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Infection risk from reprocessed duodenoscopes is low, but the goal is zero
BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.
Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.
“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”
After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.
“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.
Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.
“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.
“There is no simple answer, because every solution so far has introduced some challenges,” Dr. Lichtenstein observed. Listing some examples, he noted that autoclaving results in damage to endoscopes since they are heat labile; that some proposed sterilization techniques may be limited by sterilants that can’t penetrate biofilm formation into deeper layers that harbor viable bacteria and are associated with a risk of toxicity to technicians or patients; and that disposable endoscopes or elevator mechanisms may involve unacceptable costs or operating characteristics. However, he is convinced there is a solution.
“The problem is being addressed from different angles, and I think we will find the solution within several years. This may involve a series of additional incremental improvements, but I think no one with a stake in this issue will sit comfortably until it is no longer a problem,” Dr. Lichtenstein said.
In the discussion that followed the formal presentations, it was generally acknowledged that the ultimate solution remains unclear even though incremental progress is being made. In fact, there have been no major outbreaks in the United States in the last year following the attention given to this issue, which is likely to have promoted more diligence in disinfection, according to Dr. Lichtenstein.
“Disposable endoscopes or disposable parts on endoscopes that facilitate cleaning may be coming, but I think the best current step is a standardized method of testing scopes after cleaning to verify that disinfection has been achieved,” Dr. Lichtenstein said.
Other solutions, including new sterilization techniques may also emerge, but there was general consensus that the human factor will always be important even if the best solution proves to be a disposable endoscope. Dr. Weber said, “You can still place a disposable scope on a contaminated surface. The human factor is always important.”
Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, and past chair of the AGA Center for GI Innovation and Technology, added, “AGA will build on the relationships that we have with the manufacturers of the endoscopes along with companies developing other novel approaches to reprocessing, as well as the FDA and CDC, to further the discussion. Ultimately, we hope to see the availability of devices that are effective and reliably clean so that we do not have to be concerned about patient-to-patient transmission of infection.”
BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.
Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.
“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”
After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.
“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.
Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.
“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.
“There is no simple answer, because every solution so far has introduced some challenges,” Dr. Lichtenstein observed. Listing some examples, he noted that autoclaving results in damage to endoscopes since they are heat labile; that some proposed sterilization techniques may be limited by sterilants that can’t penetrate biofilm formation into deeper layers that harbor viable bacteria and are associated with a risk of toxicity to technicians or patients; and that disposable endoscopes or elevator mechanisms may involve unacceptable costs or operating characteristics. However, he is convinced there is a solution.
“The problem is being addressed from different angles, and I think we will find the solution within several years. This may involve a series of additional incremental improvements, but I think no one with a stake in this issue will sit comfortably until it is no longer a problem,” Dr. Lichtenstein said.
In the discussion that followed the formal presentations, it was generally acknowledged that the ultimate solution remains unclear even though incremental progress is being made. In fact, there have been no major outbreaks in the United States in the last year following the attention given to this issue, which is likely to have promoted more diligence in disinfection, according to Dr. Lichtenstein.
“Disposable endoscopes or disposable parts on endoscopes that facilitate cleaning may be coming, but I think the best current step is a standardized method of testing scopes after cleaning to verify that disinfection has been achieved,” Dr. Lichtenstein said.
Other solutions, including new sterilization techniques may also emerge, but there was general consensus that the human factor will always be important even if the best solution proves to be a disposable endoscope. Dr. Weber said, “You can still place a disposable scope on a contaminated surface. The human factor is always important.”
Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, and past chair of the AGA Center for GI Innovation and Technology, added, “AGA will build on the relationships that we have with the manufacturers of the endoscopes along with companies developing other novel approaches to reprocessing, as well as the FDA and CDC, to further the discussion. Ultimately, we hope to see the availability of devices that are effective and reliably clean so that we do not have to be concerned about patient-to-patient transmission of infection.”
BOSTON – Once attributed to human error, the outbreaks of infection from persistent contamination of reprocessed duodenoscopes have eluded an easy fix, according to three experts addressing the problem at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. This session is part of the AGA Center for GI Innovation and Technology’s ongoing efforts to convene stakeholders, including endoscope manufacturers and the Food and Drug Administration, and to collaborate on a solution to ensure zero device-transmitted infections.
Since the problem first was recognized, changes in device design and cleaning protocols have produced a fivefold reduction in the risk of infection.
“The risk is now very low and well beneath the benefits provided by endoscopy, but we will not settle for anything less than complete resolution of the problem,” said David R. Lichtenstein, MD, the director of the endoscopy program at Boston University. Leading off a program that outlined the problem and possible solutions, Dr. Lichtenstein said, “We need to make this a historical issue.”
After scrutiny by the many stakeholders, including the manufacturers, gastroenterologists, and regulatory agencies, the elevator mechanism has remained one focus of concern. The difficulty of cleaning this mechanism was recognized in the earliest devices, but redesigns to permit these channels to be flushed did not resolve the problem completely. In the AGA Tech Summit session, there was general consensus that even dedicated reprocessing technicians fully adherent to current protocols cannot reliably completely clean the currently available duodenoscopes in every case.
“In most instances, it is not the technician at fault and it is extremely difficult to get a flexible scope clean after a messy procedure,” explained Cori Ofstead, MSPH, an epidemiologist and president of Ofstead & Associates. In one study she conducted in endoscopes reprocessed using best practice recommendations, microbial presence could still be detected.
Although risk of contamination increases with repeated use of scopes, with damaged scopes, and after scopes have been used in procedures generating relatively high amounts of debris, Ms. Ofstead said, “If you look, you will find contamination.” While she emphasized the importance of developing incentives that reward quality over efficiency when attempting to reduce human error in duodenoscope reprocessing, she, like Dr. Lichtenstein, believes new strategies are needed to achieve zero tolerance for infection risk.
“Disinfection simply may not be enough,” Ms. Ofstead said. “The solution is likely to be something else, such as single-use scopes or sterilization.” Explaining how processes of sterilization and disinfection differ, David Weber, MD, MPH, professor of epidemiology, University of North Carolina School of Medicine, Chapel Hill, outlined the relative advantages and disadvantages of current options. Dr. Weber, who has been involved in numerous studies regarding duodenoscope decontamination, emphasized that that rigorous cleaning of biological debris is a central tenet of any solution, but he outlined evidence that the current standard of high level disinfection (HLD) has not been sufficient to bring the infection risk to zero.
“There is no simple answer, because every solution so far has introduced some challenges,” Dr. Lichtenstein observed. Listing some examples, he noted that autoclaving results in damage to endoscopes since they are heat labile; that some proposed sterilization techniques may be limited by sterilants that can’t penetrate biofilm formation into deeper layers that harbor viable bacteria and are associated with a risk of toxicity to technicians or patients; and that disposable endoscopes or elevator mechanisms may involve unacceptable costs or operating characteristics. However, he is convinced there is a solution.
“The problem is being addressed from different angles, and I think we will find the solution within several years. This may involve a series of additional incremental improvements, but I think no one with a stake in this issue will sit comfortably until it is no longer a problem,” Dr. Lichtenstein said.
In the discussion that followed the formal presentations, it was generally acknowledged that the ultimate solution remains unclear even though incremental progress is being made. In fact, there have been no major outbreaks in the United States in the last year following the attention given to this issue, which is likely to have promoted more diligence in disinfection, according to Dr. Lichtenstein.
“Disposable endoscopes or disposable parts on endoscopes that facilitate cleaning may be coming, but I think the best current step is a standardized method of testing scopes after cleaning to verify that disinfection has been achieved,” Dr. Lichtenstein said.
Other solutions, including new sterilization techniques may also emerge, but there was general consensus that the human factor will always be important even if the best solution proves to be a disposable endoscope. Dr. Weber said, “You can still place a disposable scope on a contaminated surface. The human factor is always important.”
Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, and past chair of the AGA Center for GI Innovation and Technology, added, “AGA will build on the relationships that we have with the manufacturers of the endoscopes along with companies developing other novel approaches to reprocessing, as well as the FDA and CDC, to further the discussion. Ultimately, we hope to see the availability of devices that are effective and reliably clean so that we do not have to be concerned about patient-to-patient transmission of infection.”
