Before you can bring a medical device to the market, you have to get it properly manufactured – and this can often be a challenge.
The good news is that there are more manufacturing options for medical devices available today than ever before. Many even come with affordability and short time-frames to get them to market. As you go through the process of bringing a medical device to manufacturing, you will want to ensure that the device meets all regulatory requirements and standards in order to successfully create it— and ensure its success.
Where do you start? How do you bring a medical device to manufacturing? Let’s look at the details.
Creating the Idea for a Medical Device
One of the very first steps in bringing a medical device to manufacturing is creating the idea for it to begin with. You will want to make sure that there is a need and a market for the product — one in which your product will be the answer that can bridge the gap.
During this initial stage, you will take a look at what is necessary to comply with regulations and quality assurance so that your design will meet these standards. Understanding the regulatory requirements and classification is critical to define the pathway for product development and commercialization. You will also want to speak to an attorney to confirm you aren’t exposing yourself to any unnecessary risk in creating the device.
Do all of your basic assessments, timelines, designs, and so forth during this stage so that as you move forward, you have the details taken care of.
Develop and Design Your Medical Device
Decide on the objectives for your medical device, clearly defining its goals and having your Engineering Department or engineering partner design it to meet them. Again, this should be done with the regulations in mind so that there are no unforeseen issues.
Expect this stage to have a lot of drawings, re-drawings, and a constant review of specifications. This has to be done so that, as your prototype is developed, it will allow you to make sure the device functions as well as intended. Qualification of the equipment and equipment installation, along with operating parameters and process qualification (IQ, OQ, PQ) are all critical steps in this phase of development.
This is all going to take time. After all, you are trying to create the perfect end product that will go to market. Your engineering group will have to gather all the information necessary for the creation of the product so that it can be repeated in manufacturing. Through the prototyping process, you can confirm the validity of the manufacturing requirements and ultimately define the process for production of the finished good(s).
This process will also confirm you have a thorough set of manufacturing instructions for a repeatable process.
Testing Your Medical Device
Testing and validation work is a very big step in the process of bringing your medical device to manufacturing. You will need to verify once again that the device will meet any necessary requirements and that the output matches the design.
Testing also needs to occur externally so that you can confirm that your medical device truly does fulfill the need successfully. This will allow you to determine whether any tweaks need to be made to enhance it.
Depending on sterility requirements, your device may require sterilization validation and/or bioburden testing by off-site laboratories.
By dedicating the time to make sure the medical device testing provides acceptable results, you will support the efficacy and safety of your product.
Choosing Your Medical Device Manufacturer
When you have everything ready for manufacturing, where do you send it? Do you enlist a contract manufacturer to handle the production of your medical device? Remember, they will need to be able to use your manufacturing instructions to be able to replicate your design — at your desired rate and in your time frame. Always keep in mind if your manufacturing partner can meet quality requirements (ISO 13485) and is FDA registered. Also, does your manufacturing plan have the capacity to scale up to meet forecasted volume requirements?
Most find that outsourcing the manufacturing of medical devices is the most cost-effective strategy for commercial production. However, it is important to choose the best location that will yield the greatest outcome all the way around. For instance, Mexico is becoming a global leader in medical device manufacturing. Tijuana, Mexico is a low-cost geographic region with a workforce that is experienced at providing consistent quality in the medical and life science industries. And, since they are geographically close to the U.S., access, logistics, and shipping times are also much quicker and convenient.
Learn More at Coastline International
Coastline International has over 4 decades of experience in nearshore manufacturing. If you are interested in outsourcing your medical device manufacturing, we can help you boost your efficiency, reduce your costs, and increase production—all while creating a high-quality product.
Contact us today to learn more.