As others have mentioned, the regulatory approval piece is big hurdle with something like this BUT there is still some good potential here...
* Regulatory approval for 'me too' devices doesn't usually require clinical trials so the cost of regulatory approval would be less that some people have suggested.
* The concept of 'open source' hardware is quite interesting. Rather than MobileECG design, build, and sell the devices all by themselves, perhaps they could focus on the design aspect so other companies can tweak the design, build and sell the devices. Essentially, MobileECG's open source hardware would be a reference architecture that other companies could use and provide feedback to.
* Would be great to see a scientific study comparing the safety and efficacy of 'open source' vs 'closed source' medical devices. Since ECG devices are so common, this seems like a great opportunity with a relatively low-risk device.
Awesome link! I'm the OP and I really appreciate your response. The reason I'm looking into this is that I work with many scientists who use commercial software packages where they don't control the code or compiler and their results are archived and can be reanalyzed years later. I was recently helping someone revive an old server to perform just such a reanalysis and we had so much trouble getting the machine going again I started planning to clone/virtualize it. That got me thinking about where to put the virtual machine (dedicated hardware, cloud, etc) and it also got me curious about hypervisors. I found some papers indicating that commercial hypervisors can have variability in their floating point math performance and all of that culminated in my post. Thanks again.
Thank you, I appreciate the link. I'm the OP and I didn't mean to speculate about or disparage Mathematica, I meant to use it as an example of a commercial software package where the person running the calculation doesn't control the code or compiling process.
Awesome! Thank you for both the posts, I'm the OP and I really appreciate them. Your comment about scientific computing is spot on with the use cases I'm interested in.
I'm the OP and I really appreciate this comment. I did give some thought as to whether it was reproducibility or repeatability and I decided on reproducibility because the experimental equipment (underlying hardware and firmware) would be different, different analysts would be involved, and the replication of analysis would be occurring after a long period of time. I agree though that it's not clear cut in my post.
Nice, I'm the OP and I appreciate your comment and experimental design. I agree that in situations where you are coding the algorithm, it's easier to control/adjust for the variability with each hardware platform. The use cases I'm really wanting to learn more about are with commercial software packages that have traditionally been run on dedicated hardware and are now being virtualized and moved across multiple hardware types. I like your approach though and may do some testing along those lines.
Thanks for your comments, I really appreciate them. Your mention of experiments was spot on with the use cases I'm trying to learn about. I've worked with many scientists who use commercial software packages for biomedical research where their experimental results may be archived for 10+ years before being reanalyzed. I recently helped a colleague pull a Windows 2000 server out of storage to rerun an experiment. We got it going after some difficulty and that got me thinking about virtualizing the harddrive, which then lead me to wonder about the portability of virtualized machines between hardware hosts (including cloud providers) and the resulting reproducibility issues that could occur. I then read through several interesting papers showing variability of floating point math in commercial hypervisors, which lead to my posting on Slashdot. Thanks again.
Some interesting links:
http://faculty.cs.gwu.edu/~timwood/papers/im2013_tech.pdfhttp://www.vmware.com/pdf/hypervisor_performance.pdfhttp://www.cc.iitd.ernet.in/misc/cloud/XenExpress.pdf
I agree with the previous commenters that it's important to have a solution or plan before raising the alarm. Having said that, once you raise the alarm and you're not being heard to your satisfication, there are several options available:
* First, clear your mind of what you think you know about software development and what SHOULD be and try to see the situation from an open-minded perspective. Are the issues you're seeing really an indicator of poor quality or are they an indicator of a system that's different from what you know/like? As a quality/regulatory person myself, I've seen many unnecessary projects and alarm bells simply because of a lack of understanding/perspective on a given topic. I'm not saying that's the case with you, just that this is the kind of issue that's good to be absolutely clear with yourself about.
* Once you're clear that there is in fact an issue, go to QA and request an internal audit on your software development/quality systems. If your QA team doesn't have a procedure by which you can request an audit, then you should find a QA partner who can work with you on this. It's good to have a QA partner anyway so building the bridge on this project won't be a waste of time regardless of the outcome.
* If auditing isn't an option, or if you need ammo to sell the audit idea, another approach is to analyze deviation and/or CAPA trends on your software development process, as well as your validation process. For example, try to find out how many validation deviations are being generated when new/updated software is released from your development team. Working with QA, you could develop an estimated cost-per-deviation, which would be a huge pile of ammo for your management presentation. Also, pretty charts and graphs will help too.