EXPERT ANALYSIS FROM 2018 AGA TECH SUMMIT
Entrepreneurs attempt to convince the Shark Tank experts that they can address unmet needs
BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.
In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”
New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
New device permits real-time stool sample analysis
A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.
Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”
The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.
In the Shark Tank session, the main concerns expressed were about how this test will fit with Clinical Laboratory Improvement Amendments (CLIA) compliance. Herb Lerner, MD, a former officer in the Food and Drug Administration (FDA) and now senior director of medical and regulatory affairs at Hogan Lovells, a Washington, D.C.–based law firm, urged Dr. Kim to approach the FDA as soon as possible for advice on how to address this and other potential obstacles to a commercial product.
GI endoscopy capture, storage, and sharing
In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.
“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.
Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.
New NG tube addresses aspiration risk
Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.
Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”
More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.
Virtual tape measure for colonoscopy measures polyp size
There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.
“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.
Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.
New device treats esophageal cancers with electroporation
There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.
“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.
The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.
A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.
“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”
BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.
In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”
New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
New device permits real-time stool sample analysis
A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.
Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”
The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.
In the Shark Tank session, the main concerns expressed were about how this test will fit with Clinical Laboratory Improvement Amendments (CLIA) compliance. Herb Lerner, MD, a former officer in the Food and Drug Administration (FDA) and now senior director of medical and regulatory affairs at Hogan Lovells, a Washington, D.C.–based law firm, urged Dr. Kim to approach the FDA as soon as possible for advice on how to address this and other potential obstacles to a commercial product.
GI endoscopy capture, storage, and sharing
In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.
“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.
Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.
New NG tube addresses aspiration risk
Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.
Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”
More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.
Virtual tape measure for colonoscopy measures polyp size
There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.
“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.
Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.
New device treats esophageal cancers with electroporation
There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.
“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.
The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.
A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.
“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”
BOSTON – At the 2018 AGA Tech Summit, this year’s Shark Tank line up included an automated system for video capture of endoscopy, a feeding tube that prevents aspiration in intubated patients, a tool to accurately measure polyps captured on colonoscopy, a device that targets gastrointestinal cancers with electrical pulses, and a new method for real-time stool testing of infectious pathogens.
In each case, the presenting entrepreneur vowed to the Shark Tank panel of experts that their innovation is addressing an important clinical need. In announcing the winner, V. Raman Muthusamy, MD, who is the chair of the AGA Center for GI Innovation and Technology (CGIT) and director of interventional endoscopy and general GI endoscopy, David Geffen School of Medicine at UCLA, Los Angeles, said, “We have rarely had such a strong group of candidates.”
New for 2018, both the Sharks and AGA Tech Summit attendees voted on a winner. The unanimous winner was Chang-Hee Kim, PhD, who presented a new rapid test for identifying infectious pathogens in stool. The sharks were looking for 1. Novelty/immediate patient impact, 2. Business plan, and 3. Pitch. While all of the participants were close, the immediate patient impact for Dr. Kim’s innovation gave him a leg up on his competitors.
New device permits real-time stool sample analysis
A new tool for rapid analysis of stool for pathogens may be revolutionary in that it can provide results within 15 minutes rather than the days normally required when stool samples are sent to a laboratory, according to Dr. Chang-Hee Kim, chief executive officer of GoDx, Inc. The patent-pending methodology developed at Dr. Kim’s company permits real-time analysis “at the point of need and without the need for a lab.” In addition to the efficiency, the paper-based test, which Dr. Kim compared to a pregnancy test in that there is a color change with positive results, has the potential to improve outcomes.
Real-time testing “will decrease the loss of patients to follow-up and accelerate the time to treatment,” Dr. Kim asserted. “The test is also likely to reduce the spread of nosocomial pathogens if rapid infection control reduces spread.”
The test, which Dr. Kim expected to be made available at a cost of $100, will also be substantially cheaper than current laboratory analyses. In experimental studies, the accuracy has been at least as accurate as polymerase-chain reaction (PCR) testing, according to Dr. Kim. He sees applications not only in hospitals but at sites where ordering laboratory studies are not normally available, such as on cruise ships, in nursing homes, or in the military.
In the Shark Tank session, the main concerns expressed were about how this test will fit with Clinical Laboratory Improvement Amendments (CLIA) compliance. Herb Lerner, MD, a former officer in the Food and Drug Administration (FDA) and now senior director of medical and regulatory affairs at Hogan Lovells, a Washington, D.C.–based law firm, urged Dr. Kim to approach the FDA as soon as possible for advice on how to address this and other potential obstacles to a commercial product.
GI endoscopy capture, storage, and sharing
In introducing an automated method of capturing videos taken during colonoscopy, Matthew Z. Schwartz, the cofounder of Virgo Surgical Video Solutions, Inc. said, “There is currently no low-cost, user-friendly way to systematically capture GI endoscopy video.” Relative to existing products that “require complicated formatting and time-consuming setup for each procedure recording,” the plug-and-play system developed at Virgo “works with any existing endoscopy system that has a video output.” The videos are designed for cloud storage.
“Our long-term vision is to create the largest and highest quality repository of GI endoscopy videos,” said Mr. Schwartz, who added that support tools, including clinical decision-making aided by artificial intelligence, are being developed to provide even more value for quality control, research, and training.
Several Sharks, including Tom Shehab, MD, managing director, Arboretum Ventures, Ann Arbor, Mich., asked for more information about the value proposition for a proposed cost of $500 per month for the system. The answer was that this value would differ for settings, such as in an academic center that might apply the system for training relative to a community setting where the main purpose might be quality improvement.
New NG tube addresses aspiration risk
Pulmonary aspiration, along with symptomatic gastric reflux, is a common clinical challenge in intubated patients on a feeding tube, but a novel nasogastric (NG) tube equipped with a dual balloon system is designed to solve this problem, according to Talal Sharaiha, MD, the founder of Aspisafe Solutions. He said that reducing the risk of aspiration is important because it is associated with pneumonia, erosive inflammation, and upper GI bleeding. He called it the most common cause of upper GI bleeding in intensive care units.
Of the two balloons, one serves as an anchor and sits in the esophagus. The other serves as an anti-aspiration reservoir and sits in the stomach. The anti-aspiration balloon, inflated after it is inserted in the stomach, blocks reflux of gastric contents. Contending that there is a large market for this device, Dr. Sharaiha said, “having a feeding tube in intubated patients that prevents gastric reflux and aspiration will dramatically reduce complications and likely help reduce length of ventilation time, ICU time, and length of hospitals stay.”
More than one Shark requested more information about safety. Michael L. Kochman, MD, the Wilmott Professor of Medicine and director of the Center for Endoscopic Innovation, Research and Training at the University of Pennsylvania, Philadelphia, noted that there have been adverse experiences in the past with other types of balloon devices introduced into the GI tract. He indicated that this may be a potential bar to clinician comfort, so a comprehensive approach to safety analyses should be a priority in clinical development.
Virtual tape measure for colonoscopy measures polyp size
There are risks from the current practice of estimating polyp size, according to Avishay Sidlesky, founder of VTM Technologies, Ltd. He called these estimates “inherently inaccurate” and asserted that they “lead to erroneous diagnoses, suboptimal treatment and follow-up.” He believes that a “virtual tape measure” dependent on an endoscopic laser emitter solves this problem and cited a published paper that confirmed the accuracy of polyp measurements conducted with this device in an animal model.
“Employing dedicated software that analyzes the laser curves in the endoscopic image, the system enables reporting of the size of lesions, diameter and profile of polyps, longitudinal cross-section of lumens and more,” Mr. Sidlesky reported, specifying that the tool can be used alone or integrated into third party endoscopes. He believes applications can eventually be developed for a variety of endoscopic procedures in addition to colonoscopy.
Of Shark comments, several regarded concern about how this measuring tool would be integrated with existing endoscopic systems. Even though the measuring tool can be introduced in an unused channel of available scopes, the image is displayed separately. Michael J. Docktor, MD, clinical director of innovation, Boston Children’s Hospital, cautioned that devices that add steps to the workflow in the endoscopy suite may not be as rapidly accepted as one in which the tool is totally integrated with existing systems.
