 Good evening. My name is Doug Hanto and I am the chair of the Surgical Ethics Working Group in the Center for Bioethics at Harvard Medical School. On behalf of the Surgical Ethics Working Group, I would like to welcome everyone to our third Harvard Surgical Ethics Conference Ethical Considerations in Surgical Innovation. Over 1,000 individuals have registered for the conference from around the world and we would like to thank you for getting up early, staying up late, and taking time off from work or leisure to join us this evening. I believe we have an exciting hour and a half ahead of us. I would like to review a few housekeeping items before introducing our moderator, Dr. Louise King, who will introduce our topic for this evening and our speakers. First, we would ask that you submit any questions that you have during the conference using the Q&A feature found in the meeting controls at the bottom of your screen. We would ask that you not use the chat room for asking questions. Next questions will be discussed after all the presentations have been completed, or you may continue the conversation on Twitter using hashtag HMS Bioethics. If you have any technical issues, please use the chat feature to send a message to all panelists and a staff member will be available to help you. If you are interested in upcoming events, news, or education programs, you may subscribe to the Center for Bioethics email at bioethics.hms.harvard.edu. And finally, just a reminder that following tonight's conference, the talks as well as the panel discussion will be available on the Center for Bioethics YouTube channel. Without any further ado, I'd like to get us started this evening. I would like to introduce Dr. Louise King, who has JD and MD degrees. She is currently an assistant professor of obstetrics, gynecology and reproductive biology at Harvard Medical School. She is director of research, minimally invasive gynecologic surgery, associate program director for the fellowship and minimally invasive gynecologic surgery at the Brigham and women's hospital in Boston. She is also director of reproductive bioethics in the Center for Bioethics and co director of the medical ethics and essentials of the profession course for first year Harvard Medical and Harvard dental students. Her areas of interest in medical ethics are broad but focus on questions of informed decision making and assisted reproduction, as well as equitable access to advanced gynecologic surgery. We're honored to have Dr. King with us tonight to moderate this evening session. Dr. King. Thank you so much that was such a kind introduction I'm so grateful and I'm so happy tonight to be here to talk about this topic. It's one that I'm deeply passionate about in my own area of gynecologic surgery. And I've been lucky enough to have sort of a preview of these talks as we've met to prepare for tonight. I'm going to find them very, very interesting I'll be moderating the chat as best I can I have my own questions for the speakers, and I will weave in as many questions as I can from the questions that you submit. My honor right now to introduce Richard White, who is the vice chair of surgery at Beth Israel Deganist Medical Center, professor of surgery at Harvard Medical School he received his MD from the University of Pittsburgh and MBA from Wharton. He's interested in bioethical issues pertaining to the field of surgery, particularly cardiothoracics. He is on the ethics committee of two national surgical organizations, the Society for thoracic surgeons, and where he is the chair, and the American College of Surgeons. I'm also lucky enough to say that he was a mentor to me in my years at the IDMC. I was so grateful and remains one today but so grateful for the time he spent with me inviting me to his office talking about surgical ethics providing me support and encouragement. He's an incredible person and I'm looking forward to his talk. Louise thank you very much for the kind introduction, let me just share my screen. Just get this set up fairly quickly. There we go. Well welcome everybody to the session this evening I hope you find it interesting. As Dr. King mentioned I'm a thoracic surgeon and vice chair of surgery at Beth Israel Deganist and had a number, a long interest in the ethics of surgical innovation. I will start out by saying that I have no disclosures. And I'll point out that this session on surgical innovation has three components. I'm representing a fairly high level look at the ethics of surgical innovation, focusing on the ethical principles and more generalized areas of ethical debate. My colleagues, Dr. Teresa Williamson, Dr. John Meyer and Dr. Martin McNeely will then focus on some specific examples. The board cloud shown here presents a number of concepts associated with innovation, both the Oxford English dictionary and the Merriam Webster dictionary to find innovation as the introduction of new things, ideas, or ways of doing things. And in this spirit, I'd like to posit that as a surgeon, some level of innovation is commonplace and arguably essential. While I was tempted to start the presentation with a case, the introduction of minimally invasive surgery or robotic surgery as a replacement for open chest or abdominal surgery, or the use of extra caporal membrane oxygenation as a bridge to lung transplant, or the introduction of aortic valve replacement by transcatheter devices rather than traditional open surgery using cardiopulmonary bypass. You're going to hear some of these things in the second and third portions of the talk. But furthermore, I think that you can use your own experiences in surgery to look at current surgical techniques. And I think you'd be hard pressed to come up with many examples of things that were done exactly the same way that they were done 20 or 30 years ago. Now this shows the results of innovation on a macroscopic level. At the level of the individual surgeon, each of us have adapted our surgical techniques and decided what level of evidence is sufficient for us to make that change. While you may take the statement that innovation and surgery is essential as a postulate. There are a number of ethical frameworks that we can use to examine the statement. For example, if one chooses a consequentialist approach to ethics, meaning that what is right or wrong depends on the outcome or intended outcome of an action. The desired outcome of a surgical procedure is an improved state of health. Given that current surgical techniques are not perfect, nor are all surgical outcomes perfect, it would be a good thing to do to devise new and better ways of doing things. As the primary focus, if the primary focus is on the individual, the surgeon's obligation is to provide an optimal outcome for that patient. If one takes a more communitarian view, the obligation of the surgeon is to provide optimal surgical care to the community as a whole. Again, our current techniques are great for some conditions, but clearly wanting for others. In other words, there's clearly room for improvement and it would be our obligation to pursue those opportunities, but more with the best interests of the community in mind, rather than those of a specific individual patient. If one chooses a day ontological or beauty duty based approach to the analysis of ethical issues, we have obligations to provide our patients the best care possible. These are codified in descriptions of the physician-patient relationship, which involves fidelity or loyalty, among other things, meaning that we have a fiduciary duty to put the patient's interests above our own. Again, since we know that surgical outcomes are currently not ideal, one could conclude that it's in the patient's best interest to improve upon our current armamentarium of techniques and devices. Interestingly, while a specific patient or clinical problem may stimulate the idea for a clinical innovation, the pursuit of that innovation is probably made more with the interest of future patients in mind. Also, while many of our obligations as physician and surgeons are to our patients, we are all members of a profession, and professionals have certain obligations. While the obvious one is that which I've alluded to above a fiduciary duty to our patients. It's been argued that these obligations include not only having and practicing a specialized body of knowledge and skill, but to apply that skill and knowledge to the betterment of society and to the advancement of the professional field. Finally, finally, from a virtuous ethics perspective, or what would a truly virtuous surgeon do, there would be an obligation to recognize the limitations of what we can currently offer our patients and to pursue better approaches to these the diseases that we treat. Who would argue that the truly virtuous position would be satisfied with the status quo. So whether one takes a consequentialist a future day ontological approach or a virtuous ethics approach, as they say all loads lead to