Semiconductors are increasingly finding their way into a variety of medical devices, after years of slow growth and largely consumer electronics types of applications.
Nearly every major chipmaker has a toehold in health care these days, and many are starting to look beyond wearable such as the Apple Watch to devices that can be relied on for accuracy and reliability. Unlike in the past, these chips also are being developed at relatively advanced processes, several generations behind the leading edge so that the processes have matured sufficiently.
Included in this mix are custom ASICs, as well as off-the-shelf analog and digital chips. And they span everything from low-power ICs for medical implants to high-performance accelerators that process images for diagnosis.
“Right now, chips manufactured at 28, 20, and 16nm are in production within medical equipment,” said Subh Bhattacharya, Health care & Sciences lead at Xilinx. That can include anything from a 510(k) device, which is demonstrated to be safe and effective, to De Novo and pre-market approval (PMA) classifications, which are further along. Many of these applications are Class II, which means they have a moderate to high risk for the user, but there are also some Class III applications, such as automated external defibrillators and infusion pumps.
As of today, the main uses of electronic medical devices are for research, collecting of public-health data, maintaining and accessing patient records, and patient health care. But the use of semiconductors in these devices is widening as devices shift into monitoring, diagnosis, and treatment via surgery or other therapeutics, such as drug delivery and stimulation of nerves in neurotechnology. Monitoring systems also include implanted clinical devices used at the patient’s home to send data back to doctors or monitoring services about vital-signs systems from sensors physically applied to the patient.
The over-arching goal in medical devices is always to make health care accurate, effective, convenient, accessible, and affordable, while making treatments safer and less invasive. Those improvements focus on using less power in a smaller form factor, and getting the signals out securely to their destinations. Sensors, analog-to-digital converters, RF, and microcontrollers are all key elements. So are image and signal processing. Increasingly, AI is being added into these systems, as well, to make monitoring and diagnosis tasks less complex, faster, and hopefully more accurate than humans.
Device form factors
Medical devices for patient health care take many forms, from tiny ingestible and implantable devices to large biomedical diagnosis and treatment machines. Devices for the consumer market are distinct from clinical/professional devices in that they may cost less and be less accurate or reliable.
What’s less obvious is the fine line between them. Devices used in clinical settings can have similar but better quality components and system design. But the lines are blurring as chips are used in more devices, including:
Externally worn devices. These include wearables, hearables (fitness and vital sign trackers; newer consumer watch/smartphone systems offer ECG tracking, sleep apnea detection, arrhythmia detection, and blood oxygen tracking); disposable sensors (for example, in glucose monitoring); and e-skin for stimulating nerves, adding a sense of touch in prosthetic hands. Some of these devices are consumer devices (over the counter — anyone can buy the device without a doctor’s prescription) or clinical (prescribed by medical professionals).
In-body devices. This group includes implants, such as pacemakers, cochlear implants, and neurostimulators. These devices have to be in hermetically sealed packages, which may be ceramic or metal. The wireless communication and signal acquisition and processing has to be extremely low-power. Electromagnetic interference (EMI) is a hazard to implanted devices. Also in this group are ingestibles, which have to be the size of pill or capsule, and made of biocompatible materials that can withstand the GI tract while housing MCUs, sensors, memory, and power supplies. Some ingestible sensors can communicate in real time with the outside world.
Clinical patient diagnosis, care, and treatment. These are predominantly monitoring systems, including sensors connected to in-hospital networks that monitor patients’ vitals. Also in this class are lifesaving machines, such as ventilators and defribrillators, surgical equipment, robotics, and diagnostic equipment (CT scans, MRIs, X-rays). Some clinical devices are designed to be used by patients at home and some have an implantable or wearable version. Blood analyzers and assays for diagnosis are progressing.
On top of these are some new applications, as well.
Read more: Rising Fortunes For ICs In Health Care