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The Agile Switch


As promised in my last post, I wanted to blog more about some of my observations of Agile methods applied particularly in the Biotech Industry. The first question I ask myself is what drives an organization to make the first attempt in switching to Agile? In Biotech, we face many compliance and regulatory processes that have to be met for various medical devices being brought into the market. The FDA and other regulatory agencies enforce design control processes similar to traditional waterfall methods. This hurts the team dynamics. Science, in my eyes, is a very collaborative space; however, when bringing Agile, we hope to achieve that same (if not better) level of communication, team energy, and focussed delivery. To resolve this issue, we need to start introducing Agile in certain parts of the design control process. Most of the time, someone comes to the development team and makes the request that we need to be agile. And what does the Project Manager/Manager/Team Lead do? That’s correct, he/she flips the Agile Switch ON!!!! The switch is usually turned on because their boss requested for that to happen to see improvements. So the switch is on and the Boss is pleased. But what does that mean now? Really, it means nothing. Nothing can be done unless the entire organization is transformed and you are most likely to hit a wall, if the entire organization is not brought into this concept of Agile.

Flipping the Switch and Adapting to Change

Once the switch is turned ON and agile tools and processes are used, many think that it’s sufficient to say that they practice TRUE AGILE. My question then is what about the team and team dynamics? Does the team feel any different? Or are they feeling more burden, since in addition to design control processes, regulatory processes, now they also have to follow the Agile process? Agility cannot happen over night; it takes some organizations years and years of practice and iterations and even then some can’t become truly agile. Agility has to be a mindset that is implanted across the entire organization (Future Blog Post). The Agile Switches have to be turned on across all the layers, departments, and teams of the organization to really see the beauty of Scrum, Kanban, XP, or any other Agile methodologies. Currently, the only switch I have seen being turned on in the Biotech space is the Software Development team. Bringing sudden and drastic change in an organization is worrisome, and that is why I advise to take baby steps when bringing this change. Flipping the Agile Switch is a significant change and can really impact a team and how they function. Instead, let the team drive the change and don’t try to enforce the change on anyone or any team. I really believe in making the team work together to adapt to the transformation or change when it comes to flipping the switch.

Regulatory/Compliance Impediment

On the other side of the spectrum, you have FDA design driven processes which have to be followed. The design itself sometimes inhibits the ability to pivot when needed, hence we constantly see scope creep as things are constantly changing. Generally, in science, we constantly see change but we need to have the ability to pivot when needed. Currently, we have very limited options in the process when it comes to medical software development. Thus, becoming Agile in the Biotech space takes more than just developing the culture and environment; it also means that a process has to be defined outside to fulfill the regulatory and compliant efforts. Many ask can that be applied to the Agile Process without overhead? There is no simple answer since most of the time it depends, and would have to be handled, on a case by case basis. I am currently working on a process with my efforts in BioScrum where I plan to address how that can be implemented into a Scrum-like process (Future Blog Post).

Understanding the Product and Process

In order for all of us to understand the full product life cycle in the Biotech space, knowing that we have various roles and scientists with expertise in specific areas, we have to attempt to work together and share the knowledge with the entire team involved in developing the product. If the communication with the scientists and development team is clear, it’ll make it easier for us to define what is done. Having too many Product Owners guiding the product vision makes it complex to creating the final end product. This has an immediate effect on the teams understanding of the sprint goal and MVP (Minimum Viable Product) when there are multiple product owners directing the vision in multiple directions. Try to make the complexity and direction clear, hence have one person playing the product ownership role. If it is a group try to come to a consensus on the product vision before presenting it to the team. Keep it simple.


I chose to set the stage with this Agile Switch because I think it’s really important that we, as a Science and Agile community, think before we flip and take time to understand the entire process of Agile and its methodologies. Don’t jump without all players understanding the process (Make it Transparent). Let the team drive the change, and EMPOWER TRUST in them so they can lead the efforts.

#Bringing Agility to Science

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