Research is hoping to address the global issue of glaucoma diagnosis, management.

The vision of Purdue University biomedical engineer Chi Hwan Lee to develop specialized smart soft contact lenses that can accurately measure intraocular pressure (IOP) in a person’s eye could be the latest answer to stopping glaucoma-related blindness.

Lee, the Leslie A. Geddes Associate Professor of Biomedical Engineering in Purdue’s Weldon School of Biomedical Engineering, led a research team that developed new ocular technology to continuously monitor patients’ IOP readings more comfortably and accurately.

The technology serves as another option for eye specialists to identify glaucoma, which, according to the Glaucoma Research Foundation, can steal a person’s vision without early warning signs or pain and affects more than 80 million people worldwide.

The only known modifiable risk factor is lowering a person’s IOP, which is difficult to monitor for long periods of time, particularly during sleep.

While exams can be performed in a specialist’s office and at-home monitoring systems are available, these all have their limitations. For instance, in-office measures are time-consuming, and current at-home technology is difficult to use, is uncomfortable and doesn’t gather sufficient data at the right time periods or over long enough time periods for specialists to appropriately use the information to make optimized treatment decisions. 

The new technology is highlighted in a study published in the journal Nature Communications. The study compares Purdue’s technology to the current gold standard and other home monitoring systems and examines how the Purdue technology can gather important IOP measurements for 24-hour cycles, even during sleep.

The technology was developed by a multidisciplinary group of engineers and health care researchers from Purdue’s colleges of Engineering and Veterinary Medicine and the Indiana University School of Optometry.

“The largest increase in IOP often occurs while people are lying down, when overnight IOP is typically 10% to 20% greater than daytime IOP. Vision loss may occur during sleep without the patient noticing it, even if daytime in-clinic or at-home measurements indicate normal IOP,” says Lee, who has a joint appointment in the School of Mechanical Engineering and a courtesy appointment in the School of Materials Engineering.

Lee, who has worked on this technology for six years, specializes in sticktronics, which are sticker-like items that contain electronics or smart technology. His lab develops wearable biomedical devices that can continuously monitor chronic diseases or health conditions in an unobtrusive manner.

Dr. Pete Kollbaum, professor and associate dean for research with the Indiana University School of Optometry and director of the school’s Borish Center for Ophthalmic Research, has worked with Lee since 2019. Kollbaum’s Clinical Optics Research Lab group, which researches contact lens technologies, helped with the human clinical testing and provided feedback for design improvements.

Some of the current wearable tonometers — or devices that measure the pressure inside one’s eyes — are equipped with an integrated circuit chip, which leads to increased thickness and is stiffer than a typical commercial soft contact lens, in many cases causing discomfort for patients. Lee’s version is different.

“To address this unmet need, we developed a unique class of smart soft contact lenses built upon various commercial brands of soft contact lenses for continuous 24-hour IOP monitoring, even during sleep at home,” Lee said.

“Our smart soft contact lenses retain the intrinsic lens features of lens power, biocompatibility, softness, transparency, wettability, oxygen transmissibility and overnight wearability. Having all these features at the same time is crucial to the success of translating the smart soft contact lenses into glaucoma care, but these features are lacking in current wearable ocular tonometers.”

The tonometer on the Purdue-developed contact lens sensor creates a wireless recording that is transmitted to a receiver in a pair of eyeglasses for daytime IOP measurement and a sleep mask for IOP measurement when sleeping.

The complete 24-hour IOP rhythm data can be shared with clinicians remotely via an encrypted server. The tonometer can generate an audible alert for detection of IOP elevation, allowing appropriate action to take place and reducing the need for clinic visits.

“This tonometer is significantly more comfortable than any other type of contact lens sensor we have come across and more comfortable than any currently available commercially available IOP sensor,” Kollbaum said. “This is related to the technology that Lee uses to apply the sensor to the lens, retaining a very thin overall sensor, and to the fact that the lens itself is a time-tested, commercially available lens, leveraging the clinical studies and associated time and money the contact lens manufacturers have spent to assure a comfortable lens.”

Kollbaum said that not only do the specialized contact lenses provide crisp vision, just as any contact lens would, but the technology also expands the benefits for both patients and eye specialists, who have wanted less expensive and more comfortable ways to monitor eye changes for years.

“The eye is a very challenging body part that is even softer, more sensitive and curvilinear when compared to the skin,” Lee said. “We hope our approach can be also tailored for aiding and detecting other chronic ocular diseases and for other functions.”Lee and colleagues have a proposal for additional clinical trials with glaucoma patients who have dry eye diseases or who have had glaucoma surgery. They are also working with Boomerang Ventures, with which Purdue has a partnership, to incorporate the technology into clinical practice.

