A young biotech company transforming the world of personalized and genomic medicine was in the midst of several years of ongoing rapid growth. Started by a small group of brilliant minds dedicated to the idea that technology could revolutionize the treatment and prevention of disease, the organization had a nimble, tech-oriented mindset. Yet it was growing exponentially—by nearly 100 employees a year, year after year. As they worked to advance the cutting edge capabilities of genomics and personalized medicine, the organization’s executives knew embedding quality into its processes was critical to ensure its life-changing advancements could scale to the next level.
Bursting with talent, the organization excelled at developing ideas in a small, iterative way. But with no solid cross-organizational process structures in place, teams couldn’t move fast enough to get ideas approved, produced and out to market as the company grew.
Future State first engaged to help build a roadmap toward quality transformation. A lack of efficient processes was slowing the company in getting its ideas to market. Bursting with talent, the organization excelled at developing ideas in a small, iterative way. But with no solid cross-organizational process structures in place, teams couldn’t move fast enough to get ideas approved, produced and out to market as the company grew.
As Future State and the executive team began to collaboratively examine the issues and tackle high-level process mapping, we came to realize the task was bigger than weaving in specific quality requirements. We discovered that, amid rapid growth, processes had grown organically over time, sometimes in parallel, sometimes up over each other. This had led to duplication of efforts; lack of standardized documentation; and a variety of distinct processes being followed in departments across the organization.
We also discovered team members saw the organization’s identity in different ways. One side of the organization saw the company as an agile tech startup that needed freedom to explore and experiment. A second group saw the company as a medical/pharmaceutical organization. Each camp believed it should be driving. In a way it was as if they were speaking two languages.
We knew from experience that a big part of our task was to get everyone on the same map at the same time, and to develop a shared language and communication process so the team could stay on the same journey into the future.
Coming Together to Build
The first step was to get everyone on the same page around the current state, to define the scope of the project we were working on. We had to suss out team members’ views on identity, process and communications. So we took what we saw as the big picture, stuck it up on the wall (literally), and let everyone throw everything out on that wall.
Once we had an initial map built, we started sifting through the pieces and puzzling together. We formed a cross-functional team, pulling individuals out of their respective networks to help build and approve components of processes. After each small segment of a process was configured, we’d bring it back in front of the bigger group to get feedback and buy-in. We were trying to reflect back to them. We wanted to be as communicative and as agile as we could, all while building a highly detailed process that aligned with the industry’s rigorous regulatory requirements.
Next, we helped map the key process at the heart of their business: the assay development process. Assay development is one of the first steps in drug development and toxicity testing. Test systems, called assays, are used to evaluate the effects of chemical compounds on cellular, molecular or biochemical processes; one base assay can be applied to develop a variety of types of genomic and personalized medicines. In mapping this key process, we developed a pilot the organization could replicate for other processes across the organization.
At its essence, success required listening to and translating the heartbeat of the organization—what we call the unseen culture, or the spirit of a place. We tried to hear the heartbeat of the community and distill it, work that ended up being something of a cultural revolution for this organization.
Ready for What’s Next
In the end, we were able to help this rapidly growing organization collaboratively create a map that will enable it to continue as a trailblazer in the industry. Although it comprised many moving parts, the bulk of the project centered on the communal, iterative work around building processes together. We invested time pulling out fundamental information about the organization using intense one-on-one interviews and group sessions.
At its essence, success required listening to and translating the heartbeat of the organization—what we call the unseen culture, or the spirit of a place. We tried to hear the heartbeat of the community and distill it, work that ended up being something of a cultural revolution for this organization. By always keeping the organization’s central mission—helping more people in the fight against cancer—at the forefront, we were able to drive the importance of these quality changes, even when we hit obstacles.
By focusing on people, processes and technology, we helped enable this organization’s brilliant minds to apply their intelligence and free time to solving problems, instead of wading through bureaucracy. While creatives sometimes shy away from process development, established protocols free up the most innovative minds in a business to do what they were recruited to do, alleviating frustration and helping companies realize the ROI of the talent in their organizations.
The success of this project was dependent on expertise, openness and passion on both sides of the equation. On the Future State side, it would have been difficult to achieve these results in a short timeframe if our team didn’t have a deep understanding of clinical studies, biotech and the biopharma space. Our expertise in these areas—the terminologies, goals and cultures of the industry—enabled us to catapult forward quickly and start doing diagnostic work right away. A few of our specific practices also came to bear. Our approach is highly visual and hands-on. We rarely go into a project with words and a PowerPoint. Even though the company was far from our headquarters, we maintained a regular physical presence. We wanted to do the work out loud. We did feedback sessions in the big open area in their campus; every session was in a fishbowl. Transparency was a big part of it. Finally, there was a good cultural fit between Future State and this organization, which is one of the most heartfelt, warm and passionate companies we’ve ever had the honor to work with. Although the work was difficult, they never wavered in their commitment to their patients and the importance of their mission. As is so often the case, a shared commitment to people and purpose is what made the project succeed.