Medical Device Testing Market: Information by Service Type (Testing Services), Sourcing Type (Outsourced), Technology (Active Implant Medical Device), and Region — Forecast till 2029

Dec 04, 2020   Market Overview Medical device testing is the process of transforming an innovative equipment design into a reliable and marketable product. It combines expert knowledge with an advanced infrastructure of accredited laboratories and research centers. Medical device testing puts it through a comprehensive assessment and helps demonstrate compliance with standards and regulations. The testing can range from prototype testing to Certification Body (C.B.) Scheme and lab tests for ergonomics, electr...
Request Free Sample Report

Report Description

Market Overview

Medical device testing is the process of transforming an innovative equipment design into a reliable and marketable product. It combines expert knowledge with an advanced infrastructure of accredited laboratories and research centers. Medical device testing puts it through a comprehensive assessment and helps demonstrate compliance with standards and regulations. The testing can range from prototype testing to Certification Body (C.B.) Scheme and lab tests for ergonomics, electrical, mechanical, and functional safety assessments, and software testing.

Medical devices are highly regulated by multiple regulations by government bodies and compliances. Additionally, there is a growing demand for exceptional performance, effectiveness, and safety from the devices. This is compelling the medical device manufacturers to define and implement effective medical device testing strategies throughout the development cycle.

An effective testing strategy includes compliance processes and technical testing for better performance and reliability of medical devices. A medical device manufacturer needs to test each function of the medical device right from the start. If an error is detected in the later phases of testing, it will be very costly and time-consuming to go back to the design phase and rectify the issues. This is why testing and certification is an important segment in the development of the medical device in the healthcare industry.

Impact of COVID-19

With the surging number of cases for the novel coronavirus pandemic across the globe, governments are scrambling to contain its spread. As a result, healthcare systems are overwhelmed in determining the effective delivery of medical care systems to the affected. The pandemic has disrupted the medical device manufacturing and testing industry.

Medical device manufacturers rely heavily on healthcare facilities for their clinical data collection. Pre and post clinical trials help manufacturers to obtain certificates for market approval. The medical device companies are finding it difficult during the pandemic to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty

Growing Demands for Validation and Verification of Medical Equipment

Consumers continuously expect outstanding performance, effectiveness, and safety from medical devices. This has increased the demand for validation and verification of medical devices. Therefore, it is mandatory for the manufacturers to properly define and test medical devices for the confirmation of quality. Several sets of test requirements, component selection, and the final assembly of a medical device are anticipated to augment the overall growth of the market. Furthermore, global companies are investing in automation, which has surged the need for automated quality assurance. The demand is further elevated due to the COVID-19 outbreak as a human intervention has reduced in the process.

Time Consuming and Expensive Licensing to Hamper the Market Growth

Excessive regulations, both national and international, can become barriers to the innovation of local medical devices. Incorporating new technologies in the licensing procedure of these devices can be lengthy and expensive, posing a potential hindrance to the market growth. Lengthy procedures also incur huge amounts of money to the manufacturers due to the prolonged delays and additional equipment costs. This is significantly challenging for low-income countries that have a lack of infrastructure and budget constraints.

Prolonged Lead Time in Gaining International Market Acceptance to Hamper Market Growth

Due to large scale globalization, import and export of products, the exchange of goods and services can be time-consuming. Acceptance of products in international markets is a challenge that companies face due to the long lead time required for overseas qualification tests. This increases the risk of losing valuable customers, product quality, and costs additional time and money. With the growth in international trade, the lead time for overseas qualification tests is increasing, marking it a critical challenge for the medical device testing market.

T Incorporation of A.I. and IoT in the Medical Sector to Offer Lucrative Growth Opportunities

Technological advancement is taking over the healthcare industry at a rapid pace. The medical device testing market is witnessing a series of developments in the field of drug-device combination, personalized medicine, and the advent of portable and wearable medical devices. Medical equipment is now implemented with IoT and A.I., which is serving as a key growth factor for market growth. Key companies in the developed, as well as some of the developing economies, are heavily investing in these technologies as they are going to rule for a longer period of time. They are also focusing on complying with the stringent regulations of these technologies in the healthcare industry.

Medical Device Testing Market: Segmentation

Service Type Segment to Hold the Largest Market Share during the Forecast Period

The growing demands of Testing, Inspection, and Certification (TIC) services, along with good quality and standard products, is a prime factor driving the segment growth. TIC services ensure that the products have met the required quality, safety, and performance regulatory standards. This includes electro-medical device testing, biocompatibility testing, and clinical research services that are assessed in the final stage of the testing.

This is done to investigate the faulty material and test the performance of the devices. Therefore, it will increase the demand for testing services manifold in the upcoming years. Manufacturers require assistance in improving the marketability of their medical devices and in lowering costs, which is bolstering the market growth. This will help the certification services segment, specifically, to grow with a higher CAGR during the forecast period.

