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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!