Portfolio:	Disposables
Implants	Surgical Inst.
Consumer	Catheters

Disposable Devices

Sample Case Studies

Pulmonary Drug Delivery Device

Client: Large Medical Device Company looking for speed and creativity

Device: Pulmonary drug delivery device for hospital use

Hantel Contributions: Concept work (Brainstorming, IP, prototyping), Test method development, Test fixture design and fabrication, Material selection, Development work, Process Development, Verification, preliminary GMP manufacturing.

Results: Device ready for Phase 1 clinical trials in 10 months.

 

Vascular Closure Device

Client: Two doctors with an idea

Device: An injection molded device with unique chemical properties

Hantel Contributions: Prototyping, Requirements documentation, Material Selection, Test Method Development, Vendor Selection, Manufacturing Process Development, Verification Testing, Packaging Design, Biocompatibility test management, Sterilization Validation management, GMP Manufacturing

Results: Concept to 1 st in Man in 10 months. 1 st in man performed with commercially viable devices.

 

Breast Biopsy and Intra-ductal Visualization System

Client: Pre-IPO Medical Device Start-up with virtual engineering

Device: A disposable instrumentation set for trans-ductal visualization and biopsy sampling of cancerous tissue in the breast.

Hantel Contributions: Prototyping, Concept Work, Test Method Development, Engineering Requirements, Injection mold design/fabrication, Verification Testing, Biocompatibility management, packaging design, Commercial GMP Manufacturing

Result: Manufacturing of the entire product line for a virtual company to this day.

 

Neonatal Diagnostic Disposable

Client: Post-IPO medical device company

Device: Disposable element of a neonatal diagnostic system

Hantel Contributions: Development of a manufacturing line for assembling and packaging the disposable device, Ongoing manufacturing in quantities of 20,000+ per week.

Result: Successful manufacturing with continual cost-reduction activities