The use of implantable devices to support, control and modify specific functions in the human body is an emerging field for the effective treatment and management of a range of health conditions, trauma, and disease. The technology behind these devices continues to grow at a rapidly evolving pace, and new technology continues to expand the benefits these devices can offer to patients and physicians.
However, with the new technology comes challenges in having the device approved and certified for use in humans. Working with a company specializing in design and production of systems used for implantable devices will be critical to making this complex process as streamlined as possible.
Miniaturization Issues
A very significant challenge in many devices is the need for miniaturization of the parts and components of the device. Highly advanced and complex systems may need to be in place on the device, but the device itself has to be small enough to be safely implanted and comfortable for the patient.
Shrinking the components is rarely an effective solution. Instead, engineering teams have to look at ways to design the component to include the required circuits and features but also to ensure long life cycles, durability and reliability once implanted.
Security Issues
Increasingly, implantable devices are designed to provide information to physicians and even to patients through the transmission of data. This includes developing security measures and protocols into the design.
To provide both security and capability with increasingly smaller and more complex devices, design teams and engineers need to consider not just how the device will function, but where and how it is most likely to fail. With this information, the team can modify, improve and proactively address challenges to eliminate or reduce issues to a level to meet the requirements for approval and certification.