* Find other tangible evidence of the issue. Without specific examples it will be difficult to be clear about the problem and/or the solution(s).
* If you find evidence and QA and/or management still won't listen, it's time to consider your options. You can either stay, knowing that a ticking time-bomb exists, or you should carefully plan and execute your exit from the company. My litmus test for working at a company is to regularly ask myself whether I'd give my company's medicine to a family-member [a family member I love:P ]. If the answer is no, I don't stick around. So far, I've only had to do that once in 10 years and it was absolutely the right choice. Good luck!
How long before someone either a) selectively breeds or b) genetically modifies cows that produce more "gas" and/or bigger cowpies? My bet is 2 to 3 years.
Why do you need an expensive, complicated device to pull a trick like that? Why not throw together a bit of tinfoil and scrap wires and tell the suspect it's the latest ACME brain analyzer and they'd better talk or ELSE... As for your other comment, I seriously doubt that the ACLU lawsuit will make interrogation of suspects any less effective than the sanctioned beatings, torture, and humiliation already have.
If you're going to produce your manual in both print and online form, AND you might possibly want to re-use some of the manual content for things like brochures and presentations, I'd go with a single-source publishing system like AuthorIT. Single-source publishing was developed specifically for software projects and it allows you to create documentation in many different formats. It also allows you to reuse content across documents, which saves time and reduces inconsistencies caused by redundant content being recreated for each document. It ain't free but I've used AuthorIT for several years now and I'll never go back to producing documentation using Word or OpenOffice.
I agree Mike. It boggles me that so many outspoken people have this opinion that Google is coming down from some moral high-ground by doing business in China and following the laws of that country. Google is a for-profit corporation that must follow the laws of the countries they wish to do business with. The people who are upset about this are those who bought into Google's marketing message of "do no evil." Admittedly, Google's leadership panders to this misperception by "admitting mistakes" when they've done nothing of the sort. [Note to Brin, don't say something is a mistake and then keep doing it.] IMO, Google (and any other business for that matter) should be unapologetic about operating in China and following the law. It's good to be interested in the social situations around the world but let's not have businesses be our moral leaders.
This might be a "neat" idea to woo the already hardcore Google fans, but I don't think any medium to large business (especially corporations) would give this a second thought. Small businesses maybe, but once they can afford it I think they too would jump to one of the entrenched leaders (MS Office or Openoffice). In the increasingly complex and regulated world of business, switching to a web-based spreadsheet hosted by an advertising company is the absolute LAST thing on non-geeks' mind. In fact, it's probably not even on their minds at all.../askaninja/ kinda like being killed by a ninja isn't on most people's mind, even though some people think it should be. Accomodate Students, thanks for your posting on Google spreadsheets, a ninja looks forward to killing you soon.//askaninja/
"...they are also used to develop many large applications."
You think they're large now? Wait 'til the million row version of Excel is phased in and you'll see some LARGE spreadsheets.
Re:Internet Ad Market - don't we all block ads?
on
Battle of the Tech Titans
·
· Score: 4, Informative
The site I run caters to businesses and I don't see lots of javascript being blocked. I'm not sure if that directly correlates to the blockage of ads but it seems to me they should be pretty closely related.
Javascript Stats:
98.66% Enabled - 1.34% Disabled
Operating System Stats: 71.83% Windows XP - 19.03% Windows 2000 - 6.64% Windows 98 - 1.10% Windows NT4.0 - 0.75% Windows ME - 0.43 PPC - 0.13% Windows 2003 - 0.05% Mac OS X - 0.03% FreeBSD
My hunch is that they're highballing the requirements to soothe the hardware vendors. If they missed the holiday shopping season AND VISTA didn't need any more hardware than XP, you can bet those vendors would be seriously PO'd!
I installed PINs, http://www.mirekw.com/winfreeware/pins.html, on a USB key over a year ago and haven't had a problem remembering passwords since. It's hard to beat a free solution that offers 448-bit Blowfish encryption and helpful features like password aging and password generation.
First of all, this article is well-researched but poorly written and the author fails to achieve a coherent voice and statement. IMHO, this was a waste of 10 pages.
Secondly, I have worked in the biotech industry for last 6 years, 2 years of which have been with THE largest biotech company and the remaining 4 years with various start-ups. From this insider's perspective, I can tell you that the number one challenge of innovating in the biotech industry has less to do with IP law and more to do with the lack of management experience amongst life scientists. When you have industry where start-ups can get $90 million in venture capital and ballon to 150 employees without have a commercial product, that's not an IP issue... it's business 101 issue...
think 1990's dot.com reduex
Slashdot Mirror
Insightful? The premise that any technology can be 100% reliable is flawed.
