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Update on AGA-Medtronic Research and 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 and Development Pilot Award in Technology, 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 functioning. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington, D.C., as a poster of distinction.
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiologic mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using the Wireless Motility Capsule (WMC, SmartPill) to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO – just the sort of innovative technology that the AGA Center for GI Innovation and Technology (CGIT) has fostered. 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 IBS and SIBO have increased expression of pro-inflammatory markers compared to those with only IBS; 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, 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.
In data to be presented in the DDW poster, Dr. Roland’s team used the SmartPill to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared to patients with 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 TNF (tumor necrosis factor)-alpha and IL (interleukin)-6, to patients with IBS alone. They will use their data to apply for future funding.
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research and Development Pilot Award in Technology, 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 functioning. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington, D.C., as a poster of distinction.
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiologic mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using the Wireless Motility Capsule (WMC, SmartPill) to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO – just the sort of innovative technology that the AGA Center for GI Innovation and Technology (CGIT) has fostered. 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 IBS and SIBO have increased expression of pro-inflammatory markers compared to those with only IBS; 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, 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.
In data to be presented in the DDW poster, Dr. Roland’s team used the SmartPill to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared to patients with 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 TNF (tumor necrosis factor)-alpha and IL (interleukin)-6, to patients with IBS alone. They will use their data to apply for future funding.
BOSTON – It’s been just a year since Bani Chander Roland, MD, FACG, was awarded the 2017 AGA-Medtronic Research and Development Pilot Award in Technology, 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 functioning. Interim data from her grant will be presented at Digestive Disease Week® 2018 in June in Washington, D.C., as a poster of distinction.
Dr. Roland and her team are testing the hypothesis that IBS and SIBO result from several distinct pathophysiologic mechanisms, each of which are associated with their own distinct microbial and inflammatory profile. For the study, they are using the Wireless Motility Capsule (WMC, SmartPill) to assess alterations in gastrointestinal pathophysiology in patients with suspected IBS and SIBO – just the sort of innovative technology that the AGA Center for GI Innovation and Technology (CGIT) has fostered. 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 IBS and SIBO have increased expression of pro-inflammatory markers compared to those with only IBS; 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, 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.
In data to be presented in the DDW poster, Dr. Roland’s team used the SmartPill to measure the gastrointestinal transit times, pH, and ileocecal junction pressures of patients with IBS and SIBO as compared to patients with 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 TNF (tumor necrosis factor)-alpha and IL (interleukin)-6, to patients with IBS alone. They will use their data to apply for future funding.
2018 AGA TECH SUMMIT
Therapeutic endoscopy expands reach to deep GI lesions
BOSTON –
“The main difficulty with these procedures is closure,” Mouen A. Khashab, MD, said at the AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology. “Sometimes you can create a large defect that you’re not sure you can close. You must have experience with large defect closure.”
In experienced hands, the endoscopic approaches spare adjacent large organs, have a complete resection rate approaching 95%, and an acceptable rate of adverse events. They can provide excellent surgical specimens that are more than adequate for histologic studies, although some cannot provide any information on margins, said Dr. Khashab, director of therapeutic endoscopy at Johns Hopkins University, Baltimore. “When doing a full-thickness endoscopic resection, you can’t comment on the margins. You’re not getting any normal tissue around the tumor, and this can create an issue with some patients.”
Dr. Khashab briefly described three endoscopic resection techniques that are suitable for the following deep GI tumors:
- Submucosal tunneling endoscopic resection. STER is most suitable for smaller tumors (4 cm or less). Tumors of this size are easily removed en bloc via the endoscopic tunnel. Larger tumors can also be resected this way, but need to be removed piecemeal after dissection off the muscle layer. This is an acceptable alternative in leiomyomas but not in gastrointestinal stromal tumors. “For this technique, you introduce the scope into the submucosal layer and create a space with tunneling,” Dr. Khashab said. “We then expose the tumor, dissect it off the wall of the muscularis propria, and pull it out of the tunnel.” A 2017 meta-analysis examined outcomes in 28 studies with data on 1,085 lesions. The pooled complete resection and en bloc resection rates were 97.5% and 94.6%, respectively. Common complications associated with STER were air leakage symptoms (15%) and perforation (5.6%). “The perforation rate is reasonable, I think. A lot of these complications can be managed intraoperatively with clipping or suturing,” Dr. Khashab noted.
- Endoscopic submucosal dissection: ESD is now being used to resect tumors that originate from the muscularis propria. “This is something I didn’t used to think was even possible,” Dr. Khashab said. “But we are seeing some literature on this now. A lot of these tumors originate from the superficial MP [muscularis propria], so we can dissect off the muscle without needing a full-thickness resection.” He presented findings from a large study comprising 143 patients with submucosal gastric or esophageal tumors that arose from the muscularis propria at the esophagogastric junction. These were large lesions, a mean 17.6 cm, but they ranged up to 50 cm. The en bloc resection rate was 94%. There were six perforations (4%), along with four pneumoperitoneum and two pneumothorax, which resolved without further surgery. There were no local recurrences or metastases when the 2012 study appeared, with a mean follow-up of 2 years.
- Endoscopic full-thickness resection: EFTR “is a technically demanding procedure, and we frequently have to work on these tumors in retroflexion,” Dr. Khashab said. He referred to a 2011 paper, which described the EFTR technique used in 26 patients with gastric cancers. The tumors (mean size, 2.8 cm) were located in the gastric corpus and in the gastric fundus. Although the procedures were lengthy, ranging from 60 to 145 minutes, they were highly successful, with a 100% complete resection rate. Nevertheless, there was also a 100% perforation rate, although all these were closed intraoperatively. There was no postoperative gastric bleeding, peritonitis sign, or abdominal abscess. No lesion residual or recurrence was found during the 6-24 month follow-up period.
Dr. Khashab is a consultant and medical advisory board member for Boston Scientific and Olympus.
BOSTON –
“The main difficulty with these procedures is closure,” Mouen A. Khashab, MD, said at the AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology. “Sometimes you can create a large defect that you’re not sure you can close. You must have experience with large defect closure.”
In experienced hands, the endoscopic approaches spare adjacent large organs, have a complete resection rate approaching 95%, and an acceptable rate of adverse events. They can provide excellent surgical specimens that are more than adequate for histologic studies, although some cannot provide any information on margins, said Dr. Khashab, director of therapeutic endoscopy at Johns Hopkins University, Baltimore. “When doing a full-thickness endoscopic resection, you can’t comment on the margins. You’re not getting any normal tissue around the tumor, and this can create an issue with some patients.”
