8 things you didn’t know about innovation in GI

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.

BOSTON – At the 2016 AGA Tech Summit, which was sponsored by the AGA Center for GI Innovation and Technology, there was a special session on “How to Innovate in Digestive Health.” Here are some of the highlights of the discussion.

1. The changing reimbursement climate is affecting innovation, too.
According to Harry Glorikian, currently an entrepreneur-in-residence to GE Ventures, Menlo Park, Calif., the clock is ticking for the “one-size-fits-all” therapeutics approach, where accuracy and precision are low to moderate, and cost and comparative effectiveness evidence may be lacking. Tomorrow’s approach, he said, will push for increased accuracy and precision, targeting diagnostics, monitoring, and therapies to appropriate subpopulations. Increased attention to cost and comparative effectiveness will be more and more important as well.

2. Medicare is agnostic to most medical technologies.
What does this mean? According to Dr. Louis Jacques, chief clinical officer and senior vice president at the health care consulting firm ADVI, Washington, CMS will generally reimburse for a medical device if there is “adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population.” This means that the presumption lies in favor of reimbursement.

3. Not only is the bar higher, but the rules of engagement are changing in medical device innovation.
According to Dr. Tom Shehab, a gastroenterologist who now is a principal at Arboretum Ventures, Ann Arbor, Mich., medical device commercialization needs to take into account the needs of all stakeholders, ranging from the FDA to CMS, to private insurers, to the physicians and patients who will be the end-users of the innovations.

However, that’s not all, said Dr. Shehab. A place at the table must be held for the health care executives who manage facilities, oversee payer groups, and administer managed care plans. To bring the device to market, innovators must also take funders’ needs and preferences into account. These may range from venture capital and private equity firms to strategic acquirers, to federal sources such as the NIH.

4. A device doesn’t need to be disruptive to be great.
As a matter of fact, said Mr. Glorikian, sometimes incremental change is a good thing – finding a new clamp or a new screw may make a tricky procedure easier, and larger medical device manufacturers are sometimes happy to acquire the rights to a clever solution to a vexing problem.

5. A truly disruptive device may be harder to get off the ground.
Dr. Christopher Macomber, a chief surgical resident at the University of Massachusetts Medical School, Boston, and a serial entrepreneur, told the story of an innovative medical device to treat systemic lupus erythematosus. Though early trials showed extremely promising results, Dr. Macomber is still searching for the backers and the buyout to bring this product to market. “It’s such a paradigm shift that it’s been a tough sell,” he said.

6. You don’t need to leave your practice to become an innovator.
Even those in academic medicine can find room to innovate, though the environment comes with challenges, said Dr. Christopher Thompson, professor of medicine at Harvard Medical School, Boston. These can include competing time demands and a less-flexible and sometimes bureaucratic administration.

On the other hand, having the support of a legal department experienced in intellectual property protection can bolster an inexperienced innovator, and there’s often the opportunity for significant intellectual cross-pollination, said Dr. Thompson.

7. Some physicians do find success and gratification outside the practice of medicine.
Dr. Steven Drury, global medical director of surgical innovations, Medtronic, Boston, said that his greatest challenge was making the decision to leave his pathology practice to join industry. However, he said that he finds great satisfaction in the challenges of his work now, and he feels that he now serves a much wider population of patients – all those who benefit from the devices he helps bring to market.

8. If you have a good idea, protect it early.
Seema Basu, Ph.D., director of licensing and strategic collaborations at Partners Healthcare, Boston, said early protection of intellectual property is key. Her institution, she said, affords early collaboration with innovators to help them protect good ideas and explore commercial potential. “Have confidentiality agreements in place before detailed discussions with third parties,” said Dr. Basu.