Bench2Bedside:
Epidurals are performed millions of times each year, and loss-of-resistance has been the standard technique for confirming needle placement for generations. Why, in 2026, is accidental dural puncture still a significant and largely unsolved problem?

Mike Dolphin:
Accidental Dural Punctures (ADP) are still generally thought of as a relatively rare problem and one that goes away on its own. Recent research has shown that both the rate and severity of the problem is higher than most practitioners believe. The reality is that the majority (50-80%) of patients who have an ADP will experience severe headaches known as Post Dural Puncture Headaches. One paper (Eley, et.al, 2022) reports that not all dural punctures are recognized during the procedure, and the real number of dural punctures is at least 50-90% higher than detected. A recent article (Weiss, et.al, 2025) revealed that over 20% of patients that experienced an ADP suffered from chronic headaches for 5+ years post-procedure. This is a much bigger issue than most clinicians are aware of. Unfortunately, most clinicians are completely unaware of these statistics and until recently, have not sought out methods to reduce the ADP rate.

Add to all that, there has never been a real solution that has been proven to greatly reduce the incidence of ADP. Clinicians have solely relied upon training and experience with no other option available. While many clinicians have become quite skilled, the problem persists, and hundreds of thousands of patients are injured every year.

What is exciting for us is that we are offering a new device that can make a huge difference. EpiZact is simply a better way to place the epidural needle and is designed to greatly reduce the chance of accidental dural punctures.

B2B: Your background is in aeronautical and astronautical engineering — precision systems where the margin for error is essentially zero. What drew you from that world to the challenge of improving one of anesthesia’s most common procedures, and what did an outsider’s perspective reveal that the medical device industry may have been missing?

MD: Many of the best inventions have come from people outside the industry. I think this is because it allows you to think outside the box and question the status quo more vigorously. One of our board members is Jack Pacey, who invented the Glidescope (the first video laryngoscope). Jack was a vascular surgeon and was able to see the intubation procedure from a new perspective, inventing something that is now the standard of care. For myself, coming from aerospace engineering, I had the perspective of what is commonly called “systems engineering”, where you consider the entire device as a whole system. This allowed me to see that one could make a device that would both sense the epidural space and control the needle movement at the same time, thus allowing for highly precise needle placement. My external perspective allowed me to see something doctors could not. They asked for a better sensor, but what I saw was an opportunity to create a whole new device that provided better control, higher precision, and ultimately, a safer outcome for the patient.

It is also important to highlight how important it is to get input and feedback from end users in the design process. We learned very early how important it was that EpiZact be able to be hand-held and not disrupt the clinician’s current workflow. Initial prototypes were tested with doctors, and what we learned in those sessions greatly influenced the product’s design. So, while having an outside perspective was vital in terms of developing something new, we needed the feedback from the medical industry to create something that clinicians would be likely to adopt and use in real life practice.

B2B: EpiZact works with the standard epidural Tuohy needle that clinicians already use and builds on the loss-of-resistance method they already know. What does it add to that technique, and why are both visual and tactile feedback — plus the automatic stop — important to making the device meaningful rather than simply incremental?

MD: EpiZact is a finely tuned, carefully engineered product. There is a lot behind the scenes that most users may not appreciate at first. The most obvious feature is that EpiZact triggers automatically in the epidural space, providing a definitive signal to the user that the needle has been positioned correctly. The automatic stop feature places the needle precisely in the epidural space just deep enough that a catheter can be inserted but prevents the needle from advancing too far and causing an accidental dural puncture. Remember, the epidural space is only 3-5 mm wide, and the needle has a 2 mm aperture, so there is very little room for error! When triggering, the clinician can see EpiZact respond, and they can also feel the device disengage. Importantly, the clinician can even feel the tissue layers being pierced by the needle during advancement prior to reaching the epidural space. This gives the clinician a lot of information, further helping to establish a precise needle placement.

