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The medical device manufacturing industry is experiencing significant growth worldwide, with contract manufacturing playing a crucial role in this expansion. Over the past few decades, this sector has evolved to meet increasing demand and reshape medical technology.
The European medical device market is the second largest region globally and is projected to grow at a CAGR of 4.5% during the forecast period. The global market for medical devices is expected to increase from $1.29 billion in 2022 to $2.67 billion by 2030.
The European medical device market is competitive due to the increasing number of small and medium-sized enterprises, a supportive regulatory framework, the development of innovative products, and the rising adoption of these devices. Currently, there are over 500,000 types of medical devices and in-vitro diagnostics (IVDs) in the European market, as reported by the European Commission.
Recent industry trends show a growing interest in developing innovative medical devices, with significant investment in the medical technology sector. According to a report by Medtech Europe in 2022, the region’s healthcare system expenditure accounts for approximately 11% of its GDP, of which the medical device industry captures 7.6%. The healthcare expenditure varies significantly across European countries, ranging from around 5% to 12% of the total healthcare expenditure.
A global overview of the contract manufacturing industry
The medical device manufacturing industry is expanding worldwide, with the United States alone accounting for nearly half of the $413 billion global market for medical devices. The industry has grown at a rate of 5 percent annually, and projected sales by 2022 are expected to reach $530 billion.
There are currently around 5,800 companies employing over 350,000 people in the industry. The increasing demand for innovative and high-quality medical devices globally underscores the vital role of contract manufacturing in meeting industry requirements.
Contract manufacturing in the medical device industry
Contract manufacturing in the medical device industry involves outsourcing the production of whole products or individual parts of larger products. Original Equipment Manufacturers (OEMs) in this field specialize in specific areas such as molding, assembly, or R&D design.
Medical device contract manufacturing entails a manufacturing company producing medical devices or components that are later sold by another company. These contract manufacturers often specialize in specific processes or tasks, offering expertise gained from extensive manufacturing experience.
What is medical device contract manufacturing
Medical device contract manufacturers offer a range of services including product concept and development, process validation and verification, production, as well as highly specialized manufacturing and packaging. They may oversee supply chain management and delivery to the end customer.
OEMs also provide specialized facilities essential for medical device manufacturing such as on-site medical labs necessary for all production phases, and cleanrooms to ensure manufacturing is free of contaminants.
Regulatory framework for medical devices
Medical devices are regulated by the MDR and are categorized into:
Each is subject to stringent regulatory policies. Regulatory compliance and adherence to quality standards are essential for OEMs and contract manufacturers to meet industry requirements and deliver high-quality medical devices.
What’s next in medical device contract manufacturing
The medical device contract manufacturing industry is poised for continued growth, playing a vital role in meeting the increasing demand for innovative and high-quality medical devices globally.
With the expansion of the global market for medical device manufacturers, the demand for companies and professionals in the industry is set to rise, highlighting the increasing importance of contract manufacturing in the years ahead.