Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Mobile Health’

Following on from my blog post last week that discussed the use of iPads and other tablet computers in clinical trials, MIM Software have just received FDA 510(k) clearance to market their iPhone and iPad medical imaging app in the United States. This is the first such approval by the FDA, and the app will be sold in Apple’s itunes store.

This new mobile radiology application will allow physicians to review medical images on their iPhone and iPad.  The FDA in their press release indicate that it is not intended to replace full work stations, but to provide the ability to view images and make diagnoses when a workstation is not readily available.

The FDA reviewed luminance, image resolution quality, and results from demonstration studies with radiologists that showed that images could be safely interpreted for diagnostic purposes under appropriate lighting conditions.

What is more, using software from MIM, the images can be further analyzed and distance measurements made.

The ability to have wireless access to medical images will be particularly useful to physicians working remotely, in emergency situations and in clinical trial networks where the central imaging review facility may not be local.

As the screen resolution of iPad’s and other tablet computers increases, perhaps we will see advanced visualization software available on the iPad?  It is certainly an area where innovation is taking place, and one that I think will impact clinical research in the biotechnology industry before too long.

The theme for the biotech strategy blog this week is innovation in bringing new drugs and devices to market.  Innovation is the lifeblood of the biotechnology industry and what drives the acquisition of companies for their pipeline by large pharma companies.

Tomorrow I will be at the Innovation in Healthcare Symposium at MIT in Cambridge, MA. See my earlier blog post for further information. I look forward to writing about the Symposium later this week.

One experienced industry professional recently told me that he believed the Ipad would revolutionize the clinical trials process.  Do you agree? On reflection, I think the IPad and similar tablets will make the clinical trials process more efficient, but is this an innovative breakthrough that will revolutionize the model? I am not so sure.

At this year’s Consumer Electronics Show in Las Vegas, analysts talked about the 80-100 new tablet computers that were on show, and the fact that an estimated 50 million e-books and tablets will be sold in 2011.  Companies have clearly innovated in bringing new technology to market, that we now have a desire for and want to use.

Health Professionals have embraced the IPad, it’s ease of use, portability and potential for a range of uses from data entry, to the viewing of medical images and access to online reference databases.  In the hospital environment, it can easily be integrated into the IT infrastructure and made HIPAA compliant if no data is stored on it.

For clinical trials, it is already being as an electronic data capture (EDC) interface for case report form (CRF) data entry, although I am not sure whether it will become the primary interface. My expectation is that IPads and similar tablets will increasingly be used as a portal for accessing study resources, the ordering of supplies, recording of adverse events and even the signing of patient informed consents.

I also expect we will see IPads being given to patients for clinical trial diary and journal entries. What’s more by using these devices with 3G wireless capability, study coordinators will be able to interact in real-time with patients, remind them of study visits and monitor medication compliance. Mobile health is set to be a real growth area.

On the medical imaging side, results from a clinical trial published at the Radiological Society of North America (RSNA) annual meeting last December showed that radiologists viewed the IPad imaging quality as equal or superior to standard LCD displays when viewing X-rays. (Erik Ridley wrote up a good post about this on AuntMinnie.com).

Reviewing X-rays to screen for TB is a lot different from diagnostic imaging in clinical trials, so I remain unconvinced that the IPad will take over for primary diagnosis, and central review of images is still going to be the gold standard.

What I think the IPad and other tablet computers will do is allow the easy sharing of images between the central review laboratory, investigators and study coordinators. This will make it easier to monitor patient inclusion, study progress and report imaging results.

So looking at the above, while I think the IPad is an innovation, I don’t necessarily think it will revolutionize clinical trials and bring products to market faster.  It will be interesting to see what industry professionals have to say at the Drug Information Association (DIA) annual meeting later this year.

What are your thoughts on how innovation will change the clinical trials process in the biotechnology industry? How can we bring products to market faster?

error: Content is protected !!