What Pill They Think of Next?

By: Matt Hotz, CIS Compliance Specialist

matthotz@cis-partners.com

We’ve addressed the topic of medical devices several times in this space over the last few months, including Alaina Confer’s post from last month regarding regulations covering medical devices, Justin Will’s post from September on the proposed Transparency in Medical Device Pricing Act, and Amy Lotman’s post from June on the FDA’s new Sentinel system, which will proactively monitor side effects and safety concerns for both drugs and medical devices.

Important topics, to be sure, but I think this blog has ignored a basic truth about medical devices: some of the new ones are so awesome.

Seriously.

I decided to write this post after reading about the Philips intelligent pill (iPill), which packs a wireless RF transceiver, a fluid pump, a drug reservoir, a pH sensor, a temperature sensor, a battery, and a microprocessor into a shell that’s the same size and shape as an ordinary pill. The developers at Philips hope that the iPill can be used to treat digestive tract diseases like Crohn’s disease, colitis, and colon cancer by releasing the appropriate drugs at the site of the problem. Targeting the drug release to the precise site of need could allow existing drugs to impart the same benefits in significantly smaller doses – this could reduce side effects and minimize the burden on the patient’s liver and kidneys.

A medical device like the iPill raises a lot of interesting questions:

· Would a device taken orally which passes naturally through the digestive system be considered implantable for regulatory purposes?

· How much diagnostic data could the pH sensors and radio provide? How could that data be used?

· How much would the iPill cost (this question is especially relevant because it’s presumably a single-use device)? FiercePharma suggests that the iPill, “will likely cost around $1,000 a pop.” The Register confirms the $1,000 figure as the upper limit for the initial price, adding, “Eventually, though, the price could come down to about $10.”
o Once the price is determined, what conditions could justifiably be treated with the iPill

from a cost-benefit perspective?

· After usage, what disposal method(s) can be used for the iPill? Can it safely be flushed or should an alternate disposal method be used?

· Could this technology be used to treat other conditions?

· How much of an improvement does the iPill represent over existing drug delivery methods, if any?

I’d guess that the iPill will be classified as a Class III restricted medical device, which means that it wouldn’t be available in the US until it was approved by the FDA (if it even gets that far). But before the testing, evaluation, and approval stages, before discussing the finer points of regulatory law as applicable to this device, before making fun of the iPill for its silly, derivative name, step back for a minute and consider this:

We’re talking about a capsule the size of a standard pill that contains a wireless RF transceiver, a fluid pump, a drug reservoir, a pH sensor, a temperature sensor, a battery, and a microprocessor, a pill that tracks its own progress through the body, measuring acidity and broadcasting the data for diagnostic analysis, delivering its payload precisely where it’s needed most.

How awesome is that?