India annually imports medical devices worth over Rs. 30,000 crores, most of them unaffordable and unsuitable for local population. There is a need to indigenously develop high-quality yet affordable devices for local manufacture and use. Biomedical Engineering and Technology (incubation) Centre or BETiC at IIT Bombay is bringing the relevant stake-holders together for this purpose.
With satellite cells at VNIT Nagpur, COE Pune, MGM Vashi, BKLWH Dervan, DMIMS Wardha, KJSCE Vidyavihar and MIT-ADT Pune, BETiC is among the largest medical device innovation groups in India with more than 100 faculty, research fellows, students, expert doctors and domain consultants. During 2015-2018, they identified over 300 unmet clinical needs, developed proof-of-concepts for 100 different devices, and filed 40 patents. Of these, 15 products are being productionized by start-ups, Indian companies and NGOs (see box), and have already benefitted many patients through initial clinical studies in different hospitals.
BETiC Products Productionized
|Device Type||Device Name||Partner Industry/Hospital|
|Screening, diagnostic & monitoring||smart stethoscope||Ayu Devices|
|clubfoot brace monitor||Metwiz Materials|
|diabetic foot screener||MGM Hospital|
|glaucoma screener||Bhandara Hospital|
|multi-use biopsy gun||Tenon Meditech|
|Surgical instruments & software||orthopaedic surgery planner||AlgoSurg Products|
|laparoscopy instrument||Eclipse Instrumentation|
|nasal osteotomy forceps||Om Surgicals|
|heart valve leaflet template||Fortis Hospital|
|orthopedic cutting jigs||MGM Hospital|
|Prostheses, orthoses & implants||above-knee prosthesis||Ratna Nidhi Charitable Trust|
|hybrid splint||MediAsha Technologies|
|silicone implants||NU OSSA Mediquip|
|3D-printed bone scaffolds||DMIMS, Wardha|
|bone compression screw||Swarup Hospital|
Facilities and Network
The BETiC initiative is envisioned and supported by RGSTC, Govt. of Maharashtra, Mumbai and DST, New Delhi, to accelerate indigenous development of affordable medical devices suitable for local manufacture and use.
Facilities at IITB include medical modelling, computer-aided design and analysis, laser cutter, 3D printers (plastic, multi-material and metal), PCB (printed circuit board) design & fabrication, and others. The team shares and utilizes complementary facilities, such as Gait Lab equipped with motion sensing cameras and force plates at MGM Institute of Health Sciences, Navi Mumbai and 3D Bio-Plotter suitable for tissue engineering at VNIT Nagpur.
BETiC team has established good links with several hundred expert clinicians in Mumbai, Pune, Nagpur, Bangalore and other cities. They represent various medical specialties like orthopedics, cardiology, neurology, urology and general medicine; as well as domains like oncology, laparoscopy, diagnostic imaging and rehabilitation. Many leading hospitals are connected to BETiC centres through exchange visits, data sharing, training and joint projects. A multi-pronged MoU has been signed with AP Med Tech Zone, Visakhapatnam for manufacturing and testing.
Clinical immersion and interaction is an important and essential part of medical device innovation. ‘Bed to bench’ – identifying an unmet clinical problem, ‘bench to business’ – developing a suitable solution, and ‘business to bed’ – taking the solution to end-users, require close interaction between doctors, researchers and entrepreneurs. The innovation process and quality management system for medical devices at BETiC has been awarded an ISO 13485 certification.
BETiC Fellows are selected from hackathons and training camps, then supported for about a year, till the ‘edge of commercialization’. After starting a device project, weekly meetings are set up with clinicians in hospital or lab. The clinicians point out unmet needs, and explain the limitations of current solutions, especially for local patients. BETiC team visits hospitals to observe clinical procedures, understand the specialty, and precisely define the problem. They also engage with other care-givers like nursing staff, radiologists, pathologists and physiotherapists. This helps in obtaining timely feedback on device specifications, design, simulation, prototypes, and test data.
Solution ideas are generated, proof-of-concepts are fabricated, and feedback is sought from domain experts to establish the feasibility of the project. This is presented to senior members of the team for feedback before committing further resources. Then several iterations of product design, rapid prototyping, lab testing and clinician feedback are carried out. Finally, a small batch of functional prototypes are produced by engaging with local vendors (this takes the most time and effort). The device is exhibited in medical fairs and other exhibitions for widespread feedback. Finally, the innovators incubate start-up companies in SINE or license the technology to Indian companies having good facilities, distribution network and track record.
The products and team members have won several innovation awards. This includes Gandhian Young Technological Award, DST India Innovation Gold Medal, Biotechnology Ignition Grant (4 times), Google Impact Challenge, Dr. Albert Schweitzer International Health Award, Dr. B.C. Roy International Award, Emerging Startup of the Year, American Bazaar StartUp Competition, Young Entrepreneur Award, and Swissnex DST AIT Award.
They have also been prominently featured in TV and print media, such as Forbes India (May 2018 issue).
The stories of 16 BETiC innovators are narrated in the book ‘The Essence of Medical Device Innovation’ authored by Prof. B. Ravi, which is published by Crossword and available in both Amazon and Flipkart.
Prof. Ravi describes his own journey in this field in an interesting presentation and interview at Living Science channel.
Do plan and visit BETiC the next time you are in IIT Bombay!