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Airway Tools Company: Changing Medical Device Standards of Care

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Andrew Maxwell1, Bahram Behnam Azad1, Michael Alvarez2
1University of Toronto; 2Stanford University

Summary and key issue/decision: Airway Tools Company is a startup medical devices company centered on the Airway Tool technology. Its founders, Dr. Adam Law (anesthesiologist), Dr. Michael Gross (orthopedic surgeon), and Dr. George Kovacs (emergency physician) formed the company in 2004 to finance and develop a novel tracheal intubation device that would address flaws they identified with current intubation devices. While the initial development work focused on making a product that was incrementally better than competitors, the developers decided to provide significant added value that would allow them to justify the creation of a new venture, rather than simply licensing the design to existing manufacturers. However, as the inventors moved from the development of a product to a business, they encountered several constraints that have slowed down the introduction of the Airway Tool into the market. These constraints are primarily around the current nature of competition in the market place, current usage patterns and several intellectual property challenges. To achieve Airway Tools, Inc.’s long-term objective of becoming a major device manufacturer in the intubation market, they are developing strategies to both add value in the existing Operating and Emergency Room environments, and possibly create a new market among first-response practitioners.

Companies/institutions: Airway Tools Company Inc., Halifax Biomedical Engineering, Panacis Medical

Technology: The Airway Tool is a portable intubation device aimed for airway stimulation. Its added features allow for round the corner visualization, ease and consistent tube passage through the tube delivery channel, and effortless soft tissue control with midline stability. In addition, its video-based technology with an on-handle screen assists the user in avoiding serious complications commonly caused by intubation procedures.

Stage of development at the time of issue/decision: Airway Tools Company is currently in the midst of pre-production development, finalizing a prototype and validating the “Airway Tool” using manikins and difficult airway simulators and clinical-grade cadavers. A single formal manikin study has been completed and a provisional patent has been filed.

Indication/therapeutic area: Several circumstances would require the use of the Airway Tool to support the respiratory function of patients. Common intubation applications include the use of the apparatus to protect the airway of comatose or intoxicated patients, or during general anesthesia where the patient’s spontaneous respiration may be decreased or absent. The Airway Tool can also be used to assist in certain respiratory airway procedures, such as bronchoscopy, laser therapy, and stenting of the bronchi. In addition, the device has applications among First Responders, but there are concerns about the effectiveness of the procedure by unfamiliar users that have reduced the use of the product. In addition, the device may allow people with less training to perform intubations and increase the number of positive outcomes.

Geography: Canada, US, UK, Australia, New Zealand, South Africa

Keywords: intubation, laryngoscope, airway stimulation, business models, adoption issues, freedom to operate.

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