Entrepreneur Interview – CervoCheck

CervoCheck™ is a medical device that accurately detects the onset of preterm labor to allow the timely prevention of preterm birth. It does this by measuring the electrical signals characteristic of contractions after it is inserted into the vaginal canal/cervical opening. The hope is for physicians to spot oncoming preterm labor in pregnant women earlier than by using an external tocodynamometer (the most commonly used device), which is less effective in women who are obese or earlier in gestation. In general, current methods lack the ability to detect early signs of preterm labor to prevent preterm births, which account for 70% of neonatal morbidity and mortality.

The device was born from a biomedical engineering project between four graduate students at Johns Hopkins University. In 2010, the team came together to form the company CervoCheck, LLC and began the path to patent, test, fund, and develop the device. Karin Hwang, one of the co-founders and CEO of the startup, was nice enough to explain that the group saw a problem and a need for such a device in the medical market, given the shortcomings of the current options. There are over 500,000 preterm births in the US of the nearly 4m babies born, costing the US healthcare system approximately $26.2b (figures that are much higher when viewed from a global context). As the medical field is sensitive to change given the inherent risk of new technology, the team decided to initially target perinatologists (physicians that see high risk-patients on a daily basis, $59m market), as they would benefit the most using the device, before widening the product for general obstetric physician use ($980m market). The conservative nature of physicians meant for the product to be adopted, the team had to prove the device was safe and easy to use and for that reputation to spread through word of mouth around physician circles. The product is still in R&D, after just completing animal trials, with hopes to have results published in major journals soon.

The company plans to target CervoCheck™ towards physicians, hospitals, and obstetric practices (the primary users) rather than the patients. This device would potentially disrupt the existing tocodynamometer market, as well as other devices that are used to measure and monitor other indicators of labor (such as the transvaginal ultrasound and the CerviLenz device). Again, due to the conservative nature of the field, the team plans to market the device by building a comprehensive set of clinical value test data supporting its effectiveness, including an in-depth multi-center clinical study and publishing results in respected medical journals to gain credibility. Once the device has proven its superiority over other devices at a comparable price point and ease of use, the company plans to engage potential customers through a direct sales force, eventually partnering with a well-known national distributor to branch into new markets and provider networks. As there are no equivalent products on the market, the company would displace existing, less precise technologies and position itself as the best solution for women at risk for preterm labor.

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