Post on 13-Jul-2020
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What is Bioengineering?
Mark S. Redfern, Ph.D.Professor, BioengineeringVice Provost For Research
Department of BioengineeringUniversity of Pittsburgh
Westinghouse Science Honors Institute
Bioengineering - Pittsburgh
What is Bioengineering?
• “Applying engineering knowledge and methods to solve biomedical problems.”
• Spans molecular to whole body
– Tissue Engineering
– Artificial Organs
– Medical Instrumentation
– Rehabilitation Engineering
– Imaging
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What is Bioengineering?
• “Advances knowledge in engineering, biology and medicine, and improves human health through cross-disciplinary activities that integrate the engineering sciences with life sciences and clinical practice.”
• [Engineering applied to health]
Professional DisclaimerClinician Life Scientist Engineer
“A good scientist is a person with original ideas. A good engineer is a person who makes a design that works with as few original ideas as possible.” - Anonymous
“Scientists dream about doing great things. Engineers do them.”– James Michener
What is a Medical Device?
Tongue depressor Heart-lung machine
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Even the iPhone!
Artificial Organs
Completely Artificial
Bio-hybrid Artificial
Organ Regeneration
COMPLEX I TY
SAFETY
EFF I CACY
PAST
PRESENT
FUTURE
What We Need to ProvideCirculatory Assistance
• provide 1.5 gallons per minute of blood flow at physiologic pressures
• non-clotting
• immuno-resistant
• quick, easy to implant
• efficient and reliable
• deliver good quality of life
• affordable
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Total Artificial Heart (TAH)
Cardiosystems Inc (Jarvik TAH)
• recipient’s entire heart, or ventricles are removed and replaced with a mechanical device
Ventricular Assist Device
Ventricular Assist Device
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Berlin Heart Pediatrics
• Started in 1980’s
• External for babies
• Pneumatic, attached to a big machine.
• Pulsatile
• Ventricle empties into the pump
• Pump pushes blood to the ascending aorta
• Used 1 month or less
• Still used today!
Pneumatic – Internal
• Titanium
• For adults
• Pneumatic, attached to a big machine.
• Pulsatile
• Used a couple months month or less
Electronic – Internal
• Pulsatile
• Batteries used
• Patient could go home!
• Clot issues due to bearings and valves.
• Can be used for up to 1 year?
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Continuous – Internal
• Continuous flow
• For adults
• VAD
• Still has bearings that can cause blood clots, but reduced.
• Most popular still!!!!
• Developed in Pittsburgh
• Can be used for 1-2 years
Ventrassist: Continuous – Internal • Continuous flow
• No valves!
• Magnetic drive
• Clots are rare
• Batteries can be used for up to 16 hours.
• Can be used for up to 6 years!!!
• Drive through skin
• Biggest problem (for all VADs still is infection at the drive line.
TandemHeart pVAD
• Continuous (non-pulsatile) flow ventricular assist device
• Short-term support (1-8 days)
Cardiac Assist Inc..
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Ventricular Assist Device
PediaFlowUniversity of Pittsburgh
Artificial Lung
Iron Lung - Polio
Artificial Lung
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Borovetz
Membrane Oxygenation
Implantable Artificial Kidney
Implantable Artificial Kidney
UCSF
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Vision-assist Device
BrainPort Device
Vision-assist Device
Neural Engineering
Neural Motor Lab-Andrew Schwartz, PhD
Rehab Neural Engineering Lab-Doug Weber, PhD
-Michael Boninger, MD
-Jen Collinger, PhD
Neural Tissue Interface Lab-Tracy Cui, PhD
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Neural Prosthetic
Univ of Pittsburgh MotorLab
http://motorlab.neurobio.pitt.edu/multimedia.php
Quadriplegic Stroke Patient
BrainGate, Brown University
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Implementing Human Studies
http://www.youtube.com/watch?v=yff20TlHv34&feature=related
Neural Engineering: What do we need to know to do this?
