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Case Study: Device Platforms & Big Pharma
“United We Stand”
In this case study, we observe a large pharma company who purchased a device platform for their portfolio. They wanted to approach this platform with the goal of reducing process inefficiencies across multiple departments for an auto injector combination product project. However, they had encountered a divided culture between their drug, device, and commercialization (CMC) departments and knew they needed to make some changes.
This big pharma, like many big pharma companies, had a CMC mindset, which puts specifications around a product after design and discovery. The device team, whose engineering should be requirement-driven, had no real voice in the process. Mistakenly, in an effort to “drive requirements,” the CMC team was taking vendor specifications and turning them into requirements and over-constraining their design.
They also had a serious “silo” mentality – common in big pharma. Departments and management groups had an inward thinking approach. There was no open line of communication for sharing information, priorities, tools, and processes with each other. This silo mentality negatively effects efficiencies in operations, and, ultimately, the success of the organization. In this case, CMC department handed off the primary container to engineering then sat on the sidelines, waiting for the combination product to make its way through the process back to them for commercialization. Neither team was integrated across the decision lifecycle so that they could affect decisions that would impact their ability to market the combination product.
The outcome of this cultural divide and lack of requirement-driven focus was:
- Massive inefficiencies costing time and money, as well as creating more risk
- Mistakes were made through non-standardized execution, causing delays in deliverables and increased program resource costs
- Programs required last-minute repeat tests due to documentation errors
- Significant (unnecessary) time was spent in document reviews and re-reviews, discussing areas that could be standardized and, therefore, non-issues
- Lessons learned across programs were not shared consistently or codified for improvement by iteration
- Considerable, unproductive time was spent on vendor interactions
On just one phase of the project, this large pharma company overspent on this project by $500,000 as a result of the situation described above.
Their processes needed to be aligned, streamlined and assigned. Big pharma should always run platform device programs with their own platforms of documentation and platforms of execution and communication – standardized across teams with multiple, similar projects running simultaneously. They need to agree on interface points between teams, adjudication process, risk management policies, defined roles and responsibilities, and requirements ownership. Stakeholders also need to assign governance of their programs to avoid obstructed decision making, as well as to avoid cases where personal concerns of team members enter into decision making that affects the platform.
The Suttons Creek team engaged and, leveraging materials and lessons learned from own in-house platforms and processes for execution, created a standardized device development framework for the device team. Their new framework:
- Followed a consistent set of user needs and a consistent set of requirements
- Combined efforts among all three teams
- Included multidivisional input at various stages to ensure stakeholders had a voice in the decisions made
- Reduced redundancy in efforts between divisions by assigning functions and creating communication strategies and responsibilities.
This enabled consistent, efficient, and cohesive execution
and project support across functions.
Steve Badelt, PhD – Steve is a seasoned expert with over 20 years of experience in combination products, engineering management, systems engineering, and business development. He founded consulting firm Suttons Creek, Inc. in 2012, which has served as the device team for pharma on over 50 combination product programs. Steve values helping others learn and grow, and when he is not consulting on behalf of Suttons Creek, he is advising startups, sitting on industry boards, speaking nationally on combination product and connectivity issues and serving as a Graduate Professor at Loyola Marymount University.