We’ve continued building upon the Smartphone Physical concept by playing around with new devices that collect clinically-applicable information. Though we knew about the uChek smartphone-based urine analysis from their success at TED, due to, well, sample collection issues we were unable to figure out how to incorporate it into the Smartphone Physical workflow. Fortunately, we were contacted by Dr. Myshkin Ingawale, the co-founder of Biosense Technologies which produces the uChek as well as ToucHb for anemia sensing. We had a chance to try out uChek and even took it with us to the American Medical Association meeting where we were doing Smartphone Physicals.
Following on the success of Scanadu’s record-breaking indiegogo raise, uChek just recently launched their own indiegogo campaign for the uChek Universal. While we are still in the process of reviewing the device and running it by our nephrologist colleagues, we were able to interview Dr. Ingawale about uChek and the FDA “letter heard around the mHealth world” that questioned their regulatory status. Here’s what he had to say:
Shiv Gaglani, Medgadget: How did you come up with the idea for uChek?
Dr. Myshkin Ingawale: The uChek concept had it origins at a workshop attended by my colleague, Dr. Abhishek Sen, from the Biosense team, conducted in 2012 by the Department of Science and Technology, Government of India, with a particular discussion on non invasive and affordable ways for diagnosis. Urinalysis is a powerful and relatively simple diagnostic method – doctors regularly use test strips, which change color based on concentration of analytes in urine, for routine urine analysis as part of their differential diagnosis. But multi-parameter strips are difficult to read visually – so automated strip readers, costing upwards of USD 800 are used.
We thought it would be useful to bring the cost of the reader down, and increase the usefulness of the test data – both of which are possible if one uses the mobile phone camera as the reader of the strips. Additionally, the system becomes open: It can support ANY present of future strip technology, with only a software app update.
Medgadget: What exactly is the clinical problem you are trying to solve?
Ingawale: We are simplifying multi-parameter urine analysis with uChek. This is useful for the management of diabetes, pregnancy, and many kidney, liver and bladder conditions, as well as common problems like urinary tract infections.
A standard commercially available urine test strip may comprise up to 10 different chemical pads or reagents which react and hence change color when immersed in, and then removed from, a urine sample. The readings can be obtained within 60 and 120 seconds of dipping. Each parameter has to be read at a specific time after the start of the reaction, as per the manufacturer’s instructions. There are many manufacturers and many types of strips. Information about concentration measurements of parameters like glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, nitrite, leukocyte, and specific gravity in urine may be obtained in this way. These parameters are useful in DDx of upto 25 medical conditions.
Medgadget: Why should someone use uChek as opposed to traditional methods of urinalysis?
Ingawale: There are two other ways to read a urine test strip: 1. Visually, or 2. using an automated lab machine. The former is subjective, inconvenient or worse – inaccurate. The latter is relatively expensive and often not available in low resource field settings.
1. The visual method suffers from 2 drawbacks:
- a. It is not convenient to read 8 or more parameters visually, in sequence, with a 120 second timer ticking. Different color pads need to be checked against the reference colors and each corresponding parameter needs to be noted at precisely 30, 40, 45, 60 etc seconds. These timings are important as these are the times at which the reaction matures for specific chemicals on the strip. After this the colors and reference colors against the parameter values on the chart may not match, and therefore, reading at the wrong time means getting the wrong result.
- b. Subjectivity introduces error. Human eyes measure color differently, in different ambient lighting conditions. Machines have consistently fared better than humans in this department. There are studies in the scientific literature documenting some of these issues. For example: “Semi-automated vs. visual reading of urinalysis dipsticks“, Peele JD Jr, et al, Journal of Clin Chem, 1977
2. Automated lab machines are power hungry, often expensive and only designed to work with specific strips.
Typically, they cost upwards of USD 800. Example device.
Medgadget: Can you discuss the regulatory hurdles you faced and the FDA’s letter?
Ingawale: We have been working within the US FDA’s framework right from the start, before the product was launched. The uChek is registred and listed with the US FDA as a Class 1 medical device. In terms of our timeline:
- 05 April 2013: uChek listed as Class 1 medical device with US FDA . Here is the link to uChek listing on FDA website and the link to FDA regulations for “Automated urinalysis systems”:.
- 28 April 2013: uChek product released. The first uChek kit ships to user number 1!
After they had processed our registration and listing information, we received a letter from the FDA specifically to discuss the uChek’s product classification. Here is the link to the full letter.
We have since discussed this issue with the US FDA, and this matter is resolved. In summary, uChek Lite, an updated version of the uChek app, which measures 8 parameters and does not measure blood or glucose (Class 2 designations required) in urine, is now available on the US App Store. This is a Class 1 medical device, and will provide accurate, convenient measurements for bilirubin, nitrites, leukocytes, proteins, ketones, urobilinogen, specific gravity and pH in urine.
[Editors Update: We heard from Ingawale who said “We understand that the full system will still require further clearance from the US FDA. So we have decided therefore to focus on the uChek Universal completely, and will be preparing our full 510k application on this, rather than focus on the older version.”]
Medgadget: Can you describe the uChek Universal, which you just launched on indiegogo?
Ingawale: The uChek Universal packs a whole new set of features: Access to uChek Cloud, more powerful analytics to make full use of personal health data tracked, and sophisticated early warning and “recommender” type features based on the data, as well as a better, shinier and easier, faster to use uChek peripheral device. It will be available on both Android and iPhone systems.
Medgadget: Do you have a sense of how many people are using uChek? Are there any interesting or unforeseen applications you’ve seen?
Ingawale: More than 1000 users are now using uChek. We’re only now hearing back from many of them. One specific interesting application that it is being used for is for the health screening of pets: Cats and Dogs!
Medgadget: What is your background in medical technology/innovation?
Ingawale: I am an electrical engineer turned B-school PhD turned management consultant turned tech entrepreneur. The company I co-founded in 2009 with 4 doctor and engineer friends – Biosense Technologies – had successfully developed and commercialized a technology called ” ToucHb” for non-invasive, point of care anemia screening. uChek is our 2nd product. My profile on linkedin: http://in.linkedin.com/in/myshkin
Medgadget: Are there any specific trends in med tech that you’re excited about?
Ingawale: I am excited by the potential impact that mobile devices will have on health. The key words for the future of healthcare are “Preventative”, “Point of care”, and “Consumer”. I think it is time people take charge of their own health, own the data about their own bodies, and take action before any serious complication happens. This could entail relatively “simple” interventions like diet or exercise changes, or more complex interventions e.g. for early kidney disease detection. This is not to replace doctors or advocate self-diagnosis – but empower consumers with better, timely, relevant health information for them to have a constructive dialogue with health experts, and manage their health more proactively. Ultimately, preventative medicine is what will ease the burden on public health systems, and lead to more healthy happy people.
Having consumers take ownership of their own health, and owning the subsequent actions is the way of the future – and this is, incidentally the only sustainable way that we can ensure high quality, affordable health for all – and democratize healthcare.
Here is a video of how the uChek system works: