Open 2013: Stanford-India Biodesign: Lessons learned from an Indo-US collaboration
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This document summarizes the Stanford India Biodesign program, which is a 12-year medical technology innovation collaboration between Stanford University and institutions in India. The program aims to train leaders in medical device innovation in India and develop technologies to address unmet clinical needs. It has included over 300 fellowship applicants, trained 25 fellows and 28 interns, filed 20 provisional patents, and developed 15 medical devices. Examples of projects include devices for fecal incontinence, intraosseous access, limb immobilization, newborn hearing screening, and neonatal resuscitation. The program has also organized annual summits and helped launch a national biodesign curriculum in India.
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Open 2013: Stanford-India Biodesign: Lessons learned from an Indo-US collaboration
- 1. STANFORD INDIA BIODESIGN Lessons Learned from an Indo-US Collaboration NCIIA Open 2013 Ritu Kamal
- 2. Disparity in India Mumbai 2013
- 3. Disparity in Indian Healthcare *Biodesign Fellows
- 4. Examples of Medical Technology Innovation What is beyond these dated examples? *jaipurknee.org, www.worlddiabetesfoundation.org/composite-2731.htm
- 5. Opportunity for Innovation ✤ Healthcare growth drivers are creating opportunities for innovation ✤ Low cost, high-quality medical devices need to be created to address unmet needs in India
- 6. The Biodesign Process is a systematic approach to medical technology innovation 12 year old innovation program based at Stanford University
- 7. need concept need need need concept need need concept need need need need need concept need need need need concept FINAL need CONCEPT need need concept need need need need need concept need need need concept need need concept need The Biodesign Process
- 8. 1. NEEDS FINDING 2. NEEDS SCREENING 2.1 2.3 Stakeholder IDENTIFY Disease State Analysis 1.2 Observation 1.3 Fundamentals 2.5 1.1 & Problem Need Statement Needs Strategic Focus Identification Development Filtering 2.2 2.4 Treatment Market Analysis Options 4. CONCEPT SELECTION 3. CONCEPT GENERATION 4.1 4.3 Intellectual Reimbursement INVENT 3.1 3.2 Property Basics Basics 4.6 4.5 Ideation & Concept Final Concept Prototyping Brainstorming Screening Selection 4.2 4.4 Regulatory Business Models Basics 5. DEVELOPMENT STRATEGY & PLANNING 6. INTEGRATION 5.7 Marketing & 5.1 5.4 Stakeholder IP Strategy Regulatory Strategy Strategy 6.1 IMPLEMENT 6.3 Operating Plan & Funding Sources Financial Model 5.5 Quality & 5.8 5.2 Process Sales & Distribution R&D Strategy Management Strategy 6.2 6.4 Licensing & Business Plan Alternate Development Pathways 5.9 Competitive 5.3 5.6 Reimbursement Advantage & Clinical Strategy Strategy Business Strategy Identify → Invent → Implement
- 9. Origins of Stanford India Biodesign New Delhi, 2006
- 10. Goals ✤ Identify and train potential leaders in the medical technology innovation in India ✤ Develop medical technologies to solve unmet clinical needs in India ✤ Fuel the growth of the Indian medical technology industry
- 11. Department of Stanford University Biotechnology IIT, Delhi Ministry of Science AIIMS, Delhi and Technology Collaborators and Supporters
- 12. Program Offerings ✤ Stanford-India Biodesign Fellowships ✤ India Biodesign Internships at AIIMS/IIT Delhi ✤ Global student and faculty exchanges ✤ Annual Indian MedTech Summit ✤ National SIB Center in Delhi ✤ Management workshops ✤ www.indiabiodesign.org networking community
- 13. Stanford India Biodesign Fellows 2007-2013
- 14. Stanford, CA AIIMS, New Delhi Understand Live Project Fellowship Year
- 15. Clinical Immersion Tertiary and Secondary Healthcare settings
- 16. Clinical Immersion Primary and Outreach Healthcare settings
- 17. SIB Internship ✤ Delhi Program trains 5-8 interns yearly ✤ Internship lasts 3-4 months ✤ SIB Fellows act as mentors ✤ Interns have produced innovative products
- 18. Indian Medtech Summit Held Annually in New Delhi 2011 attendance - over 300 including participation by the NIH
- 19. Indian Medtech Summit 2013 Keynote Speaker: State Minister for Higher Education
- 20. Launch of National Biodesign Curriculum Innovation Course taught at several engineering colleges
- 21. Results ✤ >300 applicants to the fellowship each year; 4 selected ✤ 25 Fellows trained ✤ 28 Interns trained ✤ 20 provisional patents filed ✤ 6 Summits held ✤ 15 devices developed ✤ 1 Venture backed company (Consure) ✤ 3 Licensed products
- 22. Co-Founders: Nish Chasmawala, Amit Sharma, Dr Sandeep Singh Closed first round of venture funding in August 2012 16M patients affected every year No affordable device available • Developed for all stool types and sphincter tones • Easy and hygienic to use (profile and placement) • Reduces nursing time (leakage and dislodgement) • Minimal training required Project 1: A novel way to manage fecal incontinence in non-ambulatory patients
- 23. Placement Insertion Remove Guide Infuse • Manual operation Team: Jayant Karve, Srinivas Kiran, Dr • Ergonomic design • Sterility maintenance Sandeep Singh • Needle guidance & visibility Project 2: A better way to gain intraosseous access in emergency patients “IO infusion should be the first alternative to IV in cardiac arrest patients”
- 24. 15 Million 5.4 Million Road Traffic Accidents (RTAs) per annum in India Incidence of Lower Limb Injuries in RTAs Team: Pulin Raje, Dr Darshan Nayak • A disposable splint • Easy to use • Ultra low cost • Licensed to Hindustan Latex Limited in Nov 2012 Project 3: A better way to temporarily immobilize lower limbs in trauma patients
- 25. Screening for all 100,000 are born hearing impaired in India each year • Low cost hearing screening device • Unique reusable electrode system Team: Nitin Sisodia, Dr Ramesh Agarwal, Dr Rakesh • Novel algorithm Lodha • Novel noise cancellation Project 4: A novel hearing screening device for newborns
- 26. Birth Asphyxia: 15,00,000 2,10,000 2.6 crore won’t breathe annual births babies die at birth every year Effective resuscitation can save almost all these Team: Ayesha Chaudhary, Dr Avijit Bansal, Dr Ramesh Agarwal, Dr Rakesh Lodha • Automatically positions neck • In built suction, no power required • Easier better sealing • Objective feedback • Single operator use • Built in timer and heart rate monitor Project 5: An easy to use neonatal resuscitation system
- 28. India-Biodesign.org Networking website with over 800 members