Surgical Instrumentation

Sample Case Studies

Spine Stabilization Device

Client: Pre-IPO, VC-Funded Start-up

Device: Interdisciplinary, multi-component system for improved kyphoplasty outcome

Hantel Contributions: Incorporation of client’s design into Hantel Document Control, Development of test methods and fixtures, Development of assembly processes and fixtures, Procurement of materials, Fabrication of components, Design controls, verification testing, GMP assembly.

Result: Design, Verification, and manufacture of clinical devices in 4.5 months.

 

Prostate Ablation Device

Client: Large, Publicly Traded Medical Company

Device: Multi-component, stainless steel, re-usable cannula system for access, visualization, and ablation of the prostate

Hantel Contributions: Design, Prototyping, Benchmarking, Materials selection, Metal forming, Design controls, Test method development, Manufacturing Process Development, Packaging system design, Design documentation, GMP Manufacturing

Result: Concept to Clinically-used, World Class Instrument in 8 months.

 

RF Soft Tissue Ablation Device

Client: Virtual Company with a concept

Device: Adjustable RF device for ablating solid organs

Hantel Contributions: Prototyping, Design, Materials Selection, Process Development, Insert Molding, Metal Forming, IEC 60601 Testing, Test method development, Packaging System design, Design Controls, Verification, Management of Biocompatibility, Management of Sterilization, GMP Manufacturing of commercial devices.

Result: Commercially available, effect product.

 

RF Soft Tissue Ablation device

Client: Virtual company with patented RF Technology

Device: Bi-polar RF device for large lesion formation

Hantel Contributions: Prototyping, Design, Materials selection, Manufacturing methods, Assembly fixtures, Design documentation, Verification Testing, IEC 60601 Testing, Packaging Design, GMP methods

Result: Concept to commercially viable device in 8 months.