This Guide includes many detailed pages on various aspects of the manufacturing process, but this page is intended to give you a more general overview of the entire process. The items listed below apply to most manufacturing projects, but not all.
For many projects, our engineering team will be your first stop where you will deliver your prototype and all related documentation.
Very often with new clients, our team will want to re-build your prototype using the documentation you provide. This can be an eye-opening process as our engineers will be relying entirely on your assembly instructions in their re-build.
As they go through this re-build process, our team will be noting any errors, omissions or oversights from your assembly instructions and bill of materials.
Our engineering team will also be reviewing your other documentation including testing, risk analysis and whatever compliance approvals you may have achieved to date.
Design for Manufacturability (DFM)
When you built your prototype, your goal was to build a product that would function as you intended. It might have taken you weeks or months to complete the prototype, but in the end, all you cared about was that it worked.
But unfortunately, you can’t build your finished product the same way you built your prototype.
Design for manufacturability, better known as DFM, is the process of finding the most efficient way to build your product … and to meet your schedule and budget requirements.
As you built your prototype, you created an initial list of parts that will likely be required in final assembly. This will eventually result in your supply chain.
Your supply chain starts with a list of required parts – both off-the-shelf parts and custom parts. These parts need to be provided by suppliers you can count on. You need reliable suppliers who can meet your schedule and budget needs.
Scheduling is a critical piece of this puzzle because you cannot begin final assembly until all the parts are in. Part of the supply chain discussions will focus on how much inventory you are able or willing to carry.
Sub-assemblies are much like parts in your supply chain. You need reliable sub-contractors who can meet your cost and delivery requirements on a consistent basis. Your sub-contractors will also need to stay on top of their own supply chains.
Scheduling delivery also needs to factor in some time to test the finished sub-assemblies before they get added to the finished assembly.
Just as with parts, you will want to consider how much sub-assembly inventory you are able or willing to carry.
Getting to the final assembly step is exciting milestone but there many elements to consider in preparation for this step.
How will your final assembly process be structured? Depending on the product being built, we can set up for either batch or cell production.
- Batch production is process that produces one or more elements of a product in multiple quantities, and then passes on the work to another team to produce the next section.
- Cell production keeps the entire assembly process in one place where one or more workers will work on the production until it is complete.
Which production process we use will affect many other decisions including the personnel we assign to the project, and the training needed to prepare them.
Testing is a critical part of every manufacturing project, but what you test and how much you test will depend on your product and the level of risk you run at various stages in the process.
Testing can be informal (performed inhouse) or formal (performed by third-party testing companies). Which path you take will depend what is being tested and who is requesting the tests.
The goal for all testing is to detect problems in the manufacturing process – and to detect those problems early enough to take corrective action at minimal loss of time and money.
Because it is often an ongoing process, it’s important to maintain good recordkeeping to keep track of what has been tested for each product in development.
Risk is everywhere in the manufacturing process. You can never eliminate it completely, but you can mitigate it to avoid catastrophic damage.
To quantify your risk, we use various tools including in the Process Failure Mode and Effects Analysis (PFMEA) and a related tool, Design Failure Mode and Effects Analysis (DFMEA).
Like it or not, the regulatory authorities are going to have some say in how your product is built, distributed and used. Compliance is not a choice. If you don’t comply with the regulators, your product won’t get to market.
Early in the process, you might have consulted with the appropriate regulators to get an early approval of your design and prototype. It’s always a good idea to keep the regulators involved in your development process to detect any potential problems later when you seek final approval.
We work with all the regulatory agencies around the world.
Once your product comes offline and ready for delivery, the manufacturing process might have come to end, but you have other considerations for the post-manufacturing process.
Packaging is one consideration. Will your product be delivered in your own branded packaging or will generic packaging be sufficient?
Documentation is a critical part your delivery. Have you taken steps to prepare and print the necessary documentation that will accompany your product?
The delivery itself also needs some thought. Who will deliver it? Where will it be delivered (specifically)? When will it be delivered?
Once your product is delivered, you will need to consider what level of support you will provide.
Will your product require expertise to be set up and installed?
Will your product require ongoing calibration and maintenance?
What if the product needs to be repaired? Who will be able to repair it and where will you get the parts?
Finally, once your product has been in the market for a while, and there are new and improved versions out there, how will you continue to service the earlier versions of your product?