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Where are they now? Two Shark Tank innovators share their tales of success
BOSTON – Two gastroenterology innovators spoke at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for Innovation and Technology, to share how their past participation in the AGA Shark Tank panel is helping them succeed.
Single-use endoscopes
For Invendo Medical GmbH Chief Commercial Officer John Cifarelli, who appeared before the panel during the 2015 Tech Summit, having Shark Tank experts suggest that he and his collaborators keep in mind physician practice habits when bringing their single-use endoscope technology to market was key to their ultimate product designs.
Another Shark Tank panel suggestion Mr. Cifarelli said he and his team included was the use of high definition (HD) optics to enhance diagnosis. “The panel told me that physicians have become accustomed to the clarity of HD technology and would have trouble accepting anything less.”
The timing of his appearance before the panel was perfect, since Mr. Cifarelli and his team were still at the conceptual stage with the device. “We had just gone from a company that was making an inverted sleeve colonoscope to be used without sedation, to a company that provides full-platform HD conventional GI endoscopes that are sterile and single use, so we were able to incorporate the panel’s advice into our designs,” he said.
Rather than create a separate, stand-alone, hand-held device as planned, Invendo instead is manufacturing the InvendoscopeTM, a hand-held, HD optics, sterile, single-use device that can be used either attached to or detached from the endoscope – the first such device of its kind, he said. The Invendoscope recently received its CE mark and is expected to come to market later this year.
Mr. Cifarelli said his company is also at work on an HD, single-use, sterile gastroscope and duodenoscope, both of which he expects will be introduced by early 2018.
Technology IDs progression risk in Barrett’s
Appearing before the 2015 panel gave Cernostics CEO Mike Hoerres a comprehensive perspective that subsequently has served his collaborators and him well. The company was just issued two patents on the TissueCypherTM Image Analysis Platform, a tissue systems biology approach that evaluates protein expression in the context of tissue structure when analyzing biopsies from patients with Barrett’s esophagus. The assay technology simultaneously and objectively extracts high-dimensional biomarker expression and morphology data to evaluate multiple tumor, immune, and other stromal processes in a single tissue section.
Since then, quite a lot has happened for Cernostics and TissueCypherTM, including publication of two validation studies in 2016 demonstrating TissueCypherTM’s ability to predict progression to high-grade dysplasia or cancer, which are otherwise missed by standard histology. The company also received a $1.2 million grant from the National Institutes of Health for a phase II SBIR study that is being conducted with the Cleveland Clinic and the University of Pittsburgh Medical Center.
“We have shown that TissueCypherTM can identify who is 10 times more likely to progress to esophageal cancer within 5 years of biopsy vs. low-risk patients – something that is currently difficult to determine by standard pathology. This test could enable early intervention to prevent cancer in high-risk patients, and may spare low-risk patients frequent and unnecessary endoscopies and treatments,” Mr. Hoerres said in the interview.
Currently, about 3-4 million people in the U.S. are part of active surveillance programs for Barrett’s esophagus. “If the promise of the technology to decrease the utilization of endoscopy in patients who are unlikely to progress to dysplastic Barrett’s is realized, there will likely be significant savings in the care of these patients,” Dr. Michael L. Kochman, executive committee chair of the AGA Center for GI Innovation and Technology, said in an interview.
BOSTON – Two gastroenterology innovators spoke at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for Innovation and Technology, to share how their past participation in the AGA Shark Tank panel is helping them succeed.
Single-use endoscopes
For Invendo Medical GmbH Chief Commercial Officer John Cifarelli, who appeared before the panel during the 2015 Tech Summit, having Shark Tank experts suggest that he and his collaborators keep in mind physician practice habits when bringing their single-use endoscope technology to market was key to their ultimate product designs.
Another Shark Tank panel suggestion Mr. Cifarelli said he and his team included was the use of high definition (HD) optics to enhance diagnosis. “The panel told me that physicians have become accustomed to the clarity of HD technology and would have trouble accepting anything less.”
The timing of his appearance before the panel was perfect, since Mr. Cifarelli and his team were still at the conceptual stage with the device. “We had just gone from a company that was making an inverted sleeve colonoscope to be used without sedation, to a company that provides full-platform HD conventional GI endoscopes that are sterile and single use, so we were able to incorporate the panel’s advice into our designs,” he said.
Rather than create a separate, stand-alone, hand-held device as planned, Invendo instead is manufacturing the InvendoscopeTM, a hand-held, HD optics, sterile, single-use device that can be used either attached to or detached from the endoscope – the first such device of its kind, he said. The Invendoscope recently received its CE mark and is expected to come to market later this year.
Mr. Cifarelli said his company is also at work on an HD, single-use, sterile gastroscope and duodenoscope, both of which he expects will be introduced by early 2018.
Technology IDs progression risk in Barrett’s
Appearing before the 2015 panel gave Cernostics CEO Mike Hoerres a comprehensive perspective that subsequently has served his collaborators and him well. The company was just issued two patents on the TissueCypherTM Image Analysis Platform, a tissue systems biology approach that evaluates protein expression in the context of tissue structure when analyzing biopsies from patients with Barrett’s esophagus. The assay technology simultaneously and objectively extracts high-dimensional biomarker expression and morphology data to evaluate multiple tumor, immune, and other stromal processes in a single tissue section.
Since then, quite a lot has happened for Cernostics and TissueCypherTM, including publication of two validation studies in 2016 demonstrating TissueCypherTM’s ability to predict progression to high-grade dysplasia or cancer, which are otherwise missed by standard histology. The company also received a $1.2 million grant from the National Institutes of Health for a phase II SBIR study that is being conducted with the Cleveland Clinic and the University of Pittsburgh Medical Center.
“We have shown that TissueCypherTM can identify who is 10 times more likely to progress to esophageal cancer within 5 years of biopsy vs. low-risk patients – something that is currently difficult to determine by standard pathology. This test could enable early intervention to prevent cancer in high-risk patients, and may spare low-risk patients frequent and unnecessary endoscopies and treatments,” Mr. Hoerres said in the interview.
Currently, about 3-4 million people in the U.S. are part of active surveillance programs for Barrett’s esophagus. “If the promise of the technology to decrease the utilization of endoscopy in patients who are unlikely to progress to dysplastic Barrett’s is realized, there will likely be significant savings in the care of these patients,” Dr. Michael L. Kochman, executive committee chair of the AGA Center for GI Innovation and Technology, said in an interview.
BOSTON – Two gastroenterology innovators spoke at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for Innovation and Technology, to share how their past participation in the AGA Shark Tank panel is helping them succeed.
Single-use endoscopes
For Invendo Medical GmbH Chief Commercial Officer John Cifarelli, who appeared before the panel during the 2015 Tech Summit, having Shark Tank experts suggest that he and his collaborators keep in mind physician practice habits when bringing their single-use endoscope technology to market was key to their ultimate product designs.
Another Shark Tank panel suggestion Mr. Cifarelli said he and his team included was the use of high definition (HD) optics to enhance diagnosis. “The panel told me that physicians have become accustomed to the clarity of HD technology and would have trouble accepting anything less.”
The timing of his appearance before the panel was perfect, since Mr. Cifarelli and his team were still at the conceptual stage with the device. “We had just gone from a company that was making an inverted sleeve colonoscope to be used without sedation, to a company that provides full-platform HD conventional GI endoscopes that are sterile and single use, so we were able to incorporate the panel’s advice into our designs,” he said.
