Medical devices are essential for healthcare. Indigenous development of novel, suitable, reliable, and affordable devices lead to social impact and high-value jobs in the country where they are created, thereby bolstering the local healthcare ecosystem. From studying the links between genetic code and diseases to promoting higher efficiency in hospital management systems, technology is adding a crucial new dimension to the development of biomedical engineering and research.
From a contextual standpoint, increasing community challenges offer the opportunity for a wider and more diverse set of contributors to get involved, especially in the Indian market. Many engineering and technology students now have the skills, knowledge, and tools to develop advanced instruments and solutions that can have a substantial, positive impact on the provision of medical triage and treatment.
To guide us through the key initiatives and innovations in the market, we spoke to Professor B. Ravi, Institute Chair Professor for Mechanical Engineering at IIT Bombay, who also heads BETiC (Biomedical Engineering & Technology Incubation Center). In this blog, he discusses how BETiC and its partners have developed some key medical devices and takes a wider look at how applied research has solved community challenges.
IIT Bombay is recognized worldwide as a leader in the field of engineering education, research, innovation, and entrepreneurship. I envisioned the Biomedical Engineering and Technology (incubation) Center (BETiC) at IIT Bombay to help provide a platform for entrepreneurship and innovation, which could support various medical design projects.
However, BETiC was not solely created for IIT Bombay. It has expanded to other renowned educational institutions that have a similar strategic vision, such as COE Pune and elsewhere.
BETiC was established in 2014 to catalyze indigenous medical device innovation and entrepreneurship. It facilitates rapid translation of innovative ideas from surgeons into high-quality and affordable medical devices, suitable for the local population. Its work is supported by key national and local government bodies such as RG S&T Commission, Mumbai, and DST, New Delhi.
Over the last five years, the BETiC team has developed and filed patents for 50 different medical devices, 20 of which have been licensed to startup companies or industry partners. A number of these, including a smart stethoscope, diabetic foot screener and glaucoma screener, have been used to screen several 100 patients in rural health camps.
On a parallel track, the Desai Sethi Center for Entrepreneurship (DSCE) was set up with a similar goal, to foster a culture of innovation and entrepreneurship among students. The Centre offers a B. Tech. Minor degree in entrepreneurship and manages the Ignition Studio (for proof-of-concept fabrication).
Both BETiC and DSCE have close links with the Society for Innovation and Entrepreneurship (SINE), which is the technology business incubator of IIT Bombay. This partnership has led to over 150 incubated companies, with a majority continuing to expand successfully on a global basis. More than half of the start-ups presently housed within SINE are developing novel products for the healthcare sector.
India presents a unique challenge when it comes to healthcare. The country has a rapidly increasing population, but we have limited resources such as an inadequate number of doctors per head to provide the appropriate standard of service. The availability of key medical equipment in rural areas is also very low, which indirectly increases the pressure on healthcare facilities in urban areas. To help bridge this gap, BETiC developed its unique approach to foster partnerships between medical professionals and engineers. These partnerships help identify pressing issues in the field while also employing practical technical innovations to address them effectively and efficiently.
BETiC, today, has become a center of innovation where more than 100 doctors and engineers work together closely on solving community challenges. BETiC has evolved a systematic process along with the necessary facilities and critical expertise for medical device innovation. This process enables the development of novel solutions, delivering tested devices and deploying these into clinical practice. Both the process and BETIC’s medical device quality management system received ISO 13485 certification in 2018, which recognizes the quality of medical devices and related services.
Since BETiC began working with doctors, we have identified 400 specific unmet needs and created 200 novel concepts for them. I am particularly proud that we have already filed 50 patents. Furthermore, BETiC has developed 20 devices, incubated 15 start-ups, licensed five products to industry and launched them into the market rapidly.
Higher education institutes like IITs are increasingly expected to take up research and innovation activities to solve the pressing needs of society. This requires close collaboration between different disciplines within academia as well as with industry and government agencies. Collaboration requires you to drop your personal ego and go beyond your comfort zone. This is easier in the healthcare field, which makes it an excellent sector to start building an ecosystem of translational research, product innovation and entrepreneurship.
