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Innovations in Protective Coatings for Medical Devices


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Innovations will surge in the protective coatings industry by 2020, giving rise to a range of improved biocompatible and durable coatings that enable implant devices for use in orthopedic, orthodontic and cardiac applications. The International Organization for Standardization (ISO) and American Society for Testing and Materials (ASTM) are creating new standards for upcoming industry trends in protective coatings, further encouraging patent developments.

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Innovations in Protective Coatings for Medical Devices

  1. 1. Biocompatible Protective Coatings Widen Application Scope in Medical Devices, Finds Frost & Sullivan Research PREVIEW for the Innovations in Protective Coatings for Medical Devices (D556-TI)
  2. 2. D556-TI 2 Contents Section Slide Numbers Executive Summary 4 Technology and Industry Overview 8 • Industry Trends- Medical Devices 9 • Need for Protective Coatings on Implants 11 • Technology Snapshot 12 • Types of Protective coatings- By Application 13 • Regulatory Scenario 18 • Protective Coatings–Manufacturing Process 19 • Technology Capability 20 • Value Chain Analysis 21 Impact Assessment and Analysis 24 • Market Impact of Drivers 25 • Market Impact of Challenges 26 • Recent Innovations and their Market Significance 28 • Demand Side Analysis 30
  3. 3. D556-TI 3 Section Slide Numbers • Opportunity Evaluation and Technology RoadMapping 31 • Emerging Opportunities–Types of Coatings 32 • Assessment of Emerging Opportunities 33 • Technology Strategy Management 35 • Technology Roadmap 36 • Key Patents 42 • Key Contacts 48 • Appendix 51 • The Frost and Sullivan Story 58 Contents
  4. 4. D556-TI 4 Key Findings 1 US demand for implantable medical devices is forecasted to be around $52 billion in 2015 and the market is expected to grow around the rate of 7.7% annually for the next 3 years. Orthopedic implants will remain the largest and one of the fastest growing segment. Cardiac pacing devices will lead gains among cardiovascular implants. Other implants expected to do well include neuro stimulators and drug implants. The implant market will have a huge impact on the protective coating market. 2 Protective coating industries will be more productive and emerging in the North American region. Diverse developments will also be seen in Europe after North America. The Asia Pacific countries may not see much significant growth in terms of technology development as US or European countries; but developments in Japan and China will contribute significantly to the rise of the technology. Nevertheless, in the future, there is huge market potential for these technologies developed in North America and Europe in the APAC region. 3 Stakeholder initiatives, especially collaborations will take a major step in the advancement of protective coating technologies. Across globe, technology advancements from research institutes, academia and medical device manufacturers help in increasing the adoption of protective coatings. Also, there is increase in number of government funded research consortiums in the European region. 4 From passivation coatings to anti-thrombogenic coatings to dental implants or neurovascular implants productive innovations are being implemented across the globe. More developments are in the pipeline for patents. ISO and ASTM are developing more standards for the upcoming industry trends in protective coatings. 5 By 2020, the protective coating industry shall see a massive surge in developments and a whole range of improved biocompatible and durable implant devices for orthopaedic, orthodontic, and cardiac applications ready to be commercialized across the world.
  5. 5. D556-TI 5 Overview • Protective coatings used on medical implants help the implant function in an hostile environment by protecting them against microbial attacks and bodily fluids; and preventing any sort of foreign body reaction (FBR). • It prevents triggering of any allergic reactions unlike conventionally used metallic or alloy orthopedic implants. • The type and method of coating the implant varies with the end use application and the geometry of the implant. • Various stakeholders have come up with several proprietary and patented methods and types of coatings. Significance • Similar to any other medical invasive procedure, traditionally used implants are leading to various complications such as inflammation, infection, and allergic side effects. All of these increase the chance of fibrous encapsulation, induced thrombosis, and rejection of the implants by the body. • These drawbacks of traditional implants clearly highlight significance of protective coatings on implants. Protective coatings can prevent the above mentioned complications by properly customizing it to the specific functionality of implants. Benefits • Protective coatings can be customized to get higher corrosion resistance and improved wear resistance, which can be effectively implemented for orthopedic implants. • Specialized coating and coating techniques can be designed to propagate the growth of desirable endothelial cells rather than smooth muscle cells and to prevent aggressive cell growth. • Specialized coatings can also prevent release of harmful metallic ions into the body. Technology Snapshot