New device treats esophageal cancers with electroporation
There are a variety of tools to treat upper GI cancers endoscopically, including with radiofrequency ablation, cryotechnology, and photodynamic therapy, but morbidity rates are high, according to Declan Soden, founder of Mirai Medical. He described the attributes of a new technology based on electroporation in which electrical pulses painlessly target neoplastic tissue while preserving adjacent healthy tissue. He said that the treatment is performed in a matter of minutes on an outpatient basis.
“Clinical results to date have demonstrated the benefit of the technology in the treatment of late-stage esophageal and colorectal disease,” Mr. Soden said. He believes that the “unique selling point” of this electroporation treatment, which is part of a complete treatment regimen, “is that it renders tumor tissue leaky or porous, allowing absorption and uptake of drugs.” Relative to current standards, the treatment has multiple advantages, not least of which is preservation of quality of life, he believes.
The Sharks posed many technical questions about this strategy that might narrow the applicability of this device. For example, Trey Reed, MD, medical director, Humana Inc., posed questions about the depth of penetration of the electoral pulses and where they can be adjusted for tumors of different sizes. He also questioned whether the device will be too large to penetrate lumens obstructed by tumor. Although Mr. Soden believes that the device will be versatile, he acknowledged that its role might be better understood when phase 2 trials begin later this year.
A moderator at the Shank Tank session and a previous CGIT Chair, Dr. Kochman reported that he was impressed with the crop of entries. As one of the creators of the AGA Tech Summit, Dr. Kochman has the experience to recognize good ideas when he hears them.
“It is gratifying to see the high quality of the Shark Tank presenters. Over the past years, a number of the presenting companies have gone on to obtain additional funding, be acquired, and on to successful launches,” Dr. Kochman observed. “We hope the same successes await this year’s group.”
REPORTING FROM 2018 AGA TECH SUMMIT
VIDEO: It is an exciting time in obesity treatment
BOSTON – For those in obesity treatment, things are looking up, said Reem Z. Sharaiha, MD, MSc, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. There are several new therapies to choose from, said Dr. Sharaiha, assistant professor of medicine at Cornell University, New York – and a variety of therapies coming down the pipeline. The key is to choose the right treatment, or right combination of treatments – surgical, endoscopic, or medical – for the right patient at the right time and to follow up. Obesity is a chronic disease that needs long-term, team treatment. With obesity treatments there is sometimes a trade-off between risk and results, but the innovations coming along may balance that risk-results equation for some patients, she said.
BOSTON – For those in obesity treatment, things are looking up, said Reem Z. Sharaiha, MD, MSc, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. There are several new therapies to choose from, said Dr. Sharaiha, assistant professor of medicine at Cornell University, New York – and a variety of therapies coming down the pipeline. The key is to choose the right treatment, or right combination of treatments – surgical, endoscopic, or medical – for the right patient at the right time and to follow up. Obesity is a chronic disease that needs long-term, team treatment. With obesity treatments there is sometimes a trade-off between risk and results, but the innovations coming along may balance that risk-results equation for some patients, she said.
BOSTON – For those in obesity treatment, things are looking up, said Reem Z. Sharaiha, MD, MSc, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. There are several new therapies to choose from, said Dr. Sharaiha, assistant professor of medicine at Cornell University, New York – and a variety of therapies coming down the pipeline. The key is to choose the right treatment, or right combination of treatments – surgical, endoscopic, or medical – for the right patient at the right time and to follow up. Obesity is a chronic disease that needs long-term, team treatment. With obesity treatments there is sometimes a trade-off between risk and results, but the innovations coming along may balance that risk-results equation for some patients, she said.
REPORTING FROM 2018 AGA TECH SUMMIT
VIDEO: Organ-sparing resection techniques should be way of the future
BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.
We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.
BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.
We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.
BOSTON – Organ-sparing resection techniques that remove lesions from the esophagus, stomach, and colon are being developed, Amrita Sethi, MD, said in a video interview at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Dr. Sethi, an assistant professor of medicine at Columbia University Medical Center, New York, said these techniques improve patient outcomes by maintaining organ integrity, whereas older techniques often led to removal of large amounts of tissue around lesions. And while organ-sparing techniques reduce recovery time and hospital stays, training and reimbursement for these procedures remain problematic. As much as new endoscopic package devices are needed from industry to make these procedures easier, automated or artificial intelligence is needed to help make the decisions on when these techniques are applicable. Reimbursement structures are needed so that these procedures make financial sense, she noted.
We live in a health care system now, Dr. Sethi said, in which benign polyps of the colon are being sent for surgical resection when what is really needed is referral for more advanced endoscopic treatment. This is a matter of training, and perhaps showing through comparative trials that organ-sparing techniques cost less and improve patient outcomes.
REPORTING FROM 2018 AGA TECH SUMMIT
Adapting consumer technology into GI practice
BOSTON – You can command Alexa to order pizza and spool up your favorite flick, but accessing digital health data remains a struggle. Michael Docktor, MD, wants to change that.
A pediatric gastroenterologist and the clinical director of innovation at Boston Children’s Hospital, Dr. Docktor believes that it’s just a matter of time before consumer-driven digital technology fundamentally changes the way physicians and patients interact. 
“In medicine, we are often in the habit of trying to recreate the wheel,” he said during the “Digital Health in GI Disease” session at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. “My hope and belief is that we can borrow from the best of the consumer technology world and apply that to our world in health care and GI specifically.”
Dr. Docktor shared some of the “tools and toys” that have come of his group’s program and also “exposed folks to things that they may not be thinking about traditionally in medicine.”
In particular, one area he focused on was how certain voice technologies are enhancing health care delivery, such as integration of Amazon’s Alexa. Consider Alexa a nurse on call.
he said. “We have placed a fairly large bet on voice in health care and built some skills for Alexa.”
He also highlighted a new virtual reality tool that was recently launched by Boston Children’s Hospital to help gastroenterologists better educate their patients.
HealthVoyager was developed in conjunction with Klick Health. The kid-friendly app lets children take a virtual ride through their GI tract. Clinicians draw in abnormal findings on a simplified template. The app then recreates those findings – lesions, polyps, or inflammatory changes – in the positions they actually occupy in the patient. It generates a QR code that’s given to the patient, allowing the child to access her imaging in a HIPAA-compliant manner.
It’s cool, sure, Dr. Docktor said. But does it bring any value to the physician-patient interaction?
“The challenge of digital health is to prove that there’s actual value, it’s not just a bunch of snazzy tech. Are patients really using it? Sharing it? Are they educating themselves and their family and their community? We want to study this clinically and validate whether or not it results in improved adherence and improved patient satisfaction.”
He covered other technologies, such as Chatbox and blockchain, and the roles they can play in health care.
In the not-too-distant future, Dr. Docktor envisions voice assistants integrated into daily medical practice. Amazon’s Alexa provides an aspirational goal, he said.
“We are seeing the rise of the voice assistant. By 2020, researchers predict that 50% of all Internet searches will happen just by voice. Voice interface, I believe, will be driving health care by interfacing with patients at home. I predict that over the next 5 years, most of us will have a medical encounter on a device like this. Technology is not a limiting factor in this scenario. It’s just red tape on the payer and provider side at this point.”
Dr. Docktor’s colleague, Carla E. Small, senior director of the Innovation & Digital Health Accelerator at Boston Children’s Hospital, provided another real-life example of his digital vision. The Innovation & Digital Health Accelerator is a division within the hospital devoted to identifying, nurturing, and implementing digital health care solutions.
“The world has moved to a technology-enabled health care environment, and we all have to be there along with it,” she said. “That also creates a great opportunity for those who have an interest in innovation. There is a lot of ground for changing the way we do things and really leveraging that creativity and innovation.”
One Accelerator product that’s up and running is Thermia. The online tool guides parents through the anxiety of managing a child’s fever.
