TransformationNov 19, 2021

Implementing Agile in a Skeptical, High-Risk Environment

Kelsey Kah

Have you ever spotted an agile government project in the wild? It may seem like a paradox, but it can, in fact, exist. While many organizations (like the government) are still following traditional waterfall project plans and related management methodologies, agile is making headway as a more advanced project management strategy. 

Waterfall project plans are linear. That doesn’t allow for changes to requirements or implementation after the initial planning phase. This means a project is completely planned and the product or offering set in stone before work begins. If there’s any need to change something, it’s very complex. As we know, real-life projects usually have a few unexpected surprises that put a kink in the works, which is where agile allows for the iterations that are needed to incorporate new insights and feedback.  

In this piece, we’re going to share how one medical device company began the process of agile transformation and how Credera partnered with them. 

Our Approach to Introducing Agile

Credera recently partnered with a company in the medical device industry to build an online portal to display test results. Because our work is considered a software as a medical device (SaMD), a 510K Federal Drug Administration (FDA) filing was required before our portal could go live. Unsurprisingly, this client uses waterfall project planning and execution to submit FDA fillings. Our team began this engagement with an envision phase to build a project plan and begin the initial documentation around the portal requirements. We started this engagement working 100% waterfall. 

There was an opportunity to potentially incorporate some agile methodologies into this engagement to help our teams adapt to inevitable changes though our client was unfamiliar with the process and nervous about introducing too many new variables into the effort.  Therefore, we were appreciative when, after many discussions to gain alignment, our engagement landed on a “hybrid approach” or a blend between agile and waterfall. We met with the core team to reflect on their experience implementing a hybrid agile approach and the lessons learned along the way.

From start of the project until the completion of the envision phase, what do you think went really well?

“One of the most helpful resources we had was our FDA consultant,” said Justin Mah, the engagement program manager. “As a third-party consultant, he bridged some of the gaps between our Credera team and our client team. He also had written books and articles around how it’s advantageous to treat an FDA approval process as agile rather than waterfall. So he was familiar with both perspectives.” 

Technology Lead Garrison Neely agreed: “Since we were new to the FDA processes, it was so helpful to have our FDA consultant to answer questions and give us some guiderails to think through our project plan.”

Since the engagement began as a completely waterfall project, what worked in that environment? 

“Our team communication was really strong,” said Brittany Wadsworth, our data and analytics team member. “This was critical to our success in making early iterations and incorporating feedback.” Garrison also agreed that communication was the key to early success as we were still trying to build trust and good working relationships. 

If you could start over, what is the biggest thing you would change?

“I would have spent more time understanding how to share the value of agile to a healthcare-focused client,” said Credera Senior Architect Adrian Romo. “We spent more time articulating the business value and the speed-to-market benefits than we spent on showing how an agile transformation would improve compliance and eliminate some risk.” 

In line with Adrian’s thinking around education, John Bratanov said, “We should have had more client team members in our early education sessions around agile processes. We needed higher management to understand agile better so we could build more trust in how we approached building the documentation.” 

Building trust during the early stages of a project is paramount for getting our teams the authority to make decisions and move quickly. “Credera is a very transparent company,” Garrison said. “We usually build trust with our clients by treating them as partners and letting them ‘look under the hood of the process.” 

In the early stages of this project, we saw that anytime we showed our work in progress, it raised concerns. “We had to learn to be more buttoned up before coming to ask for input,” Garrison said. “When giving our client a ‘look under the hood’ I wish I would have restructured our demos, checkpoints, and meetings to primarily focus on nearly production ready work. Demonstrating our quality work was really important to build trust and credibility, and therefore necessary for effective agile delivery.” 

In addition to being very diligent in producing polished work, Garrison and Brittany suggested starting with agile development would have helped showcase its effectiveness. In these types of waterfall FDA projects, companies like to build all the documentation for the FDA before ever writing a line of code. It would have been taking a risk in the client eyes to just begin writing code. 

“If we had started development to complement all the documentation we were building, we could have demonstrated its value early,” Brittany said. This is what happened eventually after a few months of pure waterfall. We just began to build the portal to inform our necessary filing documentation. 

What do you feel was your greatest success with this engagement?

“Getting our client to trust us enough to begin building the portal before we submitted the 510K for FDA approval,” said Garrison. Even though it was a “hybrid” approach in the end (Justin estimates that it was 70% waterfall, 30% agile), we were still able to showcase some benefits of developing in an agile manner. 

What do you consider the greatest challenge?

“As much as I would have liked to come into this engagement and use our FDA consultant who has background and experience on how to create FDA documents in an agile manner, our client just didn’t have any prior experience working in that manner,” Garrison said. “I don’t think we could have completely switched processes overnight. They were understandably very cautious, and creating a culture where questions are answered through the process rather than upfront can feel uncomfortable at first. We learned that proactively anticipating questions and preparing answers helped us become more  agile in a way that still strengthened the client relationship.”

Garrison, Gilbert, and Justin all agreed that the result of needing to be less collaborative in the early development stages led to an increased timeline and introduced inefficiencies.

What advice would you give to someone who works primarily with waterfall project plans (such as government projects) who wants to incorporate more agile into their methodologies?

The entire team agreed that education is the key. Educate yourself and educate others.

“More knowledge and more examples can build your credibility until someone allows you permission to try it out,” said Garrison.

Justin agreed: Educate your manager on how to breakdown traditional waterfall projects to apply agile methodologies. Break the bigger tasks into epics, features, and stories. Demonstrate how this will help accommodate the inevitable change and variability within your project.”

John suggested “using the existing literature around agile work in the FDA space.” He also said to lean on your available resources—in our case, the FDA consultant.

On the tactical side of things, Gilbert said, Start small. You can begin by holding daily scrums with your team. Make any changes in requirements or understanding surface through strong communication every day.” John added, “Set expectations, understand expectations.” 

Adrian mentioned that you should “double down on how we control and eliminate risk.” This is what your client or team is looking for—that you understand the concern around safety (with regards to healthcare work) while making your team comfortable with managing and controlling risk inside that agile framework.

Starting the Next Phase

Now that our delivery team has moved past the envision phase into implementation, we feel that our lessons have prepared us to be successful on this and future engagements. Our Credera team is demonstrating how agile (even in small degrees) can be used to run a government project. 

If you'd like to learn more about how you can transform your management of projects, contact Credera today at  

Have a Question?

Please complete the Captcha