Full Service Medical Device Outsourcing

Concept Through Commercialization

Intrepid Orthopedics has been helping customers bring ideas to market for over 20+ years.

Key Capabilities:
  • Concepts
  • CAD Design & FEA
  • Prototyping
  • Testing
  • Regulatory 510(k) submission
  • Quality System Management
  • Manufacturing
  • Product Launch

Intrepid Orthopedics - Product Development

Product Development Experts

iNTREPID ORTHOPEDS specializes in providing innovative medical device outsourcing solutions from concept through commercialization. When you choose us, you’ve partnered with a company that has successfully designed & developed over 30 internal fixation systems.  Our customers have ranged from a surgeon to a large orthopedic company.  

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Design & Rapid Prototyping

We utilize Mimics Software, SolidWorks 3D CAD and FEA for patient specific design and anatomical engineering. Models are developed and 3D printed quickly and accurately.

Orthopedic Design and Development

Testing & Approval

Our in house testing capabilities allow us to provide a shorter to market timeline than our competitors.

Orthopedic Quality and Regulatory

Manufacturing & Launch

Our longstanding manufacturer relationships allow us to smoothly move your product from approval to launch.


Product Realization for Pre- and Post-Market Medical Devices in the US and EU

We go beyond traditional engineering and regulatory services — we serve as a comprehensive partner in medical device realization. Our mission is to empower innovators by streamlining the journey from concept to commercialization. Whether it’s product development, manufacturing, regulatory strategy, or quality system integration, we tailor our approach to fit your specific needs and timeline. With a flexible engagement model and deep domain expertise, we simplify complexity so you can stay focused on innovation and impact.

Our Medical Device System Experience

  • Cervical Cages
  • Cervical Corpectomy Cages
  • Cervical Disc Replacements
  • Cervical Plate Systems
  • Thoracic Fixation Systems
  • ALIF & Lateral Cages
  • Lumbar Corpectomy Cages
  • Lumbar Disc Replacements
  • Minimally Invasive Systems
  • Occipital Plates
  • Cervical Systems
  • Thoracic Systems
  • Lumbar Systems
  • TLIF & PLIF Cages
  • Dynamic Posterior System
  • Magnetic Lengthening System
  • Cannulated Screws
  • Compression Screws
  • Buttress Plates
  • Humerus Plates
  • Universal Hand Implant Systems
  • Condylar Plates
  • Reconstruction Plates
  • Femoral Plates
  • Proximal Tibia Plates
  • Distal Tibia Plates
  • Foot Plating Systems
  • MTP Plates
  • Calcaneal Plates
  • Hemi Metatarsal and Phalanx Systems
  • Total Joint Replacement Systems
  • Medial Tissue Anchors
  • Lateral Tissue Anchors
  • Knotted and Knotless Anchors
  • ACL Anchors
  • Bicep Tendonitis Anchors
Additional Systems
  • Total Hip Systems
  • Custom Hip Alignment Systems

Our Proven Track Record of Commercializing Products Worldwide

46+

Customers Served

30+

Products Launched

20+

Regulatory Submissions

Orthopedic Design & Development

Orthopedic Design & Development

Our team is dedicated to providing innovative solutions to the orthopedic community. With over twenty years of experience in orthopedic design and development, we provide startup and large orthopedic companies the expertise they need from concept through commercialization. Our team utilizes the latest 3D software combined with finite element analysis (FEA) to verify designs and ensure that prototypes function per our customer requirements. Our dedication and commitment to on time delivery ensures our customers timelines are always met.

Manufacturing

We believe in concurrently working with our manufacturers during the development process. This ensures that our designs are not only innovative and unique, but can also be made simply and easily. Our team works with manufacturers to create 3D models and drawings which can be utilized in both rapid prototype and production machines. This technique speeds up the development cycle, eliminating months from our customers timeline while saving them money.

Testing

We believe in concurrently working with our testing partners from early on in the development cycle. This ensures that our designs will pass testing with a high success rate. Reducing risk of failure in testing keeps original timelines on target.

Quality & Regulatory

Intrepid Orthopedics offers medical device regulatory consulting. With over 20+ years of experience, we have the knowledge to guide you through your regulatory pathway. We can help you whether you are seeking regulatory approval for a Class I, II or III device or responding to observations and warning letters.

Our team has assembled and submitted numerous orthopedic device 510k’s that have been cleared by the FDA in as quick as three weeks. Our knowledge of the development process enhances our ability to work with our customers and assemble and submit 510k’s quickly and efficiently. Whether it is a traditional new device or special change in technology, we have the expertise to help you get your product to market.


Rapid Prototyping. Immediately bring your idea to life.

Our team utilizes the latest 3D software to transform your ideas from sketches into virtual models. We then bring your device to life on a 3D printer. With finite element analysis (FEA) we determine the weaknesses of the design and strengthen them to ensure a high quality product.

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Orthopedic Design and Development

In house testing. Don’t wait for results.

Our capabilities allow us to schedule your product testing immediately after prototyping. Our in house capabilities also allow us to have your test results immediately. After testing is complete we can submit your product for approval. With over 20 years of experience, we have the knowledge to guide you through your regulatory pathway.


Close manufacturing partners. Smooth product launch.

We work closely with manufacturers from the beginning of the design process to ensure a smooth product launch. This also ensures that your designs are not only innovative and unique, but can also be made simply and easily.

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Intrepid Orthopedics

628 Brook Hollow Dr.
Conroe, Tx  77385

(440) 465-4321