Nastent was developed with leading doctors specialized in sleep.
History of nastetn development
In the summer of 2007, a discussion for the future was held at a company, which is the predecessor of seven dreamers laboratories. The subject was “Possibility to Enter the Sleep Arena.” The company had already entered the market of cardiovascular arena and their marketing and development teams chose the sleep arena from several candidates for the next market.
Strong social contribution with a new treatment for snoring and apnea
We focused on snoring and SAS (Sleep Apnea Syndrome) one of the sleep breathing disorders, which not only harms health but also leads to traffic accidents and other social problems. We found that many people that are having trouble about snoring but there was not yet any effective treatment. SAS was getting popular in Japan but not everyone knew about it at that time. Treatment using CPAP already existed, but its treatment continuation rate was low. Then, we thought that we could contribute to the society by proposing a new treatment of SAS.
Thorough marketing survey clarified concept
After choosing a new treatment of snore and SAS for the new target, the marketing and development teams started thorough survey. As they met a large numbers of doctors and medical workers, the development concept became clear. The answer was something similar to a stent physically supporting the airway, this became the initial idea of Nastent.
Then we created prototypes. Early samples used a net spreading inside the nostril and were called “green soybeans” from its shape. The developeing team repeatedly took it to an otolaryngologist to have them insert it into their nostril to check for the feel and effectiveness of the sample. The prototypes were manufactured with various materials, including metal, plastic, and rubber. When a metal mesh was used, the developer had a nosebleed during the test. They really put their body on the line. At the end the development team reached with the answer to use silicone, which is elastic and soft.
The nose clipper took the most time for development. Since, the nose clipper requires in need to firmly fit to the nose bridge. Also work as mechanism that holds inserted Nastent into the nostril keeping the airway while asleep (for a long time) but not to cause pain, many trials and errors were necessary until we reached with the perfect nose clipper as we know today.
7 years of development
They’re where also unexpected challenges in developing Nastent. When we first sterilized the general medical device we found that some sterilization method leaves distinctive smell on the device. Initially, gamma sterilization was used because it was a popular sterilization method for general medical devices. However, this method left distinctive “irradiation smell” on the device. While this smell in general does not cause problem with most general medical devices, unfortunately, since Nastent is inserted into the nostril, some people felt that the smell was too strong. An alternate method had to be found since, it would have no meaning if the users cannot go sleep do to the smell.
After bumping into many obstacles such as the following and overcoming each obstacle, we developed the world-first snore treatment devise Nastent classic. It took 7 years in development and to put on the market under approval for general medical device. We believe that this accomplishment was from continuous development and not giving up and continuously seeking an ideal device for demanding people for new treatment.
Although we have achieved one accomplished this is not the end of our journey toward development for Nastent. We believe that many people will use Nastent and there will be further types of various demands as well from the people. In order to continue contributing to society development for Nastent is yet to continue.
Pharmaceutical Affairs and Development
For example, the tube is manufactured with silicon that is soft as human skin and a mold also with forming method, which is carefully chosen so that it does not cause damage to the nasal mucosa and pain discomfort. To this it minimizes the discomfort when inserted into a nostril. Other types of material where used at an earlier stage of development, however, as an result of pursuing materials which satisfies the condition that sterilization shall be possible and the nasal mucosa shall not be damaged and had enough strength to secure the airway, the current material and manufacturing method was chosen.
Since Nastent is completely new general medical device, we were required to show objectively that it certainly works and safety and secured. A large-scale clinical trial was difficult due to time and budget, we conducted many verifications under cooperation by our advisory doctors, sometimes by becoming test subjects ourselves, to collect data. The following required 7 years since the start of development we had limited tie to putting Nastent on the market.
As Nastent has just been put on the market, the current product is just a transit point and we will continue to improve the devise to address new demands and challenges. We appreciate all attention to the future of Nastent as well as another new product under development.
Quality Assurance Officer
・ Establishment of an obligation to submit documents required to strengthen safety measures
・ Expansion of authentication scope by registered authentication institutes for medical devices (partially including class III medical devices)
・ Construction of regulation considering characteristics of medical device and regenerative medicine
We expect that this amendment will be good both for manufacturers of general medical devices as well as for patients. Along with this amendment, suppliers will also bear liability for QMS (Quality Management System) in addition to manufacturers, and we feel further responsible for our products although we do not have manufacturing facilities.