For healthcare in India, it is particularly important to focus on low-cost devices to enable extensive screening, with early prediction typically decreasing complications and significantly reducing the cost of treatment. Recent advances in electronics, especially powerful yet low-cost elements such as those which sense, process, and connect, provide many opportunities to reinvent medical devices. We are focusing on screening devices for glaucoma, endotracheal blockage, heart diseases, chronic obstructive pulmonary disorders and clubfoot.
To give an example, the smart stethoscope developed at BETiC is already used by doctors in dozens of primary health centers to record and send auscultated sounds to experts for a second opinion.
The Arm University Program has enabled access to industry-standard tools for medical device development at BETiC. This includes a range of core subjects relevant to Electrical, Electronic and Computer Engineering, Computer Science and indeed beyond. This access to the latest technology has helped accelerate the process of creating innovative industry-specific solutions which are well suited to India’s healthcare conditions.
In particular, the Keil MDK software environment has been beneficial for programming and debugging the Cortex-M series of micro-controllers. Using it, we can develop high-quality applications involving advanced digital signal processing. For example, the glaucoma screening device required signals to be conditioned for noise removal, for which we designed low pass digital filters using the ASN filter designer (an ecosystem partner of Arm DSP). By utilizing this tool, we were able to complete the task in half the time we would have previously. The output of the filter design software is CMSIS-compliant, and therefore can be used directly in the Keil-MDK software.
There are a few devices that have been developed using the Arm Controllers. These products use advanced technology to provide a solution that is quick, specific, and can aid doctors to get a better understanding of their patients or provide treatment.
SMART Stethoscope: Heart and lung diseases have become the top causes of death in India and require effective auscultation (listening to chest sounds) for correct diagnosis. Conventional stethoscopes used by doctors require considerable training and concentration to identify the relevant sound patterns, especially in a noisy environment. We have created an innovative module that converts conventional stethoscopes into digital ones. It enables sound amplification, noise filtering and also has a provision to transfer the body sound to a PC, laptop, or a mobile device. This device uses Arm Cortex-M0+ and M4 controllers for controlling the signals in the machine. The stethoscope uses the Bluetooth low energy stack which runs on a Cortex-M0+ controller.
SMART Clubfoot Brace: Clubfoot refers to a condition in which a newborn's foot or feet appear to be rotated internally at the ankle. The foot points down and inwards, and the soles of the feet face each other. We have developed the SMART Clubfoot Brace, which treats this condition. The treatment includes stretching and casting (the Ponseti method), with a specially designed Foot Abduction Brace (FAB) used for treatment. The brace has shown positive results in practice.
Similarly, our glaucoma screening device enables early treatment to prevent blindness. All these use Arm Cortex M – Controllers, which are optimized for cost and energy-efficient processing.
First, we are currently working on an addition to the SMART Clubfoot Brace monitor, which can be attached to existing braces, leading to increased compliance and reduced recurrence. A novel user-friendly ECG electrode patch can be easily attached to patients for accurate and long-time monitoring. Second, we use a screening device under development at BETiC to earlier detect chronic obstructive pulmonary disorders such as asthma. Sadly, these sorts of conditions are increasingly prevalent due to high pollution levels. Finally, we are also developing an advanced training system for robotic laparoscopic surgeries.
Healthcare is a dynamic sector and requires effective solutions in as short a span of time as possible. Early detection and treatment are key. It has become a necessity for research teams to have an environment with sufficient world-class instruments, reducing the scope of errors to a minimum. The BETiC Lab at IIT Bombay has come up with great solutions by partnering with Arm.
Hopefully, this deep dive with Dr. B Ravi on his approach has sparked some ideas on how you might apply or modify a research and innovation process. Do let us know your thoughts and comments at firstname.lastname@example.org.
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