Therapy Delivery

VidaCare needed a partner to take their concept for a lifesaving device from concept to finished, FDA approved product.

VidaCare challenged BC Tech to build a prototype motorized intaosseous vascular access system. It could be quick and dirty - but it had to work. They needed it immediately to convince investors their concept was feasible and effective.

We delivered VidaCare a working prototype in less than two weeks and at one quarter the price of competing bidders. VidaCare and their investors were impressed. BC Tech was honored to be chosen to complete the project.

Solution

• BC Tech designed and prototyped many iterations of needles to determine optimum tip geometries, drill speeds and torque specifications.
• We conducted task analysis and human factors studies to ensure the device was safe and intuitive.
• Our engineers designed a simple motor and gear box, integrated stylet and hub assembly, waterproof housing and sterile packaging system for the needle.
• Our thorough documentation and label development assured the EZ-IO™ smooth passage through the FDA 510K notification process.

The finished EZ-IO™ system is effective, durable and inexpensive to manufacture and package. The VidaCare EZ-IO™ is now in production and being used around the World. BC Tech is currently developing VidaCare's second-generation EZ-IO™ system.

“Of the more than 15 medical-device engineering firms I evaluated, I chose to work exclusively with BC Tech because of their expert capabilities, vast medical-device experience and commitment to our goals. The entire future of our company was at stake. They did not let me down.

“Together we built a superior device (the EZ-IO™) that earned the Medical Design Excellence Gold Winner Award for 2005. More importantly the product has functioned flawlessly for more than 10,000 patients to date, saving hundreds of lives.”

—Larry Miller, M.D., CEO of VidaCare

A cryogenic catheter treatment that's more effective and less risky than traditional Angioplasty.

An estimated 10 million Americans suffer from partial blockages of the arteries in the arms or legs. In traditional Angioplasty treatment, a balloon catheter is expanded in the afflicted artery to reduce constriction and improve blood flow. While immediately successful, the procedure often traumatizes the artery and causes the formation of scar tissue.

CryoVascular founders James Joye, DO, and Ron Williams partnered with BC Tech to develop the PolarCath™, a device to precisely and dependably regulate the flow of cryogenic fluid to a proprietary balloon catheter. The treatment, CryoPlasty™, reduces vascular inflammation and scarring by cooling the arterial tissue during balloon catheter treatment with nitrous oxide gas.

From concept through pilot production:

• BC Tech developed innovative fluid delivery hardware that incorporates custom solenoids and quick connections for the catheter and pressurized coolant.
• IEC 60601-1-4 certified microprocessor control and measurement system that ensures accuracy and prevents operator errors.
• Ergonomic housing and control panel that is safe and affordable to manufacture. Our Industrial Design Group also explored second generation housing concepts (as shown.)
• Conducted Risk & Hazards testing and helped CryoVascular receive FDA 510K clearance.

Our work culminated with production of 30 units for clinical trials. The product proved immensely successful, and CryoPlasty™ treatment is now available at almost every hospital in the United States.

“I am highly satisfied with the project outcome.“

—Jim Niederjohn, CryoVascular Systems

The industry's smallest and lowest priced skin cooling device for laser dermatology.

Laserscope approached BC Tech with a great concept: a passive cooling device for improving patient comfort during laser removal of spider veins, wrinkles, acne, hair and other aesthetic procedures.

BC Tech led an aggressive eight-week research, development and prototyping effort that proved feasibility, established design requirements, and produced six fully functional prototypes. Laserscope was able to unveil their new product at a tradeshow and BC Tech was pleased to guide the project to completion.

How the CoolSpot™ works:

• A removable, fluid filled copper cylinder is chilled before the procedure and conducts heat away from the device's tip.
• A sapphire window allows the laser beam to pass while cooling the treatment region.
• A modular laser mount is compatible with existing systems.
• The highly compact design is lightweight to reduce operator fatigue, incorporates an elastomeric handgrip area for comfort, and provides excellent visibility of the treatment area.

The CoolSpot was an instant success. Its effectiveness, ease-of-use and low price have made expensive and cumbersome laser therapy refrigeration stations nearly obsolete.

Effective treatment for difficult breaks and fractures.

Bone cement has been used in the United States since the 1960s. Traditionally mixed by hand and applied with crude tools or fingers, the process was toxic and often resulted in irregular patches that were prone to failure. Norian revolutionized bone fusion therapy when it developed the world's first biologically compatible cement system.

Norian turned to BC Tech for development the SRS® automated mixing and delivery system.

• Award winning pre-filled package for easy mixing and loading.
• Automated mixing machine for perfect consistency and cure rate.
• Handheld delivery device for precise application.

The pre-filled bag is placed in the mixing machine, where a roller combines the two part bone cement and forces it into the attached delivery tube. The delivery tube is separated from the mixing bag, loaded in the delivery device and administered to the skeletal site. It's an elegant system for quick, clean and effective bone cement preparation and delivery.

The SRS® was marketed by Synthes Corporation.