WEBINAR ON

Advanced Biomaterials for

Biomedical Applications
17-22nd MARCH 2021

Organized by
Department of Electronics Engineering and Medical Electronics Engineering
BMS College of Engineering
Bangalore

In Association with

.
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Trivandrum

Presentation for “Advanced Biomaterials for Biomedical Applications”

17 March 2021
 BIOMATERIALS
IN THE LAB AND IN THE CLINIC

Dr.Manoj Komath
Scientist G, Biomedical Technology Wing
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Trivandrum

manoj@sctimst.ac.in 9387414142
Biomaterials Science

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Early history of the use of Biomaterials
Early 1900's: Bone plates used to fix fractures
1930's: Use of stainless steel, cobalt chromium alloys
1938 : First total hip prosthesis
1940's: Use of polymers in medicine: PMMA; nylon sutures
1952: Mechanical heart valve
1953: Dacron (polymer fiber) vascular grafts
1958: Cemented (PMMA) joint replacement
1960: First commercial heart valves
1974: Hydroxyapatite ceramics
1976: Artificial heart

1976: FDA controls the use of biomaterials /devices

(amendment governing testing and production)

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Evolution of Biomaterial Science & Technology

1st generation (1950s)

Doctors
Bioinertness Biomedical Engineers Biomaterials
Science
2nd generation (1980s)
Bioactivity Materials Scientists
Medical Researchers
Tissue
3rd generation (2000s) Engineering
Regenerate functional tissue
Targetted functions Materials Scientists
Biologists/Biotechnologists
Medical Researchers

Regenerative
Medicine

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Classification of Biomaterials

 Polymeric biomaterials
 Bioceramics
 Metallic biomaterials
 Biologically derived biomaterials

Composites and coatings

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Polymeric Biomaterials

• PMMA • PA
• PVC • PTFE
• PLA/PGA • PET
• PE • PUR
• PP • Silicones

ADVANTAGES
• Easy to make complicated items
• Tunable physical & mechanical
properties
• Surface modification
• Immobilization of cells etc.
• Biodegradable
DISADVANTAGES
• Leachable compounds
• Absorption of water & proteins
• Surface contamination
• Wear and breakdown
• Degradation issues
• Difficulty in sterilizing

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Bioceramics

• Alumina
• Zirconia (partially stabilized)
• Silicate glass
• Calcium phosphate (apatite)
• Calcium sulfate

ADVANTAGES
• High compression strength
• Wear & corrosion resistance
• Can be highly polished
• Bioactive/inert
DISADVANTAGES
• High modulus (mismatched with bone)
• Low strength in tension
• Low fracture toughness
• Difficult to fabricate

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Metallic biomaterials
• Stainless steel (316L) • Amalgam (AgSnCuZnHg)
• Co-Cr alloys • Ni-Ti
• Ti6Al4V • Titanium
• Au-Ag-Cu-Pd alloys

ADVANTAGES DISADVANTAGES

• High strength • High moduls

• Fatigue resistance
• Wear resistance
• Easy fabrication
• Easy to sterilize
• Shape memory
• Corrosion
• Metal ion sensitivity and toxicity
• Metallic look

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 Other biomaterials

 Biologically derived biomaterials

 Composites (Metal/Polymer/Ceramic)

 Coatings

19-Mar-21
10
 Forms of Biomaterials

Solid chip or block

Dense, porous, spongy
Soft / flowing/ setting
Gels, cements, injectables
Sheet
Cross-liking, Freeze-drying, Electrospinning
Printed
3D printing, Bioprinting
Nanostructures
Diagnostics, Sensors, Drug delivery systems

19-Mar-21
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 Some applications of biomaterials
APPLICATION
Skeletel system
• Joint replacement (Hip, Knee)
• Bone plate / screw
• Bone cement
• Artificial tendon and ligment
• Dental implant
Cardiovascalar sysem
• Blood vessel prosthesis
• Heart valve
• Catheter
Organs
• Artificial heart
• Skin repair template
• Artificial kidney
• Heart-lung machine
Senses
• Cochlear replacement
• Intraocular lens
• Contact lens
• Corneal bandage
MATERIAL
• Titanium , Stainless steel, PE
• Stainless steel, Co-Cr alloy
• PMMA
• Hydroxyapatite, Teflon, Dacron
• Titanium, alumina, zirconia
• Dacron, Teflon, Polyurethane (PU)
• Reprocessed tissue, SS, Carbon
• Silicone rubber, teflon, PU
• Polyurethane
• Silicone-collage composite
• Cellulose, polyacrylonitrile
• Silicone rubber
• Platium electrodes
• PMMA, Silicone rubber, hydrogel
• Silicone-acrylate, Hydrogel
• Collagen, hydrogel
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 Biomaterials in business
About 1500000 different medical products (biomaterial based) are in the
market - in 900 product categories, covering 50 clinical specializations.

