What Do Physicians Need from Medtech?

Doctors are using your medical devices every day—but what unmet needs do they still have?

  • Today’s medical devices enable doctors to diagnose, treat, and possibly prevent diseases and conditions like never before. But there is still much healthcare progress that can be made.

    For instance, strides have been made to minimize surgical incisions and other invasive procedures, potentially reducing procedure times, hospital stays, and recovery time. But can medtech innovators do more to enable further progress in minimally invasive surgery?

    Panelists at the upcoming BIOMEDevice Boston event will be examining that very issue in the session, “Addressing Unmet Needs in Minimally Invasive Surgery.” The discussion will explore potential opportunities for minimally invasive cardiovascular and thoracic surgery, gastrointestinal procedures, and other procedures that involve interventional devices. You’ll hear how surgeons think and what challenges they face, and you’ll learn tips to inspire your own product development teams.

    Panelists include:

    • David Brooks, MD, Director, Minimally Invasive Surgery, Brigham and Women's Hospital, Division of General and Gastrointestinal Surgery
    • Yolanda Colson, MD, Professor of Surgery, Brigham and Women's Hospital
    • Denise Gee, MD, General & Gastrointestinal Surgery, Massachusetts General Hospital
    • Al Mashal, Principal Engineer and Systems Architect, Medical Technology Division, Cambridge Consultants

    To get inspired for the discussion on how medical device companies could better help doctors, we thought we’d look back to see what doctors from past panel discussions at MD&M Minneapolis 2018 and BIOMEDevice San Jose 2018 had to share. Following are some of their calls to medtech action.

    [Image by Sasin Tipchai from Pixabay]

  • A Better Way to Track Patients at Home
    During the MD&M Minneapolis panel discussion, “Prominent Physicians Address Unmet Needs & New Technologies in Medtech," moderator Kathleen Harder, director of the Center for Design in Health at the University of Minnesota, asked what barriers exist that make it difficult to provide effective and efficient care.

    Gwenyth Fischer, MD, a pediatric critical care physician and assistant professor at the University of Minnesota Masonic Children's Hospital, pointed to remote patient monitoring. “One of the barriers we have is that a lot of our patients have ongoing chronic illnesses. They eventually do get discharged to the home, but in an area like Minnesota where they may go very far north . . . or into rural areas . . . we have a hard time keeping track of what happens at home. For instance, we have patients who get a heart transplant and they go home, and we have no idea if they are being adherent to their medications. And if they are not, the chances of them losing that heart transplant is extremely high. Another example are kids who go home on ventilators. We have no way of tracking alarms and whether or not parents are shutting alarms off at night, which they frequently do. . . . We have a very crude means of keeping track of patients at home.”

    When speaking later during the discussion about telemedicine, Fischer added that “it has to be able to fit into physician flow and practice and have to find a way to get reimburse and billing for this, and that’s probably one of the biggest barriers right now.”

    [Image by mcmurryjulie from Pixabay]

  • Coverage Constraints
    Robert Ganz, MD, chief, gastoenterology, Abbott Northwestern Hospital, answered Harder’s question at MD&M Minneapolis on barriers to effective and efficient care a little differently. 

    “In GI, the biggest barrier to delivering care are constraints on what insurance companies will pay and the kinds of drugs and pharmaceuticals and devices they’ll cover. I have a patient, I know what they need, they have the condition, the condition has been proven, I’ll prescribe the drug or treatment, and it won’t be covered. It’s frustrating,” he told the audience. “Another constraint is the level of evidence it takes for a device procedure to be covered. . . . The standards by which new devices and techniques and medications are covered is very arbitrary.”

    [Image by Free-Photos from Pixabay]

  • Innovation
    Innovation barriers were also discussed by the MD&M Minneapolis panel. “As you think about innovation, it is sort of the opposite of cost containment, at least in its early phases,” said Mohamad Bydon, MD, neurosurgeon clinician-scientist for the Mayo Clinic. “Innovation early on is very expensive and very costly. Later down the road, it can lead to cost savings, but in the system that is built today, it seems there is less and less of an appetite to invest the upfront money for innovation . . . and then to see the rewards later. It just seems everything wants the constraints today based on what we have now.”

