“Hmm that was like shooting a BB gun at a charging bear.” — Dr. Ben Merrifield on his experience with existing endoclip technology
Innovator stories never grow old for the team at PCS. Especially when they end in better control for surgeons. Meet Doctors Ben Merrifield and Drew Schembre, practicing gastroenterologists and founders of EndoGear. They lean on their clinical experience to establish the unmet need then create solutions to fill the gap. In their current project they called upon PCS to assist as they reimagined endoclips, a hemostatic device deployed through an endoscope.
The EndoGear ZipClip can be used with lesions of varying sizes and locations, and the clips enable more reliable tissue manipulation. The ZipClip will enable faster and more durable closure of GI defects with fewer clips, less medical waste, and lower costs. With the initial technology development complete, we caught up with Ben to check on progress.
“Another driver is a certain level of frustration with the prevalence of trivial device changes or “me too” products. We are most excited when we use a medical device that is truly unique.”
— Dr. Ben Merrifield, EndoGear
PCS: What drives you guys to bring new endoscopic surgical tools to market?
Ben: The short answer — We can't help it. Both Drew and I have the habit of continuously scanning for better methods for doing our job as gastroenterologists. Endoscopic procedures are demanding and involve high stakes, so having the reliable tools is critical. Another driver is a certain level of frustration with the prevalence of trivial device changes or "me too" products. We are most excited when we use a medical device that is truly unique.
PCS: Why do you make a good team for this venture?
Ben: I suppose a major reason that we make a good team is that we enjoy each other’s company. We share the experience of being both practicing gastroenterologists and involved in device invention. Although in different years, we both graduated from Middlebury College in Vermont. Drew and I are both very familiar with the market for and clinical use of clips. We both had experience inventing gastrointestinal medical devices prior to founding EndoGear.
PCS: How do you see yourselves participating in the commercialization process?
Ben: We will both be participating in commercialization by proceeding with animal lab testing, fund raising, regulatory application, and ultimately sales. I have made plans to reduce my clinical hours so that I can devote more time to moving the EndoGear product closer to market.
PCS: You are in the final cohort of LSDF grantees; non-dilutive funding issued by the State of Washington. How did you leverage grant funds to move the project forward?
Ben: The LSDF grant was critical as it allowed us to access the engineering, prototyping, and animal testing to move our clip closer to clinical use. While the grant funds were not used for patents, the engineering input made the patent application very efficient.
PCS: Why is the ZipClip your first product?
Ben: Drew and I care deeply about our clip’s ability to improve the treatment of gastrointestinal bleeding. While the currently available clips are generally useful, at times they can be inadequate. By way of example, I recently placed a commercially available clip onto an ulcer but blood continued to briskly flow prompting me to comment to my nurse, "Hmm that was like shooting a BB gun at a charging bear." Eventually, we were able to stop the flow, but surgeons would appreciate a more effective method.
PCS: We hope this product goes big, but in reality it is tiny. Were you ready for the challenge of miniature mechanism design?
Ben: Size was an issue. Given the nature of endoscopy, our device needs to pass through a 2.8 mm endoscope channel. That is a tight space, and a large hurdle. During the grant application process, the folks at LSDF (rightly) challenged our ability to make such a small device. Drew and I are capable of building larger scale concept models, but working with the engineers at PCS provided a level of sophistication in design, materials, and prototyping that allowed us to achieve high functionality with a very small device. The fun (and scary) part of the project was that we did not know at the start exactly how the device would function. PCS was excellent at keeping us on task on a project that demanded iteration throughout the process.
PCS: What are your next steps?
Ben: Currently, we are in negotiations with a company to manufacture multiple prototypes to test in an animal lab. Subsequently, we will look for additional capital to gear up for large volume manufacture and FDA 510(k) submission.