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Invisa Engr245 2022 Lessons Learned

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Invisa Engr245 2022 Lessons Learned

  1. INVISA BIO Self Assembling Medical Devices BS MaterialsScience & Engineering EMILY STEIN ZOE VONGERLACH MS Management Science and Engineering, BS Computer Science MS Education Data Science, BS Business ANNA-JULIASTORCH HELEN GORDAN BS Electrical Engineering, Icahn School of Med @ Mt. Sinai ℅ 2027 Mentor LISA MCDONALD
  2. 2 INVISA BIO WEEK 10 WEEK 0 What we were: ▪ Manufacturing and delivery of self assembling devices ▪ Injection-based device delivery 110 Interviews Where? Brain Coil What we are now: ▪ Manufacturing of self assembling medical devices ▪ Leverage mechanisms designed for drug delivery ▪ Access difficult-to-reach targets Stent What Device?
  3. INVISA BIO “You need to have a ‘killer application’” Joe DeSimone Professor of Chemical Engineering and Founder @ Carbon Optholmalogy Cardiovascular Gastrointestinal Brain Joints Skin Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  4. INVISA BIO Medical Device Distributors Need to convince them to take our product FDA & Regulatory + IP Advisors Marketing, BD, research salaries Nurses, KOLs Patient forums & digital engagement Neurointerventionalists Working at early adopter hospitals (research-based) Enable new treatments by accessing difficult-to-reach locations Key Partners Key Activities Key Resources Cost structure Value Proposition Sales Channels Customer Relationships Customer Segments Revenue Streams Medical Device Distributors Commercial manufacturers of medical device components; Chemical suppliers Top research team & lab (3D printers, etc) State of the Art Software models (simulation) and engineers R&D to launch new applications of technology (platform) Forming strong sales partnerships Clinical Trials Deliver large devices through narrow passages Real Life outcome studies Medical Device distributors Direct salesforce Corporate Partners/Licensing MedTech supply purchase by hospitals & outpatient clinics MedTech manufacturer licensing technology External Sales /Distributor Legal & IP Manufactur./ purchasing OTL licensing Hospital for clinical trials, co-development Research facilities, materials Office rent FRAMEWORK: BUSINESS MODEL CANVAS
  5. INVISA BIO MINIMALLY INVASIVE SURGERY IS ALREADY HERE! Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2 Jared Bouis Stryker Sales Rep Our 0.3mm catheter can enter any vessel, but will sometimes fail if it needs to deliver a large device through a small vessel. Our New Value Proposition: Enable access to difficult-to- reach locations
  6. INVISA BIO WE FOUND A NEED IN PEDIATRIC CARDIOLOGY! I have probably lost 8-10 years of my life on pulmonary vein stenosis Dr. Alessandro Larrazabal Pediatric Interventional Cardiologist @ UCSF If the device is too big or the delivery mechanism cannot be used on a baby then we need to have [invasive] surgery Dr. Laura Robertson Pediatric Cardiologist @ UCSF Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  7. INVISA BIO PATIENT ENROLLMENT LEADS TO LONG REGULATORY TIMELINES Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2 Adam Landsman DPM / PhD @ Mass General I can’t think of anything similar on the market. You will have to go through the whole process as a Class III device. Majority of Devices Exempt from 510(k) Requires 510(k) Premarket Notification Requires Premarket Approval (PMA) 2+ Clinical Trials = 3- 10+ Years!
  8. INVISA BIO Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  9. INVISA BIO JOINT OSTEOARTHRITIS IS A SAFER FIRST APPLICATION Osteoarthritis Simple localization Huge market Safe trials No existing solution Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  10. INVISA BIO OSTEOARTHRITIS: WE DISCOVERED A REAL NEED! Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2 "This is the holy grail” “You have NO competition.” “I would pay 1000s of dollars a year to prevent osteoarthritis” Dr. Mark Clapper, MD Former Chief of Kaiser San Diego Orthopaedic Department Dr. Bill Maloney Chief of Orthopedics @ Stanford 40 Year Old Employee @ Stanford PIVOT!
  11. 12 INVISA BIO FUNDING: ADJUST TO DEVELOPMENTAL/REGULATORY TIMELINES It’s smart to capitalize on the resources and connections of the university so that you do not have to rent lab space yourself. Incorporate & raise money as soon as possible Stay in the university as long as possible Seek academic grants while still in the university. Lisa McDonald Austin Technology Incubator Todd Morrill Instructor, Lean Launchpad Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  12. INVISA BIO BALANCING OUTSOURCING: SALES & MANUFACTURING Time = Money Knowledge “Time is the most valuable resource for early medtech companies. Outsource everything you can.” “Do things yourself and you will discover things you didn’t know that you didn’t know.” Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2 Joe Heaunue Co-Founder, Triple Ring Technologies Doug Stoakley Co-Founder, COO @ ClearCam
  13. INVISA BIO MECHANICAL SHOCK ABSORBERS AS ALTERNATIVE SOLUTION DR. JIMMY CHOW ORTHOPEDIC SURGEON AND MEDICAL ENGINEER Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2 Mechanical shock absorbers could be an interesting alternative to the stem cell solution that the industry is pursuing
  14. INVISA BIO STEM CELLS ENTER THE PICTURE Dr. Chuck Chan Professor of Surgery,Expert on Stem Cell Cartilage Regeneration stem cell Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  15. INVISA BIO WE ABANDONED OSTEOARTHRITIS DUE TO COMPLEX TECHNOLOGY INTEGRATIONS Principal @RA Capital Healthcare & Life Science Investment Firm You really don’t want to have a Frankenstein Technology Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  16. What is our key value? Collecting our Learnings Some Chocolate for the good mood:)
  17. INVISA BIO KEEP FOCUSING: INTEGRATE INTO THE STANDARD OF CARE Why don’t you use a catheter? You will still add a lot of great value! Paul Yock Former Director, Stanford Biodesign; Inventor & Interventional Cardiologist Syringe Catheter Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  18. INVISA BIO TREATING BRAIN ANEURYSMS HAS PROBLEMS WE COULD SOLVE Enable access to difficult-to-reach locations Small vessel Stent delivered in bigger environment Brain Aneurysms PIVOT TO… Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 1 Week 2
  19. INVISA BIO WE SHADOWED PHYSICIANS WEEKLY IN THE HOSPITAL Cath Lab Visit(s), Led by Head of Neuroradiology @Stanford Self-Assembly? I’m listening! Why don’t we start meeting weekly and think how we can develop something together? Stanford Hospital Cath Lab Visits
  20. INVISA BIO WHAT’S NEXT? BS Materials Science & Engineering EMILY STEIN MS Education Data Science, BS Business ANNA-JULIASTORCH HELEN GORDAN BS Electrical Engineering, Pre-Med Sales Representative Shadowing Device Design with NIR Physicians in Hospital Technology Development in Lab ZOE VONGERLACH MS MS&E, BS CS Continuing (with funding)! Own HealthTech Startup
  21. teaminvisa@gmail.com CONTACT US Feedback, ideas, advice, joining our team, and everything else… YOU? Invisa Van “Ocean”

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