Dr. Khashab briefly described three endoscopic resection techniques that are suitable for the following deep GI tumors:
- Submucosal tunneling endoscopic resection. STER is most suitable for smaller tumors (4 cm or less). Tumors of this size are easily removed en bloc via the endoscopic tunnel. Larger tumors can also be resected this way, but need to be removed piecemeal after dissection off the muscle layer. This is an acceptable alternative in leiomyomas but not in gastrointestinal stromal tumors. “For this technique, you introduce the scope into the submucosal layer and create a space with tunneling,” Dr. Khashab said. “We then expose the tumor, dissect it off the wall of the muscularis propria, and pull it out of the tunnel.” A 2017 meta-analysis examined outcomes in 28 studies with data on 1,085 lesions. The pooled complete resection and en bloc resection rates were 97.5% and 94.6%, respectively. Common complications associated with STER were air leakage symptoms (15%) and perforation (5.6%). “The perforation rate is reasonable, I think. A lot of these complications can be managed intraoperatively with clipping or suturing,” Dr. Khashab noted.
- Endoscopic submucosal dissection: ESD is now being used to resect tumors that originate from the muscularis propria. “This is something I didn’t used to think was even possible,” Dr. Khashab said. “But we are seeing some literature on this now. A lot of these tumors originate from the superficial MP [muscularis propria], so we can dissect off the muscle without needing a full-thickness resection.” He presented findings from a large study comprising 143 patients with submucosal gastric or esophageal tumors that arose from the muscularis propria at the esophagogastric junction. These were large lesions, a mean 17.6 cm, but they ranged up to 50 cm. The en bloc resection rate was 94%. There were six perforations (4%), along with four pneumoperitoneum and two pneumothorax, which resolved without further surgery. There were no local recurrences or metastases when the 2012 study appeared, with a mean follow-up of 2 years.
- Endoscopic full-thickness resection: EFTR “is a technically demanding procedure, and we frequently have to work on these tumors in retroflexion,” Dr. Khashab said. He referred to a 2011 paper, which described the EFTR technique used in 26 patients with gastric cancers. The tumors (mean size, 2.8 cm) were located in the gastric corpus and in the gastric fundus. Although the procedures were lengthy, ranging from 60 to 145 minutes, they were highly successful, with a 100% complete resection rate. Nevertheless, there was also a 100% perforation rate, although all these were closed intraoperatively. There was no postoperative gastric bleeding, peritonitis sign, or abdominal abscess. No lesion residual or recurrence was found during the 6-24 month follow-up period.
Dr. Khashab is a consultant and medical advisory board member for Boston Scientific and Olympus.
BOSTON –
“The main difficulty with these procedures is closure,” Mouen A. Khashab, MD, said at the AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology. “Sometimes you can create a large defect that you’re not sure you can close. You must have experience with large defect closure.”
In experienced hands, the endoscopic approaches spare adjacent large organs, have a complete resection rate approaching 95%, and an acceptable rate of adverse events. They can provide excellent surgical specimens that are more than adequate for histologic studies, although some cannot provide any information on margins, said Dr. Khashab, director of therapeutic endoscopy at Johns Hopkins University, Baltimore. “When doing a full-thickness endoscopic resection, you can’t comment on the margins. You’re not getting any normal tissue around the tumor, and this can create an issue with some patients.”
Dr. Khashab briefly described three endoscopic resection techniques that are suitable for the following deep GI tumors:
- Submucosal tunneling endoscopic resection. STER is most suitable for smaller tumors (4 cm or less). Tumors of this size are easily removed en bloc via the endoscopic tunnel. Larger tumors can also be resected this way, but need to be removed piecemeal after dissection off the muscle layer. This is an acceptable alternative in leiomyomas but not in gastrointestinal stromal tumors. “For this technique, you introduce the scope into the submucosal layer and create a space with tunneling,” Dr. Khashab said. “We then expose the tumor, dissect it off the wall of the muscularis propria, and pull it out of the tunnel.” A 2017 meta-analysis examined outcomes in 28 studies with data on 1,085 lesions. The pooled complete resection and en bloc resection rates were 97.5% and 94.6%, respectively. Common complications associated with STER were air leakage symptoms (15%) and perforation (5.6%). “The perforation rate is reasonable, I think. A lot of these complications can be managed intraoperatively with clipping or suturing,” Dr. Khashab noted.
- Endoscopic submucosal dissection: ESD is now being used to resect tumors that originate from the muscularis propria. “This is something I didn’t used to think was even possible,” Dr. Khashab said. “But we are seeing some literature on this now. A lot of these tumors originate from the superficial MP [muscularis propria], so we can dissect off the muscle without needing a full-thickness resection.” He presented findings from a large study comprising 143 patients with submucosal gastric or esophageal tumors that arose from the muscularis propria at the esophagogastric junction. These were large lesions, a mean 17.6 cm, but they ranged up to 50 cm. The en bloc resection rate was 94%. There were six perforations (4%), along with four pneumoperitoneum and two pneumothorax, which resolved without further surgery. There were no local recurrences or metastases when the 2012 study appeared, with a mean follow-up of 2 years.
- Endoscopic full-thickness resection: EFTR “is a technically demanding procedure, and we frequently have to work on these tumors in retroflexion,” Dr. Khashab said. He referred to a 2011 paper, which described the EFTR technique used in 26 patients with gastric cancers. The tumors (mean size, 2.8 cm) were located in the gastric corpus and in the gastric fundus. Although the procedures were lengthy, ranging from 60 to 145 minutes, they were highly successful, with a 100% complete resection rate. Nevertheless, there was also a 100% perforation rate, although all these were closed intraoperatively. There was no postoperative gastric bleeding, peritonitis sign, or abdominal abscess. No lesion residual or recurrence was found during the 6-24 month follow-up period.
Dr. Khashab is a consultant and medical advisory board member for Boston Scientific and Olympus.
EXPERT ANALYSIS FROM THE 2018 AGA TECH SUMMIT
With these pearls, the med-tech space can be your oyster
BOSTON – Having a great idea is just the first step to landing a financial partner in device development – backers also scrutinize more intangible qualities.
