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Advanced Polymers for Medical Applications: Materials, Product Development, and Market Opportunities

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 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.

About Kalorama Information
Kalorama Information, a division of, supplies the latest in market research for the life sciences. For more information, contact Steven Heffner at 212-807-2634 or

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Chapter One: Introduction to Polymers for Medical Applications

    Some Fundamental Concepts
    • Polymers
    • 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
    • Tacticity
    • Crystallinity

    Mechanical Properties
    • Tensile Properties
    • Fatigue Behavior

    Thermal Properties
    • Glass Transition Temperature

    Classes of Polymers Used in Medicine
    • Homopolymers
    • Copolymers
    • Polyurethanes

    Medical Polymers Come of Age
    • Introduction
    • 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

    Biodegradable Polymers
    • Definitions
    • Advantages
    • 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
    • Degradation
    • 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
    • Preparation
    • Hydrogel Swelling Behavior
    • Properties of Some Biomedically and Pharmaceutically Important Hydrogels
    • Applications

    Currently Available Degradable Polymers
    • First, Nondestructible Polymers, Now You Want What?
    • Polyhydroxybutyrate (PHB), Polyhydroxyvalerate (PHV), and Copolymers
    • Polycaprolactone
    • Polyanhydrides
    • Poly(ortho Esters)
    • Poly(amino Acids) and "Pseudo" -poly(amino Acids)
    • Polycyanoacrylates
    • Polyphosphazenes
    • 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

    Gene Therapy
    • The Genetics Dimension
    • Plasmids
    • 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

    Bioreactive Fabrics
    • 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

    Process Overview
    Making an Imprint
    Advantages and Limitations
    Examples of Molecular Imprinted Polymers
    Future Directions
    Pros and Cons
    Plastics with Molecular Memory
    • Host-Guest Chemistry
    • Biomimetic Recognition Systems
    • Recognition Sites

    Chemical Sensors
    • 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
    • Challenges
    • Future Outlook
    • A Promising Multidiscipline Approach
    • Microfabrication

    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

    Animal Rights
    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

    Device Testing
    • 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

    ABIOMED, Inc.
    Acordis BV
    Alexion Pharmaceuticals, Inc.
    Allergan, 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
    Biomet, Inc.
    Bionx Implants, Inc.
    Boston Scientific Corporation
    Carrington Laboratories, Inc.
    Ciba Specialty Chemicals Holding Inc.
    Clontech Laboratories, Inc.
    CryoLife, Inc.
    Curative Health Services, Inc.
    DePuy Inc.
    Guidant Corporation
    Haemonetics Corporation
    Imagyn Medical Technologies, Inc.
    Imperial Chemical Industries Plc
    Implant Sciences Corporation
    INAMED Corporation
    Integra LifeSciences Holdings Corporation
    Interpore International, Inc.
    LifeCell Corporation
    Medtronic Sofamor Danek, Inc.
    Mentor Corporation
    Nobel Biocare AB
    Organogenesis Inc.
    Ortec International, Inc.
    Orthofix International N.V.
    OrthoLogic Corp.
    Osteotech, Inc.
    Planet Polymer Technologies, Inc.
    Polymer Group, Inc.
    ProCyte Corporation
    Protein Polymer Technologies, Inc.
    Smith & Nephew Plc
    Stryker Corporation
    Sulzer Medica Ltd
    Synthetech, Inc.
    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

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