email exchange with michael, page-108

Hi blokes,

I understand that ISN's mobile app is to be developed with wheeze detection algorithms however new study protocol for assessment for measuring in both terms of accuracy and performance, I imagine, will be quite extensive for both the development pathway and associated costs.

Any mobile device that uses components to transform a mobile platform into a regulated medical device are required to comply with the regulatory device classification associated with the transformed platform, hence any mobile app such as Isonea's proposed AsthmaSense mobile app will be subject to class I requirements, which include adequate design controls, registration, device listing, adverse event reporting, and corrections and removals.

Respiratory and congestion innovation is a highly complex area of science that requires significant levels of investment and expertise and GSK are a stand out world leader in the field of Asthma management. The GSK MyAsthma app is simply about promoting awareness and education for all living with asthma - Any first mover approach for mobile medical apps by GSK would imo remain in confidentiality mode until launch date, however I do believe based on years of due dilligence carried out on a small spec I'm invested in, which have been collaborating with GSK for 6 years now bound by strict confidentiality provisions related to connected/active microarray (lab-on-a-chip) delivery systems. Moreover, one of the senior scientists I've been tracking has been filing patent applications in the field of algorithms over the same period, published a book covering it in applications and additionally registered a vehicle company which specializes in using algorithms for diagnosing symptoms of pain.

Don't get me wrong - I'm on the ISN threads because I am interested, especially at current entry levels, and their announcements have caught my interest as my long term belief for smart connected/disruptive innovations driving a new golden era for healthcare is finally upon us.

Isonea have the right idea imo, and accordingly have set out a good strategy moving forward - But will they have the means to continue raising the significant capital required along the way? Some have suggested they already have enough now, but if the planned regulatory pathway involves the FDA, as it does, they will require partnership funding from the very early stages of development. period.
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Further, a study completed in July last year concluded that lower sensitivity and high variability among patients is a preventing factor for wheeze rate to be used as a precise predictor of FEV1.

In some patients, wheezing is not present and shall not be used as the only relevant symptom. Namely, most patients with asthma complain more frequently about chest tightness than on wheezing, and in some patients, wheezing can be provoked only during forced expiration. Wheezing is also absent in many patients with significant airway obstruction. This condition is known as ”silent chest”.

Besides wheezing, changes in lung sounds during flow obstruction can be recognized on other parameters of auscultation, most noticeably a decrease in breath sound intensity, change in breathing rate and increase of the
duration of expiration [5]. This indicates the need of tracking additional respiratory parameters along with wheezing.

WIRELESS COMMUNICATION
Besides the ability to connect the node to the Internet gateway, in medical applications, communication protocols must adhere to standards. Bluetooth is standard for wireless communication between a body sensor node and a smartphone, because of its widespread compatibility and its acceptance among interoperability and standardization bodies. Also, certified Bluetooth stacks featuring Health Device Protocol are provided. Its main disadvantages are high power consumption and long and complicated pairing/connection protocols.

In the scenario of the node where data is processed locally and is transmitted only upon the positive detection of abnormal lung sounds, low data rate suffices. So, upcoming Bluetooth Low Energy (Bluetooth 4.0) is suitable for such applications. ZigBee is also becoming interesting with the advent of ZigBee Health Care Profile. A major obstacle is lack of complementary transceivers on smartphones.

Wireless sensor networks in monitoring of asthma
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From FDA Guidance - July 2011
Requirements for mobile medical device manufacturers subject to regulatory oversight
Manufacturers of mobile medical devices are subject to the requirements described in the applicable device classification regulations. Depending on the classification and the associated regulation for the mobile medical device, manufacturers of mobile medical devices are required to follow associated controls established by the regulation.

Class I devices: General Controls, including:
* Establishment registration, and Medical Device listing (21 CFR Part 807);
* Quality System (QS) regulation (21 CFR Part 820);
* Labeling requirements (21 CFR Part 801);
* Medical Device Reporting (21CFR Part 803);
* Premarket notification (21CFR Part 807);
* Reporting Corrections and Removals (21 CFR Part 806); and
* Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812)

Expectations for mobile medical app distributors
The FDA expects distributors of mobile medical apps who may or may not be a platform or service provider will cooperate with manufacturers in conducting corrections and removal actions. Mobile medical app manufacturers are required to make timely reports of corrections and removals made to reduce a health risk or remedy a violation of the FD&C Act that presents a health risk, and to keep records regarding other corrections and removals

FDA Guidance
Medicine 2.0'12 (Boston, USA)