As others have mentioned, the regulatory approval piece is big hurdle with something like this BUT there is still some good potential here... * Regulatory approval for 'me too' devices doesn't usually require clinical trials so the cost of regulatory approval would be less that some people have suggested. * The concept of 'open source' hardware is quite interesting. Rather than MobileECG design, build, and sell the devices all by themselves, perhaps they could focus on the design aspect so other companies can tweak the design, build and sell the devices. Essentially, MobileECG's open source hardware would be a reference architecture that other companies could use and provide feedback to. * Would be great to see a scientific study comparing the safety and efficacy of 'open source' vs 'closed source' medical devices. Since ECG devices are so common, this seems like a great opportunity with a relatively low-risk device.
Awesome link! I'm the OP and I really appreciate your response. The reason I'm looking into this is that I work with many scientists who use commercial software packages where they don't control the code or compiler and their results are archived and can be reanalyzed years later. I was recently helping someone revive an old server to perform just such a reanalysis and we had so much trouble getting the machine going again I started planning to clone/virtualize it. That got me thinking about where to put the virtual machine (dedicated hardware, cloud, etc) and it also got me curious about hypervisors. I found some papers indicating that commercial hypervisors can have variability in their floating point math performance and all of that culminated in my post. Thanks again.
Thank you, I appreciate the link. I'm the OP and I didn't mean to speculate about or disparage Mathematica, I meant to use it as an example of a commercial software package where the person running the calculation doesn't control the code or compiling process.
Awesome! Thank you for both the posts, I'm the OP and I really appreciate them. Your comment about scientific computing is spot on with the use cases I'm interested in.
I'm the OP and I really appreciate this comment. I did give some thought as to whether it was reproducibility or repeatability and I decided on reproducibility because the experimental equipment (underlying hardware and firmware) would be different, different analysts would be involved, and the replication of analysis would be occurring after a long period of time. I agree though that it's not clear cut in my post.
I'm the OP and I agree that I should've proofreader my post.
Nice, I'm the OP and I appreciate your comment and experimental design. I agree that in situations where you are coding the algorithm, it's easier to control/adjust for the variability with each hardware platform. The use cases I'm really wanting to learn more about are with commercial software packages that have traditionally been run on dedicated hardware and are now being virtualized and moved across multiple hardware types. I like your approach though and may do some testing along those lines.
Thanks for your comments, I really appreciate them. Your mention of experiments was spot on with the use cases I'm trying to learn about. I've worked with many scientists who use commercial software packages for biomedical research where their experimental results may be archived for 10+ years before being reanalyzed. I recently helped a colleague pull a Windows 2000 server out of storage to rerun an experiment. We got it going after some difficulty and that got me thinking about virtualizing the harddrive, which then lead me to wonder about the portability of virtualized machines between hardware hosts (including cloud providers) and the resulting reproducibility issues that could occur. I then read through several interesting papers showing variability of floating point math in commercial hypervisors, which lead to my posting on Slashdot. Thanks again. Some interesting links: http://faculty.cs.gwu.edu/~timwood/papers/im2013_tech.pdf http://www.vmware.com/pdf/hypervisor_performance.pdf http://www.cc.iitd.ernet.in/misc/cloud/XenExpress.pdf
I agree with the previous commenters that it's important to have a solution or plan before raising the alarm. Having said that, once you raise the alarm and you're not being heard to your satisfication, there are several options available: * First, clear your mind of what you think you know about software development and what SHOULD be and try to see the situation from an open-minded perspective. Are the issues you're seeing really an indicator of poor quality or are they an indicator of a system that's different from what you know/like? As a quality/regulatory person myself, I've seen many unnecessary projects and alarm bells simply because of a lack of understanding/perspective on a given topic. I'm not saying that's the case with you, just that this is the kind of issue that's good to be absolutely clear with yourself about. * Once you're clear that there is in fact an issue, go to QA and request an internal audit on your software development/quality systems. If your QA team doesn't have a procedure by which you can request an audit, then you should find a QA partner who can work with you on this. It's good to have a QA partner anyway so building the bridge on this project won't be a waste of time regardless of the outcome. * If auditing isn't an option, or if you need ammo to sell the audit idea, another approach is to analyze deviation and/or CAPA trends on your software development process, as well as your validation process. For example, try to find out how many validation deviations are being generated when new/updated software is released from your development team. Working with QA, you could develop an estimated cost-per-deviation, which would be a huge pile of ammo for your management presentation. Also, pretty charts and graphs will help too. * Find other tangible evidence of the issue. Without specific examples it will be difficult to be clear about the problem and/or the solution(s). * If you find evidence and QA and/or management still won't listen, it's time to consider your options. You can either stay, knowing that a ticking time-bomb exists, or you should carefully plan and execute your exit from the company. My litmus test for working at a company is to regularly ask myself whether I'd give my company's medicine to a family-member [a family member I love :P ]. If the answer is no, I don't stick around. So far, I've only had to do that once in 10 years and it was absolutely the right choice. Good luck!
