Author: jbadmin

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.

How a company views and approaches innovation can differ wildly depending on the fields or industries it operates within. Perhaps because of this, most companies confine their innovative efforts to a single industry or a small group of interrelated industries. The Industrial Technology Research Institute, based in Hsinchu, Taiwan, stands in stark contrast to this, producing innovations in a vast range of fields, from material science to biomedical engineering. In doing so, they have proven the ability of one company to produce innovations across industries, receiving two honors at this year’s Edison Awards. In the first international episode of the Inspiring Minds podcast, Dr. Jacob Singh Kwan Lin and Dr. Tsing Sao Chen explain how innovation is approached and executed at this highly diverse company.

In the first of their two wins, ITRI took gold in the Adhesives category for their product Celluad, a product developed in part by Dr. Lin, Research Director of Materials Research and Development at the company. Made using cellulose, an organic material found in plant cell walls, this adhesive is low-cost, strong, water-resistant, and environmentally friendly. Compatible with existing manufacturing processes, Celluad provides excellent adhesion when applied to plywood, flooring, and lumber core board. Most importantly, ITRI’s adhesive is completely free of formaldehyde, a carcinogenic chemical found in the resin used to construct most artificial wooden boards. In this way, ITRI offers an adhesive solution that is effective and affordable as well as healthier for manufacturers, consumers, and the environment.

The second award ITRI received this year was bronze in Cellular Research for iKNOBEADS, the world’s first and only biomimetic magnetic beads capable of fighting cancer by stimulating, expanding, and strengthening T cells through imitation of the immune system. Dr. Chen, who worked directly on their development, explains that the knobby shape which gives iKNOBEADS their name and makes them so effective was the result of a happy accident that occurred while experimenting with different bead sizes when it was found that the addition of texture to the beads increased expansion rate. Because of this, iKNOBEADS not only fight cancer but do so with an incubation period reduced by three to four days, reducing opportunities for contamination and saving money.

At ITRI, innovation is viewed as a process that must be curtailed by commercialization. Projects begin in feasibility testing and move beyond this point only if this testing returns positive results. According to Dr. Lin, the development of a new product at ITRI follows a general six-step path, which he outlines using Celluad as an example. This process begins with the identification of needs within a particular market or within society in general. The most important role innovation plays in this world is to respond to human needs and improve the quality of life. Approaching development as a direct response to those needs ensures that the resulting product fulfills this important role, while also guaranteeing a place on the market for that product. Celluad’s development began as a response to the high amounts of formaldehyde released from most artificial wooden boards intended for construction or decorative purposes, like plywood and particleboard. Formaldehyde is a colorless gas that, in high concentrations, is known to cause cancer and other serious health issues. In plywood and other artificial boards, this gas is released from adhesives within the boards that are made using urea-formaldehyde.

The second step, per Dr. Lin, is to design and evaluate the product with the identified need in mind. In the case of Celluad, this meant creating a formaldehyde-free adhesive that performed as well as, if not better than, traditional urea-formaldehyde adhesives. The key ingredient to this adhesive turned out to be the world’s most abundant organic material: cellulose. Using cellulose, ITRI was able to not only eliminate unnecessary health risks associated with formaldehyde use but to do so with an adhesive that is strong, resilient, and sustainably sourced.

With this solution found and its efficacy confirmed through testing, Celluad moved into the third of ITRI’s six steps: scaling up. As Dr. Lin explains, testing in the laboratory must be scaled up to ensure that products consistently pass performance evaluations. Step four entails “real testing,” or testing the product in actual usage situations, and flows directly into step five, which is receiving and acting upon lead user feedback. As these steps suggest, the value of testing and evaluation at every step of the innovative process cannot be overstated. The final step of ITRI’s product development process is searching for venture capital investments. For ITRI, this includes looking to local and international companies, Silicon Valley venture capitalists, and the Taiwanese government to invest in new startups formed by the company to manage innovations. These startups receive step-by-step templates to follow as well as all research and development are done by ITRI regarding the particular product or service. Celluad itself has spawned two successful startups, one producing plywood and the other adhesives.

This is how the innovative process works for products developed at ITRI in a general sense. However, additional steps may be required depending on the industry the product is intended for, as was the case for iKNOBEADS. All biomedical products must receive approval from the FDA or an official institute laboratory before entering the market. Requiring the product to undergo clinical trials, approval is given based on the success rate of treatment, potentially requiring further adjustments. To increase success rates, Dr. Chen explains that ITRI will collaborate with different companies whose products target different cells to make modifications that will improve the rates of both products. Dr. Chen also states that the requirement of GMP (Good manufacturing practice) compliant materials can complicate the process for biomedical products, although ITRI has an edge with seven GMP pilot plants integrated within the company.

Innovation can be achieved in any field, at any time, if the approach used is solid in its foundations. Companies like ITRI, who produce innovative products and services in a wide variety of industries, prove that this is the case. By examining their approach and process, innovators can learn what practices and ideas are crucial to innovation regardless of specifics and, in doing so, potentially open their eyes to opportunities in different industries or encourage them to pursue ideas outside the usual spheres.

Listen to ITRI’s Podcast