07.30.19
AT A GLANCE
Rank: #26 (Last year: #26)
$3.37 Billion ($5.1B total)
Prior Fiscal: $3.32 Billion
Percentage Change:+1.5%
No. of Employees: 19,675 (37,512 total)
Global Headquarters: Shinjuku-ku, Tokyo, Japan
KEY EXECUTIVES
Hiroshi Suzuki, President and CEO
Ryo Hirooka, CFO
Eiichiro Ikeda, COO, Information Technology and Chief Technology Officer
Augustine Yee, Chief Legal Officer and Head of Corporate Development and Affairs
One would think endoscope manufacturers would be extra vigilant given the bad press of recent years.
The wave of infections topped headlines as accounts of contaminated duodenoscopes came to light. In response, in 2015 the U.S. Food and Drug Administration (FDA) mandated U.S. duodenoscope manufacturers to conduct a postmarket surveillance study assessing healthcare facilities’ ability to clean and disinfect the scopes. Specifically, the three manufacturers—Olympus, Fujifilm, and Pentax Medical (Hoya Group’s surgical division)—were ordered to conduct a study to sample and culture reprocessed scopes to glean more about the issues contributing to contamination. They were also required to perform a human factors study checking whether hospital staff were adequately trained to follow reprocessing procedures.
None of the scope makers complied save for Fujifilm, which had only met requirements for its human factors study. Unsurprisingly, the noncompliance prompted the FDA to issue all three firms a warning letter last March. Pentax both failed to provide sufficient postmarket data and did not comply with the human factors study requirements.
“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a prepared statement. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”
The FDA’s not-so-gentle nudge required Pentax to submit a plan outlining how study milestones would be achieved and expected 100 percent of samples and cultures to be processed by 2018’s end. If Pentax failed to appropriately heed the FDA’s warning, retribution would likely ensue in the form of seizure, injunction, and civil money penalties.
Pentax appears to have gotten its act together, because no such punishments have come to light. In fact, according to Hoya’s most recent financial data, the scope maker was a boost rather than a burden. Medical endoscopy sales trended strongly in Europe and the U.S. thanks to new product introductions and sales framework strengthening. Hoya’s Medical segment, which contains both Pentax and intraocular lenses (IOLs) manufactured by Hoya Surgical Optics (HSO), amassed 9.18 billion yen, rising 5 percent from the previous fiscal year. Favorable IOL trends in the Japanese market also aided this boost.
In late December 2017, before Pentax had incurred the FDA’s wrath, it launched the C.A.P. HD Duodenoscope (ED34-i10T), the first FDA-cleared duodenoscope with a disposable distal cap. The new feature aimed to improve cleaning and reprocessing access that was hindered by a previous risk of cracks and gaps developing in the adhesive that seals the scope’s distal cap onto the scope. The new scope also features a simpler user interface, improved ergonomics and image quality, and a reduced length.
“In my practice, the use of the ED34-i10T [C.A.P. HD Duodenoscope] has helped improve the quality of procedures as its high definition image provides increased detailed visualization of the papilla by using advanced digital imaging technologies. This allows us to differentiate between normal papillae and adenomas,” said Dr. Carlos Robles-Medranda, Guayaquil, Instituto Ecuatoriano de Enfermedades Digestivas (IECED), University Hospital OMNI, Ecuador, at the time of launch. “Additionally, the new design provides greater comfort during long procedures and requires less lever force to cannulate and maintain the required positioning, making this scope a must have tool for successful ERCP procedures.”
Pentax also launched the J10 Series Video Naso-Pharyngo-Laryngoscopes and the DEFINA EPK-3000 Video Processor last April. The J10 Series includes a portfolio of three endoscopes, each with vivid HD image quality and advanced hygiene features. The UltraSlim HD touts a 2.4 mm distal end, currently the smallest distal end diameter on an HD video naso-pharyngo-laryngoscope available on the market. DEFINA EPK-3000 combines surface, contrast, and tone enhancement algorithms to highlight topography, edges, and color tones to augment visualization of blood vessels and surface anomalies.
