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
CERTIFICATIONS
ISO 9001:2015 | ISO 13485:2016
How can digital manufacturing support the Medical industry?
For parts produced for the medical industry, precision is key, however, being highly accurate is not the only requirement, they also need to meet strict quality standards, which can include biocompatibility and sterilisability. There is also a high demand for customised parts, such as implants that must be tailored to the individual being operated on or anatomical models that complex surgeries can be practised on first. Other key considerations include durability, chemical resistance and translucency.
Parts for the medical industry aren't limited to implants, prostheses' and surgical devices; they can also include electronic devices, test tubes, liquid & gas injectors, sutures and much more. A large portion of instruments for the medical industry must be customised or customisable as parts are often created specifically for a patient or surgeon. This can mean there is a massive gap in quantities sometimes required, e.g. the difference between a prosthetic leg designed specifically for a patient and mass-produced test tubes for blood testing and medical sampling.
The medical industry utilises all three of our digital manufacturing services; injection moulding, CNC machining and 3D printing. The uptake of 3D-printed medical parts is a relatively new trend, which we go into more detail in our Medical Applications for Additive Manufacturing report.
Not only are our digital manufacturing services used commonly within medical, clinical, dental, and healthcare areas, secondary services and post-processing options such as pad printing, laser marking, assembly and more are also used.
| COMMON MEDICAL APPLICATIONS |
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We have several capabilities within our services and processes catered to the medical industry. A few of common applications include:
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Injection Moulding in the Medical Industry
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 industry 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.
Why injection moulding for the Medical industry?
- Precision Components
- Repeatability
- Rapid Prototyping
- Scalability
- Dimensional Accuracy
- Wide range of thermoplastics
- Complex Geometries
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 does Protolabs offer for the Medical industry using injection moulding?
- Plastic Injection Moulding
- Liquid Silicone Rubber
- Overmoulding and Insert Moulding
- Assembly
- Measurement Inspection
- Part Marking
- Traceability
Available Medical-Grade Plastic/Resins for Injection Moulding
We carry the most common types of plastics and resins used in medical moulding. We can also accommodate customer-supplied resins.
| 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 |
Consultative Design Services
Try our free Consultative Design Service (CDS) to improve manufacturability of your plastic parts. Our injection moulding application engineers will work with you to ensure your part design is mouldable. Let us know if you're interested.
How We Can Help
We’re your partner to get to market faster for projects like:
- Lower volume or difficult-to-forecast products
- FDA Class I and II devices, or non-implantable components
- Early-in-development projects
- Components requiring complicated supply chains
- Development stages that require design flexibility
- Parts in which we can apply early process learnings to production
- Easy to apply modifications on iterations
CNC Machining in the Medical Industry
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.
Why CNC machining for the Medical industry?
- Precision Parts
- Strong, durable materials
- Complex Geometries
- Fast & Efficient
- Surface Finishes
- Automated Process
- Tight Tolerances
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 does Protolabs offer for the Medical industry using CNC machining?
- CNC Machining 3 axis
- CNC Machining 5 axis
- CNC Turning/ Lathe
- Threading
- Fast, reliable manufacturing.
- Consistent manufacturing.
- Anodising and chromate conversion
- Basic assembly, part marking and inspection reports.
- Medical grade materials (approved by the FDA) with known properties.
- Range of delivery options 1 to 20 days, cost effective manufacturing of one or thousands and from 1 to 1,000+ either in-house or using a global network.
Available Medical-Grade Plastic/Resins and Metals/Alloys for CNC Machining
| Material | Temp. Resistance | Chemical Resistance | Good Clarity | Suitable for Skin Contact |
|---|---|---|---|---|
| PEEK, PEI (Ultem), PPSU | X | X | ||
| Polycarbonate (PC) | X | |||
| Stainless Steel | X |
3D Printing in the Medical Industry
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.
Why 3D printing for the Medical industry?
- Highly Customisable Parts
- Complex Geometries
- Design Flexibility
- Highly Accurate Parts
- Rapid Prototyping
- Fast
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 practicing
- Surgical aids
- Microscopic structures (MicroFine materials)
- Electronic enclosures
- Cartridges
- Wearables
- Robotic arms
- Handheld devices
- Functionally clear parts
- Microfluidics
What does Protolabs offer for the medical industry using 3D printing?
- Stereolithography
- Selective Laser Sintering
- Direct Metal Laser Sintering (Metal 3D printing)
- ISO 13485 for titanium and Cobalt Chrome
- Multi Jet Fusion
- PolyJet and 3D Printed Silicone (60-65%)
- ISO 9001
- Design for manufacturability (DFM) feedback on every quote
- MicrofineTM Green and Grey for microscopic parts
- Post-Process Machining
- Measurement Reports (3D Scan) & First Article Inspections
- Range of Surface Finish Options
- And many more post processing services.
Stereolithography applications within the Medical Industry
- Highly detailed prototypes
- Medical Moulds
- Concept Models
- Microscopic Structres - MicroFineTM
Selective Laser Sintering applications within the Medical Industry
- Dental tools
- Hearing aids
- Prosthetics
- Orthotics
- Prototyping
Metal 3D Printing applications with the Medical industry
- Implants
- Dentures
- Medical & Orthopaedic Components
- Scalpels
- Special Templates
- Surgical Devices
PolyJet and 3D Printed Silicone (60-65%) applications with the Medical Industry
- Dental Crowns
- Prosthetics
- Concept and Visual Models
- Implants
- Surgical Instruments
Multi Jet Fusion applications with the Medical Industry
- Prosthetics
- Implants
- Facemasks
- Orthopaedics
Available Medical-Grade Plastic/Resins and Metals/Alloys for 3D Printing
| 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) | |||||||
| Silicone | True Silicone | ISO DIN EN 10993-05 / 10993-10) | X | Milky/ Translucent | X | X | ||
| 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?
High-Temp Plastics
PEEK 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
High 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
MicroFine™ 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
Watershed (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
Between 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.
Bridge Tooling Before Production
Leverage affordable bridge tooling for design and market validation before capital investment in tools.
Interactive Design Analysis
Make critical design adjustments that save development time and cost with design for manufacturability (DFM) feedback on every quote.
Low-Volume Production
Get low-volume production parts in as fast as 1 day to streamline your supply chain once before and after products are launched to market.
ISO 13485 Certified
for Production of Medical Implants and Instruments
Technology Agnostic
Multiple manufacturing technologies across four services mean your parts are paired with the right equipment and processes regarding your project needs.
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.
Rapid Prototyping
Create prototypes in production-grade materials for functional and regulatory testing, or 3D print models and organ scans to preview before medical procedures.
Production like Parts
Prototype Injection Moulding creates parts which allow form and function tests with the same material planned for production parts.
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.”
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