    “It seems to me that if there is an innovative technology, and it saves money immediately, the barriers to entry for that technology are quite low,” added Ganz. “If it is an innovation that costs money immediately, then the barriers to entry are quite high. . . . It’s something to consider when you’re innovating—you should think, ‘What will this do to the cost curve,’ because if you can lower costs immediately, you have a much better chance getting paid for it.”

    [Image by TeroVesalainen from Pixabay]

  • The Role of Robotics
    “As a pediatrician, I hope we’ll get some more robotics where we can perform more precise procedures—that’s a huge problem in peds,” said Fischer during the MD&M Minneapolis panel. “If you’re operating on a 2-kilo baby, it’s very difficult to do manual stitching and manual procedures with any kind of accuracy.”

    [Image by rawpixel from Pixabay]

  • Integrating AI into Decision Making
    What role could AI play in healthcare? “Most doctors are poised to integrate these new systems into our practice, and we need to—they provide a lot of benefit,” Fischer told the MD&M Minneapolis audience. “When I think of artificial intelligence in medicine, the things that I’m seeing that are probably most beneficial that are starting to be developed are closed-loop systems, so, for instance, inpatient insulin and blood pressure management and drug titrating. Sometimes I’m standing for 10 hours by a bedside titrating drugs up and down and clearly a machine could do a better job than I could. Also data integration—taking not just 2,3,4 points of patient data but 100 points within just a few minutes and being able to integrate and compare outcomes for that. We are collecting big data sets, but I think there’s a lot of possibilities for coming up with algorithms that can help us manage patients on a real-time level.”

    Ganz mentioned additional possibilities. “It turns out that what I see in GI is actually kind of limited. There’s only a certain number of conditions per organ. . . . so I could take a computer with AI and I could recognize those images and have not just a gastroenterologist do those procedures, but a nurse could or a primary care doc could do those procedures with AI recognizing the image and the pattern. And all of a sudden you greatly expand what you can do in terms of your population with service delivery,” he said. “You could also have a capsule with a camera, and the capsule could be swallowed, and it would take pictures throughout the GI tract. The images could get uploaded to a computer, and it analyzes the images and you could have a range of diagnostics possibilities without having me involved. That’s both exciting and terrifying to me, but those are the things that AI can do and almost certainly will do.”

    When asked whether the increased prevalence of telemedicine and AI would increase strain on physicians to see more patients faster, Fischer said that “theoretically things like AI will reduce some of the more menial tasks physicians are forced to do. . . . Any technology that is adding more time and another task to a physician’s daily load is not going to work.”

    Bydon added that “AI algorithms will be very good for common variables and diseases. They will fail and will potentially lead us astray for the uncommon or rare diseases. . . . The algorithms will only be as strong as the data coming into them. And risk adjustment falters in this very way where if you are risk adjusting for age or common comorbidities like diabetes, your risk adjustments can behave very well. But as soon as you have something that’s uncommon . . . then the risk adjustments fall apart. That is one of the risks of over reliance on AI. That is something we’ll have to work through as we continue the adventure in that space.”

    [Image by mohamed Hassan from Pixabay]

  • Tackling Reimbursement
    “One failure in general among medical devices companies is that devices are great, and technology is great, but people don’t think about the reimbursement strategy until it is way too late,” Ganz told the MD&M Minneapolis audience. “My advice to an engineer is, ‘when you think about a problem that needs to be solved, think about the reimbursement strategies right upfront—what is needed, is reimbursement even possible, will you be locked into a certain family of codes, how is that tech going to get paid for’—in a lot of ways that will feed back into how you will do the device.”

    Added Bydon: “Stick to the basics—find a clinical subject matter expert who will help provide clinical guidance throughout the process. Because it doesn’t stop at the identification of the problem or even at the first prototype—you have to carry it through all the way [through] the regulatory pathway and the reimbursement pathway. So finding appropriate clinical experts and following through with them.”

    [Image by mohamed Hassan from Pixabay]

  • Better Serve Pediatric Patients
    When asked whether there are any unmet needs, Fischer said: “Pediatrics—anybody from 0 to about 16 years old has been horribly undserved by the medical device world—and a lot of that is because it is a smaller market and we know that it is very hard to get those devices out. . . . I run a group at of the University of Minnesota called the Pediatric Device Innovation Consortium. We are here to help both UVM and industry help solve this problem, and we have some ways we think out of the box, so if you have any interest in that let me know.”

