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New Product Introduction


What is New Product Introduction (NPI)?

New Product Introduction (NPI) is a systematic, repeatable, step-by-step process that enables medical device manufacturing enterprises to bring new products to market efficiently, quickly, and cost-effectively. It encompasses a series of steps, from concept to final form, and requires careful planning and implementation in various areas, including design, supply chain management, and industrialization. The NPI process aims to enhance quality, increase production efficiency, reduce risks, minimize waste, improve speed to market, and save money through the application of real-world knowledge and experience.

Why implement NPI?

NPI is a critical process that streamlines the launch of a product, from engineering and design to production. It helps businesses lower costs, optimize resources, and ensure timely delivery. NPI involves collaboration between internal departments and contract manufacturers, minimizing risks and identifying market needs. By focusing on quality, NPI enhances customer satisfaction and brand reputation. It also enables effective supply chain management and inventory control. A well-executed NPI process is crucial for success and gaining a competitive edge in the market.

Steps of NPI

Although processes differ depending on the type of product and relative risks, an accepted approach to the NPI process is to define a process in a series of steps. At the end of each of the steps, the Senior Management team (and key stakeholders) makes an up-or-down decision in a formal review (often called a “gate”).  Lean practices are becoming more common where the rigid steps are replaced by lean cross-functional workshops. A typical NPI approach has six steps with five gates:


Step 1: Define / Ideation (Initial Idea)

The NPI process begins with the "Define" stage, where the objectives and specifications of the new product are established. During this stage, a contract manufacturer can provide valuable support by offering design and engineering consulting, conducting risk assessments, and providing material options and recommendations from leading suppliers.


Step 2: Feasibility / Product Definition

The next stage is "Feasibility," where the viability of the product concept and its alignment with business objectives are assessed. Contract manufacturers can assist by providing design for manufacturability support, recommending and testing custom printing and converting techniques, and evaluating various materials and components to identify the optimal version.


Step 3: Develop / Prototyping

In the "Develop" stage, the focus is on making and refining the product. Contract manufacturers can play a crucial role by accelerating testing through the production of high-quality prototypes, establishing validation plans that fulfill both internal quality assurance and compliance requirements, and ensuring that the manufacturing process is scalable from development to production.


Step 4: Validate / Detailed Design

The "Validate" stage involves analyzing and improving prototypes until the desired outcomes are achieved and conducting manufacturing process validation to ensure the effectiveness and efficiency of the final production plan. Contract manufacturers can contribute by evaluating and refining prototypes and fine-tuning processes before engaging in full-scale production.


Step 5: Implement / Manufacturing Ramp / Pre-Production (Validation/Testing)

During the "Implement" stage, the product is scaled up and released to the market. Contract manufacturers can assist by setting up and managing the pilot launch of the product and refining manufacturing processes to optimize efficiency before full-scale production begins.


Step 6: Evaluate / Manufacturing

The "Evaluate" stage involves reviewing the performance of the NPI process, exploring opportunities for continuous improvement in manufacturing processes, and ensuring regulatory compliance through the documentation of processes. Contract manufacturers can collaborate with internal teams to gather customer feedback, refine product quality, and respond to market demands.


The NPI process requires a cross-functional team, including a dedicated project manager, representatives from various departments, stakeholders, and primary points of contact for contract work. This team is responsible for tracking progress, performing assessments at different stages, and ensuring effective communication among team members to eliminate information silos and resolve potential conflicts.


The New Product Introduction process is a strategic approach to efficiently bring new products to market. It involves a series of well-defined steps and requires collaboration with experienced professionals, such as contract manufacturers, to ensure successful implementation. By following the NPI process, businesses can optimize product development, reduce risks, enhance quality, and achieve their objectives in a competitive marketplace.

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