Medical Devices Manufacturing and Production
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Production solutions for all: choosing medical devices manufacturing technology
Medical devices encompass a series of apparatus, equipment and implants that monitor, diagnose and provide therapy and treatment. Reconstructive devices for orthopedics, ultrasound instruments for diagnosis, surgery machinery, dental implants, imaging, defibrillators and continuous glucose monitoring (CGM) are a few examples of the possibilities that this market contains.
Manufacturers of medical equipment and medical products are able to use five different types of medical devices injection molding, depending on the product’s purpose. Endoscopes and other invasive equipment use thin wall molding, while 3D printing helps create prototypes before producing with injection molding. Medical device processing equipment also includes extruders, which help make components with high precision and smaller and smaller sizes using automation to speed up the process and supply chain.
Micromanufacturing and nanotechnology
The industry has been miniaturing medical devices in order to better create less invasive components to the human body. Producers are also increasing the number of capabilities in smaller product versions, improving patients’ usability. In the case of micro-manufacturing, this even involves micro-molding, as traditional injection molding cannot deliver the degree of precision needed.
Micromachinery is related to components whose size does not surpass 500µ (.020in). They are usually microparts made of titanium, stainless steel, platinum and or other materials.
The market for medical devices
The medical technology industry (medtech) has strengthened during the COVID-19 pandemic. From June 2020 to June 2021, the initial public offerings (IPO) funding grew by 100%, according to an EY report.
From 2021 to 2028, the market size is expected to reach USD 657.98 billion. One of the driving factors for it is the increase of wearable medical devices, such as pacemakers, which track vital signs and monitor activities. Another trend is the increase in ophthalmologic and orthopedic devices, as people’s life expectancy gets longer. Product development is on going in the medical sphere.
Regulations for medical devices manufacturing process and delivery
In the European Union, medical devices need to comply with the regulatory framework of EU MDR (Medical Devices Regulation). This applies to all medical devices, except In-vitro ones. They came into force in 2017, but became mandatory in May 2021. In-vitro medical decides should follow the IVDR (In-vitro Medical Device Regulation).
There are ISO standards to comply with as well. For medical devices, the management system is ISO 13485 certified. Thorough sterilization is also mandatory when manufacturing medical devices. One of the ISO standards for that is ISO 7 Clean Room Manufacturer.
Besides guaranteeing that the medical devices manufacturing equipment will satisfy safety and performance requirements, producers need to classify devices accordingly.
In the EU, the degree of invasiveness they represent, the amount of time they will be in contact with the human body, their potential toxicity and whether the device needs a source of energy to work are a few criteria that define their classification.