In virtually all areas of medicine, increasingly sophisticated devices are turning to increasingly sophisticated materials science to solve their most nagging technical problems. From passive functions like sterility and biocompatibility to active drug delivery and even conductivity, polymers are proving to be more versatile and complex than ever before. Kalorama's Advanced Polymers for Medical Applications examines the latest technological and market developments in advanced plastics for:
- Diagnostic and laboratory devices
- Blood-handling devices
- Implants and prosthetic devices
- Drug delivery systems
- Organ and tissue replacements
- Cardiopulmonary systems
Patent applications and clinical trial information combined with commercial, regulatory, and manufacturing issues will present a comprehensive picture of these quickly evolving technologies and their promising and dynamic marketplace.
Innovation in Cell Hosting, Drug Delivery, and Biocoatings Drive Advanced Medical Polymers into New Era
New York, February 5, 2002 /PR Newswire — Advanced polymer research is leading to thousands of new and innovative medical devices, many of which were not possible only a few years ago, according to a new study released today by Kalorama Information and available at MarketResearch.com. Those areas with the most potential appear to be applications in tissue engineering and transplant medicine, devices that deliver pharmaceuticals, and specialized polymer coatings that allow for more complex device design, according to the study.
The study, Advanced Polymers for Medical Applications, found a plethora of opportunity in new polymer research, noting that the markets for some applications such as cell hosting in which a polymer scaffold makes tissue growth possible, have nearly unlimited growth potential. The market potential for tissue-engineered healthcare solutions has been estimated at over $80 billion, according to the study. Some other areas of promising research identified by the study include biodegradable polymers and hydrogels, molecular imprinted polymers, conductive polymers, and biopolymers.
"A few years ago medical device designers were forced to work with a small handful of classic biomaterials, and polymers were used in medical implants only as inert structural materials," notes James P. Smith, PhD, the author of the report. "However, the standard concept of a medical implant as an inanimate, mechanical product seldom applies today. Advanced medical polymers are now capable of biological processes, and can become a functional part of living organisms."
The study also found, though, that there are significant obstacles to progress in the sector. Nuances of medical device regulation and the unique structure of the healthcare markets have created barriers to product development, especially for companies that are entering the medical arena for the first time. The report contains an extensive step-by-step review of the approval process and the industry’s standards.
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Chapter One: Introduction to Polymers for Medical Applications
Some Fundamental Concepts
- Polymeric Properties
- Naturally Occurring Polymers
- Biopolymers and Biomaterials
- Biodegradable Polymers
- Biocompatible Polymers
- Medical Polymers
- Tissue Engineering
- The Market
Properties of Polymers
- Physical and Chemical Properties
- Molecular Weight
- Addition Polymerization
- Condensation Polymerization
Physical Properties of Solid Polymers
- Tensile Properties
- Fatigue Behavior
- Glass Transition Temperature
Classes of Polymers Used in Medicine
Medical Polymers Come of Age
- Biodegradable Polymers
- From Tissues to Organs
- Degradable Inorganic Compounds
- Wound Closing
- Biomaterials are Advancing Oral Medicine
Legislation can Reduce the Risks of Innovation
- Legal Worries Now Impede Innovation
- Major Players are getting out of the Business
- Biomaterials Access Assurance Act
Merging Polymer Science and Biology
- Only a Limited Number of Building Blocks
- New Molecular Architectures Allow Control on the Nanoscale
Exciting Research: Biopolymer Optics and Electronics
- Medical Applications of Conducting Polymers
Synthesizing Active Polymers with Potential Bio-Interfaces
- Well-Defined Polymer Structures
- Future Polymers-Active Biomedical Processes
Chapter Two: Biodegradable Polymers and Medical Applications
- Moving from Inert to Reactive
- Design Criteria
Medical Applications of Biodegradable Polymers
- The Temporary Scaffold
- Degradable Sutures
- The Temporary Barrier
- The Drug Delivery Device
- Multifunctional Devices
- Tissue Engineering
- Bioactive Matrices
- Removing Blood Clots from Circulation
- New Chemistry Techniques
- Other New Formulations
- Chemistry and Physics of Biodegradable Polymers
- Processing of Biodegradable Polymers
- Mechanisms of Chemical Degradation
- Packaging and Sterilization of Biodegradable Polymers
- New Biomaterial Shows Promise for Medical Applications
- Biodegradable Polymers in Tissue Engineering
- Researchers Create First "Designer" Biomaterial for Growing Mammalian Nerve Cells
- Classification and Basic Structure
- Hydrogel Swelling Behavior
- Properties of Some Biomedically and Pharmaceutically Important Hydrogels
Currently Available Degradable Polymers
- First, Nondestructible Polymers, Now You Want What?
