Accelerating Medical Device Prototyping and Development
Get to market faster and streamline your supply chain with rapid prototyping and on-demand production of medical components
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Certifications ISO 9001:2015 | ISO 14001:2018 | ISO 13485 (Protolabs Network)
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How can digital manufacturing support the Medical industry?
Precision is key when it comes to parts produced for the medical industry; however, being highly accurate is not the only requirement; parts also need to meet strict quality standards, including biocompatibility and serializability. This is on top of the demand for customised parts, such as individually tailored implants or anatomical models for surgery practice. Other key considerations include durability, chemical resistance and translucency.
There is a stark contrast between parts and quantities in the medical industry, highlighting its diverse manufacturing needs. Prosthetic and surgical device manufacturing represents a large portion of the medical industry, and these tend to be customised to the individual, but that is not to ignore the even higher percentage of mass-produced devices, including electronics, test tubes, liquid & gas injectors and sutures – Not forgetting the massive requirement for rapid medical device prototyping.
Why Do Medical Device Development Companies Use Protolabs?
Rapid Prototyping
Create prototypes in production-grade materials for functional and regulatory testing, or use our 3D printing service to print models and organ scans to preview before medical procedures.
Low-Volume Production
Ramp up production to get quality end-use parts to market fast and use batch production to reduce financial risk with no minimum order quantity (MOQ) and low total cost of ownership (TCO).
On-Demand Production
Build agility into your supply chain by ordering quick-turn parts when needed, regardless of what stage of development you’re in.
Quality Certification
Streamline development of FDA Class I and II devices, or non-implantable components, with moulding capabilities geared towards high-requirement applications and ISO 13485 quality certification.
Medical Materials
Choose from high-temperature plastics, medical-grade silicone rubber, and 3D-printed micro-resolution and microfluidic parts, among hundreds of other plastic, metal, and elastomeric materials.
1.4 Million+
Parts produced for the Medical Industry each
year
300+
Medical companies worked with each year.
1.3 Million+ IM parts made each year
63,000+ 3DP parts made each year
18,000+ CNC parts made each year
We carry the most common types of plastics and resins used in medical moulding. We can also accommodate customer-supplied resins.
Available Medical-Grade Plastic/Resins for Injection Moulding
| Material | Temp. Resistance | Chemical Resistance | Good Clarity | Suitable for Skin Contact |
|---|---|---|---|---|
| PEEK, PEI (Ultem), PPSU | X | X | ||
| Polycarbonate (PC) | X | |||
| Liquid Silicone Rubber (LSR) | X | X | X |
Available Medical-Grade Plastic/Resins and Metals/Alloys for CNC Machining
| Material | Temp. Resistance | Chemical Resistance | Good Clarity |
|---|---|---|---|
| PEEK, PEI (Ultem), PPSU | X | X | |
| Polycarbonate (PC) | X | ||
| Stainless Steel | X |
We stock a wide variety of plastics and metals, some of which are FDA approved. Check out our complete CNC machining materials list here.
Available Medical-Grade Plastic/Resins and Metals/Alloys for 3D Printing
Our vast list of 3D printing materials includes materials which are ISO 13485 accredited, biocompatible and suitable for skin contact (available through Protolabs Network).
