Medizintechnik

Legacy Data Migration for Orthopedic Implant Design

The client, a pediatric orthopedic company based in the U.S., provides anatomically appropriate solutions for growing children suffering from orthopedic issues. They offer single-use, sterile-packed procedure kits, including clavicle plating systems, fibula plating systems, malleolar screw kits, cleft palate kits, muscle spasticity kits, and more.

Scope

The client needed to upgrade their legacy 2D CAD drawings to detailed 2D and 3D models in UG NX. They sought us to modernize their design data and align with current industry standards for orthopedic plating and screw systems, including:

Clavicle Plating System
Growth Control Plating System
Straight Fibula Plating System
Malleolar 4.0mm Cannulated Screw Kits

We also provided design refinements and material recommendations to make the implants stronger, easier to manufacture, and compliant with industry standards.

Challenge

The challenges of designing orthopedic implants were significant, including:

Legacy Data Inconsistencies: The old CAD files didn’t align with current design standards or manufacturing technologies. We needed a deep understanding of anatomy, biomechanics, and materials to ensure optimal fixation, stability, and biocompatibility of the implants.
Design Complexity: The clavicle plate needed to match the natural curvature of the clavicle, be low-profile to reduce soft tissue irritation. Additionally, it required variable-angle locking mechanisms and multi-directional screw placements to provide better stability across different fracture types.
Regulatory Compliance: The designs must meet FDA, ISO 13485, and ASTM standards to guarantee safety, performance, and regulatory approval.
Cost-Effective Manufacturability: The implants had to be designed for efficient production, considering the latest manufacturing technologies and material availability to keep the designs practical and cost-effective.

Solution

Leveraging our years of product design experience across diverse sectors, we created cost-effective and efficient solutions for the client. We conducted in-depth research on pediatric orthopedic implants, child anatomy, and biocompatible materials to ensure the best possible outcomes.

Our effective solution included:

Legacy Data Migration

With expertise in UG NX, our design team successfully converted the client’s legacy data into precise 3D CAD models. We ensured each model aligned with the latest design standards and manufacturing techniques.

We developed detailed 2D drafts and 3D models for the following products:

Anatomic Low Profile Clavicle Plate (used for clavicle fractures to minimize soft tissue irritation)
Clavicle Hook Plate (used for distal clavicle fractures that need stable fixation)
Distal Clavicle Plate (stabilizes fractures in the distal clavicle)
Growth Control Plating System (controls bone growth in pediatric patients for deformity correction)
Malleolar 4.0mm Cannulated Screw Kits (stabilizes fractures in the malleolus of the ankle)
Straight Fibula Plating System (fixes fibula fractures for stability and healing)

The designs incorporated biocompatible materials like Ti Grade 4 for the straight fibula and clavicle plates, Ti Grade 2 for the growth control plating system, and Stainless Steel 316 LVM for the screw kits.

Design Optimization

We designed the models to align with the client’s standards, ensuring smooth integration into their manufacturing process and easy system transfer. To enhance performance, we suggested improvements in plate contouring, screw hole placement, and mechanical integrity, making the implants more stable and effective for surgery.

We created 3D models for over 100 plates and screws in multiple sizes, ensuring a precise fit for different patient anatomies. This helped improve surgical precision, fixation strength, and overall clinical effectiveness.

Compliance with Standards

Our designs were optimized to meet the latest medical device standards, including FDA, ISO 13485 and ISO 10993 regulations. We also ensured the selected materials met relevant ASTM standards.

Throughout the process, we kept the client informed and incorporated their feedback, ensuring the final solutions met their needs for both functionality and manufacturability.

Orthopedic implant 2D drawing-Sedin case study.png

Value and Benefits

We transformed outdated 2D drawings into precise 3D models, eliminating inconsistencies and ensuring the client had reliable, high-quality data for internal use.

We designed 100+ plates and screws in multiple sizes, ensuring they were scalable allowing for smooth machining, easy assembly, and hassle-free integration into the client's production process.

Our designs met FDA, ISO, and ASTM standards, helping the client speed up regulatory approvals and get their products to market faster.

With a scalable 3D CAD database, the client gained a solid foundation for faster product development, design improvements, and long-term efficiency.