Indigenous Medical Device Innovation. Biomedical Engineering and Technology (incubation) Centre, IIT Bombay

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1 Indigenous Medical Device Innovation Biomedical Engineering and Technology (incubation) Centre, IIT Bombay

2 BETiC A.M. Kuthe (VNIT Nagpur), B. Ravi (IIT Bombay) and B.B. Ahuja (COE Pune)

3 Welcome! BETiC Biomedical Engineering and Technology (incubation) Centre is a network of medical device R&D facilities at IIT Bombay; VNIT, Nagpur; College of Engineering, Pune and other partner institutes. This initiative is envisioned and supported by Government of Maharashtra to accelerate indigenous development and manufacture of medical devices suitable for the local population. The centers have about 50 multi-disciplinary faculty, full-time researchers and students, collaborating with an equal number of expert clinicians from top hospitals in India to identify unmet clinical needs and develop novel yet affordable solutions. The journey usually starts from a medical device innovation camp (MEDIC), where the participants are trained how to define, develop, deliver and deploy a medical device. Successful innovators are invited to join BETiC, where they are mentored and supported till the edge of commercialization leading to start-ups or licensing. During , the BETiC team identified 300 needs, prototyped 75 devices, filed 25 patents, and licensed 10 products to Indian companies, NGOs or hospitals. Doctors, researchers, entrepreneurs, investors and facilitators interested in contributing to Made in India medical devices are invited to visit or get in touch with us. Prof. A.M. Kuthe Prof. B. Ravi Prof. B.B. Ahuja Co-PI, BETiC-VNIT PI, BETiC-IITB Co-PI, BETiC-COEP

4 Medical Device Innovation Camp Many clinicians approach BETiC with pressing problems like low-cost devices to screen rural patients or reusable surgical instruments. These are curated by senior members of BETiC team to check for market need, novelty and technical feasibility. Further, many working professionals who visit BETiC express their desire to work full time in this field. These three groups of people clinicians, mentors and potential innovators are brought together in a five-day camp to create proof-of-concepts. Medical Device Innovation Camp (MEDIC) starts with hospital visits. Participants form teams of four doctor, designer, engineer and entrepreneur. Then they brain-storm new ideas, sketch the concepts, fabricate prototypes and create business models, guided by mentors. The proof-of-concepts are evaluated on the last day by an expert jury panel. Committed innovators with the most promising ideas are invited to join BETiC. MEDIC is held in September: IIT Bombay (2015), VNIT Nagpur (2016), COE Pune (2017). The selection is through weekend Medical Device Hackathons (MEDHA). The first MEDHA was held at IISc Bangalore (2016). In 2017, four MEDHA were organised in July-August at KJSCE, Mumbai; BJMC, Pune; DMIMS, Wardha; and Shivaji University, Kolhapur. Never thought one can learn and do so much in 5 days. It was great fun learning and working with doctors. Felt like an engineer, first time in life. We are on a high even after 4 night-outs. Decided to pursue my career in medical innovation. MEDIC Participants

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6 Advanced Training in BETiC MEDIC winners and others interested in developing medical devices are invited to spend a few days at BETiC Mumbai, Nagpur or Pune. They can opt for 1-3 months internship, and associate with ongoing device projects. BETiC is equipped with facilities for medical modelling; computer-aided design and analysis; rapid prototyping by 3D printing and laser cutting; PCB (printed circuit board) design and fabrication; device inspection and testing; and others. These are maintained in line with ISO standard quality management system for medical devices. Depending on their academic background and professional experience, interns are put on a mentor-guided self-learning programme to fill any gaps in their skill-sets essential for medical device innovation. Soft skills like team work, professionalism, empathizing with patients, effective communication and presentations are emphasized. During this period, the interns explore and select suitable medical device projects. They meet clinicians, conduct market surveys, and scan relevant patents. 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. Depending on their performance and commitment, the interns are invited to join as BETiC Fellow researchers for one year. They are mandated to convert prototypes into products and create their own startup company or license the products to Indian companies.

7 IDEA Room Electronics CAD Room Proto Room

8 Clinical Immersion and Interactions Clinical immersion and interaction is an important and essential part of medical device innovation. Bed to bench finding a clinical problem, bench to business developing a suitable solution, and business to bed providing the solution to end-users, require close interaction between doctors, researchers and entrepreneurs. BETiC team has established good links with several hundred expert clinicians in Mumbai, Pune, Nagpur, Bangalore and other places. They represent various medical specialties like orthopedics, cardiology, urology and general medicine; as well as domains like oncology, laparoscopy, diagnostic imaging and rehabilitation. Many leading hospitals in Mumbai and elsewhere have agreements with BETiC institutes for exchange visits, data sharing, training and joint projects. A multi-pronged MoU has been signed with AP Med Tech Zone, Visakhapatnam. 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 define the problem clearly. They also engage with other care-givers like nursing staff, radiologists, pathologists and physiotherapists. After starting a device project, weekly meetings are set up with clinicians in hospital or lab. This helps in obtaining timely feedback on device specifications, design, simulation, prototype, and test data. Indeed, the commitment and availability of clinicians is a key criteria for taking up medical device projects.

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10 Bed Bench Business Bed I. Define (Doctor) Team Building Problem Definition Clinical Immersion Concept & Feasibility II. Develop (Researcher) Detailed Design Rapid Prototype Virtual Prototype Functional Prototype III. Deliver (Entrepreneur) Good Mfg. Practice Clinical Trials Pre-Clinical Testing Device Certification IV. Deploy (End User) IPR Management Scale Up (Funding) Business Model Improvements

11 Define Deploy Develop Deliver

12 Medical Device Exhibitions The acid test for an innovative device is its wide acceptance by clinicians, domain experts and entrepreneurs. This is ascertained by showcasing in medical expos. BETiC organized its first medical device expo at BKL Walawalkar Rural Hospital, Dervan in There were about 50 young innovators from the three centers (Mumbai, Nagpur and Pune) as well a few local colleges. The second expo was organized at the College of Engineering, Pune in There were 50 booths, where over 80 innovators drawn from both engineering and medical institutes displayed their innovative medical device prototypes. BETiC researchers have also exhibited their devices in many other events across India, including Delhi, Mumbai, Goa and Bangalore.

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14 Start-up Incubation and Licensing BETiC researchers incubate start-ups to take their devices to end users, or license them to Indian companies having good facilities, distribution network and track record. Another route is directly to the hospitals or NGOs who are associated with the specific project from the beginning. The overall goal is to ensure that the end-users benefit from an innovative product at the earliest, while ensuring world-class quality at affordable cost. Ten products developed include diagnostic, monitoring, screening, surgical instruments, software, and patient-specific devices. These have touched over 150 people. Visit us ( and to start an exciting journey!

15 Digital Stethoscope Glaucoma Screener Diagnostic Monitoring Screening Instruments Prostheses Clubfoot Brace Sensor Compression Screws Diabetic Foot Screener Surgery Planner Nasal Forceps Flexible Laparoscopy Instrument Aortic Valve Template Custom Socket for Leg Prosthesis

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