Rather than create a separate, stand-alone, hand-held device as planned, Invendo instead is manufacturing the InvendoscopeTM, a hand-held, HD optics, sterile, single-use device that can be used either attached to or detached from the endoscope – the first such device of its kind, he said. The Invendoscope recently received its CE mark and is expected to come to market later this year.
Mr. Cifarelli said his company is also at work on an HD, single-use, sterile gastroscope and duodenoscope, both of which he expects will be introduced by early 2018.
Technology IDs progression risk in Barrett’s
Appearing before the 2015 panel gave Cernostics CEO Mike Hoerres a comprehensive perspective that subsequently has served his collaborators and him well. The company was just issued two patents on the TissueCypherTM Image Analysis Platform, a tissue systems biology approach that evaluates protein expression in the context of tissue structure when analyzing biopsies from patients with Barrett’s esophagus. The assay technology simultaneously and objectively extracts high-dimensional biomarker expression and morphology data to evaluate multiple tumor, immune, and other stromal processes in a single tissue section.
Since then, quite a lot has happened for Cernostics and TissueCypherTM, including publication of two validation studies in 2016 demonstrating TissueCypherTM’s ability to predict progression to high-grade dysplasia or cancer, which are otherwise missed by standard histology. The company also received a $1.2 million grant from the National Institutes of Health for a phase II SBIR study that is being conducted with the Cleveland Clinic and the University of Pittsburgh Medical Center.
“We have shown that TissueCypherTM can identify who is 10 times more likely to progress to esophageal cancer within 5 years of biopsy vs. low-risk patients – something that is currently difficult to determine by standard pathology. This test could enable early intervention to prevent cancer in high-risk patients, and may spare low-risk patients frequent and unnecessary endoscopies and treatments,” Mr. Hoerres said in the interview.
Currently, about 3-4 million people in the U.S. are part of active surveillance programs for Barrett’s esophagus. “If the promise of the technology to decrease the utilization of endoscopy in patients who are unlikely to progress to dysplastic Barrett’s is realized, there will likely be significant savings in the care of these patients,” Dr. Michael L. Kochman, executive committee chair of the AGA Center for GI Innovation and Technology, said in an interview.
FROM THE 2017 AGA TECH SUMMIT
VIDEO: AGA Center chair seeks to streamline innovation
BOSTON – A lot has changed in GI technology since V. Raman Muthusamy, MD, the incoming chair of the AGA Center for GI Innovation and Technology(CGIT), completed his GI fellowship training 15 years ago.
“I would say that between half and two-thirds of what I do today for actual patient care delivery is from technologies that have been completed since my fellowship or [from] applications of those technologies that are new,” he said in a video interview conducted during the 2017 AGA Technology Summit, which is sponsored by the center. So if you think you’re not impacted by innovation, think again.
“I think like many practicing physicians we have great technology, but we can think of ways to do things better,” continued Dr. Muthusamy, professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
One of the goals of the center is to streamline the process of taking a good idea and making it into a product and a company. Dr. Muthusamy said such streamlining is important because the current “daunting” development process has led to many good ideas “dying on the vine” before they could be implemented. He says the CGIT, by bringing together key stakeholders from the medical, business, and regulatory arenas, can help bring forth the latest technologies to directly benefit GI patients.
BOSTON – A lot has changed in GI technology since V. Raman Muthusamy, MD, the incoming chair of the AGA Center for GI Innovation and Technology(CGIT), completed his GI fellowship training 15 years ago.
“I would say that between half and two-thirds of what I do today for actual patient care delivery is from technologies that have been completed since my fellowship or [from] applications of those technologies that are new,” he said in a video interview conducted during the 2017 AGA Technology Summit, which is sponsored by the center. So if you think you’re not impacted by innovation, think again.
“I think like many practicing physicians we have great technology, but we can think of ways to do things better,” continued Dr. Muthusamy, professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
One of the goals of the center is to streamline the process of taking a good idea and making it into a product and a company. Dr. Muthusamy said such streamlining is important because the current “daunting” development process has led to many good ideas “dying on the vine” before they could be implemented. He says the CGIT, by bringing together key stakeholders from the medical, business, and regulatory arenas, can help bring forth the latest technologies to directly benefit GI patients.
BOSTON – A lot has changed in GI technology since V. Raman Muthusamy, MD, the incoming chair of the AGA Center for GI Innovation and Technology(CGIT), completed his GI fellowship training 15 years ago.
“I would say that between half and two-thirds of what I do today for actual patient care delivery is from technologies that have been completed since my fellowship or [from] applications of those technologies that are new,” he said in a video interview conducted during the 2017 AGA Technology Summit, which is sponsored by the center. So if you think you’re not impacted by innovation, think again.
“I think like many practicing physicians we have great technology, but we can think of ways to do things better,” continued Dr. Muthusamy, professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles.
One of the goals of the center is to streamline the process of taking a good idea and making it into a product and a company. Dr. Muthusamy said such streamlining is important because the current “daunting” development process has led to many good ideas “dying on the vine” before they could be implemented. He says the CGIT, by bringing together key stakeholders from the medical, business, and regulatory arenas, can help bring forth the latest technologies to directly benefit GI patients.
Where we go from here: Successes and opportunities in the medtech arena
BOSTON – An array of potentially transformative technological innovations in gastroenterology with related effects on systemic health – including metabolic diseases – are showing promise at different stages of clinical testing, and gastroenterologists need to make sure they are not left behind in this opportunity to make a positive impact on patient health, according to an overview of recent medtech successes and coming trends presented at the 2017 AGA Tech Summit.
“Innovation in GI tech is continuing at a substantial pace because of the sustained interest among investors, entrepreneurs, and established industry players and the many opportunities and unmet needs,” Jay Pasricha, MD, MBBS, director of the Johns Hopkins Center for Neurogastroenterology, Baltimore, said in an interview. The obstacle for gastroenterologists is willingness to adapt.
The rapid, transformative changes in bariatric endoscopy provide an immediate example, according to Dr. Pasricha. There has been enormous innovation in this area with more devices coming. He suggested that meaningful participation in this growing field not only involves a commitment to mastering the technical challenges of available devices but also to providing comprehensive care.
“There needs to be a commitment to what might be described as the bookends of treatment. This means screening and appropriate selection of candidates for specific procedures and providing the follow-up and supportive care that lead to good outcomes. In other words, do it right or don’t do it,” Dr. Pasricha said.
He considers endoscopic approaches to weight loss — balloons, gastric restriction, or other strategies — emblematic of a flexion point in gastroenterology that has the potential to result in increasing polarization in the specialty. Those who adapt to deliver the advances in care permitted by new technology will participate in advancing the field. Those who do not may cede advanced procedures to those specialists who step in.
The AGA Obesity Practice Guide, for example, provides gastroenterologists with a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management, including the use of endoscopic and surgical procedures. The accompanying episode-of-care framework helps gastroenterologists understand how to operationalize obesity management for financial success (www.gastro.org/obesity).
Endoscopic mucosal resection of localized cancers, an area in which technological innovations are also promising, is another opportunity for gastroenterologists. According to Dr. Pasricha, “Innovations with the potential to leapfrog over traditional procedures are very feasible from a technical perspective, but which specialists will be the ones who collaborate on these interventions to make them a reality?”
While acknowledging that the current reimbursement structure does not incentivize complex and potentially time-consuming procedures over bread-and-butter procedures such as screening colonoscopy, Dr. Pasricha maintained that innovation in these areas represents the future. Eventually, advances in technology will simplify complex procedures, but Dr. Pasricha suggested that gastroenterologists should be leading disruptive technologies to ensure a place in delivery of next generation solutions.