Thermia quickly and easily allows concerned parents to interpret a child’s temperature and understand which steps they should consider taking. Parents enter their child’s age, temperature, weight, any associated symptoms like rash, sore throat, or GI upset, as well as comorbid medical conditions. An algorithm issues advice for treatment at home or, if the data suggest a risk or serious problem, suggests a visit to the pediatrician or the emergency room. Thermia also automatically calculates the dosage of over-the-counter antipyretic medications based on age and weight.
The Accelerator is investigating a host of other digital health products in different stages of concept, design, and execution. Health care simply has to embrace the digital trends that are changing the way people interact with their world.
The AGA Center for GI Innovation and Technology wants to hear the unique ways gastroenterologists are leveraging consumer technology in their practices. Send us an email at cgit@gastro.org.
gtwachtman@mdedge.com
msullivan@mdedge.com
BOSTON – You can command Alexa to order pizza and spool up your favorite flick, but accessing digital health data remains a struggle. Michael Docktor, MD, wants to change that.
A pediatric gastroenterologist and the clinical director of innovation at Boston Children’s Hospital, Dr. Docktor believes that it’s just a matter of time before consumer-driven digital technology fundamentally changes the way physicians and patients interact.
“In medicine, we are often in the habit of trying to recreate the wheel,” he said during the “Digital Health in GI Disease” session at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. “My hope and belief is that we can borrow from the best of the consumer technology world and apply that to our world in health care and GI specifically.”
Dr. Docktor shared some of the “tools and toys” that have come of his group’s program and also “exposed folks to things that they may not be thinking about traditionally in medicine.”
In particular, one area he focused on was how certain voice technologies are enhancing health care delivery, such as integration of Amazon’s Alexa. Consider Alexa a nurse on call.
he said. “We have placed a fairly large bet on voice in health care and built some skills for Alexa.”
He also highlighted a new virtual reality tool that was recently launched by Boston Children’s Hospital to help gastroenterologists better educate their patients.
HealthVoyager was developed in conjunction with Klick Health. The kid-friendly app lets children take a virtual ride through their GI tract. Clinicians draw in abnormal findings on a simplified template. The app then recreates those findings – lesions, polyps, or inflammatory changes – in the positions they actually occupy in the patient. It generates a QR code that’s given to the patient, allowing the child to access her imaging in a HIPAA-compliant manner.
It’s cool, sure, Dr. Docktor said. But does it bring any value to the physician-patient interaction?
“The challenge of digital health is to prove that there’s actual value, it’s not just a bunch of snazzy tech. Are patients really using it? Sharing it? Are they educating themselves and their family and their community? We want to study this clinically and validate whether or not it results in improved adherence and improved patient satisfaction.”
He covered other technologies, such as Chatbox and blockchain, and the roles they can play in health care.
In the not-too-distant future, Dr. Docktor envisions voice assistants integrated into daily medical practice. Amazon’s Alexa provides an aspirational goal, he said.
“We are seeing the rise of the voice assistant. By 2020, researchers predict that 50% of all Internet searches will happen just by voice. Voice interface, I believe, will be driving health care by interfacing with patients at home. I predict that over the next 5 years, most of us will have a medical encounter on a device like this. Technology is not a limiting factor in this scenario. It’s just red tape on the payer and provider side at this point.”
Dr. Docktor’s colleague, Carla E. Small, senior director of the Innovation & Digital Health Accelerator at Boston Children’s Hospital, provided another real-life example of his digital vision. The Innovation & Digital Health Accelerator is a division within the hospital devoted to identifying, nurturing, and implementing digital health care solutions.
“The world has moved to a technology-enabled health care environment, and we all have to be there along with it,” she said. “That also creates a great opportunity for those who have an interest in innovation. There is a lot of ground for changing the way we do things and really leveraging that creativity and innovation.”
One Accelerator product that’s up and running is Thermia. The online tool guides parents through the anxiety of managing a child’s fever.
Thermia quickly and easily allows concerned parents to interpret a child’s temperature and understand which steps they should consider taking. Parents enter their child’s age, temperature, weight, any associated symptoms like rash, sore throat, or GI upset, as well as comorbid medical conditions. An algorithm issues advice for treatment at home or, if the data suggest a risk or serious problem, suggests a visit to the pediatrician or the emergency room. Thermia also automatically calculates the dosage of over-the-counter antipyretic medications based on age and weight.
The Accelerator is investigating a host of other digital health products in different stages of concept, design, and execution. Health care simply has to embrace the digital trends that are changing the way people interact with their world.
The AGA Center for GI Innovation and Technology wants to hear the unique ways gastroenterologists are leveraging consumer technology in their practices. Send us an email at cgit@gastro.org.
gtwachtman@mdedge.com
msullivan@mdedge.com
BOSTON – You can command Alexa to order pizza and spool up your favorite flick, but accessing digital health data remains a struggle. Michael Docktor, MD, wants to change that.
A pediatric gastroenterologist and the clinical director of innovation at Boston Children’s Hospital, Dr. Docktor believes that it’s just a matter of time before consumer-driven digital technology fundamentally changes the way physicians and patients interact.
“In medicine, we are often in the habit of trying to recreate the wheel,” he said during the “Digital Health in GI Disease” session at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. “My hope and belief is that we can borrow from the best of the consumer technology world and apply that to our world in health care and GI specifically.”
Dr. Docktor shared some of the “tools and toys” that have come of his group’s program and also “exposed folks to things that they may not be thinking about traditionally in medicine.”
In particular, one area he focused on was how certain voice technologies are enhancing health care delivery, such as integration of Amazon’s Alexa. Consider Alexa a nurse on call.
he said. “We have placed a fairly large bet on voice in health care and built some skills for Alexa.”
He also highlighted a new virtual reality tool that was recently launched by Boston Children’s Hospital to help gastroenterologists better educate their patients.
HealthVoyager was developed in conjunction with Klick Health. The kid-friendly app lets children take a virtual ride through their GI tract. Clinicians draw in abnormal findings on a simplified template. The app then recreates those findings – lesions, polyps, or inflammatory changes – in the positions they actually occupy in the patient. It generates a QR code that’s given to the patient, allowing the child to access her imaging in a HIPAA-compliant manner.
It’s cool, sure, Dr. Docktor said. But does it bring any value to the physician-patient interaction?
“The challenge of digital health is to prove that there’s actual value, it’s not just a bunch of snazzy tech. Are patients really using it? Sharing it? Are they educating themselves and their family and their community? We want to study this clinically and validate whether or not it results in improved adherence and improved patient satisfaction.”
He covered other technologies, such as Chatbox and blockchain, and the roles they can play in health care.
In the not-too-distant future, Dr. Docktor envisions voice assistants integrated into daily medical practice. Amazon’s Alexa provides an aspirational goal, he said.
“We are seeing the rise of the voice assistant. By 2020, researchers predict that 50% of all Internet searches will happen just by voice. Voice interface, I believe, will be driving health care by interfacing with patients at home. I predict that over the next 5 years, most of us will have a medical encounter on a device like this. Technology is not a limiting factor in this scenario. It’s just red tape on the payer and provider side at this point.”
Dr. Docktor’s colleague, Carla E. Small, senior director of the Innovation & Digital Health Accelerator at Boston Children’s Hospital, provided another real-life example of his digital vision. The Innovation & Digital Health Accelerator is a division within the hospital devoted to identifying, nurturing, and implementing digital health care solutions.
“The world has moved to a technology-enabled health care environment, and we all have to be there along with it,” she said. “That also creates a great opportunity for those who have an interest in innovation. There is a lot of ground for changing the way we do things and really leveraging that creativity and innovation.”
One Accelerator product that’s up and running is Thermia. The online tool guides parents through the anxiety of managing a child’s fever.
Thermia quickly and easily allows concerned parents to interpret a child’s temperature and understand which steps they should consider taking. Parents enter their child’s age, temperature, weight, any associated symptoms like rash, sore throat, or GI upset, as well as comorbid medical conditions. An algorithm issues advice for treatment at home or, if the data suggest a risk or serious problem, suggests a visit to the pediatrician or the emergency room. Thermia also automatically calculates the dosage of over-the-counter antipyretic medications based on age and weight.
The Accelerator is investigating a host of other digital health products in different stages of concept, design, and execution. Health care simply has to embrace the digital trends that are changing the way people interact with their world.
