Have you ever wondered how new cochlear implant features and functionalities are created? Do scientists and engineers sit together in a room every Monday morning and brainstorm potential improvements to work on that week? How does the idea turn into a tangible product or feature? And how do we ensure that this new idea works and is safe? In this article, let me take you through the steps of how an idea becomes an innovation.
Unlike typical hearing aids, cochlear implants are complex medical devices that work differently, employing an external device and a surgically placed implant. Developing and obtaining regulatory approval for an innovative cochlear implant is not a fast process and can take many years from ideation to the implant being available on the market.
All new cochlear implant innovations must go through a tightly-controlled development process which starts with an idea to address an unmet medical or market need. To identify these unmet needs, market research is conducted by collecting feedback from healthcare professionals and patients.
Developing and obtaining regulatory approval for an innovative cochlear implant is not a fast process.
Let’s say, after extensive research and interviews with hearing care professionals, we determine that we can help cochlear implant surgeons by designing a new kind of electrode array. To design an electrode that can fulfill the need, we conduct a thorough technology scouting of available technologies that we can leverage both internally and externally – for example, from hearing aids or another medical device industry.
Then, building on existing technology, our Research & Development (R&D) team sets out to create a concept. The concept is then tested for its feasibility by creating a prototype. Having a prototype helps to assess whether the concept is viable, beneficial, and not dangerous for patients.
Then the combination of market evaluation and risk analysis determines whether the prototype makes it to the next step. Take our new electrode, for example: We perform an evaluation of prototypes with CI surgeons to get critical feedback to ensure that the design requirements will meet their needs.
During this phase, detailed requirements are established, and the device is refined and tested to meet those requirements. The design verification testing ensures that the device is built as planned. For example, our new electrode needs to be no bigger than a certain size, and have a certain flexibility. It also needs to be durable.
Validation testing is performed to ensure that the device is built to meet the user needs and work as intended when implanted in the human cochlea. If not, it’s modified and improved, and tested again.
Besides extensive lab tests, the new device may also have to undergo a variety of biological assessments and clinical investigations with real patients under strict and independent ethical and regulatory supervision. We need to make sure, for example, that our new electrode will help our patients hear their best, and not cause harm. We perform thorough risk analyses to evaluate any potential failure or hazard at any stage in the device’s life cycle, and measures are defined and implemented to control and minimize those risks.
Finally, when we determine that the device is ready, we collect all the relevant information and test results obtained during the development process and submit them to the regulatory authorities such as the FDA in the USA or TÜV SÜD in Europe to obtain their approval.
Cochlear implants are Class III devices with the highest risk for causing potential harm.
Every medical device is assigned to one of three regulatory classes based on the level of scrutiny necessary to ensure its safety and effectiveness. For example, microphone accessories are categorized as Class I while hearing aids are Class II. Cochlear implants are Class III devices with the highest risk for causing potential harm, and therefore must meet the most stringent regulatory requirements before release to the market.
These requirements and regulations are continuously updated to increase patient safety, and medical device companies must comply with the most recent requirements. In fact, every medical device company that has a certified quality management system is regularly audited to demonstrate compliance with the current and applicable quality, performance, and safety standards.
Only when the regulatory authorities approve the new device can it be sold on the market.
To be approved, Class III devices also require mandatory post-market surveillance and clinical follow-ups. This means once the new device is introduced to the market, we proactively and systematically collect and evaluate data on clinical experience with the new device to make sure that it continues to be safe and effective through its entire lifetime, and to determine if corrective or preventive actions are necessary.
We review every complaint related to the device itself, the labeling, the packaging, or even the distribution. And we thoroughly investigate and analyze the data for any trends so we can react accordingly. A benefit-risk analysis will determine whether the benefit of the device continues to outweigh the risk. If required, a complaint must be reported to regulatory authorities.
Besides monitoring for problems, post-market surveillance data can also highlight opportunities for continuous improvement, so we can continue to deliver the safest and most effective cochlear implants.
The process of developing the most innovative cochlear implant technology is long and involved. That’s part of the reason why the latest and greatest cochlear implant devices don’t debut every year like popular smartphones, or even hearing aids. But this measured and fastidiously monitored process also ensures that only the best and safest devices are available for our patients.