Rome, and it's our obligation to improve upon the current state of the art of surgery. So we've admitted what we've omitted one of the common approaches and that's the principle is few. And I think many students in the US are quite familiar with this text principles of biomedical ethics. I think that perhaps in other countries it's not so widely used. But it uses the familiar beach and children's quartet of autonomy beneficence, non maleficence or minimization of harm and justice. The principle of beneficence obligates us to improve upon the current conditions that said, as we cannot predict the future regarding new devices techniques or ideas. The potential for harm, or that or that which we are trying to avoid through non maleficence is lurking behind the veil of good intentions. While I will come back to the principles of autonomy and justice, both of which are important in the discussion of innovation and surgery. I'll first focus on the balance of the goal to be beneficent with the risk of doing harm. How can an individual surgeon be trusted to balance opposing forces for the potential for good versus the potential for harm. Perhaps a truly virtuous searching could, but most of us are mere mortals and we have our own biases, agendas, and perspectives. Does this develop a new surgical diet device for example is it not natural to want it to work. Does that introduce bias and its assessment, particularly if the initial assessment is non quantitative. If you're excited about doing new things it's possible that such excitement can lead to looking at the innovative thing through rose colored glasses, and either in foresight or retrospectively focus on the upsides, rather than the downsides. Now digressing slightly from the issue of the potential for benefit from the potential for harm is the issue of patient autonomy. The concept of autonomy is multifaceted. One of the issues of that of informed consent, meaning that the patient has some understanding of the issue at hand, as well as the options for treatment, and the relative risks and benefits of those options. The risks of standard operations the risks and benefits of the procedures are well known, as are the rash as are the rationale and intricacies, which are well characterized and can be presented to the patient at whatever level he or she desires. But in the context of innovative surgical care, the relative risks and benefits may be less well characterized. How would we pose the risks of the innovation of the patient, particularly since that the outset these risks may be largely unknown. And for a new technique technique involving innovated and complex new technology. How do we even know what the patient wants or needs to know, is it sufficient to simply ask the patient to trust the surgeon, and to make the right decision. And while this may be applicable in the emergency situation, for instance the case is going poorly and all normal avenues for salvaging thing are exhausted, and the patient may die, an innovative approach. Maybe completely appropriate, but really how often does this really happen, and aren't most opportunities for innovation known well in advance. Finally, there is the issue that if the surgeon has a vested interest in a new device or technique, might this cause him or her to downplay the potential for harm. So this leads to the content of the discussion on that of the oversight of innovation. And some of the questions I've posed. The answers to them lie in the area of incremental innovation, and with some level of oversight. Now, while none of us enjoy being under the microscope. I would say that some level of oversight of innovative surgical techniques is probably necessary. While some innovations are done really without patient consent, particularly those that are urgent in nature, or to the surgeon's perspective, rather minimal. I choose to use a new stapler or suture for example, or I do my anastomosis a little bit differently. So these changes, or innovations, there's been a relative there's been a body of predicate investigative work that makes my modification reasonable. In other words, I have expert knowledge that the patient doesn't have. But while expert knowledge is an essential characteristic of being a professional, along with it goes the responsibility to use the knowledge wisely, reasonably, and in the patient's best interests. While I probably shouldn't bring in a new instrument from my garage to try on a patient is probably completely reasonable to use a commercially available device, particularly if there is literature support in its use in a similar situation. But again what about the first time it's used. Again, for commercially available devices there's usually a regulatory process that justifies change. But again, it generally boils down to the potential for benefit versus the potential for harm. So I think that we see a distinction between trivial innovation and non trivial and trivial innovation, as well as a distinction between planned innovation and an essential or urgent one. So if the innovation is both planned and not trivial. Some element of oversight is arguably essential. An unbiased assessment done through the lens of peers, or others with expert knowledge can be protective of both the surgeon and the patient. Who else besides the patient and the surgeon has a vested interest in the act of innovation. Well at some level, the general public does have an interest, thus leading to a regulatory process. On the other hand, I don't think that we generally allow the general public to micro manage physician patient interactions. Where we practice also has a vested interest as it is, it is, it is responsible for what occurs within its wall. And it has an interest in preventing unreasonable and perhaps even dangerous practices. Further along the lines of oversight of innovation I'd like to point out what what what some institutions have done and I have a picture here of Dr. Shav Kassavji from the Toronto General Hospital who's made some remarkable innovations in the field of lung transplantation. Dr Kassavji a number of years ago introduced a surgical innovations committee at Toronto General, whereby new procedures are vetted for appropriateness. Which has the obvious attractive feature that proposed innovations are scrutinized by a body of peers, primarily surgeons, but also others in the operating room environment. Those who are likely to share a common body of expert knowledge, and to have a similar appreciation for the needs of innovation. On the other hand, a group of similarly minded individuals. It may be more prone to group think, and a lack of diverse input may lead to conclusions that while they may seem right to a group of surgeons may not be so well received by other physicians or the lay public. The concept of the surgical innovation committee has apparently been adopted successfully by other institutions, some of which has come up with centers of innovation. These are focused on peer review and supportive innovation, and others seem more focused on research around innovative approaches to surgical technology, and are designed to foster improved interactions with industry. In other institutions, including my own new procedures need to be approved by the medical executive committee, which is a medical staff committee spanning the breadth of the hospital specialties. While it encompasses a broad based or diverse set of perspectives, a shortcoming is that the actual surgical component may be quite small. Furthermore, as many people will either know or will experience hospital committees can be rather inefficient. And at least in my institution, the line between a new procedure and a modification to an existing one can get quite unclear. It may be reasonable to have every surgeon who wants to use a surgical robot trained in the credential and the use of the robot. Does it really make sense to make a quote robotic lobectomy. A new procedure when a thoracoscopic lobectomy has been done for 25 years. This being the roughly the same operation, but with hand operated instruments, rather than robotically or remote control instruments. Or what about when a new robot becomes available. If every time we change robots we have to call it a new procedure will spend our lives dealing with the with the medical executive committee and not actually getting anything done. If one of our colorectal surgeons does a procedure with a new single port robot, when he normally does it with several ports and an older device, is this a new procedure. I've argued yes, others no. But these while these may seem like fairly straightforward questions with straightforward answers to surgeons. They are not so straightforward to non surgeons, let alone lay people who often provide oversight to medical leadership. I would like to point out that the National Academy of Science, what was the Institute of Medicine has recently established a task force to examine how medical and surgical innovation is