The AGA Center for GI Innovation and Technology wants to hear the unique ways gastroenterologists are leveraging consumer technology in their practices. Send us an email at cgit@gastro.org.
gtwachtman@mdedge.com
msullivan@mdedge.com
REPORTING FROM THE 2018 AGA TECH SUMMIT
What’s in the way of you and new tech?
BOSTON – Bringing new technology to your practice is not as simple as flipping a switch, as attendees of the Thursday afternoon AGA Tech Summit session “Physician Perspective on Barriers to Incorporating New Technology” learned. The Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.
“As physicians think about being a part of taking on new technology, there are varying perspectives, including the perspective they have about their patients and the perspective they have for themselves,” Richard Rothstein, MD, chair of the department of medicine at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. “However, there are other perspectives as well, like the perspectives of the hospital or the ambulatory endoscopy center in which they work.”
He presented an intriguing historical example. Within months of the first demonstration of anesthetized surgery in 1846, the use of ether and the machine to deliver it were spreading rapidly through hospitals in large U.S. cities. European adoption soon followed.
However, decades passed before there was wide acceptance of Lister’s ideas on carbolic acid as a surgical antiseptic.
“Why was one technology adopted early and one later? Incentives to adopt both went in the same direction – improved patient outcomes. Both were based on ideas that violated prior beliefs. Both were technically complex. But one combatted a visible and immediate problem: pain. The other combatted an invisible and unproven problem: germs. Both made life better for the patient – but only one made life better for the surgeon. And that one, anesthesia, was the one that was quickly adopted.”
Even today, clinicians are the main drivers of the adoption of novel medical technology. They fall into two general categories, Dr. Rothstein said: early adopters, who want to be the first to offer an exciting new procedure, and late adopters, who wait for more information and want all the issues of that technology to be sorted out before diving in.
Each one stands in the same circle, however, forced to evaluate the issues that come along with adopting new tech, including training, credentialing and insurance, facility support, and how the new tool or procedure might affect the entire clinical team
Facilities have to tussle with these issues, too, Dr. Rothstein said.
Administrations wonder, “‘Will I get paid for this? Will it displace something else that’s equally effective that could be making more money? What resources do I need to implement it? Will it impact malpractice insurance rates for clinicians who work at my facility?’”
Patient choice also plays into the matter. Third-party payers may or may not have cutting-edge tech on their payment ledger. The specter of a self-pay procedure, no matter how potentially effective, is an enormous deterrent for patients, especially when figuring in the possibility of footing the bill for any associated complications. And of course, new technology and procedures lack the deep pool of efficacy and safety data that established ones lean upon – another potential sticking point for both clinicians and patients, Dr. Rothstein said.
“There are a lot of great ideas out there, and a lot of innovative devices, but without addressing the barriers to adoption, the technology will never get to the targeted goal of delivering better care to our patients,” he said.
BOSTON – Bringing new technology to your practice is not as simple as flipping a switch, as attendees of the Thursday afternoon AGA Tech Summit session “Physician Perspective on Barriers to Incorporating New Technology” learned. The Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.
“As physicians think about being a part of taking on new technology, there are varying perspectives, including the perspective they have about their patients and the perspective they have for themselves,” Richard Rothstein, MD, chair of the department of medicine at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. “However, there are other perspectives as well, like the perspectives of the hospital or the ambulatory endoscopy center in which they work.”
He presented an intriguing historical example. Within months of the first demonstration of anesthetized surgery in 1846, the use of ether and the machine to deliver it were spreading rapidly through hospitals in large U.S. cities. European adoption soon followed.
However, decades passed before there was wide acceptance of Lister’s ideas on carbolic acid as a surgical antiseptic.
“Why was one technology adopted early and one later? Incentives to adopt both went in the same direction – improved patient outcomes. Both were based on ideas that violated prior beliefs. Both were technically complex. But one combatted a visible and immediate problem: pain. The other combatted an invisible and unproven problem: germs. Both made life better for the patient – but only one made life better for the surgeon. And that one, anesthesia, was the one that was quickly adopted.”
Even today, clinicians are the main drivers of the adoption of novel medical technology. They fall into two general categories, Dr. Rothstein said: early adopters, who want to be the first to offer an exciting new procedure, and late adopters, who wait for more information and want all the issues of that technology to be sorted out before diving in.
Each one stands in the same circle, however, forced to evaluate the issues that come along with adopting new tech, including training, credentialing and insurance, facility support, and how the new tool or procedure might affect the entire clinical team
Facilities have to tussle with these issues, too, Dr. Rothstein said.
Administrations wonder, “‘Will I get paid for this? Will it displace something else that’s equally effective that could be making more money? What resources do I need to implement it? Will it impact malpractice insurance rates for clinicians who work at my facility?’”
Patient choice also plays into the matter. Third-party payers may or may not have cutting-edge tech on their payment ledger. The specter of a self-pay procedure, no matter how potentially effective, is an enormous deterrent for patients, especially when figuring in the possibility of footing the bill for any associated complications. And of course, new technology and procedures lack the deep pool of efficacy and safety data that established ones lean upon – another potential sticking point for both clinicians and patients, Dr. Rothstein said.
“There are a lot of great ideas out there, and a lot of innovative devices, but without addressing the barriers to adoption, the technology will never get to the targeted goal of delivering better care to our patients,” he said.
BOSTON – Bringing new technology to your practice is not as simple as flipping a switch, as attendees of the Thursday afternoon AGA Tech Summit session “Physician Perspective on Barriers to Incorporating New Technology” learned. The Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.
“As physicians think about being a part of taking on new technology, there are varying perspectives, including the perspective they have about their patients and the perspective they have for themselves,” Richard Rothstein, MD, chair of the department of medicine at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. “However, there are other perspectives as well, like the perspectives of the hospital or the ambulatory endoscopy center in which they work.”
He presented an intriguing historical example. Within months of the first demonstration of anesthetized surgery in 1846, the use of ether and the machine to deliver it were spreading rapidly through hospitals in large U.S. cities. European adoption soon followed.
However, decades passed before there was wide acceptance of Lister’s ideas on carbolic acid as a surgical antiseptic.
“Why was one technology adopted early and one later? Incentives to adopt both went in the same direction – improved patient outcomes. Both were based on ideas that violated prior beliefs. Both were technically complex. But one combatted a visible and immediate problem: pain. The other combatted an invisible and unproven problem: germs. Both made life better for the patient – but only one made life better for the surgeon. And that one, anesthesia, was the one that was quickly adopted.”
Even today, clinicians are the main drivers of the adoption of novel medical technology. They fall into two general categories, Dr. Rothstein said: early adopters, who want to be the first to offer an exciting new procedure, and late adopters, who wait for more information and want all the issues of that technology to be sorted out before diving in.
Each one stands in the same circle, however, forced to evaluate the issues that come along with adopting new tech, including training, credentialing and insurance, facility support, and how the new tool or procedure might affect the entire clinical team
Facilities have to tussle with these issues, too, Dr. Rothstein said.
Administrations wonder, “‘Will I get paid for this? Will it displace something else that’s equally effective that could be making more money? What resources do I need to implement it? Will it impact malpractice insurance rates for clinicians who work at my facility?’”
Patient choice also plays into the matter. Third-party payers may or may not have cutting-edge tech on their payment ledger. The specter of a self-pay procedure, no matter how potentially effective, is an enormous deterrent for patients, especially when figuring in the possibility of footing the bill for any associated complications. And of course, new technology and procedures lack the deep pool of efficacy and safety data that established ones lean upon – another potential sticking point for both clinicians and patients, Dr. Rothstein said.
“There are a lot of great ideas out there, and a lot of innovative devices, but without addressing the barriers to adoption, the technology will never get to the targeted goal of delivering better care to our patients,” he said.
REPORTING FROM 2018 AGA TECH SUMMIT
VIDEO: Digital health technologies are here to be embraced
BOSTON – One of the innovations in gastroenterology that is used on a day-to-day basis is digital technology, said Sri Komanduri, MD, in a video interview at the 2018 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.
