Custom-made medical devices design
digital orthodontic design
digital orthodontic workflow
The design of custom-made medical devices is at the core of Orthofan’s business and represents one of the most sought-after services by clinicians who require precision, predictability and continuity in their orthodontic treatments.
Using advanced digital technologies and expertise gained through years of experience, we develop highly customised solutions that respond to the functional and aesthetic needs of each patient.
A design process focused on the clinician
The design is structured to offer to professionals a solid support that can be easily integrated into their daily practice.
Every device originates from:
- detailed technical analysis of the case;
- direct discussion with the clinician;
- use of professional CAD software;
- certified protocols;
- multiple checks before production.
This approach allows for the creation of reliable devices that are consistent with the treatment plan and equipped with the precision required in modern orthodontic therapies.
How the design process works
1. Receipt and analysis of documentation
We accept both traditional documentation and digital files (intraoral scanners, 3D models, photographs).
At this stage:
- we examine the clinical information;
- we assess biomechanical needs;
- we identify any technical issues;
- we harmonise therapeutic intentions.
2. Device's CAD design
We use certified software and digital workflows that enable us to:
- accurate modelling of the device;
- simulations and preliminary checks;
- control of biomechanical parameters;
- optimisation of contact areas and strengths;
- consistency with recognised orthodontic protocols.
3. Project sharing and approval
The clinician can review, discuss and approve the design before production.
This step allows you to:
- prevent inaccuracies;
- adapt design details upon request;
- ensure full compliance with therapeutic objectives.
4. Certified production of the device
Once the design has been approved, the device is manufactured in accordance with the requirements of MDR 2017/745 and the ISO 9001 and ISO 13485 standards.
- The entire process is tracked and documented, ensuring:
- full traceability;
- repeatability of results;
- step-by-step quality control.
The devices we design
Digital and traditional design covers all major orthodontic categories:
- Bite and splint
- Digital expanders
- Lingual braces and palatal bars
- Thermoformed retainers
- Clear Aligners
- Functional and removable devices
- Devices on TAD
- Special techniques (Crozat, Delaire, etc.)
- sleep apnoea devices
Each design complies with clinical guidelines and the individual needs of the patient.
The advantages of Orthofan design
Choosing Orthofan for your design means you will obtain:
Digital precision at every stage
operating times and errors reduction
Better communication between the office and the laboratory
Greater clinical predictability of results
Certified and documented protocols
Customised and repeatable solutions
A reliable project partner
The design of custom-made medical devices is an ongoing collaboration: each case is handled by qualified staff who communicate directly with the clinician and assist them in making technical choices, ensuring a safe result that complies with the highest standards.
Do you have a case to design?
Contact us for immediate support and to work together to develop a custom-made, precise and certified device.
