iSirona successfully adopts an agile process within strict FDA regulations
• Industry: Healthcare
• Specialties: Medical Device Connectivity
• Company Size: 200 employees
• Headquarters: Panama City, FL
• Interviewees: Scott Kahler, CTO & Matt Davis, Director of Development At a Glance:
• cPrime-2 delivers a blend of hands-on training, executive consulting and long-term coaching at a critical time in iSirona’s maturation
• iSirona successfully adopts a lean Agile process within strict FDA quality assurance regulations
• Agile breeds a culture of personal responsibility, freedom to make your own choices, with a set of guide rails to lead you along the way
• Agile permits an innovative way to meet the challenges that FDA regulations present
iSirona provides a simplified approach to medical device integration by connecting virtually any medical device to any CIS. The iSirona solution saves clinician time and gives them faster access to more accurate information, empowering them to make more-informed decisions.
I interviewed Scott Kahler, CTO, and Matt Davis, Director of Development, to hear their story and to understand the reasons why they chose to select Agile methodologies, why they selected cPrime-2 as a vendor and what they have noticed as the biggest improvements since our engagement.
Up until 2010, iSirona consisted of a small team of software developers who responded to the medical device integration needs of a few hospitals. They did not have a clear vision or method for developing their software, but instead they depended on their team’s experience and worked in response to requirements that clients presented. With a small team, this approach worked.
However, as the company grew and began getting recognition and winning industry awards, demand for their software boomed. They needed to define a process and scale their culture to accommodate thriving teams and hefty project loads.
iSirona develops software that has to integrate with hundreds of medical devices from multiple device manufacturers, as well as the technology and communications environment unique to each hospital. Limited resources and shifting requirements made the task of creating a fixed roadmap for their software a daunting challenge.
“Every new hospital that we went to posted a new set of challenges and requirements for us.” … “During those early stages, we just adapted to the situations as they came up.” – Scott Kahler, CTO
In 2011, demand for iSirona’s software boomed.
“We realized that our sales had outgrown our ability to operationalize our sales….we got caught flat footed…We went from 25 to 160 employees and that meant in 2012 we had to build process and train people” – Scott
In 2010, the FDA put up a ruling that meant iSirona would be part of a regulated industry. The burden to comply with the strict guidelines of quality assurance regulations further complicated iSirona’s efforts to implement Agile processes. The demand for substantial documentation led some of the management at iSirona to lean towards a waterfall methodology. However, they knew that with the nature of their software they needed to stay lean.
“One of our bigger challenges was trying to implement the Agile approach in conjunction with a separate quality assurance group that was derived from medical device manufacturing that did not understand either software development or agile methodologies”-Scott
Building an Autonomous Culture
The executive team knew that with their growth, they needed a methodology that would reflect iSirona’s autonomous culture.
“Our CEO, Dave, wanted a software development methodology that reflected the culture he was instilling at the company which is a culture of personal responsibility, freedom to make your own choices, but with a set of guide rails to lead you along the way.” – Matt Davis
Developing highly flexible software
iSirona’s culture and software didn’t lend themselves well to a waterfall process, yet new FDA regulations brought challenges to adopting Agile.
“It is not software that we could just develop in a waterfall fashion because need to continually adapt to interface with electronic medical record systems and literally hundreds of medical devices.”-Scott
Agile abstracts the FDA burden from developers
“When I talk to developers about the quality system, what I end up telling them is that the same things that the FDA requires of you are the same things that you would do as a professional developer in an Agile system. So as a professional, you would unit test. As a professional, you would peer review, pair program, utilize test-driven development. You would do all these things anyway.”-Matt
The main goal of the engagement between iSirona and cPrime-2 was to create an agile process to allow for flexible software development while aligning that process to support their FDA quality assurance needs. cPrime-2 prescribed a variety of onsite agile training courses for iSirona’s teams as well as executive consulting to help align their product vision and adoption plan. The training was followed by 30 days of onsite coaching to solidify the new agile practices within their unique development environment.
• Agile for Teams
• Requirements Management & Release Planning
o Product Management Planning Session
o Epic Story Planning
• At the completion of the Training, cPrime-2’s coach spent two days with the team and management to functionally develop a release plan and backlog for the first iteration.
Team Coaching (30 days)
cPrime worked with the iSirona for two iterations (6 weeks) to help establish practices and support infrastructure needed to ensure high quality and traceability of work product to align with auditing needs.
Evaluation of cPrime:
“I think that Kendrick did a really good job. I thought he did an excellent job of evangelizing; obviously, he made believers out of us. We’ve evangelized a hundred-and-some-odd people since then.” – Matt
“The classroom session was very good. It was a good blend of training and hands-on lab-like sessions. The consulting engagement was truly necessary for us because we were very rudimentary. [cPrime-2 Coach] walked us through a couple of sprint cycles and he helped us get our physical environment set up.” – Scott
iSirona now has over 180 employees; 5 Scrum Teams, 3 Scrum Masters, 2 or 3 Managers, 5 Product Managers and is continuing to expand.
Agile Created an Autonomous Culture
“I think the thing that we enjoy the most is the autonomous teams that get to make their own decisions and self-govern. Really reflects our philosophy and company culture.” – Matt
Successfully Merged Agility with FDA Regulations
“We get the benefits of having a more structured process, I’d say, than some non-regulated businesses. We’ve taken the best out of [the process] and used Agile to meet the requirements of the FDA. – Matt
“I feel like we have successfully done that now to the satisfaction of both the quality assurance group under the FDA guidelines and to the development and the rest of the organization from a software quality perspective and an Agile approach to development.”- Scott
Ability to Respond to Customers Quicker
“We are able to respond to customer requests very quickly. We are able to change priority and remain – well, for lack of a better word – remain agile in the market place. We also give the developers the freedom so that the regulation itself doesn’t affect their daily lives.” –Matt
Reduced Meetings & Paperwork
“We’re able to meet a lot of the FDA regulation through Agile processes and those have reduced our paperwork burden.”…
“Just to give an example; the FDA requires you to have an engineering change process. We were able to abstract that out to say; “Well, our change process is the Agile process.” So anytime that there is a requirement that needed change or a new requirement needed to be added, we just treat it as a new requirement in our Agile process.”… “I would call it an innovative way to meet that challenge.”
“We drink the Agile Kool-Aid”
Matt talks about how they continue to keep their agile culture with growing personnel.
“If there’s one thing we do really well here it’s ‘on board.’ We are big evangelists for both Agile and the FDA quality process. Also, for the iSirona culture. We do a good week-long on boarding…So you come out of that week-long training, you are an evangelist for Agile, the iSirona quality system and culture. We sell it pretty hard – we all drink the Kool-Aid around here. The benefits are evident – so it’s not hard to sell people on it.”