Everything from Internet rate-your-doctor sites to bowel prep apps and EHRs qualify as digital health technology, said Dr. Komanduri, the medical director of the GI laboratory and director of interventional endoscopy at Northwestern University in Chicago and vice chair of the AGA Center for GI Innovation and Technology.
Digital technology can facilitate endoscopy procedures, help patients communicate with their doctors about chronic conditions, and help patients better understand their illness. The role of the physician is to embrace those technologies that improve the quality of care.
BOSTON – One of the innovations in gastroenterology that is used on a day-to-day basis is digital technology, said Sri Komanduri, MD, in a video interview at the 2018 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.
Everything from Internet rate-your-doctor sites to bowel prep apps and EHRs qualify as digital health technology, said Dr. Komanduri, the medical director of the GI laboratory and director of interventional endoscopy at Northwestern University in Chicago and vice chair of the AGA Center for GI Innovation and Technology.
Digital technology can facilitate endoscopy procedures, help patients communicate with their doctors about chronic conditions, and help patients better understand their illness. The role of the physician is to embrace those technologies that improve the quality of care.
BOSTON – One of the innovations in gastroenterology that is used on a day-to-day basis is digital technology, said Sri Komanduri, MD, in a video interview at the 2018 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.
Everything from Internet rate-your-doctor sites to bowel prep apps and EHRs qualify as digital health technology, said Dr. Komanduri, the medical director of the GI laboratory and director of interventional endoscopy at Northwestern University in Chicago and vice chair of the AGA Center for GI Innovation and Technology.
Digital technology can facilitate endoscopy procedures, help patients communicate with their doctors about chronic conditions, and help patients better understand their illness. The role of the physician is to embrace those technologies that improve the quality of care.
FROM THE 2018 AGA TECH SUMMIT
Update on AGA-Medtronic Research & Development Pilot Award in Technology
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research & Development Pilot Award in Technology by the AGA Research Foundation, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and its function. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington as a poster of distinction.
“Dr. Roland’s research is innovative and clinically relevant. It’s great to see the progress her team has made since receiving this grant from the AGA Research Foundation,” said Robert S. Sandler, MD, MPH, AGAF, chair of the AGA Research Foundation. “I want to thank Medtronic for their partnership on this award and their shared commitment to funding innovative research projects.”
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiological mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using a wireless motility capsule (PillCam) – just the kind of technology fostered by the AGA GI Center for Innovation and Technology – to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with both IBS and SIBO have increased expression of proinflammatory markers, compared with those with IBS only; they are attempting to correlate the inflammatory markers to specific bacteria.
“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries without understanding the etiology for this syndrome,” said Dr. Roland, the director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”
“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.
To capture the data to be presented in the DDW poster, Dr. Roland’s team used the wireless motility capsule to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared with patients who have IBS without evidence of SIBO
“Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”
Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as tumor necrosis factor–alpha and interleukin 6, with those in patients who have only IBS. They will use their data to apply for future funding.
Since 2014, the AGA Research Foundation has partnered with medical technology companies such as Medtronic to provide a total of over $450,000 in research grants to six investigators working on novel and innovative technology projects. The AGA Research Foundation will begin accepting applications for the next round of research grants in summer 2018. Stay tuned to www.gastro.org/research-funding.
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research & Development Pilot Award in Technology by the AGA Research Foundation, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and its function. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington as a poster of distinction.
“Dr. Roland’s research is innovative and clinically relevant. It’s great to see the progress her team has made since receiving this grant from the AGA Research Foundation,” said Robert S. Sandler, MD, MPH, AGAF, chair of the AGA Research Foundation. “I want to thank Medtronic for their partnership on this award and their shared commitment to funding innovative research projects.”
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiological mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using a wireless motility capsule (PillCam) – just the kind of technology fostered by the AGA GI Center for Innovation and Technology – to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with both IBS and SIBO have increased expression of proinflammatory markers, compared with those with IBS only; they are attempting to correlate the inflammatory markers to specific bacteria.
“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries without understanding the etiology for this syndrome,” said Dr. Roland, the director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”
“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.
To capture the data to be presented in the DDW poster, Dr. Roland’s team used the wireless motility capsule to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared with patients who have IBS without evidence of SIBO
“Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”
Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as tumor necrosis factor–alpha and interleukin 6, with those in patients who have only IBS. They will use their data to apply for future funding.
Since 2014, the AGA Research Foundation has partnered with medical technology companies such as Medtronic to provide a total of over $450,000 in research grants to six investigators working on novel and innovative technology projects. The AGA Research Foundation will begin accepting applications for the next round of research grants in summer 2018. Stay tuned to www.gastro.org/research-funding.
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research & Development Pilot Award in Technology by the AGA Research Foundation, and her team already has recruited 30 patients with irritable bowel syndrome (IBS) and small intestinal bacterial overgrowth (SIBO) for a study of the gut microbiome and its function. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington as a poster of distinction.
“Dr. Roland’s research is innovative and clinically relevant. It’s great to see the progress her team has made since receiving this grant from the AGA Research Foundation,” said Robert S. Sandler, MD, MPH, AGAF, chair of the AGA Research Foundation. “I want to thank Medtronic for their partnership on this award and their shared commitment to funding innovative research projects.”
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiological mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using a wireless motility capsule (PillCam) – just the kind of technology fostered by the AGA GI Center for Innovation and Technology – to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO. They also are obtaining microflora from oropharyngeal, gastric, small bowel, and fecal samples for DNA sequencing. In addition, the team is beginning to study serum samples to test the hypothesis that patients with both IBS and SIBO have increased expression of proinflammatory markers, compared with those with IBS only; they are attempting to correlate the inflammatory markers to specific bacteria.
“IBS is a very common gastrointestinal disorder, and we’re continuing to see an increase in prevalence in Western countries without understanding the etiology for this syndrome,” said Dr. Roland, the director of gastrointestinal motility at Lenox Hill Hospital and Northwell Health System in New York. “Unfortunately, we don’t have any specific or targeted therapies for this patient population because the underlying physiological mechanisms that cause IBS are not very well understood. When we treat these patients with antibiotics, often their symptoms come right back. If we can target the causes of disease in subsets of these patients, we may be able to successfully treat them.”
“We’re very excited to see what changes in the microbiome exist in this patient population, to determine if the microbiome may be another potential area that we can target for treatment,” she added.
To capture the data to be presented in the DDW poster, Dr. Roland’s team used the wireless motility capsule to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared with patients who have IBS without evidence of SIBO
“Interestingly, patients who had IBS and SIBO had significantly higher contraction frequency in the stomach and small bowel compared to patients with IBS alone,” Dr. Roland said. Those with both conditions also had lower ileocecal junction pressures. “These are physiological mechanisms that have not been well understood before,” Dr. Roland said. “We have been able to begin delineating some of the underlying physiological mechanisms in this challenging patient population for the first time, using a noninvasive, wireless motility capsule.”
Dr. Roland’s team is now partnering with the hospital’s endocrinology division to compare the circulating inflammatory markers in patients with IBS and SIBO, such as tumor necrosis factor–alpha and interleukin 6, with those in patients who have only IBS. They will use their data to apply for future funding.
Since 2014, the AGA Research Foundation has partnered with medical technology companies such as Medtronic to provide a total of over $450,000 in research grants to six investigators working on novel and innovative technology projects. The AGA Research Foundation will begin accepting applications for the next round of research grants in summer 2018. Stay tuned to www.gastro.org/research-funding.
REPORTING FROM 2018 AGA TECH SUMMIT
Serial entrepreneur examines the risk-to-reward ratio balance in GI innovation
BOSTON – Just out of fellowship, Christopher C. Thompson, MD, director of therapeutic endoscopy, Brigham and Women’s Hospital, Boston, adapted an antireflux suturing device for use in a bariatric procedure. It worked so well he began using it routinely and taught others the technique. That was the first step in a journey that has taken him from consulting with industry to a founder of start-ups.
“The device company heard about what we were doing and were interested,” Dr. Thompson recounted during his How-I-Did-It lecture at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. In the end, he served as a consultant in the development of a new suturing device specific for the bariatric procedure. This included helping secure a patent and learning first-hand what steps are needed to get a device to market.
