Changing requirements, smaller components, advanced technologies are improving these widely used devices.
Edited by Michelle Jacobson
Endoscopes have evolved since Philipp Bozzini first developed the device in 1806, with modern versions using fiber-optics, light sources, improved optical components, and cameras placed at their distal tip.
Consequently, endoscopes are now broadly used in various medical fields, such as laparoscopies, gastrointestinal endoscopies, arthroscopies, obstetrics/gynecology endoscopies, and urology, bronchoscopy, mediastinoscopy, and ear, nose, and throat (ENT) endoscopies.
Due to growing demand and expansion to new territories, the endoscopy market is expected to grow at a compound annual growth rate (CAGR) of 6.6% to reach $35 billion by 2024. However, cost pressures such as health reforms and low accessibility in developing countries, as well as safety concerns, such as nosocomial infections and contamination, are becoming challenges.
The only sustainable endoscope growth opportunity is through improving the product, operation, and device cost structure. Innovation can be supported by exploring relevant technologies from different areas – such as semiconductors, artificial intelligence (AI), and Internet of Things (IoT), while examining a specific product in depth and analyzing it.
One approach to disruptive product innovation is described in David Boyd and Jacob Goldenberg’s book, Inside the Box, where one can examine the components of a product and take one of the following approaches to create a new product:
•Division (separate functions)
•Multiplication (picture in picture)
•Task unification (visualization, diagnostic procedure)
•Attribute dependency (data collection, analysis)
When examining endoscopy using this method, consider these factors:
•Components of available devices – Endoscopes, visualization equipment, other endoscopy equipment, accessories; Examine whether they can play with the existing components via subtraction/multiplication/unification, be improved, or added to new ones based on advanced technology.
•Key addressable need of each stakeholder – Patients, physicians, hospitals/clinics, insurers; Look to improve convenience, pre-/post-procedure care, sterility, reliability, accessibility, accuracy, training needs, procedure and hospitalization costs.
•External environment – Regulatory, reimbursement
•Technological developments – Advances in precision, image quality, lag time, size, accessibility
•Key challenges, opportunities for medical device company – Operational aspects including R&D, production, marketing; challenges versus positive regulatory environment and opportunities
Recent changes driving innovation in the endoscope market include:
External Factors – August 2019 FDA finding promotes the shift to disposable endoscopes.
Following a report of a post-marketing surveillance study on the real-world contamination rates for duodenoscopes in clinical use, which showed elevated rates of contamination including high-concern organisms often associated with disease transmission, the following guidance was released.
“The FDA believes the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary,” FDA officials say in their report on reducing contamination. “For example, duodenoscopes that incorporate disposable components can facilitate cleaning, reduce contamination, and reduce disease transmission following reprocessing. Disposable designs may reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed endcaps.”
Stakeholder Interests – Cost, reimbursement pressures.
Unfavorable healthcare reforms in the U.S. and limited reimbursement in developing countries pose a challenge due to acquisition and operation costs, including training and cleaning traditional endoscopies.
Major technological developments – Semiconductor technology lowers costs and improves resolution on CCD and CMOS sensors for visual imaging needs.
The marriage between fiber-optics technology and visual imagers allowed, for the first time, in-vivo visual exploration inside the human body, without the need for highly invasive surgery. As another key development in recent years, it has become possible to reduce device sizes exponentially, with the smallest video camera being 1mm in diameter.
Cameras can connect directly to optic fiber bundles containing thousands of individual fibers, each acting as a mirroring channel, but this approach limits flexibility, and fibers are breakable and costly. Distal tip cameras situate imaging at the front end of the device. This is the first element that encounters the collected light, and an electric wire transfers the video signals.
Beyond visualization, integrating mini-cameras within endoscopes vacates precious space for other elements, allows endoscopic procedures in smaller internal cavities, and supports more complicated procedures to be performed via surgical endoscopy.
In summary, much-needed product innovation in endoscopy is driving toward disposable endoscopes. Estimates call for the disposable endoscopes market value to hit $3.1 billion by 2026. Most likely, the primary focus will be on sterile areas where infection poses high risk, such as biliary tract, urinary tract, and the central nervous system. But, other fields requiring customized solutions will follow.
All major players are exploring the area and, to-date, the FDA has approved five endoscopes with disposable elements.
Current options are still very expensive and have limited performance, so to address the needs of stakeholders, new components and advanced technologies, such as miniature affordable cameras, must be included in future designs.