conducted in the US, and how to best defy how to define best practices. So while we have considered surgical innovation committees medical executive committee and hospital board committees is their role for human subjects research committees, or IRB to weigh in on surgical innovation. In the context of IRB's, we generally consider research to be to involve the generation of generalizable knowledge, and to involve fairly rigid protocols. Not everything to do with human subjects as research and not all research deals with human subjects, but the IRB typically deals with the interaction of research and human subjects. While some surgeons or some institutions may want to study a new technique, i.e. research, others simply want to do what others have done and have been found to be beneficial. Now certainly a systematic analysis of an innovative technique would require IRB approval, but innovation like quality improvement is often continuous and not taken in large steps. So one can easily argue that IRBs are probably not so well suited to the processes involving continuous change. Finally, in terms of regulatory oversight. I would bring this example to the front the recently the recent transplant of a genetically modified pig heart to a human. This was done at the University of Maryland roughly three months ago. Now this wasn't considered research this was this was certainly innovative, and its approval involved the Food and Drug Administration, presumably in addition to some institutional approval. Now why the FDA, well this is because by statute the FDA has oversight of the administration of biological products, and certainly a genetically modified pig heart would be considered biological. In the case in question the FDA provided emergency authorization under compassionate use criteria for the use of the pig heart. Now the FDA also provides oversight for some other innovative devices, such as certain types of endographs under their exact investigational design device exemption pathway or ID pathway. And it's interesting to note that while early trials of many new devices are conducted in countries other than the US. One has to ask if this is solely because the regulatory burden is lower in other countries, and they're not all third world countries I might add. It could also be that the risk benefit ratio or availability of what we call standard treatment is different in other countries. Finally, I'd like to bring in both the concept of justice. We've talked about autonomy. We talked about beneficence and non maleficence. In terms of justice who gets access to innovative innovative approaches to surgical disease. And this is another fertile area for ethical discussion. While we have heard often read about racial and socio economic healthcare disparities in this country. How does one ensure that the benefits of an innovative approaches to surgical care are distributed in an equitable and just fashion. Additionally allocating the benefits, equitably probably also means allocating the risks similarly, as it's obviously patently unfair to assign the benefits to one group and the risk to another. Given the uneven access to health care unequal levels of trust in the medical establishment differential reimbursement mechanisms often based on insurance. The fact that innovative techniques by their very nature, or that they are new, low in volume and geographically limited makes it difficult to distribute, at least initially, an innovative technique on a wide level playing field. Yet these issues must clearly be considered by both the surgeon and the institution involved. And while there are many other questions, such as when is an innovative approach justified. There's just not enough time to do this now, I can conclude my broad strokes and high level discussion. I will now turn the podium over to my colleagues, and I thank you all for your attention. Thank you so much for that excellent overview. We're going to have questions at the end I haven't seen any in the q amp a function of zoom remember that's where to put your questions. And it's labeled q amp a I believe at the very bottom of your screen. It's my honor right now to introduce Teresa Williamson. I'm a neurosurgeon and surgical ethics researcher who cares for people with all types of spine disorders, as well as brain and spinal trauma. Dr. Williamson is a graduate of Yale College where she played varsity soccer I learned as I prepared this and Yale Medical School, she came to MGH, one of our affiliate hospitals from Duke University, where she completed her neurosurgery residency and then her orthopedic spine fellowship. She also completed the University of Chicago McLean and American College of Surgeons Surgical Ethical Fellowship in 2021. Her research focus is neurosurgical decision making and patient doctor communication. And she also focuses on healthcare disparities. She's a member of the Center for outcomes and patient safety and surgery which is abbreviated compass at MGH. And I'm just getting to know Dr. Williamson it's such a pleasure to get to know her and some of our working groups and I'm very much looking forward to her talk. Thank you so much Dr King. Gonna go ahead and share my screen. Okay. So thank you so much for that introduction. I'm Teresa Williamson as Dr King mentioned I'm a neurosurgeon and Mass General and work at the Harvard Center for bioethics. I'm going to talk a little bit today about implementation of new devices in the operating room and I'm going to give you my perspective as a relatively new spine attending surgeon. So I'll start off with my disclosures because we're talking about new device implementation and you know what's appropriate and what's conflict and so I do have a disclosure and that's that I'm a consultant with the piece of these which is a spine technology and I think that's important for you to know because you know in spine surgery we have really close relationships with industry we have you know tables and tables of instrumentation every time we do a surgery from screws to rods to you know different devices to put in cages and it's important for us from an educational standpoint from an innovation standpoint from a patient care standpoint to have some type of a relationship with industry. The question is when does that relationship go too far and how do we best manage it in an ethically appropriate manner. So this is me in the OR and you know I'll show where those relationships can be a bit challenging so while I'm in the OR I'm working here with a resident we're actually working on a new technology taking care of a patient using augmented reality to put in pedical screws. And these are this is my email inbox that I'm going to come to you when I get out of the operating room and so I'll just read you a couple of the examples of things that you know might be said from an industry representative about a surgery that you know they may want me to do or you know a technique that they may want me to use. So your business is extremely important to me and I want to build a relationship where you can trust us for all your needs from an instrumentation standpoint and technology front. I was curious if you had thought about our MIS screw system and if there's anything in particular holding you back from giving it a try. And this is in reference to a new technology that they were interested in me trying. Here is the fill in the blank new technology surgery training certification quiz. Just start the exam. So there's a lot of reasons why you know my inbox is flooded with new technologies and new ideas and some of them are related to patient care and really innovating in the space of improving our care for spine patients. And some are frankly financial so spine surgery, a single spine surgery costs on average $75,000 to complete in the United States and overall it's a $90 billion industry and expenditures yearly in the US. And thinking about balancing such a large financial gain field with the critical need to take care of patients with back pain being sort of the largest disabled or worldwide for patients. We have to think of some really critical ethical questions. The first is should there be a relationship with industry. If there is which devices should I try. And then after training as a surgeon am I obligated to pursue prior to implementing a new device. And then how do we go about monitoring that device for safety and ensuring that we're doing the right thing as we use it. So when I think about the relationships that I'm forming in the operating room with industry representatives I put them into sort of categories and I make sure to think about commercial relationships and what's appropriate there as well as what is conflict of interest. I like this definition that comes from the ophthalmologist that talks about commercial relationships and basically the principle of beneficence and non maleficence that patient care must not be affected by economic interest and commitment to or benefit