The willingness to work as part of a team, the ability to project realistic expectations, the fortitude to take risks and persevere when circumstances get tough – these attributes are critical to forging a strong strategic alliance with a financial partner, Brian Tinkham said at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Put your own skin in the game
“To me, ‘skin in the game’ is mainly money. Investing your own money, your family’s money, changes the way you behave at the board meeting and when you spend that money,” Mr. Tinkham said. “We like people who are all in on this. When I see an entrepreneur who’s showing a return that’s not good enough for his own investment, I can lose confidence and trust. We want people who won’t walk away from their money, their family’s money, or my money; when times get tough and challenging, decisions need to be made.”
Be realistic
There’s a difference between confidence and irrational confidence, Mr. Tinkham said. “If you come to me presenting a game plan that says you’ll have a commercially viable product in 1 year for a $500,000 investment, you’ll shoot your credibility right off. We know exactly how hard it is to build a $10 million business, never mind a $100 million business. When you obviously don’t understand what lies ahead of you, it hurts your credibility. Work with people who have experience and let them help you present your ideas and goals in a realistic way, and that will help with raising capital so you can execute your plan.”
Be capital efficient
“The key takeaway here is that raising $100 million doesn’t necessarily make for a strong return for investors. The strong return comes with $20-$40 million raised. Most likely businesses that have raised that much have built a commercial structure, provided proof of concept with some actual sales, and generated enough customer interest to attract strategic partners.”
Location, location, location
“This is so important when you’re developing technology: You need to know where the people with high levels of competency are, and where the money is. If you don’t live near these localities, get on a plane and get there – that’s where the business is being done.”
California and the Philadelphia-Boston-New York corridor are the two biggest med-tech and investor hot spots in the United States, Mr. Tinkham noted. Smaller centers of innovation are scattered around the country, including Seattle, Denver, Minneapolis, Chicago, Pittsburgh, Washington, Raleigh-Durham, Atlanta, Austin, and Phoenix.
Be patient
“Adopting a new technology takes time, and the more disruptive the idea, the longer it takes to achieve market adoption. Translating that into med-tech, the time from founding a company to exit will take more than 5 years. Only 10% of companies do it in less time than that,” Mr. Tinkham said. “And you have to remember that not all of the exits we see are good ones – they can be exits in which investors lose most of the capital they’ve brought into the company.”
De-risk
Be the entrepreneur who takes a vision to a viable product.
“Most physician entrepreneurs come up with an idea and protect it – but don’t move it further. We want to see an idea that’s been created and then de-risked. You protect it, you prototype it, go into preclinical studies, then clinically validate it or obtain regulatory approval. And then in the end, to us the best measure is your revenue. Are customers buying it? Do they see in it the same value that you, the entrepreneur, sees? If you can get it there, you’ve got something. The further you de-risk something, the more attractive you become.”
Are you a physician innovator?
If you have an idea for a new technology to improve gastroenterology, the AGA Center for GI Innovation and Technology can help you through the device development and adoption process.
Get in touch with us at [email protected].
BOSTON – Having a great idea is just the first step to landing a financial partner in device development – backers also scrutinize more intangible qualities.
The willingness to work as part of a team, the ability to project realistic expectations, the fortitude to take risks and persevere when circumstances get tough – these attributes are critical to forging a strong strategic alliance with a financial partner, Brian Tinkham said at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Put your own skin in the game
“To me, ‘skin in the game’ is mainly money. Investing your own money, your family’s money, changes the way you behave at the board meeting and when you spend that money,” Mr. Tinkham said. “We like people who are all in on this. When I see an entrepreneur who’s showing a return that’s not good enough for his own investment, I can lose confidence and trust. We want people who won’t walk away from their money, their family’s money, or my money; when times get tough and challenging, decisions need to be made.”
Be realistic
There’s a difference between confidence and irrational confidence, Mr. Tinkham said. “If you come to me presenting a game plan that says you’ll have a commercially viable product in 1 year for a $500,000 investment, you’ll shoot your credibility right off. We know exactly how hard it is to build a $10 million business, never mind a $100 million business. When you obviously don’t understand what lies ahead of you, it hurts your credibility. Work with people who have experience and let them help you present your ideas and goals in a realistic way, and that will help with raising capital so you can execute your plan.”
Be capital efficient
“The key takeaway here is that raising $100 million doesn’t necessarily make for a strong return for investors. The strong return comes with $20-$40 million raised. Most likely businesses that have raised that much have built a commercial structure, provided proof of concept with some actual sales, and generated enough customer interest to attract strategic partners.”
Location, location, location
“This is so important when you’re developing technology: You need to know where the people with high levels of competency are, and where the money is. If you don’t live near these localities, get on a plane and get there – that’s where the business is being done.”
California and the Philadelphia-Boston-New York corridor are the two biggest med-tech and investor hot spots in the United States, Mr. Tinkham noted. Smaller centers of innovation are scattered around the country, including Seattle, Denver, Minneapolis, Chicago, Pittsburgh, Washington, Raleigh-Durham, Atlanta, Austin, and Phoenix.
Be patient
“Adopting a new technology takes time, and the more disruptive the idea, the longer it takes to achieve market adoption. Translating that into med-tech, the time from founding a company to exit will take more than 5 years. Only 10% of companies do it in less time than that,” Mr. Tinkham said. “And you have to remember that not all of the exits we see are good ones – they can be exits in which investors lose most of the capital they’ve brought into the company.”
De-risk
Be the entrepreneur who takes a vision to a viable product.
“Most physician entrepreneurs come up with an idea and protect it – but don’t move it further. We want to see an idea that’s been created and then de-risked. You protect it, you prototype it, go into preclinical studies, then clinically validate it or obtain regulatory approval. And then in the end, to us the best measure is your revenue. Are customers buying it? Do they see in it the same value that you, the entrepreneur, sees? If you can get it there, you’ve got something. The further you de-risk something, the more attractive you become.”
Are you a physician innovator?
If you have an idea for a new technology to improve gastroenterology, the AGA Center for GI Innovation and Technology can help you through the device development and adoption process.
Get in touch with us at [email protected].
BOSTON – Having a great idea is just the first step to landing a financial partner in device development – backers also scrutinize more intangible qualities.
The willingness to work as part of a team, the ability to project realistic expectations, the fortitude to take risks and persevere when circumstances get tough – these attributes are critical to forging a strong strategic alliance with a financial partner, Brian Tinkham said at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Put your own skin in the game
“To me, ‘skin in the game’ is mainly money. Investing your own money, your family’s money, changes the way you behave at the board meeting and when you spend that money,” Mr. Tinkham said. “We like people who are all in on this. When I see an entrepreneur who’s showing a return that’s not good enough for his own investment, I can lose confidence and trust. We want people who won’t walk away from their money, their family’s money, or my money; when times get tough and challenging, decisions need to be made.”
