Loading ...
Sorry, an error occurred while loading the content.
 

Scrum in regulated environemnt

Expand Messages
  • Mahmud Mamun
    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
    Message 1 of 10 , Aug 15, 2014
      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
      Mahmud, ... You should talk to Nancy Van Schooenderwoert (http://www.leanagilepartners.com/) who frequently speaks and gives courses on this topic. - George --
      Message 2 of 10 , Aug 15, 2014
        Mahmud,

        On 8/15/14 3:48 PM, Mahmud Mamun mnmamun@... [SCRUMDEVELOPMENT] 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?
        >
        > 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
        ----------------------------------------------------------------------
      • Jim Schiel
        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
        Message 3 of 10 , Aug 15, 2014
          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

          On Aug 15, 2014, at 3:48 PM, "Mahmud Mamun mnmamun@... [SCRUMDEVELOPMENT]" <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?

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

          Thanks
          Mahmud

        • Ron Jeffries
          Medtronics builds things like pacemakers and theyÆve been doing Scrum/Xp/Agile for years. R ... Ron Jeffries www.XProgramming.com I know we always like to say
          Message 4 of 10 , Aug 16, 2014
            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 mnmamun@... [SCRUMDEVELOPMENT] <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
            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?

          • jchyip2000
            You may also want to look up Cochlear
            Message 5 of 10 , Aug 17, 2014
              You may also want to look up Cochlear
            • Cass Dalton
              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
              Message 6 of 10 , Aug 18, 2014
                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


                On Sun, Aug 17, 2014 at 8:54 AM, j.c.yip@... [SCRUMDEVELOPMENT] <SCRUMDEVELOPMENT@yahoogroups.com> wrote:
                 

                You may also want to look up Cochlear


              • Mark Graybill
                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
                Message 7 of 10 , Aug 18, 2014

                  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: SCRUMDEVELOPMENT@yahoogroups.com [mailto:SCRUMDEVELOPMENT@yahoogroups.com]
                  Sent: Saturday, August 16, 2014 9:24 AM
                  To: SCRUMDEVELOPMENT@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 mnmamun@... [SCRUMDEVELOPMENT] <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

                  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
                  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
                  Message 8 of 10 , Aug 18, 2014

                    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: SCRUMDEVELOPMENT@yahoogroups.com [mailto:SCRUMDEVELOPMENT@yahoogroups.com]
                    Sent: Saturday, August 16, 2014 9:24 AM
                    To: SCRUMDEVELOPMENT@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 mnmamun@... [SCRUMDEVELOPMENT] <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

                    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
                    Sorry for the grammatical errors. :) From: Mark Graybill [mailto:Mark@Graybill.com] Sent: Monday, August 18, 2014 12:10 PM To:
                    Message 9 of 10 , Aug 18, 2014

                      Sorry for the grammatical errors. J

                       

                      From: Mark Graybill [mailto:Mark@...]
                      Sent: Monday, August 18, 2014 12:10 PM
                      To: 'SCRUMDEVELOPMENT@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: SCRUMDEVELOPMENT@yahoogroups.com [mailto:SCRUMDEVELOPMENT@yahoogroups.com]
                      Sent: Saturday, August 16, 2014 9:24 AM
                      To: SCRUMDEVELOPMENT@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 mnmamun@... [SCRUMDEVELOPMENT] <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

                      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
                      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
                      Message 10 of 10 , Aug 18, 2014
                        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' Mark@... [SCRUMDEVELOPMENT]" <SCRUMDEVELOPMENT@yahoogroups.com>
                        To: SCRUMDEVELOPMENT@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: SCRUMDEVELOPMENT@yahoogroups.com [mailto:SCRUMDEVELOPMENT@yahoogroups.com]
                        Sent: Saturday, August 16, 2014 9:24 AM
                        To: SCRUMDEVELOPMENT@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 mnmamun@... [SCRUMDEVELOPMENT] <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
                        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?
                         


                      Your message has been successfully submitted and would be delivered to recipients shortly.