Guide to Designing, Developing and Manufacturing a Custom Device
Biomet is committed to helping surgeons engineer high quality custom implant solutions for unique or complicated anatomies. Following the PMI® design, development and manufacturing process steps will help to ensure a world-class experience.
Step 1
Contact the PMI® department at 800.348.9500 x1736 to initiate the design process.
Step 2
The success of each implant begins with accurate reconstruction of the patient's CT scan* data into a 3-D bone model (Figure 1).
Select link to access Biomet PMI® CT scan protocol
CT data may be submitted for reconstruction via either of the following modes:
- CD-ROM
Ship to:
Biomet, Inc.
PMI® Dept./Suzanne Smeltzer
56 East Bell Drive
Warsaw, IN 46582
- Online (secure site):
https://www.jointassist.com/PMI/
User ID: doc
Password: doc
Select link to view sample video of 3-D Segmentation
*While most custom implant cases are CT driven, X-rays with proper magnification markers may also be used in the design process of custom devices. Please contact the Biomet® PMI® Team for further information regarding this modality.
Step 3
Through surgeon and PMI® development engineer collaboration, an implant proposal is designed and can be reviewed by the surgeon either via 2-D templates, a digital 3-D PDF or as a rapid prototype model (Figure 2) for final approval.
Select link to view AGC Pimary Femur 2-D template
Select link to view Revision Patella 2-D template
Select link to view Total IM Humerus 2-D template
Select link to view sample 3-D PDF
Select link to view sample video of Rapid Prototype Manufacturing
Step 4
Upon receipt of the surgeon's prescription, the final implant (Figure 3) is manufactured in our 24-hour operating PMI® facility within three to four weeks*.
* Standard lead time is three to four weeks after implant proposal approval. Depending on the situation, lead time can be significantly reduced for trauma and tumor cases.
Select link to view sample video of Implant Manufacturing
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