from professionally related commercial enterprises. And then further a conflict of interest being where your professional judgment should not be influenced by other interests of the provider whether that those be financial publications participation in trials etc. You know can be challenging because I'd like to point out that in you know in a typical spine surgery we use a lot of technology and so how to manage those relationships is really important rather than just sort of separating yourself from those relationships and I'll show you on this picture that I can't separate myself so this is a patient that had a large spine surgery. This patient in particular had had prior surgery had serious pain weakness and needed an extension of their fusion meaning putting screws and rods in their back as well as an extension to free up the nerves. So in order to set up this whole space we have a CT scanner in the operating room that's operated by one company. We have augmented reality to navigate the screws that's another company. We have a table or two of instrumentation of screws and rods etc and that's a third company so those representatives are often present in the operating room. So we have to be forthcoming with our patients about that and so knowing that we have a lot of technology to use and that you know in order to use it safely and efficiently it's constantly changing. Not everyone is trained or familiar particularly nursing staff with all the different types of instrumentation so we know that we have to have some type of relationship the question is how. The things that I think are important are to be forthcoming with the patient so you know they're vulnerable they're under anesthesia and you want to make sure that you're not doing any harm to them and so we actually put on our consent form that there's going to be industry representatives in the room with them and I actually beyond just reading the letting them read the consent form I will actually mention that fact to them and tell them which companies are going to be there so that that's fully disclosed. So being able to really rush that separation between industry and medicine but the it's important to discuss the benefits of having an industry representative there with your patient. And then there's the other side of things which is not getting things letting things get too far. And so we don't want to rush to replace clinical judgment with industry judgment, particularly given the possibility for a financial complex of interest. So this is an interesting article out of the Hastings Center that I would recommend to you that talks about industry technicians being embedded in clinical teams and times at which device sales people are sort of taking over the case in the sense that the surgeon is unclear on how to proceed without their help. And then we have to think about how actually that device got into our hands and how it got into our operating room and should it be there because when you're evaluating a new device want to make sure that it truly is doing something better for the patient. It's innovative in some way that's adding something. And then it's sort of free from bias and how that process has been evaluated. So this is an article from the Boston Globe that talked about how many Boston hospital CEOs sit on healthcare company boards and there's nothing, you know, special about Boston there's certainly a role for surgeons to surgeons and doctors to be part of companies because without us you know it's really hard to inform change in clinical care and figure out what the needs are for new things and new devices. And it's important to remember, you know, what type of bias may or may not be playing a role in the decision to, you know, as Dr. White mentioned use that new robot that was a big capital expenditure and you know there's a motivation for it to be used or as a junior surgeon I often will have people come to me and say, you know, try this device and they may or may not be financially sort of stockholders and that in that company or consultants for that company and it's just something to keep in mind. There's a place where getting multiple opinions we're hearing from your colleagues about a new technology can be really helpful to sort of mitigate that bias coming from one view to use a certain device. So in summary, as I think about using new techniques post training now that I'm a new attending. These are sort of some rules that I've thought of in my head. So, and thinking about them through an ethically guided framework. So a new technology should have a benefit. It should be better, or at least thought to be better than what you were using before. If you're getting ready to use something you should be competent at using that meaning you should be agile at troubleshooting and figuring out you know exactly how things work you shouldn't be fully dependent on a sales person. And that a competition is actually comes from commitment to formal study of that device, not just from certification so if you remember that email that I got about, you know, just a 10 question quiz that's not sufficient if you're wanting to use a new device. And then it's really important as you go to use that device and I'll use an example in a second to think about patient selection. And, you know, thinking about the process of how you're going to select a patient who can be well informed and can understand what they're taking on in terms of a novel innovation but also doing that in a way that you're making sure is equitable and you're taking good resources to all patients. When you're thinking about the process of informed consent with a new technology, especially we have lots of patients that come to us as surgeons as fine surgeons that are very vulnerable they're in a lot of pain they're really really eager to get better and so that vulnerability can be get eagerness to participate with a new device and so you need to be cautious of that and also make sure that we're giving enough sort of informed information about the risks of a procedure. And then this concept that research is research. And so when you're bringing in a new device really need to be sure that you're not doing research and if you are that it's gone through the appropriate IRB processes. Just to talk a little bit about that new device process. So currently in the US we use the 510 K pathway for devices with moderate risk that are considered to be just a small change from a prior device. But that process has come under a lot of scrutiny because it's a way that a significant at least a third of the devices come into the US ORs, but it's not totally clear that that process does a good job of evaluating new technologies and so the Institute of medicine was actually tasked in 2010 and 2011 to look at our current process and look at what I've highlighted and read are some of what I think are really ethically from an individual patient, and also public health ethics standpoint very important so how do we optimally protect patients, promote innovation and support public health doing the best for the common good. And if we're not doing that what are the processes to do so so they wrote a report on it and really said that this is not a new device process that we should be using but rather we really have to be careful that this is just looking at devices that are very, very similar to those that were used before and I think they overall called for some some changes to that to that process and there's a lot of people I probably a lot on this call even that would be critical of this process and want us to make sure that we're thinking through guidelines as to how we're using new devices. And so I'll give you an example of a case that I had earlier in my practice that you know where I use a new device and where it can go well and where it can not go well and and how I mitigated that process and so this was a patient with a degenerative spine disease who had two levels that needed to be treated meaning to lumbar vertebrae were degenerated and causing his symptoms. Typically, when I do this surgery you have to go through the front of the belly and sometimes the side and the back as well. And so there's a new procedure from a certain company that allows you to just go through sort of anterior laterally and potentially saves the patient positioning operating room time, a smaller incision a smaller surgical corridor. So there's some evident early evidence that this would be beneficial. I talked to the patient about Frank very frankly in the consent conversation about the fact that I had never done one of these procedures before that I had been trained and had done cadaver labs and was working within a surgeon who had done the exposures before but that this would be my first case of this type of surgery and even in this case, they had a video. The company had a video that I think was really helpful to share with the patient and he watched it and he actually had some really great questions