MAJOR PLAYERS IN THE MARKET

• Baxter International develops technologies related to the blood and circulatory system.
• Biocompatibles Ltd. develops commercial applications for technology in the field of biocompatibility.
• Carmeda makes a biologically active surface that interacts with and supports the bodys own control mechanisms
• Collagen Aesthetics Inc. bovine and human placental sourced collagens, recombinant collagens, and PEG-polymers
• Endura-Tec Systems Corp. bio-mechanical endurance testing of stents, grafts, and cardiovascular materials
• Howmedica develops and manufactures products in orthopaedics.
• MATECH Biomedical Technologies, development of biomaterials by chemical polymerization methods.
• Medtronic, Inc. is a medical technology company specializing in implantable and invasive therapies.
• Molecular Geodesics Inc., biomimetic materials for biomedical, industrial, and military applications
• Polymer Technology Group is involved in the synthesis, characterization, and manufacture of new polymer products.
• SurModics, offers PhotoLink(R) surface modification technology that can be used to immobilize biomolecules
• W.L.Gore Medical Products Division, PTFE microstructures configured to exclude or accept tissue ingrowth.
• Zimmer, design, manufacture and distribution of orthopaedic implants and related equipment and supplies

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14
BIOMATERIAL – THE CONCEPT

The working definition of a BIOMATERIAL

A non-viable material (without any pharmacological or biological
function) used in a medical device, intended to interact with
biological systems
or a substance (other than a drug), natural or synthetic, that treats,
augments, or replaces any tissue or organ, and body function
in a safe, reliable, economic, and physiologically acceptable manner.

Biomaterials help to treat defects, injuries and conditions which

cannot be solved with conventional therapies or procedures
Replacement of functionally impaired body parts
(total hip, heart).
Correction of abnormalities (spinal rod).
Improvement of function (pacemaker, stent).
Assistance in healing (wound dressings sutures).

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BIOMATERIAL – THE CONCEPT

The ultimate aim is the clinical use

BIOMATERIAL MEDICAL DEVICE

Enhances the quality of life

Adding more years to life-span

Something divine

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Biomaterials - from Lab to Clinic
The wonder material
(Tumor Terminator !? )

FROM LAB TO CLINIC

Is it really workable ?
Is it safe for the patient ?
What are the risks ?
What are the real benefits ?
Give the evidences with you…

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Hierarchical structure of human body

THE
BIOLOGICAL
MILIEU

Atomic
Molecular
Cellular
Tissue
Organ
System
Organism

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Tampering with human body …

Many-in-one system
remaining in a dynamic
equilibrium (HOMEOSTASIS)

A conservative system which

protects itself
identifies its own components
keeps them together
expels anything alien to it

Insertion of a biomaterial / device

can evoke an unexpected, adverse
or detrimental response

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 Response of human body …

The biomaterial / device should

HOST RESPONSES TO perform its function without
BIOMATERIALS eliciting serious host responses
Thrombosis
Haemolysis
Inflammation
Infection
Carcinogenesis
Hypersensitivity
Systemic Effects

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Challenges in biomaterial research

The basic ‘mantra’ in biomaterial development

The material/device should be safe and

efficacious in the clinical use

The real challenges in biomaterials research

EFFICACY / FUNCTIONALITY STUDIES

“BIOCOMPATIBILITY” STUDIES

Methods ? Infrastructure ?

Test Facilities ? Reliability ?

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 Beyond the laboratory
Reliable Methods
International Standards (ASTM, ISO, ANSI…)

Time Manpower
You need Meticulous
planning
Funds Support

Time estimate for ISO 10993

essential Biocompatibility tests
3 -4 years !

Prove it in animals
before human trials

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 Beyond the laboratory

Preclinical Animal Studies

Regulatory permission
Animal model selection
Experiment planning

Time estimate 2 years !

Human Clinical Trials

Clinical Investigational Plan
Ethics committee’s approval
DCGI approval
Registration in CTRI

Time estimate 2 -3 years !

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 To the marketplace

Entrepreneur

Commercial Viability
(Market Survey)

TECHNOLOGY TRANSFER 2 years

+
Manufacturing license
(Drug Controller)
2 years
Product +
specifications, SCALE-UP & PRODUCTION
Packaging & 3 years
Sterilization
Marketing license
(Drug Controller)

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 F r o m s ci en t ist t o p a t ie n t

15 years, at least …. !

Products currently being approved (in the

US/EU) are conceived 15 years back !!

In India, the products coming into the market are

25-30 years old ideas (because they are tested in
comparison with the products approved in the US/EU).

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Biomaterial-based Products -

“ OLD IS WORKABLE “

Novel Biomaterials ?

Tissue Engineered Products

Additional biological processing
Clinical logistics

Nano-biomaterial Products
Unknown pathways of toxicity
Nano toxicology is in infancy

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27
1 . BIOLOGICALLY DRIVEN REPAIR :
A more biologically based method of repair / regeneration of
tissues is needed. Bioactive materials with biochemical stimuli
provide the starting point for this shift.

2. VASCULAR TISSUE ENGINEERING

Obtaining and maintaining a blood supply in tissue-engineered
constructs is necessary for their long-term success.
Techniques required to enhance vascularization of regenerated
soft tissue construct using new generation biomaterial.

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3 . STEM CELL ENGINEERING
Encourage stem cells to differentiate into a required lineage,
derive highly purified populations of the required cell phenotype,
ensure there is no carcinogenic potential in the cell population.
Ensure that the cells will proliferate and replace / augment the
function of the diseased or degenerating tissues.
4. CONTROL OF INFECTION
It is needed to achieve localized control of bacteria and
inflammation that lead to cellular de-differentiation.
This will reduce systemic antibiotic use and its ill effects.

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5 . PREDICTIVE IN VITRO TESTS
Present day regulation prescribes in vivo animal testing to
establish safety of new biomaterials.
Tissue engineered constructs and nanoparticles is a societal
concern for both ethical and economic reasons.
Developing predictive in vitro tests based upon human cells
that are sufficiently reliable and cost effective is an important
challenge.

 TOXICITY AND BIOCOMPATIBILITY OF BIOMATERIALS

 TOXICOKINETICS OF NANOPARTICLES

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3/19/2021
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