In-House Sourcing Type Segment to Hold the Largest Share of the Medical Device Testing Market

At a time like the COVID-19 crisis, it is difficult for manufacturers to gather funds for the infrastructure to conduct in-house tests of medical devices. Therefore, many large firms are increasingly outsourcing medical device testing services to help reduce overall testing costs. There is a growing trend to outsource TIC services to third-party vendors if the testing requires the implementation of complex technologies. The in-house sourcing type segment held the largest share of the medical device testing market in 2019 and is expected to witness the fastest-growth with some limitations this year.

Regional Outlook

Asia-Pacific-Lead-Medical-Device-Testing-Market

Advancements in the Healthcare Infrastructure in China, South Korea, and Japan Drives APAC's Market Growth

Asia-Pacific dominates the medical device testing market, owing to the rising disposable income and advancements in the healthcare infrastructure in China, South Korea, and Japan. Growing awareness regarding healthcare devices in India, especially after the pandemic, has compelled the government to invest in research and development of new portable and accurate equipment. Rising consumer awareness has also increased the importance of testing and certification in the region, which is bolstering the market growth

Growing Demands for Long-Term Therapy in North America and Europe to Drives the Market Growth

Strict regulations have been established by the North American and European governments to maintain quality and safety standards in the pharmaceutical and healthcare industries. The market growth can further be attributed to the increasing R&D activities, early adoption of new technologies, and the growing demand for long-term therapy by patients. North America accounts for the largest number of the geriatric population globally, which is accelerating the growth of the medical devices market in the region. Contract Research Organizations (CROs) are investing heavily in this region due to lower costs and easy availability of skilled labor.

A Glance at the Regulatory Highlights of Medical Device Testing in U.S. and Europe

  • The Food and Drug Administration (FDA) issued an Emergency Use Authorizations (EUA) for medical devices in the U.S. This includes In-Vitro Diagnostic (IVD) test kits to diagnose COVID-19 as well as PPE needed to protect healthcare providers interacting with patients. The FDA has authorized rapid emergency use of specific devices via expedited premarket under EUA declarations. The EUA submission should include safety, effectiveness, and risk-related data available pertaining to the medical device. Obtaining EUA designation provides speedy access to the U.S. healthcare market; however, these authorizations are applicable only during the public health emergency
  • The Medical Device Regulation (MDR) in the European Union (E.U.) mandates manufacturers to conduct Post Market Clinical Follow-Up (PMCF) studies to demonstrate the continued safety and performance of their devices. It is also necessary to identify hidden risks. Certain trials such as Investigator-Initiated Studies (IIS) are necessary for the broader healthcare system to define the efficacy of certain therapeutic options. Clinical trials are initiated by sponsors to satisfy regulatory requirements. In April 2020, the European Commission adopted a proposal to postpone the application date of the MDR for one year. This was done to avoid any risks of potential shortages or delays in the availability of such devices caused by the capacity limitations of conformity assessment bodies. Based on the proposal, the functionality of the European Database on Medical Devices (EUDAMED) will be announced by March 2021, with reporting requirements beginning May 2021
  • In June 2020, a product testing and Certification Company, Intertek, expanded its personal protective equipment services by including the pre-certification testing of N95 respirators to requirements set by the National Institute for Occupational Safety and Health (NIOSH). The company has also expanded its solutions and resources to support global customers during the COVID-19 pandemic

Key Players

  • SGS
  • Eurofins Scientific
  • Bureau Veritas
  • Intertek
  • Elements Material Technology
  • Envigo
  • Avomeen Analytical Services
  • Gateway Analytical
  • Medistri SA
  • North American Science Associates
  • Pace Analytical Services

Medical Device Testing Market: Segmentation

By Service Type

  • Testing Services
  • Inspection Services
  • Certification Services

By Sourcing Type

  • In-house
  • Outsourced

By Technology

  • Active Implant Medical Device
  • Active Medical Device
  • Non-Active Medical Device
  • In-vitro Diagnostic Medical Device
  • Ophthalmic Medical Device
  • Orthopedic and Dental Medical Device
  • Vascular Medical Device

By Region

  • North America
  • Europe
  • Asia-Pacific
  • SAMEA

Frequently Asked Questions (FAQs)

Growing demands for validation and verification of medical equipment, growing demands of Testing, Inspection, and Certification (TIC) services are the key factors expected to drive Medical Device Testing Market during the forecast period.
SGS, Eurofins Scientific, Bureau Veritas, Intertek, Elements Material Technology, Envigo, Avomeen Analytical Services, Gateway Analytical, Ministry SA are the top players in Medical Device Testing Market.
Asia Pacific is expected to hold the highest market share in Medical Device Testing Market.
Service Type Segment is expected to be the leading segment in Medical Device Testing Market during the forecast period.
Call us, email us, or chat with us! We encourage your questions and feedback. We have a research concierge team available at all times and included in every purchase.
We will send you an email with login credentials to access the report. You will also be able to download the pdf.
Basically, choose Pay by Purchase Order when you are checking out. We will connect with you via email to set up your order.

