Master of Technology
Medical Devices
Lecture 1: Introduction of Medical Devices
20/03/2025 Elective 1: Biomedical Devices and Systems 1
Course Contents and Suggested Readings:
1. Gail D. Baura. Medical Device Technologies: A Systems Based Overview Using Engineering Standards Academic Press,
Oxford, UK 2012
2. Paul H. King, Richard C. Fries. Design of Biomedical Devices and Systems. CRC press, Boca Raton, 2009
3. James Moore and George Zouridakis. Biomedical Technology and Devices Hand Book. CRC press, Washington DC, 2004
4. Martin Culjat, Rahul Singh, Hua Lee. Medical Devices: Surgical and Image-Guided Technologies, John Wiley & Sons, Inc
New Jersey, 2013
5. ASM Handbook Volume 23, Materials for Medical Devices
6. Joseph D. Bronzino, Donald R. Peterson. Medical Devices and Human Engineering, CRC Press, New York, 2015
7. Frank E. Johnson, Katherine S. Virgo, The Bionic Human: Health Promotion for People with Implanted Prosthetic
Devices, Humana Press Inc., New Jersey, 2006
20/03/2025 Elective 1: Biomedical Devices and Systems 2
Introduction to Medical Devices
Biomedical Engineering is a interdisciplinary field which improves human
health through cross-disciplinary activities that integrate advance
knowledge of natural sciences, engineering sciences, medical science and
clinical practice
The application of concepts and methods of engineering, biology, medicine,
physiology, physics, materials science, chemistry, mathematics and computer
sciences to develop methods and technologies to solve health problems in
humans.
• Understand and gain new knowledge of living beings
• Development of tools, devices, process and systems to understand these living
beings
20/03/2025 Elective 1: Biomedical Devices and Systems 3
Science and Technology
Science
Technol
ogy
Science and Technology
DNA sequencing then, now, tomorrow
Faster (15 min to couple of hours ), cheaper,
precise, less sample requirement and more
importantly portable
Faster (many samples in a day), costly, more
Time consuming (weeks
reliable to months),
, but costly, erroneous,
not portable
large sample requirement
Medical Devices:
Areas involved
biomechanic
And many Tissue
more ML, AI Engineering
etc.
Computer Bio-
Science instrumentation
MD
Medical Biomaterials
Imaging
Engineering Medical
Sciences Sciences
6
20/03/2025 Elective 1: Biomedical Devices and Systems
Medical Devices:
Areas involved
Tissue Engineering
Regeneration: Is it possible?
• Grass, Plant grows back
• starfish arms, zebra fish’s fins grows back,
Why not amputated arm or damaged liver grows back?
Applications
• Tissue replacement for
• Disease
• Trauma
• Congenital problems
• Battlefield wounds
• Transplantation
• Improve performance
Medical Devices:
Areas involved
Bio-instrumentation:
– Sensors
– Amplifier and Signal • Signal analysis ( statistics and
transform) of biological signals
Processing • Use data to uncover the
– Biopotential mechanisms of signal production,
and the fundamental origins of the
– Clinical Laboratory Instrument variability in the signal.
• Data collection and analysis to
– Therapeutic And Prosthetic assist in decision making
Devices • Radiography
• Magnetic Resonance
– Medical Imaging
• X-ray Imaging
1. Methods for obtaining invasive and noninvasive information from
• Ultrasound imaging
the human body, organs, cells, and molecules.
2. Electronic instrumentation, principles of analog and digital signal• Electromyogram (EMG):
processing • Electrocardiogram and
3. Measurement concept such as accuracy, reproducibility, noise Pulses (ECG)
suppression, calibration methods, safety requirements.
20/03/2025 Elective 1: Biomedical Devices and Systems 9
Medical Devices:
Areas involved
Biomaterials
A natural or synthetic material suitable to be deliberate to interface with biological
systems to evaluate, treat, augment or replace any tissue, organ or function of the body.
Examples:
• Polymeric biomaterials: Poly(α-hydroxy esters) including poly(lactic acid) (PLA),
poly(glycolic acid) (PGA) and their copolymers (PLGA) etc.
• Bioceramics: Alumina, zirconia and hydroxyapatite etc.
• Metallic biomaterials: Stainless steel, CoCr alloys, and Ti and Ti alloys
• Biocomposite: Sodium alginate/silk fibroin, starch/lignin, poly(lactic acid)/ lignocellulosic
fiber, starch/PVA/cellulose etc
• Biologically based or drived materials: Chitosan, Alginate, Slik, Cellulose etc.
Application : Few of them
Skeletel system Cardiovascalar sysem Organs
• Joint replacement (Hip, knee) • Blood vessel prosthesis • Artificial heart
• Skin repair template
• Bone plate, Bone cement • Heart valve
• Artificial kidney
• Artificial tendon and ligment • Catheter • Heart-lung machine
• Dental implant
Medical Devices:
Areas involved
Medical Sciences
• Anatomy
• Physiology
• Biochemistry
• Biopotential
Medical Devices:
Areas involved
Medical Sciences
Using engineering principals and techniques to solve medical
problems
Mechanical Engineering: To machine the implants, designing the joints and fluid-
dynamics of joints, designing, fabrication and evolution of implants, diagnostic
device manufactureing
Electical Engineering: Measurement of biopotential and electical signal detection
and single processing etc.