Be realistic
There’s a difference between confidence and irrational confidence, Mr. Tinkham said. “If you come to me presenting a game plan that says you’ll have a commercially viable product in 1 year for a $500,000 investment, you’ll shoot your credibility right off. We know exactly how hard it is to build a $10 million business, never mind a $100 million business. When you obviously don’t understand what lies ahead of you, it hurts your credibility. Work with people who have experience and let them help you present your ideas and goals in a realistic way, and that will help with raising capital so you can execute your plan.”
Be capital efficient
“The key takeaway here is that raising $100 million doesn’t necessarily make for a strong return for investors. The strong return comes with $20-$40 million raised. Most likely businesses that have raised that much have built a commercial structure, provided proof of concept with some actual sales, and generated enough customer interest to attract strategic partners.”
Location, location, location
“This is so important when you’re developing technology: You need to know where the people with high levels of competency are, and where the money is. If you don’t live near these localities, get on a plane and get there – that’s where the business is being done.”
California and the Philadelphia-Boston-New York corridor are the two biggest med-tech and investor hot spots in the United States, Mr. Tinkham noted. Smaller centers of innovation are scattered around the country, including Seattle, Denver, Minneapolis, Chicago, Pittsburgh, Washington, Raleigh-Durham, Atlanta, Austin, and Phoenix.
Be patient
“Adopting a new technology takes time, and the more disruptive the idea, the longer it takes to achieve market adoption. Translating that into med-tech, the time from founding a company to exit will take more than 5 years. Only 10% of companies do it in less time than that,” Mr. Tinkham said. “And you have to remember that not all of the exits we see are good ones – they can be exits in which investors lose most of the capital they’ve brought into the company.”
De-risk
Be the entrepreneur who takes a vision to a viable product.
“Most physician entrepreneurs come up with an idea and protect it – but don’t move it further. We want to see an idea that’s been created and then de-risked. You protect it, you prototype it, go into preclinical studies, then clinically validate it or obtain regulatory approval. And then in the end, to us the best measure is your revenue. Are customers buying it? Do they see in it the same value that you, the entrepreneur, sees? If you can get it there, you’ve got something. The further you de-risk something, the more attractive you become.”
Are you a physician innovator?
If you have an idea for a new technology to improve gastroenterology, the AGA Center for GI Innovation and Technology can help you through the device development and adoption process.
Get in touch with us at [email protected].
EXPERT ANALYSIS FROM 2018 AGA TECH SUMMIT
Evidence is essential but not sufficient to move guidelines
BOSTON – For those considering how to navigate their innovative health care strategy into a position that will lead to an eventual guideline recommendation, it is important to think beyond demonstration of efficacy and safety in the design of randomized trials, according to an overview of how guideline committees currently function.
“In the old days, it was only the strength of the evidence. Now, in addition to the evidence, we have three other issues we look at to form the strength of a recommendation,” John M. Inadomi, MD, AGAF, head of the division of gastroenterology, University of Washington, Seattle, said at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“I think the big thing is that we are trying to move away from is just-the-evidence [approach],” Dr. Inadomi explained to an audience that included physician entrepreneurs and investors with an interest in how to establish a new diagnostic tool or treatment device as a standard of care.
There is no doubt that randomized controlled trial data are critical for objectively establishing safety and efficacy, but there has been an evolutionary change. According to Dr. Inadomi, guideline committees are posing more pointed questions about the practical value of one strategy relative to others. They also have increased their scrutiny of the quality and consistency of the RCT data in relation to the specific indication being considered.
“The implication of a strong recommendation is that most people in the situation would want the recommended course of action and that only a small proportion would not,” Dr. Inadomi explained. On the basis of this criterion, an inconvenient, costly, or poorly accepted therapy may not receive a strong recommendation even if effective. Strong recommendations typically set a standard.
“For the health care provider, that means that most patients should receive that course of action,” Dr. Inadomi said. Conversely, “for a weak recommendation, it implies that the majority of people would want this, but many would not.”
Strong versus weak recommendations have an impact on health care policy, Dr. Inadomi added. Those measuring quality of care might, in some cases, evaluate the frequency with which patients receive guideline-based care that has been given a 1A rating, which identifies the strongest recommendation. Weak recommendations encourage a greater emphasis on shared decision making that recognizes alternative treatment strategies in the context of patient preferences and values.
A reorientation that considers the limits of objective data by itself is reflected in a less restrictive view on the source of the data used in guideline deliberations, according to Dr. Inadomi. “It was once thought that all RCTs are good and observational studies are bad,” he said, adding that this view has changed with greater appreciation of publication bias and RCT study limitations, such as enrollment of nonrepresentative patient populations. While RCT data are preferred, he contended that observational studies are influential to guideline committees when there is a large effect size and there is consistency of evidence.
The move away from evidence-only guidelines is driven by a greater appreciation of value, Dr. Inadomi suggested. For entrepreneurs who hope to shepherd their devices or tools into a central position in clinical medicine, safety and efficacy are critical but may no longer be sufficient.
Dr. Inadomi has no disclosures relevant to this topic.
BOSTON – For those considering how to navigate their innovative health care strategy into a position that will lead to an eventual guideline recommendation, it is important to think beyond demonstration of efficacy and safety in the design of randomized trials, according to an overview of how guideline committees currently function.
“In the old days, it was only the strength of the evidence. Now, in addition to the evidence, we have three other issues we look at to form the strength of a recommendation,” John M. Inadomi, MD, AGAF, head of the division of gastroenterology, University of Washington, Seattle, said at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“I think the big thing is that we are trying to move away from is just-the-evidence [approach],” Dr. Inadomi explained to an audience that included physician entrepreneurs and investors with an interest in how to establish a new diagnostic tool or treatment device as a standard of care.
There is no doubt that randomized controlled trial data are critical for objectively establishing safety and efficacy, but there has been an evolutionary change. According to Dr. Inadomi, guideline committees are posing more pointed questions about the practical value of one strategy relative to others. They also have increased their scrutiny of the quality and consistency of the RCT data in relation to the specific indication being considered.
