Brianna Wronko, Group K Diagnostics, on the highs and lows of starting a biotech company and navigating the regulatory world for medical devices.
Imagine you are a patient with a chronic liver disease, hence, you visit the doctor every six months. Every time, your physician requests a series of tests to evaluate your liver function. You need to schedule the test ahead of time and plan to get the bloodwork done before your doctor’s visit, so that your physician has the results in hand when you show up at her office. The truth is that this coordination rarely flows smoothly. You might get caught up in other things and forget to get your liver function test done before your doctor’s visit. Your insurance plan will likely limit your testing facility options (sometimes to only one), making scheduling more burdensome. Or you plan everything perfectly, and the results still have not reached your provider by the time you arrive at her office.
Physicians, who often spend 1–2 hours every day releasing test results and calling patients, are also burdened by the inefficient workflow. In fact, 36% of abnormal test results never even return to patients. Miscommunication is an immense problem for the US healthcare system — 40% of medical cases involve a communication failure, which costs the system a total of USD $1.7 billion in malpractice costs and about 2000 lives every year.
Diagnostics is one of the most critical areas of medicine — 70% of medical decisions are based on diagnostic test results, but only 2% of the U$2 trillion healthcare expenditure goes into it every year. In fact, Brianna Wronko, founder and CEO of Group K diagnostics, would argue “it is more important to diagnose things early than to treat a condition once it has already developed.” After working for a number of years in microfluidics and diagnostics, Brianna developed a point of care solution, the Kroma Health Kit, a paper microfluidics-based finger prick test that aims for metabolic and molecular biomarkers to be analyzed in 20 minutes with a mobile application. Like a glucometer, the finger prick test requires minimal training, and does not demand table space, refrigeration, or calibration.
Her model envisions that the almost instantaneous blood test during the doctor’s appointment together with a physical exam will inform patients’ treatment regimen. Aside from not having the burden of arranging tests ahead of time, “you walk out of the clinic knowing what adjustments need to be made to the treatment plan.” Rapid test results not only contribute to more efficient monitoring of disease and adaptation of therapeutic regimen, but also provide greater peace of mind to the patient who no longer waits days before knowing how his/her condition is progressing.
From student researcher to CEO
Brianna founded Group K Diagnostics as a senior at University of Pennsylvania.
“You can’t solve a problem if you have not seen or been involved with that problem,” she recognizes.
Working in a local HIV clinic, Brianna identified the need for point of care solutions for lab results.
“My original idea was to create a device and publish it in a medical journal, so somebody else carried it on.”
However, a mentor warned her that only publishing an article would not guarantee the device would have real-world impact. Even though academics are vital to innovations and advancing the field, he argued that if Brianna wanted the device to reach the patients who needed it most, she would have to think about its commercial use. So on Valentine’s Day of 2017, Brianna dove into an entrepreneurial adventure, “without knowing what [she] was getting [her]self into.” Along the way, Brianna has grown into a businesswoman, and is motivated daily by the possibility of impacting even just one patient.
Being a student entrepreneur does not come without its fair share of challenges, but Brianna claims it is “totally possible, as long as you manage your time wisely. Know what your priorities are; know that you will miss out in several parts of college life and that you will be [exposed to] ‘adult real world’ very quickly.”
On the other hand, students often find more open doors for conversations, and can benefit from the proximity to professors and entrepreneurship resources available at the university. Like many other founders her age, Brianna recognizes that people might not take students very seriously, and are wary of them having to split time between studies and company building.
Gaining credibility: Let Science Speak for Itself
“You are blonde, you are the CEO of a diagnostic startup that uses finger prick tests, you MUST be Elizabeth Holmes,” Brianna has been told.
She confesses she has had to fight the stigma of Theranos again and again, but is confident that Group K’s science can speak for itself. Unlike Theranos, which has been charged with “massive fraud”, Group K welcomes the critique and feedback of the FDA, surrounds itself with experts, and is not searching for a loophole to deploy tests without regulatory approval.
Brianna argues that good science is necessary to show a product is accurate and feasible. Hence, she invested time in gathering data to prove Kroma Health Kit’s viability; this attracted Group K’s initial investors, most of which were scientists and physicians. These first supporters were able to examine the product closely, and they then spread the credibility of the device to the scientific community and investors.
Nonetheless, Brianna urges young founders to get involved with their communities.
“Just because you are young it does not mean that you don’t have something important worth sharing or that your voice is not valuable.”
She shares how she got involved with her own community by sharing her successes and pitfalls and getting close with other biotech founders, striving to make Philadelphia more of a home for startups.
Navigating the Regulatory world
Brianna deconstructs the myth that the regulatory world is dreadful. Through her experience thus far, she insists that the Food and Drug Administration (FDA) has developed clear protocols, which help prove a new device is comparable to current standard of care.
“If you follow in detail the FDA guidelines, you should be able to evaluate the accuracy, reproducibility, sterility, shelf-life, specificity, sensitivity and other parameters of your device.”
She also shares that the FDA has not yet developed protocols for machine learning, which she is working to incorporate into the Kroma Health kit, making the regulatory process for that portion of the solution less clear. Yet, Brianna emphasizes that machine learning is the future of healthcare, and that FDA will likely release a pathway soon.
In addition, Brianna has been able to count on a patent attorney who is specialized in microfluidics, which has made her life “a lot easier.” She has filed for patents on the company’s automated manufacturing process, the device’s case, assays, and design. As a result, her strategy evolves as new regulations emerge and other works come into the field.
She advises other entrepreneurs to spend money on patents and trademarks, since you only have one year after the creation to file them, because “at the end of the day, a company’s uniqueness comes from its intellectual property.”
She underlines that patent law is an extremely broad subject, that no one will likely ever master it fully — therefore, interviewing several attorneys who specialize in the space you hope to act on is important to ensure you are being well-advised.
Because the process is not straightforward, Brianna does not leave it all for attorneys to figure out, and she urges other women seeking FDA approval for their medical devices to “read, read, read, and read some more.” She advises that reading all guidelines applicable to your product is essential to follow the FDA pathway correctly, and submit an application in excellent shape for approval. Guidelines must be purchased from their organizations and each costs hundreds of dollars. After an iterative process of reading codes and the ones each code references, you will have a better understanding of where your body of work lies, and will be able to focus on the specific codes and layouts to your company.
Brianna’s story reflects her “all in” mentality. As a sole founder, she jumped into entrepreneurship as a college student to become a protagonist in revolutionizing diagnostics by committing herself full-time to improving lab testing experience for patients and providers. In addition, she feels fulfilled by the impact her work generates, creating jobs in her community, and above all, the prospect of making point of care lab testing easily available to the patients who need it most.
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Story written by Luiza Perez and Priya Kumar.
