Discussion:
Scrum in regulated environemnt
Mahmud Mamun mnmamun@yahoo.com [SCRUMDEVELOPMENT]
2014-08-15 19:48:52 UTC
Permalink
Anyone has any real life experience to implement Scrum in regulated environment, to be specific in life science domain? I'm struggling to understand how we can adopt agile values where the process has to comply with FDA regulations that seemingly coming from waterfall concept?

Any link to research papers, text or personal experience will be appreciated.

Thanks
Mahmud
George Dinwiddie lists@idiacomputing.com [SCRUMDEVELOPMENT]
2014-08-15 20:26:13 UTC
Permalink
Mahmud,
Post by Mahmud Mamun ***@yahoo.com [SCRUMDEVELOPMENT]
Anyone has any real life experience to implement Scrum in regulated
environment, to be specific in life science domain? I'm struggling to
understand how we can adopt agile values where the process has to comply
with FDA regulations that seemingly coming from waterfall concept?
Any link to research papers, text or personal experience will be appreciated.
You should talk to Nancy Van Schooenderwoert
(http://www.leanagilepartners.com/) who frequently speaks and gives
courses on this topic.

- George
--
----------------------------------------------------------------------
* George Dinwiddie * http://blog.gdinwiddie.com
Software Development http://www.idiacomputing.com
Consultant and Coach http://www.agilemaryland.org
----------------------------------------------------------------------



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Jim Schiel schiel@comcast.net [SCRUMDEVELOPMENT]
2014-08-15 20:32:50 UTC
Permalink
Madmud,

I've been working in the regulated space with patient care software and medical device software for over twenty years. Let me know what you're trying to do...

Jim Schiel.

Sent from my iPhone
Post by Mahmud Mamun ***@yahoo.com [SCRUMDEVELOPMENT]
Anyone has any real life experience to implement Scrum in regulated environment, to be specific in life science domain? I'm struggling to understand how we can adopt agile values where the process has to comply with FDA regulations that seemingly coming from waterfall concept?
Any link to research papers, text or personal experience will be appreciated.
Thanks
Mahmud
Ron Jeffries ronjeffries@acm.org [SCRUMDEVELOPMENT]
2014-08-16 14:23:55 UTC
Permalink
Medtronics builds things like pacemakers and they’ve been doing Scrum/Xp/Agile for years.
R
Post by Mahmud Mamun ***@yahoo.com [SCRUMDEVELOPMENT]
Anyone has any real life experience to implement Scrum in regulated environment, to be specific in life science domain? I'm struggling to understand how we can adopt agile values where the process has to comply with FDA regulations that seemingly coming from waterfall concept?
Ron Jeffries
www.XProgramming.com
I know we always like to say it'll be easier to do it now than it
will be to do it later. Not likely. I plan to be smarter later than
I am now, so I think it'll be just as easy later, maybe even easier.
Why pay now when we can pay later?
'Mark Graybill' Mark@Graybill.com [SCRUMDEVELOPMENT]
2014-08-18 17:10:08 UTC
Permalink
Medtronics were doing Scrum and some components of Xp back in 2005 on the
OS2 to Windows RT pacemaker programmer project I was on. The Scrum part of
it was practiced as I learned it from Ken Schwaber and Mike Cohen..



On a side note, another medical device company that used to use Scrum was
purchased by a Japanese medical conglomerate, after which Scrum practices
was retired. The claim of the regulatory manager was that international
regulatory bodies were not amenable to Agile. That view is false, at least
for FDA.



From: ***@yahoogroups.com
[mailto:***@yahoogroups.com]
Sent: Saturday, August 16, 2014 9:24 AM
To: ***@yahoogroups.com
Subject: Re: [SCRUMDEVELOPMENT] Scrum in regulated environemnt





Medtronics builds things like pacemakers and they've been doing
Scrum/Xp/Agile for years.

R
Anyone has any real life experience to implement Scrum in regulated
environment, to be specific in life science domain? I'm struggling to
understand how we can adopt agile values where the process has to comply
with FDA regulations that seemingly coming from waterfall concept?




Ron Jeffries

www.XProgramming.com <http://www.xprogramming.com>

I know we always like to say it'll be easier to do it now than it

will be to do it later. Not likely. I plan to be smarter later than

I am now, so I think it'll be just as easy later, maybe even easier.

Why pay now when we can pay later?
'Mark Graybill' Mark@Graybill.com [SCRUMDEVELOPMENT]
2014-08-18 17:25:35 UTC
Permalink
Forgot to mention, the one thing that annoys me about waterfall vs. Agile is
that Agile iterates natural stages stipulated in waterfall - even if one of
the stages (requirement-to-design-to-code for instance) lies entirely in the
mind of the programmer for the moment before code is written.