“The implication of a strong recommendation is that most people in the situation would want the recommended course of action and that only a small proportion would not,” Dr. Inadomi explained. On the basis of this criterion, an inconvenient, costly, or poorly accepted therapy may not receive a strong recommendation even if effective. Strong recommendations typically set a standard.
“For the health care provider, that means that most patients should receive that course of action,” Dr. Inadomi said. Conversely, “for a weak recommendation, it implies that the majority of people would want this, but many would not.”
Strong versus weak recommendations have an impact on health care policy, Dr. Inadomi added. Those measuring quality of care might, in some cases, evaluate the frequency with which patients receive guideline-based care that has been given a 1A rating, which identifies the strongest recommendation. Weak recommendations encourage a greater emphasis on shared decision making that recognizes alternative treatment strategies in the context of patient preferences and values.
A reorientation that considers the limits of objective data by itself is reflected in a less restrictive view on the source of the data used in guideline deliberations, according to Dr. Inadomi. “It was once thought that all RCTs are good and observational studies are bad,” he said, adding that this view has changed with greater appreciation of publication bias and RCT study limitations, such as enrollment of nonrepresentative patient populations. While RCT data are preferred, he contended that observational studies are influential to guideline committees when there is a large effect size and there is consistency of evidence.
The move away from evidence-only guidelines is driven by a greater appreciation of value, Dr. Inadomi suggested. For entrepreneurs who hope to shepherd their devices or tools into a central position in clinical medicine, safety and efficacy are critical but may no longer be sufficient.
Dr. Inadomi has no disclosures relevant to this topic.
BOSTON – For those considering how to navigate their innovative health care strategy into a position that will lead to an eventual guideline recommendation, it is important to think beyond demonstration of efficacy and safety in the design of randomized trials, according to an overview of how guideline committees currently function.
“In the old days, it was only the strength of the evidence. Now, in addition to the evidence, we have three other issues we look at to form the strength of a recommendation,” John M. Inadomi, MD, AGAF, head of the division of gastroenterology, University of Washington, Seattle, said at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“I think the big thing is that we are trying to move away from is just-the-evidence [approach],” Dr. Inadomi explained to an audience that included physician entrepreneurs and investors with an interest in how to establish a new diagnostic tool or treatment device as a standard of care.
There is no doubt that randomized controlled trial data are critical for objectively establishing safety and efficacy, but there has been an evolutionary change. According to Dr. Inadomi, guideline committees are posing more pointed questions about the practical value of one strategy relative to others. They also have increased their scrutiny of the quality and consistency of the RCT data in relation to the specific indication being considered.
“The implication of a strong recommendation is that most people in the situation would want the recommended course of action and that only a small proportion would not,” Dr. Inadomi explained. On the basis of this criterion, an inconvenient, costly, or poorly accepted therapy may not receive a strong recommendation even if effective. Strong recommendations typically set a standard.
“For the health care provider, that means that most patients should receive that course of action,” Dr. Inadomi said. Conversely, “for a weak recommendation, it implies that the majority of people would want this, but many would not.”
Strong versus weak recommendations have an impact on health care policy, Dr. Inadomi added. Those measuring quality of care might, in some cases, evaluate the frequency with which patients receive guideline-based care that has been given a 1A rating, which identifies the strongest recommendation. Weak recommendations encourage a greater emphasis on shared decision making that recognizes alternative treatment strategies in the context of patient preferences and values.
A reorientation that considers the limits of objective data by itself is reflected in a less restrictive view on the source of the data used in guideline deliberations, according to Dr. Inadomi. “It was once thought that all RCTs are good and observational studies are bad,” he said, adding that this view has changed with greater appreciation of publication bias and RCT study limitations, such as enrollment of nonrepresentative patient populations. While RCT data are preferred, he contended that observational studies are influential to guideline committees when there is a large effect size and there is consistency of evidence.
The move away from evidence-only guidelines is driven by a greater appreciation of value, Dr. Inadomi suggested. For entrepreneurs who hope to shepherd their devices or tools into a central position in clinical medicine, safety and efficacy are critical but may no longer be sufficient.
Dr. Inadomi has no disclosures relevant to this topic.
EXPERT ANALYSIS FROM 2018 AGA TECH SUMMIT
Physiology, not mechanics, explains benefit of bariatric procedures
boston – Rather than being a better strategy to block absorption of ingested calories, the future of bariatric surgery depends on treatment combinations that promote weight control through healthy physiology, according to three experts participating in a panel on this topic at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“When we think about the mechanisms of surgery, the mechanical model is dead. There is no good supporting evidence for the mechanical model. The current model is all physiological, involving changes in signaling from the gut to the rest of the body,” asserted Lee Kaplan, MD, PhD, AGAF, director of the Weight Center at Massachusetts General Hospital, Boston.
The list of evidence suggesting that change in physiologic function is a far more important explanation for weight loss from bariatric interventions is long, according to Dr. Kaplan. Of his many examples, he noted that pregnant women gain weight normally after bariatric surgery.
“Now, if you cannot absorb food normally after bariatric surgery, how do you gain weight normally when pregnant?” Dr. Kaplan asked. The answer to this and other examples of a disconnect between a simple food-blocking mechanism and what is observed is that bariatric procedures favorably alter signals that control hunger, satiety, and metabolism.
The two other experts on the panel largely agreed. In discussing advances in small-bowel devices for the treatment of type 2 diabetes mellitus, Christopher Thompson, MD, AGAF, director of therapeutic endoscopy at Brigham and Women’s Hospital, Boston, also looked to physiologic effects of bariatric surgery. He placed particular emphasis on the foregut and hindgut hypotheses. These hypotheses are “not yet written in stone,” but they provide a conceptual basis for understanding metabolic changes observed after bariatric procedures.
“One way that gastric bypass might work is that it alters the incretins that drive insulin secretion and sensitivity,” Dr. Thompson said. The same principle has been proposed for a novel incisionless magnetic device developed by Dr. Thompson that is now in clinical trials. The device, which creates an anastomosis and a partial jejunal diversion, achieved a 40% excess weight loss and a significant reduction in hemoglobin A1c levels among patients with type 2 diabetes mellitus in an initial study. Dr. Thompson contended that this effect cannot be explained by a change in nutrient absorption.
A surgeon serving on the panel, Marina Kurian, MD, of New York University’s Langone Medical Center, New York, also referenced the evidence for physiologic effects when speaking about gastric bypass and sleeve gastrectomy. Although both involve a blocking function for food absorption, she agreed that there are several reasons why this may not account for benefits.
