Context

Young adults with Cystic Fibrosis often stop using airway clearance treatment around ages 18-24, which results in worsened lung health long term.

Approach

Design a new airway clearance system that integrates into the lifestyle of young adults with Cystic Fibrosis, creating higher compliance rates.

1819 Innovation Award Winner

Research

What is Cystic Fibrosis?

Cystic Fibrosis is a genetic disease that causes the body to produce thick, sticky mucus that can clog organs and airways. This can cause issues that affects the lungs, pancreas, and other organs.

Who does it affect?

There are close to 40,000 children and adults living with cystic fibrosis in the United States. This population continues to grow as medical solutions advance. More than 75 percent of people with CF are diagnosed by age 2. The number of people with CF is growing due to evolving medication.

Current Airway Clearance Technology

The Nebulizer

Delivers medication into the lungs as a fine mist that helps thin mucus, fight infections, and open airways

Technology Landscape

User Journey Map

High Burden

Low Burden

The Vest

The vest is used to help loosen mucus in the lungs by delivering rapid vibrations to the chest. This helps move mucus into the larger airways, where it can be more easily coughed out.

Select Application

Universal Application

Pain Points

This is one example of a typical airway clearance routine. However, routines can vary depending on the variant of Cystic Fibrosis the individual has, so treatment can take longer.

  • Least favorite part was sitting with the vest on

  • Couldn’t do homework at the same time because of shaking from the vest

  • Stuck to the machine, so he’s forced to stop what he’s doing to do treatment which is difficult for him and parents

  • Difficult to convince him to do the clearance some days

Online Questionnaire

How does Cystic Fibrosis affect your daily routine?

How Often do you Perform Airway Clearance Techniques?

User Interviews

Franki

Cystic Fibrosis Foundation

  • Senior Development Director

  • Highly involved in Ohio CF community

  • Niece has CF and has issues with keeping vest strapped on

Dave & Mara

CF Patient and Wife

  • Used to have siblings hit back (airway clearance)

  • Doesn’t need to use ACT anymore because of modulator drugs

  • When vest came out, didn’t have issues since it was better than physical impact

Stephanie

Caretaker - 10 y/o Son

  • Hates being tied down to machine

  • Difficult to travel with

  • Portable vest is not as effective

  • Needs to time out meals with treatment

  • Wants something more subtle

Kathy

Caretaker - 16 y/o Daughter

  • Monarch vest is heavy

  • Used to do cupping before vest

  • Doesn’t think Afflovest helps much

  • Air vest is most comfortable

  • Difficult to travel with vest

  • Emphasis on exercise

Key Insights

CF greatly affects the daily routine of patients:

Movement & Exercise

Exercise can be challenging for people with cystic fibrosis due to shortness of breath and fatigue.

Daily Treatments

Daily treatments take an average of 6 hours, making it hard for patients to maintain treatment routines or plan freely.

Time Management

Since treatment is done at home, everything takes longer and requires strong time management.

Design Goals

Technology

Nanoparticles

What are Nanoparticles?

Nanoparticles are tiny particles, typically ranging from 1 to 100 nanometers in size.

How are they used?

Nanoparticles are utilized for different medical purposes including targeted drug delivery, diagnostic imaging, and even therapeutic applications like cancer treatment and tissue regeneration

Electromagnetic Waves

What are Electromagnetic Waves?

Electromagnetic waves are invisible waves of energy made up of electric and magnetic fields moving together. They can travel through air, space, and even the human body.

How are they used?

Electromagnetic waves can cause agitation, or increased movement, of molecules and charges within a material. When controlled, they can activate materials like magnetic nanoparticles without needing direct contact.

A Smarter Solution

By using magnetic nanoparticles that are inhaled into the lungs and applying electromagnetic waves, the particles vibrate within the lungs through magnetic activation. This has the potential to loosen mucus in a less physically demanding way.

Value Proposition

This device seamlessly integrates into the daily lives of young adults with CF, using magnetically responsive nanoparticles to clear mucus. This makes airway clearance more comfortable, portable, and hassle-free, leading to higher compliance rates.

Ideation

Design Directions

This system requires two parts:

Nanoparticle Nebulizer

Distributes magnetic nanoparticles into the lungs

Magnetic Wave Vest

Uses magnetic waves to vibrate magnetic particles in the lungs to agitate mucus

Ideation

Looked into organic handheld device, but could become overly complicated

Wearable nebulizer didn’t hit user needs

Moved forward with portable nebulizer concept

Clay Prototypes

Clay Prototypes were used to explore different methods of magnetic wave application and nebulizer form

Vest Ideation

Sketched around main airway clearance agitation points for optimal performance

Vest Prototype

Iteration 2 was the final design direction. It hit all the main agitation points while providing a secure fit.

Iteration 1

Iteration 2

User Validation

Interview Goals

Nebulizer

Understand which application provides the most ease of use

Understand which form best fit the user needs

Electromagnetic Wave Application

Validation Overview

This was an in-home interview with a family of four. The youngest son, age 10, has Cystic Fibrosis.

All four family members participated in the user validation, providing different perspectives with the same values

Nebulizer Validation

The focus of this validation activity was to understand which form met the needs of someone with Cystic Fibrosis. These forms were judged based on comfort, sanitization ability, and level of subtleness. They liked the size of the two smaller ones, but didn’t like the ones that strongly resembled vapes.

Final Direction

This nebulizer was the family’s favorite because of the ease of use, the cap to keep the mouthpiece clean, and the subtlety of it.

Additional Surveys

Nebulizer 3

Non-CF Users

This group fit the age range of 18-23 to provide feedback on which form was their favorite, but realized the values of people with Cystic Fibrosis are different. However, the form feedback was still valuable.

Online CF Community Ranking

Nebulizer 1

Nebulizer 2

Nebulizer 4

In addition to an in-person validation, this online survey was posted in a CF subreddit. Users were asked to rank their favorite to least favorite portable nebulizer. The purpose of this was to get a quick analysis, but these were not in-depth results.

Non-CF User Ranking

Nebulizer 1

Online CF Ranking

Nebulizer 1

Nebulizer 2

Nebulizer 2

Nebulizer 3

Nebulizer 3

Nebulizer 4

Nebulizer 4

Magnetic Wave Validation

The focus of this validation activity was to figure out which method of magnetization provides the most flexibility and ease of use for the user. The handheld and adhesive prototypes made the least sense since it would be difficult for users to reach their back to apply it.

Final Direction

The vest was the family’s favorite because of its ability to reach all the agitation spots. However, they were reluctant to choose another vest solution.

Final System Direction

Based on the feedback, these are the two concepts fit the design goals the best.

The aspects that users liked about this nebulizer are strong, and the feedback is easy to accommodate.

This magnetization application made the most sense since it provides the most ease of use.

Concept Process

Nebulizer Form Progression

This grip is comfortable and the interaction is easy to understand. The only button on the front is for dispensing. All secondary features are on the back.

The earlier prototypes were too small and cluttered, making it difficult to use. The prototypes on the right are straightforward and comfortable.

Vest Progression

This vest only covers the lungs and hits the necessary agitation points while also providing a secure and adjustable fit.

Final Concept

Exploded

CMF Variations

Dispense

Cartridge Release

Final Render

Final Prototypes

User Journey

Key Differences

Thank you || Alina Hyder