Michael Barbella, Managing Editor12.03.21
Conquering the Final Frontier won’t be easy.
Space is not the kindest environment for human biology: It deflates muscles, decalcifies bones, damages eyes, stresses the heart, changes immunity, and disrupts the genome.
Simply put, the cosmos shortens homo sapiens’ overall life expectancy.
The kidneys are particularly vulnerable to the universe’s harsh conditions because they can collect all the lost calcium from bones. Such an inclination can be dangerous for rocketeers—more than 30 astronauts have developed kidney stones within two years of their space flights, leaving them vulnerable during future trips to Mars or the moon (the average ETA to the Red Planet is seven months).
Consequently, NASA is interested in technology being tested at the University of Washington Medical Center that would enable patients with small kidney stones to “push” the tiny rocks from their bodies, thereby avoiding surgery. The technology uses ultrasound waves to dislodge and move small kidney stone fragments remaining after surgery so the body can naturally expel them. A clinical trial currently is being conducted; researchers hope to finalize results and submit the data to the U.S. Food and Drug Administration next year.
The same idea is under development at UCI Health, where four urologists are tweaking designs for a new ureteroscope that can remove all kidney stone fragments during surgery. The ureteroscope will include features intended to improve kidney stone removal efficiency and efficacy such as multiple laser channels and multidirectional deflection.
“The ureteroscope, which is only one-eighth of an inch in diameter, allows the surgeon to move across the urethra, bladder, and ureter and enter the kidney, all through normal passageways,” Ralph V. Clayman, M.D., a UCI Health urologist, a distinguished professor of urology and dean emeritus of the UCI School of Medicine, said. “The ureteroscope is commonly passed through an outer sheath that protects the ureter during stone extraction and facilitates passage of the ureteroscope into the kidney. Stones are then fragmented using a laser fiber that is the size of three human hairs.”
Demand for minimally invasive surgical techniques and the rising prevalence of chronic diseases are expected to fuel growth of the global endoscope market over the next seven years. Grand View Research Inc. data predicts the worldwide market to swell 9.2 percent annually through 2028, with the disposable endoscopes segment growing the fastest during the forecast period.
MPO’s feature “Widening Scope” explores the trends and challenges impacting the global endoscope market, as well as the promising future for these devices. Charles Golub, market development manager for Saint-Gobain Life Sciences Medical Components, was among the experts interviewed for the story. His full input is provided in the following Q&A:
Michael Barbella: Please discuss the current trends in the global endoscopy market and the factors driving those trends.
Charles Golub: There are a few major trends shaping the global endoscopic procedures market. The first is the broadly increasing adoption rate of minimally invasive or endoscopic procedures within the surgical setting. Previously, standard treatment options involved highly invasive procedures; recently though, endoscopic procedures are becoming more routine, which is enabling quicker patient recovery times and reducing the burden on hospitals. Along those lines, flexible endoscopes are replacing some of the rigid scopes, enabling physicians to conduct surgeries in previously inaccessible areas. Some of the devices used for the endoscopic procedure are evolving towards single use to reduce patient risk associated with reprocessing for multi-use.
Barbella: What challenges are currently facing the market? How is your company working to overcome these challenges?
Golub: One of the largest hazards the industry faces today is hospital acquired infections (HAI). There are a number of ways in which Saint-Gobain is offering solutions. The first is providing custom filtration products to the automated endoscope reprocessors (AERs). These filters reduce complexity for technicians, making them easy to replace during routine preventative maintenance. Having the unique ability to come to sanitization temperature rapidly, they can improve the reprocessing cycle time. Proper preventative maintenance of the filter is a critical step towards ensuring the AER operates in the manner it was designed every time. Some filters have also been designed and validated to retain microorganisms that are present in clinical settings that are typically smaller than other standard reference organisms. This provides even greater confidence in preventing HAIs.
As a result of the increasing concern for HAI we are also seeing an increase in demand for single-use endoscopy. Saint-Gobain offers custom high-performance shaft tubing, where our material and extrusion expertise enables us to optimize the balance of flexibility and rigidity for our customer’s single use design. We have some unique process technologies that include engineering thermoplastics such as thin walled PEEK, over-molding connectors to the shaft assemblies, or even designing the distal portion of the scopes.
Barbella: What new applications and procedures are endoscopes currently being used for? How has this changed in recent years?
Golub: One of the rapidly growing areas is neuroendoscopy due to miniaturization of devices and choice of practitioner. Neurosurgeons are using endoscopic procedures more often when treating things such as hydrocephalus, craniosynostosis, and treatment of tumors and cysts and this is largely because the advancements in devices has enabled procedures to have higher success and shorter recovery over more invasive ones that have the potential for peripheral damage. Ultimately, this trend will lead to a number of serious health conditions being much more treatable with greater patient safety.
Barbella: How has medical device/component miniaturization impacted endoscope design? Is there a growing interest in/effort to develop capsule endoscopic devices as a result?
