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Re: Group Design

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On 08/07/2020 16:19, Rick C wrote:
> On Wednesday, July 8, 2020 at 8:14:05 AM UTC-4, Stef wrote:
>> On 2020-07-08 Rick C wrote in comp.arch.embedded:
>>> Wow!  Designing in a group is strange.  I'm helping with the
>>> design of a ventilator and it is a unique experience.  We have
>>> people of many skill levels and talents, many I don't even know.
>> 
>> That is the good part of designing with a group. You can have many
>> more talents and skills than can be combined in a single person.
>> For a medical product like this you need medical, software,
>> hardware, mechanical and lots more skills. Not something that can
>> be found in one person very often.
>> 
>> <snip, some project frustrations etc.>
>> 
>>> I literally have no idea how they are ever going to get this
>>> thing past any sort of approval process.  No one working on the
>>> project even seems to understand what is required.
>>> 
>> 
>> This is very worrying. As David already explained, documentation
>> and approval is a very large part of medical device development.
>> There is this famous Boeing quote about the weight of the paperwork
>> required for a plane. I think you can extend this to medical
>> devices as well.
>> 
>> Did they at least have a look at some standards that apply to
>> ventilators to check what will be required? I would start off with
>> IEC 60601-1, IEC 62304 and ISO 80601-2-12, make sure you use the
>> latest versions. But there will be more.
>> 
>> And this should have been done before the first schematic was drawn
>> or line of code was written. Some standards put requirements on the
>> development process and you can not comply with those if you start
>> your certification efforts after the development is completed.
>> 
>> 
>>> I guess I'm a bit frustrated by the lack of organization.  I'd
>>> like to step away, but the person acting as a leader seems to
>>> want me in the group.
>>> 
>>> There is some work of my own I should do, so maybe I'll stick
>>> around to get to rev 2 of the board and then step out.
>>> 
>> 
>> If there has indeed been done nothing on the certification side, my
>> feeling would be to step away as well.
>> 
>> 
>>> I guess I'm used to working on my own.
>>> 
>> 
>> Yes, than all is in your own hands. ;-)
>> 
>> But the advantage of a team is that you can concentrate on what you
>> are good at and let others do what they are good at. And if the
>> team is diverse and skilled enough (and properly led) the end
>> result will be better that that of a single developer.
>> 
>> And I think a lot of medical device stuff can not be done by a
>> single person. There are many cases where you need an (expert)
>> reviewer in the process. Reviewing your own work is less than
>> optimal. ;-)
> 
> It seems the UK has an abbreviated set of requirements for response
> to COVID-19 and that is what they are mostly working with.  I forget
> the name of it.
> 
> They do get advice from time to time from professionals in the field.
> My main concern is a direction they are currently going in where more
> and more valves, pressure relief, etc. is being added to the tubing
> right at the patient.  I'm not sure how it all will be held in place.
> That and how they plan to get this through the approval process.
> 
> I had a friend who worked on medical devices for a while before
> getting out.  He said they required that you "prove" your design will
> not hurt the patient in any way.  Hard to do with a ventilator.

I have worked on the side-lines of a few medical-related devices.  The
requirements and approval process is hard.  On a board I worked with,
the prime function - the top priority function that must not fail - was
to turn off all outputs and make sure it did not interfere with manual
use of the system when auto mode was not enabled.  Running the motor was
a secondary function that could be done if enabled and all is well, but
having everything off was still classified as "working correctly".  It's
a weird way to think about things.

> 
> I don't mind working on the team.  It's seeing them go in odd
> directions that bugs me.  This thing will probably cost hundreds of
> dollars in the final BOM without anything like profit or overhead
> added in.  People were arguing against adding $0.10 for more pins on
> a processor.  Then later they decided to not only go with the larger
> pin count, but bump from an 8 bit AVR to an ARM CM4F adding several
> dollars.  That sort of inconsistency drives me nuts.  "Every dollar
> counts!"  Yes it does, so you need to justify the cost *rationally*.
> 
> 