EpiZact also has some incredible features that no other device has. Besides being highly reliable and precise, EpiZact responds within 0.2 seconds of reaching a loss of resistance, much faster than a typical human response of nearly 1.0 seconds. EpiZact operates at a low pressure of just under 7 psi, much lower than what a clinician would typically generate on their syringe (20-50 psi), making EpiZact more sensitive to the epidural space and less likely to be subjected to a false loss of resistance. By design, EpiZact does the loss of resistance detection for you; this frees up both of the clinician’s hands to direct the needle, providing better stability and more accurate placement. EpiZact is very easy to use, essentially being swapped in for the typical loss of resistance syringe. All of these features were important in our design process, and we are very proud of the device and its capabilities.

When we watch clinicians use EpiZact, it is amazing to see its benefits. It is simply a better way to perform epidurals.

B2B: EpiZact saw its first clinical use in March 2024 and has since been introduced at hospitals across the U.S. through a controlled market release. What are clinicians — anesthesiologists and CRNAs — telling you about how it changes the experience of placing an epidural, both for themselves and for their patients?

MD: The biggest benefits we hear from clinicians over and over is how EpiZact lowers their stress and improves their performance. We have had several clinicians state that they are faster when using EpiZact, because they can advance the needle with confidence. Other clinicians have said that EpiZact is particularly beneficial for “squirmy” patients who are likely to move. Since EpiZact will trigger automatically, even if the patient moves, the device will trigger and prevent the needle from advancing too far. The net result of these benefits is lower stress for the clinician as they have one less thing to worry about.

For patients, a faster procedure can be a huge benefit. Asking a pregnant women to arch her back and lean forward and then hold still for a full minute, all whilst they are having contractions, can be quite demanding. With EpiZact, this portion of the procedure can be significantly shortened, meaning less stress and discomfort for the patient, not to mention the lower chance of injury (even if most patients are not fully aware of the potential consequences).

B2B: Introducing a new device into the epidural suite means competing not just with existing tools, but with decades of ingrained technique and clinical habit. What has been the biggest challenge in building adoption, and what has surprised you about how quickly — or how readily — clinicians have embraced a device that changes something as fundamental as how they feel for loss-of-resistance?

MD: By far the biggest challenge is overcoming the inertia of clinical habit. The medical industry is inherently slow at adopting new technology, and for those clinicians that are very confident, it is even slower. Our best customers have been the relatively young CRNAs (Certified Registered Nurse Anesthetists), generally at smaller facilities. Small hospitals are much quicker to approve the use of new devices than large hospitals, and CRNAs are generally very keen to try something that will make them a better clinician, especially if it makes their job easier.

As we continue to build more data, and show that EpiZact is not only effective, but far superior to the current standard of care, we believe that more and more clinicians will be looking to try EpiZact. We have built a small but very loyal following, and EpiZact has now been used over 1100 times. The results have been simply stellar. As we approach 2000, 5000, and 10,000 uses, the evidence will start to become overwhelming, which will further drive adoption.

B2B: Where do you hope GuideStarMedical and EpiZact will be five years from now — and what does success look like, not just commercially, but for the patients who receive an epidural?

MD: Five years is a long time, but not long at all in medicine. I would love to see EpiZact become the standard of care by then, but realistically, that may take several more years beyond that. There are over 4.5 million epidurals conducted in hospitals in the USA every year. If EpiZact is being used in 10% or 20% of those, that would be a tremendous success. Even just 5% of those procedures would be a massive commercial success for EpiZact, but clinically, we think EpiZact (or some other device that uses similar technology) should be used in every epidural procedure.

I believe it is just a matter of time before EpiZact becomes the standard of care across the industry, just like Glidescope, just like ultrasound for central line placement, and many other examples. Once you see a device that is definitively better, safer, faster, and easier to use than the current standard of care, it is hard to imagine any other outcome than it becoming the new standard.