• Neuroscience (i.e. the brain)• Electrode interface issues:
– Material Science– Bio-compatibility
• Signal & Image Analysis• Computational modeling• Control Systems• Robotics & Mechatronics• Medicine & Surgery• Veterinary Science
Rehabilitation Engineering
• Wheelchair evaluations and upper extremity injuries
Rory Cooper, Michael Boninnger, Alicia Koontz
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Human Engineering Research Laboratory
http://www.herlpitt.org/video.htm
Robotic-assisted Surgery
Biologic Scaffoldsfor Regenerative Medicine
Stephen F. Badylak, DVM, MD, PhD
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Badylak
GORE ALERT!!!!
“Pixy Dust” to encourage tissue re-growth
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Sara Doll and Katie O’CallaghanPitt Alumni!
…and…Biomedical Engineers and Scientific
Reviewers@ FDA – Office of Device Evaluation
Off the Beaten Path…working at the FDA
Sara Doll and Katie O’CallaghanPitt Alumni!
…and…Biomedical Engineers and Scientific
Reviewers@ FDA – Office of Device Evaluation
Off the Beaten Path…working at the FDA
Who Are We?
Sara
BS: Bioengineering Systems/Signals
Concen ECMO Tech at
Children’s IAESTE Internship
Minor: Neuroscience NIMH Fellowship
Study AbroadEngineering World
Health
Katie
BS: Bioengineering
Hybrid Concentration
Intramural Internship
Industrial Internship
BA: German
Dual Degree Program
Study Abroad
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Who Are We?
One year after graduation…
• Full-time employees at the FDA
• Sara: Surgical and Neurological devices
• Katie: Cardiovascular devices
ACTIVE Education
• Hybrid Concentration• Minor• Double Major• Double Degree Program• …just take a lot of
interesting classes!
talk to profs, P.I.s, other students
Practical Work Experience
• Internships–Intramural–Industrial–Other: INROADS, NIH, programs through other universities
• Fellowships (NIMH, MDFP)• Co-op• Hospital (ECMO, etc.)
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I’ve got my degree, now what?
Why We Joined FDA
– BROAD perspective (the field, the process, the game)
– RELEVANT Bioengineering experience
– INTERSECTION of medicine, engineering, critical thinking & writing…
– Regulatory knowledge?
– (Not ready to specialize)
– (Not ready to commit)
What is FDA?
United States government regulatory agency
–Our mission is to:»Promote the public health
»Protect the public health
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What is FDA?
• Food and Cosmetics– Labeling, supplements, cosmetic safety
• Veterinary Medicine– Vet drugs, animal feeds
• Biologics – Vaccines, blood supply, human tissues, gene
therapy
• Drugs
• Devices – CDRH
What does CDRH regulate?
We don’t regulate medical procedures.
We regulate the products, but not
how doctors choose to use them.
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Division of Cardiovascular Devices
• Ventricular Assist Devices
• Heart Valves
• Drug Eluting Stents
• PFO Occluders
• Pacemakers
• Defibrillators (External and Implantable)
• Balloon catheters; other percutaneous cardiology devices
Division of General, Restorative, Neurological Devices
• Transcranial magnetic stimulators
• Silicone implants
• Deep brain stimulators for Parkinson’s
• Computer-aided surgery devices
• Orthopaedics
Bioengineering Education @ Pitt
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Getting a Bioengineering Education
• Degrees in Bioengineering
Or
• Degrees in other Engineering Field with application to biomedicine
BioE Educational Objectives
• Fundamentals in Engineering & Biology
• Broad base of knowledge
• Education Beyond the Classroom
• Provide an individualized education for students specific to their post-graduate goals (i.e. industry, graduate school or medical school)
• ….not a terminal degree
B.S. in Bioengineering• Basic Sciences
– Mathematics
– Chemistry
– Physics
• Engineering– Mechanics
– Materials
– Electronics
• Humanities– Literature
– Communication
– Ethics
• Biological Sciences– Biology
– Physiology
• Bioengineering– Core Courses
– Concentration
– Internships
– Design
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Concentration Areas
Biomechanics(R. Cham)
Orthopedic Biomech.Cardiovascular Biomech.
Rehab. EngineeringErgonomics
Biosignals and Imaging
(A. Batista)Signal Processing
BiocontrolImaging
Cellular andTissue
Engineering(L. Davidson)Biomaterials
Tissue Engineering
Medical DeviceEngineering
(J. Patzer)Artificial OrgansNeural Devices
Biomaterials
THE END
THANKS!