“Certainly with gastric bypass, we talk about foregut and hindgut theory in terms of incretin effect,” Dr. Kurian said. She also noted that even the procedures that produce the greatest restriction on food absorption are not typically effective as a single therapeutic approach. Rather, her major point was that no approach, whether surgical, endoscopic, or lifestyle, is generally sufficient to achieve and maintain weight loss indefinitely. In her own practice, she has been moving to a “one-stop shopping” approach to coordinate multiple options.
“Those of us working in obesity are very aware of its chronicity and how one intervention is not enough,” Dr. Kurian said. She suggested that coordinated care among surgeons, gastroenterologists, dietitians, behavioral therapists, and others will provide the road forward even if the next set of surgical procedures or endoscopic devices are incrementally more effective than current options for weight loss.
One reason that a single intervention may not be enough is that obesity is not a single disease but the product of multiple different pathological processes, according to Dr. Kaplan. This is supported by the varied response to current therapies. Producing a variety of examples, he showed that, although there are large weight reductions with the most successful therapies, some patients are exceptional responders, while a proportion of patients lose little or no weight and others actually gain weight. He expressed doubt that there will be a single solution applicable to all patients.
“Patients who respond to one therapy may not respond to another and vice versa, and so the goal is to match each patient with the therapy that is most appropriate and protective for them,” Dr. Kaplan said.
GIs are uniquely positioned to lead a care team to help patients with obesity achieve a healthy weight. The POWER (Practice Guide on Obesity and Weight Management, Education and Resources) white paper provides physicians with a comprehensive, multidisciplinary process to guide and personalize innovative obesity care for safe and effective weight management.
Learn more at http://www.cghjournal.org/article/S1542-3565(16)309880/fulltext.
boston – Rather than being a better strategy to block absorption of ingested calories, the future of bariatric surgery depends on treatment combinations that promote weight control through healthy physiology, according to three experts participating in a panel on this topic at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“When we think about the mechanisms of surgery, the mechanical model is dead. There is no good supporting evidence for the mechanical model. The current model is all physiological, involving changes in signaling from the gut to the rest of the body,” asserted Lee Kaplan, MD, PhD, AGAF, director of the Weight Center at Massachusetts General Hospital, Boston.
The list of evidence suggesting that change in physiologic function is a far more important explanation for weight loss from bariatric interventions is long, according to Dr. Kaplan. Of his many examples, he noted that pregnant women gain weight normally after bariatric surgery.
“Now, if you cannot absorb food normally after bariatric surgery, how do you gain weight normally when pregnant?” Dr. Kaplan asked. The answer to this and other examples of a disconnect between a simple food-blocking mechanism and what is observed is that bariatric procedures favorably alter signals that control hunger, satiety, and metabolism.
The two other experts on the panel largely agreed. In discussing advances in small-bowel devices for the treatment of type 2 diabetes mellitus, Christopher Thompson, MD, AGAF, director of therapeutic endoscopy at Brigham and Women’s Hospital, Boston, also looked to physiologic effects of bariatric surgery. He placed particular emphasis on the foregut and hindgut hypotheses. These hypotheses are “not yet written in stone,” but they provide a conceptual basis for understanding metabolic changes observed after bariatric procedures.
“One way that gastric bypass might work is that it alters the incretins that drive insulin secretion and sensitivity,” Dr. Thompson said. The same principle has been proposed for a novel incisionless magnetic device developed by Dr. Thompson that is now in clinical trials. The device, which creates an anastomosis and a partial jejunal diversion, achieved a 40% excess weight loss and a significant reduction in hemoglobin A1c levels among patients with type 2 diabetes mellitus in an initial study. Dr. Thompson contended that this effect cannot be explained by a change in nutrient absorption.
A surgeon serving on the panel, Marina Kurian, MD, of New York University’s Langone Medical Center, New York, also referenced the evidence for physiologic effects when speaking about gastric bypass and sleeve gastrectomy. Although both involve a blocking function for food absorption, she agreed that there are several reasons why this may not account for benefits.
“Certainly with gastric bypass, we talk about foregut and hindgut theory in terms of incretin effect,” Dr. Kurian said. She also noted that even the procedures that produce the greatest restriction on food absorption are not typically effective as a single therapeutic approach. Rather, her major point was that no approach, whether surgical, endoscopic, or lifestyle, is generally sufficient to achieve and maintain weight loss indefinitely. In her own practice, she has been moving to a “one-stop shopping” approach to coordinate multiple options.
“Those of us working in obesity are very aware of its chronicity and how one intervention is not enough,” Dr. Kurian said. She suggested that coordinated care among surgeons, gastroenterologists, dietitians, behavioral therapists, and others will provide the road forward even if the next set of surgical procedures or endoscopic devices are incrementally more effective than current options for weight loss.
One reason that a single intervention may not be enough is that obesity is not a single disease but the product of multiple different pathological processes, according to Dr. Kaplan. This is supported by the varied response to current therapies. Producing a variety of examples, he showed that, although there are large weight reductions with the most successful therapies, some patients are exceptional responders, while a proportion of patients lose little or no weight and others actually gain weight. He expressed doubt that there will be a single solution applicable to all patients.
“Patients who respond to one therapy may not respond to another and vice versa, and so the goal is to match each patient with the therapy that is most appropriate and protective for them,” Dr. Kaplan said.
GIs are uniquely positioned to lead a care team to help patients with obesity achieve a healthy weight. The POWER (Practice Guide on Obesity and Weight Management, Education and Resources) white paper provides physicians with a comprehensive, multidisciplinary process to guide and personalize innovative obesity care for safe and effective weight management.
Learn more at http://www.cghjournal.org/article/S1542-3565(16)309880/fulltext.
boston – Rather than being a better strategy to block absorption of ingested calories, the future of bariatric surgery depends on treatment combinations that promote weight control through healthy physiology, according to three experts participating in a panel on this topic at the 2018 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
“When we think about the mechanisms of surgery, the mechanical model is dead. There is no good supporting evidence for the mechanical model. The current model is all physiological, involving changes in signaling from the gut to the rest of the body,” asserted Lee Kaplan, MD, PhD, AGAF, director of the Weight Center at Massachusetts General Hospital, Boston.
The list of evidence suggesting that change in physiologic function is a far more important explanation for weight loss from bariatric interventions is long, according to Dr. Kaplan. Of his many examples, he noted that pregnant women gain weight normally after bariatric surgery.
