Intellectual property (IP) is a high priority consideration when designing a new medical device. If you are outsourcing all or part of the development to a third-party contractor, it’s even more important to take steps to ensure your IP is protected.
There are many reasons for this, but one of the most important is that third-party contractors are treated differently to employees of your organisation. In most jurisdictions, your organisation owns the IP of any work that an employee does. This doesn’t apply to work done by a third-party contractor, however. Therefore, it is absolutely critical that IP issues are considered and dealt with at the earliest possible stage.
When you work with us at Arrotek, your IP will remain 100 percent yours. This includes all aspects of the IP for your product, including the idea, design, appearance, functionality, and specification, as well as any outcomes that result from work that we do for you.
The good news is that there are straightforward solutions to ensuring your IP is protected when outsourcing medical device design and development. The tips below also apply if you are outsourcing the manufacturing of your product to a contract manufacturer.
1. Understand the Risks
The unauthorised disclosure of your IP can result in significant damage, including both financial and reputational damage. The key point to remember is that an unauthorised disclosure can be either intentional or accidental.
Therefore, you should leave nothing to chance – handshakes and verbal assurances are not enough. Instead, you need to make sure the protection of your IP is watertight.
2. Understand that Different Countries Have Different IP Frameworks
IP frameworks can vary from country to country, so it’s important you understand how IP works in the location of your third-party partner. Arrotek, for example, is based in Ireland, so we operate under Irish IP rules. Those rules provide you with strong protection over your IP. Furthermore, finding information is quick and easy.
3. Sign an NDA and Ensure There is Clarity About IP Protection
You should only discuss your idea for a new medical device with potential partners who are willing to sign a non-disclosure agreement (NDA). By having an NDA in place, your IP will be protected even if you decide not to take the relationship any further.
During your initial discussions, you should get full clarity about IP protection, making sure it is in the contract you put in place with the contractor.
4. Explore Your Patent Options
It can be helpful to explore your patent options as early as possible. You can then decide whether it is worth filing a patent application, as well as understanding the best type of IP protection to pursue. You are likely to need expert advice as part of this process.
Remember also that if you are outsourcing medical device design and development to update or improve an existing product, you may need to file a new patent application to cover the new elements of the design.
5. Choose a Partner Who Clearly States They Will Make No Claim on Your IP
Medical device design and development contractors have different ways of working. The contractor you select should be upfront about how they deal with IP.
When you work with us at Arrotek, your IP will remain 100 percent yours. This includes all aspects of the IP for your product, including the idea, design, appearance, functionality, and specification, as well as any outcomes that result from work that we do for you.
It is also recommended that you carry out due diligence on the partner you are considering appointing. This includes assessing the steps they will take to protect your IP as well as their systems and procedures. If the company is serious about IP protection, they will have robust levels of protection in place, and they will be proactive in sharing this with you.
6. Carry Out Ongoing Reviews into Your IP Risks
The medical device design and development process can take many months. Over this time, various circumstances can change. As those changes might impact the protection of your IP, it makes sense to regularly review your risks both internally and with your partners to identify areas for improvement.
Protecting Your IP
Outsourcing the design and development of your medical device idea offers a range of benefits, including getting access to industry experts and ensuring the process is as efficient as possible. With proper planning and clear communication, protecting your IP doesn’t have to be a barrier to realising those benefits.
At Arrotek, we have significant experience in this field, so we can provide guidance on any IP questions you have in relation to your new medical device idea. Get in touch with us today to speak to a member of our team.