    [Image by Mylene2401 from Pixabay]

  • Don’t Forget about Gas and Other Nuisance Diseases
    “Gas,” was Ganz’s answer to unmet needs. “GI is a field [with] tens if not hundreds of millions of patients, but the illnesses aren’t typically severe. They’re kind of nuisance diseases. Flatulence. Gas. Belching. Constipation. Diarrhea. There is a lot of room for improvement.”

    [Image by mcmurryjulie from Pixabay]

  • And Don’t Overlook Orphan Diseases, Either
    “Orphan diseases in general—there’s a lot of unmet need,” said Bydon. “If you do go down the orphan disease route there is a special regulatory pathway and the bar is different. So there is sort of an incentive. Now it may not make up for a lack of funding but there are foundations and there are companies who have started in orphan diseases and have become large companies today. Anything we can do as a society to encourage research into orphan diseases would be a good thing.”

    [Image by mcmurryjulie from Pixabay]

  • Ask Patients, Families, and Other Caregivers
    “While physicians are a really great resource to look for underserved patient needs, you should not neglect the patients themselves, the families, the home providers, the ancillary staff, the nurses,” said Fischer. “When I ask about families what [their] greatest technology need [is] at home, frequently they come up with five things that never would have crossed my mind because as a physician I am one level removed from a lot of that. . . . There’s a lot of great needs that can be harvested from nonphysician care providers as well.”

    [Image by rawpixel from Pixabay]

  • Gaining Physician Acceptance for Your New Device
    At BIOMEDevice San Jose during the panel discussion, “Addressing Unmet Need in Minimally Invasive Surgery,” Moderator Marshall Stoller, MD Professor, Department of Urology, UCSF, asked panelists how doctors can be convinced to use new devices.

    “Truth is, by and large, particularly in my field, people are pretty conservative, and they are not early adopters of technology,” Shant Vartanian, assistant professor, Department of Surgery, UCSF, told the audience. “A lot of people don’t want to expose themselves to risk.” To get the word out about new devices, he suggested papers and presentations, but “it also helps have someone in the clinical world or academic institution to fly the flag for you and be the key opinion leader.”

    Johannes Kratz, MD, assistant professor, Department of Surgery, UCSF, agreed that physicians tend to be “very risk averse,” especially surgeons. "We want to do things that are safe and comfortable . . . . Really the only crack you have is to understand what problem that particular physician or clinician has and if you can understand that and what motivates them to do a good job everyday . . . you have a crack at introducing how your product might solve their particular problem. If you are trying to solve a problem they don’t have, you’re wasting your time.”

    Data also help. “Whenever you are building your technology, it’s important to get that prototype to a point where you can actually get out there and generate data,” said Kyle Miller, MD, medical research scientist, Intuitive Surgical. “To have any type of paradigm shift in everyday use cases, you really want to see that data. . . That’s the crux of the entrepreneurial effort—you want to rapidly iterate on your prototypes and get things into a controlled environment and generate good, sound data to figure out whether or not there is a true benefit there to impact outcomes, decrease length of stay, decrease complications, etc.”

    [Image by rawpixel from Pixabay]

  • Could Innovation Slow Practitioners Down?
    Stoller asked what limitations faced companies working to innovate in minimally invasive surgery.

    Ian Metzler, MD, chief resident in urology, UCSF, mentioned one-incision, or single-port procedures. “What is the advantage of that truly? Are you disadvantaging yourself in other ways? A single port is cool, but if it takes twice as long in the operating room and costs twice as much, nobody is going to do that. We really have to ask ourselves, are we shooting ourselves in the foot to push this idea just because it is more minimally invasive?” he asked.

    [Image by TeroVesalainen from Pixabay]

  • But Don’t Give Up Innovating
    “Every time I can imagine in our history where we’ve said we’ve never been able to do X, somehow we innovate and figure out to do that very thing we said was impossible,” Kratz told the BIOMEDevice San Jose audience. “It’s probably more useful to think what hasn’t been done that can be done. How can we continue to innovate? To change the field? To challenge ourselves?”

    “The longer you spend with a problem . . the more time you spend being completely immersed in the problem, getting out in the field, seeing the various workarounds, that’s when innovation happens,” Miller said.

    Added Metzler: “Talking to people and seeing how other people approach problems that could be completely unrelated to what you’re trying to do is really a great way to stimulate your ideas and force yourself to think about things differently.”

    [Image by OpenClipart-Vectors from Pixabay]

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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