- Polyhydroxybutyrate (PHB), Polyhydroxyvalerate (PHV), and Copolymers
- Poly(ortho Esters)
- Poly(amino Acids) and "Pseudo" -poly(amino Acids)
- Poly(lactic Acid) and Poly(glycolic Acid)
Chapter Three: Bone and Cartilage Replacement
Bone Morphogenic Proteins
- Bone Cement
- The Bone Growth Factor
Starting the Bone Growth Process
Tissue Engineers Build New Bone
- Biomaterials Laced with Molecular Signals
- Expanding Bone Growth Techniques to other Tissues
- The Genetics Dimension
- New Polymer System for the Delivery of Plasmids
New Stem Cell Sources
- Bone Marrow Stem Cells
- Mesenchymal Stem Cell Trials Await Food and Drug Administration Action
- Competitive Pressures Limit Research
Artery/Cartilage Replacement Biomaterial
Production of Human-Like Finger Joint
Protein Delivery System May Help Fight Osteoporosis
Inorganic Materials and Enzymes Disperse into Biodegradable Composites
Cell-Loaded Matrix Can Repair Bones
Chapter Four: Dressings for Burns and Chronic Wounds
- Wound Dressings
- Hydrogel Drug Delivery System
- Imbedded Polymer Fabrics
- A Nontoxic Sterilization Process for Biomaterials
- Wound Care After Laser Resurfacing
- Artificial Cell Membranes for Medical Use
- Artificial Skin and other Biotech Devices Aid Wound Repair
- Wound-Healing Products
- Antiadhesive Products
Chapter Five: Molecular Imprinted Polymers
Making an Imprint
Advantages and Limitations
Examples of Molecular Imprinted Polymers
Pros and Cons
Plastics with Molecular Memory
- Host-Guest Chemistry
- Biomimetic Recognition Systems
- Recognition Sites
- Sensor Design Criteria
- Evolving Biosensor Technology
- Future Sensor Prospects
Molecular Imprinted Polymers for Chromatographic Separation
- Separation Technology
- Producing Molecular-Imprinted Polymers
Preparation and Optimization
- Molecular Recognition
- Specific Examples for Chromatographic Separations
- Chiral Separations with Molecular Imprinted Polymer Stationary Phases
Cutting Edge Research and the Future
- Making Polymer Coats for Molecules
- Plastic Pharmaceuticals
- Stretching Polymers May Effect Molecular Recognition
Chapter Six: Polymer Coatings and Surfaces for Medical Applications
Polymer Coatings for Medical Products
- Increased Functionality and Versatility
- Coating Adhesion-Resistant Devices
- Conductive Coatings
- Implant Coatings
- Increasing Heat Resistance
- Special Cases
- Antibacterial Coatings
Polymer Coatings and Substrates for Drug Delivery Applications
- Drug-Delivery Coatings
- Getting Drugs to Hard-to-reach Places
- Engineering a New Drug Delivery Profile
- New Gel Could Mean Fewer Pills
- Star Polymer Has Drug Delivery Potential
Coating Process May Prevent Body from Rejecting Medical Implants
Surfaces Provide Key to Design of Clinically Useful Materials
- Self-Assembled Monolayers and RhoA
- Oligomers Of Ethylene Glycol (OEG)
Chapter Seven: Tissue Engineering
An Emerging Industry
- Skin Engineering
- Bone Regeneration
Factors Driving Tissue Engineering Development
- Escalating Costs of Health Care
- Aging of the Population
- Organ Failure and Transplantation
- Future Outlook
- A Promising Multidiscipline Approach
Dog Bladders and Human Hearts
- The Bladder is Almost Here
- On to the Kidney and the Heart
Mass-Producing Polymer Scaffolds
- Standards for Organ Builders
- Building a Liver in Tubes and Layers
Cell Culture in Three Dimensions
- From Cell Layers to Organs
- Cartilage Engineering
Preserving and Shipping Artificial Tissues and Organs
Chapter Eight: Product Development, Approval, and Regulations
- Time is Money
- Testing the Biomaterial or the Medical Device?
Historical Overview of Medical Materials and Device Regulation
- Food, Drug, and Cosmetic Act of 1938
- Medical Device Amendments
- What Is a Medical Device?
- Safe Medical Devices Act of 1990
- Device Classification (21 CFR 860.3)
The Review and Approval Processes: Step by Step
- Premarket Approval Application
- Investigational Device Exemption (IDE)
- Alternative Product Development Protocols
- Nonclinical Testing
- Clinical Testing
Factors in Biocompatibility Evaluations
- Biocompatibility of Medical Materials
Who Writes Standards?
- The Standards Organizations
- Good Laboratory Practices
- Center for Devices and Radiological Health Premarket Review Staff
- Types of Standards
Who Uses Standards?
The American Society For Testing and Materials System
- Biocompatibility Standards
Chapter Nine: Market Perspective
The Healthcare Marketplace
The Evolution of Medical Polymers
Tissue Engineering: Spare Parts
Medical Coatings Market Segment
Diagnostic Testing Segment
- Commercial Biodegradable Devices
- Spinal Bone Graft
- New Directions in Coronary Stenting
Barriers to Progress
Chapter Ten: Company Profiles
Alexion Pharmaceuticals, Inc.
Alza Corporation (Johnson & Johnson)
Apogent Technologies Inc.
Arrow International, Inc.
Ballard Medical Products (Kimberly-Clark Health Care)
C. R. Bard, Inc.
Bausch & Lomb Inc.
Baxter International Inc.
Becton, Dickinson and Co.
Biocompatibles International Plc
Bionx Implants, Inc.
Boston Scientific Corporation
Carrington Laboratories, Inc.
Ciba Specialty Chemicals Holding Inc.
Clontech Laboratories, Inc.
Curative Health Services, Inc.
Imagyn Medical Technologies, Inc.
Imperial Chemical Industries Plc
Implant Sciences Corporation
Integra LifeSciences Holdings Corporation
Interpore International, Inc.
Medtronic Sofamor Danek, Inc.
Nobel Biocare AB
Ortec International, Inc.
Orthofix International N.V.
Planet Polymer Technologies, Inc.
Polymer Group, Inc.
Protein Polymer Technologies, Inc.
Smith & Nephew Plc
Sulzer Medica Ltd
Tutogen Medical Inc.
Wright Medical Group, Inc.
Zimmer Holdings, Inc.
Appendix A: Standard Terminology for Abbreviated Terms Relating to Plastics ASTM D 1600-92
Appendix B: Plaspec Materials Selection Database