A Fully Functioning Agile Shop in an FDA Environment

As an application and software development project manager at Pathfinder, I’ve been on the front lines of many product development processes, and I’ve witnessed both the successes and obstacles that cross the development path. Working with Agile Method lends itself to a fast-paced development cycle, but challenges can easily sneak up on you and throw a project off track. In order to stay ahead of possible snags, I suggest keeping an eye out for some common problems and tackling them as soon as they arise.

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Common Agile Method Challenges 

No Automation – Embrace automation for all appropriate aspects of the project, from general to repetitive tasks. This frees up time for the developers to work on manual development. Automating our tasks and trace matrix on a recent project really helped with FDA requirements and design documentation. But be warned: creating a proper automation system takes time and costs you money.

Lack of Discipline – Keeping a disciplined team and maintaining workflow is key to avoiding possible pitfalls like scrummerfalling and waterfalling. Find a champion who will keep the team on track, following the Agile Method throughout the entire development process.


At Pathfinder, we specialize in FDA software development. We leverage our experience with FDA and HIPAA compliance to rapidly align your product with government regulations.                     

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Scrummerfall – If your iterations are bleeding into your successive iterations, watch out! This is a sign that you’re going in the wrong direction. An easy fix is to test as you go - not just at the end - and to refactor your process ASAP.

Unclear Velocity – Project velocity changes throughout the development process, but it’s important to share the challenges and successes with the whole team. Stakeholders and customers will want an end date for development. Be respectful and keep them in the loop.

Lack of Trust – Establish trust between stakeholders and the development team. The development team is closest to the problems and solutions. You hired them for their expertise - now let them deliver on the project, and don’t undermine their efforts.

Varying Lengths of Iterations – Shorter iterations can reduce complexities within the workflow, while longer iterations widen the scope, creating more complex work that may lead to issues and problems that will need to be addressed at a later time.

Lack of Ownership – Stakeholders, product owners and developers should take equal ownership in the work. It shouldn’t be a ‘toss over the wall’ project for anyone. Stakeholders and product owners should be engaged in feedback loops for each iteration. It’s the only way to know that the development process is matching management’s expectations.

Lack of Expertise – The Agile Method doesn’t replace the expertise and experience of your team members. Experienced developers add value to the team by assuming leadership roles, understanding and following best practices and guidelines, and mentoring junior members.

No Documentation – Forget the perception that you don’t need to document with Agile Method, especially if you’re working with FDA projects. Don’t underestimate the need to do all of the correct documentation, and the time required to do it.

If any of these symptoms pop up during your development process, they are red flags, signaling that you may be derailing from the Agile Method. Take the time to step back, reevaluate your processes and fix every issue before it becomes more than just a small hiccup. Staying on track is crucial to a successful Agile implementation.