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)

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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

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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

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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.

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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

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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.

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Dri

ve

rs

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

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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

Ch

all

en

ge

s

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Interested in Full Access? Connect With Us

Ariel Brown Associate Corporate Communications

(210) 247-2481

Ariel.brown@frost.com

Research Authors

Sanchari Chatterjee Research Analyst

Chemicals, Materials & Food

Vivek Ninkileri Research Analyst

Chemicals, Materials & Food

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Global Perspective 40+ Offices Monitoring for Opportunities and Challenges

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