Innovators often set out with the goal of creating solutions that will make a lasting impact within their field of interest and in the world at large. Yet, rarely do they manage to completely disrupt a particular market with a solution that revolutionizes long-established approaches and methods currently in use. With the Zsquare™ ENT-F, Zsquare Medical has achieved exactly that. Taking Silver in Advanced Surgical Instruments in this year’s Edison Awards, the Zsquare™ ENT-F is a single-use endoscope that has a wide variety of applications, opening the opportunity to access multiple indications currently unserved and transforming the approach taken to endoscopy as a whole. The Inspiring Minds podcast proudly hosts Asaf Shahmoon, CEO and co-founder of Zsquare Medical, as he discusses how the Zsquare™ ENT-F was conceived and what makes it a revelation in medical optical systems.
Many innovations begin their development journey as a response to a single, specific problem facing a particular device, application, or practice. The development of Zsquare’s innovative endoscope, in contrast, began with the identification of major challenges facing endoscopy as a whole. According to Asaf, three components of the field were mapped: the clinical arena, the healthcare arena, and the market. Regarding the clinical aspect, improvements to the scope’s flexibility and size were required to allow for the exploration of areas existing scopes cannot access. The new scope, then, needed to be highly flexible and as small as possible, while continuing to provide high-resolution images. The Zsquare™ ENT-F is outfitted with patented miniature fibers much smaller in diameter than competing technologies whose optical structure allows for the transmission of high-quality images even when they are bent. Due to this, the endoscope is able to respond to a number of unserved indications; for example, it can be used in gynecology to access the Fallopian tubes and in otolaryngology to view the Eustachian tube. When used in a bronchoscopy, the scope is able to reach deeper into the lungs than others.
Within the healthcare arena, the continuous reuse of endoscopes from patient to patient proved to be a major source of cross-contamination, an issue that faces all multi-use products and is particularly relevant at this time due to COVID-19. Zsquare’s response to this issue was to devise a new, unique design in which the endoscope is consistent of two parts rather than one. The first part of this system is a single, reusable imaging core containing all the state-of-the-art components that make the capture of high-resolution images possible. The second part of the endoscope is a disposable shell comprised completely of optical components, the single-use nature of which completely eliminate the risk of cross-contamination during repeated use. Finally, from a market perspective, cost-effective solutions were needed that were applicable in as many settings as possible, from hospitals to outpatient clinics, and from privileged countries to those currently developing. Addressing this, the Zsquare™ ENT-F excels at being cost-effective, as its single-use shells are designed and designated for use in different applications. This allows the system to respond to more needs than any single existing endoscope with the use of only one main tower. Further, the shells themselves use no electricity or complex integration, making the cost of materials extremely low.
Having achieved these significant advancements in the endoscopic field, Zsquare is now setting their sights on commercialization, launching off their efforts within the ENT market. Supported by their network of key opinion leaders, the company intends to increase the scale of operations following FDA approval to expand the number of indications served. Ultimately, they plan to perform a soft launch of the product in major hospitals around the world, primarily in the United States and Japan. With the Zsquare™ ENT-F in the hands of leading medical professionals, Zsquare can acquire the feedback and support that will be needed for the device to reach the larger medical industry. Further, the company plans to employ sales teams and promotions to push the device into more facilities. Yet, the marketing for this endoscope began from the first day of its development, with Zsquare collaborating with premiere Israeli hospitals and leading department and hospital directors to construct an expert support network for both the clinical and technological aspects of the device. Companies and entities with manufacturing expertise in the medical and disposable fields were partnered with to reduce development time. Meanwhile, key opinion leaders were acquired from the United States and Japan to understand variations in hospital integration, physician requirements, and market needs as they relate to geography.
For Asaf, the journey to the Zsquare™ ENT-F’s conception began in university, while he was acquiring his doctorate in electrical engineering with a concentration in the optical field. Here, he recognized the very challenges faced by the endoscopy market that spurred and guided the development of Zsquare’s scope. With the goal of providing clinical as well as market value, Zsquare approaches development with the philosophy that problems are more than the sum of their parts and plans extensively to respond to upcoming needs and desires within the market, with Asaf stating that business development and go-to-market strategies are often devised looking five years into the future. At the same time, he stresses the importance of adaptability and responsiveness as various parameters of design, such as physician needs, hospital budgets, and market needs, may change rapidly. Ultimately, Zsquare approaches the creation of solutions seeking to benefit as many people as possible with a single product.
With many startups looking to enter the medical device development field at this time, Asaf recommends that aspiring innovators look for broad solutions capable of disrupting their market of interest, stating they must “color outside the lines and not focus on very narrow problems.” Solutions should be created that improve quality of life for as many as possible, with patients, doctors, and healthcare facilities being the primary beneficiaries in the medical field, allowing them to save time, money, and effort through the use of the product. More than this, Asaf emphasizes that startups should aim for a short time to market, beginning with defining the minimal viable product that requires the least amount of technological effort while continuing to make the desired impact in the market. In the medical device development field, he says that innovators should focus on predicates, using them whenever possible to reduce the time taken in the regulatory process and reduce the risk of complications.
Flipping an entire market on its head is the ultimate goal for most innovations; yet, it is extremely hard to achieve in practice. Zsquare Medical has risen to the challenge and triumphed, with the Zsquare™ ENT-F providing solutions to many of the major problems that have faced endoscopy for decades. Their success in this arena proves that revolutionary advancements can be created in any field at any time, provided one approaches the development of solutions through a holistic perspective. By focusing on the whole rather than the individual components, solutions can be created that break from the mold of existing practices and create tangible and lasting change within the field.