In addition to Lee and Kollbaum, members of the research team were Shin Ae Park, Seul Ah Lee, Bryan W. Boudouris, Yumin Dai, Keely E. Harris, Bongjoong Kim, Ho Joong Kim, Kyunghun Kim, Hyowon (Hugh) Lee, Kangying Liu, Haesoo Moon, Woohyun Park, Jay V. Shah and Jinyuan Zhang from Purdue; Dawn Meyer from the Indiana University School of Optometry; and Pedro Irazoqui and Brett Collar from Johns Hopkins University.

The technology was disclosed to the Purdue Research Foundation Office of Technology Commercialization (OTC), which has applied for a provisional patent from the U.S. Patent and Trademark Office to protect the intellectual property. For information on licensing opportunities, contact Patrick Finnerty of OTC at pwfinnerty@prf.org about 2021-LEE-69240.

Lee’s work at Weldon School of Biomedical Engineering is just one of many life-changing projects conducted by the biomedical engineering faculty and students. Many of those projects are partnerships among Weldon, health care providers, medical researchers and medical device companies that are key in taking aspects from classes and research labs into clinical settings.

Chicago-based business takes its cloud manufacturing operations beyond Midwest.

Cloud manufacturing company, Fractory, one of Estonia’s famed high-growth startup businesses, is continuing to expand across the US.

Fractory entered the U.S. market earlier in the year, with a base in Chicago from which it began doing business across the Midwest. Now, with its supplier network growing across the country, it began offering its automated manufacturing procurement service coast to coast October 1, 2022.

Fractory is an automated on-demand manufacturing platform connecting engineers and manufacturing companies.

“Our beta stage, trading across Illinois and surrounding states, has shown us the way ahead for national expansion,” says Nikodem Pancewicz, who runs Fractory’s USA operations. “In operating across the whole of the US we aim to grow Fractory’s customer base by more than 700% within two years. Fractory is well-established in Nordic and Baltic countries. We have been successfully expanding in the U.K. And we are now ideally placed to service the entire US market.”

Fractory Country Manager USA, Nikodem, studied at Harvard and Northwestern and worked at ABB and Eaton. He specializes in sustainable manufacturing and supply chains.

“Fractory’s built by engineers for engineers. Every function is run by people with engineering expertise, which has allowed us to create something that users value and come back to on a regular basis.” he says.

“The Fractory solution is born out of the Estonian experience where, very quickly, after achieving independence in 1991, Estonia became, arguably, the world’s most digitally advanced society, where much of everyday life is automated. That experience explains Fractory’s engineer founders automating the processes within their own industry, specifically manufacturing procurement, with the aim of saving time and money and making manufacturing more sustainable.”

Fractory provides access to manufacturing processes online, including laser, sheet and tube cutting, metal bending, surface treatment and CNC machining.

Fractory funding In June Fractory was issued with a $4M USD venture debt facility from Kreos Capital, an investor which specializes in high-growth companies. Eligible startups often opt for venture debt to extend their growth period and maximize value in the next funding round.

Fractory had earlier raised $9M USD in Series A funding in 2021, before beginning its operations in Chicago and across the Midwest.

Martin Vares, Fractory co-founder & CEO, says, “Raising a strong A round last year gave us the tools to improve our position and this new funding helps as we expand further. This type of funding, a loan facility, is not issued because of Fractory’s potential, but because of our strong business performance.”

Kreos Capital is a sought after and experienced growth partner which works exclusively with carefully vetted high-growth businesses. Since 1998, Kreos Capital has committed in excess of $3.7bn across +670 transactions, to more than 550 high-growth companies. Today, Kreos invests more than $500m a year.

Fractory’s mission Fractory has been trading since 2017 and was founded by mechanical engineer-turned entrepreneur Martin Vares along with Joosep Merelaht (COO) and Rein Torm (CTO). Fractory connects engineering companies to production capacity online, providing instant access to manufacturing processes - including laser, sheet and tube cutting and CNC machining. It improves efficiency, accessibility and quality. Through its cloud-manufacturing platform which enables access to market availability for fabrication services, Fractory makes manufacturing more sustainable.

Since inception, Fractory has demonstrated average annual growth of 300% and employee number growth of 250%.

The company unveiled its new branding at IMTS 2022, introducing a new name, logo, and website to better support its distribution network and customers.

Tsugami America, the exclusive North American importer of Precision Tsugami Machine Tools, has launched an extensive rebranding effort in response to expansive growth in the United States and beyond.

“We are very excited to reintroduce ourselves as Tsugami America here at IMTS” says Tsugami America president Michael Mugno. “Our hope is that this new look better matches the modern technology of the machinery and reflects our partnership with our customers.”

Tsugami America will continue to operate as the official source for Tsugami Machine Tools in North America, as well as continue to provide application engineering services, support an extensive domestic spare parts warehouse, provide operator and programmer training classes, and perform preventative maintenance and on call service support.

