Medical devices- definitions and types

• Other than drugs, medical-related instruments, apparatuses,

implements, machines, appliances, implants, in vitro reagents or
calibrators, software, materials or other similarly related articles are
considered medical devices.
• Examples of medical devices range from something as simple as
bandages, medical thermometers, stethoscopes, or disposable gloves
to advanced devices such as equipment and/or computers with
software that assists in the conducting of medical tests (e.g., MRI,
ultrasound, CT), implants, and prostheses; there are approximately
1.5 million different devices.
Medical devices- definitions and types
• The different regulatory authorities in each country recognize
different classes of medical devices based on their design complexity,
their use characteristics, and their potential safety hazard if misused.
• Each country defines these categories in different ways. But typically,
they are regulated into class I, II (IIa, IIb), and III (or A, B, C, D) based
on the risk level to patients, ranging from low risk to high risk.
Examples of medical devices based on Singapore
classification [HSA GN-15]
Categorization of medical devices
• The categorization of medical devices was based on the nature of
body contact and contact duration for the ISO 10993 biocompatibility
test.
• The categorization will determine what biocompatibility tests should
be done before clinical trials.
• some devices are provided in combination with drugs.
• Tissue-engineered products are treated as combination products
because they are usually comprised of a cellular or tissue component
as well as a device component, thus they need to go through separate
reviews for each component.
Categorization of medical devices [ISO
10993]
Nature of body contact Examples
Surface-contacting devices
Skin Electrodes, external prostheses, fixation tapes, compression
bandages and monitors of various types
Mucosal membranes Contact lenses, urinary catheters, intravaginal and intraintestinal
devices (stomach tubes, sigmoidoscopies,
colonoscopies, gastroscopes), endotracheal tubes,
bronchoscopes, somedental prostheses and orthodontic devices
Breached or compromised Dressings or healing devices and occlusive patches, for
surfaces ulcers, burns and granulation tissue
Categorization of medical devices [ISO
10993]
Nature of body contact Examples

External communicating
devices
Blood path, indirect Solution administration sets, extension sets, transfer sets and
blood administration sets
Tissue/bone/dentin Laparoscopes, arthroscopes, draining systems, dental
cements, dental filling materials and skin staples
Circulating blood Intravascular catheters, temporary pacemaker electrodes,
oxygenators, extracorporal oxygenator tubing and
accessories, dialysers, dialysis tubing and accessories,
haemoadsorbents and immunoadsorbents
Categorization of medical devices [ISO
10993]
Nature of body contact Examples
Implant devices

Tissue/bone Pacemakers, drug supply devices, neuromuscular sensors

and simulators, replacement tendons, breast implants,
artificial larynxes, subperiosteal implants, ligation clips and
intra-uterine devices; orthopaedic pins, plates, replacement
joints, bone prostheses, bone cements and intra-osseous
devices
Blood Pacemaker electrodes, artificial arteriovenous fistulae, heart
valves, vascular grafts, internal drug-delivery catheters and
ventricular assist devices
Definition of medical device
• US FDA-“An instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component part, or
accessory which is:
• recognized in the official National Formulary, or the United States Pharmacopoeia, or
any supplement to them,
• 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 intended to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary 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 primary intended purposes” [1].
Definition of medical device
• WHO GHTF SGI- any instrument, apparatus, implement, machine, appliance, implant, reagent for in
vitro use, software, material or other similar or related article, intended by the manufacturer to be
used, alone or in combination, for human beings, for one or more of the specific medical
purpose(s) of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological process.
• supporting or sustaining life,
• disinfection of medical devices,
• providing information by means of in vitro examination of specimens derived from the human body;
• and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
[2].
Definition of medical device
• EU- Any instrument, apparatus, appliance, software, material or other article,
whether used alone or in combination, together with any accessories, including
the software intended by its manufacturer to be used specifically for diagnostic
and/or therapeutic purposes and necessary for its proper application, intended
by the manufacturer to be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment, or alleviation of disease
• diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or
handicap.
• investigation, replacement, or modification of the anatomy or of a physiological process
• control of conception
• This includes devices that do not achieve their principal intended action in or on the human body by
pharmacological, immunological, or metabolic means—but may be assisted in their function by such
means [3].
Definition of medical device
• ISO 13485-any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or
calibrator, software, material or other similar or related article, intended by the manufacturer to be
used, alone or in combination, for human beings for one or more of the specific purpose(s) of-
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury.
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information for medical purposes by means of in vitro examination of specimens derived
from the human body, and which does not achieve its primary intended action in or on the human
body by pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means.
Examples of medical devices for the human
body
Market trend
• The global medical device market reached approximately $363.8
billion in 2013 with annual average growth of the global market
around 18.41% from 2010 to 2020.
Market trend
• The top 10 medical device markets by sales revenue in 2012 are
United States (36.3%), Japan (9.9%), Germany (7.0%), China (4.3%),
France (4.1%), UK (3.0%), Italy (2.6%), Russia (2.1%), Canada (2.1%),
and Brazil (1.6%).
• The four BRIC markets (Brazil, Russia, India, and China) have rapidly
grown to a total market of US$26.2 billion in 2012.
Top 10 companies in medical device sales
Top five companies in orthopedics medical device sales
Top 5 companies in cardiology medical
device sales
Market trend
•In almost every country, the
population aged 60 years and
above is growing faster than any
other age group, as a result of both
longer life expectancy and declining
birth rates.
•For example, the life expectancy in
Singapore has increased from 75 to
83 years old from 1990 to 2012.
•Seventy years was the average life
expectancy rate of the global
population in 2012.

Drivers of growth for medical devices.

Safety issues