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Medical device manufacturing refers to the process of designing, developing, testing, and producing medical devices.
Medical device prototyping is also a crucial step in this process to ensure the development of the medical product. Testing and first validations are mainly depending on those prototypes and iterations.
When we talk about medical devices, this includes a wide range of products such as surgical instruments, diagnostic equipment, implants, prosthetics, orthotics, tools, training models, etc. As you might know, medical devices must meet strict safety and quality standards before they can be sold to healthcare providers.
When we talk about medical device manufacturing, it regroups a large range of applications, from heart valves and hearing aids to medical tools and surgical guides. Established technologies as well as new cutting-edge technologies such as 3D printing.
In the US, medical devices are regulated by the FDA (Food and Drug Administration). The main areas covered by these regulations are: Registration, Medical Device Listing, Premarket Notification, Premarket Approval, Investigational Device Exemption, Quality, System Regulation, Labeling, Medical Device Reporting.
In Europe, you can access all the regulations regarding medical device manufacturing on the website of the Europe Commission, dedicated to this subject.
A number of parameters need to be considered will choosing a manufacturing technique for your medical device. Do you need custom parts? Is it a prototype or an end product? Is it a large or low-volume part?
Let’s review the different manufacturing possibilities you have to see which one could be the most adapted to your medical project.
CNC Machining is a subtractive manufacturing technology where parts are created by removing material from a block by using a variety of cutting tools.
CNC Machining is best suited to manufacturing large series of medical devices as well as parts with complex geometries. This technology is adapted to higher volumes.
Also, because of machine costs, training, etc. CNC machining offers quite a high start-up cost, and it won’t be possible to create custom or low-volume parts.
Injection molding is also best suited for high volumes. Indeed, this manufacturing method is particularly helpful for mass production and will offer interesting material options with strong and durable plastics.
This is one of the most common manufacturing techniques, as almost everything around us is manufactured using injection molding.
3D printing is a technique that builds objects layer by layer from a 3D file. The process is literally giving you the ability to transform a digital version of an object into a physical version. 3D printing is a manufacturing technique, more and more used today to make proofs of concepts, prototypes, or end-products. Companies are implementing 3D printing at different stages of their manufacturing processes and rethinking their business strategy with this competitive advantage. Medical 3D printing is also becoming quite common.
It is a real asset for medical device manufacturing. It offers interesting material options,
great technologies, and happens to be a real asset for design freedom as well as for mass customization
Daniel Robert Orthopedic, a leader in technical orthopedics, partners with Sculpteo, a leader in 3D printing and digital fabrication, to launch the first fully customizable orthosis made from a bio-sourced and recyclable material, PA11, made from castor oil.
Macu4 is a Zurich-based start-up founded in 2021 by a dedicated team of medical and entrepreneurs with expertise in healthcare to revolutionize arm prosthetics through new technologies such as design automation and 3D printing. Combining new technologies such as additive manufacturing and advanced materials creates unique and economical solutions that are tailor-made and optimal for each individual’s needs.
Schlather’s aim is to create medical aids that are individualized and customized. This was made easier with 3D printing’s innovative technology. With 3D printing and PP material, Schlather developed a Dynamic Foot Orthosis (DFO) to correct various deformities such as a clubfoot or extremely high arches.
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