about anatomy and possible complications after that to make me feel very comfortable that he had a good idea of what was going on. Unfortunately, during his surgery we got into a small bleeder but it was really difficult to contain in the small sort of surgical corridor and we ended up converting the surgery to open. I think the question there you know and I think that if we were open from the beginning I think it's important to note that if you know using this new technology probably made it more difficult to correct that problem and made his surgery longer his blood loss higher certainly a surgical complication that we discussed with him afterwards. The question is, you know, should I do that surgery again does that mean that this new technology is not worthwhile doesn't need to be reported and I'll be frank as a new surgeon I didn't really know. We obviously presented in our in our internal conferences of morbidity and mortality but who do you report it to or where do you go. It's actually a process to learn you know how to report something a complication with a new device and you know obviously reporting it to the company they may or may not have the incentive to to move forward with that information. And then I discussed it with my senior colleagues and and those that I knew and done the case before just to make sure that we were sharing our experiences and making sure that if there was a trend we weren't you know proceeding to just do this case if it potentially caused more harm than good. So learning from that experience and from the literature on implementation of new devices. These are some things that I think are really important. When you draft guidelines or when you propose a new device it should be free of bias and so, including folks that are you are not necessarily financially tied to the particular device in decision making seeking multiple opinions as I mentioned in the last case, making sure there's adequate data prior to transitioning that into a full clinical practice or standard, and then making sure there is long term oversight both institutionally and on the sort of national or international level to think about how we're going to log data to say you know if there are sort of poor outcomes or complications from this particular intervention. There's several groups that have thought about this and published on it. So this is the responsible development and application of surgical innovations position statement that talks about how do you define a new innovation which I think is is part of that challenge when you think about like the 510 K pathway, and then talks about setting up institutional committees and registries in order to track information when you bring in a new device. The ideal framework was recently published in JAMA which similarly talks about how to look at the quality of evidence before using a new device and how to implement a new device if you feel like it's appropriately innovative and safe. So summary as I look you know as a surgeon who works in an industry that is very financially beneficial but also really beneficial to patients in terms of the ability to treat and improve people's quality of life. There's a balance between the role of relationships with industry and so that relationship I believe should be an ethically guided one with the patient first thinking about how we can do the best for our patients. So think about implementing new devices which devices do I try the answer is the better ones so devices that have a potential for improved outcome or shorter lengths of stay better patient experience. How much training is enough training I think that's defined by competence so making sure that you actually have the ability to understand how to use and how to navigate a device. So by using monitor device safety we have data and registries and guidelines that involve multiple opinions and multiple sources without bias. So thanks so much and I look forward to taking questions after all the talks. Thank you so much. I just want to say, Dr. Williams and thank you for sharing your experience in such an open and honest way. I know that that's very hard to do, but it's exceptionally helpful for the people listening in and trying to learn about these topics to be able to hear your personal perspective of this in such a way so I'm really grateful to you for sharing that. We have a few questions coming in that I'm going to be working to collate together for everyone towards the end. I'm about to introduce two people at once just to give you context as I do these introductions, and then we'll have our final speakers together. John Meyer is a graduate of Yale Medical School, and he trained in general and cardiothoracic surgery at the University of Minnesota. He's a professor of surgery at Harvard Medical School and the first Tommy Kaplan chair in cardiovascular studies at Boston Children's Hospital. He's interested in health policy and has served as a society of thoracic surgeons representative to the AMA relative value update committee and by the way there was some questions in the chat about how these things get paid and how we determine how they get paid and that's the committee, the relative value update or RVU committee that that does make those types of determinations, as well as other very important committee work that guides our practice. He's the past president of the Society of Thoracic Surgeons and past chair of the finance committee in the same group, and does a lot of work with with that group to help guide us again in policy decision making has been such an important member of our working group contributing wonderful comments about all of our work as we share together and move some of these projects that we're all working on forward. And I'd also like to introduce Martin McNeely. He served as the professor of well I have to preface first of all I don't think I can do justice to this introduction because the list of accolades is quite long. And Dr McNeely has served as our leader of this group until very recently, and he's been an incredible mentor to me as I've explored areas of ethics and surgery, but I'll give you a snippet of some of his accomplishments. He served as professor of surgery in chief of the division of cardiothoracic surgery at Albany Medical Center, and later as chair of the division of thoracic surgery at University of Toronto and Toronto General Hospital co chair of the American College of Surgeons committee and surgical technology director of the American Board of thoracic surgery president of thoracic surgery foundation for research and education. Chairman of the ethics committee of the American Association for thoracic surgery and ethics editor of the Journal of the same. He's working with colleagues from our bio ethics center, and the University of global health equity in Boutaro, Rwanda to establish an intensive course and global ethics for the students at this new medical school, which was established by the late pal farmer and his colleagues at partners in health. That's only one of the many things that he contributes to our community here at the center, and I'm so grateful to him for all his guidance and mentorship so without further ado I'll turn it over to our speakers. Can everyone see my slides I hope. I'm John Meyer, and we're going to take a slightly different perspective, and that is the perspective of almost if you will an organizational ethics perspective, trying to understand the role of professional medical societies in the implementation and dissemination of innovative devices. And we'll use a case of the introduction of trans catheter aortic valve replacement so called TAVR as a new way of replacing one of the hearts valves the aortic valve as sort of a case example. So I have no disclosures. And I'd like to start by just reminding everyone about what the roles and responsibilities are for a profession. So the professions are charged with maintaining advancing and disseminating a body of knowledge and to advance that knowledge that is innovate. And in so doing, analyze critically and report the results. Personal societies are required to self regulate to place patients interests above their own, and to place performance above personal reward. And finally, a responsibility to fairly distribute finite medical resources. So the case, as we are describing is this introduction of trans catheter valves into the US market. And the promise of this technology was that a heart valve could be replaced with a much less invasive method. And then it could actually be done during a heart catheterization, rather than an open heart operation, which would mean the patients did not need to have an incision in their chest there was no need for using a heart lung machine and stopping the heart to carry out this procedure offered because of the less invasive aspect of this to have a shorter hospital stay and be less morbid for the patients. The uncertainties at the outset though was how well these new