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Introduction to Biodesign - Stanford University - Ravi Pamnani

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Empreender Saúde
Empreender Saúde

Ravi Pamnani is a Biodesign alumni and marketing manager of Transcendent, a medtech startup in San Francisco. The Biodesign program from Stanford University is a cross-discipline course to educate better medical device entrepreneurs. This presentation was given in August 2014 in Brazil for the MedTech World, as part of launch of the research I Research on R&D for medical devices in Brazil created by Empreender Saude, that can be found at the link: http://www.slideshare.net/EmpreenderSaude/i-pesquisa-status-da-indstria-de-medical-devices-no-brasil

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Introduction to the Stanford Biodesign Program Ravi Pamnani Research Affiliate, Stanford University Sr. Manager, Marketing & Medical Affairs, Transcend Medical 27 August 2014 MD&M Brazil, São Paulo
How Does Innovation Happen? 2
Innovation is a Process 3 I have not failed. I've just found 10,000 ways that won't work. Thomas Edison, Really, Really Persistent
4 1.1 Strategic Focus 1.2 Observation & Problem Identification 1.3 Need Statement Development 2.1 Disease State Fundamentals 2.2 Treatment Options 2.3 Stakeholder Analysis 2.4 Market Analysis 2.5 Needs Filtering 4.6 Final Concept Selection 1. NEEDS FINDING 3. CONCEPT GENERATION 5. DEVELOPMENT STRATEGY & PLANNING 5.1 IP Strategy 5.3 Clinical Strategy 5.6 Reimbursement Strategy 5.5 Quality & Process Management 5.2 R&D Strategy 6. INTEGRATION 5.8 Sales & Distribution Strategy 6.2 Business Plan Development 6.3 Funding Sources 5.9 Competitive Advantage & Business Strategy 6.1 Operating Plan & Financial Model 2. NEEDS SCREENING IDENTIFY INVENT IMPLEMENT 3.1 Ideation & Brainstorming 4.1 Intellectual Property Basics 4.5 Prototyping 4.2 Regulatory Basics 4.3 Reimbursement Basics 4.4 Business Models 3.2 Concept Screening 4. CONCEPT SELECTION 5.7 Marketing & Stakeholder Strategy 6.4 Licensing & Alternate Pathways 5.4 Regulatory Strategy 4 The Biodesign Process
To develop leaders in biomedical technology innovation Educate. Collaborate. Innovate. Mission of the Biodesign Program
Stanford Biodesign White Team – 2010-2011 6
•Introduction to Program •Clinical and Innovation Lectures •Meetings with Mentors •Introduction to Sponsors Intensive Background Learning –1 month 7
Become a Mini-Clinical Expert 8
Become a Mini-Biodesign Expert 9
Start with the Unmet Need I find out what the world needs. Then, I go ahead and invent it. Thomas Edison, Good Inventor, Better Need Finder 10
Clinical Immersion – 2 months 11
Identify >200 Needs and Rank Them 12 1.Clinical / User impact •Convenience •Life-saving 2.Prevalence/Incidence •Birth defects •Headaches 3.Economic impact •Sometimes a function of #1 above