However, some features of modern day pacemakers (AKA pulse generators) can
be too complex for mere text (use stories) and modeling the feature
beforehand may be beneficial in the process of conceptualizing the feature's
requirement. But that is usually the research team - the experts in the
domain.



FDA regulation does not prescribe waterfall or proscribe Agile. The gist of
FDA regulation is that your process has certain components and that you can
prove you follow it (objective evidence).



For instance, if you're using Xp and your process requires design diagrams
as objective evidence for design, use a software tool to create them from
code. This is acceptable if your process incorporates it in a way that
satisfies FDA regulatory requirements.



From: ***@yahoogroups.com
[mailto:***@yahoogroups.com]
Sent: Saturday, August 16, 2014 9:24 AM
To: ***@yahoogroups.com
Subject: Re: [SCRUMDEVELOPMENT] Scrum in regulated environemnt





Medtronics builds things like pacemakers and they've been doing
Scrum/Xp/Agile for years.

R
Anyone has any real life experience to implement Scrum in regulated
environment, to be specific in life science domain? I'm struggling to
understand how we can adopt agile values where the process has to comply
with FDA regulations that seemingly coming from waterfall concept?




Ron Jeffries

www.XProgramming.com <http://www.xprogramming.com>

I know we always like to say it'll be easier to do it now than it

will be to do it later. Not likely. I plan to be smarter later than

I am now, so I think it'll be just as easy later, maybe even easier.

Why pay now when we can pay later?
Mahmud Mamun mnmamun@yahoo.com [SCRUMDEVELOPMENT]
2014-08-18 17:55:30 UTC
Permalink
Thanks all for the helpful replies.
At least now I have some bargaining power while talking to the management that it is not new trying Agile/Scrum in FDA regulated environments.

I'm trying to explore more on some of the references I've received from all the replies. If anyone knows any paper/blog where it was explained how Scrum with validation/traceability was implemented in real life that would be highly appreciated.

Mahmud


________________________________
From: "'Mark Graybill' ***@Graybill.com [SCRUMDEVELOPMENT]" <***@yahoogroups.com>
To: ***@yahoogroups.com
Sent: Monday, August 18, 2014 1:25 PM
Subject: RE: [SCRUMDEVELOPMENT] Scrum in regulated environemnt



 
Forgot to mention, the one thing that annoys me about waterfall vs. Agile is that Agile iterates natural stages stipulated in waterfall – even if one of the stages (requirement-to-design-to-code for instance) lies entirely in the mind of the programmer for the moment before code is written.
 
However, some features of modern day pacemakers (AKA pulse generators) can be too complex for mere text (use stories) and modeling the feature beforehand may be beneficial in the process of conceptualizing the feature’s requirement.  But that is usually the research team – the experts in the domain.
 
FDA regulation does not prescribe waterfall or proscribe Agile.  The gist of FDA regulation is that your process has certain components and that you can prove you follow it (objective evidence).
 
For instance, if you’re using Xp and your process requires design diagrams as objective evidence for design, use a software tool to create them from code.  This is acceptable if your process incorporates it in a way that satisfies FDA regulatory requirements.
 


From:***@yahoogroups.com [mailto:***@yahoogroups.com]
Sent: Saturday, August 16, 2014 9:24 AM
To: ***@yahoogroups.com
Subject: Re: [SCRUMDEVELOPMENT] Scrum in regulated environemnt
 
 
Medtronics builds things like pacemakers and they’ve been doing Scrum/Xp/Agile for years.
R
On Aug 15, 2014, at 3:48 PM, Mahmud Mamun ***@yahoo.com [SCRUMDEVELOPMENT] <***@yahoogroups.com> wrote:


Anyone has any real life experience to implement Scrum in regulated environment, to be specific in life science domain? I'm struggling to understand how we can adopt agile values where the process has to comply with FDA regulations that seemingly coming from waterfall concept?
 

Ron Jeffries
www.XProgramming.com
I know we always like to say it'll be easier to do it now than it
will be to do it later. Not likely. I plan to be smarter later than
I am now, so I think it'll be just as easy later, maybe even easier.
Why pay now when we can pay later?
 

'Mark Graybill' Mark@Graybill.com [SCRUMDEVELOPMENT]
2014-08-18 17:26:41 UTC
Permalink
Sorry for the grammatical errors. :)



From: Mark Graybill [mailto:***@Graybill.com]
Sent: Monday, August 18, 2014 12:10 PM
To: '***@yahoogroups.com'
Subject: RE: [SCRUMDEVELOPMENT] Scrum in regulated environemnt



Medtronics were doing Scrum and some components of Xp back in 2005 on the
OS2 to Windows RT pacemaker programmer project I was on. The Scrum part of
it was practiced as I learned it from Ken Schwaber and Mike Cohen..



On a side note, another medical device company that used to use Scrum was
purchased by a Japanese medical conglomerate, after which Scrum practices
was retired. The claim of the regulatory manager was that international
regulatory bodies were not amenable to Agile. That view is false, at least
for FDA.



