Leaving a guidewire inside a patient is classed as a "never event", and it still happens. Why does such a simple mistake keep getting through, and what would stop it?
Nevent is a US MedTech startup making a safety sheath that stops guidewires being left behind when a vascular catheter is placed. It replaces the dilator that already comes in the kit and catches the guidewire, so clinicians do the procedure exactly as before.
“If we were never distracted or inattentive, we would not need airbags. But every single car has an airbag. Soon every single catheter will have a safety sheath.”
Rhodel Dacanay, CEO, Nevent
In this episode of the GS MedTech Podcast, Nevent CEO Rhodel Dacanay tells us how one case he reviewed on a hospital quality board led him to invent the device, while still working full-time as an anaesthesiologist. We also talk about his FDA plan and how you sell a safety product to hospitals watching every dollar.
Along the way, he shares how one journal article turned the laryngeal mask airway into a standard of care, and why his investor pitch went from eight minutes of science to eight minutes of business. Watch the full episode above, or listen on Spotify.
Key takeaways
- Most retained guidewires go unreported. When one is left behind, about 15.5% of cases end in death or serious harm, and 55% are missed on the first check X-ray. They're also the top cause of catheter-related payouts in US anaesthesia closed claims.
- Clinicians don't change a thing. The sheath goes in where the dilator used to, so there's no new step to learn.
- First customers are hospitals that have had a case. Nevent is targeting hospitals that reported a retained foreign body to CMS or published one in the medical literature.
- No clinical trial expected. Nevent is filing for FDA Breakthrough Device designation, then a 510(k). Rhodel hopes for designation in about 90 days and clearance 6 to 9 months later.
- A $3M Series A to get through FDA. Rhodel self-funded the first two years. The round pays for regulatory work and first manufacturing, and hospitals have already signed letters of intent.
Building your team ahead of the next round? Rhodel got this far by bringing in experts for everything outside his clinical background. When you’re ready to make those hires permanent, Guided Solutions can help. Get in touch
