7 min reading time

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

Yet he finds relatively few medical device manufacturers have adopted the methodology. Why?

Aaron says, “There’s a mistaken belief that medical device regulations and standards don’t allow for agile methods. But agile can be defined as iterative development to drive rapid learning (as in the scrum method). When combined with empowered product development teams, agile methods can address common problems including:
· Design flaws discovered late in development leading to expensive delays
· Schedule overruns with software development
· Compliance problems with design controls
· Product recalls.”

Is the main challenge to adopting agile methods a simple resistance to change? Perhaps a company is comfortable doing things the familiar way?

Or are the perceived benefits outweighed by the perceived difficulty changing methodologies?

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For the group,

· Has your company adopted agile methods for medical device software development?
· If so, what challenges have you faced in adopting the new methods?
· If not, were there particular reasons that prevented you from adopting the new methods?

Meet Aaron, Maren Nelson, and Kelly Weyrauch at their 10x Medical Device Conference panel in San Diego, May 3: http://medgroup.biz/10x

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Medical Devices Group Webinars on Demand

In case you’ve missed the past few, you can get immediate replay and slides access to this content from our group members.

How to Check Your Patents for Loopholes: http://medgroup.biz/check-patent

Advanced Product Registration Techniques for Faster Global Access: http://medgroup.biz/mktaccess

How to Get an Insurer to Reimburse Your Medical Device: http://medgroup.biz/get-paid

How to Prepare a Medical Device 510(k) Submission for FDA: http://medgroup.biz/submit-510k

How to Qualify and Choose a Medical Translations Agency: http://medgroup.biz/translations

How to Simplify Your Compliance with the New ISO 13485:2016 http://medgroup.biz/iso13485

… and many more at http://MedicalDevicesGroup.net/webinar

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Only seven weeks until the 10x Medical Device Conference in San Diego. Join us! http://medgroup.biz/10x

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Aaron Joseph
Streamlined Compliance for Medical Device Development
There are many excellent comments in this thread. The discussion prompted me to write up my own thoughts on this subject, based on my experiences as well as those of other consultants and managers trying to adopt agile methods in a medical device company. Here’s the link to my summary of the 3 main challenges: http://consensiainc.com/med-tech/challenges-adopting-agile-methods-for-medical-device-software-development/

Aaron Joseph
Streamlined Compliance for Medical Device Development
Atif, those are good observations, although I would widen the list of departments resisting change beyond QA–I’ve seen organizations where engineering groups are the main ones resisting change. I think it’s a general challenge facing any improvement efforts that organizations, even ones that have a stated goal of process improvement, will instinctively resist changing. The risk of undermining compliance just amplifies that effect at medical device companies. And your point about scrum teams missing necessary stakeholders is something I’ve seen on multiple occasions–a company has to be willing to allocate scare resources (experienced product managers) to the scrum teams for them to be truly effective.

Steve Maylish
Chief Commercial Officer, Fusion Biotec
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.

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
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.

Janet Andrews, M.A.
Executive Career & Job Search Coach 🔹 Outplacement 🔹 Land the Best Fit Executive Job 🔹 Healthcare, Biotech, Pharma, Medical Devices, Pharmacy, Technology, IT, IOT
Fascinating! Look forward to hearing a lively panel discussion on this topic at the 10x Medical Device Conference in San Diego in May!

Esther Alexander
(Software and Security) Quality, Governance, and Compliance Expert
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.

Marc L.
Consultant at Bowery Engineering
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.

Deb Fisher
Semi-retired writer, editor and publisher
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.

Scott Bacewich
Director Beaverton PM – Strategic Engineering Vision Care at Welch Allyn
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.

Michael Harris
Chief Innovation Officer, CHA, PMP, FGMG
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?

Kristian Larsen
Marketing & Communications Director at Data Narro
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]

Todd Murphy
Co-founder at Tueo Health
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.

Aaron Liang
Watson Health Quality Analyst at IBM
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.

Kristian Larsen
Marketing & Communications Director at Data Narro
[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.

James (Jim) Dent
Manufacturing Validation Enginee at DePuy Synthes Companies
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.

Roca Welch
Senior Engineer, Quality at Pacific Biosciences
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==

Deborah Sloan
Data-Driven Stanford Alumna; Medical Devices.
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).

Kjetil Kraemer
R&D Senior Executive | Strategy & Execution | Digital Transformation | Innovation | Customer focus | Business savvy, IoT
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.

Martin Berka
IoT systems: putting it all together
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.

Atif Mahmood
Cloud Solutions Architect
The real problem seems to be QA (quality assurance) departments that want to keep things they way they are. In medical device startups you’ll find more user engagement and agile development. It’s hard to teach a large origination new tricks 🙂

What’s worse, is that they start talking scrum but have no user engagement or don’t include the necessary stakeholders in the scrum team. The California company IMPAC did a good job with Agile before they were acquired by Elekta. Great ISO/FDA compliant quality system using without waterfall.