About the Course:

This short program is designed to give a detailed overview of Biomedical device development from an industry perspective. The program would touch upon the entire process from conception to development of devices from a research, regulatory, clinical, marketing, engineering and legal perspective. Emphasis would be given on the engineering part starting from capturing the requirements and converting them into specifications which would translate into a functional module and later on into a prototype ready for testing and bringing you close to market. The program will be a guide on how to start from scratch to develop a fully functional prototype for your idea/research. This is especially useful for young faculty and students who wish to apply to BIRAC Biotechnology Ignition Grant and other startup grants for career development. This will also benefit mid level and senior level academics who wish to teach Biomedical Engg courses and setup labs in their colleges

 

The course would be divided into following subparts for medical device development:

• Academia Vs Industry - what’s the line that separates academia from industry and what are the crucial elements in a successful translation.

• Regulatory Basics

• Project Management Basics

• Project Planning (Requirement capture till prototype)

• Pre-clinical Research, Design & Development (DFM(Design for manufacturing), DFA(Design for assembly), Fabrication techniques, Design Management

• Pre-clinical and Academic Clinical Testing

• Business 101 - Making a business model

 

​Who May Benefit:

Academics (Young, mid-level and senior-level) that need to translate ideas to biomedical products or wish to apply for startup grants for career development or setup companies

Physicians that have a medical device idea and wish to know the basics of how to get started

Biomedical Engineering (or other STEM) majors who want to learn about medical device development

People fresh out of college that need a basic primer on device development for their job/career development

This course is NOT for seasoned medical device project professionals

 

Hands on Facility:

Yes, using software and demo for the following:

For research methodology

For Project Management

For Mechanical Design (CAD, 2-D Designs, 3-D Printing)

For Electronics Design (PCB’s & Wiring)

 

Course Duration: 5 Days

Dates: September 2019, December 2019, February 2020, May 2020

Registration Last Date: 10.09.2019 / 01.12.2019 / 15.02.2020 / 31.05.2020

Venue: VMCC, IIT Bombay

Certificate issued by IIT Bombay to all successful participants.

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About the organizers/speakers:

The course has been conceptualized by Prof. (Dr.) Rohit Srivastava who has been working on translational Research in India for the past 15+ Yrs. He is Professor & Head of Department at Dept. of Biosciences and Biomedical Engineering, IIT Bombay, Powai, Mumbai. He is the also the PI for Nanobios Lab, IIT Bombay which he established in 2005. His passion for translational work is shared by his students, PhD's, Post Docs & Lab staff which has resulted in multiple successful startups coming out of his lab in the Medical & Healthcare Domain. His main interests areas are : Diagnostics, Orthopedics, Drug Delivery,  Cancer medicine & Nano-Technology. He is known worldwide for his impactful work & research.

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Prof. Srivastava would be assisted by Anurag Meena (Me) for this course. I am an IIT Bombay alumni having done my B.Tech. from IIT Bombay in 2015. Due to immense interest in healthcare & medicine, I started working at Nanobios lab in 2012 and since then I have been a part of it. I started my first company CareNx Innovations along with 2 co-founders in 2014 aimed towards reducing maternal & child mortality in developing countries using software algorithms along with conventional devices. Till now we have touched 30,000 + mothers in 500+ villages through 9+ states in India using our product CareMother, which has won many awards & recognition in India. CareNx is funded & revenue generating now. I started my second Entrepreneurial venture to design & develop medical devices & instruments in 2016 along with two other IIT Bombay alumni. We have till date designed Diagnostic Devices, Point of Care Analyzers, Surgical instruments & allied software for our clients. We have a team who is experienced not only in the design, development & engineering of such devices but also in the QMS (Quality Management System), Requirement capture, Project planning & regulatory framework for the same. 

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Besides Prof. Srivastava & Mr. Anurag, the course would be managed & taken by:

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Doctors involved in Clinical research on finding problems & clinical requirement capture to design products that have a strong Problem-Need-Solution Fit

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Senior Personnel for Regulatory requirements & QMS for medical product development

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Mechanical & Electrical Engineers for Designing & Developing various subsystems of the device

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Project Manager for delivering lecture on project planning, management & resource allocation

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