Telltale heart monitor
December 16, 2016— Burlington, Ontario
Every seven minutes, a Canadian dies from heart disease or stroke. Many of those deaths are preventable, says Sandy Schwenger.
In 1998, Schwenger and a co-founder started their first entrepreneurial venture, PatientCare Solutions. To test market needs for mobile technology, they undertook a feasibility study, supported by the National Research Council of Canada’s Industrial Research Assistance Program (NRC IRAP).
That study confirmed that devices equipped with mobile applications could overcome some challenges in fighting Canada’s second- and third-ranked killers: heart disease and stroke. So, in 2010, they formed a sister company, m-Health Solutions, to instantly record and wirelessly report irregular heart rhythms.
Again, they sought IRAP’s help. This time, support ranged from business analysis and technical advice to financial assistance and regulatory guidance.
Never miss a beat
Traditionally, family doctors referred patients to hospitals, clinics or cardiologists for cardiac diagnostics. After lengthy waits, patients would get summoned to have a medical professional attach a Holter monitor. Holter monitors would record for a mere day or two, during which time problems might not show up. Data would get analyzed only after patients returned to have monitors removed.
By contrast, m-Health Solutions developed m-CARDSTM— a service and technology seemingly straight out of science fiction—that speeds up the process and cuts down on in-person medical visits. When a patient visits a doctor and complains of potential cardiac issues, that doctor can initiate testing immediately. The doctor applies two electrode patches on the patient’s chest, explains what to expect and what to do in an emergency, and the patient leaves. Within two days, patients receive an m-CARDS diagnostic kit by home delivery, anywhere in the province. Inside, video instructions show patients how to finish the hook-up in the convenience of their own home by attaching a heart recorder to the patches and wirelessly connecting a customized, secure BlackBerry phone.
For two weeks, m-CARDS monitors every heartbeat, transmitting all irregularities directly to remote cardiac technologists. They analyze incoming data, flagging issues that arise. Cardiologists can securely review the data from anywhere, any time, and quickly send diagnoses to doctors. Later, patients ship the kit back in a postage-paid envelope.
An obvious need for m-CARDS is for diagnosing Canadians living in remote communities without resident cardiologists. Yet, its simplicity makes m-CARDS equally important for urban populations hindered by disabilities, wait lists, a lack of transportation, and more. The Canadian solution also benefits patients fortunate enough to survive mini-strokes (TIAs) or strokes of unknown cause. Using m-CARDS, these patients can be monitored to determine if a treatable condition called ‘silent’ atrial fibrillation is the cause.
As IRAP’s industrial technology advisor for m-Health Solutions, Carol Slama’s experience with health technologies led her to identify market needs, propose strategies for reaching rural doctors, and share opportunities for complementary partnerships with companies, universities and colleges.
"I also engaged my colleague Lisa Boreanaz’s help for regulatory expertise," said Slama. Federal regulators require that medical devices, including software, comply with standards for quality processes and management systems. Boreanaz recommended ways to create compliant policies and procedures, and reviewed documentation.
Results in a heartbeat
Achieving that compliance opened up markets for m-Health Solutions. More than 40,000 diagnosed patients later, Schwenger enjoys hearing patients say, “This kit saved me.” Plus, she noted, hundreds of physicians appreciate the convenience and speed for giving patients answers.
What’s next? Expanding m-CARDS beyond Ontario to give more Canadians access to efficient, mobile diagnoses. Alberta’s Health Services will begin an m-CARDS™ demonstration project in 2017. Schwenger sees faster diagnoses translating into healthcare savings. Thanks to m-CARDS, fewer Canadians will require hospitalization for heart disease and stroke, which are estimated to hospitalize 350,000 Canadians annually, accruing $21 billion in healthcare costs and lost productivity.
Healthier Canadians and cost savings tell the tale of another IRAP-supported company applying technology to solve socioeconomic problems. "We could not be where we are today without IRAP’s funding, its staff’s collaborative attitude, and support for our certification process," said Schwenger.
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