Companies like Cellnovo represent the key role IT is playing in the evolution of medical devices. UK-based Cellnovo began in 2002 as Starbridge Systems Ltd. to develop a novel micropump with only one moving part that made it smaller, more accurate and less expensive. Somewhere along the line, their conventional medical device transformed into a mobile health offering. It now consists of:

1. Pump: A small, waterproof device that can be easily applied, removed, and repositioned on the body. Also includes a built-in accelerometer that registers and stores user activity data.

2. Handset: A hand-held device that communicates wirelessly to control the pump and sends data to a secure website. User can manage dosage, schedule, log supplemental data like food intake, activities, emotions, etc. through this device. The look-and-feel has been compared to today’s appealing smartphones with icon-driven intuitive graphical display and touch screen ability.

3. Online: Websites customized for various participants that are usually involved in managing diabetes- provider, patient, caregivers, etc. Given the variety of people that can be involved in the care team (primary doctor, dietitian, diabetes nurse educator, eye doctor, foot doctor, endocrinologist, exercise trainer…), communication and coordination is an often under-served part of diabetes management. Seems like Cellnovo Online is an attempt to improve just that.

The overall concept is not new. OmniPod by Insulet Corporation (a public company) has a pump and handset. Big players like Medtronic, Sanofi-Aventis, J&J have shown signs of moving in similar direction. With the February 2011 series B financing round of $48.4 million, Cellnovo also seems to have enough runway in this space. As an interesting aside, combining insulin pumps with Continuous Glucose Monitoring System (CGMS) makes a terrific combo- uninterrupted sensing and coordinated, intelligent drug delivery. OmniPod does this.

Solutions like Cellnovo provide not just a way to deliver therapy, but a novel way to collect detailed data about given patient population. Analyzing aggregate data like that can lead to insights at multiple levels- clinical evidence (EBM), provider performance, population health, etc. An interesting decision fork in this evolution would be whether manufacturers leverage commercial computing hardware like smartphones or create their own (like Cellnovo). The former gives wider reach, while latter provides better, medical-grade control (something that FDA probably mandates).

But the key point in all this is about the future of traditional consumer medical devices. The next-generation devices seem to be less conspicuous, continuously connected, more personalized and come with an integrated online component that becomes the window to interaction with multiple parties (caregivers, friends, insurers…like an evolved, niche form of social networking). The new value proposition doesn’t stop at just a hardware device, but becomes a continuous service for managing chronic disease.

One can argue that managing all chronic diseases requires understanding an ever-changing constellation of information continuously generated by a whole ecosystem of participants. This ever-connected disease management approach that removes the burden of keeping journals and pushes information to healthcare professionals can to be applied to many diseases besides diabetes. I’m sure a number of those are already underway.

Here is a simple overview of their offering: pay $500 to be tested for 10 common conditions or upgrade to $2,500 for all conditions (28 currently). The upgraded package has perks of genetic counseling, personalized updates and educational content for a year.  Beyond  that you pay $250/year to keep it going. What sets Navigenics apart (as I understand) is that they only tell you your results from the perspective of these 28 (and growing) conditions whereas others (deCODEme, 23andMe) let you ‘explore’ your results for every trait/condition they are continuously covering.

Regardless of what company it is, the question remains that how much can you learn from you genetic profile? If you are at 64% risk for Diabetes type 2 and 47% risk for macular degeneration, what can you do about it?  Well, the advice would mostly include one or more of- exercise,  dont smoke, eat healthy, avoid alcohol, sleep well, vitamins, lookout for warning signs etc. So why get the test; you should be doing all that anyways. I’m not knocking down genetic testing per se, just trying to find utility for it in a DTC model.

The future of healtcare is more personalized, for sure. I’m happy that the commercial foundation for it is being laid down right now. But personally, I wouldnt invest in these services till we firmly and clearly establish an end-to-end causal linkage between genes, diasease, and therapy. We havent even agreed on how important is the role of enviornment and habits (is it only genes that determine a disease outcome?) Heck, who said it’s genes- what about proteomics?

There is no doubt that our genes hold valuable information that can help predict and treat diseases. There are a number of success stories like Warfarin Senstivity, Herceptin Treatment as well as failures. Unregulated advertising that often tends to exaggerated around the connection between genetic informtion and disease risk is what turns me off though. As always, the commercial industry is one step ahead of itself. Maybe all these early-adopters will help bring enough money into the field and the list of clinically proven (and FDA approved) applications of genetic testing will grow rapidly.