By Allan Maurer
ROSWELL, GA—One of the difficulties of getting a really new medical device to market—say one using a novel material—is that no standards may exist for testing it, but test it a company must to get it approved by regulatory agencies such as the U.S. Food and Drug Administration. That’s one place where Secure BioMedical Evaluation can help, says Dr. Linda Braddon, founder and head of the engineering firm that helps medical device companies get their products to market.

The five person company performs risk assessments, mechanical test design and execution and other services to help medical device makers get their products to market more quickly. Braddon, a PhD, founded the company about four years ago, but has been doing the same type of work since 1997, she tells TechJournal South.

The company was funded “Out of my pocket,” says Braddon.

Essentially, she says, “SBME serves as an engineering staff for its clients, performing product development, risk assessment, mechanical test design, technical due diligence and corporate training.

“Some companies bring us in to get their staff up to speed on a complex issue so that everyone from the CEO to the head of R&D understands the technology,” she says.

While the medical device industry is growing in the Southeast and SMBE has had clients in Georgia, most of its customers are in the traditional biotech hubs such as San Diego and Boston, she says. A great many come to the company through word-of-mouth referrals.

“We deal with testing labs and one in Colorado we work with has a lot of California clients who need what we do,” says Braddon.

“Georgia and the Southeast are definitely coming up the chain in medical devices, but there is still a lot more infrastructure supporting the industry in other places,” she says. More Southeast business would be welcome, she adds. “If I didn’t have to get on a plane quite as much it would be nice,” she says.

Medical devices have been a hot sector for several years now, much of that success spurred by the needs of aging baby boomers “Who don’t want cranky old knees,” says Braddon. Much of SMBE’s work is with clients in the orthopedic world.

One client makes hydrogels for cartilage repair, which Braddon says is “One of those niche areas we live in.” Because they’re so new, few set standards for how to test them exist as yet. Braddon is going to an American Standards and Test Methodology conference in Vancouver, BC in May to discuss how to properly test them.

The FDA will want a device clearly characterized before approving it. So medical device makers have to consider what sort of body pressures the device will be subjected to, backed up by published values the device might see when implanted.

“You have to justify everything to the FDA,” notes Braddon. “You can’t just say I’m going to test a device with five million cycles, you have to justify it with published literature and what the current thought processes in communities that deal with it are.”

“Medical device companies, especially startups, often don’t have the expertise we bring to the table,” says Braddon. “They’re not members of the ASTM committee and don’t know the up and coming thinking, they haven’t done a literature review to figure out what kind of environment their device will see when implanted.”

The smaller companies know they have to do the testing, but “They often have small staffs with everyone wearing multiple hats.”

On the other hand, “We’ve seen a lot of devices,” says Braddon, and “If we haven’t see it, we can figure it out. Our goal is to help them make the safest, most effective device they can.”

Some medical devices are not that far off from others already on the market. “If something is not that far off from something already approved, you can make analogies. Those devices can go through the relatively easier 510k approval process. “None of the approval processes are easy, but 510k is as easy as it gets,” says Braddon.

Recently, however, the FDA has said some devices approved under the 510k process really should have required the more rigorous Premarket Approval (PMA) route. “If you’re introducing something novel and potentially industry changing, you have to go through a lot more hoops and clinical trials—a much more costly route for the medical device company,” says Braddon.

“I have some sympathy for the FDA,” says Braddon. “You can’t please everyone. Companies want a smooth and easy approval process. Consumers want a safe, effective product that’s cheap. The FDA takes the heat if their process is too hard or if a product is approved and harms someone.”

Braddon admits that her firm “Is not the cheapest out there.” A typical failure mode analysis, she says, will cost about $5,000. The hourly rate her firm charges varies depending on the skill sets of the people involved and range from $100 to $250 an hour.

“We’re very sensitive to costs,” she notes. “These companies are very sensitive to costs. We’re very good at documenting how we spend our time and why it costs what it costs.”

She points out that her firm’s services are still going to be less costly than bringing a fulltime person on board with equivalent credentials.

Braddon says that while her company sees a lot of “me-toos” with products similar to others already in the market, “It’s really fun to see the ones that are a jump in technology and you can see how the device will affect quality of life for a patient.”
Online: www.securebme.com

Southeast Venture Conference, February 29 – March 1, 2012 at the Ritz Carlton in Tysons Corner, VA – Where Smart Money Meets Smart People.
www.seventure.org

© 2009, TechJournal South. All rights reserved.