Let’s Talk About STDs
Making Testing Accessible
Hey, I’m Kanoa! I joined SEP in Fall 2017 as part of the Nu class and have loved every day that I’ve been a part of this organization. From various excursions to late-night talks, I’ve made some of the deepest friendships that will last a lifetime. It’s just a bonus that people are entrepreneurial.
What I’m Working On
My team and I are creating a point-of-care microfluidic device that can process up to 10mL of urine and provide a smartphone-based readout for Chlamydia in under 30 minutes. We call ourselves CleanSlate.
There are a ton of scary health facts that surround Chlamydia:
- Almost 1/10th of the world is infected with Chlamydia, and recent years have seen a significant spike in transmission.¹
- The Center for Disease Control (CDC) estimates that each year in the US, 20 million new STI incidences will be reported, costing an annual sum of $16 billion in diagnostic services and treatment. Specifically for Chlamydia, the US reports 2.8 million² new cases annually; however, this is an even greater burden in developing countries with 131 million³ people diagnosed each year.
And the big one:
- Upwards of 70% of affected individuals don’t show symptoms which can lead to infertility, ectopic pregnancies, and pelvic inflammatory disease.³
Here’s a short timeline of how we came together.
Fall 2018
I enrolled in a BioMEMS class led by Dr. Luke Lee, where we were assigned a group project to use the fundamentals of microfluidics to design something novel. As a group, we rallied around the central idea idea of an STD detection device. We iterated on various designs, but kept running into the same wall: how could we concentrate the bacteria within the microfluidic device itself? After ideating for weeks on different ways the user could pre-process their own urine sample, Dr. Luke Lee was adamant that we limit the amount tasks that the user must perform. Eventually, he told us about a concurrent project he had been developing for years to allow for bacterial enrichment via a microfiltration device, so we immediately hopped onto figuring out how to optimize this to enhance the user experience. Since then, we’ve been putting our heads together in the lab, trying to bring this project to life. It was during this semester we were also encouraged to apply for UC’s Big Ideas, NSF I-Corps Regional Node, and UC Berkeley’s LAUNCH Accelerator, which we are currently participating in.
Spring 2019
Over winter break, we tried to prepare for the upcoming semester by reading scientific literature and writing out our methods in advance; however, no amount of pre-planning would make us ready for the semester to come. This semester, we’ve driven ourselves crazy tackling business development and technical development simultaneously. At times, we’ve felt overwhelmed — actually, we still feel overwhelmed on a daily basis. But it’s been a growing process, and we’ve persevered through maintaining a strong team dynamic. Shoutout to my teammates Mehek Mohan and David Mai!
From pledging with Sigma Eta Pi, I learned how to take an idea and bring it to life via one word: HUSTLE. But there is something magical about learning from the brilliant people we’ve met at UC Berkeley’s LAUNCH. Shoutout Rhonda, Darren, and Andre! Having worked in various parts of industry, they were able to share a wealth of knowledge to help us plan product-to-market strategy. After countless chats, our team feels like they’ve actively gotten to know us on a personal level and are altruistically invested in our growth personally and professionally. For an undergraduate team of 3 members with technical backgrounds, I’d say we’ve gained more business acumen by taking ourselves out of the lab and talking to potential customers. It taught us more about hustle than any business class could.
On the technical side, it’s been pedal to the metal. Trial, error, analyze, tweak, retry. It’s been a long, iterative process, which is to be expected. We’re currently in the process of filing a patent through UC Berkeley’s IPIRA office and an accompanied manuscript soon to follow.
Future
Who knows. The biggest issue with entrepreneurship is there is no predicting the future — you just do your best to prepare. We’re looking to register as a company very soon, which will open up new doors for potential funding. With funding will come opportunities to bring in new talent and grow. As far as device development goes, we’re looking to incorporate a panel of tests: Chlamydia, Gonorrhea, Urinary Tract Infections (UTI), etc. So with incoming changes, our business model will require adjustments as well. One of the biggest looming concerns has been preparing for FDA regulations, for which we are still seeking guidance.
For any aspiring biotech entrepreneurs, I’ve included a few pieces of advice that I learned this past year.
Outlook on Entrepreneurship in Biotech
- Be VERY patient.