| Type | Material | Process | ISO 13485 Accreditation |
Biocompatible | Chemical Resistance | Good Clarity | Suitable for Skin Contact | Temperature Resistance +100°C/ Thermal Conductivity |
|---|---|---|---|---|---|---|---|---|
| ABS-Like | ABS-Like Black (Accura Black 7820) | Stereolithography | ||||||
| ABS-Like | ABS-Like Translucent/Clear (WaterShed) | With post-processing | ||||||
| ABS-Like | MicroFine™ Green & Grey | |||||||
| PC-Like | PC-Like Advanc High Temp (Accura 5530) | Up to 250°C with thermal post cure | ||||||
| PC-Like | Ceramic-Like (Advanc HighTemp PerFORM) | Up to 268°C with thermal post cure | ||||||
| PP-Like/ABS-Like | ABS-Like Grey (Accura Xtreme Grey) | |||||||
| PP-Like/ ABS-Like | ABS-Like White (Accura Xtreme White 200) | |||||||
| PA (Nylon) | PA 12 Smooth White | Selective Laser Sintering | X | X | X | |||
| PA (Nylon) | PA 12 - Glass Filled Smooth White | X | ||||||
| PA (Nylon) | PA 12 - Carbon Filled SMooth Black | X | ||||||
| PA (Nylon) | PA 12 Flex Pure Black | X | ||||||
| TPU | TPU-88A Pure Black | |||||||
| PA (Nylon) | PA 12 Smooth Light Grey | Multi Jet Fusion | X | X | X | |||
| PA (Nylon) | PA 11 Smooth Grey | X | X | |||||
| TPU | Ultrasint™ TPU-01 - 88A Pure Grey | |||||||
| Digital | Digital Clear / Translucent, White and Black | PolyJet | Milky/ Translucent | |||||
| Digital | 3DP Silicone | X | Milky/ Translucent | 200°C (35 Shore A) 150°C (65 Shore A) | ||||
| Aluminium | Aluminium AlSi10Mg Grey | Direct Metal Laser Sintering | X | X | ||||
| Cobalt Chrome | Cobalt Chrome | X | ISO 13485 | X | X | X | ||
| Inconel | Inconel 718 | X | X | |||||
| Maraging Steel | Maraging Steel 1.2709 | X | X | |||||
| Stainless Steel | Stainless Steel 316L 1.4404 | X | X | |||||
| Titanium | Titanium / Ti6Al4V | X | ISO 13485 | X | X | X |
What Materials Work Best for Medical Applications?
A look into which materials work the best in medical applications and the most commonly used.
High-Temp Plastics
expand_less expand_morePEEK and PEI (Ultem) offer high-temperature resistance, creep resistance, and are suited for applications that require sterilisation.
PEEK is often used as a replacement for metal in the medical industry due to it being a lightweight material with good mechanical strength, fatigue resistance and high-temperature resistance (Protolabs' PEEK material - Victrex - can be used continuously at temperatures of 260°C). It is also very chemically non-reactive.
From an environmental point of view, PEEK is re-processable and recyclable, meaning it can be melted down and used again.
PEI is another popular material used for it's weight saving characteristics and for it's use in serialisable components (it can withstand repeated cycles in a steam autoclave).
Ultem also has really good chemical resistance, is extremely strong and has high dielectric strength. Like PEEK it can be used at high temperatures .
PEI is commonly used in the medical industry for medical instruments such as surgical instrument handles, trays and external prostheses, it is also used for electrical insulation parts, scientific equipment parts and housings or enclosures.
Liquid Silicone Rubber
expand_less expand_moreHigh temperature resistance and chemical stability fit for applications that require sterilisation and flexibility.
Other useful characteristics of LSR to the medical industry include it's transparent appearance, resistance to UV radiation and x-rays and biocompatability.
LSR materials are used in numerous medical applications such as tubing, connectors, masks, syringes, valves and catheters.
3D Printed ABS
expand_less expand_moreMicroFine™ Green/ Grey is a proprietary material developed by Protolabs to build complex 3D-printed parts with micro-sized features as small as 0.07mm.
The material properties make it a great solution for form and fit testing during prototyping phase and design iteration.
It is ideal for use in medicine since it is possible to produce particularly fine, high-resolution structures such as; miniaturised catheters, a part less than a mm in size for a pacemaker and minimally invasive tools.
Microfluidics
expand_less expand_moreWatershed (ABS-like) is a clear material, which can be used to prototype microfluidic parts and transparent components like lenses and housings.
It's near colourless, clear appearance makes it ideal for flow-visualisation models, microfluidics and light pipes. The material is also water resistant and it's tensile strength and elongation at break are amongst the highest of 3D printed thermoset materials.
To achieve functional clarity, custom finishing is required.
Medical Alloys
expand_less expand_moreBetween machined and 3D-printed metals, there are more than 20 metal material options available for medical components, instrumentation, and other applications. Metals like titanium and Inconel have attributes like temperature resistance while various stainless steel materials brings corrosion resistance and strength.
Protolabs Europe holds ISO 13485 certification for 3D printing DMLS, meaning we can support with medical implants.
If you would like to read in more detail about medical alloys, in particular for 3D printing, please read our Medical Applications for Additive Manufacturing Whitepaper.
What are the applications of injection moulded parts in the medical industry?
- Surgical prep equipment
- Syringes
- Test tubes and beakers
- Orthopaedics
- Components for medication delivery.
- Housings, casings, and enclosures for medical and laboratory equipment.
What are the applications of CNC machined parts in the medical industry?