In a broad survey of the likely directions, Dr. Pasricha provided examples of several frontiers in which technological innovation has a potential role. Efforts to harness the microbiome, for example, include devices with the potential to improve bowel function. Vagal stimulators in various forms have the potential to address pathology along the gut-brain axis.
“Devices designed to modify gut-brain signaling are not just relevant to GI diseases but are being pursued for much broader indications, such as those relating to mood and cognitive function,” Dr. Pasricha reported.
Casting a large net to touch on the science and economics of medtech innovations across a wide variety of unmet needs in gastroenterology, Dr. Pasricha described a common barrier. At the stage when new devices are introduced, innovators are faced with obstacles, including uncertain reimbursement and potential medico-legal risk, yet innovations depend on finding a path.
“Who is going to make the leap?” asked Dr. Pasricha, describing several areas of device innovation in which “people are testing the waters with no one yet willing to jump in.” He made the point that in fields relevant to their expertise, gastroenterologists should be participating in opportunities that may lead to better patient care.
“Otherwise, we may end up in an unhappy compromise – a small subset of technically advanced GI docs will compete with a larger and growing cadre of surgeons who are becoming increasingly skilled in flexible endoscopy,” Dr. Pasricha explained.
“But, in either scenario, the cognitive components of what represents best care for a given patient, which is the epitome of personalized medicine, may get short shrift,” he added. He envisions a worst case scenario in which screening colonoscopy is replaced by a pill or a fecal test, “and our specialty is not ready for taking care of all the other unmet needs because we have been complacent.”
Still, there are large areas in which opportunities abound, such as motility and functional disorders, that represent a huge socioeconomic and clinical burden, according to Dr. Pasricha, who believes advances in this field should be embraced.
For entrepreneurs pursuing medtech overall and in GI diseases specifically, Dr. Pasricha had some specific advice. He suggested that efforts should not be restricted to the development of new devices or other solutions but should include developing a context for the innovation, such as training of those who will employ the innovation, creating awareness among physicians who will refer, and helping to ensure reimbursement.
“All stakeholders need to invest in the growth of their markets and not just in the technology,” Dr. Pasricha said. He emphasized that one of the most important roadblocks are the gatekeepers who fail to refer patients to specialists capable of implementing a new procedure.
However, he believes that there is enormous room for successful innovation in GI medtech.
“The future remains bright. The gut, the gut-brain axis, and the gut-metabolic axis are all keys to unlocking the potential for endoscopic interventions to impact so many chronic diseases,” Dr. Pasricha maintained. “It’s up to us to recognize this and take ownership of this space. This conference as always serves to highlight these opportunities and potential road maps to that future.”
BOSTON – An array of potentially transformative technological innovations in gastroenterology with related effects on systemic health – including metabolic diseases – are showing promise at different stages of clinical testing, and gastroenterologists need to make sure they are not left behind in this opportunity to make a positive impact on patient health, according to an overview of recent medtech successes and coming trends presented at the 2017 AGA Tech Summit.
“Innovation in GI tech is continuing at a substantial pace because of the sustained interest among investors, entrepreneurs, and established industry players and the many opportunities and unmet needs,” Jay Pasricha, MD, MBBS, director of the Johns Hopkins Center for Neurogastroenterology, Baltimore, said in an interview. The obstacle for gastroenterologists is willingness to adapt.
The rapid, transformative changes in bariatric endoscopy provide an immediate example, according to Dr. Pasricha. There has been enormous innovation in this area with more devices coming. He suggested that meaningful participation in this growing field not only involves a commitment to mastering the technical challenges of available devices but also to providing comprehensive care.
“There needs to be a commitment to what might be described as the bookends of treatment. This means screening and appropriate selection of candidates for specific procedures and providing the follow-up and supportive care that lead to good outcomes. In other words, do it right or don’t do it,” Dr. Pasricha said.
He considers endoscopic approaches to weight loss — balloons, gastric restriction, or other strategies — emblematic of a flexion point in gastroenterology that has the potential to result in increasing polarization in the specialty. Those who adapt to deliver the advances in care permitted by new technology will participate in advancing the field. Those who do not may cede advanced procedures to those specialists who step in.
The AGA Obesity Practice Guide, for example, provides gastroenterologists with a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management, including the use of endoscopic and surgical procedures. The accompanying episode-of-care framework helps gastroenterologists understand how to operationalize obesity management for financial success (www.gastro.org/obesity).
Endoscopic mucosal resection of localized cancers, an area in which technological innovations are also promising, is another opportunity for gastroenterologists. According to Dr. Pasricha, “Innovations with the potential to leapfrog over traditional procedures are very feasible from a technical perspective, but which specialists will be the ones who collaborate on these interventions to make them a reality?”
While acknowledging that the current reimbursement structure does not incentivize complex and potentially time-consuming procedures over bread-and-butter procedures such as screening colonoscopy, Dr. Pasricha maintained that innovation in these areas represents the future. Eventually, advances in technology will simplify complex procedures, but Dr. Pasricha suggested that gastroenterologists should be leading disruptive technologies to ensure a place in delivery of next generation solutions.
In a broad survey of the likely directions, Dr. Pasricha provided examples of several frontiers in which technological innovation has a potential role. Efforts to harness the microbiome, for example, include devices with the potential to improve bowel function. Vagal stimulators in various forms have the potential to address pathology along the gut-brain axis.
“Devices designed to modify gut-brain signaling are not just relevant to GI diseases but are being pursued for much broader indications, such as those relating to mood and cognitive function,” Dr. Pasricha reported.
Casting a large net to touch on the science and economics of medtech innovations across a wide variety of unmet needs in gastroenterology, Dr. Pasricha described a common barrier. At the stage when new devices are introduced, innovators are faced with obstacles, including uncertain reimbursement and potential medico-legal risk, yet innovations depend on finding a path.
“Who is going to make the leap?” asked Dr. Pasricha, describing several areas of device innovation in which “people are testing the waters with no one yet willing to jump in.” He made the point that in fields relevant to their expertise, gastroenterologists should be participating in opportunities that may lead to better patient care.
“Otherwise, we may end up in an unhappy compromise – a small subset of technically advanced GI docs will compete with a larger and growing cadre of surgeons who are becoming increasingly skilled in flexible endoscopy,” Dr. Pasricha explained.
“But, in either scenario, the cognitive components of what represents best care for a given patient, which is the epitome of personalized medicine, may get short shrift,” he added. He envisions a worst case scenario in which screening colonoscopy is replaced by a pill or a fecal test, “and our specialty is not ready for taking care of all the other unmet needs because we have been complacent.”
Still, there are large areas in which opportunities abound, such as motility and functional disorders, that represent a huge socioeconomic and clinical burden, according to Dr. Pasricha, who believes advances in this field should be embraced.
For entrepreneurs pursuing medtech overall and in GI diseases specifically, Dr. Pasricha had some specific advice. He suggested that efforts should not be restricted to the development of new devices or other solutions but should include developing a context for the innovation, such as training of those who will employ the innovation, creating awareness among physicians who will refer, and helping to ensure reimbursement.
“All stakeholders need to invest in the growth of their markets and not just in the technology,” Dr. Pasricha said. He emphasized that one of the most important roadblocks are the gatekeepers who fail to refer patients to specialists capable of implementing a new procedure.
However, he believes that there is enormous room for successful innovation in GI medtech.
