Kai Worrell had a vital moment of clarity in the midst of a high profile cardiac rhythm management consulting project.
“It became evident that the cardiac device industry shared an enormous problem,” says the President of Worrell Design, a 37 year old international product design and development firm headquartered in Minneapolis.
“At the end of the day, lives were at stake.”
There are millions of people in the US and beyond with cardiovascular diseases, which often times necessitate sensitive implantable devices known as defibrillators, pacemakers and biventricular CRT devices.
Worrell’s consulting capacity typically centers around the design and human factors engineering of such critical technologies, but now they’re taking it one step further with Geneva Healthcare, a new big data software spin-out.
“If there’s anything going on with these patients, that is, whenever they come into an emergency room, clinic, or operating room, the first thing that a doctor will do is pick up the phone and call the sales rep on behalf of the manufacturer,” says Worrell, explaining how makers such as Medtronic, St. Jude, Boston Scientific and Biotronik are acting as the default go-to support provider to their products.
“Clinicians typically do not interact with the device for a variety of reasons, and the specialist who performed the procedure is unreachable more often than not, so it has become a ‘service burden’ for the device manufacturer to chase these patients around,” Worrell says in describing the precise pain point.
“We thought, if we can make this data easier to access and understand, that would solve a range of problems for patients, providers and manufacturers right out of the gate.
Geneva Healthcare has developed a visual dashboard displaying data of all makes and models of implantable cardiac devices across the silos, tying it all into one place. Device specifics and patient vitals are updated in real time directly from the implant itself through remote monitoring techniques.
A physician or similar care provider can take the reading from the device on the spot and observe it through a HIPAA compliant mobile browser experience, which includes EHR integration. It’s also easily accessible by the cardiac specialist, trained to translate readings to other stakeholders.
Worrell maintains that this approach enables them to review more patient data in less time. In terms of re-admissions, the potential to better monitor factors such as heart rate variability, blood pressure, weight, etc. allows for the specialists to be more pro-active about their patients using data analytics.
The hospitals contract with Geneva directly, paying a software subscription fee for access, but because it’s shifting the expense off the manufacturer to the hospital, reimbursement can be captured.
“Nobody has been sharing the device data with one another, not even the patient,” Worrell says in astonishment. “We’re already working directly with the clinicians to make this much more open and accessible to improve clinical and economic outcomes.”
Geneva has been collecting data from thousands of patients so far, with implementations throughout a handful of hospitals in San Diego, including UCSD. Worrell believes that the market for a product like Geneva is ripe in the US, a $300m market, not counting Europe and Asia.
“Our experience shows that the speed at which these unique patients can be serviced increases significantly, without having to contact a specialist or service rep. It can turn hours into minutes while potentially identifying a life or death situation much faster.”
Geneva was formed by Kai and two other partners in the venture – Cardiac Electrophysiologists Dr. GilAnthony Ungab and Dr. Manish Wadhwa, both from San Diego. “These are EP’s intimately familiar with the industry and the problem,” Worrell says. The collective team includes a dozen or so — executives, design and operations. Next steps for Geneva include a patient portal which will enable those who have pacemakers or defibrillators to view and understand the data on their own terms.
“Because we’re starting with implantables, we’re coming at this from the highest level of acuity possible. There’s certainly a lot of class 1, class 2, and wearable technologies that Geneva Healthcare may some day address.”