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Medical device manufacturing: What are your options?

Introduction

The field of medical device manufacturing has been growing rapidly in recent years, with advances in technology but also increased demand for healthcare products. From diagnostic equipment to implants and prosthetic devices, these medical devices play a crucial role in modern healthcare. 

CNC machining and injection molding are the two most common traditional manufacturing processes used for medical device manufacturing. However, additive manufacturing is becoming an interesting alternative for the medical sector. 

In this article, we will discuss what you need to know about medical device manufacturing and review the different manufacturing processes that could be adapted to your potential project.

What is Medical Device Manufacturing?

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.

What are the different key considerations in Medical Device Manufacturing?

Medical device manufacturing is complex and there are several key considerations to keep in mind. These include:

  • Regulatory Compliance: Medical devices must meet strict regulatory standards set by the FDA (Food and Drug Administration) to ensure patient safety. Manufacturers must comply with these regulations throughout the entire product lifecycle, from design to production to post-market surveillance.
  • Quality Control: Quality control is critical in medical device manufacturing. Medical manufacturers must have robust quality systems in place to ensure that their products meet the required specifications and standards.
  • Cost: Medical device manufacturing can be expensive, particularly for complex devices such as implants or customized devices such as orthotics. Manufacturers must balance the cost of production with the need to produce safe and effective devices.
  • Innovation: Innovation is key in the medical device industry and that is why this industry is constantly evolving! Manufacturers must continue to develop new and innovative products to meet the changing needs of healthcare providers and patients.

Medical device manufacturing: What kind of applications are we talking about?

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.

  • Device prototyping for modeling and validation
  • Custom and complex geometry device
  • Modeling for simulation and training for medical professionals
  • Personal protective equipement

Medical device manufacturing: What about regulations?

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.

What are the processes used for medical device manufacturing?

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

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

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

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

Focus on Additive Manufacturing: Why could it be the perfect manufacturing technique for your project?

Add flexibility to your process

Additive manufacturing is a good solution if you are willing to implement more flexibility to your process. Either for prototyping or production, 3D printing has something to offer you in terms of adaptability. For your prototyping process, you can easily benefit from faster iterations. This manufacturing technique is also a great advantage in simplifying some processes such as your assembly process, by creating products in less parts. You will also be more reactive to the market’s demand. Indeed, 3D printing is a great on-demand manufacturing solution, you can 3D print a part when you need it. You don’t have to build a whole stock!

Enjoy the freedom of design for complex geometries

If traditional manufacturing techniques also allow you to build complex and accurate parts, additive manufacturing has the potential to create geometries impossible to make with CNC machining and injection molding. With Design for Additive Manufacturing, you’re free from the constraints of traditional manufacturing.  It is possible to manufacture complex designs for MedTech projects or for any intricate project. This process is giving more space to innovation and adaptability in your project, opening the possibility to 3D print a device in just one part, saving assembly time.

Mass customization is your ally for parts adapted to patient’s morphology

 Mass customization is a big asset of additive manufacturing. 3D printing allows to create made-to-measure devices. You might have noticed in your previous experiments that using traditional manufacturing is quite long and expensive for custom projects.  While using 3D printing no mold is required, you just have to get a 3D file, which can be generated from a 3D scan, medical imaging, or created from scratch. From this file, it will be possible for you to create as many iterations of you project as needed. Thanks to that, you will be able to 3D print prosthesis, orthosis, or insoles perfectly adapted to the morphology of the patients and to the issues they are facing. New technologies such as additive manufacturing can be used to create surgical instruments adapted to doctors needs. These devices can be adapted without being too expensive !

What technologies should you use?

 
  • Selective Laser Sintering
  Selective Laser Sintering (SLS) a versatile solution for your medical projects. Both for prototyping and functional products, and for small to medium production runs. SLS creates parts additively by sintering fine polymer powder particles to fuse them locally. Your plastic piece will be created layer by layer, according to your 3D model.    Nylon PA12: An interesting substitute for injection molding for medical tools and prrosthetics Ultrasint® PA11:  Based on 100% renewable biomass sources, PA11 is a more sustainable option if you are looking for a versatile plastic Ultrasint® TPU 88A: Highly flexible plastic, this TPU has good shock absorbing properties, which is quite ideal for orthopedic models.
  • Multi Jet Fusion
  HP Multi Jet Fusion (or MJF) is an additive manufacturing method invented and developed by the company Hewlett-Packard (HP). It creates parts additively thanks to a multi-agent printing process. Your plastic part will be created layer by layer, according to your 3D mode   PA12: Approved for skin contact, this PA 12 can be used to manufacture the prototype of your medical devices as well as your end-products. PA11:  Perfectly adapted to the creation of made-to-measure medical devices, this PA11 is apporved for skin contact. PP: PP is perfect for manufacture-resistant and custom-made tools. Get tools or surgical guides adapted to your tasks and meet your professional requirements and constraints. Ultrasint® TPU01: This rubbery material is perfect for creating a custom-made insole adapted to the patient’s morphology.  
  • Stereolithography 
  Stereolithography (SLA) is a resin 3D printing technique where the liquid polymer is exposed to light when the build plate is incrementally moved, and the UV laser uses this exposure to create a cross-section. This is a layer-by-layer process that is repeated until a model is produced.   Prototyping resin: If you are looking for a resin with a great accuracy to create prototypes, this might be a great option to consider.   Forward AM’s dental line: For dental models and mold, these three materials from the dental line developed by Forward AM could be helpful – Ultracur3D® DM 2505, Ultracur3D® DM 2304, Ultracur3D® DMD 1005.   

Medical device manufacturing: they work with Sculpteo to create their medical project

Daniel Robert Orthopedics: 3D printing to create unique eco-responsible orthopedic devices.

daniel robert orthopedic

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.

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MACU4: They design, iterate and produce their successful arm prosthesis, The Explorer!

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.

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SCHLATER: Creating customized medical aids

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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Partner with an online 3D printing service!

Medical device manufacturing is a complex and rapidly evolving industry that plays a crucial role in modern healthcare. Key considerations in medical device manufacturing include regulatory compliance, quality control, cost, and innovation. As the industry continues to evolve, it will be important for manufacturers to stay up-to-date with the latest developments and trends to ensure that they can continue to produce safe and effective products. Partnering with an online 3D printing service for your medical device manufacturing could be the ideal option allowing you to benefit for the numerous advantages of 3D printing, without investing into expensive industrial 3D printers. Our 3D printing expert will take care of your projects and 3D printing needs. Contact us for more information.  If you already have a 3D file, feel free to upload it on our website to get your instant quote.

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