“The future remains bright. The gut, the gut-brain axis, and the gut-metabolic axis are all keys to unlocking the potential for endoscopic interventions to impact so many chronic diseases,” Dr. Pasricha maintained. “It’s up to us to recognize this and take ownership of this space. This conference as always serves to highlight these opportunities and potential road maps to that future.”
BOSTON – An array of potentially transformative technological innovations in gastroenterology with related effects on systemic health – including metabolic diseases – are showing promise at different stages of clinical testing, and gastroenterologists need to make sure they are not left behind in this opportunity to make a positive impact on patient health, according to an overview of recent medtech successes and coming trends presented at the 2017 AGA Tech Summit.
“Innovation in GI tech is continuing at a substantial pace because of the sustained interest among investors, entrepreneurs, and established industry players and the many opportunities and unmet needs,” Jay Pasricha, MD, MBBS, director of the Johns Hopkins Center for Neurogastroenterology, Baltimore, said in an interview. The obstacle for gastroenterologists is willingness to adapt.
The rapid, transformative changes in bariatric endoscopy provide an immediate example, according to Dr. Pasricha. There has been enormous innovation in this area with more devices coming. He suggested that meaningful participation in this growing field not only involves a commitment to mastering the technical challenges of available devices but also to providing comprehensive care.
“There needs to be a commitment to what might be described as the bookends of treatment. This means screening and appropriate selection of candidates for specific procedures and providing the follow-up and supportive care that lead to good outcomes. In other words, do it right or don’t do it,” Dr. Pasricha said.
He considers endoscopic approaches to weight loss — balloons, gastric restriction, or other strategies — emblematic of a flexion point in gastroenterology that has the potential to result in increasing polarization in the specialty. Those who adapt to deliver the advances in care permitted by new technology will participate in advancing the field. Those who do not may cede advanced procedures to those specialists who step in.
The AGA Obesity Practice Guide, for example, provides gastroenterologists with a comprehensive, multi-disciplinary process to personalize innovative obesity care for safe and effective weight management, including the use of endoscopic and surgical procedures. The accompanying episode-of-care framework helps gastroenterologists understand how to operationalize obesity management for financial success (www.gastro.org/obesity).
Endoscopic mucosal resection of localized cancers, an area in which technological innovations are also promising, is another opportunity for gastroenterologists. According to Dr. Pasricha, “Innovations with the potential to leapfrog over traditional procedures are very feasible from a technical perspective, but which specialists will be the ones who collaborate on these interventions to make them a reality?”
While acknowledging that the current reimbursement structure does not incentivize complex and potentially time-consuming procedures over bread-and-butter procedures such as screening colonoscopy, Dr. Pasricha maintained that innovation in these areas represents the future. Eventually, advances in technology will simplify complex procedures, but Dr. Pasricha suggested that gastroenterologists should be leading disruptive technologies to ensure a place in delivery of next generation solutions.
In a broad survey of the likely directions, Dr. Pasricha provided examples of several frontiers in which technological innovation has a potential role. Efforts to harness the microbiome, for example, include devices with the potential to improve bowel function. Vagal stimulators in various forms have the potential to address pathology along the gut-brain axis.
“Devices designed to modify gut-brain signaling are not just relevant to GI diseases but are being pursued for much broader indications, such as those relating to mood and cognitive function,” Dr. Pasricha reported.
Casting a large net to touch on the science and economics of medtech innovations across a wide variety of unmet needs in gastroenterology, Dr. Pasricha described a common barrier. At the stage when new devices are introduced, innovators are faced with obstacles, including uncertain reimbursement and potential medico-legal risk, yet innovations depend on finding a path.
“Who is going to make the leap?” asked Dr. Pasricha, describing several areas of device innovation in which “people are testing the waters with no one yet willing to jump in.” He made the point that in fields relevant to their expertise, gastroenterologists should be participating in opportunities that may lead to better patient care.
“Otherwise, we may end up in an unhappy compromise – a small subset of technically advanced GI docs will compete with a larger and growing cadre of surgeons who are becoming increasingly skilled in flexible endoscopy,” Dr. Pasricha explained.
“But, in either scenario, the cognitive components of what represents best care for a given patient, which is the epitome of personalized medicine, may get short shrift,” he added. He envisions a worst case scenario in which screening colonoscopy is replaced by a pill or a fecal test, “and our specialty is not ready for taking care of all the other unmet needs because we have been complacent.”
Still, there are large areas in which opportunities abound, such as motility and functional disorders, that represent a huge socioeconomic and clinical burden, according to Dr. Pasricha, who believes advances in this field should be embraced.
For entrepreneurs pursuing medtech overall and in GI diseases specifically, Dr. Pasricha had some specific advice. He suggested that efforts should not be restricted to the development of new devices or other solutions but should include developing a context for the innovation, such as training of those who will employ the innovation, creating awareness among physicians who will refer, and helping to ensure reimbursement.
“All stakeholders need to invest in the growth of their markets and not just in the technology,” Dr. Pasricha said. He emphasized that one of the most important roadblocks are the gatekeepers who fail to refer patients to specialists capable of implementing a new procedure.
However, he believes that there is enormous room for successful innovation in GI medtech.
“The future remains bright. The gut, the gut-brain axis, and the gut-metabolic axis are all keys to unlocking the potential for endoscopic interventions to impact so many chronic diseases,” Dr. Pasricha maintained. “It’s up to us to recognize this and take ownership of this space. This conference as always serves to highlight these opportunities and potential road maps to that future.”
FROM THE 2017 AGA TECH SUMMIT
21st Century Cures Act creates opportunities, risks
BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.
“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.
In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.
“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.
“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.
Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.
“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.
Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.
Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.
“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.
AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.
BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.
“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.
In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.
“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.
“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.
Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.
“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.
Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.
Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.
“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.
AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.
BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.
“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.
In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.
“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.
“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.
Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.
“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.
Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.
Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.
“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.
AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.
FROM THE 2017 AGA TECH SUMMIT
VIDEO: Innovation fuels push toward therapeutic, safety advances in gastroenterology
BOSTON – In the next 5 years there is going to be a “huge swing” in gastroenterology to minimally invasive therapies, improved diagnostics, and additional therapeutics and disease management strategies that can be applied on an ambulatory basis and, perhaps, even in the office.
That’s the prediction of Michael L. Kochman, MD, AGAF, of the University of Pennsylvania, Philadelphia, who is the executive committee chair of the American Gastroenterological Association Center for GI Innovation and Technology. In a video interview conducted at the 2017 AGA Tech Summit, sponsored by the center, Dr. Kochman discussed five emerging trends in gastroenterology.
The trends include advances in endoscopic technologies and an expansion of the role of personalized medicine that would allow gastroenterologists to better target medications to individual patients. Office-based physicians will be able to evaluate patient risk for various diseases more easily through the use of stool or blood samples or cheek swabs and, then, steer toward additional tests for those found to be at high risk. Improvements in patient safety also are on the horizon, he said, as new technologies will provide earlier warning signs of failed therapies and potential complications.
Finally, as innovation continues in the area of minimally invasive surgery and transorifice surgery, “we need to look more and more to what we will end up calling organ-preserving surgeries, where we are able to treat just the area of pathology,” he noted. “We will be moving to leaving the patient without lasting scars and remembrances of having to have an organ removed.”
Dr. Kochman disclosed that he serves as a consultant to Boston Scientific and Dark Canyon Labs.
BOSTON – In the next 5 years there is going to be a “huge swing” in gastroenterology to minimally invasive therapies, improved diagnostics, and additional therapeutics and disease management strategies that can be applied on an ambulatory basis and, perhaps, even in the office.
