Medical Devices

The future of noninvasive glucose meters? I-Pod sized and ear-clipped

Woman uses Glucotrack, courtesy of Integrity Applications

Woman uses GlucoTrack, courtesy of Integrity Applications

The healthcare startups in the race to launch an approved noninvasive, bloodless glucose meter for the growing diabetes patient population is on. While each company etches out its value proposition and aims for commercial launch, a look at what the devices with potential for success in this space have in common.

What the successful breakout devices will likely have:

  1. An ear clip. Whether the data measures your glucose using spectroscopy–light-sensing technology–or ultrasound, if not for sheer number alone, the device will likely clip on the patient’s ear.
  2. Substantial data storage.  It’s obvious in the age of big data: Patients want to be able to see, categorize and manipulate progress, and that goes for monitoring glucose levels as well. Integrity Application‘s GlucoTrack stores up to a thousand readings and patients can look at a particular date or range of dates. The device recently earned a CE Mark and will launch in Europe in 2014. CEO Avner Gal said depending on the FDA process, the device could be on the U.S. market in two years time.
    In the U.S. especially, more data and mobility will be leveraged in later generation devices to ensure speedier approval processes. Socrates Health Solutions CEO Scott Smith said the original design for their glucometer, Companion, was a wireless device that would sync with an iPhone or Android. “We realized that was going to put us on a different FDA route,” he said. A more expensive, longer FDA route. Instead, the company went back to the basics–an accurate, quick, painless reading with a 510(k) clearance path.
  3. A design reminiscent of an i-Pod.  Something small, cute, portable and handheld. Socrates’ Companion technology fits the bill here, as do some others, such as does Grove Instruments’ crack at the noninvasive device.
  4. Recalibration needs and hidden costs. Oh yeah. About that ear clip. That will need to be replaced every once and a while. For a product like GlucoTrack, that replacement clip runs about $100. The way to bring these costs down? Lower how often recalibration is needed. Gal said for the GlucoTrack, though the device is currently marked for one-month replacements, the company has proven it can go as long as six months without being replaced and giving accurate readings.
  5. A strong founder’s story with a diabetes experience that hits very close to home. Aside from potential for a big pay-off, many from outside the healthcare bailiwick have entered the noninvasive bloodless glucose meter ring because they have someone close to them that suffered from diabetes. For Smith, it was his father. For Gal, fellow founder Dr. David Freger died due to complications related to diabetes.
  6. Watch out J&J. Solutions are coming from the startups and small companies.  With diabetes, it’s all hands on deck. The Integrity Applications team doesn’t even come from a healthcare background. Rather the team brings engineering knowledge to use ultrasound, electromagnetic and thermal measurements to give an accurate glucose level reading. Smith has been in healthcare since graduating college, but gravitated toward more entrepreneurial companies.
  7. A fast read. If it takes more than a minute, the competition has already got it beat (several times over). Grove Instruments, of course, takes less than 20 seconds. Smith said the Companion offers a reading in about 2.5 seconds.

Many (if not most) of the startups in this space use spectroscopy or some form of light-sensing technology, so it’s likely the medical device companies to come out on top will do the same. However, Gal warned against “optical technology,” saying his company decided against it from day one because it didn’t work. (Although the startups using the technology are accumulating data that would contradict that notion.) Like GlucoTrack, a device that considers usability beyond just being pain-free–such as audible readings because diabetic patients often have vision problems–offers greater value to patients.

But, at least in the near future, a noninvasive glucose meter is unlikely to have a cheap price tag. The GlucoTrack costs about $2,000. As all leaders in the noninvasive glucose meter space claim, so does Gal–that with a long-use life that price is amateurized over time. But it sure is a lot to shell out at once.

“All we’re comfortable saying right now is consumers will pay a fraction of the cost they pay today monitoring their blood glucose,” Smith said. Though Smith was unable to offer a price-point for the Companion, he did point to the good intentions of folks in this space.

“We do feel we have a moral obligation as healthcare professionals to take cost out of the entire healthcare system.”

Price and reimbursement will certainly be sticking matters with the diabetes patient population largely being middle-income and middle-aged.

For more on the major players in noninvasive glucose meters, click here.

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