Business Details
Expert Medical Device Design & Development Services
At Jortek Surgical, we specialize in delivering cutting-edge product development services in orthopedics, spine, and sports medicine. Our expertise extends to mechanical design across a broad range of medical devices, from RF generating consoles to dialysis machines. With a commitment to high-quality designs, we assist clients in meeting regulatory requirements, industry standards, and custom design specifications. Our team has successfully handled complex projects, including implant and instrumentation design, expandable cage development, and RF console creation. Founded by Kelly Ammann, a seasoned professional with over 20 years of experience in medical device innovation, we guide products from concept to market launch.Our services encompass detailed design, verification, validation, and process development, supported by advanced simulation and testing capabilities. We pride ourselves on integrating clinical feedback with engineering excellence to create solutions that address real-world medical challenges. Our work has resulted in over 10 U.S. patents and 20 pending patents, reflecting our dedication to innovation. We collaborate with both Fortune 500 companies and startups, offering tailored support for regulatory strategies, design for manufacturing, and surgical environment integration. Our mission is to empower medical device advancements through technical expertise and unwavering commitment to quality.
Services
Mechanical Engineering Design
Product Development
3D Modeling
FEA Simulation
Verification Protocols
Bench Testing
Process Development
Manufacturing Transfer
Regulatory Compliance
Expandable Cage Design
Highlights and features
- We have over 20 years of experience in medical device design and development.
- Our team holds 10+ U.S. patents with 20+ pending in medical innovation.
- We implement proven regulatory strategies for FDA and international compliance.
- We conduct advanced cadaveric evaluation of surgical instruments and implants.
- Our engineers specialize in design for manufacturing and assembly optimization.
Services
Mechanical Engineering Design
We create precision mechanical designs for medical devices, including implants and surgical instruments. Our process involves 3D modeling, tolerance analysis, and production drawings using SolidWorks. We ensure designs meet functional requirements while optimizing for manufacturability and regulatory compliance.
FEA Simulation
Our team conducts advanced finite element analysis to evaluate device performance under stress, thermal changes, and impact scenarios. This simulation-driven approach identifies potential failures early in development, reducing prototyping costs and ensuring structural integrity for demanding medical applications.
Product Development
We guide medical products through full development cycles, from concept to market readiness. Services include requirement specification, risk analysis, verification/validation protocols, and bench testing. Our expertise spans orthopedic implants, RF consoles, and dialysis equipment with rigorous regulatory adherence.
Expandable Cage Design
We specialize in designing expandable intervertebral cages with adjustable height and lordosis angles. Our solutions undergo 5 million load cycle testing to ensure durability. The single-point adjustment mechanism simplifies surgical implementation while maintaining structural reliability for spinal fusion procedures.
Regulatory Compliance
We help clients navigate regulatory requirements for medical devices, including FDA submissions and international standards. Our approach integrates compliance into every development phase, ensuring documentation aligns with quality system regulations and customer design inputs.
People
Kelly Ammann
Founder, P.E., M.E.
With 20+ years in medical device innovation, Kelly holds 10+ U.S. patents and has led product development from concept to FDA approval. He specializes in orthopedic implants, surgical instruments, and regulatory strategies.
Questions
What medical device specialties does Jortek Surgical offer?
We specialize in orthopedic, spine, and sports medicine device development, including implants, surgical instruments, RF consoles, and dialysis machines with mechanical engineering expertise.
How does Jortek ensure regulatory compliance?
We integrate FDA and international regulatory requirements throughout development, providing documentation support for submissions and ensuring designs meet quality system regulations.
Can Jortek handle complete product development cycles?
Yes, we manage projects from concept through verification, validation, and manufacturing transfer, with expertise in regulatory approval and commercial launch strategies.
What engineering tools does Jortek use?
We utilize SolidWorks for 3D modeling and simulation, advanced FEA for stress analysis, and develop detailed verification protocols for comprehensive device testing.
How experienced is Jortek's team?
Our founder has 20+ years in medical device development, including Fortune 500 and startup experience, with 10+ issued patents and 20+ pending in medical innovation.
