The Power of Perseverance in MedTech Innovation
- V Khanna
- Jun 12
- 2 min read
The journey of an entrepreneur is rarely a straight line, but for Kevin Connley, founder and CEO of VesiFlo, it has been a twelve-year marathon. Having founded and operated five medical device manufacturing companies, Connley is no stranger to the industry, but his latest venture, the inFlow Voiding Prosthesis, presented unique challenges that offer invaluable lessons for any innovator.
Lessons from a 12-Year Journey
The Regulatory and Reimbursement Hurdle: Even after receiving FDA approval, VesiFlo faced a decade-long battle for reimbursement. The existing healthcare system is often not designed for "breakthrough" technologies, leading to significant delays even when market demand is high.
Creative Incubation: When the company had no revenue and no ability to raise money due to non-payment policies from Medicare, Connley incubated VesiFlo within another of his existing companies to keep the project alive.
Purpose-Driven Persistence: When asked why he didn't give up over twelve years of setbacks, Connley highlighted the potential impact: a device that can save thousands of women's lives every year by reducing infection rates. He noted that most entrepreneurs must be "stubborn" to succeed.
The Innovation: inFlow Voiding Prosthesis
The inFlow addresses a critical need for half a million American women with neurologically impaired bladder function who currently rely on urinary catheters.
Active vs. Passive: While traditional catheters are tubes that passively drain urine, the inFlow is a monthly insert with a valve pump mechanism that mimics natural urination.
Dignity and Health: Controlled by a remote, the device allows users to use a normal toilet, preserving the "flush mechanism" essential for bladder health and restoring a sense of dignity.
Market Potential: With a recurring revenue model—patients require a new device every month—the estimated total addressable market (TAM) is $1.5 billion.
Connley’s story serves as a reminder that the path to changing clinical practice is long, but the impact on patient lives makes the journey worthwhile.
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