Re: Group Design

From	Don Y <blockedofcourse@foo.invalid>
Newsgroups	comp.arch.embedded
Subject	Re: Group Design
Date	2020-07-09 18:33 -0700
Organization	A noiseless patient Spider
Message-ID	<re8gi7$koo$1@dont-email.me> (permalink)
References	<a4d4857d-e915-49ef-a7d7-6015277edbeco@googlegroups.com>

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On 7/7/2020 6:46 PM, Rick C wrote:
> 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.

The downside of groups is folks tend to have narrow "specialties"
and there often are not "generalists" who can look at the entire
project and see where (function) responsibilities could better
be shifted.

(I worked on a 30-man project where one developer designed a ~80 sq in
PCB populated entirely with DIP switches -- cuz it didn't occur to him
that the processor could make those settings more economically and in
a more user-friendly manner than he -- with no MCU experience -- had
ever considered)

> We have semiweekly meetings on zoom or other sites.  There is no strong
> organization.
> 
> I'm surprised as much is getting done as it has been.  The original design
> used an Arduino and once the lack of I/Os became a hindrance we are
> switching to an ARM, but nothing remotely like a proper spec was generated
> and the processor initially picked is now out of pins.  The first rev of the
> main board has many issues including the isolation of the heat sink tabs by
> thermal relief connections.
> 
> 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.

If the goal is just to develop a proof-of-principle prototype *or*
to develop something for second/third world markets, this MIGHT work.
But, in the US (and I imagine similarly in the EU), there is a strong
emphasis on PROCESS... not just "results".  How does anyone know
that it will ALWAYS work??  And, under which conditions it won't?

A continuous ventilator is probably a Class II device.  (Class III
being the most stringent requirements)

cGMPs tend to center around having a thorough (documented!) process
and good papertrail to show that you took the effort "seriously".  If
you don't have a written spec BEFORE you start the design, how do you
know WHAT you are designing ("Did you make this up, as you went?")?
And, how can you evaluate whether or not you have met your design goals?

What tests did you run?  What were the results?  What did you do to
remedy substandard behaviors?  Did these efforts achieve the desired
result (did you even BOTHER to rerun the tests after those changes?)

There is no one at the FDA who is going to evaluate your schematics,
check your code for errors or even check that your device does what it
claims to do!  They typically don't have the resources nor expertise to
do so.  *You* make those assertions and convince them of your sincerity
and diligence with your papertrail/process (and reputation).

[And, of course, expose yourself to future litigation if things
go tits up!]

Bottom line, any manufacturer who would consider producing the device
would want the same sort of assurances (from you) that the FDA wants as
they would be putting THEIR reputation (and assets) on the line.  They're
likely NOT going to opt for an "Arduino" as a key component unless
they have some assurances that the module will remain available for
a considerable amount of time AND won't change (i.e., no firmware
upgrades as they'd require the product to be revalidated)

OTOH, if you're trying to *hack* together something for disadvantaged
third-world countries (pandemic or otherwise), they'll likely be
grateful for whatever they can get their hands on.  And, you'll likely
want to use components that can be easily acquired instead of
requiring some significant design or purchasing investment.

Thread

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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