5 Groundbreaking Innovations in Medical Technology — All from Small Businesses

By Patrick Daly, President and CEO, Cohera Medical, and Chairman, AdvaMed Accel

Wearable Breast Pump. Source: Willow

Most people are familiar with the saying, “Big things come in small packages.” What most may not realize is that some of the biggest innovations in medical technology come from small companies. These “up and coming” businesses in medical technology are often the drivers of disruptive innovation, job creation, and economic expansion.

In honor of National Small Business Week (April 30-May 6), here are examples of five groundbreaking medical technology innovations that are making people’s lives better every day — each of which is thanks to a small business:

A system that prevents epileptic seizures at their source. Seizures start in the brain. Neurons in the brain release electrical signals that tell a body what to do. These electrical signals, or brain activity, can be observed on an electroencephalogram (EEG). Occasionally, these brain signals can suddenly misfire and cause seizures. Other than surgery, most epilepsy therapies do not directly treat the source of seizures. Antiseizure medications and other medical devices deliver therapy whether or not a seizure is occurring — which can cause chronic side effects that negatively impact quality of life. The RNS® System developed by NeuroPace is a medical device that is smart enough to respond to what’s happening in the brain to stop seizures at their source. It automatically delivers treatment when it’s needed. Learn more.

A wearable breast pump. All mothers want to give their babies the best start in life, and for many, that means breast milk. Willow™ is the first all-in-one breast pump that cuts the cords, ditches the dangling bottles, and fits easily inside a bra. Mobile, discreet, and hands-free, Willow allows women to achieve their breastfeeding goals without pressing pause on their own lives. Willow’s design completely re-imagines the breast pump, bringing humanity and dignity to the pumping experience, so women no longer need to be tethered to the wall and undressed while they pump. Willow is smart and connected to an app that syncs data from each pump, enabling mothers to track their milk expression in real time while the pump stays hidden inside their bra. Learn more.

A connected ecosystem that automates the delivery of insulin. Bigfoot Biomedical is a startup founded by those with a personal connection to Type 1 Diabetes (T1D), with over 250 years of T1D across their small team. Tying together components like a Bluetooth-enabled insulin pump, continuous glucose monitor, and a smartphone mobile app, Bigfoot is developing a closed loop automated insulin delivery system (sometimes referred to as an “artificial pancreas” in the media) as part of a monthly subscription service, upending the traditional durable medical equipment business model and aiming to deliver a Class III medical device with the elegance of consumer technology and the reliability of enterprise software. Having completed initial clinical trials, Bigfoot is on target to complete a pivotal trial and submit its solution to FDA in 2018. The company’s focus is on making solutions that are simple for health care providers to prescribe, simple and affordable for people to use, and that improve quality of life. Learn more.

Technology that biologically heals rotator cuff disease. From the time Rotation Medical was founded in 2009, it has worked in partnership with leading clinical experts to address the limitations of current treatments for rotator cuff disease. Traditional approaches focus on biomechanical repair, but do not address the underlying biology of the tendon. This can lead to unpredictable results, disease progression and a high rate of re-tears. In addition, patients require lengthy rehabilitation and face disruption to quality of life. In contrast, the Rotation Medical Rotator Cuff Repair System incorporates a breakthrough technology and technique that balances biomechanics and biology to enhance the body’s natural healing response. The bioinductive implant technology enables tendons to heal by inducing growth of new tendon-like tissue, offering the potential to prevent tear progression and reduce the incidence of re-tears. Learn more.

A device that completely replaces the human heart. Heart Failure is a devastating disease that affects more than 11 million people in the United States and Europe, with an incidence of 1.1 million new cases per year. Furthermore, current growth rates predict a 25 percent increase in the incidence of heart failure by 2030. According to the U.S. National Institutes of Health (NIH), 100,000 patients could immediately benefit from a ventricular assist device or total artificial heart (TAH), and the European market is similarly sized. Without intervention, patients with severe heart failure have a bleak outlook. For these patients, drug therapy is a limited, relatively ineffective option. Although a heart transplant would meet their needs, only 4,000 donor hearts are available globally each year. Thanks to Bivacor, a start-up founded in 2008, implantation of a Total Artificial Heart is a treatment option for patients with end-stage heart failure who need support while on a heart transplant waiting list or who do not qualify for a transplant. Removal of the native ventricles allows the device to completely replace the function of the native heart. The BiVACOR TAH is designed to be a long-term device that can replace the total function of the patient’s native heart. The small, compact device uses proven rotary blood-pump technology to provide the required cardiac output. Learn more.

This piece has been updated to include a fifth example from BiVACOR.