KNOX Medical Diagnostics Wants to Let Patients Test Their Lungs at Home

The explosion of smart phones over the last decade has paved the way for an industry of personalized and portable medicine. The combination of smart phone technology and cloud storage is rapidly bringing once expensive medical diagnostic tools to the personal consumer, with everyone from tiny startups to tech behemoths such as Google and Apple getting in on the action, and recent UCSF startups are no exception.

One such UCSF medical diagnostic entrepreneur is former UCSF biomedical imaging master’s student Charvi Shetty. She started KNOX Medical Diagnostics, which is working to develop a home version of the spirometer, a device used to measure air flow. Her team includes software engineer Huyson Lam, hardware engineer Inderjit Jutla, and UCSF pulmonologists Drs. Ngoc Ly and Kensho Iwanaga.

A Medical Need

Spirometers are used in the clinic to measure lung capacity and airway tract obstruction, most often in asthmatic children. The current inexpensive, home-based alternative is the peak-flow meter, in which a patient blows into a tube forcing a ball to rise. According to Shetty, these devices are inaccurate. On top of that, Shetty said that children’s desire to please often results in cheating, which leads to false readings.

“Currently people use home peak flow meters that are cheap but inaccurate,” Shetty said. “Spirometers in the clinical setting can cost over $2,000 and that doesn’t include the laptop you have to buy or the lab tech you need to hire.”

Creating a product that can collect clinical grade data at a fraction of the price was the challenge facing KNOX. They have now built a handheld device that interfaces with a mobile app via Bluetooth. The app can not only record data collected using the device but assay the data’s quality. The app also provides initial instructions as well as real-time feedback to the user on ways to improve blowing technique for optimal data collection. Shetty believes the production cost can be reduced to $20 dollars per device and an overall retail price of $200.

Starting the Company

Shetty entered the UCSF Masters of Science of Biomedical Imaging Program in 2012. While working with a team of students, she was introduced to Dr. David Van Sickle, an epidemiologist and CEO of Propeller Health, who explained challenges in diagnosing and treating asthma. Shortly thereafter, her team began working with the UCSF Pulmonary Function Testing Lab. Interviews with patients there validated the clinical need for a home spirometer, so they began trying to develop one.

During this time, Shetty also took three popular UCSF entrepreneur courses that she considers key in starting her company: Idea to IPO, Lean Launchpad for Life Science and Healthcare, and Financing New Ventures. In 2013 Shetty was a finalist for the UCSF Early Translational Research Catalyst Award. Soon after, she incorporated KNOX through QB3.

The Future

Shetty plans to sell the device as a research tool to hospitals where it can be directly compared to clinical spirometers. To this end she has begun partnering with the UCSF pulmonologists Ly and Uwanga, who plan to benchmark their device with spirometers in their clinical trials. Fortunately this can all be done without FDA approval. Eventually, after getting FDA approval, she plans to market the device directly to consumers.

Shetty does not plan to stop with home spirometers. “We’re leveraging software and hardware to enable patients to use the device without a lab tech by providing the analysis and troubleshooting through the app itself. To expand this, we want to take any kind of medical device that currently requires a lab tech and bring it to the home setting where you can collect clinical grade data.”

Partnering with Healthcare, Technology, and Big Data

Currently, Apple is positioning themselves as a health data warehouse through their  expanding HealthKit line. Ultimately, Apple and other tech companies want to act as the hub for relaying patient information from patients to physicians through web-based portals.

Shetty explained, “Apple is currently building up its healthcare line. Spirometry is one piece, but they don’t have their own spirometer to collect the measurements. They are partnering with large institutes like the Mayo Clinic. Their physicians are asking for it (spirometers). They approached us and wanted to help with the user interface and design.”

Shetty said that Bayer and Genentech have also expressed interest in using the technology as a remote monitoring tool to drive up their own patient enrollments.

Currently, the data collected is sparse and often incomplete. Patients are treated by relating a few data points to a general model. However, Shetty pointed out that more data points means that patients can be monitored in real time.

Shetty said, “Some people travel up to 3 hours [for a spirometry test]. [Our device] would give the physician the opportunity for real-time patient monitoring rather than the lag time that can stand between office visits. We can see if a medication is working in a couple of days or weeks rather than months or a year.”

Start-up Life

Between product development, fundraising, and refining her business plan, Shetty keeps a busy schedule. One recent day began with a 6 a.m. meeting with an investor on the East Coast and continued with additional meetings, working with her team on product assembly, and a Berkeley Launch Event Accelerator Program in the evening. For Shetty, working from 6 a.m. to midnight is pretty common, and 2 a.m. or even 6 a.m. is not unheard of. Working weekends is a must.

Shetty admitted, “It does consume much of my time and gives me less time with my friends and family. Finding that balance is a challenge.”

Despite her long hours, Shetty remains upbeat and energized. “I don’t even drink coffee. I am just running on the adrenaline and passion I have for this company. The reason I stayed away from the research side is that I want to directly impact lives in a couple of years rather than decades.” Shetty advises that people learn from their mentors. She credits much of her initial success to the UCSF QB3 Lean Launch Pad course she took from Allan May, chairman of the Life Science Angels. She says that it is important to learn from someone who has done it before and has insight into your specific field. Shetty was new to the world of business and says that the her master’s program and QB3 family were both very helpful.

Shetty emphasizes, “We (initial team members) were all engineers of some sort and had no idea about starting a company.” For Shetty, those days are rapidly fading into the background as she positions her medical diagnostics business for success.