Market Overview

Medical device testing is the process of transforming an innovative equipment design into a reliable and marketable product. It combines expert knowledge with an advanced infrastructure of accredited laboratories and research centers. Medical device testing puts it through a comprehensive assessment and helps demonstrate compliance with standards and regulations. The testing can range from prototype testing to Certification Body (C.B.) Scheme and lab tests for ergonomics, electrical, mechanical, and functional safety assessments, and software testing.

Medical devices are highly regulated by multiple regulations by government bodies and compliances. Additionally, there is a growing demand for exceptional performance, effectiveness, and safety from the devices. This is compelling the medical device manufacturers to define and implement effective medical device testing strategies throughout the development cycle.

An effective testing strategy includes compliance processes and technical testing for better performance and reliability of medical devices. A medical device manufacturer needs to test each function of the medical device right from the start. If an error is detected in the later phases of testing, it will be very costly and time-consuming to go back to the design phase and rectify the issues. This is why testing and certification is an important segment in the development of the medical device in the healthcare industry.

Impact of COVID-19

With the surging number of cases for the novel coronavirus pandemic across the globe, governments are scrambling to contain its spread. As a result, healthcare systems are overwhelmed in determining the effective delivery of medical care systems to the affected. The pandemic has disrupted the medical device manufacturing and testing industry.

Medical device manufacturers rely heavily on healthcare facilities for their clinical data collection. Pre and post clinical trials help manufacturers to obtain certificates for market approval. The medical device companies are finding it difficult during the pandemic to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty

Growing Demands for Validation and Verification of Medical Equipment

Consumers continuously expect outstanding performance, effectiveness, and safety from medical devices. This has increased the demand for validation and verification of medical devices. Therefore, it is mandatory for the manufacturers to properly define and test medical devices for the confirmation of quality. Several sets of test requirements, component selection, and the final assembly of a medical device are anticipated to augment the overall growth of the market. Furthermore, global companies are investing in automation, which has surged the need for automated quality assurance. The demand is further elevated due to the COVID-19 outbreak as a human intervention has reduced in the process.

Time Consuming and Expensive Licensing to Hamper the Market Growth

Excessive regulations, both national and international, can become barriers to the innovation of local medical devices. Incorporating new technologies in the licensing procedure of these devices can be lengthy and expensive, posing a potential hindrance to the market growth. Lengthy procedures also incur huge amounts of money to the manufacturers due to the prolonged delays and additional equipment costs. This is significantly challenging for low-income countries that have a lack of infrastructure and budget constraints.

Prolonged Lead Time in Gaining International Market Acceptance to Hamper Market Growth

Due to large scale globalization, import and export of products, the exchange of goods and services can be time-consuming. Acceptance of products in international markets is a challenge that companies face due to the long lead time required for overseas qualification tests. This increases the risk of losing valuable customers, product quality, and costs additional time and money. With the growth in international trade, the lead time for overseas qualification tests is increasing, marking it a critical challenge for the medical device testing market.

T Incorporation of A.I. and IoT in the Medical Sector to Offer Lucrative Growth Opportunities

Technological advancement is taking over the healthcare industry at a rapid pace. The medical device testing market is witnessing a series of developments in the field of drug-device combination, personalized medicine, and the advent of portable and wearable medical devices. Medical equipment is now implemented with IoT and A.I., which is serving as a key growth factor for market growth. Key companies in the developed, as well as some of the developing economies, are heavily investing in these technologies as they are going to rule for a longer period of time. They are also focusing on complying with the stringent regulations of these technologies in the healthcare industry.

Medical Device Testing Market: Segmentation

Service Type Segment to Hold the Largest Market Share during the Forecast Period

The growing demands of Testing, Inspection, and Certification (TIC) services, along with good quality and standard products, is a prime factor driving the segment growth. TIC services ensure that the products have met the required quality, safety, and performance regulatory standards. This includes electro-medical device testing, biocompatibility testing, and clinical research services that are assessed in the final stage of the testing.

This is done to investigate the faulty material and test the performance of the devices. Therefore, it will increase the demand for testing services manifold in the upcoming years. Manufacturers require assistance in improving the marketability of their medical devices and in lowering costs, which is bolstering the market growth. This will help the certification services segment, specifically, to grow with a higher CAGR during the forecast period.