How long before someone either a) selectively breeds or b) genetically modifies cows that produce more "gas" and/or bigger cowpies? My bet is 2 to 3 years.
Why do you need an expensive, complicated device to pull a trick like that? Why not throw together a bit of tinfoil and scrap wires and tell the suspect it's the latest ACME brain analyzer and they'd better talk or ELSE... As for your other comment, I seriously doubt that the ACLU lawsuit will make interrogation of suspects any less effective than the sanctioned beatings, torture, and humiliation already have.
If you're going to produce your manual in both print and online form, AND you might possibly want to re-use some of the manual content for things like brochures and presentations, I'd go with a single-source publishing system like AuthorIT. Single-source publishing was developed specifically for software projects and it allows you to create documentation in many different formats. It also allows you to reuse content across documents, which saves time and reduces inconsistencies caused by redundant content being recreated for each document. It ain't free but I've used AuthorIT for several years now and I'll never go back to producing documentation using Word or OpenOffice.
I agree Mike. It boggles me that so many outspoken people have this opinion that Google is coming down from some moral high-ground by doing business in China and following the laws of that country. Google is a for-profit corporation that must follow the laws of the countries they wish to do business with. The people who are upset about this are those who bought into Google's marketing message of "do no evil." Admittedly, Google's leadership panders to this misperception by "admitting mistakes" when they've done nothing of the sort. [Note to Brin, don't say something is a mistake and then keep doing it.] IMO, Google (and any other business for that matter) should be unapologetic about operating in China and following the law.
It's good to be interested in the social situations around the world but let's not have businesses be our moral leaders.
This might be a "neat" idea to woo the already hardcore Google fans, but I don't think any medium to large business (especially corporations) would give this a second thought. Small businesses maybe, but once they can afford it I think they too would jump to one of the entrenched leaders (MS Office or Openoffice). In the increasingly complex and regulated world of business, switching to a web-based spreadsheet hosted by an advertising company is the absolute LAST thing on non-geeks' mind. In fact, it's probably not even on their minds at all... /askaninja/ kinda like being killed by a ninja isn't on most people's mind, even though some people think it should be. Accomodate Students, thanks for your posting on Google spreadsheets, a ninja looks forward to killing you soon. //askaninja/
"...they are also used to develop many large applications."
You think they're large now? Wait 'til the million row version of Excel is phased in and you'll see some LARGE spreadsheets.
My hunch is that they're highballing the requirements to soothe the hardware vendors. If they missed the holiday shopping season AND VISTA didn't need any more hardware than XP, you can bet those vendors would be seriously PO'd!
http://66.102.7.104/search?q=cache:vu0EKWi4lTYJ:ww w.hamilton-co.org/cinlawlib/resources/303cv80109.p df+%22James+McCalla%22+%2Bspam&hl=en
I installed PINs, http://www.mirekw.com/winfreeware/pins.html, on a USB key over a year ago and haven't had a problem remembering passwords since. It's hard to beat a free solution that offers 448-bit Blowfish encryption and helpful features like password aging and password generation.
First of all, this article is well-researched but poorly written and the author fails to achieve a coherent voice and statement. IMHO, this was a waste of 10 pages. Secondly, I have worked in the biotech industry for last 6 years, 2 years of which have been with THE largest biotech company and the remaining 4 years with various start-ups. From this insider's perspective, I can tell you that the number one challenge of innovating in the biotech industry has less to do with IP law and more to do with the lack of management experience amongst life scientists. When you have industry where start-ups can get $90 million in venture capital and ballon to 150 employees without have a commercial product, that's not an IP issue... it's business 101 issue... think 1990's dot.com reduex