X-HALE Diagnostics

Market Strategy

From our company to your home

Cost of Asthma

On average, a person spends $3,266 on asthma-related costs. $1,830 was for prescriptions, $529 for hospitalizations, and $105 for emergency room care. Our company has high hopes to help patients save money by reducing the number of hospitalizations and improving asthma control (this includes the visits to the office, emergency room and outpatient).

Asthma Market Growth

Marketing Plan

Phase 1:

We will have a direct distribution channel by selling online. We will advertise by word-of-mouth, our website, and social media. We also plan to attend various medical device or asthma-related events to showcase our product. We will finish the prototype, and conduct testing and verification. Our key partners are our professors and our physician mentor. Our key supplier is Alphasense Technologies.

Phase 2:

In this phase we will file for a patent, start clinical studies, and file for a 510K. We will participate in competitions and apply to the NIH for funding within the first five years. We will be expanding throughout California, and hiring more employees.

Phase 3:

We will shift to an indirect distribution channel, and expand into the national market. Our goal is to have different intermediaries like a manufacturing department. We will also start partnerships or be bought by a larger company such as Propeller Health.

In the Market

Price

First time users will get the device at value price, meaning that they will be able to qualify for a bundle: 10 single use masks and the device for only $250.00 USD. For continuing users, we will continue selling single-use masks, uniquely made by our company.

Quality and Warranty

X-hale Diagnostics ensures to obtain the highest quality sensors. Our sensors are at a range of parts per billion (ppb) to capture the Nitric Oxide released from an asthma attack with the utmost accuracy.The device lasts around 1 to 2 years. However, if the device is malfunctioning before, our company will gladly provide a replacement.

FDA Class & ISO Standards

Our device is classified as a Class II FDA device. Therefore, we will file a 510K. Our device can be used to make a decision or monitor a disease. It is not invasive, so there is no high risk of harm nor it is an implantable device.
Some of the ISO Standards we need to follow:
ISO 80369-1 First edition 2010-12-15 ISO 18562-1 First edition 2017-03 IEC 60812 Edition 3.0 2018-08 ASTM F3268-18 Standard Guide for in vitro Degradation Testing of Absorbable Metals

Competition

Competitor Analysis

Why is our product the best?

In the clinical sector, FDA has approved similar devices by Spirosure and NIOX for use by healthcare professionals. Daily measurement of Nitric Oxide is not practical for most clinical care and would only be possible if home monitoring was available. Currently, there is only one company making home use devices; Vivatmo home-use devices by Bosch are intended for physicians to have remote access to the device, providing healthcare for their patients.

Other Products in the market

Vivatmo me

First exhaled Nitric Oxide measuring device for home use by Bosch. It sends information to doctors via app. Thus, patients rely on physicans for information about medication usage.

So Why Choose X-Hale?

We have identified a need in the market that not only allows patients to measure their own degree of airway inflammation at any time but also give supplemental information to assist patients undergoing treatment at home. The novelty is to create a user-friendly device that will allow patients or their caregivers to better understand how asthma treatment is affecting them without the need for emergency department visits and hospitalizations.
Our product will give patients greater independence and help them to have better control of their asthma and optimize medication usage.