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Designing a Project Management Framework for a New Product Introduction (NPI) Portfolio

Clarkston Consulting designed and implemented a standardized NPI project management framework. Read a synopsis of the project below or download the full case study.

Download the NPI Project Management Framework Case Study Here


medical device contract manufacturer engaged Clarkston Consulting to strengthen its New Product Introduction (NPI) process as business complexity and project demands increased. With commercial and engineering teams collaborating across three continents, the organization identified opportunities to strengthen governance, cross-functional coordination, and visibility into project execution.  

As customer expectations and delivery requirements evolved, leadership sought a more structure approach to managing NPI projects. Clarkston partnered with the organization to establish a standardized framework, define stage-gate criteria, and enhance decision-making processes through formalized escalation pathways, providing greater transparency and alignment throughout the organization. 

Clarkston designed a comprehensive NPI project management framework from the ground up, structured around two macro phases. The Lead to Win phase covers early-stage evaluation and quoting, negotiations, and project award. The Win to Manufacture phase spans project readiness, design and development, verification and validation, design transfer, and production. This ensures what is sold is executed in a controlled, compliant, and repeatable way. 

Supporting the framework, Clarkston developed a full suite of PM tools: a Project Approval Request form to gate commercial viability before execution begins, a Project Charter to anchor accountability and risk planning, a Lead-to-Manufacture RACI to clarify cross-functional ownership and break down silos at every phase, and a Project Portfolio Tracker and RAID log to give leadership real-time portfolio visibility. 

To drive adoption, Clarkston delivered training sessions to the Commercial, Engineering, and the newly formed Project Management teams, covering the full framework, tools, escalation protocols, common NPI pitfalls, and a hands-on readiness scenario with structured debrief. The result is a stage-gated, governance-backed NPI process that replaces informal workarounds with a shared, repeatable methodology. giving the organization the foundation it needs to scale efficiently and deliver for its customers. To date, there are 20+ projects impacted by the enhanced process, representing greater than $10M in revenue for our client. 

Download the NPI Project Management Framework case study, and learn more about our Life Sciences and Project Management consulting services by contacting us below. 

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Tags: Case Study, Project & Program Management, Medical Device, Quality and Compliance
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