Hoya made the first of two notable investments in the endoscopy business last May. Israel-based 3NT Medical, a developer of endoscopes for ENT surgeons, closed a major portion of its $15 million financing round from Hoya. The funds will be used to complete 3NT’s family of specialty single-use endoscopes and therapeutic devices, as well as to begin U.S. and European commercialization of its Sinusway Driveable Endoscope. 3NT is Hoya’s first venture investment in an Israeli company.
Pentax gained majority stake in PlasmaBiotics last August. The Parisian firm specializes in endoscope storage and drying, with core products that significantly reduce scope reprocessing cycle times and minimize bacterial contamination via ultra-fast endoscopic channel drying and active storage with plasma. PlasmaBiotics’ products integrate easily into most current reprocessing protocols.
HSO began the purchase of California-based Mid Labs and Germany-based Fritz Ruck last October. Mid Labs specializes in ophthalmic surgical devices to prevent blindness caused by traumatic injuries and some retinal diseases. Fritz Ruck manufactures dual function phacoemulsification machines and accessories and distributes other ophthalmic equipment. The acquisitions fortify Hoya’s position in the IOL market and permits entry into the global retinal market, which is forecasted to grow as a result of the increasing elderly population.
The Hoya MW10 HiKARI wearable device, which was developed based on Kyushu University contract research implemented in 2016, hit the Japanese market last November. The eyeglasses-type wearable supports dim-light vision of patients with night blindness, projecting images captured by a low-light, high sensitivity compact camera on a display screen in front of the wearer’s eyes. Unlike infrared cameras, the device amplifies faint lights in places to recreate an object’s natural color.
Last January HSO opened the doors of its new global R&D facility aimed at developing breakthrough IOL technologies in Singapore. The move made Hoya the first IOL company in the world to establish worldwide integrated operations in Singapore—HSO’s headquarters, manufacturing plant, and R&D center are all based there.
Hoya’s Health Care segment, comprised of eyeglass lenses, contact lenses, and related accessories, garnered 281.61 billion yen. Growth in existing business in the Americas and the recent Performance Optics acquisition provoked the 6 percent rise. New “Eyecity” retail stores and enhanced existing stores also increased new customers and grew contact lens sales.
Rank: #26 (Last year: #26)
$3.37 Billion ($5.1B total)
Prior Fiscal: $3.32 Billion
Percentage Change:+1.5%
No. of Employees: 19,675 (37,512 total)
Global Headquarters: Shinjuku-ku, Tokyo, Japan
KEY EXECUTIVES
Hiroshi Suzuki, President and CEO
Ryo Hirooka, CFO
Eiichiro Ikeda, COO, Information Technology and Chief Technology Officer
Augustine Yee, Chief Legal Officer and Head of Corporate Development and Affairs
One would think endoscope manufacturers would be extra vigilant given the bad press of recent years.
The wave of infections topped headlines as accounts of contaminated duodenoscopes came to light. In response, in 2015 the U.S. Food and Drug Administration (FDA) mandated U.S. duodenoscope manufacturers to conduct a postmarket surveillance study assessing healthcare facilities’ ability to clean and disinfect the scopes. Specifically, the three manufacturers—Olympus, Fujifilm, and Pentax Medical (Hoya Group’s surgical division)—were ordered to conduct a study to sample and culture reprocessed scopes to glean more about the issues contributing to contamination. They were also required to perform a human factors study checking whether hospital staff were adequately trained to follow reprocessing procedures.
None of the scope makers complied save for Fujifilm, which had only met requirements for its human factors study. Unsurprisingly, the noncompliance prompted the FDA to issue all three firms a warning letter last March. Pentax both failed to provide sufficient postmarket data and did not comply with the human factors study requirements.
“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a prepared statement. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”
The FDA’s not-so-gentle nudge required Pentax to submit a plan outlining how study milestones would be achieved and expected 100 percent of samples and cultures to be processed by 2018’s end. If Pentax failed to appropriately heed the FDA’s warning, retribution would likely ensue in the form of seizure, injunction, and civil money penalties.
