The medical device testing market is expected to have steady growth during the forecast period 2020-2030. The increased demand for medical devices is on account of growing focus on health and wellness in developing countries. For many years, many developing countries have been focusing on increasing healthcare budget, and this has led to greater opportunities for medical device manufacturers as well as testing companies.
It is a mandatory for medical devices to gain mandatory approvals before they are launched commercially in the market. The USA follows FDA guidelines, India follows CDSCO and Europe considers CE approval. Testing and regulatory approval is a complex procedure and requires use of accurate testing equipment and skilled personnel. As governments around the globe put medical device approval under higher scrutiny, medical device testing companies are witnessing sustained momentum.
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Medical devices are classified into 6 types:
- Consumables and disposables including syringes and needles.
- Diagnostic imaging includes MRI, X-Ray, Ultra-sounds, etc.
- Dental Products such as dentures, braces, etc.
- Orthopaedics and Prosthetics including knee implants, artificial joints, etc.
- Patient aid such as hearing aids, pacemakers, etc.
Growing Scrutiny of Medical Device Testing
Technological development is acting as a guiding light for the market. Testing of medical devices is performed under various guidelines to ensure the device is performing remarkably. Its effectiveness, efficiency, etc. is checked as the end-user demands exceptional working of the product.
Companies are coming forward to invest in automation as automated medical testing is less time consuming. Also, vulnerability to human errors is also lower in automated testing.
Beneficial in Medical Device Compliance
Continuous medical device testing can help manufacturers in ensuring a seamless audit process. Detecting some errors at an early stage can help medical device manufacturers in understanding and rectifying glitches at an early stage. This can help manufacturers in saving investments in the long run.
Data Security Issue for Telemedicine
Increase in the handling of remote patient monitoring medical devices is an effortless target for hackers to hack the personal data and patient’s health data. Remote patient monitoring medical devices are connected with the internet to share data with their doctors. The data is private and confidential which can be leaked by these hackers. Details of patients such as medical questionnaires, driving licenses, passport copies can be leaked. These concerns continue to be a deterrent for medical device, as well as medical device testing industry.
Obstacles in Medical Device Development
Although the rules and standards are meant for verification of medical devices, these rules and regulations declared by the authorities can act as a barrier for local innovations. It can hamper the innovations by exposing them to complex licensing procedures. Also, in many countries, regulations regarding medical device compliance are lax, due to which focus on testing is low.
Development of Automation and IoT based systems
The automated medical devices can act as a boon for old patients and those who live in remote areas where the help cannot be reached easily. More developments and awareness regarding automation is needed in developing countries to make use of the technology.
COVID-19 Impact
Requirement of hiring lesser workers in the market place due to covid-19 is acting as a breakthrough for remote medical devices. The need for manufacturing of medical devices is also at an all-time high. Thus, the pharmaceutical market is leveraging the market growth, and the development of automation and smart system is expected to grow during the forecast period.
Medical Device market- Competitive Landscape
The key players in the medical device market include,
- Eurofins Scientific
- Intertek Group Plc
- BSI Group
- Wuxi Apptec
- Pace Analytical Services
- Elements Material Technology
- Avomeen Analytical Services
- Toxicon
- Envigo
- Medistri SA
- Medical Device Testing Services
- Charles River Laboratories
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In June 2020, Intertek announced the inclusion of pre-certification testing of N95 respirators by expanding its personal protective equipment services according to the guidelines set by the National Institute of Occupational safety and health.
In October 2019, TUV SUD signed a memorandum of Understanding with the NUS Centre at the National University of Singapore for Addictive Manufacturing and to promote the research activities in 3D printed biomedical implants for clinical trials.
In May 2019, Intertek in Melbourne announced the expansion of its Pharmaceutical services laboratory to 20,000 sq. ft. doubling the size of previous laboratory.
In February 2019, Bureau Veritas and Microsoft, two giants in service providing announced the conclusion of a global technical and collaboration for laboratory services based on Artificial Intelligence.
Medical devices market- Regional Outlook
North America continues to be the largest market for medical devices. Due to the outstanding testing market and high number of companies that serve the medical device industry, the US market share is the highest. The efforts made by the companies regarding cost-cutting is a breakthrough in market growth.
Asia-Pacific is also a growing market. Growing adoption of new technologies and the research and development sector increase the market rate. Medical devices market in India has the potential to reach $50 bn by 2025. Around 65% of the manufacturers are domestic players catering with limited exports. There are almost 800 domestic manufacturers in India with an average investment of $2.3-2.7 million with an average turnover of almost $7 million.
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