Developing an MVP takes years and novel scientific discovery. An idea must be validated and repeatable before it is considerable to be an viable as opposed to industries where an MVP is subject to change where there is product-to-market fit. Given the slow nature that surrounds biotech, we would have lacked credibility going into accelerators had it not been for the strides made in Dr. Lee’s lab prior to our arrival. Some numbers to keep in mind. On average, it takes 10 years and $2.6B to get a drug onto the market as opposed to the 3–7 years it takes for medical devices.⁴
2. Communicate.
You need to have the hard talks as early into the venture as possible and promote an open feedback culture. Establish the solid foundation. Ask people’s commitments and hold them accountable. Especially within STEM, your classes will take a hit, so make sure to plan accordingly. My personal opinion: make sure to like your team because you’re going to spend a TON of time with them.
3. Seek out hands-on experience.
Biotech is a huge field, and becoming an entrepreneur in this space requires a deeper understanding of various aspects of experimentation and theory. Study whichever topics you think are fascinating and results will come. Always look for opportunities to get your hands dirty. A great example of this for me was comparing taking organic chemistry classes versus conducting research. Solving multi-step synthesis problems was fun on paper until I stuck my head in a fume hood 6 hours per day for research. My viewpoint is that having a vast knowledge of different concepts will allow you to figure out what you’re passionate about and allow you to have a greater toolbelt when it comes time for innovation.
4. Find mentorship.
We would have been a group of lost nerds had it not been for the amazing mentorship we’ve received. These people are called professionals for a reason — use them. They will provide guidance, prod you at specific intervals, and seek out answers to questions that you have. If you think you have a great idea, seek out validation. Apply for hackathons/accelerators, talk to professors, or even just cold email people who you think are interesting! Huge thank you to our mentors Cathy Farmer, Liz Klinger, Ioana Aanei, and Rhonda Shrader!
5. Stay grounded.
There will be times where you feel like the next Steve Jobs, and others where you feel like Elizabeth Holmes (not good). You need to be the first person to rain on your own parade, and the first person to cheer yourself up. Trust me, there will be great days and terrible ones. Just be ready for the ride.
Things to watch out for:
The excitement:
- If you successfully explain your innovation to people, they will naturally get excited listening to your pitch. Speaking intelligently about your product is essential to gaining public trust and might require using concepts that the general public isn’t too familiar with. People love hearing about deep technology applications due to the ‘Wow Factor’ and investors will give their early attention out of FOMO. This should be used as a measure of your ability to convey a dense concept in layman’s terms rather than traction. Still an accomplishment nonetheless.
The criticism:
- It might sound contradictory, but you want criticism more than compliments. If an investor is interested, they will try to poke holes at the proposed innovation and its potential impact. Especially for undergraduate founders, they will question your intentions to continue working on the product and your technical ability to actually deliver. Prepare for these questions, and don’t be discouraged from them.
Talking scientific:
- When someone does their due diligence, they will attack specific parts of your scientific claims. Be precise with your answers. When unsure about an answer, either preface the answer with your degree of certainty or state that you don’t know. Never give a blatantly wrong answer. I cannot emphasize enough, there is power behind saying the words “I don’t know” as long as you seek out the answer at a later time.
Regulatory demands:
- A surefire way to lose someone’s trust or interest is by not knowing the current standard of pre-existing technology or the regulations the current market you plan to enter. Know your direct competitors, and have a good understanding of the their technology. Your competitor analysis should be two-pronged: the technology and the business model.
Business model:
- It’s easy to get lost in the secret sauce that is your innovation, but you need to be able to explain the business model concisely. Investors want to make money and your business needs to reflect that capability.
“Explaining your business should be as easy as putting a box on a table, inserting a quarter, and receiving a dollar.” ~ Chloe Alpert
If you think you have a cool idea, feel free to reach out! I wouldn’t consider myself an expert in any regard, but I might have an idea of some cool people to contact and help out!
Sources
[1]: “Chlamydia — 2016 STD Surveillance Report.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, www.cdc.gov/std/stats16/chlamydia.htm.
[2]: “Chlamydia Research Laboratory at CHORI.” Family Heart & Nutrition Center, www.chori.org/Principal_Investigators/Dean_Deborah/dean_overview.html.
[3]: Report on global sexually transmitted infection surveillance 2015 (Rep.). (2016, April 14). Retrieved March 3, 2019, from World Health Organization website:https://apps.who.int/iris/bitstream/handle/10665/249553/9789241565301-eng.pdf;jsessionid=AFDD5A776D1BA6F176D2A04F12AE5900?sequence=1.
[4]: Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices https://www.sciencedirect.com/science/article/pii/S2452302X16300183
