Delay in Manufacturing

Hello Everyone,

Long update alert*

Hope you have been doing good and thanks again for your patience. As mentioned above, this is a long post and a detailed update on what we have been upto,

First of all, we sincerely apologize for the delay in shipping, we know that according to our original plan, we were going to start shipping in September, however there has been a delay from our side and we can only start the shipping from early 2016. We can however, explain this delay in detail.

1. Diabeto Mold Corrections: The mold for the outer casing of Diabeto took 4 corrections, the major challenge was on the connector side since we need a strong internal mechanism to withstand pressure and stress when Diabeto is connected and removed over a period of time from Glucometer ports.

2. FDA filing: Initially, we had planned to ship the devices to US and classify the users as testers and submit the study forms to FDA to get 510(k) approval, however to our pleasant surprise, FDA changed its rules for connected devices and our entire system was exempt from 510(k) FDA filing however we still had to get our qualitative systems in place and make a FDA file to be submitted to FDA authorities and also notify the US customs about the import so that we don’t have any issues at the customs. We hired a great FDA consultant who took us through the entire FDA process and we make a FDA file and took us in total a little more than 3 months. We will be filing for FDA, i.e. notifying them about Diabeto, pay the necessary fee and that would allow us to start exporting Diabeto to US from 2016. Moreover, our top pre-orders have come from USA and hence USA is a very important country for us in terms of market and business.

3. Partner Glucometer delay: We have partnered with Bruno Farmaceutici for providing Glucometers for users who have orders Glucometer + Diabeto deal. However, the entire shipment of glucometers was withheld by the Indian customs for more than 2 months on suspicion of inappropriate pricing, the issue was however solved and we cleared the shipment yesterday.

4. API delay: We had a great response from the diabetes business industry (B2B side) wherein the Diabetes businesses/Hospitals wanted to integrate their mobile application with Diabeto hardware. We already coded the demo API for iOS and have started integrating with businesses/apps in USA and Europe however due to the complexity in Android devices and compatibility, we are still working on the Android app and the Android API with complete documentation.

5. Telemedicine cloud feature: When we were surveying about cloud features and about the current state of healthcare, we found out that access to primary care is still an issue in India, Asia, Middle East and even in Europe. We wanted to solve this issue with the help of technology and started working on the tele-medicine feature. This feature would allow you to upload the readings via the mobile application on the cloud server and take a video consultation from one of our panel doctors that would comprise of Endocrinologists/Diabetologists/Diabetes specialists. Thus Diabeto would be providing 360-degree care in Diabetes. Although building this feature which was complex took us time, we think, it would provide tremendous value to people with diabetes.

6. IR Device (Diabeto Red): Glucometers manufactured by Roche like the Accuchek series use Infra Red (IR) protocol for transferring the data. Earlier when we had announced the sale of IR adapter, the design was clunky and difficult to use since the users would have to buy both the Diabeto birdie and the Diabeto IR adapter. After brainstorming, we are coming up with an entire new device called as Diabeto Red. Diabeto Red will be a standalone device that will have IR sensor as well as Bluetooth for transferring the data to the smartphones. We will be showing a picture and later post a video of Diabeto Red working with Diabeto application. Moreover, we have also included Diabeto Red in the FDA filing.

7. Beta Testing: In spite of the delay, we are steadily working on the software and we have decided to release the entire Diabeto solution in phases.

The first phase would be Diabeto Android application that would allow manual entry of Blood glucose data. The readings would be stored securely on the cloud server that will also have the telemedicine facility. For the beta testing, we would be allowing selective participants access to the Android application, cloud and also provide them with 1 free video consultation with the endocrinologist (If they choose to do so).

If you want to take part in the beta testing, please fill the following form,

Beta testing of the Android application (Manual entry) and cloud starts from 13th October 2015.

Finally, although we have delayed the shipping process, we want to make sure that we deliver a sturdy and useful product, we again want to thank you for your patience and promise that we will deliver a quality product.

Thanks,
Shreek