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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.

Saving money on manufacturing is a priority, irrespective of the product. Whether you’re bringing a new medical device to market, or have secured a bid for electronics components, manufacturers need affordable contract partners. But where do you find lower-cost manufacturers? You may be surprised to learn that you no longer need to travel overseas. 

Tijuana, Mexico is the Most Cost Effective Region for Lower Cost Manufacturing of Select Items

Over the past several decades, Tijuana, Mexico has emerged as an attractive, lower-cost manufacturing hub for electronics, medical devices, and more. Rather than outsourcing manufacturing to Asia, countless U.S.-based companies have chosen this city just minutes from San Diego for their manufacturing. The reasons are plentiful.

Tijuana Has Favorable Labor Costs

While Mexico labor costs may be close to equivalent to those in some areas of Asia, the labor rates are incredibly favorable compared to U.S. labor costs. When factoring in other considerations, the labor costs of manufacturing in Mexico are very competitive. 

Mexico Offers Excellent Tax Incentives

U.S.-based companies do not need to establish another corporation to manufacture in Mexico. Moreover, thanks to the USMCA, free trade between the U.S. and Mexico is thriving, with duty-free access for manufacturers.

Tijuana Has a Large, Young, Educated Labor Pool

While the U.S. continues to struggle with labor shortages, Tijuana is known for its reliable, educated, and experienced labor force. Tijuana often boasts the lowest unemployment rate in the nation. Moreover, the labor pool is enriched each year with tens of thousands of mechanical, electronic, and chemical engineering graduates.  

Travel to Tijuana Offers Significant Time Savings

One of the reasons that nearshore manufacturing in Baja, CA results in lower costs for American companies is due to proximity. Tijuana is accessible from anywhere in the U.S. on the same day. This means that businesses have greater oversight, shipping is expedited, and shipping is not at the mercy of overseas supply chains. Any problems can be remedied quickly, executives can be onsite in hours, and products can be brought to market sooner. Moreover, your team won’t waste hours on planes or need to communicate outside of normal business hours, thanks to sharing a timezone. 

Savings of 30%+ 

U.S.-based companies who opt to outsource manufacturing to Tijuana often realize savings of 30% or more. Reduced labor costs, lower fuel costs, less warehousing costs, lower shipping costs, lower tax burdens, and faster start-up times are just some of the ways that savings add up. 

How to Get Started with Low-Cost Manufacturing in Tijuana

If you’ve never outsourced manufacturing, the process can feel overwhelming. That’s why it’s smart to partner with a contract manufacturer with decades of proven, successful experience in Tijuana.  From helping you source your materials to providing facilities built to U.S. standards and timely product delivery, a contract manufacturing partner can save you time, money, and stress by managing your nearshore manufacturing in Mexico.  

Contact the Leading Manufacturing Partner for Electronics and Medical Devices in Tijuana

For more than 40 years, Coastline International has helped U.S. companies to manufacture their products safely and affordably, just minutes from the U.S. border. Headquartered in San Diego, CA, Coastline International boasts more than 50,000 square feet of operational capacity including ISO Class 8 Cleanrooms. To learn more call 888-748-7177, or send us a message and we will respond promptly. 

If you need to expand your manufacturing capabilities, nearshore manufacturing offers several key benefits when compared to domestic manufacturing. Nearshore manufacturing also eliminates many of the risks of manufacturing in China. So, is nearshore manufacturing in Mexico superior to domestic manufacturing? Read on to learn about reasons you may want to consider supplementing your current production or outsourcing your production to our neighbor to the south.

 

Mexico Has a Large Pool of Experienced Manufacturing Employees 

As many as one in four Mexican workers are employed by industrial manufacturers. By contrast, according to the Bureau of Labor Statistics, only 9% of U.S. workers are employed in domestic manufacturing. This means that there are millions of experienced employees that your company can recruit if you choose to move your manufacturing to Mexico. Experienced employees also help prevent delays, backlogs, and quality issues. 

Perhaps more notably, the U.S. has been undergoing the “great retirement.” Labor shortages continue to plague the domestic manufacturing space.  The shortage is so severe, that the National Association of Manufacturers has predicted that labor shortages in the U.S. may lead to as many as 2.1 million unfilled jobs by 2020. Domestic manufacturers continue to report that it is much more difficult to attract reliable workers than it was just a few years ago.  Moreover, more than 75% of domestic manufacturers predict ongoing difficulties in filling positions for the long term.

Finally, of note is the median age difference between the U.S. and Mexico, particularly as it relates to the future workforce. The median age in Mexico is nearly ten years younger at 29.2, compared to the median age of 38.1 in the U.S. 

 

You’ll Save a Small Fortune in Labor and Materials

The cost of living in Mexico is much cheaper than in the U.S. As a result, wages are lower in Mexico than in the U.S. Likewise, many materials are cheaper in Mexico than they are in the U.S. The combined savings on labor and materials is a leading reason U.S. companies opt for nearshore manufacturing.  

 

Tax Benefits

The maquiladora program offers U.S.-based businesses that engage in nearshore manufacturing in Mexico unique tax breaks. These include the elimination of the Value-Added Tax (VAT) on temporarily imported machinery, equipment, and material.

The maquiladora program also allows for expedited production start-up and greater production flexibility. When nearshore manufacturing with a maquiladora, U.S. manufacturers can also benefit from low shipping costs, simplified corporate income taxes, and payroll taxes. 

 

Learn More About Nearshore Manufacturing Just Minutes from the U.S. Border

If you’re interested in learning more about the potential benefits of nearshore manufacturing, Coastline International can help. For 40 years, we’ve served as a trusted contract manufacturing partner for the medical device and electronics industry.  Our 50,000+ square feet of operational capacity for manufacturing in Tijuana, Mexico qualifies for the maquiladora program. We welcome your questions and interest at 888-748-7177. You may also send us a message for a free estimate, or cost-benefit analysis.