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
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