Transcript Biomaterials 2013

Beth Zielinski, PhD
Jeffrey Scott, PhD
Implantable Cardioverter Defibrillators
> Number of procedures: 133,262
> Total annual expenditure: $5.5 billion
> Average cost per procedure: $40,000
> Major manufacturer: Medtronic (40%), St. Jude Medical, and Boston Scientific
Artificial Hips
> Number of procedures: 230,000
> Total annual expenditure: $10.5 billion
> Average cost per procedure: $45,000
> Major manufacturers: Zimmer (24%), Stryker, DePuy/J&J, Biomet, Wright Medical
Heart Pacemakers
> Number of procedures: 235,567
> Total annual expenditure: $4.5 billion
> Average cost per procedure: $20,000
> Major manufacturers: Medtronic (40%), St. Jude Medical, Boston Scientific
Breast Implants
> No. of procedures: 366,000
> Total annual expenditure: $992 million
> Average cost per procedure: $3,351
> Major manufacturers: Allergan, Mentor
Metal Screws, Pins, Plates, and Rods (Traumatic Fracture Repair)
> Number of procedures: 453,000
> Total annual expenditure: $4.5 billion
> Average cost per procedure: $2,000-$20,000
> Major manufacturer: Synthes (50%)

Basic pathophysiology of several
conditions

Repair and replacement
options/devices

Structures (including materials) and
functions of these options/devices

Relationships between hosts and
devices
Facialart.com

Device
 What function is the device
augmenting or replacing?
 What are the material design
characteristics of the that lend the
device as an appropriate
alternative to native tissue/organ?
 Once in line with host tissue, how
will the host tissue respond?
 How will the device respond to the
new physiological environment?
 Will this marriage be a success?
History

the chicken (device) or the egg (biomaterial)?

The materials existed before the device

Available materials were used to fabricate necessary
devices and implants.
Dacron fibres from E.I. DuPont de Nemours &
Company, Inc. were the first polyester fibres
to gain acceptance by the Food and Drug
Administration (FDA) in the U.S.A.-1950
Cleveland Clinic
Implanted by Dr. Debakey in 1957

2500+ years ago Egyptians,
Romans, Chinese and Aztecs

Gold, wood, ivory and gems to
replace teeth and fill bone
defects
Discoverynews.com
Homeopathicdentristy.com

1759 - Repair of lacerated brachial artery using wood
and twisted thread

1804 – Steel pins

1860 - Development of aseptic techniques

1914 – Steel plates

1924 – First assessment of
biocompatibility of
metals/alloys

1926 – Stainless steel (18-8)
developed

1940 – Ti first used in
pacemakers and heart
valves
First implanted
pacemaker,
Sweden, 1958

Explosion of new materials
 WWI
▪Celluloid – craniofacial plates
▪Natural rubbers – synthetic grafts and artificial hearts
 WWII
▪PMMA – craniofacial plates, ocular lenses, vascular grafts
▪Silicone breast augmentation
Silicone breast
implant
Jarvik-7

1960 – Biomer (Lycra) – artificial hearts, catheters,
ACL repair

1969 – PTFE (Teflon)

1971 – ePTFE – vascular grafts
St. Jude Medical

Materials developed over last 40-60 years
 New materials are being designed with “nanofeatures”
▪ The goal is optimization of the host-material interface

Many devices require combinations of different
materials and include drug delivery components
Natural, Synthetic, Combination Products, Regenerated Tissues
Rules and Regulations
Medical devices have several components
The FDA/Center for Devices and Radiological Health regulates companies
that design, manufacture, repackage, relabel, and/or import devices but
does not regulate how and which physicians use a device

Therapeutic and diagnostic products that
combine drugs, devices, and/or biological
products
 Drug-eluting stent
 Nicotine patch
ABCNews.com


Pure Food and Drug Acts of 1904 did not
include provisions for medical devices
Medical Device Amendment of 1976

Subsequent legislation includes:
 Safe Medical Device Act of 1990
▪ Quality systems
▪ Post-market surveillance
 FDA Modernization Act of 1997
▪ Automatic Class III designation
▪ Fee schedule for shorter reviews
 Medical Device User Fee and Modernization Act of 2002
▪ Inclusion of pediatric experts
 FDA Modernization Act of 2007
▪ Expanded MDUFMA

Risk-Based Device Classification
 Class I -Simple, no risk (latex gloves, arm slings)
 Class II -Higher risk devices (catheters)/510(k)
 Class III -Highest potential risk (heart valves)/ PMA
FDA.gov
Following approval based upon one of these pathways, devices can still
be subject to post-approval studies
Investigational Device Exemption (IDE)
Allows an investigational device to be used in a
clinical study to collect data for safety and
effectiveness
This is required for a PMA and 510k
Pre-market notification application (510 (k))
Medical devices mfg must provide data to demonstrate that the new devices
is “substantially equivalent” to a legally marketed device
Class I and II devices
Premarket Approval (PMA)
Medical devices that do not show SE
Class III devices; extremely rigorous review process
Annals of Internal Medicine



Commercialization of Class III devices
designed to address small markets
Diseases or conditions that effect fewer that
4000 patients in the US/year
Device is safe and probable benefits
outweigh probable risks