That’s the prediction of Michael L. Kochman, MD, AGAF, of the University of Pennsylvania, Philadelphia, who is the executive committee chair of the American Gastroenterological Association Center for GI Innovation and Technology. In a video interview conducted at the 2017 AGA Tech Summit, sponsored by the center, Dr. Kochman discussed five emerging trends in gastroenterology.
The trends include advances in endoscopic technologies and an expansion of the role of personalized medicine that would allow gastroenterologists to better target medications to individual patients. Office-based physicians will be able to evaluate patient risk for various diseases more easily through the use of stool or blood samples or cheek swabs and, then, steer toward additional tests for those found to be at high risk. Improvements in patient safety also are on the horizon, he said, as new technologies will provide earlier warning signs of failed therapies and potential complications.
Finally, as innovation continues in the area of minimally invasive surgery and transorifice surgery, “we need to look more and more to what we will end up calling organ-preserving surgeries, where we are able to treat just the area of pathology,” he noted. “We will be moving to leaving the patient without lasting scars and remembrances of having to have an organ removed.”
Dr. Kochman disclosed that he serves as a consultant to Boston Scientific and Dark Canyon Labs.
BOSTON – In the next 5 years there is going to be a “huge swing” in gastroenterology to minimally invasive therapies, improved diagnostics, and additional therapeutics and disease management strategies that can be applied on an ambulatory basis and, perhaps, even in the office.
That’s the prediction of Michael L. Kochman, MD, AGAF, of the University of Pennsylvania, Philadelphia, who is the executive committee chair of the American Gastroenterological Association Center for GI Innovation and Technology. In a video interview conducted at the 2017 AGA Tech Summit, sponsored by the center, Dr. Kochman discussed five emerging trends in gastroenterology.
The trends include advances in endoscopic technologies and an expansion of the role of personalized medicine that would allow gastroenterologists to better target medications to individual patients. Office-based physicians will be able to evaluate patient risk for various diseases more easily through the use of stool or blood samples or cheek swabs and, then, steer toward additional tests for those found to be at high risk. Improvements in patient safety also are on the horizon, he said, as new technologies will provide earlier warning signs of failed therapies and potential complications.
Finally, as innovation continues in the area of minimally invasive surgery and transorifice surgery, “we need to look more and more to what we will end up calling organ-preserving surgeries, where we are able to treat just the area of pathology,” he noted. “We will be moving to leaving the patient without lasting scars and remembrances of having to have an organ removed.”
Dr. Kochman disclosed that he serves as a consultant to Boston Scientific and Dark Canyon Labs.
FROM THE 2017 AGA TECH SUMMIT
VIDEO: Five ‘revolutionary’ market forces poised to impact medical practice
BOSTON – Five “revolutionary” forces in medicine are going to impact patients and physicians, two health care consultants say, and the federal government will act either as a brake or an accelerator on those forces.
In a video interview conducted during the 2017 AGA Tech Summit, Patrick D. Pilch, managing director and national healthcare advisory leader at the BDO Center for Healthcare Excellence and Innovation, New York, and his colleague David B. Friend, MD, MBA, managing director and chief medical officer at the center, discussed these market forces and their potential effects on the practice of medicine.
One such force is the convergence of molecular biology and computer science, which will lead to the creation of new medical devices that use software and will require Food and Drug Administration approval, including devices that can remotely monitor patient compliance with taking medication. Some health care apps also would need FDA approval.
“Increasingly, health care will be mobile,” Dr. Friend continued. “The concept of the right care at the right place at the right time at the right cost is going to increase, and the ability to deliver this in the mobile setting is going to be very powerful.”
A change in who bears financial risk is another important driver. Insurance companies are decreasing their risk, Dr. Friend said, while health care providers and health systems are bearing more financial risk as they increasingly accept bundled payments and value-based payments. Physicians will need to understand and be prepared for this shift in risk, he warned.
Dr. Friend also noted a move toward an integrated supply chain model that will have “profound implications” throughout the delivery process and a movement of care away from the hospital to a nonhospital setting such as home care or skilled nursing facilities.
The summit was sponsored by the AGA Center for GI Innovation and Technology.
BOSTON – Five “revolutionary” forces in medicine are going to impact patients and physicians, two health care consultants say, and the federal government will act either as a brake or an accelerator on those forces.
In a video interview conducted during the 2017 AGA Tech Summit, Patrick D. Pilch, managing director and national healthcare advisory leader at the BDO Center for Healthcare Excellence and Innovation, New York, and his colleague David B. Friend, MD, MBA, managing director and chief medical officer at the center, discussed these market forces and their potential effects on the practice of medicine.
One such force is the convergence of molecular biology and computer science, which will lead to the creation of new medical devices that use software and will require Food and Drug Administration approval, including devices that can remotely monitor patient compliance with taking medication. Some health care apps also would need FDA approval.
“Increasingly, health care will be mobile,” Dr. Friend continued. “The concept of the right care at the right place at the right time at the right cost is going to increase, and the ability to deliver this in the mobile setting is going to be very powerful.”
A change in who bears financial risk is another important driver. Insurance companies are decreasing their risk, Dr. Friend said, while health care providers and health systems are bearing more financial risk as they increasingly accept bundled payments and value-based payments. Physicians will need to understand and be prepared for this shift in risk, he warned.
Dr. Friend also noted a move toward an integrated supply chain model that will have “profound implications” throughout the delivery process and a movement of care away from the hospital to a nonhospital setting such as home care or skilled nursing facilities.
The summit was sponsored by the AGA Center for GI Innovation and Technology.
BOSTON – Five “revolutionary” forces in medicine are going to impact patients and physicians, two health care consultants say, and the federal government will act either as a brake or an accelerator on those forces.
In a video interview conducted during the 2017 AGA Tech Summit, Patrick D. Pilch, managing director and national healthcare advisory leader at the BDO Center for Healthcare Excellence and Innovation, New York, and his colleague David B. Friend, MD, MBA, managing director and chief medical officer at the center, discussed these market forces and their potential effects on the practice of medicine.
One such force is the convergence of molecular biology and computer science, which will lead to the creation of new medical devices that use software and will require Food and Drug Administration approval, including devices that can remotely monitor patient compliance with taking medication. Some health care apps also would need FDA approval.
“Increasingly, health care will be mobile,” Dr. Friend continued. “The concept of the right care at the right place at the right time at the right cost is going to increase, and the ability to deliver this in the mobile setting is going to be very powerful.”
A change in who bears financial risk is another important driver. Insurance companies are decreasing their risk, Dr. Friend said, while health care providers and health systems are bearing more financial risk as they increasingly accept bundled payments and value-based payments. Physicians will need to understand and be prepared for this shift in risk, he warned.
Dr. Friend also noted a move toward an integrated supply chain model that will have “profound implications” throughout the delivery process and a movement of care away from the hospital to a nonhospital setting such as home care or skilled nursing facilities.
The summit was sponsored by the AGA Center for GI Innovation and Technology.
EXPERT ANALYSIS FROM THE AGA 2017 TECH SUMMIT
AGA Tech Summit offers packed agenda of innovation and technology
The 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology, promises to provide gastroenterologists and gastrointestinal surgeons with an insider’s perspective on regulators, payors, and companies in the medtech space during its 2017 session from April 12-14 in Boston. “This year’s agenda will highlight personalized diagnostics and the impact of MACRA on gastroenterology,” said Michael L. Kochman, MD, AGAF, of Penn Medicine, Philadelphia, who is executive committee chair of the center. “The intimate nature of the meeting will allow attendees to interact with fellow gastroenterologists and GI surgeons while benefiting from sessions on critical innovation and technology issues in our field.”
