Essential Biomaterials Science Professor David Williams Adjunct Professor, University of Technology, Sydney Professor, Wake Forest Institute of Regenerative Medicine, USA Chairman, Strait Access Technologies Pty, Ltd, South Africa Partner, Morgan & Masterson LLC, USA Immediate Global Past-President, TERMIS Professor Emeritus, University of Liverpool, UK Visiting Professor Universities in Cape Town, Shanghai, Beijing, Taipei Seminar at University of Technology, Sydney, Australia 19 th April 2016
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Professor David Williams - University of Technology Sydney · Essential Biomaterials Science: Professor David Williams Biomaterials-based statistics (2) One-third of women under 60
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Essential Biomaterials Science
Professor David Williams Adjunct Professor, University of Technology, Sydney
Professor, Wake Forest Institute of Regenerative Medicine, USA Chairman, Strait Access Technologies Pty, Ltd, South Africa
Partner, Morgan & Masterson LLC, USA Immediate Global Past-President, TERMIS
Professor Emeritus, University of Liverpool, UK
Visiting Professor Universities in Cape Town, Shanghai, Beijing, Taipei
Seminar at University of Technology, Sydney, Australia 19th April 2016
Essential Biomaterials Science: Professor David Williams
Biomaterials-based statistics (1) In the USA, 138,000 hip replacements were performed in 2001.
By 2010, the number was 310,000 There was a 92% increase in patients over 75
But a 205% increase in those aged 45-54. 16% of USA adults (20 million people) live with chronic kidney disease
600,000 patients are treated by haemodialysis, but life expectancy is 5 years 100,000 on transplant waiting list, 16,000 performed a year, but far more cost effective
Wound care market globally is US$ 17 billion Of which the market for wound dressings is US$ 10 billion
85,000 adults implanted with aortic valve replacements in the US 45,000 patients globally receive TAVI treatment at $30,000 per valve
20 million Americans suffer from cataracts 3 million receive IOLs per year at $3,500 per procedure
98% successful
Essential Biomaterials Science: Professor David Williams Biomaterials-based statistics (2)
One-third of women under 60 years have some symptoms of Stress Urinary Incontinence, One half for those over 60 years -
no fully satisfactory treatment yet For diabetic patients, the market for human insulin is US$ 20 billion
Need better (biomaterials-based) delivery systems Deep brain stimulators for treatment of Parkinson’s disease now relatively successful.
With market size of over US$ 1 billion Gene therapy market, in early stage of development expected to be US$ 11 billion by
2020; need safe non-viral, biomaterials-based vectors Imaging contrast agent market already at US$ 4 billion, expected to grow with newer
nanomaterials systems Annual world-wide sales of cochlear implants 50,000 Australian company Cochlear has 53% market share
160,000 implants would be needed annually to treat all children who have severe-profound sensorineural hearing loss
Essential Biomaterials Science: Professor David Williams
q Applications and performance specifications for biomaterials
q Classification of biomaterials q Biocompatibility pathways
q Biomaterials in medical devices q Biomaterials in regenerative medicine q Biomaterials in drug and gene delivery
q Biomaterials in imaging systems q Future perspectives
Essential Biomaterials Science: Professor David Williams
Applications and Performance Specifications for Biomaterials
• What is a biomaterial ?
• What are biomaterials used for? • What are the essential characteristics of
biomaterials? • How do we define their performance specifications?
The Classification of Biomaterials Applications (1)
Class 1 Permanent (Long-term) Implantable Devices
Class 1.1 Permanent implantable devices for the anatomical replacement of parts of the body that have undergone some form
of degenerative disease. Class 1.2 Permanent implantable devices for the anatomical
replacement of parts of the body that have undergone surgical removal of cancerous tissue.
Class 1.3 Permanent implantable devices for the correction of congenital or developmental deformities.
Class 1.4 Permanent implantable devices for the restoration or correction of function after injury.
Class 1.5 Permanent implantable devices for the restoration or correction of function as a consequence of disease.
Class 1.6 Permanent implantable devices for cosmetic purposes.
The Classification of Biomaterials Applications (2)
Class 2 Short-term Implantable Devices
Class 2.1 Implantable devices to assist in the repair of broken bones Class 2.2 Implantable devices to assist in the repair of soft tissue
Class 3 Invasive but Removable Devices
Class 3.1 Indwelling catheters and shunts
Class 3.2 Contraceptive devices
Class 4 External Artificial Organs / Organ Assist devices
Class 4.1 Devices attached to the patient that deliver short-term support Class 4.2 Devices attached to the patient that act as a bridge to transplant or life-long
support
Class 5 Surgical and Clinical Accessories
Class 5.1 Wound dressings Class 5.2 Short-term catheters and drains
The Classification of Biomaterials Applications (3) Class 6 Drug and Gene Delivery Systems
Class 6.1 Oral drug delivery systems Class 6.2 Infusion systems
Class 6.3 Systems for delivery across epithelial / mucosal surfaces Class 6.4 Monolithic implantable devices
Class 6.5 Microparticulate and nanoparticulate systems Class 6.6 Prodrugs and polymer therapeutics
Class 6.7 Anti-microbial systems Class 6.8 Immunotherapy and chemotherapy hybrids
Class 6.9 Non-viral gene vectors Class 6.10 Engineered viral vectors Class 6.11 Vaccine delivery systems
Class 6.12 Theranostic systems Class 7 Tissue Engineering Systems
Class 7.1 Engineered cell therapy products for regenerative medicine purposes Class 7.2 Engineered gene therapy products for regenerative medicine purposes
Class 7.3 Ex vivo / bioreactor generated tissue constructs Class 7.4 Cell seeded implanted scaffolds
Class 7.5 Cell-free implanted scaffolds Class 7.6 Injectable cell seeded products
Class 7.7 Injectable cell-free products Class 7.8 Cell sheet engineered constructs
Class 7.9 Engineered systems for drug discovery and testing Class 7.10 Engineered tumor models Class 8 In Vivo Diagnostic Systems
Class 8.1 MRI contrast agents Class 8.2 Ultrasound contrast agents
Class 8.3 Fluorescence and bioluminescene imaging systems Class 8.4 Contrast enhanced micro CT systems
Class 8.5 Implantable biosensors
The Baseline Biomaterial Configuration: The material is a single-phase, isotropic, homogeneous,
chemically-defined substance Interaction 1
There is a thermodynamically-driven adsorption of tissue components onto the material surface; components of blood, extracellular fluid, urine, saliva, tears etc immediately attach themselves to the biomaterial surface.
Interaction 2
The tissue responds to the presence of the material; a non-specific response of the body to invasion by a foreign object, mediated by size, shape and surface characteristics.
Interaction 3
The tissue responds to the physical characteristics of the material; biophysical processes influence the relationship between the biomaterial surface and the tissues.
Interaction 4
The tissue and material interact mechanically; mechanical forces significantly influence the development of the longer term response from the tissue and its components and also the response of the material to these
components.
Interaction 5 The material responds to the fluid tissue environment; the time dependent response of the material to the
aggressive tissue fluids, where deviations from the baseline biomaterial configuration (such as the presence of complex microstructures and additives / contaminants) start to influence the material response, either beneficially
or deleteriously.
Interaction 6 The tissue responds to the chemical nature of the material and any released components; this is the ultimate
determinant of the performance and safety of the biomaterial, and is significantly influenced by compositional and structural deviations from the simple, baseline configuration.
The Generic Requirements for Biomaterials (1) Functionality; optional, depending on application