Health and Healing 101 is proud to review a brilliant innovation addressing female incontinence - a most widely prevalent health and medical concern for women. As a team with extensive experience in medical device design and entrepreneurship, co-founders Gloria Kolb and Eric Kolb embarked on development of a wearable medical device called ELITONE to provide a non-intrusive incontinence treatment, capturing the attention of an expanding number of clinicians in the US. Team Kolb shares their valuable insights on the creation of this remarkable device, while also sharing the process of achieving regulatory success for product launch. For any aspiring developers of innovation, this interview promises to be a valuable educational tour depicting the journey of how medical technologies come to market.
ELITONE® is FDA cleared to treat stress urinary incontinence (SUI) and is the first transcutaneous pelvic floor muscle stimulation available in the US. The ELITONE device:
- Use externally applied electrical muscle stimulation to exercise the pelvic floor muscles
- Performs pelvic floor muscle exercises more effectively than many women can do alone
- Requires little to no instruction from a healthcare provider.
- Can be used at home, under clothing, making it easy for women to continue their everyday tasks during treatment.
- Is ideal for women with mild to moderate symptoms who would benefit from pelvic floor muscle training.
Gloria and I started the company and made the first prototypes in our dining room. We are both engineers, both with strong backgrounds in medical device product design. Although our skill sets have a lot of overlap, I tended to work more on design, manufacturing, and quality systems, while Gloria focused on funding, clinical research, and business operations. Over time, we hired other talented people and divested some of those responsibilities to others.
Our current Indication for Use is for treating female stress urinary incontinence, which represents about half women with incontinence. Stress incontinence is leaking associated with coughing, sneezing, exercising, or any other increase in abdominal pressure that causes urine to leak. It is primarily affected by pelvic floor muscles, and often starts after childbirth. If untreated, it worsens as the woman ages. Thankfully, with treatment like ELITONE, many of these women can get back to living life without leaks.