13 needs NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED
Concept Generation - Brainstorming 14 The best way to have a good idea is to have lots of ideas. Linus Pauling, Had lots of really good ideas
15 needs concepts NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT
Concept Selection and Prototyping 16 1.Predicted efficacy 2.Estimated technical feasibility 3.Intellectual property 4.Regulatory pathway established 5.Payment / business model known
17 needs concepts NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT
Development Strategy & Planning 18 5. DEVELOPMENT STRATEGY & PLANNING 5.1 IP Strategy 5.3 Clinical Strategy 5.6 Reimbursement Strategy 5.5 Quality & Process Management 5.2 R&D Strategy 5.8 Sales & Distribution Strategy 5.9 Competitive Advantage & Business Strategy IMPLEMENT 5.7 Marketing & Stakeholder Strategy 5.4 Regulatory Strategy 18
Integration 19 6. INTEGRATION 6.2 Business Plan Development 6.3 Funding Sources 6.1 Operating Plan & Financial Model 6.4 Licensing & Alternate Pathways
20 1.1 Strategic Focus 1.2 Observation & Problem Identification 1.3 Need Statement Development 2.1 Disease State Fundamentals 2.2 Treatment Options 2.3 Stakeholder Analysis 2.4 Market Analysis 2.5 Needs Filtering 4.6 Final Concept Selection 1. NEEDS FINDING 3. CONCEPT GENERATION 5. DEVELOPMENT STRATEGY & PLANNING 5.1 IP Strategy 5.3 Clinical Strategy 5.6 Reimbursement Strategy 5.5 Quality & Process Management 5.2 R&D Strategy 6. INTEGRATION 5.8 Sales & Distribution Strategy 6.2 Business Plan Development 6.3 Funding Sources 5.9 Competitive Advantage & Business Strategy 6.1 Operating Plan & Financial Model 2. NEEDS SCREENING IDENTIFY INVENT IMPLEMENT 3.1 Ideation & Brainstorming 4.1 Intellectual Property Basics 4.5 Prototyping 4.2 Regulatory Basics 4.3 Reimbursement Basics 4.4 Business Models 3.2 Concept Screening 4. CONCEPT SELECTION 5.7 Marketing & Stakeholder Strategy 6.4 Licensing & Alternate Pathways 5.4 Regulatory Strategy 20 The Biodesign Process
Biodesign Year OUS, US Clinical Status Business Status Acquired 1-C 1-F 1-F 2-F 2-C 5-F 5-C 6-F OUS, US OUS, US OUS, US OUS OUS, US OUS Preclinical Acquired Acquired Acquired Series B Series D Series C SBIR Ph. 1 5-C Series A Preclinical 5-F Preclinical Series A Fellow and Student Companies
Biodesign Year Clinical Status Business Status 6-C 8-F 8-I 6-F 8-F 7-F Series A Seed Series A Seed Angel Angel FIH OUS Approved US Preclinical OUS 6-C OUS Series C 6-F OUS Series B 6-C Series B Preclinical 8-F Seed Preclinical Fellow and Student Companies
Biodesign Year Clinical Status Business Status 9-F Seed Preclinical 10-C 10-F Series A Series A Seed US Preclinical 11-F FIH 9-C Seed US 9-F Series A Preclinical BioTrace Medical 9-F Series B US Seed 11-F Preclinical SFDA Series A 12-F FIH 10-F OUS Series B Fellow and Student Companies
Obrigado! 24