devices were going to work. And this slide will just demonstrate to you what some of these devices look like so this is a typical surgically implanted aortic valve over here in the upper left corner, which would require an open heart operation as I said, this in the upper right hand corner is the trans catheter valve, which can be sort of compressed down as demonstrated in the illustration in the left lower quarter of your screen. And so it can be compressed down around a balloon catheter. So, and then passed through an artery typically in the groin into the position in the aortic valve, the balloon expanded as is shown both in this x-ray picture here in the middle, as well as this cartoon here in the lower right part of your screen. Basically to expand this valve into the aortic position and then would be deployed without a problem. So our case involves what happened at the beginning, if you will, of the introduction of this device into the US market. There were actually at least two devices that were being pursued and marketed by two different US companies. The background is that these devices had already been approved in Europe, they've been given the CE mark which is the equivalent of FDA approval. Although initially they had been treated as somewhat experimental and were placed initially in high risk patients, but very quickly when it appeared that they seem to work at least reasonably well. They were disseminated throughout all patients needing this type of valve replacement, including much lower risk and much healthier patients at the start. And the early results actually indicated that the complication rates were higher for those patients than they were in a comparable surgical patient population. So applications had been placed by both of these companies for the FDA to approve and for Medicare to pay for this because this disease process, aortic valve diseases, more common in the Medicare age population in the United States that is over 65. So there were a number of obvious potential conflicts. And this would be a new procedure for the cardiologists so there would be an opportunity to effectively increase one's practice and generate more revenue. And the cardiologists were frequently the ones who were identifying the disease to start with and there's the whole issue of self referral for monetary gain at least that argument could be made. And certainly for the surgeons who traditionally had owned this area, that is, it required an operation to replace a heart valve. This was a big threat. It was if all the patients were having procedures done by somebody else that would mean it would be a loss of revenue. Both situations representing significant conflicts of interest between what was potentially good for the patient. Although that was still in doubt and versus what was good for the individual surgeon or cardiologists. The regulatory issues were a little bit muddy in the sense that multiple US entities regulatory entities are involved. So the FDA assesses devices for safety and efficacy. Whereas Medicare has to make payment decisions particularly for this patient population in this age group. And then the issue ultimately was this device was not inexpensive in fact was just for the device forget the hospitalization and the professional fees and everything else. The device alone was at least $30,000 in costs. So they clearly were an abundance of potential conflicts of interest as I've already outlined. There was the potential for adverse effects on patients and as profession. The members of that profession have duties to patients as you've already heard Dr white talk about. A significant question about patient selection and how much the patient should be allowed to choose what form of treatment they got. There were clearly the obvious potential for turf wars between a medical specialty and a surgical specialty. From a professional society perspective, there was a significant potential for legal liability in the sense that if this was not an entirely free trade if you will sort of process, and there was the potential for any trust issues to be raised. And as well as the obvious and ongoing issue about medical malpractice, particularly when you're doing something new. So, given that I was in the leadership of the thoracic surgical group so called STS. And when these issues were coming up. We were faced with several choices. We could do nothing and leave this decision up to the government agencies who without being too pejorative frequently don't have a lot of experience with clinical medical issues. We could leave it up to the payers and that is both Medicare as well as private payers. There was obvious potential for turf protection by writing guidelines that would favor one or the other approach. The third option was whether or not these two potentially competitive societies one representing the cardiologists the ACC and one representing cardiothoracic surgery the STS, you know could actually collaborate and try to make sure that this technology was introduced in a rational fashion. Professional societies have their own internal conflicts and ethical obligations, which included not only duties to their members but also duties to patients and duties to society. One of the most most ethical controversies arise when the pursuit of one or the other of a duty actually is puts an organization in internal conflict with itself. And what what happened, and what we did was we actually recognized based on that European experience the potential for significant adverse patient outcomes. And following my time in the leadership of the STS Dr. Michael Mack became the president year or two later. And he has an interesting background as both a cardiac surgeon but also as a trained internal medicine physician prior to his surgical career. And his counterpart at the American College of cardiology is Dr. David Holmes, who is an interventional cardiologist so clearly the leadership of these two professional groups were on opposite sides, if you will, of the of the of the procedure. And importantly, one of our surgeon members had actually taken a position for a year at Medicare, where he was actually had a major decision making role in how the payment decisions in particular would be made by the agency. And in his background, you can see there but he and I both had been through the Kennedy School course on government relations, executive course at the same time, sat next to each other and so we had a close working relationship. And what emerged through this collaboration across potentially conflicting or competing societies was the following. The agreement to begin with a randomized trial, which would be a way, the only way that any patients would get access to the new device here in the United States and this was actually a comparison of surgical valve replacement versus the trans catheter. The replacement appropriately named the partner trial, which included informed consent that was uniform, required local IRB approval, but also the collaboration between the two professional societies established several requirements that the regulatory agencies, particularly the FDA as well as Medicare actually bought into. And one of them was that there would be heart teams established which would give equal footing to both the cardiologist and the surgeon in evaluating patients, and also in actually carrying out these procedures. There were a number of sites where these procedures could be done were limited. And there were some criteria agreed on in order to qualify a given center for being able to participate in this trial. An existing database that has been maintained by the Society of Thoracic Surgeons for quality improvement purposes was used to generate the risk model that would allow us to classify patients in particular for the initial phase, which was the high risk phase, so we call partner one where patients who were thought to be at high surgical risk would then qualify for this trial. And then, based on those initial results and that higher risk group then subsequent trials involved gradually loosening the patient eligibility criteria. And as part of trying to generate new knowledge, a collaborative registry was established that followed all patients was committed to publishing the results as they emerged from the trials. And remarkably enough, this registry actually was supported by the device manufacturers. So, this example, which I think is probably somewhat unique, at least in American medicine, did achieve several other professional societies responsibilities, certainly helped to maintain an advanced knowledge to introduce and evaluate innovation. It represented clear cut self regulation such that not every cardiologist or surgeon in the country could qualify as a participant. There were standards that were set. Ultimately, the collective belief was that we actually were serving the patient's interest because of the lack of certainty about many aspects of this device. We certainly were