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30 Years/30 Devices : 1979 : The 1980s : The 1990s : The 2000s :

Older Technologies
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Some of the devices nominated by our readers are small enough to travel through a
blood vessel. Some are so large they fill an entire room. Some cost thousands of dollars
but will stay in the body for 10 years, and some cost pennies and are designed to be
thrown away a er one use. This industry is characterized by innovators looking for the
best way to engineer a solution to a problem. And device designers are noted for their
ability to borrow ideas from other industries.
Jun 01, 2009

MD&DI 30th Anniversary

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SPONSORED CONTENT

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Blood and Cell Separator 1979

The CS-3000 system was the first automated blood and cell separator. The device
was able to draw whole blood, keep the desired component, and return the
remaining blood components to the donor. This product eliminated the risk of
contamination associated with manual methods and enabled donors to give blood
more frequently. It also made it possible for patients to receive blood from fewer
donors.

Implantable Cardioverter-Defibrillator 1980

An implantable cardioverter-defibrillator (ICD) is a small battery-powered electrical

impulse generator that is implanted in patients who are at risk of sudden cardiac
death due to ventricular fibrillation. The device is programmed to detect cardiac
arrhythmia and correct it by delivering a jolt of electricity. In current variants, the
ability to revert ventricular fibrillation has been extended to include atrial and
ventricular arrhythmias as well as the ability to perform biventricular pacing in
patients with congestive heart failure or bradycardia. ICDs were pioneered at Sinai
Hospital in Baltimore in 1969, but it was 11 years later that a patient first received
Photo courtesy of
treatment. Another decade of research went into the development of an implantable
MEDTRONIC INC.
defibrillator that would automatically sense the onset of ventricular fibrillation and
deliver an electric countershock within 15–20 seconds, converting the rhythm to sinus rhythm. Levi
Watkins Jr MD implanted the first functioning device in February 1980 at Johns Hopkins Hospital
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Watkins Jr., MD, implanted the first functioning device in February 1980 at Johns Hopkins Hospital.

Intra Articular Arthroscopic Shaver System 1980

Arthroscopic shavers are used in orthopedic procedures to remove tissue and

reshape a patient's anatomy. A surgeon may use an arthroscopic shaver to remove
bone or cartilage and other so tissue from a patient's joint, or in procedures such as
septoplasty (sinus reduction). The shavers include a rotating burr housed within a
rigid insertion tube but exposed to body tissue through a small aperture in the side
or end of the insertion tube. Suction is applied through the insertion tube so that
debrided tissue can be sucked into the tube and removed from the body. This device
contributed significantly to a radical transformation of orthopedic surgery. Prior to
introduction, arthroscopy was mainly a diagnostic tool. This device was an essential
development for minimally invasive orthopedic surgery.
Images courtesy of
SMITH & NEPHEW
Cochlear Implants 1980

In 1980, giving deaf people the ability to hear became a real possibility. William
House, MD, performed the first cochlear implant on a child using a 3M/House device.
Around the same time, Australian Paul Trainor began developing a cochlear implant,
known as the Nucleus Multichannel Cochlear Implant. The device was first implanted
in a human in 1982. FDA approved the 3M/House device for deaf adults in 1984 and Image courtesy of
the Nucleus implant in 1985. Today, one-year-old children are eligible for cochlear COCHLEAR LTD.
implants. The Nucleus Freedom (pictured above) is the modern version of Trainor's original design. It
uses an electrode to o er a finer resolution of sound, as well as a sound processor that features four
computers built on a microchip. At end of 2006, FDA reported that more than 112,000 people worldwide
had received cochlear implants.

Angioplasty Balloon Catheter 1980

In the 1970s, German cardiologist Andreas Gruentzig pioneered coronary angioplasty

with the development of the double-lumen dilation catheter that used an inflatable
balloon. The angioplasty balloon catheter, used for percutaneous coronary
Photo courtesy of intervention, has both saved and improved the lives of patients. Before it hit the
MEDTRONIC INC. market in 1980, vessel bypass surgery was the most viable way to repair blocked
vessels but carried more risks, pain, and cost. In addition to relieving chest pain and
helping to prevent heart attacks, the device's significant potential has pulled dozens of medical device
companies into the catheter space.

