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.