Pentax appears to have gotten its act together, because no such punishments have come to light. In fact, according to Hoya’s most recent financial data, the scope maker was a boost rather than a burden. Medical endoscopy sales trended strongly in Europe and the U.S. thanks to new product introductions and sales framework strengthening. Hoya’s Medical segment, which contains both Pentax and intraocular lenses (IOLs) manufactured by Hoya Surgical Optics (HSO), amassed 9.18 billion yen, rising 5 percent from the previous fiscal year. Favorable IOL trends in the Japanese market also aided this boost.
In late December 2017, before Pentax had incurred the FDA’s wrath, it launched the C.A.P. HD Duodenoscope (ED34-i10T), the first FDA-cleared duodenoscope with a disposable distal cap. The new feature aimed to improve cleaning and reprocessing access that was hindered by a previous risk of cracks and gaps developing in the adhesive that seals the scope’s distal cap onto the scope. The new scope also features a simpler user interface, improved ergonomics and image quality, and a reduced length.
“In my practice, the use of the ED34-i10T [C.A.P. HD Duodenoscope] has helped improve the quality of procedures as its high definition image provides increased detailed visualization of the papilla by using advanced digital imaging technologies. This allows us to differentiate between normal papillae and adenomas,” said Dr. Carlos Robles-Medranda, Guayaquil, Instituto Ecuatoriano de Enfermedades Digestivas (IECED), University Hospital OMNI, Ecuador, at the time of launch. “Additionally, the new design provides greater comfort during long procedures and requires less lever force to cannulate and maintain the required positioning, making this scope a must have tool for successful ERCP procedures.”
Pentax also launched the J10 Series Video Naso-Pharyngo-Laryngoscopes and the DEFINA EPK-3000 Video Processor last April. The J10 Series includes a portfolio of three endoscopes, each with vivid HD image quality and advanced hygiene features. The UltraSlim HD touts a 2.4 mm distal end, currently the smallest distal end diameter on an HD video naso-pharyngo-laryngoscope available on the market. DEFINA EPK-3000 combines surface, contrast, and tone enhancement algorithms to highlight topography, edges, and color tones to augment visualization of blood vessels and surface anomalies.
Hoya made the first of two notable investments in the endoscopy business last May. Israel-based 3NT Medical, a developer of endoscopes for ENT surgeons, closed a major portion of its $15 million financing round from Hoya. The funds will be used to complete 3NT’s family of specialty single-use endoscopes and therapeutic devices, as well as to begin U.S. and European commercialization of its Sinusway Driveable Endoscope. 3NT is Hoya’s first venture investment in an Israeli company.
Pentax gained majority stake in PlasmaBiotics last August. The Parisian firm specializes in endoscope storage and drying, with core products that significantly reduce scope reprocessing cycle times and minimize bacterial contamination via ultra-fast endoscopic channel drying and active storage with plasma. PlasmaBiotics’ products integrate easily into most current reprocessing protocols.
HSO began the purchase of California-based Mid Labs and Germany-based Fritz Ruck last October. Mid Labs specializes in ophthalmic surgical devices to prevent blindness caused by traumatic injuries and some retinal diseases. Fritz Ruck manufactures dual function phacoemulsification machines and accessories and distributes other ophthalmic equipment. The acquisitions fortify Hoya’s position in the IOL market and permits entry into the global retinal market, which is forecasted to grow as a result of the increasing elderly population.
The Hoya MW10 HiKARI wearable device, which was developed based on Kyushu University contract research implemented in 2016, hit the Japanese market last November. The eyeglasses-type wearable supports dim-light vision of patients with night blindness, projecting images captured by a low-light, high sensitivity compact camera on a display screen in front of the wearer’s eyes. Unlike infrared cameras, the device amplifies faint lights in places to recreate an object’s natural color.
Last January HSO opened the doors of its new global R&D facility aimed at developing breakthrough IOL technologies in Singapore. The move made Hoya the first IOL company in the world to establish worldwide integrated operations in Singapore—HSO’s headquarters, manufacturing plant, and R&D center are all based there.
Hoya’s Health Care segment, comprised of eyeglass lenses, contact lenses, and related accessories, garnered 281.61 billion yen. Growth in existing business in the Americas and the recent Performance Optics acquisition provoked the 6 percent rise. New “Eyecity” retail stores and enhanced existing stores also increased new customers and grew contact lens sales.
