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    Date submitted
  • 17-Dec-2016

AssistENT

Abstract

http://assistent.tech

AssistENT is an early medical device venture developing the first nasal dilator designed for use during the day. The technology was created at Johns Hopkins by engineering students in the Center for Bioengineering Innovation and Design (CBID), and Patrick Byrne, MD, FACS, MBA, the Director of Facial Plastic and Reconstructive Surgery.

Video

Original YouTube URL: Open

Introduction Video

Additional Questions

Who is your customer?

Over 40 million Americans suffer chronically restricted nasal breathing, yet each year only 125,000 of these individuals undergo functional rhinoplasty procedures at an annual cost of $625M to the United States healthcare system. The many remaining patients are left without treatment during the day but often use nasal dilators in the privacy of their own homes. Breathe Right strips lead the nasal dilator market with annual revenues of $145M, amounting to an 80% market share.

What problem does this idea/product solve or what market need does it serve?

Restricted nasal breathing is one of the most common complaints heard by ENT (Ear, Nose, and Throat) specialists. In fact, one in eight people experiences regular difficulty breathing through the nose. This condition is a daily source of discomfort that reduces productivity and quality of life. Sufferers report shortness of breath throughout the day, difficulty sleeping and habitual snoring, and limited stamina during sports and exercise. Slight dilation of the nasal passages directly counteracts nasal obstruction and reverses symptoms in 89% of those afflicted. To this end, many patients undergo functional rhinoplasty procedures to surgically widen the nasal passages. However, up to 20% of patients experience unimproved or worsened symptoms postoperatively. Moreover, these surgeries entail a yearlong recovery that is disruptive to daily life. Nasal dilators such as Breathe Right strips offer a potential alternative to surgery, as they mechanically expand the nasal passages to instantly relieve obstruction. However, existing products are designed as sleep aids, and customers find them uncomfortable, difficult to use, and too visible to wear in public. Although the mechanism for reversing nasal obstruction is straightforward, there is no viable alternative to surgery for those who struggle with nasal breathing.

What attributes will make this idea/product successful? Why do you believe that those features will create success?

We are developing Schnozzle, a patent pending nasal dilator that improves breathing instantly upon insertion. The device is undetectable during use, eliminating the social stigma associated with existing products that have visible components. The dilator's use case is analogous to that of a contact lens; rather than undergoing nasal reconstruction, users will simply deploy the invisible device in the nose to breathe better instantly. Based on extensive customer and stakeholder interviews conducted within and beyond the I-Corps framework, Schnozzle has the potential to improve of the quality of life for the millions of nasal obstruction sufferers who currently forgo treatment. Faced with the choice between inaction and the appointments, yearlong recovery period, and uncertain outcome inherent with surgery, the majority of individuals—especially those with minor to moderate obstruction—elect to live with their symptoms, which present a constant bother, source of embarrassment, and long-term health risk. These same individuals insist that our daily-wear device presents a vastly preferred alternative, as it immediately provides the functional benefit of surgery without the stigma of visible nasal dilators.

Explain how you (your team) will execute to make this idea/product successful? What gives you (your team) an advantage over others already in the market or new to this market?

Schnozzle is regulated as a 510(k) Class I exempt medical device eligible for sale over-the-counter. Leveraging our partnerships with key opinion leaders in the ENT community across the country, we will provide product samples to pilot hospitals and clinics, where medical professionals will size patients for dilators and instruct them in proper device care and use. This medical distribution channel will legitimize Schnozzle as a valuable medical technology trusted by physicians and surgeons, promoting product awareness. AssistENT will sell Schnozzle directly to consumers through Amazon’s highly efficient fulfillment services at $4 per pair. This revenue is offset by a per-unit production cost of $0.15 through an ISO 13485 certified manufacturer. We expect to begin sales in 2018 and project a breakeven in 2021, the fourth year since incorporation in 2017.