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Medical Device Prototyping
Medical Device Prototyping
3D printing is of great value to teams developing medical and drug delivery devices. Going a step further, we have a medical cell that produces prototype parts for non-implantable medical devices and drug delivery devices for limited contact with the body.
Operating procedures
We have strict protocols for operating our medical cell. For example, restricting how often the door is opened and how many people can enter helps to maintain cleanliness, minimise contamination risks and prevent temperature fluctuations.
What is the medical device prototyping process?
Orders are processed in line with our ISO 9001 Quality Assurance procedures. If our engineers have any queries, they liaise with the customer to ensure the part we deliver is exactly what is expected.
The part file is then pre-processed and downloaded to the 3D printer. To minimise turnaround times, our 3D printers operate round the clock, typically running unattended overnight. Furthermore, we use a webcam to monitor progress without entering the medical cell.
Once the parts have been built, they are cleaned following a procedure we developed in-house. This incorporates the manufacturer’s cleaning guidelines, yet is suitable for parts that will have limited patient contact.
After cleaning, parts are bagged, sealed and labelled, all within the medical cell.
When is medical device prototyping used?
Customers utilise our medical prototyping facilities at many different points in the product development cycle. Typically, we produce prototype parts for early-stage clinical trials and usability testing, but parts are also ordered for other purposes.
Medical device prototyping capabilities
SLA
A 3D Systems Viper SLA machine is installed permanently in the medical cell. It has a build volume of 250 x 250 x 250 mm, and prints in layers of 100 microns or 50 microns and operates with Accura ClearVue resin.
This combination of machine and material produces transparent, high-quality, rigid parts with smooth surfaces, good isotropy, no porosity and good water resistance.
DLP technology is similar to SLA but far quicker. The DLP Standalone build envelope is 124.8 x 70.2 x 196 mm (XYZ), horizontal resolution is 65 microns and layer thickness is 50 microns.
We offer two materials for medical device prototyping on our DLP 3D printer. Both build high-quality parts that have good rigidity, smooth surfaces, isotropy, water resistance and no porosity.
Materials for medical device prototypes
Our 3D Systems Viper SLA machine uses Accura ClearVue resin. This high-clarity material is similar to polycarbonate, being durable, rigid, strong, and humidity and moisture stable.
We build parts with two materials on the DLP machine, both of which can be autoclaved:
MED-AMB 10:
A translucent amber material with high stiffness and good thermal resistance
MED-WHT 10:
A white material with high stiffness, good thermal resistance and excellent humidity/moisture resistance
Characteristics of medical device prototypes
We established our medical cell specifically for producing prototypes parts for limited patient contact. These parts therefore serve a particular purpose and are not offered with the same aesthetic as other prototype parts. Nevertheless, customers find that having access to parts suitable for patient contact is invaluable in today’s fast-paced product development environment.
The materials we use in our medical cell are high-quality, rigid and strong, and can be used for simulating parts with snap fits and detailed features.
Finishing options for medical device prototypes
Medical device prototype parts are cleaned according to USP Class VI standards.
If requested, we can carry out assembly operations, following procedures agreed with the customer. For example, we can install threaded inserts or cast silicone onto parts to create integral seals.
Service levels for medical device prototyping
The production of medical device prototype parts requires additional quality control procedures to be followed, so we do not offer an Express service. However, we quote lead times that are as short as possible without compromising on quality.
Talk to us
If you need medical or drug delivery devices prototype parts for patient contact, talk to us 01763 249760 or complete the enquiry form below to request a quote.
Model Making & RP Workshop team
Our model making and RP workshop team deliver high-quality 3D printed and vacuum cast prototype parts. We offer next day dispatch on SLS, SLA, Polyjet and DLP. Request a quote for your next prototype project.
Tim Rowell
Quality & Operations Manager
Gemma Zouher-Lewis
Senior RP Workshop Technician - Team Leader
Jordan Cooney
RP Technician
Alex Barnett
RP Technician
Nick Crown
RP Technician
Chris Johnson
RP Technician
Mark Avory
RP Technician
Wayne Titmus
RP Technician
Ryan Brown
Workshop Technician
Pete Robinson
3D Print Manager
Jan Mlynarcik
3D Print CAD Technician
Emily West
Workshop administrator