Personal Glucose Meter 1980

The first portable glucose meter was approved in 1969, but improvements to the
technology cannot be emphasized enough. One of the most significant steps in the
treatment of diabetes was moving the glucose testing from the hospital to the home.
The first personal glucose meter was developed by Miles Laboratories Inc. (later
purchased by Bayer). Since the early 1980s, these home-use devices have
i d d i F l bl l
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experienced steady improvements. For example, portable glucose meters with
memory have become critical to diabetes care, because they enable diabetics to
keep a record and observe trends and patterns. Event markers, digital user
interfaces, and no-coding technology have also advanced the treatment standard.
The modern meter, such as the True2go glucose meter shown here, can weigh less
than an ounce.
Image courtesy of
Pulse Oximeter 1981 HOME
DIAGNOSTICS
The first pulse oximeter was introduced in the United States in 1981. Rather than
drawing blood, the device provided a noninvasive way to measure a patient's oxygen
saturation level via wavelength measurements. In the 1980s, manufacturers of pulse
oximeters introduced much smaller technology that was less expensive and easier to
Photo courtesy of use. The Nellcor Pulse Oximeter (pictured) has evolved from its beginnings 25 years
NELLCOR ago into a range of di erent products, from handheld devices that conduct spot
check measurements to compact monitors that use nonadhesive specialty sensors for patients with
fragile skin.

Laryngeal Mask Airway 1981

In 1981, anesthesiologist Archie Brain invented the Laryngeal Mask Airway (LMA), a
device that establishes an unobstructed airway in unconscious patients or patients
under anesthesia. Brain was looking for a device that could replace endotracheal
intubation, a procedure that can cause trauma or unwanted reflux responses in
patients. Since Brain's LMA was first used in a hospital in 1988, it has become a staple
in operating rooms and ambulances. Many versions of the device exist today Image courtesy of
including the AuraOnce Disposable Laryngeal Mask (pictured above), which comes in AMBU INC.
a variety of sizes to fit a range of patients. LMAs have been used in millions of procedures.

EXCEL and PAB IV Containers 1983

Since July 12, 2002, FDA has encouraged the reduction of patient exposure to Di(2-
ethylhexyl)phthalate (DEHP) and recommends replacing DEHP-plasticized PVC
medical products with products that contain alternative materials or plasticizers.
This is particularly true for IV containers, for which plasticizer leaching may be a
critical concern. Although the exact risk presented by DEHP is yet to be determined,
many manufacturers took steps long before FDA made the recommendation to
provide users with DEHP-free products. Manufacturer B. Braun Medical has o ered a
Photo courtesy of line of DEHP-free and PVC-free containers since 1983. Its signature products are the
B. BRAUN Excel and PAB IV containers. Plastic IV containers were first used in the 1950s.
MEDICAL
Automated External Defibrillator 1985

The automated external defibrillator (AED) has been instrumental in saving lives
since it was first developed in 1985. Studies have shown that early defibrillation with
an AED can dramatically increase survival rates—up to 70%. The device, which uses
electricity to stop cardiac arrhythmia and help the heart reestablish a solid rhythm,
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has become so valuable that CPR training courses o en include a segment on their
use. These days, AEDs are ubiquitous: commercial aircra s as well as police, fire, and
EMT vehicles usually carry them. FDA approved the first home-use AED in 2004. Image courtesy of
DEFIBTECH

Digital Hearing Aid 1987

A digital hearing aid isn't automatically superior to analog devices. But starting with
the creation of the Nicolet Phoenix—the first digital hearing aid—in 1987, the devices
have become increasingly sophisticated. Much of this owes to digital signal
processing technology, which has allowed manufacturers to enhance features and
provide users with more comfort and higher-quality hearing. For example, digital
hearing aids can drastically reduce feedback while the listener is wearing the device
Image courtesy of and enhance speech based on temporal or spectral content. The Lyric is the only
INSOUND extended wear hearing device on the market—it can be worn continuously for up to
MEDICAL INC. 120 days.

