Publish Date:
Executive Summary
Access Airway has developed a novel device for improving access to difficult airways. Access Airway requested the University of Minnesota’s Earl E. Bakken Medical Devices Center (BMDC) to review their current airway access concept and provide their initial thoughts. The BMDC is an inter-disciplinary department working in all-aspects of healthcare and well-respected by industry and academia.
The overall assessment of the concept and prototype by the BMDC is ‘positive.’ The project experts confirm the need is an existing problem in healthcare and the proposed device appears intuitive and ‘capable’ of addressing the need when used by someone practiced in the art. Dr. Derechin observed this concept “fuses the best of a Bougie with flexibility of the fiber-scope, currently part of the standard for care, and would be a welcome tool for difficult airways. It is technically feasible to build and mass-produce the concept using existing manufacturing techniques and readily available materials. There are no obvious obstacles from a manufacturing perspective. The design appears to be user-friendly with no apparent issues once the procedure is understood, that would complicate the user from achieving the desired outcomes (although a user study is recommended to confirm these first impressions).
The BMDC assembled a team of trained product development practitioners and an anesthesiologist for this review to provide user feedback:
*CV’s for each team members are available upon request.
BACKGROUND INFORMATION
The following files were provided by Access Airways for review, prior to and during the review meeting:
PROJECT PLAN
WORKSHOP AGENDA
OBSERVATIONS
The following is the summary of all participants observations. Detailed notes are available upon request.
A visual guide like a racing strip could assist the users in aiming and understanding position of the shaft
Significant degrees of motion and tip sensitivity based upon the movements in the finger grip.
The ability to ‘feel’ the articulating region through the finger grip/controller is a significant feature. It potentially could reduce the need ‘eyes’ using fiber-scope. It will also be important to provide the clinician with the tactile feel so they can feel the tracheal rings to confirm the placement.
Length of the articulating region is well thought-out to ‘fit’ the dimensions of the anatomy where needed.
Prototype appears to have enough stiffness to assist in access, while enough flexibility to conform to anatomical features allowing for easy access, and avoiding possible perforations
Prototype appears to have the correct rigidity to allow for the users to direct the device during the procedure
It would seem there is a potential for it to be easier to pull the finger rip/controller than push. However, the design allows for equal forces in both directions
The ‘pencil grip’ design allows for natural control and good grip
A roller mechanism is a possible alternative controller design
Design appears to allow for orienting the device to achieve multiple angles of entry, without undue fatigue to the fingers, hands, or arms/shoulders
The ball is well made to fit the curvature of the hand regardless of the hand size (small enough for small hands and large enough for confirmation in large hands.
Does the handle obstruct the view into the airway during the procedure? If so, could a sightline be built into the handle?
Finger indentations/ridges in the handle can communicate the handle position to the user’s fingers
Intuitive design that allows the user to only require one-hand to open the clasp when performing the procedure
Could a spring-loaded top with a latch in the base be an alternative option?
Device length is appropriate for the proposed procedure. Initially the user will need instruction on the purpose and use of the tubing on the proximal end of the guide.
The design does not inform the user as to its use, or how to use the device. Once explained to the user, understanding how to use it should not be a problem.
Lightweight, easy to hold with one hand and control without causing undue fatigue
Access Airway has performed user studies with people that have different hand sizes with success.
Device diameters are comparable to existing standard of care devices – by transitive law that would imply this device has the proper/accepted diameter.
It may be difficult to hold the finger grip/controller in place, when entering a throat where high levels of resistance are present
It should be possible to build a robust device that will withstand the rigors of the procedure based on this design using current materials and manufacturing techniques
Consider the options for changing the devices position (rotation, depth) once the handle is removed
The design does not, in and of itself, instruct the user how to properly use the device. User guidance will be required.
Alternative uses outside the ER should be considered (e.g. EMT in an ambulance/helicopter) and reviewed for potential errors
COMPARISONS
Performing a comparison to the existing standard of care was not specifically on the agenda for this project, however it is unavoidable with the data presented to not make comparisons. The current standard of care since the 1970’s is the (gum elastic) ‘Bougie.’ Demonstrations using the Bougie, followed by Access Airway’s device on a mannequin clearly demonstrate the Access Airway device has all the capabilities of the Bougie, with additional functionality that is useful with difficult airways and could reduce the time to intubate the patient.
Dr. Derechin mentioned a previous case during the project where he needed multiple people and thousands of dollars of equipment to access a difficult airway, and due to the time it took, the patient “was not in a good place.” It was suggested, this device could have been useful for this case.
There are mini hand-held video laryngoscopes with several blade options available in China for a few-hundred dollars (not in the US). However, they do not offer the bidirectionality of the Access Airway device. It is proposed that the Access Airway device would be available at a lower prince-point than the Chinese laryngoscopes making it even more valuable to the market.
It was observed Access Airway’s device, due to its functionality, could improve the time and percent of successful intubations when optical equipment is not available. This functionality could extend its usefulness to lower class hospitals with limited budgets. There are other benefits not pursued in this review such as reducing the force required, and in some cases saving the patients teeth from slips, that are not part of this report.
The team was asked to comment on their thoughts regarding adoption of this device. The team was chosen based on their technical expertise and not on market adoption expertise. However, as purchasers of items, we all have some untrained level of experience. It is the teams’ opinion that medical staff deviate from standard of care only when required to. This is typically due to liability and reimbursement reasons. Despite this initial limitation, we can envision an immediate future where this device could be added to emergency kits as a ‘just in case’ item when the standard of care is not working well. After enough market familiarity and cases in the books using this device, the team can envision, adoption of this device increasing from a ‘just in case’ tool to a ‘first-attempt’ tool. The logic behind this is that the device does not cost a significant amount and the usefulness is ‘high.’ Instead of failing an attempt and then pulling this tool out, approach each case as if there is a potential for a difficult airway and save time.
DISCLAIMER
The comments provided in this report are the opinions of the participants of this review, based on their experiences and education at the time of the review along with the materials made available by Access Airways. The reader is encouraged to seek other information and data to form their own opinions and conclusions. Users of the information, in-full or part, contained in this report will use at their own risk. The University of Minnesota and Earl E. Bakken Medical Devices Center shall not be liable for any indirect, incidental, special, consequential, or punitive damages or any loss of profits or revenues, whether incurred directly or indirectly, or any loss of goodwill or other intangible losses resulting from using the data and information in this report.