“We think our customers will enjoy our new name and logo, but we also want our customers to know while our look and name have changed, we still provide the same world class technology and dedicated local service and support,” Mugno says.

The company name change was determined as the most direct correlation to the partnership between Tsugami America and Precision Tsugami and the shared dedication to fast, accurate, and rigid machining solutions. The new branding will be rolled out across North America in the coming weeks.

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Growth in demand for syringes requires a faster production process.

Demand for pharma packaging products vastly increased following the COVID crisis, requiring an accelerated production process. This includes faster inspection and packing without negatively impact on quality, a factor of great importance for SCHOTT POONAWALLA, a leading manufacturer of premium pharmaceutical containers made of neutral glass tubing such as vials, syringes, ampoules, and cartridges.

Since the beginning of vaccine rollout for the epidemic, SCHOTT POONAWALLA has provided pharmaceutical glass for primary packaging to fill billions of COVID vaccines worldwide. The Indian pharmaceutical packaging market of 2017 reached €1.76 billion and is expected to rise to €3 billion by the end of 2023. As a provider of high-quality pharma products for manufacturers, the company prepared its facilities for the increase in vaccine sales that was expected to triple last year.

To stay ahead of the anticipated growth in demand, SCHOTT POONAWALLA implemented a fully automated GMP-compliant production line along with a clean and hygienic environment at its plant in Umarsadi, Gujarat for the inspection and packing of pre-filled nested syringes. After comparing the speed of manual inspection and packing to an automated process, SCHOTT POONAWALLA decided to make its Umarsadi plant fully automated.

One step in a six-point process that yields two tubs per minute: Six-axis robots carry out the delicate task of nesting the syringes with high speed and precision.

Implementing Stäubli Robotics cuts time of inspections and packing time in half Stäubli Robotics contributed to the production line by doubling the speed of inspections and packing at SCHOTT POONAWALLA’s Umarsadi plant. Manual production at the plant equated to the speed of one tub per minute; with Stäubli Robotics automation, it is done with a speed of two tubs per minute. Three types of cleanroom robot models are used to pre-fill syringes and ampoules. Stäubli Robotics Suite lessens programming time as well as modification time in offline activity.

First, SCARA robots pick and place syringes from a conveyor. Next, 6-axis robots perform nesting of the syringes. Afterward, the robots handle and inspect the syringe nest, then place QC-approved nests into the tub. This is followed by packing the nest and tub by placing inner and outer Tyvek on the tub. Lastly, the robots perform heat-sealing on the tub and bag the products.

The surface of these robots has a special coating, and the entire structure is fully sealed. Therefore, they can be cleaned with IPA, an agent for disinfecting the equipment used in the cell, normally 70% diluted. Alcohol is used as a medium of disinfecting the cell; the diluted alcohol also coagulates proteins, but at a slower rate, so that it penetrates all the way through the cell before coagulation can block it. Then the entire cell is coagulated, and the organism dies.

Following a six-point process, the robots provide clean and consistent performance of packaging and inspection of pre-filled syringes, maintaining the quality of the products. SCHOTT POONAWALLA concluded that the Stäubli robots provided consistent day-to-day, batch-to-batch production with a clean and hygienic operation. The fully automated setup with the robots also offers the company the flexibility to produce new variants.

SCHOTT POONAWALLA ensures each batch is processed identically, delivering reliable and reproducible results. By using the Stäubli TX2 and TS2 robots, SCHOTT POONAWALLA achieves great speed and repeatability. The company finds great use for automation to meet the volume of production demanded without compromising quality, as the compact robots comply with hygienic requirements.

Robots handle and inspect syringe nests, placing QC-approved nests into a tub, nearing completion of the packaging process cycle. End user safety is assured.

Stäubli enhances patient safety while performing twice as fast as manual workers The SCHOTT POONAWALLA Umarsadi Gujarat plant began by implementing manually performed inspection and packing processes. The task was completed at a speed of one tub per minute. When the company tested an automated process using robots, the task was finished at a speed of two tubs per minute. This shows a 50% time reduction.

The company’s reputation for quality-focused products, implementing the latest technologies, has made it one of the first in the world to introduce new products like nested sterile syringes and cartridges, over and above its existing portfolio of sterile nested syringes. With quality as the central point for SCHOTT, the integration of an automated process needed to meet demanding standards to ensure end-user safety. The robots fit GMP standards and contribute to a clean and hygienic environment, the number one reason SCHOTT chose Stäubli. In addition to this, the flexibility offered by the robots to produce new variants of vials, ampoules and pre-filled syringes allows SCHOTT POONAWALLA to meet the changing demands of its customers.

Overall, the robots provide a clean and consistent performance of packaging and inspection of syringes, maintaining the quality of the products and speeding up the process. This allows SCHOTT to remain committed to international quality standards, quality assurance methods, and fully automated inspection systems.