“Now, if you cannot absorb food normally after bariatric surgery, how do you gain weight normally when pregnant?” Dr. Kaplan asked. The answer to this and other examples of a disconnect between a simple food-blocking mechanism and what is observed is that bariatric procedures favorably alter signals that control hunger, satiety, and metabolism.
The two other experts on the panel largely agreed. In discussing advances in small-bowel devices for the treatment of type 2 diabetes mellitus, Christopher Thompson, MD, AGAF, director of therapeutic endoscopy at Brigham and Women’s Hospital, Boston, also looked to physiologic effects of bariatric surgery. He placed particular emphasis on the foregut and hindgut hypotheses. These hypotheses are “not yet written in stone,” but they provide a conceptual basis for understanding metabolic changes observed after bariatric procedures.
“One way that gastric bypass might work is that it alters the incretins that drive insulin secretion and sensitivity,” Dr. Thompson said. The same principle has been proposed for a novel incisionless magnetic device developed by Dr. Thompson that is now in clinical trials. The device, which creates an anastomosis and a partial jejunal diversion, achieved a 40% excess weight loss and a significant reduction in hemoglobin A1c levels among patients with type 2 diabetes mellitus in an initial study. Dr. Thompson contended that this effect cannot be explained by a change in nutrient absorption.
A surgeon serving on the panel, Marina Kurian, MD, of New York University’s Langone Medical Center, New York, also referenced the evidence for physiologic effects when speaking about gastric bypass and sleeve gastrectomy. Although both involve a blocking function for food absorption, she agreed that there are several reasons why this may not account for benefits.
“Certainly with gastric bypass, we talk about foregut and hindgut theory in terms of incretin effect,” Dr. Kurian said. She also noted that even the procedures that produce the greatest restriction on food absorption are not typically effective as a single therapeutic approach. Rather, her major point was that no approach, whether surgical, endoscopic, or lifestyle, is generally sufficient to achieve and maintain weight loss indefinitely. In her own practice, she has been moving to a “one-stop shopping” approach to coordinate multiple options.
“Those of us working in obesity are very aware of its chronicity and how one intervention is not enough,” Dr. Kurian said. She suggested that coordinated care among surgeons, gastroenterologists, dietitians, behavioral therapists, and others will provide the road forward even if the next set of surgical procedures or endoscopic devices are incrementally more effective than current options for weight loss.
One reason that a single intervention may not be enough is that obesity is not a single disease but the product of multiple different pathological processes, according to Dr. Kaplan. This is supported by the varied response to current therapies. Producing a variety of examples, he showed that, although there are large weight reductions with the most successful therapies, some patients are exceptional responders, while a proportion of patients lose little or no weight and others actually gain weight. He expressed doubt that there will be a single solution applicable to all patients.
“Patients who respond to one therapy may not respond to another and vice versa, and so the goal is to match each patient with the therapy that is most appropriate and protective for them,” Dr. Kaplan said.
GIs are uniquely positioned to lead a care team to help patients with obesity achieve a healthy weight. The POWER (Practice Guide on Obesity and Weight Management, Education and Resources) white paper provides physicians with a comprehensive, multidisciplinary process to guide and personalize innovative obesity care for safe and effective weight management.
Learn more at http://www.cghjournal.org/article/S1542-3565(16)309880/fulltext.
EXPERT ANALYSIS FROM 2018 AGA TECH SUMMIT
VIDEO: Nanotechnology is making a mark in gastroenterology
BOSTON – Nanotechnology, though small in scale, is making a big difference in gastroenterology. Nanoparticles can deliver therapeutic compounds or enable other diagnostic tools, said Vadim Backman, PhD, the Walter Dill Scott Professor of Biomedical Engineering at Northwestern University, Chicago, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Nanotechnology can treat disease by reprogramming gene expression or gene regulation. Nanoparticle formulations are FDA approved now for treatment of esophageal, colon, and pancreatic cancers, said Dr. Backman in a video interview, but the ability of nanotechnology to reprogram biological processes at the genetic level has researchers looking at treating inflammatory diseases and regenerating tissues.
BOSTON – Nanotechnology, though small in scale, is making a big difference in gastroenterology. Nanoparticles can deliver therapeutic compounds or enable other diagnostic tools, said Vadim Backman, PhD, the Walter Dill Scott Professor of Biomedical Engineering at Northwestern University, Chicago, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Nanotechnology can treat disease by reprogramming gene expression or gene regulation. Nanoparticle formulations are FDA approved now for treatment of esophageal, colon, and pancreatic cancers, said Dr. Backman in a video interview, but the ability of nanotechnology to reprogram biological processes at the genetic level has researchers looking at treating inflammatory diseases and regenerating tissues.
BOSTON – Nanotechnology, though small in scale, is making a big difference in gastroenterology. Nanoparticles can deliver therapeutic compounds or enable other diagnostic tools, said Vadim Backman, PhD, the Walter Dill Scott Professor of Biomedical Engineering at Northwestern University, Chicago, in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Nanotechnology can treat disease by reprogramming gene expression or gene regulation. Nanoparticle formulations are FDA approved now for treatment of esophageal, colon, and pancreatic cancers, said Dr. Backman in a video interview, but the ability of nanotechnology to reprogram biological processes at the genetic level has researchers looking at treating inflammatory diseases and regenerating tissues.
FROM THE 2018 AGA TECH SUMMIT
VIDEO: Digital innovation, consumer point of view can solve clinical problems
BOSTON – Carla E. Small, MBA, senior director of innovation at Boston Children’s Hospital, addressed digital health care in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. It is really just providing health care to patients in a digital world, she said, adding that she prefers the term “tech-enabled health care.” One up-and-coming example of this is the use of Alexa-type voice devices to do work and solve small clinical problems. Her program did a nationwide survey of pediatricians and found that half were interested in using voice technology. Artificial intelligence is another area of technology that Boston Children’s is using – in particular, they have created algorithms that help pediatricians analyze brain scans of young children, because so few pediatricians are trained in this area. The innovation program also has taken the digital world to pediatric patients in a program called Health Voyager in which children can take a virtual journey through their own diseased intestinal system.