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Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-07 18:46 -0700
  Re: Group Design Paul Rubin <no.email@nospam.invalid> - 2020-07-07 19:02 -0700
    Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-07 20:36 -0700
      Re: Group Design David Brown <david.brown@hesbynett.no> - 2020-07-08 09:31 +0200
        Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-08 07:08 -0700
  Re: Group Design Stef <stef33d@yahooI-N-V-A-L-I-D.com.invalid> - 2020-07-08 14:13 +0200
    Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-08 07:19 -0700
      Re: Group Design Stef <stef33d@yahooI-N-V-A-L-I-D.com.invalid> - 2020-07-08 18:57 +0200
        Re: Group Design Theo <theom+news@chiark.greenend.org.uk> - 2020-07-08 18:28 +0100
        Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-08 11:12 -0700
          Re: Group Design Stef <stef33d@yahooI-N-V-A-L-I-D.com.invalid> - 2020-07-08 23:34 +0200
            Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-08 15:20 -0700
              Re: Group Design Paul Rubin <no.email@nospam.invalid> - 2020-07-08 23:00 -0700
              Re: Group Design Stef <stef33d@yahooI-N-V-A-L-I-D.com.invalid> - 2020-07-10 10:09 +0200
              Re: Group Design Chris <xxx.syseng.yyy@gfsys.co.uk> - 2020-08-07 00:01 +0100
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-06 17:37 -0700
                Re: Group Design Paul Rubin <no.email@nospam.invalid> - 2020-08-07 03:06 -0700
                Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-08-06 21:50 -0400
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-06 19:12 -0700
                Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-08-06 22:27 -0400
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-06 19:36 -0700
                Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-08-06 23:39 -0400
                Re: Group Design Chris <xxx.syseng.yyy@gfsys.co.uk> - 2020-08-07 12:30 +0100
                Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-08-07 09:57 -0400
                Re: Group Design Chris <xxx.syseng.yyy@gfsys.co.uk> - 2020-08-08 00:37 +0100
                Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-08-07 20:29 -0400
                Re: Group Design upsidedown@downunder.com - 2020-08-08 08:59 +0300
                Re: Group Design David Brown <david.brown@hesbynett.no> - 2020-08-10 15:43 +0200
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-10 09:18 -0700
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-07 07:12 -0700
                Re: Group Design Chris <xxx.syseng.yyy@gfsys.co.uk> - 2020-08-08 00:00 +0100
                Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-08-07 20:30 -0400
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-07 17:57 -0700
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-07 17:56 -0700
                Re: Group Design Paul Rubin <no.email@nospam.invalid> - 2020-08-07 18:10 -0700
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-07 19:43 -0700
                Re: Group Design Dimiter_Popoff <dp@tgi-sci.com> - 2020-08-07 20:42 +0300
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-08-07 13:48 -0700
      Re: Group Design Paul Rubin <no.email@nospam.invalid> - 2020-07-08 14:11 -0700
      Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-07-09 04:25 -0400
        Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-09 11:37 -0700
          Re: Group Design Paul Rubin <no.email@nospam.invalid> - 2020-07-09 11:54 -0700
          Re: Group Design Tom Gardner <spamjunk@blueyonder.co.uk> - 2020-07-09 20:02 +0100
          Re: Group Design Phil Hobbs <pcdhSpamMeSenseless@electrooptical.net> - 2020-07-09 15:31 -0400
            Re: Group Design lasselangwadtchristensen@gmail.com - 2020-07-09 15:36 -0700
              Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-09 18:36 -0700
                Re: Group Design Clifford Heath <no.spam@please.net> - 2020-07-10 16:17 +1000
                Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-09 23:36 -0700
                Re: Group Design Stef <stef33d@yahooI-N-V-A-L-I-D.com.invalid> - 2020-07-10 10:22 +0200
      Re: Group Design David Brown <david.brown@hesbynett.no> - 2020-07-09 14:40 +0200
  Re: Group Design John Speth <johnspeth@yahoo.com> - 2020-07-09 07:59 -0700
  Re: Group Design Don Y <blockedofcourse@foo.invalid> - 2020-07-09 18:33 -0700
    Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-09 19:01 -0700
      Re: Group Design Don Y <blockedofcourse@foo.invalid> - 2020-07-09 22:32 -0700
      Re: Group Design George Neuner <gneuner2@comcast.net> - 2020-07-10 17:36 -0400
        Re: Group Design Ed Prochak <edprochak@gmail.com> - 2020-07-14 11:09 -0700
          Re: Group Design George Neuner <gneuner2@comcast.net> - 2020-07-16 00:26 -0400
  Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-09 22:48 -0700
    Re: Group Design Don Y <blockedofcourse@foo.invalid> - 2020-07-09 23:53 -0700
      Re: Group Design Rick C <gnuarm.deletethisbit@gmail.com> - 2020-07-10 01:15 -0700
        Re: Group Design Don Y <blockedofcourse@foo.invalid> - 2020-07-10 02:22 -0700

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