Medical Devices

[Bud Cookson]

We are in the process of developing the requirements for a new medical
device and the question has been raised about what development tool/language
should be used. The application(s) will be primarily user interface on a
Windows CE on a Single Board Computer. We see the choices as:
1. embedded C++
2. embedded VB
3. VB.Net
4. C#.Net
There is the potential for a combination of these but out preference is to
do a majority of the application development in VB.Net (we know we will need
to do some pieces in C++ in order to get to the hardware level or very fast
interrupt handling). However, the concern lies in the issues surrounding
experience in developing applications for FDA approval and the stability of
VB.Net in this type of environment (embedded).

What I am looking for is any experience people have in the development of
medical devices and what you would recommend. I am guessing that few, if
any, devices have been built using VB.Net but if there have been, I would
really like to know about them.

I am not looking for any sort of proprietary information and don't want to
know who the device was built by or for or anything about the FDA
validation. All I am interested in is experiences that will help us decide
which language or combination of languages to use on this project.

Thanks very much in advance.

BUD

 

[Phil Frisbie, Jr.]

We are in the process of developing the requirements for a new medical
device and the question has been raised about what development tool/language
should be used. The application(s) will be primarily user interface on a
Windows CE on a Single Board Computer. We see the choices as:
1. embedded C++
2. embedded VB
3. VB.Net
4. C#.Net
There is the potential for a combination of these but out preference is to
do a majority of the application development in VB.Net (we know we will need
to do some pieces in C++ in order to get to the hardware level or very fast
interrupt handling). However, the concern lies in the issues surrounding
experience in developing applications for FDA approval and the stability of
VB.Net in this type of environment (embedded).

What I am looking for is any experience people have in the development of
medical devices and what you would recommend. I am guessing that few, if
any, devices have been built using VB.Net but if there have been, I would
really like to know about them.

I am not looking for any sort of proprietary information and don't want to
know who the device was built by or for or anything about the FDA
validation. All I am interested in is experiences that will help us decide
which language or combination of languages to use on this project.

All I can tell is is to CAREFULLY read all the license agreements for Windows CE
and those tools you referenced above (and good luck finding full copies of those
licenses). Microsoft has always excluded their OSs and tools from being used to
control devices that could harm human life.

 

[Chris Tacke, eMVP]

CE is used in many medical devices, it just isn't to be used in
life-sustaining applications. Medical monitoring/ECG devices, infusion
pumps, defibrillators, ultrasound and many other devices have been done
under CE.

-Chris

 

[Phil Frisbie, Jr.]

CE is used in many medical devices, it just isn't to be used in
life-sustaining applications. Medical monitoring/ECG devices, infusion
pumps, defibrillators, ultrasound and many other devices have been done
under CE.

That is correct; perhaps I should have been more clear. Also, past Windows
licenses specifically excluded use in nuclear weapons controllers

 

[Steve Maillet \(eMVP\)]

FDA testing remains the same regardless of the runtime, OS or language used.
A managed application is likely to get through testing sooner as the managed
environment makes it harder to make common coding mistakes. However, interop
with native code done incorrectly can introduce instabilities so be sure to
carefully test all unmanaged code.

--
Steve Maillet
EmbeddedFusion
www.EmbeddedFusion.com

Do have an opinion on the effectiveness of Microsoft Windows Mobile and
Embedded newsgroups? Let us know!
https://www.windowsembeddedeval.com/community/newsgroups

 

[Ginny Caughey [MVP]]

Bud,

Aside the the licensing discussion, there is an article on MSDN you might
find interesting that covers mixing .NetCF code and C++ for real-time apps:
http://www.windowsfordevices.com/articles/AT4038220377.html

 

[Bud Cookson]

Looks like I have created a very interesting conversation. However, this is
a laboratory device although it is used for diagnostics, it is NOT used for
life sustaining functions. Therefore, the caveats are not applicable.
However, I do appreciate the insights.

As Steve Maillet indicated in a separate post, testing is key. That is
always the case with FDA validation and general, good practice. We are
definitely planning that into the mix. However, trying to get off on the
right foot.

Still looking for the insights on what people have seen as far as languages
and tools used in this environment. Thanks for the help.

BUD

 

[Steve Maillet \(eMVP\)]

I'd recommend C# for the GUI and native code for drivers an critical
real-time code. If you can wait for VS2005 release you can expose all of the
native code can as COM components. Makes things fairly simple.

--
Steve Maillet
EmbeddedFusion
www.EmbeddedFusion.com

Do have an opinion on the effectiveness of Microsoft Windows Mobile and
Embedded newsgroups? Let us know!
https://www.windowsembeddedeval.com/community/newsgroups

 

[Dick Grier]

Hi Bud,

Chris' comment is on target. His company is an embedded Windows CE device
manufacturer, so he sees lots of potential and actual applications.

--
Richard Grier (Microsoft Visual Basic MVP)

See www.hardandsoftware.net for contact information.

Author of Visual Basic Programmer's Guide to Serial Communications, 3rd
Edition ISBN 1-890422-27-4 (391 pages) published February 2002.

 

[Steve Maillet \(eMVP\)]

My company is in the business of helping OEMs create devices as well and
I've done bio-med diagnostic devices with Windows CE including FDA and AOAC
testing.

But that doesn't address the original question of the tools to use for such
a device. Ultimately the best tool depends on a number of factors. Chief
among them being your dev teams current skill sets. If they know nothing
about C#, VB.NET or the .NET Compact Framework, then it's probably not a
good choice to go with managed code. If everyone is proficient in MFC that
might be a better option. If you have a bunch of Anti - C++ devs then raw C
will have to do. There are other technical factors that can sway things one
way or another on a case by case basis. Generally speaking most such
projects use native code for low level drivers and hardware control with
managed code (C# or vb.net) providing the UI.


--
Steve Maillet
EmbeddedFusion
www.EmbeddedFusion.com

Do have an opinion on the effectiveness of Microsoft Windows Mobile and
Embedded newsgroups? Let us know!
https://www.windowsembeddedeval.com/community/newsgroups

 

[test]

Bud,

Contact elantechnologies in india. they have written programs like these.
i'm having a program developed by them right now and i would recommend them.
www.elantechnologies.com
maybe you can even outsource (part of) the program to them. works for me.

Mischa

 

[Bud Cookson]

Ginny - very useful article. Thanks for the reference. BUD

 

[Bud Cookson]

Mischa - thanks for the reference. I am definitely looking for more
specific references but I am not going to worry about it for now. Thanks
for everyones time. BUD