interested in performance above personal reward, because not every one could go out and do these procedures and enhance their remuneration. And in a sense, this provided the basis for fairly distributing this are finite medical resources because the door was not thrown open wide with, you know, the rapid dissemination of this technology as had occurred in Europe with potentially at least some compromise of the patient's best interest. So I would argue that we have demonstrated through this case that new technology can be rationally and ethically introduced at a nationwide level, accomplishing the goals of advancing knowledge and minimizing patient risk. As evidence for that the results from the trans catheter valve now are equivalent to those of the surgical valve at least in the United States. There was an ability to demonstrate cost effectiveness. And I would argue this provides a template, potentially for future innovations to be introduced. The professional society collaboration and leadership were essential. And I think it's actually in retrospect, it was a remarkable public private partnership between the potentially competing professional medical societies, federal government agencies, and even the device manufacturers. There were a number of questions that we could always, you know, put on our rose colored glasses and say of course this is exactly the way we should do things going forward. But I think I would pose the questions was this an ethically appropriate role for the professional societies to take. The way that this was rolled out in the United States, particularly beginning with high risk patients and a randomized controlled trial actually equitable lower risk patients were initially denied access to the new technology. And conversely, one might argue that the high risk patients were in some ways unfairly exploited. And finally, I leave you with this question about whether or not the audience feels that this represents a reproducible template that should be the basis for the introduction of other new technologies, particularly in this country. Thank you. I'm Martin McNeely, John's partner on this short trip. I have no financial conflicts to disclose. But I must disclose that I've operated on uncountable numbers of patients using innovative technologies and procedures. With all the informed consent, though many patients don't want to know the amount of detail that was disclosed in most of the top and the talks that you've heard earlier. Next slide. Over 60 years ago I chose the University of Minnesota for surgical training because of its reputation for innovation in surgical treatment. A few years ago, Walt Little High and Richard Varko performed an innovative open heart operation to close a ventricular septal defect in a one year old boy, Gregory Glidden. Gregory's father, Lyman, was connected to perfuse Gregory's body with oxygenated blood, while his heart was repaired. With the two operating tables side by side. The heart lung machine was not yet sufficiently developed. In the past seven decades we have advanced to the point where a minimal incision over an artery and a catheter. A catheter enclosed valve can be placed in the beating heart without a chest incision or heart lung bypass as John Meyer has described. I've taken us back to Gregory's operation to remind us of the courage and persistence of the heroes of surgical innovation, particularly the patients, the patients and their parents, and the pioneering surgical teams. Also their overseers all are part of a moral community. The issue of oversight of innovation is evolving, as outlined by Dr. White, who should review and approve the interventions that depart from conventional standards of practice. For Dr. Lilahe in the 1950s, the chief of surgery, Dr. Owen Wangenstein, gave his permission with a note on Dr. Lilahe's door that said by all means go ahead. Good luck. It's become more complicated since then. Since then, approval of a surgical innovation committee, such as the one based on the Toronto model, provides the oversight in many departments. As Dr. White mentioned, the surgical executive committee at our hospital, the Beth Israel decommence, serves this function. The Toronto surgical innovation committee has been active for many years. It is described in the reference at the foot of this slide and will be available in the course materials. Many centers have asked their institutional ethics review boards to serve as surgical for surgical oversight. As surgical treatment becomes more complex, specialized committees working in concert with the IRB are evolving. The state's federal food and drug administration and recently the National Academy of Medicine are providing oversight. Two closing thoughts about innovation. We're currently celebrating the development of MRNA vaccine against a lethal pandemic disease, a seemingly near miraculous innovation. To celebrate this accomplishment, we need to improve it beyond disposable sterile needles distributed throughout the world and sterile syringes and an electrically powered cold chain. It is a communitarian. To celebrate this accomplishment. But we realize we must improve it to the level of applying a stable oral vaccine, which would overcome the geographic and socio economic hurdles still before us. The vaccine, the TAVR that Dr Meyer described and open heart surgery in general are examples of collaboration of the government industry and clinical care. It is a communitarian, not an individualistic approach to innovation, innovation for the common good that provides a framework for the heroes of innovation to succeed. In the menacing time in our history. It has been inspiring for us, preparing this course and for you, participants is hopeful for all of us to gather together in the surgical innovation conference and celebrate these accomplishments. Thank you for your attention. Thank you so much for all these wonderful presentations. As I've been monitoring the Q&A, and thinking through what you've presented you've given us an overview of the ethical constructs and frameworks that we should consider as we think about surgical innovation and you've identified the stakeholders, patients, ourselves as surgeons, and industry who may be pushing forward for these innovative techniques. And within those stakeholders and probably others we can all identify there will be certain conflicts so you can imagine that our questions are all centering around these conflicts of interest that arise. Each of you might resolve those conflicts. And the questions are nuanced and try to come at various ways in which these conflicts do arise. So let's lead off with a question for Dr. Williamson. As you're talking about the new technology that you'll be incorporating into your work. Two questions come up. How do you decide and you dress this briefly you said you try to pick things that have good outcomes, but then how do you decide if something is and I'll quote the question, a new innovation truly with promise and not a fad. And then building upon that as you're bringing that forward. How do you decide when you're competent enough to undertake your first non mentored procedure you talked about the consent process but how do you personally figure that out. And those are the different conflicts that can arise in this area. Yeah, thanks for those questions are really tough ones that I think especially as a new, new surgeon I think really have been relevant I think when I was in training I didn't really have to make those decisions I got to do the cool stuff, but I didn't have to make those decisions that's something that's very new. I think in terms of the question of whether or not it's a fad I think this is really a critical question so because there are a lot of fads there's like you know a new device for everything in this screw of course and when you're in an industry that's making this much money that many, a lot of people are going to want to develop something there I look for things that that actually there's a need so the example that I use of the lateral surgery. We spend 45 minutes in the operating room flipping the patient from one position to another position so that's something that that slows down the operating room it makes the patient have more anesthesia time. It's you know positioning their positioning injuries so when I see that there's a need and then there's an actual solution to a need I think that that's where I feel like it's not a fad and it's more of an innovation. That doesn't mean it's always going to work or be better and I think you do have to be willing to accept that you picked something that may have been a fad, even though you thought it was an innovation and get rid of it. Don't stick with that technology I remember doing some cases in training where we had you know multiple x-ray machines coming in all the users like one piece of new technology and it turned out that it actually wasn't helpful and so I think if you're not conflicted it makes