View Mobile Site
 

Ask the Expert

Signal Photos

 

Biomedical engineer launches company that quickly turns successful

Posted: March 4, 2014 6:42 p.m.
Updated: March 4, 2014 6:42 p.m.

Julie Matheny, director of biomedical engineering, and Gene Zamba, director of R&D, sit for a portrait in their engineering lab at Cal Biomedical Research.

View More »
 

Backed by 40 years of engineering experience in the biomedical industry, Gene Zamba first launched Cal Biomedical Research in Santa Clarita in 2011 as one of a handful of companies across the nation to take a medical device from point A to Z.

Helping to launch medical devices for other companies, Cal Biomedical is also busily developing its own products – with one near ready to go before the FDA for approval.

Having opened his first company, begun in Florida, in 1974, Zamba has also worked as a research and development engineer for a number of companies along the way including BioGenetic Technologies Inc., Gen-Probe, and TriMed Ortho Inc.

But, with a growing number of clients, Zamba invested his energies full time into Cal Biomedical in January to assist companies, ranging in size from a start-up to a full blown company, develop medical devices and bring them to market.

From design and prototype to validation testing, clinical trials, regulatory approval and clearance to manufacturing, and even marketing and distribution, Cal Biomedical is working on a number of projects as Zamba gears up to hire biomedical engineers to help with the growing demand.

“We’re working on an air handling system for operating rooms which basically purifies the air in the room,” Zamba said. “But, we also do a lot of work on orthopedic implants – fracture fixations – to replace the ankle and knee joints.”

Currently Cal Biomedical is also working on an R&D project for itself that excites Zamba, he said.

“We’re working on implants that can be turned around quickly if someone has a bad accident or immediate need for replacement, like a portion of jaw,” Zamba said. “Usually it takes years of surgeries to try and match up the bone and gradually make the repairs.”

On this project, Zamba said a doctor would send them a CAT Scan, take a picture of the missing parts and send both over for reproduction. The project entails mimicking the lost bone fragments exactly and making replicas through 3D printing using FDA approved material - PEEK plastics.

The process allows implants to be turned around in a matter of hours by receiving a CAT scan in the morning and shipping a product out to a physician or hospital in the afternoon, he said.

“We’re at a point where we’re ready to file for FDA approval,” Zamba said. “We’ve clinically proven it and expect to have approval within four months once we file.”

The biomedical device firm is also working to repair tendons, that have been torn or ruptured, by developing a device that is temporarily implanted in the tendon until it heals.

Aside from its own projects, Cal Biomedical also develops devices for surgeons, hospitals and medical suppliers. In some cases, individual surgeons have come on with an idea and will pay Cal Biomedical to develop a device, he said. The same is true for healthcare related organizations that ask the company for help with new products that it needs.

Some projects are simple, like the disposable masks and machinery used for anesthesia in operating rooms. A company in New Jersey requested a way to capture the market by keeping the prices down.

Cal Biomedical is also working on other devices – all of which help to fund its own innovative projects. A machine designed to run test results on vials of blood samples can allow a diagnostic firm to perform the tests in a central lab, automatically, producing test results on maybe 1,000 samples in eight hours compared to today’s manual testing processes, Zamba said.

The firm also works on building more sophisticated monitoring systems for vital signs in hospitals and neonatal centers.

“Whatever is needed, we work it out with our biomedical engineers,” Zamba said. “We develop the device and tools and work out the surgical procedures with the doctor so they can put the devices into a body.”

And Cal Biomedical does a lot of work with electrosurgical devices that both cut and coagulate while in the surgery room.

What’s key to its success, Zamba said, is Cal Biomedical’s ability to get to market quickly with a device. It does that, in most cases, by working with materials the FDA has already approved for use in other devices, drastically slashing the approval time from years to an average of 90 days. Costs are substantially lower as well when working with pre-approved materials.

“We do a lot of FDA submissions; perform the R&D, physically make the parts, take care of the regulatory aspect of all the devices and then we submit to FDA approval to get a product to market,” Zamba said. “We give (clients) a total turnkey operation from concept to end user.”

Cal Biomedical also works with a number of local companies in Santa Clarita to ensure they have a good handle on the quality control process to meet FDA requirements.

The company has enough revenue and work coming in that it can fund its own projects, he said. But, it will be looking for more investors as time goes on.

“We are extremely busy, we’re actually at the point of turning work down because we can’t do it all so we’re looking for more engineers and regulatory people,” Zamba said. “So we can give clients a ready-to-go-product.”

Comments

Commenting not available.
Commenting is not available.

 
 

Powered By
Morris Technology
Please wait ...