Safety Needles and Syringes 1988

During the late 1980s and into the 1990s, the most frequent cause of bloodborne
infections in healthcare settings was a needlestick. Safety needles have come a long
way to help prevent such risks. The safety mechanism is o en built into the needle.
The needle can be manually attached to a conventional syringe or a commercially Photo courtesy of
prepared prefilled syringe. Both active and passive methods are available. For the BECTON,
active system, the clinician activates the safety mechanism a er the injection. In a DICKINSON AND
passive system, the needle is automatically shielded a er injection. Devices that CO.
o en incorporate safety mechanisms include IV connectors, needle guards, sheathed syringes, needle-
recapping products, blood-drawing devices, IV catheters, and needleless injection devices. In 1988,
Becton Dickinson introduced the BD Safety-Lok, the first safety-engineered syringe. In 2000, the
company launched the Safety Compliance Initiative, a nationwide education program to raise
awareness about the risk of accidental needlesticks and to help healthcare institutions comply with
federal mandates for safety-engineered devices.

Demineralized Bone Matrix Gel 1991

In 1965, Marshall Urist identified the process of osteoinduction and ultimately

discovered the first bone morphogenetic protein in demineralized bone. Orthopedic
manufacturers later built on Urist's research to provide surgeons with o -the-shelf
products for bone healing. In 1991, Oseotech Inc.'s Gra on demineralized bone
matrix (DBM) Gel, made from allogra bone, was the first product of its kind to earn
Photo courtesy of approval for use in musculosketal surgery. Today, Oseotech says that its Gra on DBM
OSTEOTECH INC. products have been used in more than 1 million surgical procedures.

Ventricular Assist Device 1992

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A ventricular assist device (VAD) is a mechanical pump that helps a weak heart pump
blood through the body. It is o en called a “bridge to transplant” because it can help
patients survive until they get a new heart. The BVS 5000, a biventricular assist
system manufactured by Abiomed, was the first VAD to earn FDA approval. It has
supported thousands of patients since entering the market. Most recently, VADs have
evolved to provide long-term support to patients with congestive heart failure.

Smart Infusion Systems 1992

Infusion pumps have been around for at least 30 years. But certain
patient safety–related features, such as tools to ensure that
patients receive the correct dosage, didn't appear until decades
Image courtesy of later. In 1992, Kendall McGaw developed the Horizon infusion
B. BRAUN system (now part of B. Braun Medical's pipeline)—the first system Image courtesy of
MEDICAL with a dose-rate calculator. Future iterations added more safety ABIOMED
features, including a drug library inside the pumps (1994) and an integrated bar
coding system (2001). Such advances, which are also found in the modern Outlook Safety Infusion
System pictured here, have helped significantly reduce pump-related IV medication errors.

Headless Cannulated Bioabsorbable Interference Screw 1994

The headless cannulated interference screw has replaced many metal screws for
anterior cruciate ligament (ACL) reconstruction surgery in the knee. The titanium
screw was released in 1991 and was followed by a bioabsorbable screw three years
later. The advantage of the bioabsorbable screw is that the body resorbs the
polymer, replacing it with bone, so there is no need for a second surgery to remove
Photo courtesy of
the screw (as sometimes is the case when using metal screws). To accelerate
ALASKA
reincorporation rates, the screw has been made with human cortical and bovine
ORTHOPEDIC
bone as well. Surgeons are also now using the screws for posterior cruciate, lateral
LABS
collateral, and medial collateral ligament (MCL) procedures. Its use has led to the
development of other cannulated interference screws and anchor devices for applications in the wrist,
elbow, shoulder, hip, and ankle.

Palmaz-Schatz Balloon Expandable Stent 1994

The Palmaz-Schatz balloon expandable stent was a cutting-edge device that changed
the game for coronary artery obstructions. The bare-metal stent was approved in
August 1994 and made it clear that the new wave of treatment (stents) solved
problems that balloon angioplasty alone could not. Johnson & Johnson held a
critical patent relating to inflation-deployed stents, and this device enjoyed a period
of market dominance once it debuted. The treatment options this device provided
were an important stepping stone to the drug-eluting stent.