“I do not have any regrets. It was good for my career and fun to be involved, but there was not much financial gain for me or for my department,” Dr. Thompson said.
His subsequent experience with licensing was an incremental step forward. In one example, he worked on developing an endoscopic simulator, an important unmet need both for teaching and evaluating skills in diagnostic colonoscopy, including a kinematic analysis that helped identify techniques that are associated with high levels of skill.
“We developed the technology in-house through a series of grants. The risks were low, but the rewards were better because the money helped fund activities in our department,” he said.
That device, too, has been very successful, but Dr. Thompson said it is important to recognize how far innovation can go when the work stays in the academic setting and the goal is licensing the technology. More recently, he took a nonsurgical anastomosis device through preclinical testing, but he was then unable to attract a device company for the next steps of development.
“With no one interested, we created a start-up,” Dr. Thompson said. The company, GI Windows, has now taken this product, a magnetic endo-luminal anastomosis bypass device for the treatment of diabetes mellitus, into advanced stages of clinical testing. Relative to licensing arrangements, this involved a different level of participation.
“A start-up means creating a board, raising money, and being involved in details that can involve a lot of heavy lifting,” Dr. Thompson said. “It is basically a second job.”
The ongoing clinical studies in patients with diabetes have been very encouraging. Dr. Thompson reported that a large proportion of patients with diabetes fitted with the device have been able to reduce or discontinue their antidiabetic medications, and high rates of excess weight loss have been documented.
GI Windows was created for the sole purpose of developing the anastomosis device, but Dr. Thompson was also involved in creating another company, now sold, that started without a specific device in mind.
“The products we developed were just from brainstorming on unmet needs, and we had several successes. That was a chance to learn new areas of the business, including building a sales force and learning how to get involved in international distribution, which were separate from trying simply to produce a viable clinical tool,” he said.
Creating companies, rather than licensing ideas, trades higher risk for greater reward, but Dr. Thompson emphasized that these rewards are not just financial.
“It is exciting to develop a team you trust, get a successful company off the ground, and watch it grow,” Dr. Thompson said. He indicated that the risk-to-reward calculation should not be undertaken independent of the value of the learning experience.
BOSTON – Just out of fellowship, Christopher C. Thompson, MD, director of therapeutic endoscopy, Brigham and Women’s Hospital, Boston, adapted an antireflux suturing device for use in a bariatric procedure. It worked so well he began using it routinely and taught others the technique. That was the first step in a journey that has taken him from consulting with industry to a founder of start-ups.
“The device company heard about what we were doing and were interested,” Dr. Thompson recounted during his How-I-Did-It lecture at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. In the end, he served as a consultant in the development of a new suturing device specific for the bariatric procedure. This included helping secure a patent and learning first-hand what steps are needed to get a device to market.
“I do not have any regrets. It was good for my career and fun to be involved, but there was not much financial gain for me or for my department,” Dr. Thompson said.
His subsequent experience with licensing was an incremental step forward. In one example, he worked on developing an endoscopic simulator, an important unmet need both for teaching and evaluating skills in diagnostic colonoscopy, including a kinematic analysis that helped identify techniques that are associated with high levels of skill.
“We developed the technology in-house through a series of grants. The risks were low, but the rewards were better because the money helped fund activities in our department,” he said.
That device, too, has been very successful, but Dr. Thompson said it is important to recognize how far innovation can go when the work stays in the academic setting and the goal is licensing the technology. More recently, he took a nonsurgical anastomosis device through preclinical testing, but he was then unable to attract a device company for the next steps of development.
“With no one interested, we created a start-up,” Dr. Thompson said. The company, GI Windows, has now taken this product, a magnetic endo-luminal anastomosis bypass device for the treatment of diabetes mellitus, into advanced stages of clinical testing. Relative to licensing arrangements, this involved a different level of participation.
“A start-up means creating a board, raising money, and being involved in details that can involve a lot of heavy lifting,” Dr. Thompson said. “It is basically a second job.”
The ongoing clinical studies in patients with diabetes have been very encouraging. Dr. Thompson reported that a large proportion of patients with diabetes fitted with the device have been able to reduce or discontinue their antidiabetic medications, and high rates of excess weight loss have been documented.
GI Windows was created for the sole purpose of developing the anastomosis device, but Dr. Thompson was also involved in creating another company, now sold, that started without a specific device in mind.
“The products we developed were just from brainstorming on unmet needs, and we had several successes. That was a chance to learn new areas of the business, including building a sales force and learning how to get involved in international distribution, which were separate from trying simply to produce a viable clinical tool,” he said.
Creating companies, rather than licensing ideas, trades higher risk for greater reward, but Dr. Thompson emphasized that these rewards are not just financial.
“It is exciting to develop a team you trust, get a successful company off the ground, and watch it grow,” Dr. Thompson said. He indicated that the risk-to-reward calculation should not be undertaken independent of the value of the learning experience.
BOSTON – Just out of fellowship, Christopher C. Thompson, MD, director of therapeutic endoscopy, Brigham and Women’s Hospital, Boston, adapted an antireflux suturing device for use in a bariatric procedure. It worked so well he began using it routinely and taught others the technique. That was the first step in a journey that has taken him from consulting with industry to a founder of start-ups.
“The device company heard about what we were doing and were interested,” Dr. Thompson recounted during his How-I-Did-It lecture at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. In the end, he served as a consultant in the development of a new suturing device specific for the bariatric procedure. This included helping secure a patent and learning first-hand what steps are needed to get a device to market.
“I do not have any regrets. It was good for my career and fun to be involved, but there was not much financial gain for me or for my department,” Dr. Thompson said.
His subsequent experience with licensing was an incremental step forward. In one example, he worked on developing an endoscopic simulator, an important unmet need both for teaching and evaluating skills in diagnostic colonoscopy, including a kinematic analysis that helped identify techniques that are associated with high levels of skill.
“We developed the technology in-house through a series of grants. The risks were low, but the rewards were better because the money helped fund activities in our department,” he said.
That device, too, has been very successful, but Dr. Thompson said it is important to recognize how far innovation can go when the work stays in the academic setting and the goal is licensing the technology. More recently, he took a nonsurgical anastomosis device through preclinical testing, but he was then unable to attract a device company for the next steps of development.
“With no one interested, we created a start-up,” Dr. Thompson said. The company, GI Windows, has now taken this product, a magnetic endo-luminal anastomosis bypass device for the treatment of diabetes mellitus, into advanced stages of clinical testing. Relative to licensing arrangements, this involved a different level of participation.
“A start-up means creating a board, raising money, and being involved in details that can involve a lot of heavy lifting,” Dr. Thompson said. “It is basically a second job.”
The ongoing clinical studies in patients with diabetes have been very encouraging. Dr. Thompson reported that a large proportion of patients with diabetes fitted with the device have been able to reduce or discontinue their antidiabetic medications, and high rates of excess weight loss have been documented.
GI Windows was created for the sole purpose of developing the anastomosis device, but Dr. Thompson was also involved in creating another company, now sold, that started without a specific device in mind.
“The products we developed were just from brainstorming on unmet needs, and we had several successes. That was a chance to learn new areas of the business, including building a sales force and learning how to get involved in international distribution, which were separate from trying simply to produce a viable clinical tool,” he said.
Creating companies, rather than licensing ideas, trades higher risk for greater reward, but Dr. Thompson emphasized that these rewards are not just financial.
“It is exciting to develop a team you trust, get a successful company off the ground, and watch it grow,” Dr. Thompson said. He indicated that the risk-to-reward calculation should not be undertaken independent of the value of the learning experience.
REPORTING FROM 2018 AGA TECH SUMMIT
CGIT intensifies efforts to put new technologies into the hands of clinicians
There is no change in the core mission of the AGA’s Center for GI Innovation and Technology (CGIT) since two cochairs took over the leadership last year. As always, the goal is to support the development and adoption of new technologies for the treatment of digestive disorders. However, the cochairs want to do more to identify and dismantle the obstacles that slow the process.
