How do you know if you are ready for manufacturing and to launch your product? If you are saying to yourself “Of course I am. I have a product design. I have a prototype. I have funding.” It would seem on the surface that you are ready for production. But, ask yourself: have you tested your design? Have you tested and refined your assembly process? How do you know you can repeatedly produce the same product? Have you identified risks in the assembly and manufacturing process and developed a plan to mitigate them? If the answer to all of these isn’t a resounding “YES!”, then you are not ready for manufacturing.
After reading the above paragraph you maybe wringing your hands with worry wondering how you will accomplish all of that. Don’t fret; this is where NPI comes in. NPI stands for new product introduction and is the phase of product development in between prototyping and contract manufacturing. During this time, you test, validate, and fine tune all your processes so you can have a seamless transfer to manufacturing. If you have a medical device, this is where you will complete the bulk of the paperwork required for FDA approval. To ensure you have a quality manufacturable product, you need NPI.
At Synectic, NPI is phase 4 of the new product development process. Since it is a long and sometimes arduous process, we break it up into three parts: DFM/DFA, Pilot Production, and Pilot Manufacturing. These parts are broken down further into different requirements based on your individual project needs. Below we thoroughly dissect each component of the new product introduction process. For a successful product launch you may need all the requirements or just some. The more complicated or regulated your invention, the more that is required to successfully launch.
DFM/DFA stands for design for manufacturing and design for assembly, respectfully. During this part of NPI each component of your prototype will be designed for optimal fabrication and cost. Here is what will happen with your design and product during DFM/DFA:
Critical Tolerance Analysis - This is a preliminary analysis of the most critical to function fits and assembly stack ups that will contribute to reducing risk in the design. This ensures that once manufactured, the critical parts will fit together, and your design will work.
Fully Toleranced Production Drawings
Each part and component will be redesigned for manufacturing DFM/ DFA and pre-production drawings, with these modifications, will be drawn up. These drawings are fully detailed and contain all the dimensions, call outs, and specifications required to fabricate parts and assemblies. They take into account fabrication method, assume a full tolerance study has been done, and that every part and every dimension is appropriate and will fit together correctly.
Suppliers are chosen based on current ISO certifications, ability to make the parts to specification, good business practices, appropriate internal systems to support production needs, and the ability to deliver parts on time.
Final Materials Selection
Considering strength, robustness, sterilization, biocompatibility, working conditions, fabrication method, and assembly methods, materials are selected to be used in the final production.
The Bill of Materials, or BOM, is a cohesive list, including necessary quantities, of all materials, components, parts, and assemblies required to produce the finished product. The BOM can be thought of as the ingredient list in the “recipe” to create your product. In the case of a costed BOM, the bill of materials includes the cost of each component in the quantities necessary to provide a yearly supply of parts.
Work instructions outline the manufacturing assembly process. They are used to train manufacturing assembly personnel and the manufacturing team on how to assemble your new product. The work instructions contain detailed steps outlining how to carry out procedures. They also include the assembly line layout and process description.
Detailed Design Review
Once the product has been refined for manufacturing and assembly, the final product design will be reviewed and approved. The purpose of this review is to suggest improvements in the design at a detailed level before proceeding. This is the final review of the design before it is completely frozen.
Machined Pre-Production Prototypes
Machined pre-production prototypes are tested against a series of protocols to see if the changes to design modifications done earlier affected the product functionality.
This phase of the NPI process can be broken up into three main parts: documentation, building, and testing.
Pilot manufacturing requires a large amount of documentation focused primarily around quality checks. More paperwork occurs during this phase than any other. Until you move from NPI to contract manufacturing, all documentation is stored within the DHF set up at the beginning of the project. Every part and process need to be cataloged and traceable. If your project is a medical device, even more documentation may be required based on what you will need to pass FDA inspection. Depending on where you are in the process, certain documents are not easily changed so accuracy and communication between parties is key.
Several lots of units will be built at various points during the pilot manufacturing phase to be used in debugging both the assembly and manufacturing process. Packaging will be designed and built. The units that are produced during this process are not sellable, but are primarily used as demo units in the field.
This part of the NPI process is also where everything and anything that goes into producing your product is tested. The units and packaging are tested to ensure they can withstand normal wear and tear, shipping, handling, and, in the case of medical devices, sterilization and biocompatability. The assembly and manufacturing processes are also tested to make sure the build is accurately repeatable. Here is what you can expect to occur to your product during pilot production:
Quality & Manufacturing Plan
To ensure a high level of quality is followed throughout the entire build process, a manufacturing and quality plan is developed. It lays out which party is responsible for each build task, quality document, and procedure. It also helps smooth out any rough edges in the manufacturing process.
Pre-Production Tooling Design
Tooling is the process of designing and developing tools that are needed to manufacture the parts and components of your product. Tools can refer to a variety of manufacturing aids including dies, fixtures, and molds. They each perform a specific function from cutting a part to producing an injection molded plastic part. Each tool must be designed specifically to each part. Since tools can be complicated to design and create, the lead time and cost for most tools can be high.
