[Last issue we highlighted the emergence of Clinical Apps—smartphone apps that can contribute to diagnostic testing and healthcare. This issue we follow up with an in-depth look at the inception and design of such an app (and its related company), from the perspective of the developer and president, Sharon Cunningham.]
Smart Phone, Smarter Healthcare, and Better Health.
The Belleisle Bay is a scene of tranquility. Away from the cacophony of Yonge Street traffic back home, I was entranced by the gently rocking sailboats on the Saint John River. I met Sharon Cunningham, my hostess at the Pleasantview Hostel in Hatfield Point, New Brunswick, over a delightful breakfast of blueberry pancakes and tea. I learned that this tiny, picturesque hamlet is in fact an unexpected home to innovation in clinical smartphone technology, with Cunningham leading the way.
Sharon Cunningham is the President of ThyroMetrix, a company that aims to develop diagnostic tests to better monitor thyroid health. Thyroid diseases arise from an imbalance in the production of thyroid hormones (thyroxine and triiodothyronin) as a result of dysfunctions in the hypothalamus, pituitary gland, or the thyroid gland itself. Thyroid-stimulating hormone (TSH), which is produced by the pituitary, is often used as a screening measure: elevated levels of TSH signify low thyroid hormone production, whereas low TSH indicates that these hormones are in excess. ThyroMetrix has been marketing qualitative tests for thyroid dysfunction for many years. However, it is believed by many in the field that thyroid testing should occur more routinely than periodic doctor’s visits, since chronic thyroid dysfunction is linked to diabetes, cardiac diseases, and reproductive problems. “A single snapshot lab test result alone is not adequate for predicting long term health,” Cunningham explained. “We need a way to test quantitatively and frequently so that an individual would have an entire baseline of TSH values.”
Thyroid Disease Testing at Your Fingertips
Cunningham’s company has partnered up with Holomic LLC, a spinoff from UCLA’s Engineering School previously involved in developing Google Glass, to create a “smartphone lab” for immediate TSH testing that patients can perform themselves. Instead of having to send blood tests out to the lab, a drop of blood from a finger prick can be collected on a test card and read at home. The Holomic Rapid Diagnostic Reader (HRDR-200) is an “add-apter”—an accessory to a smartphone attached to the existing camera unit that can image test cards under LED-based illuminations in a special optical interface. The raw images are then digitally processed and analyzed by an app. Cunningham’s target market is in the US, where TSH testing for Medicare and Medicaid currently takes up 10% of the $6 billion lab budget. The idea is that harnessing smartphone technology to provide a rapid, non-invasive TSH test will save on laboratory costs, allowing revenue to stay within the healthcare system. Although the publicly funded healthcare system in Canada presents a smaller market, Cunningham still hopes to test her product in her home province of New Brunswick, where cost-effective diagnostic technology can save on public healthcare spending.
Developing a Clinical App: Strategies and Struggles for Funding Innovation
Good ideas need investment—be it public, private, or both—in order to get off the ground. As a native of New Brunswick, Cunningham’s home province provided an opportunity for her to launch her venture. “I needed a place where I would not be distracted and where there was a government mandate to support new tech businesses,” Cunningham said. In 2014, ThyroMetrix received $40,000 from the New Brunswick Innovation Voucher Fund; this program partners small-to-medium enterprises with scientists and engineers at the universities and research organizations in the province in order to produce R&D projects with a demonstrable commercial outcome. Through this program, Cunningham was able to engage the Horizon Health Network to undertake studies for the US Food and Drug Administration (FDA) approval. However, these east coast-specific government-sponsored programs are less helpful after individuals get their start-ups to the market. “No government program anywhere is going to take the kind of risks entrepreneurs need to take,” Cunningham explained.
…[D]igital technology will be a force in moving towards personalized health care, leading to easy and cost-effective ways of monitoring multiple biological parameters without repeated visits to the clinic….”
In addition to conventional funding sources, Cunningham attempted two largely unsuccessful internet crowdfunding campaigns. In retrospect, she believes that their message was too confusing and that they poorly defined their audience. Intellectual property also became an issue since ideas have to be revealed online in order to garner interest for fundraising. The lesson that Cunningham took away from this experience is that crowdfunding is a numbers game; a winning proposition usually requires you to have a strong partner, such as the American Thyroid Association, attached to the project already.
Balancing the Pros and Cons of Handheld Healthcare
The HRDR-200 is currently in the pre-submission process of its FDA approval application. Cunningham and her team have been working on a protocol for submission, and the FDA will likely provide feedback for further revisions. The hope is that the product would qualify for a Class II medical device that is subject to special controls such as special labelling requirements, mandatory performance standards, and post-market surveillance for professional use. Although the last few years have seen several forms of biomedical smartphone devices receive FDA approval, Cunningham aims to be the first to deliver rapid diagnostic testing on a smartphone.
However, rapid diagnostics understandably come with certain risks. As handheld devices are starting to become platforms for biomedical use, patient privacy and information security become paramount issues. In the US, the Health Insurance Portability and Accountability Act (HIPAA) requires that there are physical and technical safeguards to unauthorized access of digital patient information such as unique user IDs, automatic log-offs, encryption/decryption, and procedures for emergency access (standards that the HRDR-200 has successfully reached). Other policies and securities will need to be in place to protect data transmission and identify unauthorized alteration or deletion of patient data. The Canadian counterpart to HIPAA is the Personal Information Protection and Electronic Documents Act (PIPEDA), which—much like the European Union’s Directive on Data Protection—is much broader than just the scope of collecting healthcare information. As medical information becomes more and more digitalized, instilling trust and confidence in patients will be fundamental to whether these devices can be successful in the marketplace.
The Future of Rapid Diagnostic Testing
Reflecting upon the role of hand-held technology in health care, Cunningham is confident that “at-home” smartphone diagnostic tests will be the norm in the future. “Cardiac health has been monitored by telephone for at least ten years. It is a natural progression to move into apps,” she elaborated. “The fact that an app integrates patient involvement may provide better health outcomes.” Although some may be wary that increased patient accessibility could lead to misinformation and misinterpretation of medical information, Cunningham believes that smartphone diagnostics will improve interactions between patient and physician/health care worker to not only ensure timely diagnosis and treatment, but also provide patients with more information on their health. Indeed, digital technology will be a force in moving towards personalized health care, leading to easy and cost-effective ways of monitoring multiple biological parameters without repeated visits to the clinic and prolonged waiting times for results. When asked to reflect on the emergence of cost-effective, hand-held bioassay development, Cunningham is optimistic about the current landscape of health technology. “The whole healthcare system will be smarter,” Cunningham concluded, “and we will all be much healthier.”
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