Medical Device Daily Washington Editor

Diagnostic systems continue to shrink, very notably those allowing physicians dealing with gastrointestinal issues to get a close look at the goings-on in the digestive tract without a wholesale invasion of the abdominal cavity.

Hollywood has given us Jules Verne-like bits of prescience, such as the 1966 film “Fantastic Voyage.” And the SmartPill, made by SmartPill (Buffalo, New York) is a real medical device that continues the trend of merging fact and sci fi-like scenarios in the field of healthcare.

The SmartPill is a system that starts with a capsule measuring 13 mm by 26 mm that encases tiny sensors geared to pick up data on gastrointestinal (GI) pressure, pH, temperature and the total “transit time” of food. The tiny tracker also records the time it spends in each section of the GI tract, providing physicians with a comprehensive survey of the patient's digestive system.

The pill transmits data to a data receiver, which can be worn in a pocket or on a lanyard around the neck. Within 24 to 48 hours, the pill has completed its trek through the GI tract and the patient returns the data receiver, which the doctor hooks up to a computer via a USB port. One of the benefits of this approach to evaluation of digestive function is that it cuts out the radiological exposure entailed in GI scintigraphy, but the patient also spends less time in a doctor's office because scintigraphy procedures can consume two or more hours to complete.

According to SmartPillCorp, the system's competitive advantage consists of “its ability to . . . capture and transmit in real-time biomedical data from specified segments of the GI tract that can be used to evaluate GI motility.”

That competitive advantage is a reference to the predicate device – SmartPill passing through the FDA maze by means of a 510(k) filing – the so-called Heidelberg pH capsule.

This device, which came into being prior to 1976 and thus did not have to go through the PMA process, is manufactured by Heidelberg Medical (Blairsville, Georgia). However, the name of this device is based on its place of origin, Heidelberg University (Heidelberg, Germany).

Another device player in this space, of course, is Given Imaging (Yokneam, Israel), with its PIllCam, an ingestible capsule containing a tiny camera providing a photographic view of the small bowel.

Smartpill managed a regulatory happy hour, obtaining 2-for-1 clearance for sales in Canada and the U.S. in the same week (July 17 in Canada and July 20 in the U.S.). While the device is not yet available in Europe, the company's president, Daviod Barthel, said he expects to obtain clearance for the European market in October.

SmartPillCorp intends to pursue both private and public-sector reimbursement, but rather than go after one sector first, “We're going to do it in parallel,” Barthel said. As for the advertising strategy, he noted that ads would not tackle consumers at first. “You have to get it adopted and validated by the GI community, but the consumers will become aware of it” and discuss it with their doctors. Eventually, “we could be a consumer-marketed product, but not initially,” Barthel noted.

For now, the company's marketing plan is restricted to dealing with North America and Europe. Barthel noted that “the potential [for sales in Asia] is huge because many Asians suffer from stomach and motility disorders,” but SmartPillCorp has no immediate plans to go west with their product.

The current iteration of the SmartPill includes no patentable technology, but Barthel said that could change. However, “future product development will be aimed at reducing the size of the capsule,” but he offered no additional detail. Barthel pointed out that at present, “[i]t takes about three years to get things through the PTO,” so any design changes will be heavily scrutinized for their overall regulatory burden.

On the other hand, everyone at the firm is happy to have finally muscled this product through its developmental and regulatory program. “This is what the entire SmartPill team has been working for, ever since our company was founded in 2003,” said Barthel. “Our goals all along have been to provide gastrointestinal (GI) professionals with a new, less invasive, cutting-edge medical device for patient evaluation.”

Some digestive-tract problems are related to age, and one of the more common of these, hypochlorhydria, involves a gradual decline in the production of stomach acid, leading to a failure to properly digest food and, implicitly, malnutrition.

While estimates of the prevalence of hypochlorhydria vary, an article in the Aug. 27, 1997, edition of the Journal of the American Medical Association indicates that for the geriatric population, the group most subject to this condition, the prevalence is on the order of 10%. Numbers such as this one suggest that the SmartPill may have a bright future in the years to come.

Dr. Braden Kuo, chairman of SmartPill's scientific advisory board and an assistant professor of medicine at Massachusetts General Hospital (Boston), said that the SmartPill's arrival will help diagnose conditions other than age-related declines in GI function. He noted that thanks to the SmartPill, he and other physicians will be able to diagnose slow gastric emptying “in a way that's never been done before.” He stated that previous methods for diagnosing slow emptying have relied on “inaccurate, test methodology” and said that motility disorders are largely under-diagnosed.

Slow gastric emptying, or gastroparesis, is said to afflict as many as half of all diabetics and an unspecified number of those with Parkinson's disease. Thanks to the SmartPill, detection of co-morbidities in these populations will be much easier.