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Introduction to Biodesign - Stanford University - Ravi Pamnani

  • 1. Introduction to the Stanford Biodesign Program Ravi Pamnani Research Affiliate, Stanford University Sr. Manager, Marketing & Medical Affairs, Transcend Medical 27 August 2014 MD&M Brazil, São Paulo
  • 3. Innovation is a Process 3 I have not failed. I've just found 10,000 ways that won't work. Thomas Edison, Really, Really Persistent
  • 4. 4 1.1 Strategic Focus 1.2 Observation & Problem Identification 1.3 Need Statement Development 2.1 Disease State Fundamentals 2.2 Treatment Options 2.3 Stakeholder Analysis 2.4 Market Analysis 2.5 Needs Filtering 4.6 Final Concept Selection 1. NEEDS FINDING 3. CONCEPT GENERATION 5. DEVELOPMENT STRATEGY & PLANNING 5.1 IP Strategy 5.3 Clinical Strategy 5.6 Reimbursement Strategy 5.5 Quality & Process Management 5.2 R&D Strategy 6. INTEGRATION 5.8 Sales & Distribution Strategy 6.2 Business Plan Development 6.3 Funding Sources 5.9 Competitive Advantage & Business Strategy 6.1 Operating Plan & Financial Model 2. NEEDS SCREENING IDENTIFY INVENT IMPLEMENT 3.1 Ideation & Brainstorming 4.1 Intellectual Property Basics 4.5 Prototyping 4.2 Regulatory Basics 4.3 Reimbursement Basics 4.4 Business Models 3.2 Concept Screening 4. CONCEPT SELECTION 5.7 Marketing & Stakeholder Strategy 6.4 Licensing & Alternate Pathways 5.4 Regulatory Strategy 4 The Biodesign Process
  • 5. To develop leaders in biomedical technology innovation Educate. Collaborate. Innovate. Mission of the Biodesign Program
  • 6. Stanford Biodesign White Team – 2010-2011 6
  • 7. •Introduction to Program •Clinical and Innovation Lectures •Meetings with Mentors •Introduction to Sponsors Intensive Background Learning –1 month 7
  • 10. Start with the Unmet Need I find out what the world needs. Then, I go ahead and invent it. Thomas Edison, Good Inventor, Better Need Finder 10
  • 11. Clinical Immersion – 2 months 11
  • 12. Identify >200 Needs and Rank Them 12 1.Clinical / User impact •Convenience •Life-saving 2.Prevalence/Incidence •Birth defects •Headaches 3.Economic impact •Sometimes a function of #1 above
  • 13. 13 needs NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED
  • 14. Concept Generation - Brainstorming 14 The best way to have a good idea is to have lots of ideas. Linus Pauling, Had lots of really good ideas
  • 15. 15 needs concepts NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT
  • 16. Concept Selection and Prototyping 16 1.Predicted efficacy 2.Estimated technical feasibility 3.Intellectual property 4.Regulatory pathway established 5.Payment / business model known
  • 17. 17 needs concepts NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED NEED CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT CONCEPT
  • 18. Development Strategy & Planning 18 5. DEVELOPMENT STRATEGY & PLANNING 5.1 IP Strategy 5.3 Clinical Strategy 5.6 Reimbursement Strategy 5.5 Quality & Process Management 5.2 R&D Strategy 5.8 Sales & Distribution Strategy 5.9 Competitive Advantage & Business Strategy IMPLEMENT 5.7 Marketing & Stakeholder Strategy 5.4 Regulatory Strategy 18
  • 19. Integration 19 6. INTEGRATION 6.2 Business Plan Development 6.3 Funding Sources 6.1 Operating Plan & Financial Model 6.4 Licensing & Alternate Pathways
  • 20. 20 1.1 Strategic Focus 1.2 Observation & Problem Identification 1.3 Need Statement Development 2.1 Disease State Fundamentals 2.2 Treatment Options 2.3 Stakeholder Analysis 2.4 Market Analysis 2.5 Needs Filtering 4.6 Final Concept Selection 1. NEEDS FINDING 3. CONCEPT GENERATION 5. DEVELOPMENT STRATEGY & PLANNING 5.1 IP Strategy 5.3 Clinical Strategy 5.6 Reimbursement Strategy 5.5 Quality & Process Management 5.2 R&D Strategy 6. INTEGRATION 5.8 Sales & Distribution Strategy 6.2 Business Plan Development 6.3 Funding Sources 5.9 Competitive Advantage & Business Strategy 6.1 Operating Plan & Financial Model 2. NEEDS SCREENING IDENTIFY INVENT IMPLEMENT 3.1 Ideation & Brainstorming 4.1 Intellectual Property Basics 4.5 Prototyping 4.2 Regulatory Basics 4.3 Reimbursement Basics 4.4 Business Models 3.2 Concept Screening 4. CONCEPT SELECTION 5.7 Marketing & Stakeholder Strategy 6.4 Licensing & Alternate Pathways 5.4 Regulatory Strategy 20 The Biodesign Process
  • 21. Biodesign Year OUS, US Clinical Status Business Status Acquired 1-C 1-F 1-F 2-F 2-C 5-F 5-C 6-F OUS, US OUS, US OUS, US OUS OUS, US OUS Preclinical Acquired Acquired Acquired Series B Series D Series C SBIR Ph. 1 5-C Series A Preclinical 5-F Preclinical Series A Fellow and Student Companies
  • 22. Biodesign Year Clinical Status Business Status 6-C 8-F 8-I 6-F 8-F 7-F Series A Seed Series A Seed Angel Angel FIH OUS Approved US Preclinical OUS 6-C OUS Series C 6-F OUS Series B 6-C Series B Preclinical 8-F Seed Preclinical Fellow and Student Companies
  • 23. Biodesign Year Clinical Status Business Status 9-F Seed Preclinical 10-C 10-F Series A Series A Seed US Preclinical 11-F FIH 9-C Seed US 9-F Series A Preclinical BioTrace Medical 9-F Series B US Seed 11-F Preclinical SFDA Series A 12-F FIH 10-F OUS Series B Fellow and Student Companies