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Better IV -taking IV catheters in a new direction.

by James Rawls MD, MD

We have re-designed the simple IV catheter in a simple and intuitive way that solves the many problems with current technology.

Folly Beach, SC Medical Device

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About this project

The problem we solve:
In the United States alone over 375,000 peripheral IVs are started every day. Many of them will fail. Of those left in for more than 24 hours 50% of them will have to be replaced. The authors of the pivotal paper "Accepted but Unacceptable: Peripheral IV Catheter Failure" (http://www.ncbi.nlm.nih.gov/pubmed/25871866) estimate that the cost of these failures approaches $2.3 Billion. The main problem that causes these failure is catheter movement -any movement of the thin-walled and relatively stiff intravascular portion of the catheter rubs up against the intima (inner lining) of the vein and causes damage that eventually results in extravasation (a "blown" IV) due to erosion through the vein wall. There have many approaches to solving this problem such as catheter hub (the part that the clear IV tubing screws into) stabilization and promotion of ultrasound guided deep vein catheter placement, but none of these have become common practice due to cost/training/clinical barriers.

About our solution:
We at Better IV have designed a simple, innovative but intuitive to use IV catheter that will be inexpensive to make and yet solves all of the above problems. Because it is intuitive for experienced IV clinicians to use there is little need for training. The design allows IV access in challenging parts of the body while at the same time allows for full catheter stabilization and thus greater longevity and less complications. The photo below is a drawing showing the basic idea: An IV catheter with a flexible portion between the intravascular catheter and the hub.
Progress to date: We have fully functional prototypes that we are using in a veterinary referral hospital. We have been able to refine the design and manufacturing process in partnership with a bioengineering firm that is now poised to begin low-volume manufacturing for use in the veterinary market. This same firm is ready to take the device through the FDA 510K process and then to the human market. We have a Method Patent and are expecting to be granted a Device Patent within a few months. Our board of advisors is made up of executives with experience in the medical device start-up world. Our core team is strong and is determined to bring this device to the human market. The photo below is of a 20 gauge Better IV in use in a small dog's front leg. With a traditional catheter his leg would have been taped to a stiff foam board to keep it from bending. With a Better IV he can walk on it normally and it lasts longer and irritates him less.

About Our Team

Dr. James Rawls MD, MD
Anesthesiology, Practicing Physician
Location: Charleston, South Carolina
Medical school: Medical University of South Carolina
Bio: I grew up in New Bern, NC and I have always been an innovator. I wanted to be an inventor when I was younger but ended up taking the more conservative route by attending medical school and training to practice anesthesia. Along the way I have always focused on improving patient care and tried to approach problems by looking at them from the patient's perspective. My Better IV innovation is a reflection of that instinctive drive to think outside the box and always wonder.
Practice: Anesthesia Associates of Charleston
Hospital Affiliation: Roper Hospital System
Title: CEO of Better IV

About Team Members

Brian Tice MBA
Chief Operating Officer, MBA
Biography: Brian grew up in Eastern North Carolina, studied bioengineering as an undergrad at Vanderbilt, served 10 years as a US Marine (combat special forces) and then earned an MBA from Stanford. His most recent success is Snapcastr.com. He has brought his significant business acumen to Better IV because he wants to "do something that really helps people"
Darlene Rawls MD
Chief Financial Officer, MD
Biography: Darlene is a native american and the first in her family to graduate from college. She went from earning a BS at Duke University in Chemistry to Bowman Gray School of Medicine for her MD and then MUSC for Internal Medicine training. After a successful practice in Charleston she is now CFO for Better IV (and a wonder wife)

About Our Company

Better IV LLC
Location: Folly Beach, South Carolina
Product stage: proto
Sales: Working on it
Employees: 3-5

How We Help Patients

We will all be called "patient" at some point in our lives. There is a high likelihood that will involve having an IV catheter placed. As we age or get sick, IV access gets harder. Some of us are unlucky enough to be born with "bad veins" and the places we do have for IV access are mostly near places where our bodies bend -such as elbows, wrists, hands, neck and even ankles and legs sometimes. Any of us who have experienced current IV catheter technology know that it can be lacking... As an anesthesiologist I deal with IV access every day. I have had times when IV failure resulted in critical situations that demanded quick action. Several years ago my natural inclination to invent and improvise led me to create what has become Better IV. I have followed this passion to the point where it is now drastically improving the IV experience for a few lucky dogs and cats. Please help me bring this device to the human world so that we can all have a Better IV experience when we need it.

How We Help Education

Though I cannot claim this device will directly impact physician education, I feel that it would make patient care easier for our future physicians. One of my distinct memories from medical school was during my Pediatric Surgery rotation doing "cut downs" on babies to re-gain lost IV access during the wee hours. Though certainly it was educational for me, I think it would be best avoided for all parties involved. Our device would help avoid this situation by allowing IV access in infants in places that are now avoided and making it so that once IV access is gained it can more easily and safely be maintained. This would allow the residents and students to get the sleep they need to learn more important aspects of Pediatric Surgery and other wonderful things that we physicians are allowed to do.

How We Help Physicians

Our device will make many physicians daily lives better by making it easier for them to care for their patients. Almost every specialty has to deal with lost time etc due to lost IV access or time spent getting an IV in the patient who is a "hard stick". Medications get delayed, hospital discharges get delayed, surgeries get cancelled sometimes. As an anesthesiologist I personally have had critical situations arise from failed IV access. In fact I had two in one day -this is what was the original impetus for this invention. I know our device will help prevent these things from happening. It is already doing so on a small scale in a veterinary hospital. Please help me bring it to the human market. You and your patients will be glad you did.

Challenge Mission

Mission: If I am able to bring this idea to patients with the help of this contest, certainly it will inspire me to do another (I have a few) and it will inspire the many physicians who ask me how they can too
Use of funds: I would specifically use these funds to buy materials and labor to do a limited run of 20 gauge catheters to sell to veterinarians. This would provide proof that indeed veterinarians are willing to pay a little bit more for a Better IV than what they are currently using and will begin to get our company noticed in the veterinary market. In this way it would truly be "seed" money because proof of the veterinary market would go a long way towards garnering investment aimed at introducing us to the human market. $25,000 would be a great "shot in the arm" for our company right now.
Intellectual Property Status: I originally applied for patent protection on this idea in January of 2010. In 2014 I was granted a "Method Patent" which protects me from anyone using any IV catheter in the way that I have defined. We have a Device Patent pending.
Patent Link: http://www.google.com/patents/US8641677
FDA Status: We have reviewed the device with a consultant (and former FDA executive) who feels confident that the device would be approved via the 510K process. We are using Medical Murray device development company for our prototyping and have a proposal in hand for them to take it through the 510K process.
Personal Message: I am passionate about this device coming to market because I see the need for it every day in my practice as an anesthesiologist. It drives me as much as I drive it. Success here will help a multitude of patients have a Better and safer hospital experience. If it is successful, one day it may help you! It would also empower folks like me -a regular working anesthesiologist, to innovate and not fear failure.

Supporters

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    05/21/2016 Dr. Ryan Ribeira - Physician

    Liked the project.

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    05/02/2016 RUSSELL LIBBY - Physician

    Liked the project.

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    04/30/2016 Mohitkumar Ardeshana - Private

    Liked the project.

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    04/26/2016 James Weintrub - Physician

    Liked the project.

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    04/23/2016 Alex Fair - Investor

    Liked the project.

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    04/22/2016 Mr. ASASD ASFSADF - Physician

    Liked the project.

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James Rawls MD, MD
Physician
CEO of Better IV
Medical University of South Carolina

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