Medical device manufacturing covers small goods like surgical tools to massive MRI machines and biomedical devices. It also involves building custom parts like specialty surgical implants and prosthetics. Hardware medical device startups and mechanical engineers who wish to produce medical devices need to understand a few key points.
There is a lot of information out there about building devices, the right materials, and proper prototyping. In this article, we will break down five things to know about medical device manufacturing.
1. Recommended Materials
There are many materials involved in medical devices and contract manufacturing. The most common and recommended materials include a variety of metals, elastomers, resins, and thermoplastics.
Titanium and cobalt chromium are recommended for CNC machining. That’s because titanium has great biocompatibility. Additionally, Stainless steel may also be used to create surgical tools and temporary implants.
On the other hand, multi-color and multi-material Polyjet printing is usually used and recommended for manufacturing artificial organs and visual planning models for surgery.
While FDM has a high tolerance and works well in the process of making prosthetics and medical models. Such technology works well with a variety of materials, including PPSF, ULTEM, ABS M30i, and more.
Furthermore, ABS is recommended for sturdier prosthetics and bone implant replacements.
2. Understanding Processes
The processes used for CNC machining and 3D printing depend on a number of different factors. First and foremost, specific schedules and overall applications should be considered. To help paint a clearer picture of the processes that one should use, ask the following questions:
- Am I building a unique part?
- Am I building a low-volume part?
- Is the part supposed to be complex or custom for each individual patient?
- Are we creating a prototype, proof of concept, or a completed product?
- What materials will we be using?
It becomes much easier to figure out the process to use once you’ve answered these questions. Whether you should opt for additive manufacturing, injection molding, or CNC machining for your project.
It’s also good to note that traditional processes are often better for high-volume parts due to longer lead times. While additive processes are preferable for custom or low volume parts and prototypes.
3. Prototyping vs Production
Understanding the differences between prototyping and production is the key to successful medical device manufacturing. To get a more solid idea, it helps to look at a basic product life cycle.
Most manufacturers start with a concept and a customer contact. The next part is prototyping or engineering sampling. This is considered the design stage which involves the building of a few samples. In this phase, the design for the product is experimented with, changed, and ultimately finalized.
Thereafter, all necessary contact with the FDA must be established and your product must be approved for marketing.
Next, comes the development stage. This is where the production cycle will be planned and fine-tuned. This is a very important stage. It will determine how the product will be made, what materials should be used, what manufacturing techniques should be implemented, and what production documents need to be finalized.
From here comes the production stage. This is where the product is mass-produced using the techniques developed in the design and development stages. The result is the final product.
Hence, the difference between prototyping and production is that prototyping is much more flexible. It is a period of experimentation and development. While production is determined with design processes. The end result is what the consumer wants.
4. How to Accelerate the Production Process
Many medical device manufacturing startups make a lot of mistakes in their production process that eats up time. Ask yourself these questions:
- Have we failed to establish a clear need?
- Does the world actually need our product?
- Is our product different from competitor products?
- Is our compliance paperwork disorganized?
- Have we timed when to submit our product to the FDA appropriately?
- Have we considered the supply chain from the very beginning?
- Are the requirements established for capital equipment and tools at the very beginning?
Identify your pain points and fix them as soon as possible.
5. Dealing with the FDA
Medical device manufacturing development processes should focus on quickly getting past FDA roadblocks. This means that manufacturers would want to provide prototypes as quickly as possible.
It’s important to remember to submit your 510(k) to the FDA as soon as possible to demonstrate that your part or device is safe and effective. This premarket notification must be submitted 90 days before the product is set to be marketing, unless your product is exempt.
Most medical devices, however, are not exempt. Premarket approval can be quite a stringent process that involves some pretty heavy communication and paperwork. Unfortunately, this is completely necessary.
Once your 510(k) has been sent, The Institutional Review Board (IRB) will review your project. Thereafter, they will ensure that any human test subjects involved in the creation and prototyping of the device are not facing dangerous risks. They will also check that fully-informed consent is given before participation.
You’ll need this approval to move on to pre-clinical trials for prototyping.
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