Medical Lasers 1995

Image courtesy of
CORDIS CORP. Even now, many industry observers say that the surface has only
b h d ih di l l d h i i l M di l l
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been scratched with medical lasers and their potential. Medical lasers (light
amplification by stimulated emission of radiation) use focused light sources to treat
or remove tissue, and they are used for a variety of vision, dental, cosmetic, and
general surgery procedures. One benefit for surgical procedures is less bleeding; heat
from lasers cauterizes blood vessels, which leaves medical personnel with less blood Image courtesy of
to deal with compared with scalpels. Perhaps the most popular application is LASIK, ABBOTT
a type of refractive laser eye surgery to correct myopia, hyperopia, and astigmatism. LABORATORIES
LASIK surgery has transformed outcomes for patients su ering from these conditions. FDA approved
the first excimer laser in 1995.

Angio-Seal 1996

The Angio-Seal is a breakthrough vascular closure device that uses bioabsorbable

components to mechanically seal punctures in the femoral artery a er a
catheterization procedure. The quick seal occurs in three easy steps—locate, set, and
seal—and is created by sandwiching the arteriotomy in the tissue tract between a
copolymer anchor and a collagen sponge. In addition to providing patients with a
Photo courtesy of shorter hospital stay, the seal dissolves within 60 to 90 days. The device was
ST. JUDE MEDICAL developed by Kensey Nash Corp., which licensed it to St. Jude Medical.

LightCycler Real-Time PCR 1998

Molecular diagnostics have paved the way toward individualized medicine. The
technology enables point-of-care diagnoses for infectious diseases, meaning
infected patients can be identified quickly, enabling immediate treatment and
protection for those at risk. One of the best-known devices is the LightCycler Real-
Time polymerase chain reaction (PCR) System from Roche Diagnostics. Using PCR,
scientists can take a specimen containing a minute amount of genetic material,
repeatedly copy a selected region from it, and within hours, generate a sample
su icient to perform a variety of tests. PCR is versatile. Many types of samples (e.g.,
blood, skin cells, saliva, hair) can be analyzed for nucleic acids. Any sample used for
PCR must contain the DNA strand encompassing the region to be amplified.
Photo courtesy of
CyberKnife Robotic Radiosurgery System 1999
ROCHE APPLIED
SICENCES
The CyberKnife is a miniature linear accelerator mounted to a
robotic arm. It noninvasively delivers concentrated beams of radiation to a targeted
tumor from multiple positions and angles. The tumor receives a cumulative dose of
radiation high enough to control or kill the tumor cells while minimizing radiation
exposure to surrounding healthy tissue. It delivers to almost all parts of the body,
Photo courtesy of particularly for surgically complex tumors. In 1999, the device was approved for
ACCURAY treatment of tumors in the head and base of skull. In 2001, FDA cleared
enhancements to the CyberKnife System for tumors anywhere in the body.

da Vinci Surgical System 1999

The da Vinci surgical system has made it possible to treat a broader range of
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conditions with a minimally invasive approach. The system's microchip technology

and 3-D optics enable surgeons to perform complex procedures by making tiny
incisions. The da Vinci o ers users greater precision, an increased range of motion,
improved dexterity, and enhanced visibility. Because of the device, patients may Image courtesy of
experience less pain, less scarring, reduced risk of infection, and a faster recovery INTUITIVE
time. The surgical system has been used to treat heart conditions, prostate cancer, SURGICAL
endometrial cancer, morbid obesity, and mitral valve regurgitation.

PillCam 2001

Is your digestive tract ready for its close-up? The PillCam is a capsule that houses a
miniature video camera, lights, a transmitter, and batteries. Once a patient swallows
the pill and it passes through the digestive tract, it takes photos of the small intestine
and sends them to a small recorder a ixed to the patient's belt. This technology has
helped patients avoid invasive and painful endoscopic diagnostic procedures just by
Image courtesy of swallowing a pill. It also allows the entire small bowel to be viewed (endoscopes
GIVEN IMAGING allowed physicians to see only the upper part of the small bowel).