- Bone & Joint replacements
- Catheters
- Implants
- Forceps
- Blade handles
- Electronic medical equipment e.g. pacemakers
- Tweezers
- IV stands
What are the applications of 3D printed parts in the medical industry?
- Implants
- Anatomical models
- Concept models
- surgical instruments
- Prosthetics and orthopaedics
- Specialised instruments and implants
- Models of body parts for training and practising.
- Surgical aids
- Microscopic structures (MicroFine materials)
- Electronic enclosures
- Cartridges
- Wearables
- Robotic arms
- Handheld devices
- Functionally clear parts
- Microfluidics
Why manufacturers of Medical products used Protolabs
A closer look at why Medical companies are choosing Protolabs for medical device prototyping and medical device manufacturing.
Injection moulding is the go-to service when repeatable, large-scale parts are a requirement. Generally, it can be more cost-effective to produce large quantities using this service as the same mould can be used and consistent, precise parts can be made. Medical parts that are needed in volume, such as; syringes, test tubes, casings, beakers and surgical equipment, are perfect for production using on-demand production. The service also boasts a vast array of thermoplastics and high dimensional accuracy. The offering also includes liquid silicone rubber moulding, perfect for parts that demand flexibility, elasticity and transparency.
- Scientific moulding, Critical to Quality (CTQ) capability report, Coordinate-Measurement Machines (CMM) and more
- Maximise traceability of raw materials from prototyping to production, with clear lines of sight over inventory, such as serial numbers for resin used in injection moulding.
- Digital front-end and automated workflows to improve part management.
- Utilise our Consultative Design Services at any stage of the process for expert engineering know how.
- Design for Manufacturability Analysis (DfMA), our propriety software analyses your part and often returns it in minutes. (May take up to 48 hours for more complex parts)
- Variety of Thermosets and Thermoplastics - choose from hundreds of materials or provide your own material.
- Supply Chain Resilience - allowing for large-scale production or just-in-time production types.
- Rapid Prototyping and Iterative Design - enabling you to keep ahead of the competition
- Scalability and flexibility - allowing for ramping up production quickly whilst maintaining quality standards and meeting delivery times.
CNC Machining is essential for the medical industry; its ability to quickly produce precision parts with complex geometries and tight tolerances is key. Its flexibility to produce small batches from 1 is extremely useful, as is the manufacturing speed when making larger quantities. Other important benefits include smooth finishes (with minimal post-processing), high-quality parts and complex geometries.
Due to the nature of the medical industry and how certain parts can be used, precision is key, and digital CNC machining can help negate the risk of variation from the original design.
- Wide variety of suitable materials, including a selection of FDA approved and biocompatible materials.
- Benefit from out extended partner network - offering additional services and specifications (including additional certifications).
- Rapid prototyping and iterative design to stay ahead of the competition
- Digital front-end and automated workflows to improve part management
- Numerous surface finishes and secondary services available such as; threading, anodising, assembly and much more
- Quality assurance - ISO 9001:2015 certification for quality along with various quality control measures that can be included when producing your part.
3D printing is increasingly used in the medical industry due to its ability to quickly and efficiently produce unique and complex geometries. 3D printing also boasts the ability to offer highly customisable parts, which is critical for an industry that produces implants, prostheses, orthoses etc., specifically created for individual patients. Its highly flexible design limitations (or lack thereof) also make it perfect for producing anatomical models for concept validation, visualisation and surgical procedure preparation and practice.
- Protolabs is ISO:13485 certified enabling us to produce medical instruments and implants.
- A vast selection of materials, including ISO 13485, biocompatible materials and materials that are suitable for skin contact.
- Suitable for tailored products, low-volume, difficult to forecast products such as those requiring a Just-in-time approach.
- Five 3D printing processes available through are factory including SL, SLS, DMLS, MJF and Polyjet. Further services such as FDM, available through our partner network.
- A wide range of post-processing treatments including, powder analysis and material traceability, mechanical testing, heat treatments and much more.
- Flexible prototyping for early developmental stages, easy to apply modifications on iterations.
Your Complete Guide to Digital Manufacturing for the Medical Industry
Combining volumes 1 and 2, this comprehensive 68 page guide gives you an insight into how digital manufacturing is being used to support the medical industry, covering prosthetics, dentistry, implants, medical devices and surgical instruments.
“Time was of the essence for this work. Patients need to receive their implant as quickly as possible. After we received the final information about dimensions, we started work on the construction and manufacture of the implant with Protolabs.”
Additional Resources
Take a look at our vast array of free medical resources;
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