BB Medical Surgical is staffed by engineers, clinicians, regulatory and marketing experts who provide support for all aspects of our products. We can prepare and submit all FDA paperwork to clear a device for marketing in the USA. Check out our Success Stories:
SAAVI pediatric device at LA BioMed
BB Medical Surgical is taking the lead to license, test, and commercialize a device to provide a temporary airway and deliver surfactant to premature, very low birth weight infants. A combination of FDA, NIH and private grants are in the funding pipeline. There are over 50,000 premature births in the USA annually and this device will help a vulnerable population achieve good health with minimal collateral damage. The adult rescue airway addresses a much larger market. Contact us to receive updates as we spin off SAAVI.
Kobold Medical, LLC
While the founding physicians had the clinical knowledge to apply to product development, they needed expert guidance on device commercialization. BB Medical Surgical provided a range of services to successfully commercialize Kobold Medical’s products. When approaching Kobold Medical’s FDA, EU , and Australian MOH submissions and registrations, BB Medical Surgical did not cut corners but found an efficient and cost-effective path forward.
“BB Medical Surgical was very helpful in our work with the FDA. We received great service and advice, and they undoubtedly saved us time and money.” - Wayne Lamoreaux, MD, Kobold Medical
As the U.S. agent for Laboratorium Dr. Deppe®, BB Medical Surgical set the stage for successful U.S. commercialization of the company’s Thixo-Gel® product. During the 510(k) submission process, the company discovered that there were no set protocols for physical bench testing of its ultrasound spray with comparable products. BB Medical Surgical leveraged its contacts to identify a boutique engineering firm that would develop the protocols, run the testing and generate the necessary reports for half the cost of the other labs – and do so in a more timely manner.
“We from Laboratorium Dr. Deppe GmbH, a family run German company in the medical disinfectant and cosmetic branch with a turn-over of about 32M euros, have achieved through Mrs. Christina Bernstein and her professional consulting service the first ever FDA registration for one of our products... We are now looking forward to registering ... our next product and to further develop our market entry into the USA.” - Tilmann Junger, Export Manager, Laboratorium Dr. Deppe GmbH, Germany