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

SUMMARY

In virtually all areas of medicine, increasinglysophisticated devices are turning to increasingly sophisticated materialsscience to solve their most nagging technical problems. From passive functionslike sterility and biocompatibility to active drug delivery and evenconductivity, polymers are proving to be more versatile and complex than everbefore. Kalorama's Advanced Polymers for Medical Applications examines thelatest 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 ofthese quickly evolving technologies and their promising and dynamic marketplace.

Innovation in Cell Hosting, Drug Delivery, and Biocoatings Drive AdvancedMedical Polymers into New Era

New York, February 5, 2002 /PR Newswire — Advanced polymer researchis leading to thousands of new and innovative medical devices, many of whichwere not possible only a few years ago, according to a new study released todayby Kalorama Information and available at MarketResearch.com. Those areas withthe most potential appear to be applications in tissue engineering andtransplant medicine, devices that deliver pharmaceuticals, and specializedpolymer coatings that allow for more complex device design, according to thestudy.

The study, Advanced Polymers for Medical Applications, found a plethora ofopportunity in new polymer research, noting that the markets for someapplications such as cell hosting in which a polymer scaffold makes tissuegrowth possible, have nearly unlimited growth potential. The market potentialfor tissue-engineered healthcare solutions has been estimated at over $80billion, according to the study. Some other areas of promising researchidentified by the study include biodegradable polymers and hydrogels, molecularimprinted polymers, conductive polymers, and biopolymers.

"A few years ago medical device designers were forced to work with asmall handful of classic biomaterials, and polymers were used in medicalimplants only as inert structural materials," notes James P. Smith, PhD,the author of the report. "However, the standard concept of a medicalimplant as an inanimate, mechanical product seldom applies today. Advancedmedical polymers are now capable of biological processes, and can become afunctional part of living organisms."

The study also found, though, that there are significant obstacles toprogress in the sector. Nuances of medical device regulation and the uniquestructure of the healthcare markets have created barriers to productdevelopment, especially for companies that are entering the medical arena forthe first time. The report contains an extensive step-by-step review of theapproval process and the industry\'s standards.

TABLE OF CONTENTS

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
• Synthesis
• 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

• Biocompatibility
• 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 GrowingMammalian Nerve Cells
• Hydrogels
• 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
• History
• 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

• Overview
• 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
• Photopolymers

Chapter Eight: Product Development, Approval, And Regulations

• Overview
• 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
• Committees
• 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
• Biomaterials
• 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.
• ConvaTec
• 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 B: Plaspec Materials Selection Database