The importance of IP protection while nearshoring lies in one simple fact: it makes your company unique. In an increasingly competitive market, being different is what sets you apart. Are you going to let someone take that away from you?
How can you ensure that your company’s secret sauces remain safe? You may find this problematic. However, with the right partners, this will no longer be a problem.
The Value and Vulnerability of Medical IP in Nearshoring
Medical manufacturing in Mexico carries risks. After all, there are specific regulatory shortcomings regarding IP protection nearshoring:
- For example, the Mexican Institute of Industrial Property can take up to three years to issue patents. Furthermore, COFEPRIS typically takes up to two years to approve medical devices. This creates risk windows for information leaks.
- Piracy is a well-known problem in this country. Design theft and unauthorized duplication reduce opportunities for manufacturers wishing to start operations in the country.
- Bureaucracy can also present challenges when it comes to complying with Mexican regulations. Although these are aligned with international standards, certain irregularities can undermine intellectual property.
IP protection nearshoring is a top priority for any company looking to manufacture in this country. It is an investment that will mitigate the risks associated with a flawed regulatory system that still offers benefits to companies.
Choosing a Manufacturer with Secure, Documented Workflows
To make nearshoring efficient, it is essential to have partners operating under transparent and diverse systems. How can we ensure this? Here are some tips to follow:
- Evaluate the systems implemented by the manufacturing partner. For example, consider product identification using barcodes or databases for real-time monitoring. There must be the possibility of tracking upwards and downwards.
- You should also request internal audits to verify whether the company uses standardized processes.
- If necessary, the company can provide certificates demonstrating that it complies with regulatory requirements, such as FDA regulations and ISO 13485.
- For better traceability, choose partners that utilize automation tools. This approach streamlines workflows and significantly minimizes the potential for errors
This culture is essential to ensuring quality in device design and protection. To ensure IP protection while nearshoring, strong communication, meticulous management, and an unwavering commitment to quality are crucial.
Key Legal and Operational Safeguards to Consider
What should a contract include? It must be a comprehensive document that clearly explains what is being protected and how non-compliance will be penalized. Some of the clauses for OEM contracts are as follows:
- Confidentiality agreements are used to protect sensitive company information during the contractual relationship.
- Clauses in employment contracts that favor the company. Even when an employee participates in a design, they must not disclose information and cannot claim intellectual property rights over said design.
- Licenses for use allow other companies to use the technology developed and protected by the above-described laws.
These licenses allow relationships between companies or between companies and employees without posing a risk to intellectual property. However, each organization must protect its interests by implementing safeguarding protocols.
Protocols to follow
Every company develops technology and creates new designs, so they must have a clear understanding of how to protect their creations. For medical manufacturing in Mexico, this can be achieved as follows:
- Define and classify trade secrets, which must be kept confidential. This requires that they be shared only with a select group of personnel and protected using secure storage methods, whether in physical documents or digital systems.
- Register patents and industrial designs at the IMPI entity in Mexico. This process grants you legal recognition and the exclusive rights provided under patent and industrial design laws.
- Finally, you must ensure that the OEM contracts comply with the country’s legal framework. Therefore, you must adjust the contractual clauses.
Of course, many other protocols can be followed. The specific protocols followed will depend on the company’s needs, but the goal remains the same: to protect inventions and comply with regulations.
Working with Manufacturers That Prioritize Compliance and Transparency
The most important thing is for Mexican manufacturers to comply with regulations. After all, this enables you to establish a commercial relationship that meets your needs.
- If you want to export to the United States, it is crucial that you comply with these laws. Companies that comply with them will face fewer obstacles.
- Maintaining a strong reputation in the US market is also essential. This becomes very difficult if products are recalled or found to be defective. IP regulations indirectly, but significantly, prevent this.
- Clearly, complying with regulations brings operational benefits by avoiding fines and other penalties. This includes the risk of temporary closure for non-compliance.
Therefore, it is essential to work with a manufacturer that guarantees IP protection and regulatory compliance. This protects your inventions and prevents future problems.
Why RexMed Is a Trusted Nearshore Partner for IP-Sensitive Devices
Why is RexMed the best solution for nearshoring IP protection? If you are looking for a business partner in Mexico, you need guarantees. Protecting your business and ensuring compliance with regulations are our priorities.
- We have carefully controlled spaces to minimize the risk of any adverse effects on product quality. Similarly, we take care of everything related to security to ensure that no confidential information leaves the company.
- Our regulated and standardized processes ensure that each product meets the required quality and functionality standards. We are familiar with the intellectual property regulations for medical manufacturing in Mexico.
- As a strategic partner, we anticipate problems and propose precise solutions. This consultative approach guarantees device design security in any nearshoring operation.
Want to know more? At RexMed, we are happy to answer all your questions. Visit the ‘Contact’ section to find out how to access our services.
