Medical devices are the machines, implants and instruments that doctors and nurses use to diagnose, treat and support a patient. An artificial hip, a pacemaker, the monitor over a hospital bed and the pump that feeds medicine into a vein are all medical devices. Most of them are now as much software as hardware.
Consider a 66-year-old woman who has a hip replacement at a private hospital in Nagpur. The artificial hip inside her body is a medical device. So is the robot arm that may have helped the surgeon place it. After the operation, more devices surround her bed. A monitor shows her heartbeat and the oxygen in her blood. A pump feeds medicine into her vein at a set rate. Meanwhile, in another part of the hospital, a sterilizer cleans the surgical instruments for the next patient.
This page groups these devices into two zones. The first is implants and surgical robots: the devices placed inside the body, and the machines used to place them. It includes cardiac implants such as the pacemaker, orthopaedic implants such as artificial hips and knees, and the surgical robot. The insulin pump and two kinds of dental device belong here too.
The second is hospital and home care equipment: the devices of the ward and the home. It includes the patient monitor, the infusion pump, medical sterilizers and the CPAP machine. A CPAP machine treats sleep apnoea, a condition in which breathing stops again and again during sleep.
Why are these devices "mostly software"? A pacemaker decides every second whether to send a pulse to the heart. That decision is made by firmware, the program stored inside the device. Many devices also send their readings to an app or to a cloud service, where a doctor reads them. Some are even updated after they are implanted. When a piece of software itself diagnoses or treats, it is regulated as a device in its own right. That idea is called software as a medical device (SaMD).
Every change is regulated. In India, the regulator is the Central Drugs Standard Control Organisation (CDSCO). Under the Medical Devices Rules, 2017, each device is placed in one of four risk classes, from class A, the lowest risk, to class D, the highest. A pacemaker is in class D. Before a maker may sell a device, it must prove that the device is safe. It must also test and record every later change to the device's software. This kind of proof is described in safety certification.
The buyers are hospitals, clinics and patients. The makers are among the largest companies in medicine, and most of them run engineering centres in India, in Hyderabad, Pune, Bengaluru and Chennai. There, engineers write the software inside the devices, the apps connected to them, and the systems used to design, test and track them. Machines that take pictures of the inside of the body, such as CT and MRI scanners, have a page of their own, medical imaging.