  6. 6. D556-TI 6 Need for Protective Coatings on Implants Implant Failure Thrombosis Infection Corrosion and Mechanical Failure Defective Surgical Procedure Implants generally fail due to four different causes: • Thrombosis is caused due to the element of shear stress that the blood is subjected to when flowing near to the implants. • Surface characteristics of the implants contribute significantly to the failure of implants due to infections. • Corrosion and mechanical failures mainly occur in alloy and metallic implants used for orthopedic and orthodontic applications. • Defective surgical procedure can be a cause of implant failure, wherein the failure could be a resultant of improper location of implants or improper sterilization of implants or invasive surgical instruments. • Thrombosis: Formation of blood clots on implants like stent and catheters that will lead to implant rejection. • Infection: Infection caused during the implantation procedure or in-vivo will propagate bio-film and associated complications would lead to implant rejection. • Corrosion: Corrosion of implants is a major concern particularly for orthopedic and orthodontic implants. Corrosion would lead to allergic reactions and reduced mechanical strength of the implant, hence requiring replacement. • Defective Surgical Procedure: This could be resultant of improper sterilization of the surgical implements and implants and also due to inappropriate location of the implant.
  7. 7. D556-TI 7 Drivers Factor Occurrence of post operative infections Need for Biocompatibility Technological advances in surface kinetics and advanced coating sectors Availability of Funding Enhanced in vivo functionality Global Demand Factor Description Post-operative cochlear implant infections can be effectively controlled with proper medical device coatings such as anti-microbial coatings. With appropriate treatment s and management strategy of implant coatings, these infections can be negated. Selection of the appropriate coating material enables a device to deliver the proper therapeutic effect. For passive therapeutic coatings, such as polymeric hydrogels, the ability to covalently bond a molecule to the surface of a device provides for a more durable hemo compatible effect. Technological advancements that define the development of modern medical implants is a multi- stage design and technology specific manufacturing process that is primarily based on in-vitro tests. Successful technological advances in the implant coating industry have made it one of the strongest drivers. With increase in global demand and technological advancements funding has become inevitable for industry growth. Sponsorships and alliances from companies are increasing as these companies are interested in funding and sponsoring various research trails. Governmental bodies such as US NSF, European Commission and Dutch Ministry of Economic Affairs, Agriculture and Innovation have shown interest in funding for implant coatings. Market Impact of Drivers Biocompatible materials are needed to minimize tissue rejection and promote the anchor of implants to the targeted area. Biocompatibility is a major driver for present implant coating modifications. Successful implant coatings have been devised which enhance biocompatibility actively. The ageing population in 2030 is projected to be twice as large as in 2000, growing from 35 million to 72 million in USA and representing nearly 20% of the total U.S. population according to US governmental statistics. This tens in expected across all developed nations and is expected to push the growth of implants and thereby, protective coatings. 1-3 years Impact 4-6 years Above 6 years Key: Impact: High Medium Low Protective Coatings for Medical Implants- Key Drivers, Global, 2014-2020
  8. 8. D556-TI 8 Factor Increased cost of raw materials Lack of skilled resources Stringent regulations and standards Need for ecofriendly coatings Biodegradability of coatings Low durability and shelf life Factor Description Expensive raw materials is a big challenge to this industry, especially for development of nano coatings such as carbon nanotubes and bio active coatings. Biodegradability is the recyclability of an implant. Some implant coatings such as Titanium and other metal coatings are loosing degradability owing to corrosive nature in due course of time. So scientists are working on this issue and developing anti-corrosive implant coatings with long lasting effects. Stringent regulations and coating safety procedures delay the efforts to commercialize .To bring a biomedical implant to the market, manufacturers need to adhere to various regulations in terms of manufacture, safety, and sustainability of the coating and its quality. Coatings used in implants are mostly not environment friendly as these are either synthetic or chemical based. Research is to focus on development of alternatives for chemical coatings and use more of environment friendly green coatings, which would be safe for the host tissues and also be effective in functioning. Market Impact of Challenges Given the rapid changes in implant technology and rehabilitative strategies, coating professionals need quick access to a variety of training resources related to material properties and behavior of coatings. These training needs should be considered and addressed by professional associations and research institutes and more trained material science experts with proper knowledge of surface activities and coating technologies are required. Owing to high degradability of coating, the shelf life of the implant as a whole is drastically reduced and the need for operation for the end user becomes frequent. This adversely affects consumer confidence..Implants require coatings which are long lasting for better effectiveness for greater period of time. 1-3 years Impact 4-6 years Above 6 years Key: Impact: High Medium Low Protective Coatings for Medical Implants- Key Challenges, Global, 2014-2020 Challenges
  9. 9. D556-TI 9 Interested in Full Access? Connect With Us Ariel Brown Associate Corporate Communications (210) 247-2481 Research Authors Sanchari Chatterjee Research Analyst Chemicals, Materials & Food Vivek Ninkileri Research Analyst Chemicals, Materials & Food Facebook LinkedIn Group SlideShare Twitter Frost & Sullivan Events GIL Community
  10. 10. D556-TI 10 Global Perspective 40+ Offices Monitoring for Opportunities and Challenges
  11. 11. D556-TI 11 Industry Convergence Comprehensive Industry Coverage Sparks Innovation Opportunities Automotive & Transportation Aerospace & Defense Measurement & Instrumentation Information & Communication Technologies HealthcareEnvironment & Building Technologies Energy & Power Systems Chemicals, Materials & Food Electronics & Security Industrial Automation & Process Control Automotive Transportation & Logistics Consumer Technologies Minerals & Mining