New Product Introduction

Introduce your product the right way

New product introduction is the first step in the process of transferring your product design into a full scale manufactured product. The NPI space offers a controlled manufacturing environment to debug and fine tune the manufacturing process.  This critical step is a low cost solution to mitigating risk early. Our goal during this time is to successfully test out the manufacturing and assembly processes and strategy before transferring to pilot or contract manufacturing. By fine tuning and optimizing the process at this step we are able to identify and eliminate issues that could arise during lot builds. If you were to skip this critical step and move from DFM/DFA straight into full scale production, you would find yourself spending more time, money, and effort to correct processes and assembly strategies that could have been optimized earlier. 

new product introduction part inspection

new product introduction area

Take control of your new product

Our brand-new controlled manufacturing environment is one of the exciting capabilities now possible through our new facility in Woodbridge, CT. Able to be customized for different production line layouts, we have the perfect space for products starting the journey into full scale manufacturing.


Mitigate risk with new product introduction

Once phase 3 of the product development process is complete, your design moves into our new product introduction area for phase 4. Unlike the previous three phases, phase 4 consists mostly of design and documentation activities. If you were to skip or cut out parts of this phase, you would increase your risk of building higher scrap or costly assembly errors that could occur during contract manufacturing. Each step of new product introduction is crucial to ensure you have an end product that you can manufacture using a stable process. 

controlled manufacturing space in new product introduction area

New Product Introduction Services

Learn about all our NPI services below and see how our capabilities can address your specific problem.

Design For Manufacturing / Design For Assembly

production drawings

Production Drawings

Production drawings contain the specifications of the materials required to produce the components, as well as the tolerances required to ensure that once manufactured the parts will fit together and your design will work.
supplier selection

Supplier Selection & Costed BOM

Suppliers are chosen based on a variety of quality parameters. The Bill of Materials (BOM) is a cohesive list, including necessary quantities and cost, of all materials, components, parts, and assemblies required to produce the finished product.
writing work instructions

Work Instructions

Detailed work instructions are necessary in outlining the assembly process. Used in training personnel on how to assemble your new product, they contain detailed steps that outline how to carry out procedures. They can also include an assembly line layout and process description.
detailed design review

Detailed Design Review

Once the product has been refined for manufacturing and assembly, the final design will be reviewed and approved. The purpose of this review is to suggest design improvements at a detailed level before proceeding.
pre-production prototypes

Pre-Production Prototypes

Pre-production units are built and tested against a series of protocols to ensure the manufacturing process changes do not affect functionality. The results of these tests are presented to you in a pre-production testing report.

Have a new product introduction question?

Ask an engineer!

Our engineers are happy to answer any of your technical questions.

Pilot Manufacturing

quality and manufacturing plan

Quality & Manufacturing Plan

The quality and manufacturing plan lays out who is responsible for each build task and each quality document and procedure. This ensures a high level of quality is followed throughout the entire build and smooths out any rough edges in the manufacturing process.
pre-production tooling

Pre-Production Tooling & FAI

Tooling is the process of designing and developing tools that are needed to manufacture the parts and components of your product. A First Article of Inspection (FAI) verifies that the part produced from the tool complies to the original measurements laid out in the design drawings.
MFMEA

MFMEA

MFMEA stands for Machinery Failure Mode and Effect Analysis and is a methodical approach used for identifying risks associated with machinery and equipment failure. If the risk score is above a specified threshold then a fixture or test is recommended to address this risk.
fixture and nest design

Fixtures & Nest Design

Fixtures and nests are used in the manufacturing process to ensure uniformity of assembly and each one needs to be designed and developed individually as there is no universal part that fulfills the requirements for your specific product.
assembly process development

Assembly Process Development

A series of tests are conducted to develop the assembly process for building each subassembly. Based on previously agreed upon performance specifications, optimal operating parameters are established as well as a process window.
r&d build

R&D Build & Test

The R&D build is a low-cost solution to mitigate risk early, when changes to the work instructions can easily be made outside of document control. Once the R&D build is complete, the product will be tested against the same procedures that are used in full scale production.
packaging design and testing

Packaging Design & Testing

Like the product itself, packaging must be designed, prototyped, and subjected to a variety of tests including: dropping, shaking, and real time aging. This ensures the product can endure shipping, handling, and storage conditions.
DMR

DMR

The Device Master Record (DMR) is a compilation of all instructions, drawings, packing specifications, labeling, and maintenance procedures for your device. It separates the manufacturing process from the design process and contains everything needed to build and test your completed product.
verification and validation lot build

Verification & Validation Lot

The V&V build is done under fully documented quality control. The units built in the verification and validation lot build are tested against the requirements outlined in the product development specification. The results are used as a baseline for sterilization and packaging testing.
biocompatibility testing

Biocompatibility Testing

Biocompatibility testing is required to obtain regulatory approval in most markets. Biocompatibility tests help determine whether a product performs as intended without causing any adverse or harmful effects for patients or users, and mitigate any biological risks posed by the product.
sterility testing

Sterility Testing

Sterilization validation checks that the manufactured medical device can withstand proper sterilization processes to ensure a workable and safe device. It also guarantees that the product is not changed by the sterilization process.

Pilot Production

IQ, OQ, PQ

IQ, OQ, PQ

Stands for installation qualification, operational qualification, and performance qualification respectively. The finished product goes through a series of tests that stresses it against real-world conditions and worst-case scenarios. It expands the process window previously established to include the highest and lowest limits needed to produce a safely working product.
qualification lot builds

Qualification Lots

Several qualification lots are built using parts from multiple production lots to ensure that the manufacturing process of producing usable components has been adequately stressed. Qualification lots are built in succession and tested against the previously approved end of line testing protocol.

Launch Your New Product

Build

Document

Test