Contract manufacturing
Micromachined medical components – such as some stents – are produced at extremely tight tolerances for specialised and low-volume device manufacturing.
contract manufacturers to outsource their manufacturing operations. The benefits are akin to what contract manufacturing offers for other industries, notably pharma and automotive. It makes companies more flexible, since they do not need to commit to new equipment or make changes to their factory lines, and it also saves time and money.
Enabling technologies and models Advanced medical devices typically have components made to precise, and often tiny, measurements. “The advantage of a contract manufacturer is that they are seasoned in manufacturing the specific kind of device you need,” says Gourabathini. Another major push comes from the regulatory environment. As medical device regulations have become more complex and stringent, companies find it more convenient to collaborate with contract manufacturers that have the required regulatory expertise rather than navigate the regulations themselves, particularly while developing new products. Working with contract manufacturers benefits medical device start-ups and smaller companies servicing niche markets, too. It gives them access to GMP-compliant facilities to scale products from prototypes to market-ready devices. Low-volume
“The advantage of a contract manufacturer is that they are seasoned in manufacturing the specifi c kind of device you need.”
Pujitha Gourabathini
contract manufacturers can produce pilot runs as small as a few dozen units for verification or validation testing. This allows medical companies to simultaneously investigate many small batches of different variations of a new product. Contract manufacturers are often categorised as contract manufacturing organisations (CMOs) or, when they also support design and prototyping, contract development and manufacturing organisations (CDMOs).
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For medical device start-ups, CMOs can turn a prototype into a small batch for market validation without having to invest in a production facility. For larger companies, they can manufacture niche device lines or low-volume components used in medical equipment without having to expand in-house production capacity. Additionally, CMOs can sterilise a manufacturer’s medical devices as well as package or label them in sterile, GMP-compliant conditions. Niche medical devices, such as implantable sensors or specialised stents for rare vascular conditions, often use materials or geometries incompatible with existing sterilisation or processing equipment. CDMOs, on the other hand, provide end-to-end support in developing and scaling devices. For start- ups, this translates to low-cost access to complicated manufacturing techniques required for every stage of device development. Larger manufacturers benefit from the rapid production of niche devices they do not have the expertise to produce in-house. CDMOs can also help companies optimise their global supply chains and adapt production quickly to demand fluctuations.
Contract manufacturing operations are supported by a range of technologies, all of which are nascent in medical device manufacturing. Additive manufacturing can use biocompatible polymers and metals, reducing tooling costs by minimising or eliminating the need for moulds. Conversely, subtractive manufacturing – through micro-milling, laser machining or high-pressure waterjet cutting – creates intricate geometries typical of microscale medical components. Computer numerical control (CNC) machines using waterjets or electrical discharge machining (EDM) techniques carve intricate designs and cut through a wide range of materials. A range of adjacent microfabrication and micromachining technologies also enables high-precision production of medical devices. Together, manufacturing technologies allow manufacturers to quickly produce even small batches of the most complicated medical device designs at extremely tight tolerances. Speed, however, is only part of the equation. Fast production of niche devices makes it challenging to ensure quality control keeps pace with manufacturing. Contract manufacturers specialise in that too.
Validating production Smart factory technologies – such as IoT-enabled sensors monitoring manufacturing equipment, automated inspection systems and AI-based vision analytics – help improve production rates and real-time quality assurance. Data from these feeds into manufacturing execution systems that streamline operations on the factory floor. This software tracks production in real time, thereby minimising material waste and equipment downtime. Moreover, by reducing errors and automating workflows on the factory floor, it improves regulatory compliance and reporting.
www.medicaldevice-developments.com
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