Medical device contract manufacturing no further a mystery
The stakes are high in medical device manufacturing. Competition is stiff. Every breakthrough represents millions of dollars of research and development. Ideas, innovations and processes are precious resources. Companies each have their own “secret sauce,” such as a specialized production process, that they guard zealously. What’s more, medical devices may be protected by patents, but knowledge has no legal protection — which is why intellectual property theft can be so damaging.
With so much on the line, medical device companies may hesitate to partner with a contract manufacturer due to concerns over the security of their intellectual property. After all, when the IP is no longer in your hands, it’s harder to guarantee security. But there is a solution: with high standards and proactive methods, manufacturers can ensure rigorous protections for medical intellectual property. Here’s how.
1. Technology & authorization levels.
To start with, manufacturers should use technology to provide the same standard of security as your own internal systems. Because medical intellectual property is typically housed within computer systems, including software programs or trade secrets, reputable manufacturers ensure that their own systems are guarded.
Of course, secure walls aren’t enough on their own. Manufacturers must also verify that only the right people can access the data behind those walls.
In a factory setting, this entails configuring the computer system so that medical intellectual property is only accessible at certain levels of authorization. Factory floor workers are unable to view core product secrets; information is distributed on a “need-to-know” basis. Someone working on attaching a battery, for instance, will only be able to access the knowledge required for that specific process.
This user management ensures that the distribution of information is strictly controlled. If someone downloads sensitive information, the manufacturer can monitor, track and control that access to verify whether that user’s actions were justified — and if not, how to recover and lock down the information that was accessed.
2. Separate production stages.
In certain cases, you may need to provide additional protection for medical intellectual property — such as highly sensitive proprietary software. Manufacturers can leverage their facilities to spread out the stages of assembly across multiple locations. Dispersed production provides an extra layer of security that makes it nearly impossible for competitors to track and understand how a particular process or trade secret works.
For instance, if a client raised concerns about the security of their software, conscientious manufacturers can institute a custom production process by separating a particular part of the contract manufacturing process. For example, engineers might program the device’s chips in a facility in Arizona, then ship them off to a factory in Malaysia to be assembled.
3. Legal protection.
The best data protection should also be backed up by strong legal security. Everyone who interacts with medical intellectual property, from factory workers to account managers, should sign an employment contract with very clear IP protection.
Manufacturers must also make it clear how this legal protection will aid their clients, should it ever be needed. For instance, a manufacturer may have a global supply chain but be based in the US. As a result, they’re liable in US courts of law, and their client would not have to worry about pinning down an international vendor.
Choosing a manufacturer: transparency, trust & track record.
With all these tools, how does a medical device company sift through manufacturers and know who to trust? After all, while there are many accolades and trustmarks that a medical device manufacturer can achieve, there’s no clear certification for IP protection. Customer concerns over medical intellectual property are valid, and these best practices are only effective if a manufacturer employs them rigorously.
It comes down to this: it’s up to the manufacturer to prove themselves worthy of trust. Manufacturers should address lingering concerns by promoting absolute transparency into their standards, processes and security policies.
By the same token, medical device companies should thoroughly assess potential partners, including their track record:
- Has the manufacturer ever had an IP incident or breach? Why or why not?
- How familiar is the manufacturer with the needs of medical intellectual property?
- Is the manufacturer willing to provide visibility into their operations and security?
- Does the manufacturer listen and respond to the particular needs of your medical device or its production process?
Security policies can help ensure that medical intellectual property receives the protection it deserves. The right manufacturer will engender trust by demonstrating that they consistently achieve those high standards by leveraging all the tools at their disposal, from authorization to secure production stages to legal backing.