The USA medical device market is more than $100 Billion
source: US Dept. of Commerce
While there are numerous regulatory consultant companies that specialize in filing 510(k) applications, their fees can be cost-prohibitive for smaller MedTechs. In our experience, many tend to take a “bigger is better” approach, recommending a “kitchen sink approach” that serves to increase costs and paperwork without offering added benefit to their customers. Furthermore, many regulatory consulting firms have a narrow scope of expertise that limits them from offering knowledgeable guidance outside of the filing process.
Understanding that there is no “one size fits all” approach to regulatory approval, BB Medical Surgical works closely with clients to structure individualized programs. While many MedTech companies come to us initially for FDA 510(k) paperwork, they often tap into our broader range of expertise. When a client requires resources to meet its product commercialization needs, BB Medical Surgical builds a collaborative team of professionals with specific expertise and experience matched specifically to the client. Our collaborators include engineers, clinicians, regulatory affairs professionals and marketing experts. Leveraging these resources, BB Medical Surgical assists with key processes critical to successful commercialization, from engineering and packaging/labeling configurations to marketing and sales strategy.