Development of the program started at the 2016 conference, building on that session’s highlights, as well as on the needs and interests of its attendees and speakers. “It takes a full 9 months to lock down the topics and find appropriate presenters,” explained Dr. Kochman. “The program is continually assessed and updated to keep up with medtech developments. Handpicked faculty members include prominent leaders in the medical, medtech, and regulatory communities.”
“Two important sessions demonstrate the breadth of the meeting,” stated Dr. Kochman. “This year’s Shark Tank will cover novel developments in GI medtech.” Participating companies and entrepreneurs will have 5 minutes to present their projects to an expert panel of venture capitalists, physicians, and industry executives who make acquisition decisions. “There will also be a cutting-edge session covering liquid biopsy and personalized medicine in gastroenterology,” he added. Other highlights include presentations on “The Macroeconomics of Care Delivery: MACRA and the Change to Come” and practice and device development.
The event includes a wide range of opportunities for networking with faculty and attendees, including during the breaks on both days, a Thursday night reception, and luncheons.
Summit sessions will span critical elements affecting how innovation in the GI space evolves from concept to reality. Other topics covered will include a digestive world outlook, driving innovation adoption, research updates, quality outcomes, raising capital, medtech success in GI and metabolic diseases from 2016, opportunities and challenges in personalized medicine, and improving patient outcomes via quality efforts.
Those who cannot attend the conference can look forward to “Highlights of the 2017 AGA Tech Summit,” which will be published as a supplement to GI & Hepatology News. “There will be writers in Boston attending and capturing highlights of the event sessions,” said Dr. Kochman. “AGA members will have the opportunity to experience the salient points of the presentations through this publication.”
The AGA Tech Summit will foster innovation and technology in the field of digestive health. “The keynote speakers and presenters, along with the audience’s multiple perspectives will be something we can build on to hopefully shape the future of gastroenterology,” concluded Dr. Kochman.
Dr. Kochman disclosed that he serves as a consultant for Boston Scientific Corp. and Dark Canyon Labs.
The 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology, promises to provide gastroenterologists and gastrointestinal surgeons with an insider’s perspective on regulators, payors, and companies in the medtech space during its 2017 session from April 12-14 in Boston. “This year’s agenda will highlight personalized diagnostics and the impact of MACRA on gastroenterology,” said Michael L. Kochman, MD, AGAF, of Penn Medicine, Philadelphia, who is executive committee chair of the center. “The intimate nature of the meeting will allow attendees to interact with fellow gastroenterologists and GI surgeons while benefiting from sessions on critical innovation and technology issues in our field.”
Development of the program started at the 2016 conference, building on that session’s highlights, as well as on the needs and interests of its attendees and speakers. “It takes a full 9 months to lock down the topics and find appropriate presenters,” explained Dr. Kochman. “The program is continually assessed and updated to keep up with medtech developments. Handpicked faculty members include prominent leaders in the medical, medtech, and regulatory communities.”
“Two important sessions demonstrate the breadth of the meeting,” stated Dr. Kochman. “This year’s Shark Tank will cover novel developments in GI medtech.” Participating companies and entrepreneurs will have 5 minutes to present their projects to an expert panel of venture capitalists, physicians, and industry executives who make acquisition decisions. “There will also be a cutting-edge session covering liquid biopsy and personalized medicine in gastroenterology,” he added. Other highlights include presentations on “The Macroeconomics of Care Delivery: MACRA and the Change to Come” and practice and device development.
The event includes a wide range of opportunities for networking with faculty and attendees, including during the breaks on both days, a Thursday night reception, and luncheons.
Summit sessions will span critical elements affecting how innovation in the GI space evolves from concept to reality. Other topics covered will include a digestive world outlook, driving innovation adoption, research updates, quality outcomes, raising capital, medtech success in GI and metabolic diseases from 2016, opportunities and challenges in personalized medicine, and improving patient outcomes via quality efforts.
Those who cannot attend the conference can look forward to “Highlights of the 2017 AGA Tech Summit,” which will be published as a supplement to GI & Hepatology News. “There will be writers in Boston attending and capturing highlights of the event sessions,” said Dr. Kochman. “AGA members will have the opportunity to experience the salient points of the presentations through this publication.”
The AGA Tech Summit will foster innovation and technology in the field of digestive health. “The keynote speakers and presenters, along with the audience’s multiple perspectives will be something we can build on to hopefully shape the future of gastroenterology,” concluded Dr. Kochman.
Dr. Kochman disclosed that he serves as a consultant for Boston Scientific Corp. and Dark Canyon Labs.
The 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology, promises to provide gastroenterologists and gastrointestinal surgeons with an insider’s perspective on regulators, payors, and companies in the medtech space during its 2017 session from April 12-14 in Boston. “This year’s agenda will highlight personalized diagnostics and the impact of MACRA on gastroenterology,” said Michael L. Kochman, MD, AGAF, of Penn Medicine, Philadelphia, who is executive committee chair of the center. “The intimate nature of the meeting will allow attendees to interact with fellow gastroenterologists and GI surgeons while benefiting from sessions on critical innovation and technology issues in our field.”
Development of the program started at the 2016 conference, building on that session’s highlights, as well as on the needs and interests of its attendees and speakers. “It takes a full 9 months to lock down the topics and find appropriate presenters,” explained Dr. Kochman. “The program is continually assessed and updated to keep up with medtech developments. Handpicked faculty members include prominent leaders in the medical, medtech, and regulatory communities.”
“Two important sessions demonstrate the breadth of the meeting,” stated Dr. Kochman. “This year’s Shark Tank will cover novel developments in GI medtech.” Participating companies and entrepreneurs will have 5 minutes to present their projects to an expert panel of venture capitalists, physicians, and industry executives who make acquisition decisions. “There will also be a cutting-edge session covering liquid biopsy and personalized medicine in gastroenterology,” he added. Other highlights include presentations on “The Macroeconomics of Care Delivery: MACRA and the Change to Come” and practice and device development.
The event includes a wide range of opportunities for networking with faculty and attendees, including during the breaks on both days, a Thursday night reception, and luncheons.
Summit sessions will span critical elements affecting how innovation in the GI space evolves from concept to reality. Other topics covered will include a digestive world outlook, driving innovation adoption, research updates, quality outcomes, raising capital, medtech success in GI and metabolic diseases from 2016, opportunities and challenges in personalized medicine, and improving patient outcomes via quality efforts.
Those who cannot attend the conference can look forward to “Highlights of the 2017 AGA Tech Summit,” which will be published as a supplement to GI & Hepatology News. “There will be writers in Boston attending and capturing highlights of the event sessions,” said Dr. Kochman. “AGA members will have the opportunity to experience the salient points of the presentations through this publication.”
The AGA Tech Summit will foster innovation and technology in the field of digestive health. “The keynote speakers and presenters, along with the audience’s multiple perspectives will be something we can build on to hopefully shape the future of gastroenterology,” concluded Dr. Kochman.
Dr. Kochman disclosed that he serves as a consultant for Boston Scientific Corp. and Dark Canyon Labs.
Get on board with APMs or risk having your practice commoditized
Gastroenterologists need to get on board with assuming risk through the adoption of advanced alternative payment methods under Medicare’s new Quality Payment Program or risk losing money through the commoditization of their services.
That’s the message Lawrence Kosinski, MD, of the Illinois Gastroenterology Group, has for his fellow gastroenterologists.