BOSTON – Carla E. Small, MBA, senior director of innovation at Boston Children’s Hospital, addressed digital health care in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. It is really just providing health care to patients in a digital world, she said, adding that she prefers the term “tech-enabled health care.” One up-and-coming example of this is the use of Alexa-type voice devices to do work and solve small clinical problems. Her program did a nationwide survey of pediatricians and found that half were interested in using voice technology. Artificial intelligence is another area of technology that Boston Children’s is using – in particular, they have created algorithms that help pediatricians analyze brain scans of young children, because so few pediatricians are trained in this area. The innovation program also has taken the digital world to pediatric patients in a program called Health Voyager in which children can take a virtual journey through their own diseased intestinal system.
BOSTON – Carla E. Small, MBA, senior director of innovation at Boston Children’s Hospital, addressed digital health care in a video interview at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. It is really just providing health care to patients in a digital world, she said, adding that she prefers the term “tech-enabled health care.” One up-and-coming example of this is the use of Alexa-type voice devices to do work and solve small clinical problems. Her program did a nationwide survey of pediatricians and found that half were interested in using voice technology. Artificial intelligence is another area of technology that Boston Children’s is using – in particular, they have created algorithms that help pediatricians analyze brain scans of young children, because so few pediatricians are trained in this area. The innovation program also has taken the digital world to pediatric patients in a program called Health Voyager in which children can take a virtual journey through their own diseased intestinal system.
FROM THE 20I8 AGA TECH SUMMIT
VIDEO: In 2018, the AGA Center for GI Innovation and Technology is going strong
BOSTON – The AGA Center for GI Innovation and Technology (CGIT) was founded 9 years ago to foster innovation in GI disease, according to Sri Komanduri, MD, AGAF, and V. Raman Muthusamy, MD, the current cochairs. The mandate is still the same, with the idea that CGIT will continue to provide support and resources to a wide variety of stakeholders throughout the daunting process of getting a new technology or product through funding and approval to reimbursement and adoption. Dr. Komanduri, the medical director of the GI laboratory and director of interventional endoscopy at Northwestern University in Chicago, emphasized the need to support the entire process from idea to adoption as a continuum that should not be handled by different silos – CGIT should be there every step of the way.
CGIT will concentrate on six main areas now, although Dr. Muthusamy, director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, said in a video interview that they are flexible enough to work with any GI-applicable technology that will help practicing clinicians. These six areas are endoscopy for bariatric treatments, endoscopy for resection in place of surgery, endoscope reprocessing, interventional endoscopy, endoscopic reflux technology, and endoscopic diagnostic colorectal advances.
BOSTON – The AGA Center for GI Innovation and Technology (CGIT) was founded 9 years ago to foster innovation in GI disease, according to Sri Komanduri, MD, AGAF, and V. Raman Muthusamy, MD, the current cochairs. The mandate is still the same, with the idea that CGIT will continue to provide support and resources to a wide variety of stakeholders throughout the daunting process of getting a new technology or product through funding and approval to reimbursement and adoption. Dr. Komanduri, the medical director of the GI laboratory and director of interventional endoscopy at Northwestern University in Chicago, emphasized the need to support the entire process from idea to adoption as a continuum that should not be handled by different silos – CGIT should be there every step of the way.
CGIT will concentrate on six main areas now, although Dr. Muthusamy, director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, said in a video interview that they are flexible enough to work with any GI-applicable technology that will help practicing clinicians. These six areas are endoscopy for bariatric treatments, endoscopy for resection in place of surgery, endoscope reprocessing, interventional endoscopy, endoscopic reflux technology, and endoscopic diagnostic colorectal advances.
BOSTON – The AGA Center for GI Innovation and Technology (CGIT) was founded 9 years ago to foster innovation in GI disease, according to Sri Komanduri, MD, AGAF, and V. Raman Muthusamy, MD, the current cochairs. The mandate is still the same, with the idea that CGIT will continue to provide support and resources to a wide variety of stakeholders throughout the daunting process of getting a new technology or product through funding and approval to reimbursement and adoption. Dr. Komanduri, the medical director of the GI laboratory and director of interventional endoscopy at Northwestern University in Chicago, emphasized the need to support the entire process from idea to adoption as a continuum that should not be handled by different silos – CGIT should be there every step of the way.
CGIT will concentrate on six main areas now, although Dr. Muthusamy, director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, said in a video interview that they are flexible enough to work with any GI-applicable technology that will help practicing clinicians. These six areas are endoscopy for bariatric treatments, endoscopy for resection in place of surgery, endoscope reprocessing, interventional endoscopy, endoscopic reflux technology, and endoscopic diagnostic colorectal advances.
FROM THE 2018 AGA TECH SUMMIT
VIDEO: It’s all about improving the patient experience
BOSTON – “When I assess a new technology,” said V. Raman Muthusamy, MD, chair of the AGA Center for GI Innovation and Technology (CGIT), “I look for three things” – it should allow us to do something we couldn’t do before, give better outcomes and/or do the procedure less invasively, or provide cost savings. Ideally, he said during an interview at the AGA Tech Summit, it should do all three. Dr. Muthusamy, director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, said one of the goals of the CGIT is to keep physicians up to date on new technologies, but he recommends all physicians assess the data on new technologies and weigh the advantages before incorporating a new device into their practice. Better diagnostic tools and novel therapeutics should improve the patient experience.
BOSTON – “When I assess a new technology,” said V. Raman Muthusamy, MD, chair of the AGA Center for GI Innovation and Technology (CGIT), “I look for three things” – it should allow us to do something we couldn’t do before, give better outcomes and/or do the procedure less invasively, or provide cost savings. Ideally, he said during an interview at the AGA Tech Summit, it should do all three. Dr. Muthusamy, director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, said one of the goals of the CGIT is to keep physicians up to date on new technologies, but he recommends all physicians assess the data on new technologies and weigh the advantages before incorporating a new device into their practice. Better diagnostic tools and novel therapeutics should improve the patient experience.
BOSTON – “When I assess a new technology,” said V. Raman Muthusamy, MD, chair of the AGA Center for GI Innovation and Technology (CGIT), “I look for three things” – it should allow us to do something we couldn’t do before, give better outcomes and/or do the procedure less invasively, or provide cost savings. Ideally, he said during an interview at the AGA Tech Summit, it should do all three. Dr. Muthusamy, director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, said one of the goals of the CGIT is to keep physicians up to date on new technologies, but he recommends all physicians assess the data on new technologies and weigh the advantages before incorporating a new device into their practice. Better diagnostic tools and novel therapeutics should improve the patient experience.
FROM THE 2018 AGA TECH SUMMIT
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