Transcript Coulter Foundation Proposal Department of Biomedical Engineering

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BIOME :
Bio Innovations
and Opportunities in
Medicine and Engineering
Robert G. Radwin, Professor & Chair, Biomedical Engineering
Lawrence A. Casper, Asst. Dean, Research & Tech. Transfer
biome.wisc.edu
Basic Format of the Course
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Interdisciplinary grad course
(engineering, medicine, business,
law, others)
Identifies new medical technologies
needed in clinical practice through
collaborative technology assessment
Students vet innovations based on
technical feasibility, market, IP, FDA,
reimbursement, and faculty
Outcomes include technologies at
various stages that can be carried
forward through translational
research and commercialization
projects
Unique Features of BIOME
Challenges
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Fostering an Innovation
Community
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Needs assessment panels and
focus groups
Solicitations for physician initiated
projects
Grand rounds
Physician shadowing
Identifying interested faculty in
medicine and engineering
Expertise in technology and
commercialization
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Interdisciplinary teams
 Guest speakers in patenting, IP
barriers, FDA, venture investing
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Vetting technologies
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Category Title
Clear Problem
Statement
Personnel
Support
Availability
Ethical
Considerations
Clinical and research champions
Technical feasibility
Intellectual Property
Marketability
Regulatory barriers
Description
Criteria/ Parameter
Is there a clear statement of the problem that is understandable by the
team members or the assigned champion?
Clarity of problem and vision
of solution. Sponsor
Availability of university, clinical and industry specialists to assist in
defining solutions and possibly directly supporting the development of the
proposal.
Names, departments,
companies.
Are there ethical issues (positive or negative) that need to be considered
in solving this problem?
Summary of good and bad
issues.
Technical
Feasibility
Within the guidelines of “Translational Research), is there confidence that
we can find technologies and resources to clearly define a deployable plan
by the end of the semester, not necessarily developing a prototype?
Departments, consultants,
labs, grants
Clinical Impact
Is there confidence that there will be a significant clinical or patient
impact in a relatively broad sense?
Intellectual
Property
Marketability
Is there confidence that we can develop unique Intellectual property and
associated financial motivation with a solution?
Cases over time, payer
interest, clinical/patient
interest
Patent search, WARF, BME
undergrad design projects?
Clinical
Implementation
Clinical Trials
Regulatory
Barriers
Are we confident that there is a big enough market for the solution and
that we can take a sufficient share of that market, easily, with a solution?
Is it feasible that a solution can pass the hurdles associated with clinical
implementation in a reasonable timeframe?
Dollars, competition, past
failed attempts at entering.
Physician, clinical interest.
Do we feel that we can get a commitment to do trials in the Madison
area?
Do we feel that we can get support to take the solution through the
regulatory approval process? Projected time may be considered.
Contacts, UHS.
FDA approval of similar items
Notes
Positive or
negative score
allowed.
Example
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Need: External fixation devices
utilized for lengthening a bone requires
surgical angular corrections and
almost always results in infection
Innovation: A solution that combines
the technologies of an intramedullary
lengthening device and the external
fixator device is an extramedullary
implantable device using a linear drive
motor for angular correction and
infusion of bone growth promoting
materials and medications
Market: 5,000 to 10,000 units per year
at a patient cost of $5,000 each ($25
to $50 million in annual sales)
IP: Disclosed to WARF and a patent
was applied for
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Regulatory: Premarket Approval (not
anticipated. A 510k can be filed using
existing technologies
Faculty: New collaboration with
orthopedic surgeon, biomedical
engineer and mechanical engineer
Follow-on: Coulter TRP/ CTSA pilot
project