Transcript The Device Development Industry

The Device Development Industry
Frank Fischer
President and CEO
NeuroPace, Inc.
December 4, 2010
North American Neuromodulation Society
14th Annual Meeting
Confidential
DEVICE DEVELOPMENT HAPPENS IN STAGES
STAGE 1 : CONCEPT DEVELOPMENT
STAGE 2 : TESTING IN ANIMALS
STAGE 3 : CLINICAL EVALUATION IN HUMANS
Confidential
DEVICE DEVELOPMENT HAPPENS IN STAGES
STAGE 1 : CONCEPT DEVELOPMENT
• Test and refine theory – translate to a therapeutic
approach
• Characterize and improve approach in a representative
bench system
• Easy to iterate
• Bench & In Vitro testing minimal regulatory issues
• Cost of failure is minimal
Confidential
DEVICE DEVELOPMENT HAPPENS IN STAGES
STAGE 2 : TESTING IN ANIMALS
• Learn about the downsides - characterize side effects,
adverse reactions, limitations, technical hurdles
• Glean some insights into efficacy, if possible
• Iteration possible but at a cost
• Testing requires compliance to
protocols
• Failure results in greater loss of
financial resources and time
Confidential
DEVICE DEVELOPMENT HAPPENS IN STAGES
STAGE 3 : CLINICAL EVALUATION IN HUMANS
• Prove safety and efficacy of your approach
• If any uncertainty, parse this stage into parts (e.g.,
feasibility and pivotal)
• Iterating the concept can be
much more difficult
• Clinical evaluation requires IRB
and/or FDA approval
• Failure in almost every case is
very costly
Confidential
STAGES ONE AND TWO LAY THE FOUNDATION FOR
COMMERCIAL SUCCESS
Goals of stages 1 and 2
1
• Confirm your product concept is
feasible and has no obvious safety
issues
• Develop intellectual property
2
Confidential
STAGES ONE AND TWO CAN BE COMPLETED WITH ONLY BASIC
RESOURCES AND MINIMAL FUNDING
Resources required
1
• Basic engineering
and prototyping skills
• Internet/ library
2
• Intellectual property
support
• Minimal funding
Confidential
Typically
available
at your
university!
READY TO BLAST OFF? A SPECTRUM OF OPTIONS EXIST FOR
HUMAN EVALUATION
STAGE 3 : CLINICAL EVALUATION IN HUMANS
Use already marketed,
FDA approved devices
Build semi-custom
“Boldly go where no one
devices via partnership has gone before” – build
with OEM device firm(s) fully custom devices or
systems
Confidential
EXAMPLE: FUNCTIONAL NEUROSCIENCE
STAGE 3 : CLINICAL EVALUATION IN HUMANS
October 2010
November 2010
• Used off-the-shelf Medtronic DBS
System
• 6 patients with mild Alz disease;
stimulate the fornix/ hypothalamus
• Surgery and stimulation well tolerated
• Results were mixed but highly
encouraging
Confidential
“Functional Neuromodulation
Inc., a medical technology
company, closed a $600,000
seed financing from Genesys
Capital”
EXAMPLE: LEPTOS
STAGE 3 : CLINICAL EVALUATION IN HUMANS
• Began human trials using Cyberonics
• Stimulation of splanchnic
nerve for obesity
devices
• Learned that gradual stimulation
ramping was important to acclimate
patients to stimulation
• Partner with OEM device
manufacturers to build semi-custom
neurostimulators and leads
•
•
Automatic stimulation ramping
Custom lead specific for nerve target
Confidential
EXAMPLE: NEUROPACE
STAGE 3 : CLINICAL EVALUATION IN HUMANS
• Early realization that a fully custom
system was necessary
• Build multi-functional team to develop
• Responsive stimulation
for the treatment of
epilepsy
and test implantable responsive
neurostimulator, leads, programmer,
remote patient monitor, and patient
data management system
• Develop protocols for clinical
evaluation; secure IDE approval from
FDA; conduct clinical evaluations
Confidential
EXAMPLE: NEUROPACE
2000
Development
Clinical
Evaluation
2005
2010
External RNS
Implantable RNS
eRNS Study
Perform basic
testing in hospital
setting with
external system
RNS System
Feasibility study
65 patients
Evaluate implantable
system for safety and
secondarily, efficacy.
Gather data and learn!
Confidential
RNS System
Pivotal trial
191 patients
Evaluate implantable
system for efficacy
and safety.
EXAMPLE: NEUROPACE
Confidential
COMPARISON OF STAGE 3 OPTIONS REVEALS KEY DIFFERENCES
RESOURCES AND EXPERTISE REQUIRED
In-house
engineering
Device dev
expertise
Financial
efficiency
+
++
+++
+
++
+++
+++
++
+
+
++
+++
IP opportunity
Confidential
CONCLUSION
• Don’t be afraid to get started
• Fail quickly!
• Iterate until your concept is ready for clinical
evaluation
• You cannot over invest in this phase
• Product development can take many
paths, but almost always can be
accomplished
Confidential