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History and Scope of
Biomaterials
J. L. Ricci, Ph.D.
Department of Orthopaedics, UMDNJ
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Biomaterials Characterization
Website
www.rci.rutgers.edu/~moghe/622.htm
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
What is a biomaterial?
Who uses biomaterials?
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Biomaterial — A biomaterial
is a nonviable material used in a
medical device intended to
interact with biological systems.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Device — an instrument,
apparatus, implement, machine,
contrivance, implant, in vitro reagent,
or other similar or related article.
including any component, part, or
accessary, which is...
• as defined in Medical Device Amendments of 1976
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
• (1) recognized in the official National
Formulary, or the United States
Pharmacopeia, or any supplement to
them,
• (2) intended for use in the diagnosis
of disease or other conditions, or in
the cure, mitigation, treatment, or
prevention of disease, in man or
other animals, or
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
• (3) intended to affect the structure or
any function of the body of man or
other animals, and which does not
achieve any of its principal intended
purposes through chemical action
within or on the body of man or other
animals and which is not dependent
upon being metabolized for the
achievement of any of its principal
intended purposes.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Examples of Devices
• prescription lenses and frames,
hearing aids, intrauterine
devices, surgical instruments,
cardiac pacemakers, etc.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Biomaterial — A biomaterial
is a nonviable material used in a
medical device intended to
interact with biological systems.
(see biocompatibility)
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Biocompatibility — The
ability of a material to perform
with an appropriate host response
in a specific application.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Host Response — The
response of the host organism
(local and systemic) to the
implanted material or device.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
What are biomaterials
used for?
• Dentistry, surgery, drug
delivery...
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Short-term implants
• Catheters (including balloon
catheters)
• IVs
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Long-term implants
• Dental fillings, caps, crowns...
• Opthalmic implants (lenses)
• Orthopaedic total joint replacements (hips,
knees, fingers, shoulders, ankles)
• Pacemakers, defibrillators, etc...
• Cardiovascular stents
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Federal Food and Drug
Administration Regulation
• Federal Food, Drug, and Cosmetic Act of
1938 — Drug premarket approval, removal
of fraudulent devices, proper labeling.
• Medical Device Amendments of 1976 —
regulation of development, testing,
production, distribution, and use. Three
classes of devices, Class I (least
regulated) to Class III (most regulated).
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
• Safe Medical Devices Act of 1990 —
expanded FDA authority in premarketing
and postmarketing stages. Established
tracking for some devices.
• Biomaterials Access Assurance Act of
1998 — limits liability of biomaterials
suppliers.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Classes of Devices
• Class I — General controls. A device
for which controls other than
standards and premarket approval
are sufficient to assure safety and
effectiveness.
• Examples — dental floss, tongue
depressor, surgeon’s glove
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
• Class II — Performance Standards.
General controls are insufficient but
there is sufficient information for
establishment of a performance
standard.
• Examples — Oxygen mask, blood
pressure cuff, ultrasound imager.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
• Class III — Premarket Approval
(PMA). Insufficient information for
reasonable safety and effectiveness,
required to have approved premarket
approval application.
• Examples — Intraocular lenses,
replacement heart valves, most
orthopaedic and dental implants.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Premarket notification for new or
substantially modified devices —
The 510(k) rule — substantial
equivalence to a device already on the
market prior to the 1976 amendments.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
New devices — Premarket Approval
(PMA) applications — nonclinical and
clinical information establishing safety
and effectiveness.
• Investigational Device Exemption
(IDE) — needed to conduct clinical
studies — nonsignificant or
significant risk.
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Voluntary Standards
• American Society for Testing and
Materials
• Examples — ASTM F-4 committee —
implant devices
• Materials — ASTM F75 standard for cast
cobalt-chromium-molybdinum alloy
• Test Methods — ASTM D638M Test
method for tensile properties of plastics
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Additional Voluntary Standards
• AAMI — Association for Advancement of
Medical Instrumentation
• ANSI — American National Standards
Institute
• ISO — International Standards
Organization
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Biomaterials — A
Historical View
• Four generations of devices
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
First Generation Implants
• “ad hoc” implants
• specified by physicians using
common and borrowed materials
• most successes were accidental
rather than by design
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Examples — First
Generation Implants
• gold fillings, wooden teeth, PMMA
dental prosthesis
• steel, gold, ivory, etc., bone plates
• glass eyes and other body parts
• dacron and parachute cloth vascular
implants
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Examples — First
generation Implants
• breast implants
• titanium dental implants
• plaster of paris bone cements
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Second generation
implants
• engineered implants using common
and borrowed materials
• developed through collaborations of
physicians and engineers
• built on first generation experiences
• used advances in materials science
(from other fields)
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Examples — Second
generation implants
• titanium alloy dental and orthopaedic
implants
• cobalt-chromium-molybdinum
orthopaedic implants
• UHMW polyethylene bearing
surfaces for total joint replacements
• heart valves and pacemakers
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Examples — Second
generation implants
• Most current implants fit this
category
• Many represent second generation
versions of first generation implants
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Third generation implants
• bioengineered implants using
bioengineered materials
• few examples on the market
• some modified and new polymeric
devices
• many under development
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Fourth generation implants
• tissue engineered implants designed to
regrow rather than replace tissues
• Integra LifeSciences artificial skin
• Genzyme cartilage cell procedure
• some resorbable bone repair cements
• many new products under development —
genetically engineered “biological”
components (Genetics Institute and
Creative Biomolecules BMPs)
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Biomaterials Development and
Marketing vs. Biomaterials
Characterization
• market pressures for new materials
and devices
• cost of development and
characterization
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Corporate biomaterials
research
• characterization of new and
licensed technologies for
product development
• quality control (GMP)
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics
Academic biomaterials
research
• development of new materials and
application of advanced materials to
biomedical applications
• new tissue engineered materials
• technology transfer
University of Medicine and Dentistry of New Jersey
John L. Ricci, Ph.D., Department of Orthopaedics