Medical Device Outsourcing by definition gives an impression of a key to unlock profit by reducing Time-To-Market, optimizing cost, and adding new ideas to the existing design. But, what if the outsourcing partner fails to protect your IP?
Seems scary, isn’t it!
Medical Device Development & Research involves years of investment in terms of Time, effort and money. A minor glitch or unauthorized access can incur major damage. Especially in volatile dynamics when the Medical Device industry as a whole is undergoing a massive transformation.
The big MedTech giants are looking for trusted contract manufacturers to outsource their projects. But, the fear of losing rights over their trade secrets, Patents, Designs, and so on is a major inhibition for them.
Here we briefly take you across the steps that we as a Global Medical Device Contract Manufacturer, keep in mind to protect our client’s IP across various steps in the manufacturing process.
- Physical Security
- Technology & Authorization
- Dispersed Production Stages
- Legal Protection
- Complete Transparency across standards, processes, and security policies
1. Physical Security
IP Protection has multiple layers. Physical security is the first and primary necessity that includes having a dedicated space where the engineers work on OEM projects. The space must have Security personnel, restricted entry/exit, Physical monitoring of the premises, and limited access to authorized people. We at Johari Digital Healthcare Ltd ensure physical security at every level to eliminate unauthorized access.
2. Technology & Authorization
As a contract manufacturer, we are involved in developing different types of Medical Devices including IVDs, Life science instruments, AI-based devices, and Cloud-storage devices. Each of these devices involve high cybersecurity concerns. While manufacturing we ensure that internal systems are guarded efficiently. The information is floated across the organization on a “need to know” basis. For instance, someone working on the enclosure part will have limited access to know what goes into the electrical part or some other aspect. This way we ensure most of the information remains inside the closet.
We control the access to information and track every sensitive data downloaded. Tracking helps us identify the threat and figure out ways to mitigate it immediately.
3. Dispersed Production Stages
In several cases, clients do not want to reveal their assembly or manufacturing locations. In such premises, the manufacturing and assembly are split across locations to ensure that competitors do not get information on where the manufacturing is done and how is the product finally assembled. There are always high-security concerns associated with this kind of demand and we efficiently manage each of our client’s concern in this regard.
4. Legal Protection
Every employee in the Contract Manufacturer’s facility who is involved in the manufacturing process at any stage must comply by the fact it’s their sole responsibility to protect the sensitive information. Any infringement, in any case, puts the contract manufacturer’s credibility at risk. Even the vendors located in various regions across the globe also come under the umbrella of the contract manufacturer’s work domain. In case the IP infringement is done by the Vendor by any means, still, the Contract Manufacturer is held legally responsible and answerable.
At Johari, we perform regular vendor analysis to keep our vendor network filtered, accountable and authentic.
5. Complete Transparency across standards, processes, and security policies
Every change made at any stage of manufacturing must be communicated to the client. The clarity in communication keeps everything aligned and helps in mitigating conflicts and risks associated at all levels.
Types of Intellectual Property Protection
Medical Devices range from simple biosensor devices to large-scale clinical device models. Some of the common Medical Devices are imaging devices, sensors, analytical tools, implantable products, and prostheses. It’s utterly important to protect the idea and its different aspects. There are many categories of IP protection for different segments of Medical Device including:
Any specific word, symbol, representation, design, or combination together are to be protected under the trademark policy. Trademark is for any entity associated with the identity of the product. Even if the product design changes over time the trademark entities need to be constant.
Trade dress Protection
Trade dress refers to the overall look and feel of the products. Trade dress must have identifiable characteristics to be protected. The total image of the product includes size, shape, color, color combinations and, so on that are specifically aligned with the product’s identity.
In the series of new devices, utility patents help in keeping the core identity intact. An invention is protected and can be given for licensing to competitors. Utility patents have a validity of around 20 years.
Design patents protect the design aspect of the product. Nobody owns the authority to use a similar design and commercialize it without legal notice. The design patents have a time duration of 14 years.
Trade Secret Protection
Trade secrets include source code, business plans, customer lists, marketing strategies, and process-related inventions. These are called the secret sauce formula that makes a successful product. These are also protected under the “Uniform Trade Secrets Act.” At Johari Digital Healthcare Ltd we have a long history of handling our partner’s IP as we know the value of sensitive data. We pro-actively establish, monitor, and enforce security protocols to limit access to sensitive data so that your ideas are safe with us.