OraQuick Advance Rapid HIV-1/2 Antibody Test 2002

Major progress has been made since the first AIDS-related diagnostic test was
commercialized in 1988. In 2002, the OraQuick Advance Rapid HIV-1/2 Antibody Test
became the first rapid HIV test to earn FDA approval. In clinical studies conducted by
the manufacturer, OraSure Technologies Inc., the test correctly identified 99.6% of
people who were infected with HIV-1 and 100% of people who were not infected with
it. The test provides results for patients in about 20 minutes. This is key because with
previous tests, which took several days to process, a significant number of patients
never returned to the clinic to learn whether or not they were infected. The test can
be stored at room temperature, requires no specialized equipment, and can be used
in both laboratory and nontraditional clinical settings.

Drug-Eluting Stent 2003 (U.S. release)

Blocked coronary arteries used to be addressed by coronary

artery bypass gra surgery. Then came balloon angioplasty. But
Image courtesy of angioplasty was o en plagued by restenosis, a narrowing of a
ABBOTT blood vessel that restricts blood flow. The stent was the next
LABORATORIES development, and although it improved outcomes, it also
increased the risk of thrombosis (clotting) and occlusion of the
stent. Eventually, stent developers wondered whether the device itself could be a
Image courtesy of
conduit for medication. Enter the drug-eluting stent, which was first approved in
ORASURE
Europe in 2002. It has reduced restenosis rates and provided significantly better
TECHNOLOGIES
clinical outcomes for patients. The drug-eluting stent has also had bigger
INC.
implications for the medical device industry—it has helped usher in the era of
combination products The marriage of devices and drugs is still changing the industry as regulators
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combination products. The marriage of devices and drugs is still changing the industry as regulators
and developers continue evaluating how these products are dealt with.

Sidne Voice Activation System 2003

As the first FDA-approved Bluetooth-ready medical device, Sidne represents where

the future of Bluetooth is headed in the device industry. The system, which stands for
Stryker integrated device network, uses voice recognition to give surgeons control
over endoscopy equipment in the operating room without touching a button.
Bluetooth technology eliminates tangled cable wires from the control unit to devices Photo courtesy of
on the operating table, and a wireless headshot gives surgeons the freedom to move, STRYKER
as well as answer and dial calls through the hospital. The device is also modular, allowing hospitals to
customize the control package based on their needs.

LifePort Organ Transporter 2003

The method of storing and transporting organs has traditionally involved placing an
organ in a cooler filled with ice—until the LifePort Organ Transporter came into the
picture. The product uses mobile machine perfusion to improve transplant
outcomes, allowing the use of more organs and lowering the number of organs
discarded. The process involves pumping a cold solution through the organ to
Photo courtesy of reduce tissue damage even while the organ is in transport. The LifePort started as a
WI MEDICAL transporter for kidneys and has been so successful that the product is branching out
DEVICE into use for the heart, pancreas, liver, lung, and intestines.
DEVELOPMENT
OxyMask 2005

The OxyMask is designed to overcome the common side e ects of closed oxygen
masks such as mucosal drying, nose bleeding, facial sores, and the claustrophobic
nature of the device. Its open oxygen system design eliminates CO2 rebreathing,
allows patients to communicate more easily with clinicians, and enables drinking
through a straw. A nasogastric tube can also be threaded through the mask, and a
swivel elbow expands the device's flexibility by allowing le -to-right positioning of
oxygen tubing. The mask also has a PVC-free version. Photo courtesy of
SOUTHMEDIC INC.
Pinnacle TPN Management System 2007

In an improvement on patient safety, the Pinnacle system provides a safe and easy
way to check, compound, and deliver total parenteral nutrition (TPN) to patients. The
device controls intravenous formulations using amino acids, dextrose, electrolytes,
and lipids for patients who rely on tube feeding or can't tolerate oral intake of food.
Photo courtesy of
The Pinnacle system streamlines the TPN process by combining automated
B. BRAUN
compounding technology with a safety verification system and special so ware. The
MEDICAL
system can accurately measure and combine up to nine nutritional compounds and
prepares one liter of TPN solution in less than one minute. Its safety-check so ware and bar coding
ensure that solution is going to the correct patient.

