Project A. Pharyngeal airway device
Proposed by James Bates - Physician in Anesthesia
Summary of Project:
A device designed to assist with airway management in patients who need assistance with respiration. The primary
use is to help with endotracheal intubation, but it can also serve as an airway support to help with mask assisted or
spontaneous ventilation. The general design is a curved cylinder that can be placed in the mouth and passed down
the pharynx near to the larynx. It will hold the upper airway open allowing a fiberoptic scope or miniature camera
to look through the device and visualize the vocal cords to guide endotracheal intubation. The cylinder will have a
diameter large enough to pass an endotracheal tube and perhaps other catheters, scopes, or devices. In order to
make placement easier the cylinder is placed while partially collapsed and then opened after it is positioned near
the larynx.
Initial Market Assessment by MBA Student Julian Valencia
Market Size:
21 million laryngoscopies are performed each year in the U.S.
Incidences of “Difficulty” are at 10%, translating into 2.1 million cases.
4% are “unanticipated difficult” airways, translating into roughly 840,000 cases.
10% of intubations require multiple attempts.
Complications are significantly more common among patients who require more than two attempts.
Conclusion: We have the opportunity to reduce multiple intubation attempts in about 2 million patients
annually.
Complications
Current solutions:
A Laryngoscope with either the curved (Macintosh) blade or the straight (Millar) blade.
The Laryngeal mask.
Competition:
Many manufacturers exist that rely on varying sizes, shapes, lights and integrated cameras/displays.
Some manufacturers include: Riester, Welch Allyn, ADC, Glidescope, McGrath, and Covidien.
Trends and Questions to consider:
What are the factors that lead to “difficult” or “unanticipated difficult” laryngoscopies?
What pain points exist for doctors performing these procedures?
Is equipment too expensive?
Are different shapes needed?
Is sanitizing and re-use too difficult?
What needs exists in emergency situations?
Is access to the right kind of equipment a problem?
92% of survey respondents reported having access to video laryngoscopes, but only 3% had the
equipment in every OR.
Reported varying availability of different Laryngoscopy equipment.
Response from the U Iowa physician:
The short version is that direct laryngoscopy works about 95-98% of the time, which is pretty good for a
technique that is almost 100 years old. However, in our OR’s where we do about 70-100 intubations a
day that means every day there are 2 or 3 people for whom direct laryngoscopy is either inappropriate
or unsuccessful. Actually, being a high risk center we get patients referred to us who are more likely to
have problems and we have more than 2 or 3 patients a day who we can’t use direct laryngoscopy
on. Notice in the ad for Covidien they begin with “Maximize your chance for first-attempt success “
which alludes to the problem. And this is in highly trained people; physicians, paramedics, nurses, etc.
who have less experience have an even higher failure rate. Success is important because a failed
intubation, in the most extreme situations, is a fatal event. Even in the less extreme situations it can
lead to injury, delay or denial of appropriate care, or at a minimum, inconvenience and increased
expenses (think of an elective surgery that gets cancelled because a safe airway cannot be established,
so you leave the hospital with the surgery not performed but you still have generated a lot of medical
bills).
The market for my device is similar to the market Covidien is appealing to: anywhere a lot of
endotracheal intubations take place, especially intubations that occur in critically ill patients or where
special difficulties can be expected. That is mainly operating rooms, emergency rooms, intensive care
units, trauma scenes, and code blue events. There are many devices being sold that are aimed at the
market of successful management of difficult airways. However, all of the devices fail some of the
time. The uniqueness of this device is that it employs a novel strategy that should allow success in
situations where most current devices fail.
Also, the device described in the disclosure is one of a variety of instruments that use the same basic
strategy for airway control, but differ in the mechanics of how they accomplish this. So for an accurate
marketing analysis you will need a device description that is a bit broader than what is specifically given
in the UIRF disclosure.
Final conclusion:
The market opportunity exists in creating a solution that can eliminate or reduce difficulties that lead to
multiple intubations in about 2 million patients. We are looking for a solution that accomplishes the
same airway control with a innovative mechanical strategy.
Sources:
Covidien: Laryngoscopy Practices, 2013 survey report
http://solutionscontent.covidien.com/uploads/10/1079713AW0024aHDTMcGRATHMACAnesthSurveyReport_FINAL-1376319697.pdf
Covidien: Clinical Studies Quickguide
http://solutionscontent.covidien.com/uploads/12/12693-14AW0030bCSMAWMortEXTERNAL_FINAL1402937419.pdf