Mitigating Medical Device Software Risk

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electronics862
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Will avoid disaster
electronics862   11/30/2011 8:24:19 PM
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Thanks for the blog, it is really needed to define some policies to avoid the malfuction of the medical instruements which are embedded in key areas of medical environment. They should be rigourously tested before sending out to the market. Quality assurance in the medical area should definitely be 100% will avoid disaster. 

Barbara Jorgensen
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Mitigating risk
Barbara Jorgensen   11/30/2011 1:58:46 PM
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This blog is a real eye-opener. It makes perfect sense that the software in medical devices should be defect-free. But look at consumers' tolerance for software flaws--we pretty much take them for granted. I'm glad there are agencies and companies looking out for this type of thing, and recommendations like the ones you outline here.

Ms. Daisy
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Re: Mitigating Medical Device Software Risk
Ms. Daisy   11/30/2011 12:59:10 PM
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@ Anne, I agree with your call for OEMs to provide adequate and regular software maintenance to forestall any malfunction. I also see the need for the call by Andy for governance solution as a good one. The potential risk associated with software malfunction calls for ongoing tuning and performance analysis.

 

Ms. Daisy
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Mitigating Medical Device Software Risk
Ms. Daisy   11/30/2011 12:54:01 PM
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Andy, great post! As a consumer of medical devices, I had been really concerned with the increase in the electronic software in patient care and pondered about managing the risk posed by potential failure of software in these devices.

You are absolutely right about the need for ongoing requirements of effective management of risks posed by software use in medical device. The policies and procedures you mentioned provides comprehensive support for information governance solutions. This will help OEMs to respond to data quality, security, privacy at the entry points and auditing, retention, archiving and optimizationat a later stage. 

The need for information governance to help transform data into strategic assets that can help lower cost and risks, increase the organization’s profitability is  critical especially now during this weak economic period. 

Anne
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Re: Mitigating Medical Device Software Risk
Anne   11/30/2011 11:03:08 AM
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This is a nice blog with good points on mitigating the medical device software risk.  In addition, OEM should also provide adequate and regular software maintenance plan and agreement to forestall any malfunctioning, and give the performance improvement.

Dave Sasson
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Re: A new methodology is required
Dave Sasson   11/30/2011 10:23:12 AM
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Good points and they can be applied to every industry.  The embedded device field of Machine-to-Machine (M2M) technology is expected explode in the coming years.  In fact, in a recent research report by Analysis Mason, the global market for M2M device connections will grow to 2.1 billion in 2020.

Jay_Bond
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re:
Jay_Bond   11/30/2011 8:03:41 AM
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I think having a governance solution is vital. Without governance companies are putting themselves at serious risk and could be wasting many resources ensuring the software is functioning properly. There needs to be a better system in place to ensure things are running properly.

prabhakar_deosthali
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A new methodology is required
prabhakar_deosthali   11/30/2011 6:14:02 AM
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When a million lines of code becomes part of an embedded device for some life critical medical devices, just following compliance procedures and having the documentation is not enough. We need traceability of the fault embedded into the product itself which should be able to pinpoint a particular module or the interface very precisely in that maze of 1 miilion lines of code. 

A new methodology is required to integrate such huge amount of code which  forces automated tests as each code module gets integrated into the product and kind of regressive analysis when a bug is found at a certain stage of integration.

Jacob
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Re: Mitigating Medical Device Software Risk
Jacob   11/30/2011 1:21:16 AM
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Andy, you are right. Most of the medical devices are making use of embedded software and IT applications. But I think the credibility of such systems is yet to be proven. I have experienced these difficulties during the diagnostics phases in hospitals. For example, there are differences in values for BP reading between the manually taken and from automated machines. The case is same for diabetics and lipid profiles. Those hospitals who possess such machines are clamming that machines are accurate than manual and others as vice versa. 

Ms. Daisy
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Mitigating Medical Device Software Risk
Ms. Daisy   11/29/2011 3:59:54 PM
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Andy, great post! As a consumer of medical devices, I had been really concerned with the increase in the electronic software in patient care and pondered about managing the risk posed by failure of software in these devices. You stated in your post the need for ongoing and effective management of risks posed by software use in medical device, and the call for governance solution is a good call.  

The policies and procedures that meet regulatory standards are important aspects of the risk management since they provide comprehensive support for information governance solutions and help companies to respond to data quality, security, and privacy at the entry points; auditing, retention, archiving and optimization at a later stage.  The ongoing tuning, performance analysis, and monitoring will certainly go a long way to mitigate software risks.

 We need information governance solutions to help transform data into strategic assets that can help lower cost and risks, increase the organization’s profitability is  critical especially now during this weak economic period.

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