In-House Sourcing Type Segment to Hold the Largest Share of the Medical Device Testing Market

At a time like the COVID-19 crisis, it is difficult for manufacturers to gather funds for the infrastructure to conduct in-house tests of medical devices. Therefore, many large firms are increasingly outsourcing medical device testing services to help reduce overall testing costs. There is a growing trend to outsource TIC services to third-party vendors if the testing requires the implementation of complex technologies. The in-house sourcing type segment held the largest share of the medical device testing market in 2019 and is expected to witness the fastest-growth with some limitations this year.

Regional Outlook

Asia-Pacific-Lead-Medical-Device-Testing-Market

Advancements in the Healthcare Infrastructure in China, South Korea, and Japan Drives APAC's Market Growth

Asia-Pacific dominates the medical device testing market, owing to the rising disposable income and advancements in the healthcare infrastructure in China, South Korea, and Japan. Growing awareness regarding healthcare devices in India, especially after the pandemic, has compelled the government to invest in research and development of new portable and accurate equipment. Rising consumer awareness has also increased the importance of testing and certification in the region, which is bolstering the market growth

Growing Demands for Long-Term Therapy in North America and Europe to Drives the Market Growth

Strict regulations have been established by the North American and European governments to maintain quality and safety standards in the pharmaceutical and healthcare industries. The market growth can further be attributed to the increasing R&D activities, early adoption of new technologies, and the growing demand for long-term therapy by patients. North America accounts for the largest number of the geriatric population globally, which is accelerating the growth of the medical devices market in the region. Contract Research Organizations (CROs) are investing heavily in this region due to lower costs and easy availability of skilled labor.

A Glance at the Regulatory Highlights of Medical Device Testing in U.S. and Europe

  • The Food and Drug Administration (FDA) issued an Emergency Use Authorizations (EUA) for medical devices in the U.S. This includes In-Vitro Diagnostic (IVD) test kits to diagnose COVID-19 as well as PPE needed to protect healthcare providers interacting with patients. The FDA has authorized rapid emergency use of specific devices via expedited premarket under EUA declarations. The EUA submission should include safety, effectiveness, and risk-related data available pertaining to the medical device. Obtaining EUA designation provides speedy access to the U.S. healthcare market; however, these authorizations are applicable only during the public health emergency
  • The Medical Device Regulation (MDR) in the European Union (E.U.) mandates manufacturers to conduct Post Market Clinical Follow-Up (PMCF) studies to demonstrate the continued safety and performance of their devices. It is also necessary to identify hidden risks. Certain trials such as Investigator-Initiated Studies (IIS) are necessary for the broader healthcare system to define the efficacy of certain therapeutic options. Clinical trials are initiated by sponsors to satisfy regulatory requirements. In April 2020, the European Commission adopted a proposal to postpone the application date of the MDR for one year. This was done to avoid any risks of potential shortages or delays in the availability of such devices caused by the capacity limitations of conformity assessment bodies. Based on the proposal, the functionality of the European Database on Medical Devices (EUDAMED) will be announced by March 2021, with reporting requirements beginning May 2021
  • In June 2020, a product testing and Certification Company, Intertek, expanded its personal protective equipment services by including the pre-certification testing of N95 respirators to requirements set by the National Institute for Occupational Safety and Health (NIOSH). The company has also expanded its solutions and resources to support global customers during the COVID-19 pandemic

Key Players

  • SGS
  • Eurofins Scientific
  • Bureau Veritas
  • Intertek
  • Elements Material Technology
  • Envigo
  • Avomeen Analytical Services
  • Gateway Analytical
  • Medistri SA
  • North American Science Associates
  • Pace Analytical Services

Medical Device Testing Market: Segmentation

By Service Type

  • Testing Services
  • Inspection Services
  • Certification Services

By Sourcing Type

  • In-house
  • Outsourced

By Technology

  • Active Implant Medical Device
  • Active Medical Device
  • Non-Active Medical Device
  • In-vitro Diagnostic Medical Device
  • Ophthalmic Medical Device
  • Orthopedic and Dental Medical Device
  • Vascular Medical Device

By Region

  • North America
  • Europe
  • Asia-Pacific
  • SAMEA

Frequently Asked Questions (FAQs)

Growing demands for validation and verification of medical equipment, growing demands of Testing, Inspection, and Certification (TIC) services are the key factors expected to drive Medical Device Testing Market during the forecast period.
SGS, Eurofins Scientific, Bureau Veritas, Intertek, Elements Material Technology, Envigo, Avomeen Analytical Services, Gateway Analytical, Ministry SA are the top players in Medical Device Testing Market.
Asia Pacific is expected to hold the highest market share in Medical Device Testing Market.
Service Type Segment is expected to be the leading segment in Medical Device Testing Market during the forecast period.
Call us, email us, or chat with us! We encourage your questions and feedback. We have a research concierge team available at all times and included in every purchase.
We will send you an email with login credentials to access the report. You will also be able to download the pdf.
Basically, choose Pay by Purchase Order when you are checking out. We will connect with you via email to set up your order.