Challenges Adopting Agile Methods?

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10x faculty member Aaron Joseph believes agile methods can almost universally be appropriate for medical device software development. Yet he...

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Posted by Joe Hage (Discussions: 3, Comments: 4)
Replied on March 14, 2017 12:00 am
Category: Medical Devices
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I have heard agile discussed as primarily a cost- and time-saving measure (the benefits listed above do little to counter this) that gets part of its savings from skimping on documentation - certainly there are many implementations, and some agile groups are writing excellent documentation, but that's the perception. And documentation and regulation go hand-in-hand.
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Posted by Martin Berka (Discussions: 0, Comments: 15)
Replied on March 14, 2017 8:00 pm
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Fascinating! Look forward to hearing a lively panel discussion on this topic at the 10x Medical Device Conference in San Diego in May!
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Posted by Janet Andrews, M.A. (Discussions: 0, Comments: 2)
Replied on March 14, 2017 8:00 pm
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I have personally found that a hybrid approach may be the best way to transition teams to the Agile methodology versus Waterfall for software development. I do not work in the medical device industry yet, but in my experience with working in Software teams in the semiconductor industry, it is also a challenge for developers to make the switch. An approach that may help drive the transition easier is to start dividing the waterfall development cycle into smaller checkpoints which can be based on completing certain features or portions of features. From there setting up certain performance indicators, acceptance reviews, and customer evaluations at these checkpoints may help to start driving the team to the Agile approach. From there adding scrums and other elements of Agile will be somewhat easier to move to.
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Posted by Esther C. Alexander, MSc., PMP, ASQ CSQE, CMQ/OE (Discussions: 0, Comments: 2)
Replied on March 14, 2017 8:00 pm
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Joe, It may not be as simple as resistance to change. There could be other factors, such as:
'-- the needed expertise,
'-- the learning curve, and how it will affect the current schedule
'-- the risk of failure or struggle to maintain current schedule while learning
'-- the many articles some have written relative to Agile not working as effectively as claimed.
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Posted by Jim Dent, LSSBB, DTM (Discussions: 0, Comments: 10)
Replied on March 14, 2017 8:00 pm
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The main challenge IMHO is reconciling agile methods with FDA Design Controls regulations. IEC62304 embodies these regulations (as well as IOS13485) and reading it, it's difficult to see how to fit Agile methodology within that framework. There have been many case studies published on this issue. In fact the uncertainty led AAMI to issue TIR45 five years ago. In the grand scheme of things that's not that long ago, so I think you're seeing a slow migration of QMS software procedures to embrace Agile.
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Posted by Marc Lindahl (Discussions: 0, Comments: 1)
Replied on March 14, 2017 8:00 pm
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I found a white paper that was written for Rally (competitor to Jira) that really hits the nail on the head with incorporating Agile SW methods into a medical device environment. Software people "get" this perspective. www.scaledagileframework.com/?wpdmact=process&did=NjguaG90bGluaw==

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Posted by Roca Welch (Discussions: 0, Comments: 1)
Replied on March 14, 2017 8:00 pm
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The agile SW development is, to me, a highly non-linear process: a little akin to Brownian motion, where the oscillations occur around more or less stationary points and larger 'wild' swings occur statistically infrequently (this is a definition of a chaotic behavior with 'attractors' as well, btw). To me, this is largely antithetical to the FDA design controls which force/cajole/demand a largely linear development: well defined direction and progression, from one milestone to the next, making sure that all i's are dotted and all t's are crossed. One can argue that sw milestones can be managed via agile practices, but I don't think this will be very efficient or effective, due to the fast zigs and zags of agile (every day?). I'm not a sw developer, though, just a 'customer' for it. So I would like to hear, as well as Joe, what do sw folks have to say.
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Posted by Gary Abramov (Discussions: 0, Comments: 13)
Replied on March 14, 2017 8:00 pm
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One challenge I've encountered attempting to apply agile methods to device development is the lead time that can be introduced when developing hardware vs software. While a 2 week sprint can produce testable functionality in software, it may only be enough to design and order parts for a hardware prototype.
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Posted by Todd Murphy (Discussions: 0, Comments: 1)
Replied on March 14, 2017 8:00 pm
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I've got a feeling that the problem with using Agile for software development is the same problem faced by those who adopt other software development methods - failure or inability to commit resource to the job in hand. Without that, nothing is ever going to be easy.
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Posted by Deb Fisher (Discussions: 0, Comments: 1)
Replied on March 14, 2017 8:00 pm
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We develop software. For everything. We SCRUM, were adopting Agile and if you develop iPhone apps, big brother Apple will force you to go the DevOps way!
I think the biggest challenge today with software development in the medical space is having a really definitive set of requirements! Between sales and product management requests, a project can run amuck. Just learning to say "NO" is some of the best Agile methods around. Now, what about automated testing processes?
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Posted by Michael Harris (Discussions: 0, Comments: 1)
Replied on March 14, 2017 8:00 pm
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Our Company, True Process, adopted Agile for our software development processes about three years ago. While we don't develop medical devices (hardware), we do have extensive experience writing medical software and operating in this regulated space. Our VeriScan and ViNES software products are both produced under Agile methodologies. And whenever possible, we use Agile methods when developing software for our partner/clients.

