Developing Integrated Circuits for Implantable Medical Devices (AIMDs)

AIMD-ASICs are a special subset within integrated circuit development. They require very specific knowhow, and while they don't require the most advanced technologies, they do need high voltage (handling up to a few tens of volts), micro/nano-power consumption, or special packaging, technologies among others. The design cycle for a product is somewhat different, for example, from a chip for the automotive, robotics, or consumer electronics industries. Millions of units will not be manufactured, but sometimes only a few thousand, so the design teams must be small and stable over time. It is also necessary to consider reliability and safety practices, as well as regulations, during the ASIC development.

This talk will present, from the perspective of a small design house, some aspects related to the development of an integrated circuit aimed at being part of an implantable medical device. Firstly, we will introduce implantable electronics, how to stimulate biological tissue, and sense biological signals, including examples such as pacemakers, FES, and cochlear prostheses. We will review the concepts of reliability and safety in medical devices, as well as the main regulatory frameworks. We will examine topics such as the state of the art in low-power, low-noise micro-amplifiers for recording biological signals, stimulation circuits for biological tissue, a RISC-V processor for implantable applications, different packaging techniques being used in AIMD-ASICs, and even the characteristics of a PCB for implantable applications.

Finally, we will consider testing and qualifying ASICs for medical devices, and recommendations for responsibly approaching the design of an electronic device on which the patient's health depends in some way.