In Conversation: Sue Carr, Founder and President of CarrTech, LLC
The traditional two-needle approach to filtering injectable glass ampoule-based medications is unsafe to health care providers and patients. The process is also time-consuming and costly.
Glass shards left in injected medications and accidental needle sticks suffered by healthcare professionals are hazards caused by this traditional approach to rendering medications. A single needle stick injury can cost between $500 and $4,000 per stick, causing U.S. hospitals an estimated $5B every year in associated losses.
Frederick, Maryland’s CarrTech, LLC is seeking to solve these problems by revolutionizing medication preparation. CarrTech, a recent cohort member of the Frederick Innovative Technology Center’s (FITCI) The EDGE Program, was founded by 30-year hospital and retail pharmacy veteran Sue Carr in 2012.
After seeing the traditional two-needle filtering approach cause problems firsthand, Carr developed The FROG™, an acronym for “Filter Removal of Glass.” It is the only all-in-one package filter and hypodermic needle combination. The FROG is safer, easier, quicker, and greener than the traditional two-needle approach.
We recently caught up with Carr to discuss her background, how she founded the company, and where The FROG currently sits within the regulatory and commercialization processes.
Tell us about your career background as a hospital pharmacist and how that led to identifying an issue with needles and filters.
I worked my way through pharmacy school as an IV tech at a Boston hospital. During that time a lot of the medications were packaged in glass ampules and the glass shards needed to be filtered. What should have taken five minutes took about 15 minutes because of the filtering process. And I thought, ‘I hope they’re doing this right in the ER’ because people can die from glass shards. I noticed it was time-consuming and cumbersome also. I went to my director and said there’s got to be a better way.
I eventually moved into retail pharmacy work in Northern Virginia and Maryland at busy locations. I enjoyed my work in retail, but I ultimately decided to return to working in hospitals because that’s where my passion was. I left retail and returned to the hospital world and worked in the ICU, NICU, ER, Oncology, and Med Search.
I continued to see the same challenges with the traditional filtering approach and started to do research. I found that glass shards could cause death, internal bleeding, and also might have contributed to Sudden Infant Death Syndrome (SIDS) cases; all infants are given vitamin K that requires the use of glass ampules.
This issue continued to bother me and my colleagues in the ER and ICU. I decided to make a difference and I spoke to people at the hospital who understood my ‘why.’ That’s when I started pursuing patents for my idea; when I received my second patent I knew I was on to something and that’s when CarrTech really started.
What makes The FROG device different and what benefits does it provide to healthcare providers and patients?
The current process requires both a filter needle and a hypodermic needle. First, you have to break the ampule, then you have to open up a filter needle package. You always have to filter the product because 100% of the time glass shards will be in the ampule. Once you break the ampule, you insert a filter needle to filter out the glass shards. Then you place the filtered solution in the syringe and it has to be recapped, which is when most needle sticks occur. There are multiple other steps. And every time you touch the needle there is an increased risk of sepsis and a needle stick.
A lot of people don’t realize what has to happen if there is a needle stick. A health care provider has to stop everything, call out the HAZMAT team, report it to their boss, go to employee healthcare and also report it to risk management. We calculate the wasted time caused by needle sticks could cost hospitals $5B annually. There were 2B needle stick injuries reported in 2019, according to the World Health Organization (WHO).
The FROG stands for the Filter Removal of Glass. It is an all-in-one package, single-needle system. Right off the bat, we estimate the FROG reduces needle sticks by 50% and perhaps even more than that because there is no needle exchange. You break your ampule and filter. We’ve relocated the filter to the tip of the needle, removing any dead space, so that health care providers can get all the drug into the syringe. Once it’s safely in the syringe, you remove the cover and you have a sterile needle ready to inject.
And that’s in addition to preventing glass shards from remaining in the medication and potentially hurting or even killing patients.
What is the potential market for The FROG and where does CarrTech sit within the regulatory and commercialization processes?
The market for The FROG, with a conservative estimate, is about $600M in the U.S. and $2B globally. The ampule market is a $4B market that is growing at a CAGR of 7.5%. These numbers are pre-COVID.
We’ve already met with the FDA and received valuable feedback and feel we have a clear path forward for 510K, class two device approval. We’re going to start in the U.S. and Canada, and then we’ll explore the global marketplace.
Our preparation timeline for 510K approval is about 60 weeks, and we are currently a few months in. We have also partnered with a major company in North Carolina to manufacture The FROG and to provide other services. They can push out 10,000 products a day and have everything we need to bring the product to the market once approved by the FDA. We’re also engaged with several of what I call the BNCs, or Big Needle Companies, about The FROG.
TEDCO has provided us with $50K through its Builder Fund. We also won the Shore Hatchery Pith Competition in 2020 that gave us additional funding. And we have several grants that have supported our hiring efforts.
We are currently in the process of talking to angel investors and are pursuing grants and other funding sources.
How have the Frederick life science community and business development groups helped support your company?
Honestly, FITCI and other people in Frederick have been rock stars. They have totally transformed CarrTech. If not for the EDGE program, Kathie Callahan Brady, Jan Gardner, the Fort Detrick Alliance, and others, we wouldn’t be where we are. Kim Mozingo and Gary Evans from DefTech were mentors at the Edge as well and continue to provide me with guidance. There have been so many mentors and advisors that have helped me, including those at the Inova Center for Personalized Health Accelerator.
The EDGE program taught me so much. Everyone in the program was so positive and it was a great culture. The same with the TEDCO Builder Fund. In hospital and retail pharmacies you’re under constant stress, and to come out of that into this supportive environment that pushes you was really great.
Right before COVID hit, I won the Judges’ Choice and People Choice Frederick County Economic Development-sponsored pitch competitions. And then in February, I pitched for Connectpreneur. When I came to the EDGE program, my pitching needed a lot of work. After my last practice pitch, Kathie, FITCI’s CEO, came up and gave me a big hug. I wouldn’t have had this success without the EDGE program and my other advisors giving me help at the start.
What advice would you give entrepreneurs looking to start a life science company or that are in the early startup days?
Remember that there’s a learning curve. Before you build anything, do your discovery, develop your mission and vision. If you’re passionate about what you’re doing and you have a solid idea, it’s contagious and other people will spread the word.
There are a lot of highs and lows. Find a balance. Keep going. Don’t stop moving forward and don’t stop learning.
What is your vision for CarrTech over the next five years?
We still have a ways to go yet, but we are exploring a variety of exit strategies for CarrTech. We’re keeping the door open to all possibilities, including licensing, royalties, and acquisitions. We also have other product designs in the pipeline.
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