Golub: Miniaturization has pushed traditional designs and materials to their physical limits, prompting the use of unique composites and new materials we wouldn’t have seen 15 years ago. The ability to create materials that have a low coefficient of friction while maintaining flexibility and the ability to coextrude or bond to other materials has opened up unique possibilities. We’ve seen our Tygon LCF (low coefficient of friction) that was launched last year being evaluated for some novel endoscopic designs because it is a truly unique option that satisfies both of those needs—a soft flexible material that can be coextruded and/or easily bonded.
Barbella: What safeguards are endoscope developers/manufacturers incorporating into designs to reduce hospital-acquired and medical scope-transmitted infections?
Golub: We have a dual approach to reduce hospital-acquired infections. The first is customized filtration solutions for automated endoscope reprocessors (AERs). Traditionally, many of the endoscope reprocessors have filters that require an operator to change the capsule as preventative maintenance. By opening the housing this could increase the risk of cross contamination. Our custom filter designs offer ease of change out for the AER operator so inadvertent installation risk is significantly reduced, as well as less likelihood of any contamination by opening the filter housing. The second approach we take is helping customers develop single-use solutions. With our experience in various endoscope designs, we can help guide customers to a solution that will meet their needs as well as provide for ease of manufacturing.
Barbella: Is there more interest now in single-use endoscopes in the wake of infections and patient deaths tied to dirty duodenoscopes? Please elaborate.
Golub: There has been an increase of technical literature highlighting remaining bacteria on multi-use endoscopes after reprocessing and the FDA looking into infections from certain urologic endoscopes. This seems to be driving interest as we’ve seen a number of new products entering the market, and some device manufacturers that were traditionally not offering duodenoscopes decided to use their expertise in other areas to enter this market. Now, more than ever, we need to find solutions for single-use devices; that trend is only going to accelerate in the coming years.
Barbella: How is AI and robotics being incorporated into endoscope design and technology?
Golub: Many endoscopic surgeries started using robotic assisted devices years ago, specifically some of the thoracic procedures for lung cancer. Newer procedures are rapidly adopting this technology, such as the natural office surgeries (NOTES procedures). As these devices gain more acceptance and popularity with physicians and practitioners, I anticipate we’ll see many new challenges arise in the design and ease of use for these endoscopic devices.
Barbella: What is the future growth potential for the endoscope market? Is there any sub-sector within the market that is especially primed for growth?
Golub: I look forward to seeing how new materials can help to enable ease of use for practitioners. Specifically, more flexible, lower coefficient of friction materials that can help make endoscopes more malleable, which in turn will allow for the scope to be more easily maneuvered throughout the body. Using these materials in single-use applications to help reduce HAIs will bring forth the next generation of endoscopic devices.
Space is not the kindest environment for human biology: It deflates muscles, decalcifies bones, damages eyes, stresses the heart, changes immunity, and disrupts the genome.
Simply put, the cosmos shortens homo sapiens’ overall life expectancy.
The kidneys are particularly vulnerable to the universe’s harsh conditions because they can collect all the lost calcium from bones. Such an inclination can be dangerous for rocketeers—more than 30 astronauts have developed kidney stones within two years of their space flights, leaving them vulnerable during future trips to Mars or the moon (the average ETA to the Red Planet is seven months).
Consequently, NASA is interested in technology being tested at the University of Washington Medical Center that would enable patients with small kidney stones to “push” the tiny rocks from their bodies, thereby avoiding surgery. The technology uses ultrasound waves to dislodge and move small kidney stone fragments remaining after surgery so the body can naturally expel them. A clinical trial currently is being conducted; researchers hope to finalize results and submit the data to the U.S. Food and Drug Administration next year.
The same idea is under development at UCI Health, where four urologists are tweaking designs for a new ureteroscope that can remove all kidney stone fragments during surgery. The ureteroscope will include features intended to improve kidney stone removal efficiency and efficacy such as multiple laser channels and multidirectional deflection.
“The ureteroscope, which is only one-eighth of an inch in diameter, allows the surgeon to move across the urethra, bladder, and ureter and enter the kidney, all through normal passageways,” Ralph V. Clayman, M.D., a UCI Health urologist, a distinguished professor of urology and dean emeritus of the UCI School of Medicine, said. “The ureteroscope is commonly passed through an outer sheath that protects the ureter during stone extraction and facilitates passage of the ureteroscope into the kidney. Stones are then fragmented using a laser fiber that is the size of three human hairs.”
Demand for minimally invasive surgical techniques and the rising prevalence of chronic diseases are expected to fuel growth of the global endoscope market over the next seven years. Grand View Research Inc. data predicts the worldwide market to swell 9.2 percent annually through 2028, with the disposable endoscopes segment growing the fastest during the forecast period.
MPO’s feature “Widening Scope” explores the trends and challenges impacting the global endoscope market, as well as the promising future for these devices. Charles Golub, market development manager for Saint-Gobain Life Sciences Medical Components, was among the experts interviewed for the story. His full input is provided in the following Q&A:
Michael Barbella: Please discuss the current trends in the global endoscopy market and the factors driving those trends.