“To me, MIPS [Merit-based Incentive Payment System] is just an extension of what we were doing with PQRS and meaningful use, value-based modifiers,” Dr. Kosinski, who serves as practice councillor on the AGA Governing Board, said in an interview in advance of his presentation at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
If gastroenterologists choose to stay on that path rather than accept the two-sided risk of following the APM track of the Quality Payment Program, “you are going to have commoditized services and you are going to just make less money and work for somebody else. But if you want to be in control of your own future, we have to strive to work in [the APM] direction.”
To get there, the culture of gastroenterology will need to shift.
“Our culture right now is one where we get paid for making widgets,” he said. “And the more widgets we make, the more money we make. The more colonoscopies we do, the more money we make. The more we can charge for those colonoscopies and get collected, the better things are for us.”
The future could allow gastroenterologists to charge for more and different services, he added.
“A lot of people are working to replace colonoscopies with much less expensive alternative,” Dr. Kosinski said. “So where does a gastroenterologist have a competitive advantage? It’s in the knowledge of these complex diseases that are running up the cost of health care. Over 80% of the cost of health care is for the management of chronic disease. We happen to have a very expensive set of chronic diseases that we take care of in GI, very complicated illnesses. We need to leverage that. We need to leverage the management of those patients, but we need to be able to show how our work decreases the overall cost of care so that we can get a piece of that risk premium.”
He warned: “If we don’t do that, we’re just going to be commoditized proceduralists.”
And the upside will be better reimbursements for doctors and lower overall costs for health systems.
“We may be able to increase our own reimbursement as long as we are critical in lowering the overall cost of care for the entire population,” he said.
To that end, “well-managed GI practices should be able to develop a competitive advantage in a value space to be able to supply the needed services,” he said, adding that “we’re going to have to provide value by improving quality through a focus on patient outcomes. We have to assure a new level of patient relationships and ultimately focus on lowering the cost of care for a population of patients.”
Gastroenterologists need to get on board with assuming risk through the adoption of advanced alternative payment methods under Medicare’s new Quality Payment Program or risk losing money through the commoditization of their services.
That’s the message Lawrence Kosinski, MD, of the Illinois Gastroenterology Group, has for his fellow gastroenterologists.
“To me, MIPS [Merit-based Incentive Payment System] is just an extension of what we were doing with PQRS and meaningful use, value-based modifiers,” Dr. Kosinski, who serves as practice councillor on the AGA Governing Board, said in an interview in advance of his presentation at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
If gastroenterologists choose to stay on that path rather than accept the two-sided risk of following the APM track of the Quality Payment Program, “you are going to have commoditized services and you are going to just make less money and work for somebody else. But if you want to be in control of your own future, we have to strive to work in [the APM] direction.”
To get there, the culture of gastroenterology will need to shift.
“Our culture right now is one where we get paid for making widgets,” he said. “And the more widgets we make, the more money we make. The more colonoscopies we do, the more money we make. The more we can charge for those colonoscopies and get collected, the better things are for us.”
The future could allow gastroenterologists to charge for more and different services, he added.
“A lot of people are working to replace colonoscopies with much less expensive alternative,” Dr. Kosinski said. “So where does a gastroenterologist have a competitive advantage? It’s in the knowledge of these complex diseases that are running up the cost of health care. Over 80% of the cost of health care is for the management of chronic disease. We happen to have a very expensive set of chronic diseases that we take care of in GI, very complicated illnesses. We need to leverage that. We need to leverage the management of those patients, but we need to be able to show how our work decreases the overall cost of care so that we can get a piece of that risk premium.”
He warned: “If we don’t do that, we’re just going to be commoditized proceduralists.”
And the upside will be better reimbursements for doctors and lower overall costs for health systems.
“We may be able to increase our own reimbursement as long as we are critical in lowering the overall cost of care for the entire population,” he said.
To that end, “well-managed GI practices should be able to develop a competitive advantage in a value space to be able to supply the needed services,” he said, adding that “we’re going to have to provide value by improving quality through a focus on patient outcomes. We have to assure a new level of patient relationships and ultimately focus on lowering the cost of care for a population of patients.”
Gastroenterologists need to get on board with assuming risk through the adoption of advanced alternative payment methods under Medicare’s new Quality Payment Program or risk losing money through the commoditization of their services.
That’s the message Lawrence Kosinski, MD, of the Illinois Gastroenterology Group, has for his fellow gastroenterologists.
“To me, MIPS [Merit-based Incentive Payment System] is just an extension of what we were doing with PQRS and meaningful use, value-based modifiers,” Dr. Kosinski, who serves as practice councillor on the AGA Governing Board, said in an interview in advance of his presentation at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
If gastroenterologists choose to stay on that path rather than accept the two-sided risk of following the APM track of the Quality Payment Program, “you are going to have commoditized services and you are going to just make less money and work for somebody else. But if you want to be in control of your own future, we have to strive to work in [the APM] direction.”
To get there, the culture of gastroenterology will need to shift.
“Our culture right now is one where we get paid for making widgets,” he said. “And the more widgets we make, the more money we make. The more colonoscopies we do, the more money we make. The more we can charge for those colonoscopies and get collected, the better things are for us.”
The future could allow gastroenterologists to charge for more and different services, he added.
“A lot of people are working to replace colonoscopies with much less expensive alternative,” Dr. Kosinski said. “So where does a gastroenterologist have a competitive advantage? It’s in the knowledge of these complex diseases that are running up the cost of health care. Over 80% of the cost of health care is for the management of chronic disease. We happen to have a very expensive set of chronic diseases that we take care of in GI, very complicated illnesses. We need to leverage that. We need to leverage the management of those patients, but we need to be able to show how our work decreases the overall cost of care so that we can get a piece of that risk premium.”
He warned: “If we don’t do that, we’re just going to be commoditized proceduralists.”
And the upside will be better reimbursements for doctors and lower overall costs for health systems.
“We may be able to increase our own reimbursement as long as we are critical in lowering the overall cost of care for the entire population,” he said.
To that end, “well-managed GI practices should be able to develop a competitive advantage in a value space to be able to supply the needed services,” he said, adding that “we’re going to have to provide value by improving quality through a focus on patient outcomes. We have to assure a new level of patient relationships and ultimately focus on lowering the cost of care for a population of patients.”
Real-time data, transparency needed to improve safety
With an increasing number of emerging technological advances in both medical devices and procedures, two factors will help improve safety and outcomes for patients: better real-time data and information transparency.
And the key to getting that data will be broader use of registries, according to Dana Telem, MD, director of the Comprehensive Hernia Program at the University of Michigan, Ann Arbor.
Dr. Telem will discuss the importance of real-time information and registries during her April 13 presentation at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Speaking in advance of the meeting, Dr. Telem noted that understanding value and finding potential safety issues are among the reasons for using data registries.
“I think that’s really why we need to focus on getting real-time data and that’s why I think registry efforts are so important,” she said. “What registries are really great at [is] identifying those isolated events.”
In addition, they help with another key concept she will highlight during her talk: transparency, something that is especially important as new techniques and devices are introduced.
“We understand that there are going to be early adopters, and you need to have the pioneers in order to take those next steps,” she said.
But to get the most out of those new technologies, data need to be recorded not only for short-term outcomes but over the long term as well “so that we can really assess the value of the techniques or the devices that we are putting out into the community.”
And by providing transparency on what is known, as well as unknown, it also helps patients in making their own decisions on whether to proceed with something new.