Material Engineering: Designing materials depending on the medical
requirements
Electronic and Communication: Development of instrument for various
measurement
Medical Devices:
Areas involved
Biomechanics:
1. Application of mechanics in cardiovascular and musculoskeletal
systems.
2. Biological transport processes and systems
3. Interrelationship between biomechanics and physiology in medicine,
surgery, sports, sports medicine,
4. Design and physics of prosthetic devices.
5. Also involves Mechanobiology
Gliding joints Saddle joints Ball and socket Synovial
Joints Joints
Medical Devices
What is a Medical Device?
“Any instrument, apparatus, appliance, material or other article, whether
used alone or in combination, including the software necessary for its proper
application intended by the manufacturer to be used on human beings for the
purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, or alleviation of or compensation for an
injury or handicap,
• investigation, replacement or modification of the anatomy or of a
physiological process,
• control of conception
and which does not achieve its principal 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.” (MDD Article 1(2a))
14
MDD: Medical Device Directive of EU
Medical Devices
All devices including an instrument, apparatus, appliance, implant, material or other
article, whether used alone or in combination, including a software or an accessory,
intended by its manufacturer to be used specially for human beings or animals
which does not achieve the primary intended action in or on human body or animals
by any pharmacological or immunological or metabolic means, but which may assist
in its intended function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or
disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or
disability;
(iii) investigation, replacement or modification or support of the anatomy or of a
physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception
S.O. 648(E).— In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs
and Cosmetics Act, 1940 (23 of 1940), 1 st day of April, 2020
Medical Devices
HealthCare Practice or Function
• Prevention
• Diagnosis
• Therapeutic care
• Rehabilitation
• Long-term care or Palliative care (when cure is not possible)
16
Medical Devices
Medical Imaging Devices (in vivo diagnosis)
• X-ray projection imaging
• Computerised Tomography (CT)
• Ultrasound (USI), Doppler imaging
• Magnetic resonance imaging (MRI)
• Radionuclide imaging (nuclear
medicine)
• Thermography and other
techniques
17
Medical Devices
Medical Laboratory Devices (in vitro diagnosis)
• sample separation, centrifugation etc
• electrophoresis, capillary
electrophoresis
• pH / ISE meters
• particle / cell counters
• spectrophotometers
• flow cytometry
• microscopy
• HPLC (chromatography)
• clinical chemistry
• haematology
• immunology
• scintillation systems
• genetic analysis
Medical Devices
Physiological Measurement Devices
(in vivo diagnosis)
• Instruments for measuring physical and chemical
variables in vivo
• Thermometers
• Cardiovascular physiology: blood pressure monitors,
flowmeters, pulsed Doppler US systems
• Electrophysiology: ECG, EEG, EMG
• Audiology and ophthalmology
• Respiratory physiology: spirometers, pulse oximetry,
impedance pneumograph….
• Endoscopes
19
Medical Devices
Screen of a multipurpose clinical monitor
sphygmomanometer
ECG
20
Medical Devices
Paediatric Intensive Care Endoscopy
21
Medical Devices
Radiotherapy Devices
• X-ray and electron, resp. hadron
beams from accelerators (shape,
direction, and intensity of beam
changed often continuously)
• gamma-ray beams from tele-isotope
radioactive sources like Co-60
• treatment planning systems Linear accelerator
• simulators
• brachytherapy
• dosimeters
22
Leksell gamma knife
Medical Devices
Physical therapy
Devices
• Electrotherapy
• UV and IR therapy
• Shortwave Ultrasound
diathermy therapy unit
• Ultrasound therapy
• Laser therapy Laser therapy unit
Shortwave diathermy
23
Muscle stimulator
Medical Devices
POC (Point of Care) Devices
• Aaddress clinicians’ requirements for rapid
access to information to support critical
care decisions
• Advances in microelectronics and
biosensor tools have brought technology to
the bedside in a miniaturized form.
• Examples:
• Performing blood tests at the patient's side
rather than in a central laboratory
• portable ultrasound imaging devices
• Lateral flow devices
• Microfluidic devices
24
• Plastic devices
Medical Devices
Surgical theatre devices, lithotripsy
cryosurgery anaesthesia electrocautery
25
Operating lamps
Medical Devices
Prosthetic Devices, and Implants
26
Medical Devices
Artificial Organs (Implants)
Cochlear implant
Cardiopul-monary bypass Ventilator
Medical Devices
Artificial Organs
Stents are inserted into the
damaged blood vessels,
oesophagus etc. They are
often made of a metal with
a „shape memory“ –
nitinol, which adopts the
intended shape when
heated to body
temperature. 28
Medical Devices
Disposable Medical Devices
Suction catheter
Umbilical cord clamp
I.V. cannulae
29