Charles Golub: There are a few major trends shaping the global endoscopic procedures market. The first is the broadly increasing adoption rate of minimally invasive or endoscopic procedures within the surgical setting. Previously, standard treatment options involved highly invasive procedures; recently though, endoscopic procedures are becoming more routine, which is enabling quicker patient recovery times and reducing the burden on hospitals. Along those lines, flexible endoscopes are replacing some of the rigid scopes, enabling physicians to conduct surgeries in previously inaccessible areas. Some of the devices used for the endoscopic procedure are evolving towards single use to reduce patient risk associated with reprocessing for multi-use.
Barbella: What challenges are currently facing the market? How is your company working to overcome these challenges?
Golub: One of the largest hazards the industry faces today is hospital acquired infections (HAI). There are a number of ways in which Saint-Gobain is offering solutions. The first is providing custom filtration products to the automated endoscope reprocessors (AERs). These filters reduce complexity for technicians, making them easy to replace during routine preventative maintenance. Having the unique ability to come to sanitization temperature rapidly, they can improve the reprocessing cycle time. Proper preventative maintenance of the filter is a critical step towards ensuring the AER operates in the manner it was designed every time. Some filters have also been designed and validated to retain microorganisms that are present in clinical settings that are typically smaller than other standard reference organisms. This provides even greater confidence in preventing HAIs.
As a result of the increasing concern for HAI we are also seeing an increase in demand for single-use endoscopy. Saint-Gobain offers custom high-performance shaft tubing, where our material and extrusion expertise enables us to optimize the balance of flexibility and rigidity for our customer’s single use design. We have some unique process technologies that include engineering thermoplastics such as thin walled PEEK, over-molding connectors to the shaft assemblies, or even designing the distal portion of the scopes.
Barbella: What new applications and procedures are endoscopes currently being used for? How has this changed in recent years?
Golub: One of the rapidly growing areas is neuroendoscopy due to miniaturization of devices and choice of practitioner. Neurosurgeons are using endoscopic procedures more often when treating things such as hydrocephalus, craniosynostosis, and treatment of tumors and cysts and this is largely because the advancements in devices has enabled procedures to have higher success and shorter recovery over more invasive ones that have the potential for peripheral damage. Ultimately, this trend will lead to a number of serious health conditions being much more treatable with greater patient safety.
Barbella: How has medical device/component miniaturization impacted endoscope design? Is there a growing interest in/effort to develop capsule endoscopic devices as a result?
Golub: Miniaturization has pushed traditional designs and materials to their physical limits, prompting the use of unique composites and new materials we wouldn’t have seen 15 years ago. The ability to create materials that have a low coefficient of friction while maintaining flexibility and the ability to coextrude or bond to other materials has opened up unique possibilities. We’ve seen our Tygon LCF (low coefficient of friction) that was launched last year being evaluated for some novel endoscopic designs because it is a truly unique option that satisfies both of those needs—a soft flexible material that can be coextruded and/or easily bonded.
Barbella: What safeguards are endoscope developers/manufacturers incorporating into designs to reduce hospital-acquired and medical scope-transmitted infections?
Golub: We have a dual approach to reduce hospital-acquired infections. The first is customized filtration solutions for automated endoscope reprocessors (AERs). Traditionally, many of the endoscope reprocessors have filters that require an operator to change the capsule as preventative maintenance. By opening the housing this could increase the risk of cross contamination. Our custom filter designs offer ease of change out for the AER operator so inadvertent installation risk is significantly reduced, as well as less likelihood of any contamination by opening the filter housing. The second approach we take is helping customers develop single-use solutions. With our experience in various endoscope designs, we can help guide customers to a solution that will meet their needs as well as provide for ease of manufacturing.
Barbella: Is there more interest now in single-use endoscopes in the wake of infections and patient deaths tied to dirty duodenoscopes? Please elaborate.
Golub: There has been an increase of technical literature highlighting remaining bacteria on multi-use endoscopes after reprocessing and the FDA looking into infections from certain urologic endoscopes. This seems to be driving interest as we’ve seen a number of new products entering the market, and some device manufacturers that were traditionally not offering duodenoscopes decided to use their expertise in other areas to enter this market. Now, more than ever, we need to find solutions for single-use devices; that trend is only going to accelerate in the coming years.
Barbella: How is AI and robotics being incorporated into endoscope design and technology?
Golub: Many endoscopic surgeries started using robotic assisted devices years ago, specifically some of the thoracic procedures for lung cancer. Newer procedures are rapidly adopting this technology, such as the natural office surgeries (NOTES procedures). As these devices gain more acceptance and popularity with physicians and practitioners, I anticipate we’ll see many new challenges arise in the design and ease of use for these endoscopic devices.
Barbella: What is the future growth potential for the endoscope market? Is there any sub-sector within the market that is especially primed for growth?
Golub: I look forward to seeing how new materials can help to enable ease of use for practitioners. Specifically, more flexible, lower coefficient of friction materials that can help make endoscopes more malleable, which in turn will allow for the scope to be more easily maneuvered throughout the body. Using these materials in single-use applications to help reduce HAIs will bring forth the next generation of endoscopic devices.