“Innovators face challenges at every stage, from attracting investors to refining an idea into a viable clinical tool. Even once a device has obtained regulatory approval, issues of training and reimbursement can keep a good idea from improving patient care,” explained V. Raman Muthusamy, MD, director of interventional endoscopy and general GI endoscopy, at the University of California, Los Angeles. “We want to identify these obstacles and use the CGIT resources to provide solutions.”
“CGIT was set up to foster collaboration between stakeholders in new technology, but we have been increasingly concerned about the roadblocks that keep important technology from getting into the hands of clinicians,” Dr. Komanduri said at the 2018 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “In addition to the role that the CGIT has played in bringing together interested parties, we are taking a closer look at how we can help accelerate both the processes of development and implementation once the technology is available.”
One strategy is to expand the presence and activities of CGIT. Established in 2010, the CGIT is best known for the AGA Tech Summit, which has been an important event for bringing together innovators, investors, clinicians, and those involved in navigating regulatory issues, but Dr. Komanduri said that he and Dr. Muthusamy are working to make the summit “more of a launching point” for ideas and projects that follow the meeting.
“The AGA Tech Summit has provided an opportunity to recognize hot areas, and the goal will be to drive new ideas forward after the meeting by facilitating communication and cooperation among those who can contribute to advancing the concepts, ” Dr. Komanduri explained.
To help focus the mission of the CGIT, six areas of concentration have been identified. These are colorectal cancer screening and diagnosis, endoscope reprocessing, weight loss interventions, interventional endoscopy platforms, antireflux devices, and tissue resection technologies, according to Dr. Muthusamy. These focus areas do not preclude CGIT involvement in other types of innovations, but Dr. Muthusamy said this list helps emphasize strengths for those who do not yet consider CGIT a resource.
“We want to intersect better with the AGA members who think CGIT is not relevant to them because they are not involved in the development of new technology,” Dr. Muthusamy said. In drawing attention to these specific areas, Dr. Muthusamy said, “We plan to do more with technology updates and keep the AGA membership aware of how opportunities in clinical medicine are evolving through technological innovation.”
The mission of CGIT begins with the encouragement of new technology but it includes all the steps needed to shepherd innovations into routine clinical application. This includes helping with the strategies that will incentivize clinicians to learn the technology. While this has always been part of the CGIT mission, the cochairs are increasing their attention to eliminating delays in the process, which they recognize as a threat to fulfilling the CGIT mandate.
“There are challenges to bringing new ideas to the marketplace, and we think that pace between idea and product is too slow,” Dr. Komanduri said. “We want to increase the emphasis on finding ways to streamline the process.”
There is no change in the core mission of the AGA’s Center for GI Innovation and Technology (CGIT) since two cochairs took over the leadership last year. As always, the goal is to support the development and adoption of new technologies for the treatment of digestive disorders. However, the cochairs want to do more to identify and dismantle the obstacles that slow the process.
“Innovators face challenges at every stage, from attracting investors to refining an idea into a viable clinical tool. Even once a device has obtained regulatory approval, issues of training and reimbursement can keep a good idea from improving patient care,” explained V. Raman Muthusamy, MD, director of interventional endoscopy and general GI endoscopy, at the University of California, Los Angeles. “We want to identify these obstacles and use the CGIT resources to provide solutions.”
“CGIT was set up to foster collaboration between stakeholders in new technology, but we have been increasingly concerned about the roadblocks that keep important technology from getting into the hands of clinicians,” Dr. Komanduri said at the 2018 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “In addition to the role that the CGIT has played in bringing together interested parties, we are taking a closer look at how we can help accelerate both the processes of development and implementation once the technology is available.”
One strategy is to expand the presence and activities of CGIT. Established in 2010, the CGIT is best known for the AGA Tech Summit, which has been an important event for bringing together innovators, investors, clinicians, and those involved in navigating regulatory issues, but Dr. Komanduri said that he and Dr. Muthusamy are working to make the summit “more of a launching point” for ideas and projects that follow the meeting.
“The AGA Tech Summit has provided an opportunity to recognize hot areas, and the goal will be to drive new ideas forward after the meeting by facilitating communication and cooperation among those who can contribute to advancing the concepts, ” Dr. Komanduri explained.
To help focus the mission of the CGIT, six areas of concentration have been identified. These are colorectal cancer screening and diagnosis, endoscope reprocessing, weight loss interventions, interventional endoscopy platforms, antireflux devices, and tissue resection technologies, according to Dr. Muthusamy. These focus areas do not preclude CGIT involvement in other types of innovations, but Dr. Muthusamy said this list helps emphasize strengths for those who do not yet consider CGIT a resource.
“We want to intersect better with the AGA members who think CGIT is not relevant to them because they are not involved in the development of new technology,” Dr. Muthusamy said. In drawing attention to these specific areas, Dr. Muthusamy said, “We plan to do more with technology updates and keep the AGA membership aware of how opportunities in clinical medicine are evolving through technological innovation.”
The mission of CGIT begins with the encouragement of new technology but it includes all the steps needed to shepherd innovations into routine clinical application. This includes helping with the strategies that will incentivize clinicians to learn the technology. While this has always been part of the CGIT mission, the cochairs are increasing their attention to eliminating delays in the process, which they recognize as a threat to fulfilling the CGIT mandate.
“There are challenges to bringing new ideas to the marketplace, and we think that pace between idea and product is too slow,” Dr. Komanduri said. “We want to increase the emphasis on finding ways to streamline the process.”
There is no change in the core mission of the AGA’s Center for GI Innovation and Technology (CGIT) since two cochairs took over the leadership last year. As always, the goal is to support the development and adoption of new technologies for the treatment of digestive disorders. However, the cochairs want to do more to identify and dismantle the obstacles that slow the process.
“Innovators face challenges at every stage, from attracting investors to refining an idea into a viable clinical tool. Even once a device has obtained regulatory approval, issues of training and reimbursement can keep a good idea from improving patient care,” explained V. Raman Muthusamy, MD, director of interventional endoscopy and general GI endoscopy, at the University of California, Los Angeles. “We want to identify these obstacles and use the CGIT resources to provide solutions.”
“CGIT was set up to foster collaboration between stakeholders in new technology, but we have been increasingly concerned about the roadblocks that keep important technology from getting into the hands of clinicians,” Dr. Komanduri said at the 2018 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “In addition to the role that the CGIT has played in bringing together interested parties, we are taking a closer look at how we can help accelerate both the processes of development and implementation once the technology is available.”
One strategy is to expand the presence and activities of CGIT. Established in 2010, the CGIT is best known for the AGA Tech Summit, which has been an important event for bringing together innovators, investors, clinicians, and those involved in navigating regulatory issues, but Dr. Komanduri said that he and Dr. Muthusamy are working to make the summit “more of a launching point” for ideas and projects that follow the meeting.
“The AGA Tech Summit has provided an opportunity to recognize hot areas, and the goal will be to drive new ideas forward after the meeting by facilitating communication and cooperation among those who can contribute to advancing the concepts, ” Dr. Komanduri explained.
To help focus the mission of the CGIT, six areas of concentration have been identified. These are colorectal cancer screening and diagnosis, endoscope reprocessing, weight loss interventions, interventional endoscopy platforms, antireflux devices, and tissue resection technologies, according to Dr. Muthusamy. These focus areas do not preclude CGIT involvement in other types of innovations, but Dr. Muthusamy said this list helps emphasize strengths for those who do not yet consider CGIT a resource.
“We want to intersect better with the AGA members who think CGIT is not relevant to them because they are not involved in the development of new technology,” Dr. Muthusamy said. In drawing attention to these specific areas, Dr. Muthusamy said, “We plan to do more with technology updates and keep the AGA membership aware of how opportunities in clinical medicine are evolving through technological innovation.”
The mission of CGIT begins with the encouragement of new technology but it includes all the steps needed to shepherd innovations into routine clinical application. This includes helping with the strategies that will incentivize clinicians to learn the technology. While this has always been part of the CGIT mission, the cochairs are increasing their attention to eliminating delays in the process, which they recognize as a threat to fulfilling the CGIT mandate.
“There are challenges to bringing new ideas to the marketplace, and we think that pace between idea and product is too slow,” Dr. Komanduri said. “We want to increase the emphasis on finding ways to streamline the process.”
