We recently had the opportunity to interview Dr. Dave Albert, the founder of AliveCor – which just announced earlier this month that it raised $3 million in its first round of funding – and inventor of the iPhone ECG, about his plans for releasing the product as well as his general views of the medical device space.
Shiv Gaglani, Medgadget: Congratulations on your successful and healthy first round of funding. When do you expect to receive FDA and/or CE approval for the iPhone ECG?
Dave Albert: We will be CE Marked when we start production in the fourth quarter (Q4) of 2011, as our manufacturing partner is CE self-certifying and we are in the testing process and quality system validation process. FDA 510(k) approval will come afterwards and we suspect that will be in 2012.
Medgadget: Once the iPhone ECG is approved, do you have an idea of how much consumers will be able to purchase it for?
Dave Albert: Less than $100 at retail. Similar to what you might pay for a high end consumer blood pressure device
Medgadget: Who do you expect to be your primary consumers (physicians, medical groups, patients, etc)?
Dave Albert: Physicians, first responders and other health professionals (nurses, med students, PAs) will make up one of our markets and they will use the device on others. Consumers who want to monitor their own cardiac rhythm will be a potentially far larger market.
Medgadget: What are your views on the July announcement by the FDA to regulate certain mobile medical technologies?
Dave Albert: The iPhone ECG and our other products have always been considered “medical products” which are regulated by the FDA under the 510(k) program as Class II devices. We are not involved in making non medical products so we always believed that we would apply for FDA marketing clearance and all that entails.
Medgadget: How will the iPhone ECG and other AliveCor products currently being developed relate to other mobile-based technologies such as the Basis Watch and Fitbit? Are those devices competitors or will they integrate with your vision?
Dave Albert: The Basis watch and the Fitbit (and others) are personal health and fitness products while our device is a medical product which allows the diagnosis and monitoring of cardiac rhythm disturbances. Those devices cannot be used to do what the iPhone ECG does and it is not a fitness monitor (yet).
Medgadget: You have said that tablets in general, and the iPad in particular, will be the main clinical device in the near future, as opposed to current interfaces and the smartphone. What is your overall vision of how healthcare will be delivered in the future?
Dave Albert: Healthcare in the US has to get less expensive on a per patient basis. There is no way that cannot happen, so technology which may be disruptive to current solutions will inevitably become the norm if it can deliver what is needed at a lower cost.
Medgadget: As a serial entrepreneur (having sold two of your companies, Corazonix and Data Critical) and physician, do you have any specific advice to other aspiring inventors of medical gadgets?
Dave Albert: Make sure you understand that healthcare is changing. The “how” and “who” of healthcare payment will change from “reimbursement” to personal “payment” and that will be disruptive and will create great new opportunities just as it will threaten old business models.
Medgadget: Thank you for your time, Dr. Albert. We look forward to the release of the iPhone ECG and other AliveCor products currently in development.
Flashbacks: iCard ECG Turns Any iPhone/iPad Into a Powerful Electrocardiograph ; ECG Attachment for Your iPhone