'Consumerism of medical devices offers huge opportunity': ADI
Som: While 80% of the medical devices are imported for India's consumption, we are seeing increasing number of designs being done by Indian arms of MNCs and Indian design houses.
"Higher performance, more integration, compact size, ultra-low power and in general the consumerism of medical devices brings about opportunities for semiconductor makers like Analog Devices. In India 80 per cent of the devices are still imported, but we are seeing the MNCs and Design Houses in India routinely designing for global medical electronics companies. From a design standpoint, we see more integration as the requirement for the designs starting in India," says Somshubhro (Som) Pal Choudhury, managing director, Analog Devices India (ADI). In an interview with EE Times India's Arti Singh, Som talked about how medical electronics market is changing in India and how the company is moving into this growing market.
EE Times India: What are the trends and challenges in the medical electronics market today in India as well as globally?
Som: Globally, the biggest driver for medical electronics today is consumer health monitoring and diagnostics. With the ageing population, growing cost of healthcare and more lifestyle diseases, monitoring of vital signs in many cases by wearable devices and giving timely alerts via a consumer gadget like a watch or a smartphone is where the growth will come from. The trend from an electronics requirements standpoint is ultra-low power devices that are small enough and integrated so that they can be body worn but the performance and quality have to match the devices at the clinics and hospitals.
From a hospital and clinic equipment standpoint, we see two trends. First, more accurate medical instrumentation on one hand, and second a parallel track towards miniaturisation with lesser functionality. A classic case is ultrasound. The cart-based systems continue to improve in image quality and performance, but we now also have hand-held ultrasound. So the range of equipment available from the big players is getting wider. The smaller, cheaper and less functionality equipment is particularly beneficial for places like rural India (even though portable ultrasound is a wrong example for India as it has been banned) where portability and battery power would be important, while the larger machines improve performance at the larger urban centres.
A second trend worth mentioning is what is referred to as 'reverse innovation', where large MNCs set up operations in India to 'redesign' medical equipment grounds-up for the emerging market. The record of the Indian design centres has been such that the same equipment is now being re-sold back in the developed countries as a new part of the product line-up at the value end of the spectrum.
Looking specifically at India, we all expect the regulations to control and regulate medical devices would be coming out soon.
How does the medical device industry differ from other safety-critical industries, such as avionics?
Medical Devices is part of a heavily regulated global industry and every part of the product lifecycle including R&D, trials, approval process, manufacturing, labelling etc. are regulated. In US, the US Food and Drug Administration (FDA) and in Europe, CE marking agencies regulate the quality and patient safety of these devices.
The major difference between other regulated industries and medical electronics has to do with clinical trials. With avionics, and other similar industries, there are very tight standards which equipment (and the components inside) must meet, but if you follow these and maintain a good audit regime, your equipment goes straight onto the market i.e. the release is determined by the manufacturer. In medical equipment, it is effectively FDA approval which determines release based not only on development methodologies, but also on performance in suitable clinical trials. This is often a tough hurdle. Each equipment is assigned a particular 'Class' depending on its criticality and ability to do harm. Implanted devices for example would be in the highest class. The requirements of the trial depend on the class. It is often a challenge to assemble enough volunteers to get a reasonable trial size. It is an extremely expensive process. So it acts as a significant barrier to entry for new entrants who do not have the hospital contacts and reach to get trials successfully completed.
However, there is a sea change in progress due to mobile phone attachments and Apps for the healthcare area. New players are rushing into this market, but they are circumventing the FDA by not describing their devices as 'medical' i.e. the user is not making clinical decisions based on the results. They call them 'entertainment' or 'wellness' or 'fitness' products, even though they overlap with classic medical equipment.
Medical devices are seen as the next big opportunity for semiconductor makers. What kind of opportunities do Analog Devices see in the Indian medical equipment market? What are the growth drivers in India?
Higher performance, more integration, compact size, ultra-low power and in general the consumerism of medical devices brings about opportunities for semiconductor makers like Analog Devices. In India 80 per cent of the devices are still imported, but we are seeing the MNCs and Design Houses in India routinely designing for global medical electronics companies. From a design standpoint, we see more integration as the requirement for the designs starting in India. A classic example is Analog Devices' ADAS1000 which is a single chip ECG analogue front end solution. To make healthcare affordable, and with the proliferation of smartphones and tablets, simple add-on medical class monitoring and diagnostic devices attached to the smartphones and tablets as enablers, display and conduit to the cloud is the way forward. At Analog Devices we have made ready reference designs for several class of such devices including ECG, pulse oximeter, fall detector, pedometer etc. connected via low power Bluetooth to the smartphones.
How the medical equipment market is changing and how is ADI catering to the growing needs?Requirement is for higher accuracy and performance in high end medical equipment primarily for imaging applications like CT Scan, Dig XRay, MRI which means higher accuracy sensors, amplifiers and converters and packing more number of channels in a given form factor. Lower functionality less expensive devices means more integration. Consumerism of medical electronics with monitoring and diagnostics available outside of hospitals and clinics opens up opportunities for semiconductor companies to innovate in ultra-low power, tighter integration with compact form factor and using sensors either available on or attached to the smartphone or tablet. This is an entirely different approach for medical electronics with much bigger consumer electronics like volumes and with much shorter time to market.
Analog Devices is heavily investing in all of the above sectors. While traditionally Analog Devices has focused more on the higher end of the spectrum with more accurate and higher performing signal chain components, the bigger investment is now on the "Consumer Health." Packaging technologies that can combine the entire signal chain on a single package, System on a Chip (SoC) and innovative packaging technologies with our System-on-a-Film techniques are already available products from Analog Devices.
Can you tell us about some of your innovations designed specifically for emerging markets like India? What role does ADI India centre play in the development of medical electronics?
Emerging markets like India would use both sophisticated equipment like in the developed markets and also cheaper and smaller less functionality products. From an ECG market standpoint, the integration and performance we offer in a compact form factor with our ADAS1000 product is seeing a lot of activity in India and China.
Similarly integrated single lead heart rate monitors and hearing aid solutions like with our MEMS microphone are getting traction in emerging markets. We are seeing designs being done for global markets by the Indian designers in MNCs and design houses in the vital signs monitoring and consumer health with activity monitors, fall detectors, ECG etc. Many of the DSPs, MEMS devices and precision converters that are used worldwide in medical electronics devices are being designed out of our India Product Development Centre now.
How are things shaping up for Analog Devices in the medical devices market in India? If we talk about the Indian medical electronics market, where do ADI stand in terms of market share? Can you tell us about other developments that we can expect from Analog Devices India in the near future?
The Indian Medical Electronics market is still relatively small compared to the industrial, defence, automotive and communication infrastructure electronics markets both in terms of design and consumption. While 80 per cent of the medical devices are imported for India's consumption, we are seeing increasing number of designs being done by Indian arms of MNCs and Indian design houses. For the designs happening out of India, Analog Devices prominently features as either #1 or #2 supplier.
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