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RETINA surgical navigation system to enter global smart medical devices market

Sandy Du, DIGITIMES, Taipei 0

Improving medical technology and better quality of life have led to longer average life expectancies around the world. According to a UN estimate, the average life expectancy of the global population in 2019 was 72.3 years, but may soon grow to 74.3 years in 2030. This positive trend however is an increasing strain to the healthcare systems of many countries. To maximize the utilization of progressively limited medical resources, development towards smart and precision medicine is inevitable, subsequently driving up demands for surgical navigation systems. Furthermore, even though minimally invasive surgeries are safer, require smaller incisions, and allow patients to recover in shorter period of time, its usage is limited to just some cases in neurosurgery, craniofacial surgery or ENT surgery, because the areas to operate are not accessible to the naked eye. In these cases, doctors still have to rely on traditional surgeries which require larger incisions. With the latest technology, nonetheless, it is now possible to perform minimally invasive surgeries using surgical navigation systems, which allow the surgeons to see 3D radiology images in real-time while their surgical instruments are guided by the system into the surgical site.

Douglas Huang, president of EPED Inc, mentioned that even though international surgical navigation system brands like Medtronic, Brainlab, and Stryker have dominated the market over the past years, RETINA, the first fully made-in-Taiwan surgical navigation system developed by EPED is starting to receive recognitions beyond local medical device industry. Owing to its quick and precise tracking, great instrument compatibility, and high price-performance value, RETINA is becoming a rising star in the global medical device market. Huang emphasized that their graphical user interface was designed with user-friendly operation in mind and was therefore made to be as intuitive and accessible as possible. Surgical staff can simply use the system's laser scanner to register the patient after which the surgeon will not have to touch the software interface at all, ensuring that the surgery can be performed quickly, precisely, and safely.

Critical optical space location technology provides quick and precise tracking

Founded in 2007, EPED has been engaged in optical navigation technology research for many years. The team has a solid foundation and experience in the design and development of optical tracking unit, including optical tracking and positioning algorithms as well as medical software and related hardware. The company has already acquired many patents for its technology in several countries. Seeing the strong demand for surgical navigation systems in the global medical device market, EPED decided to use 3D optical positioning technology and professional medical software as their core technology. Building it up with medical imaging technologies like 3D computed tomography (CT) and magnetic resonance imaging (MRI) then combining them with image interpretation and 3D model data reconstruction, EPED then followed up by developing a software-user interface, establishing a surgical instrument database, implementing adaptable design for different instruments, and preoperative surgical path planning to create their RETINA surgical navigation system.

RETINA is a stereotactic surgery navigation system suitable to convey neurosurgery, craniofacial, ENT, oral & maxillofacial as well as plastic surgery and other types of minimally invasive surgical procedures. It can be combined with surgical instruments of major brands to allow for minimally invasive treatment at various surgical sites in a fast and safe manner, meeting the needs of surgeons in different specialties. Not only is the RETINA system more precise than those of major international brands, but the low cost of the consumables used for the system also gives it a higher price-performance value. RETINA has acquired certification from the Taiwan Ministry of Health and Welfare since October 2017, and has also obtained CE Marking Certification since November 2018 which opened the doors of the European markets for EPED; 510k registration from the US FDA is currently underway.

Huang points out that even though surgical navigation systems have very high precision requirements, the RETINA surgical navigation system is not only capable of completing registration in less than 90 seconds, but the system can also operate at fine precisions within 2.0mm when used in combination with higher resolution medical image, offering superior care quality to patients.

Starting from Southern and Eastern Europe to eventual global expansion

Ever since RETINA surgical navigation system entered the market, it has won a series of awards such as the 2019 Taiwan Excellence Award and the 2021 COMPUTEX d&i Awards. EPED hopes that they will be able to acquire more market exposure by working with TTA, leading to more sales both domestically and abroad.

In terms of actual market presence, EPED has already attained many clinical successes under its belt thanks to its long-term partnership with Kaohsiung Medical University, the Chung-Ho Memorial Hospital, and Show Chwan Memorial Hospital. EPED also hopes to be supported by Taiwan's IRCAD to further promote its products in the global market. Having obtained the CE Marking Certification, the company is first targeting markets in Southern and Eastern Europe before entering western markets which are currently dominated by prominent international brands. EPED has already established its sales systems and exhibition centers in Greece, Turkey, and Malaysia by working with local partners and expects that it will be able to penetrate into Spain, Italy, France, Ukraine, and Georgia markets as well as expand south into West Asia and the Arab world in the near future. As for the company's medium and long-term plan, it has already started to establish a presence in Southeast Asian countries like Vietnam and Thailand. With brand awareness established in the aforementioned markets, EPED will finally move on to the Americas and take on the global surgical navigation system market.


(Editor's note: The original article was published in TTA Magazine Issue 10. Read more startup stories in TTA Magazines.)

EPED's team

EPED's team
Photo: EPED