ve discussed software forensics tools before. Yes, bad software … Continue reading →

Posted in FDA, Medical Devices, Software Quality | 3 Comments

Connecting Computers to FDA Regulated Medical Devices

Posted on June 18, 2008 by Bob

Pete Gordon asked a couple of questions regarding FDA regulations for Internet-based reporting software that interface with medical devices. The questions are essentially: How much documentation (SRS, SDS, Test Plan) is required and at what stage can you provide the … Continue reading →

Posted in FDA, HL7, Medical Devices, Networking, Software Quality | Tagged , | 2 Comments

Corrective and Preventive Action (CAPA) and the FDA

Posted on March 11, 2008 by Bob

It’s Easy to Get into Trouble Because of CAPA summaries an audio conference on Implementing an Effective CAPA System: What You Need to Know (pdf) sponsored by FOI Services. Creating a corporate culture that can carry out a quality system … Continue reading →

Posted in FDA, Medical Devices | 1 Comment

Patient Command Centers

Posted on January 19, 2008 by Bob

I read with interest “Art Vandelay’s” (an anonymous Seinfeld fan and HIStalk contributor) comments regarding Patient Command Centers on HIStalk Update 1/21/08. Here’s what the PCC is supposed to do: It will manage service desks for IT, facilities, clinical engineering, … Continue reading →

Posted in EMR, Medical Devices | Leave a comment

BCI: Brain Computer Interface

Posted on December 21, 2007 by Bob

I ran across Commercial brain computer systems are coming today (original article is here). This is a cool graphic: I’ve talked previously about Human-Computer interface (HCI) work. Invasive BCI technologies have incredible potential. In addition to the unique device-human interface … Continue reading →

Posted in EEG, HCI, Medical Devices | 9 Comments

More Mind Reading: fMRI

Posted on November 3, 2007 by Bob

Earlier today I was in my auto shop’s waiting area while my car had its annual smog check. I started looking through the pile of magazines and came across the November 2007 issue of Popular Mechanics. To my amazement the … Continue reading →

Posted in EEG, fMRI, Medical Devices | Leave a comment

Ever heard of FRACAS?

Posted on October 27, 2007 by Bob

FMEA (Failure Mode and Effects Analysis) is a regular part of our development process (we call it “Hazard Analysis”), but I was unfamiliar with FRACAS (Failure Reporting, Analysis, and Corrective Action Systems) until I ran across this: 10/21/2007 FRACAS? – … Continue reading →

Posted in Medical Devices, Software Quality | 2 Comments

Medical Device Software Forensics

Posted on October 17, 2007 by Bob

“The Gray Sheet” has an article called CDRH Software Forensics Lab: Applying Rocket Science To Device Analysis. Can it really be true that CDRH is doing static code analysis for detecting software defects in recall investigations? Static code analysis has … Continue reading →

Posted in FDA, Medical Devices, Software Quality | 4 Comments