She believes that, especially when it comes to newer technologies, patients will be willing to be a part of that data collection if doctors are transparent.
“Many people are willing as long as you are honest with them,” Dr. Telem said. “I think particularly that when newer devices and techniques come out, particularly endoscopic procedures that can save them an operation, they are more willing than not, oftentimes, to do it, which is also where it gets a little bit dangerous if you are not transparent.”
But even being transparent can be a challenge.
“I think a lot of the issue that we have in health care is what type of information we are providing and how are we providing it, and is the receiver of information actually understanding what we are saying?” she pondered.
“I don’t think we know the answers to that, but I think part of the solution at least is to be as open about what we know as well as what we don’t know at the same time and let the patient make a decision based on their value system,” she continued. “A lot of times with these newer technologies or techniques, you really have to sit down with the patient and ask them about their long-term goals, what are acceptable and unacceptable outcomes.”
Recognizing the importance of data registries, in 2014 AGA launched a new initiative working as a neutral, objective broker to establish clinical research studies. Through this program, AGA collects important data to assess the value of new technologies and procedures on patient care. Ultimately, the data AGA collects will support the approval, coverage, and adoption of new technologies that demonstrate promise and merit. To learn more about AGA’s registry initiative or get involved, please contact Sonya Serra, AGA’s senior director of registry development and integrity, at sserra@gastro.org.
With an increasing number of emerging technological advances in both medical devices and procedures, two factors will help improve safety and outcomes for patients: better real-time data and information transparency.
And the key to getting that data will be broader use of registries, according to Dana Telem, MD, director of the Comprehensive Hernia Program at the University of Michigan, Ann Arbor.
Dr. Telem will discuss the importance of real-time information and registries during her April 13 presentation at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Speaking in advance of the meeting, Dr. Telem noted that understanding value and finding potential safety issues are among the reasons for using data registries.
“I think that’s really why we need to focus on getting real-time data and that’s why I think registry efforts are so important,” she said. “What registries are really great at [is] identifying those isolated events.”
In addition, they help with another key concept she will highlight during her talk: transparency, something that is especially important as new techniques and devices are introduced.
“We understand that there are going to be early adopters, and you need to have the pioneers in order to take those next steps,” she said.
But to get the most out of those new technologies, data need to be recorded not only for short-term outcomes but over the long term as well “so that we can really assess the value of the techniques or the devices that we are putting out into the community.”
And by providing transparency on what is known, as well as unknown, it also helps patients in making their own decisions on whether to proceed with something new.
She believes that, especially when it comes to newer technologies, patients will be willing to be a part of that data collection if doctors are transparent.
“Many people are willing as long as you are honest with them,” Dr. Telem said. “I think particularly that when newer devices and techniques come out, particularly endoscopic procedures that can save them an operation, they are more willing than not, oftentimes, to do it, which is also where it gets a little bit dangerous if you are not transparent.”
But even being transparent can be a challenge.
“I think a lot of the issue that we have in health care is what type of information we are providing and how are we providing it, and is the receiver of information actually understanding what we are saying?” she pondered.
“I don’t think we know the answers to that, but I think part of the solution at least is to be as open about what we know as well as what we don’t know at the same time and let the patient make a decision based on their value system,” she continued. “A lot of times with these newer technologies or techniques, you really have to sit down with the patient and ask them about their long-term goals, what are acceptable and unacceptable outcomes.”
Recognizing the importance of data registries, in 2014 AGA launched a new initiative working as a neutral, objective broker to establish clinical research studies. Through this program, AGA collects important data to assess the value of new technologies and procedures on patient care. Ultimately, the data AGA collects will support the approval, coverage, and adoption of new technologies that demonstrate promise and merit. To learn more about AGA’s registry initiative or get involved, please contact Sonya Serra, AGA’s senior director of registry development and integrity, at sserra@gastro.org.
With an increasing number of emerging technological advances in both medical devices and procedures, two factors will help improve safety and outcomes for patients: better real-time data and information transparency.
And the key to getting that data will be broader use of registries, according to Dana Telem, MD, director of the Comprehensive Hernia Program at the University of Michigan, Ann Arbor.
Dr. Telem will discuss the importance of real-time information and registries during her April 13 presentation at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.
Speaking in advance of the meeting, Dr. Telem noted that understanding value and finding potential safety issues are among the reasons for using data registries.
“I think that’s really why we need to focus on getting real-time data and that’s why I think registry efforts are so important,” she said. “What registries are really great at [is] identifying those isolated events.”
In addition, they help with another key concept she will highlight during her talk: transparency, something that is especially important as new techniques and devices are introduced.
“We understand that there are going to be early adopters, and you need to have the pioneers in order to take those next steps,” she said.
But to get the most out of those new technologies, data need to be recorded not only for short-term outcomes but over the long term as well “so that we can really assess the value of the techniques or the devices that we are putting out into the community.”
And by providing transparency on what is known, as well as unknown, it also helps patients in making their own decisions on whether to proceed with something new.
She believes that, especially when it comes to newer technologies, patients will be willing to be a part of that data collection if doctors are transparent.
“Many people are willing as long as you are honest with them,” Dr. Telem said. “I think particularly that when newer devices and techniques come out, particularly endoscopic procedures that can save them an operation, they are more willing than not, oftentimes, to do it, which is also where it gets a little bit dangerous if you are not transparent.”
But even being transparent can be a challenge.
“I think a lot of the issue that we have in health care is what type of information we are providing and how are we providing it, and is the receiver of information actually understanding what we are saying?” she pondered.
“I don’t think we know the answers to that, but I think part of the solution at least is to be as open about what we know as well as what we don’t know at the same time and let the patient make a decision based on their value system,” she continued. “A lot of times with these newer technologies or techniques, you really have to sit down with the patient and ask them about their long-term goals, what are acceptable and unacceptable outcomes.”
Recognizing the importance of data registries, in 2014 AGA launched a new initiative working as a neutral, objective broker to establish clinical research studies. Through this program, AGA collects important data to assess the value of new technologies and procedures on patient care. Ultimately, the data AGA collects will support the approval, coverage, and adoption of new technologies that demonstrate promise and merit. To learn more about AGA’s registry initiative or get involved, please contact Sonya Serra, AGA’s senior director of registry development and integrity, at sserra@gastro.org.
VIDEO: Innovation key to gastroenterology’s future
Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, Sidhartha R. Sinha, MD, told attendees at last year’s AGA Tech Summit.
Gastroenterologists should get involved in innovation early because there is much to learn, Dr. Sinha of Stanford (Calif.) University advised in this video interview from the meeting. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, he noted.
Innovation in gastroenterology will be front and center again at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, Sidhartha R. Sinha, MD, told attendees at last year’s AGA Tech Summit.
Gastroenterologists should get involved in innovation early because there is much to learn, Dr. Sinha of Stanford (Calif.) University advised in this video interview from the meeting. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, he noted.
Innovation in gastroenterology will be front and center again at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Many of the disorders that gastroenterologists treat do not have very effective treatments, so there is lots of room for innovation, Sidhartha R. Sinha, MD, told attendees at last year’s AGA Tech Summit.
Gastroenterologists should get involved in innovation early because there is much to learn, Dr. Sinha of Stanford (Calif.) University advised in this video interview from the meeting. It can be a tough business, but if one focuses on the clinical need and considers the number of patients who could benefit from such advances, then innovation can be a rewarding path to pursue, he noted.
Innovation in gastroenterology will be front and center again at the 2017 AGA Tech Summit, which is sponsored by the AGA Center for GI Innovation and Technology.