From: ***@yahoogroups.com
<mailto:***@yahoogroups.com>
[mailto:***@yahoogroups.com]
Sent: Saturday, August 16, 2014 9:24 AM
To: ***@yahoogroups.com
<mailto:***@yahoogroups.com>
Subject: Re: [SCRUMDEVELOPMENT] Scrum in regulated environemnt





Medtronics builds things like pacemakers and they've been doing
Scrum/Xp/Agile for years.

R
Anyone has any real life experience to implement Scrum in regulated
environment, to be specific in life science domain? I'm struggling to
understand how we can adopt agile values where the process has to comply
with FDA regulations that seemingly coming from waterfall concept?




Ron Jeffries

www.XProgramming.com <http://www.xprogramming.com>

I know we always like to say it'll be easier to do it now than it

will be to do it later. Not likely. I plan to be smarter later than

I am now, so I think it'll be just as easy later, maybe even easier.

Why pay now when we can pay later?
j.c.yip@computer.org [SCRUMDEVELOPMENT]
2014-08-17 12:54:10 UTC
Permalink
You may also want to look up Cochlear
Cass Dalton cassdalton73@gmail.com [SCRUMDEVELOPMENT]
2014-08-18 13:06:23 UTC
Permalink
My experience is in a different type of regulation, but I work at a defense

contractor and waterfall is heavily entrenched in the DoD. Many contracts

require specific waterfall-like milestones such as an SRR (Software
Requirements Review), PDR (Preliminary Design Review), and a CDR (Critical
Design Review). We have requirements to track Earned Value (
http://en.wikipedia.org/wiki/Earned_value_management) which is the epitome
of build-to-plan. I have spent the last 4 years working to change the
culture in our software organization and I'll describe my experiences.


When you are trying to change an entrenched waterfall culture, it is
imperative that you truly understand why both sides (your traditional
waterfall culture and agile) do the things that they do. Most processes
don't happen by accident. There is a reason that the gov't requires us to
have an SRR early in the process. There is a reason that agile wants short
iterations. And remember, agile is not a process. Scrum is a process.
DSDM is a process. Agile is a set of values and principals. You are
going to have to find compromises between the agile process you pick (most
likely a combination of Scrum and XP) and the culture built around your
regulatory processes. If you don't truly understand why your culture does
what it does, then it will be virtually impossible to show the skeptics how
you can achieve the same results through agile. If you don't truly
understand why agile does what it does, then you might easily "tweak" your
agile process to suit your culture in a way that destroys some of the value
of the agile process. My inward journey took me through all of the
Poppendieck books all the way to "The Toyota Way" by Jeffery Liker. Lean
and Agile share many of the same core beliefs and an understanding of Lean
philosophies gives you a deeper understanding of Agile philosophies. But
even more important, the story of how GM tried to implement the lean
processes of the Toyota Production System in the 80s without making the
necessary culture change was enlightening. This hammers home the concept
that it's the values and the principals that's important, not the actual

process. The process and facilitate or hinder the culture, but process
change without culture change will not help you (and will often make things
worse). Often you can get the most benefits out of culture change without
ever changing a word of your process.


I also had to learn quickly that your culture doesn't change overnight.
I've been pushing culture change for 4 years, and for the most part,
everyone is on board, but I have yet to find a set of developers that
actually want to try pair programming. I have suggested it several times,
but there are still more pressing hurdles to overcome. But if you really
get to know the concerns of the skeptics and figure out how to address
them, change will happen. It is important in the early stages to make
changes that are practically guaranteed to be successful. A few early
successes will ease the change. A few early failures can be fatal to
culture change.


It's also important to have at least one executive advocate. No matter how
powerful a grass-roots campaign is, having no executive support for agile
or culture change will make your life very difficult.


Regarding fixed requirements, we stared working with our customers to
understand what their real requirements were. There are a core set of high
level requirements that are essentially fixed (i.e. the contract would be
considered a "failure" if you didn't achieve them). Sometimes all the high
level requirements are fixed. Sometimes you get a set of goals. But it's
important to specify these "must haves" at the highest level possible
conceptually. We use the term "epics" for these. We prioritize these epics
based on need/risk/etc.. When we decompose these epics into stories, the
stories relating to the minimal/simplest solution that satisfies these
epics are put in the backlog at the priority of the epic. And the epics
don't describe the solution, the describe the need. The epics are tracked
by the PM and stakeholders like fixed requirements. The user stories under
these epics are tracked by the team per Scrum. This is our compromise
between the fixed requirements and tracking to plan of the defense
contracting world and the flexible scope and emergent design of agile.


Hope this helps.


-Cass
Post by ***@computer.org [SCRUMDEVELOPMENT]
You may also want to look up Cochlear
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