Quality Inspection Forms
Quality Inspection Forms (QIFs), also known as receiving inspection or material inspection, validates the quality of incoming parts/components/materials based on a set acceptance criterion which is pre-determined based on the project plan. Receiving inspection is performed by quality assurance personnel to resolve quality issues during pre-production.
A First Article of Inspection (FAI) is performed on all parts that come off these tools to ensure that critical dimensions were maintained during the manufacturing process. The FAI verifies that the part produced from the tool complies to the original measurements laid out in the design drawings.
MFMEA stands for Machinery Failure Mode and Effect Analysis and is a methodical approach used for identifying risks associated with machinery and equipment failure. In short, each manufacturing operation will be reviewed and assigned a risk score. If the risk score is above a specified threshold then a fixture or test is recommended to address this risk.
Fixture & Nest Design
Fixtures and nests are used in the manufacturing process to ensure uniformity of assembly. Depending on the type of assembly process required for the finished product, several different nests and fixtures may be required. Each fixture and nest need to be designed and developed individually as there is no universal part that fulfills the requirements for your specific product. When designing your tools and fixtures, we optimize for efficiency, cost-reduction, and longevity.
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. The process window is the acceptable test value that needs to be achieved for each part to be considered correctly assembled. In a nutshell, these tests ensure that the assembly process works.
R&D Build & Testing
The R&D build offers a lower cost solution to identifying and remedying risks early. Here is when you want to make changes to the work instructions, before they come under document control later in the process. Once the R&D build is complete, the product will be tested against the same procedures that will be used in full scale production. These R&D units are fully functional and are often used as demo units.
Packaging Design & Testing
New products sold on store shelves have different requirements than medical devices sold to hospitals. All of these requirements, along with cost and materials, are considered when designing the packaging for your finished product. Just like the product itself, packaging must be designed, prototyped, and tested to ensure that it meets all requirements and does not damage the product inside. The packaging is subjected to a variety of tests that simulate what the product can endure during transport, such as shaking or dropping. If your new product is sealed in tray with a peel off lid, the lid will be tested for peel strength and adhesion. For products requiring an airtight seal, the packages will be die tested for air bubbles. A real time aging test is also done to analyze the effects that time and aging have on the product and the packaging.
The Device Master Record (DMR) is a compilation of all instructions, drawings, packing specifications, labeling, and maintenance procedures for your device. The DMR separates the manufacturing process from the design process and contains everything needed to build and test your completed product. It also contains the documents outlining how a specific group of assemblies are made referring to each assembly’s lot number that was assigned to it the day it was produced. A complete, well organized DMR is critical for a medical device to pass FDA inspection.
Verification & Validation Lot Build and Testing
Unlike the R&D build, the V&V build is done under fully documented quality control using our proprietary quality documentation system. The units produced from this build are used to test verification and validation, biocompatibility, sterility, and packaging. Any changes to the work instructions at this point will require a paperwork trail adding time and cost. The units built in the verification and validation lot build are tested against a series of parameters laid out against the requirements outlined in the product development specification. This is to guarantee that the resulting product can function accordingly. The results determined during the verification and validation testing are used as a baseline for sterilization and packaging testing.
Biocompatibility testing determines whether a product performs as intended without causing any adverse or harmful effects to the end user. They also mitigate any biological risks posed by the product. For medical devices that directly or indirectly contact patients, biocompatibility testing is required in most markets to obtain regulatory approval by the FDA.
Sterilization validation checks that the manufactured medical device can withstand proper sterilization processes. It also tests to make sure that the product is not changed by the sterilization process. This guarantees that after sterilization you will have a workable and safe device.
This is the final part of the journey your product will take through our NPI area, before heading to full-scale contract manufacturing. The units that are produced in the NPI area during these pilot production builds are tested against real-world scenarios to ensure a safe working product at the end of the manufacturing process. Additionally, the process window established during pilot manufacturing is expanded to include the highest and lowest limits needed to produce a safely working finished product Best of all, the units produced out of this part of the process are traceable and sellable.
IQ – Installation Qualification establishes objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.
OQ – Operational Qualification is a collection of approved protocols and tests used to verify the proper functioning of a system. OQ is used to assess the performance of a system is consistent and within the parameters of the user requirement specifications.
PQ – Performance Qualification is a series of test cases used to verify a system performs as expected under simulated real-world conditions. PQ is used to establish confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirements for functionality and safety, and that the procedures are effective and reproducible.
Qualification lots are built in succession and tested against the previously approved end of line testing protocol. They are built using parts from multiple production lots. These confirm that the manufacturing process of producing usable components has been adequately stressed and that the process is stable and repeatable. The units produced from these lots are traceable and sellable units. This is the final test done in the NPI area before contract manufacturing.