Of course, it is challenging to use Agile in a regulated space and under strict quality systems that demand design controls and extensive documentation. Like many others, we used the AAMI TIR45:2012 to get us rolling. It took a lot of trial and error in the beginning months to streamline the system. At this point, it has become second nature.

[CONTINUED IN NEXT POST]
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Posted by Kristian Larsen (Discussions: 1, Comments: 2)
Replied on March 14, 2017 8:00 pm
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[CONTINUED FROM PREVIOUS POST] We are a smaller company (~50 people), so we are a little bit more nimble when it comes adopting new technology and processes. I can understand how hard to can be for larger manufacturers to upend their rigorous quality systems by putting a (seemingly) unordered system in place.

Agile has been the dominant model outside of healthcare, it's only a matter of time before it is commonplace there as well. The benefits are real, but there is hard work to get system rolling, and a lot of diligence, and sometimes course corrections, that needs to happen to keep the system working as intended.
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Posted by Kristian Larsen (Discussions: 1, Comments: 2)
Replied on March 14, 2017 8:00 pm
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I think one could even make the case that agile is *maximally* beneficial in the medial device context, *especially* because of regulations and standards - on the basis of the problems that it can address (e.g. late and expensive discovery of design flaws, as indicated in the post).
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Posted by Deborah Sloan (Discussions: 0, Comments: 1)
Replied on March 15, 2017 8:00 pm
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Deb Fisher hit it on the head for our transition to Agile methodology in our SW development. The issue seems to be the age old too many projects and not enough people. One major challenge we deal with is prioritization and clear definition of done of the backlog well ahead enough that the development team isn't doing planning during the sprint.
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Posted by Scott Bacewich, PMP (Discussions: 0, Comments: 1)
Replied on March 15, 2017 8:00 pm
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I agree with much that has been commented on this topic. We incorporated Agile Scrum at Source Scientific and Fusion Biotec. The way to beat the software hardware issue is to start with off-the-shelf development boards and modify as you go or have some basic platform boards in your pocket with an existing software framework. In my mind, Agile Scrum allows project management to take a leap forward (part of my next article for MPO). Yes the process is iterative in the short run, but progressive/sequential in the long run. Agile Scrum does not work during the design input phase however, but then again it's not needed there.
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Posted by Steve Maylish (Discussions: 0, Comments: 4)
Replied on March 15, 2017 8:00 pm
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Good point @Deborah. An agile approach done correctly may actually be good for medical devices. Compared to a linear waterfall approach it allows for earlier identification of potential show stoppers or blocking issues while providing faster integration of user feedback into design iterations which contributes to improved usability and satisfactory outcomes.
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Posted by Aaron Liang (Discussions: 0, Comments: 48)
Replied on March 15, 2017 8:00 pm
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Great topic! In My former Company I took part in The establishment of a software development function and later introduction of scrum. We had a nice hybrid of stage-gate to cater for higher level QMS requirements and Scrum to be agile on an operational level. Scrum goes perfectly with 62304 :) only real challenge might be to properly manage risks.
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Posted by Kjetil Kraemer (Discussions: 0, Comments: 1)
Replied on March 15, 2017 8:00 pm
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I’ve been working on multiple IT projects (also) for pharma/healthcare companies following Agile methodologies and they were all successful. Some of them were even Validated (GxP) projects!

The secret is to be flexible and understand that sometimes even the best SCRUM best practices cannot fit certain scenarios.

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Profile photo of Paolo Matrascia Posted by Paolo Matrascia (Discussions: 0, Comments: 2)
Replied on March 22, 2017 6:33 pm
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