FastTraCS collaborates with healthcare innovators to help translate medical device ideas from napkin sketch to design concept. We offer design support ranging from CAD assistance (3D modeling) to more in-depth product development and guidance services.

Depending on the project's needs, collaboration can range from several weeks to longer term engagements. Innovators will receive a whiteboard ideation of their project, final design report, and 3D representative model of their device idea.

FastTraCS project example

Tracheostomy Tube Monitor

Through initial interviews and observation, FastTraCS can assist you in arriving at a solution.

Identifying the problem

A leading cause of death in pediatric patients is accidental tracheostomy dislodgement (decannulation) which occurs when a tracheostomy tie is too loose or when a patient coughs, pulls, or tugs on it. When the tracheostomy tube dislodges, the stoma may close and lead to asphyxiation of the patient. If the dislodgement is noticed before the stoma fully closes, the caregiver may be able to insert a smaller size tracheostomy tube to keep the airway open and then seek emergency care to replace the smaller tracheostomy tube with the original size.

Since most pediatric patients with tracheostomy tubes are non-verbal, they are unable to alert the caregiver when a decannulation happens, especially if they are not in the same room. Given this unmet need, a tracheostomy decannulation detection device is needed to alert caregivers when a decannulation event is occurring. With an adequate response time by the caregiver, such a device will allow the caregiver to reinsert the tracheostomy tube before the stoma closes, decreasing the chance of death by asphyxiation.

Concept Drawing and Key Features

FastTraCS worked with the ENT physician to determine the key features of the device. The following are design features identified prior to, or during intake design meetings:

  • Must be able to detect dislodgement before the tracheostomy tube is completely out.
  • Must be able to adapt to various makes and models of pediatric tracheostomy tubes.
  • Must be low-profile such as not to prevent the tracheostomy tube from sitting flush against the patient’s neck dressing or skin.
  • Must be able to work in the home care setting.

Computer Aided Design, Prototype Generation & Validation

FastTraCS designed and prototyped two separate sensor mechanisms to detect decannulation: a contact switch approach and a light-detection approach.

The contact switch approach integrates a "pogo-pin" into the tracheostomy flange and remains in contact with the tracheostomy dressing, sending out an alert when contact is broken (decannulation, dislodgement). The spring pin can accommodate varying anatomy and small movements, such as breathing and coughing, without breaking contact and sending out a false positive signal. Multiple configurations for the pins and detection circuitry were generated that can be used to provide redundancy.

By contrast, the light-detection method can take two embodiments: one that uses an active light source (such as an LED) and another that makes use of ambient light. In either embodiment, a light-detection sensor is used to monitor for the presence or absence of light. If the amount of light hitting the sensor climbs above a threshold indicating partial or complete dislodgement, the circuitry will notify the user(s). The approach using an active light source provides a more robust detection method as filters and wavelength selection can be used to reduce the probability of false positives or false negatives. Active light source provides the additional safeguard for low-light conditions (e.g. night time, dark room, or clothing blocking ambient light).

Both techniques demonstrated the ability to detect partial and complete tracheostomy dislodgement.

Methods & Skills

  • Interviews
  • Concept drawings
  • Device features
  • Computer Aided Design
  • Prototype generation
  • Validation

Tools & Resources

FastTraCS is an experienced team of biomedical engineers who identify solvable problems at UNC Hospitals and swiftly develop solutions. We quickly translate discoveries, ideas and inventions into marketable products by providing R&D and research commercialization support through concept generation, design and advanced prototyping.

Related Work

To learn more about the program, request a consultation.

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Cite Us

CitE and SUBMit CTSA Grant number - UM1TR004406

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