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Impella 2.5 Circulatory Support System 2008

The Impella 2.5 is a minimally invasive, percutaneous cardiac assist device that
allows the heart muscle to rest and recover. Impella is designed to actively unload
the le ventricle, reduce heart muscle workload and oxygen consumption, and
increase cardiac output and coronary and end-organ perfusion. Impella received FDA
510(k) clearance in June 2008 and has been used to treat heart attack patients,
patients undergoing high-risk angioplasty, peripartum cardiomyopathy, and viral Photo courtesy of
1
myocarditis. It is ∕100 the size of the heart. The device is approved in more than 40 ABIOMED
countries, has been used to treat more than 1700 patients worldwide, and has been the subject of more
than 50 peer-reviewed publications. The device was the recipient of a 2007 Medical Design Excellence
Award.

Many key technologies got their start before MD&DI's inception and before current regulations. Here are
a few that have made a significant contribution to the way medicine is practiced.

Vena Cava Filter 1973

Unique in healthcare disciplines is the fact that devices o en draw inspiration from
the outside world to solve medical problems. In oil pipelines, a cone-shaped filter
traps sludge and debris. The geometry of the cone allows oil to continue flowing
around its edges while concentrating the sludge in the center, whereas a flat screen,
with sludge spread across it, could completely clog the pipeline. The vena cava filter
is the same basic shape as that used in oil refining and is used to prevent life-
threatening pulmonary embolisms.

Computed Tomography Scanner 1972

Photo courtesy of
BOSTON Since its introduction in the 1970s, computed tomography (CT)
SCIENTIFIC CORP. has become an important tool in medical imaging. It is the gold
standard in the diagnosis of a number of di erent disease entities.
CT produces data that are manipulated through a process known as windowing. It
demonstrates bodily structures based on their ability to block the x-ray beam. Photo courtesy of
Although historically the images were in the axial or transverse plane, orthogonal to SIEMENS
the long axis of the body, modern scanners allow this volume of data to be
reformatted in various planes or even as 3-D representations. The first commercially viable CT scanner
was invented by Sir Godfrey Hounsfield in Hayes, UK, at EMI Central Research Laboratories. Hounsfield
conceived his idea in 1967, and it was publicly announced in 1972. Allan McLeod Cormack of Tu s
University in Massachusetts independently invented a similar process, and both Hounsfield and
Cormack shared the 1979 Nobel Prize in medicine. The original prototype took 160 parallel readings
through 180 angles, each 1˚ apart, with each scan taking about five minutes. The images from these
scans took 2.5 hours to be processed by algebraic reconstruction techniques on a large computer.

Magnetic Resonance Imaging 1977

The first magnetic resonance (MR) image was published in 1973 and the first study performed on a
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The first magnetic resonance (MR) image was published in 1973 and the first study performed on a
human took place on July 3, 1977. MR imaging was developed from the study of nuclear magnetic
resonance. In its early years, the technique was referred to as nuclear magnetic resonance imaging. The
technology is used to visualize the internal structure and function of the body. MR provides contrast
between the di erent so tissues of the body, making it especially useful in neurological,
musculoskeletal, cardiovascular, and oncological imaging. Applications for MR technology continue to
evolve. For example, recent applications in functional MRI measure changes in the brain, which could
lead to more information about the nature of diseases, such as stroke. They are also being moved into
the OR to take images during surgical procedures.

Hemodialyzers and Dialysis Machines 1800s–1970s

These devices provide an artificial replacement for lost kidney function due to renal failure. In
hemodialysis, the patient's blood is pumped through the blood compartment of a dialyzer, exposing it
to a semipermeable membrane. The cleansed blood is returned via the circuit back to the body.
Ultrafiltration occurs causing water and dissolved solutes to move from blood to dialysate and allows
the removal of excess fluid.

Artificial Pacemaker 1960s–1970s

The development of the pacemaker arguably gave legitimacy to the discipline of

medical device engineering. Its history is linked to famous developers, such as Earl
Bakken, Manuel Villafaña, and Wilson Greatbatch. Modern pacemakers have multiple
functions. The most basic monitor the heart's native electrical rhythm. When the
pacemaker fails to sense a heartbeat within a normal beat-to-beat time, it stimulates
Photo courtesy of the ventricle with a short low-voltage pulse. This activity continues on a beat-by-beat
ST. JUDE MEDICAL basis.

Copyright ©2009 Medical Device & Diagnostic Industry

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