it a lot easier to just move forward you know that's the didn't really work and then I think my other way to tell the difference is I ask a ton of questions of the reps. And they probably get a little bit annoyed by me but I think if you're an annoying surgeon to a rep it's probably a good thing because you're asking so many questions to really interrogate whether or not it's helpful. Similarly with being competent I actually like to know how to use it myself. I like to know how to load a pedicle screw how to when I started using the alarm, they were just like oh it's just a CT scanner. It works like all the other CT scanners and I was like no no no if I'm there at three o'clock in the morning I want to buy so I have like physically drove the machine myself figured out like okay if it gets stuck how are we going to get the patient out and so I think that at the end of the day you're responsible for everything that happens in the OR and so you have to feel comfortable that you can take accountability and have the skills to deal with that technology. It doesn't mean that you can't have help to make things more efficient but but you certainly are the last line of defense and so I use that sort of as my marker as to whether or not I would feel comfortable doing a procedure. Thank you so much. So building upon that we've had a series of four questions that sort of build on the conflicts as they arise both in the OR with industry reps present in the room, and then further forward into the fact that we're we're essentially working with or maybe even for companies, these industry companies that are deriving significant financial benefit, and sometimes we're as consultants but sometimes just purely in terms of the surgeries that we perform. And then another layer on top of that raised by one other commenter was, how do you keep balance in corporate hospitals and the sustainability, you know sustainability of hospitals, the pressure to use certain technology from the hospital itself. I'd love to hear anybody I'm summarizing questions that were put into the chat just in the interest of time but, you know, thinking about those different layers of interpersonal relationships or relationships with industry or relationships with corporate hospitals and how do we navigate all those conflicts as they arise and that's for anybody that like to join in. I'd like to general answer. John illustrated a collaborative approach that was very attractive to me, and I'll take the somewhat controversial position that we need more industry working with us as surgery is getting more complex care is getting more complex, and we shouldn't be worrying about industry as some kind of alien presence that's dangerous for patients. The more we work with them and teach them how to deal with the fiduciary issues, the better off everybody will be. I totally agree and I, I, those relationships can be really complex and that's why I brought up like the emails in the beginning because it is pressure right to have that relationship with with industry and I think you know someone asked about that you know how to balance that being in the or and I think that there is a real role and I hope that I you know kind of said that in my talk to have people there and so I do feel like in the ideal world that's it's a pretty professional relationship I think often reps will try to make it a little bit more of a personal relationship so that you do feel a little bit more guilt when you are are not using something that they that they want you to use and I feel like in my short time. In the end I've learned to not let those relationships be anything more than professional so that you know you don't feel guilty when you're thinking like oh my goodness, I know they're having to have a new kid on the way you know maybe I should use their their company or I don't want them to go out of business maybe I think you know and so that you can really evaluate things but I but I think they should absolutely be there. Yeah, I would just add that, although it may not be quite as apparent, but clearly there are even industry relationships at the professional society level. There are initiatives at the sort of professional society wide level that are supported by industry. There is been a role for professional societies to conduct educational sessions that primarily are you know directed at maybe learning how to use new techniques and new technologies such as the ones that we describe. I can tell you that the device makers for that transcatheter aortic valve were not very happy with the professional societies when it was to be not a free open market rollout but rather it would be done in a controlled fashion and yet ultimately they came around and actually as I indicated help support the registry because they actually needed the data as well to demonstrate safety and efficacy for further FDA level approvals. So it became a nice confluence of interests and a great partnership, which, you know, beginning at the, you know, when it was first these discussions were first being held where it was not so apparent that the interest would actually all be aligned and ultimately at the end of the day I think what sort of carried the day was, you know, we're all obligated to do what's best for the patients and that really became the sort of unifying theme for guiding how it was that we would go forward. Thank you Dr Meyer I think you've answered a pretty direct question in the, the chat, which was, you know, essentially is industry ever truly patient first aligned in the sense that they have such a strong financial incentive to proceed forward with continually moving more and more technology forward and more and more expensive options. But as you noted, in your case presentation and in your discussion just now. At the end of the day with the type of collaboration that you've described you were able to ensure at least the industry that may already have had good intentions for the patient population was truly patient aligned and ethically focused on the patient first is that correct. Yes, thank you. And so, someone had proposed that perhaps of thinking again about this relationship with industry there's these are multi billion dollar companies. So our role though in these relationships that we have with industry to not engage with them in any financial way whatsoever. So there's been some people who've proposed one person proposed in the chat that we just certainly can't have any financial with industry whatsoever and my first flush I'm thinking of consultation fees. But of course we're paid to do the surgeries we have incentives to do these surgeries that are financial as well you could get quite into the weeds trying to define where that relationship could even end Does anybody have a comment about that perhaps Dr McNeely because I know that you're very much in favor of having continued relationships with industry and I do see the benefit from that. Well I was inspired from those early closure of ventricular septal defects, which when patched occasionally the conduction system was injured, requiring the invention of the pacemaker. So the whole pacemaker industry grew out of collaboration between the Medtronic company and the surgeons at the University of Minnesota. That kind of collaboration was inspiring to me to watch, and it can go on as I'm sure, Teresa experiences with the spine companies. If it's a thorough the patient oriented patient motivated collaboration, then it's a winner for all of us. Any other comments on that point. I think Louise is important to realize that the companies are there to make a profit to make money for their, their shareholders. If they didn't do that they would go out of business. So their, their business is to generate in some cases new and innovative surgical products. If they fail at that, they'll go out of business and there won't be any new innovative surgical products. So I think that they may have a bias to the success of their, their various products, but in no way are they interested in just pushing failing devices on people, because in the long run it's going to come back to bite them. I think that they're sort of the evil empire and I think that many of these innovative technologies would not exist were it not for industry which supports them which funds them, which goes that pays the bills for these long regulatory processes and obviously they need to get something back in the end. They're not they're not charities. I think along a similar line one of the questions here had to do with corporate hospitals and I think it's important to realize that corporate hospitals are, are there to make that have to make money but not for profit hospitals are definitely not there to make a loss. Because if they make a loss year after year, they go out of business too. So everybody has to do things that to some extent are in the patient's interest and some extent are in their only in their own best interest in terms simply of existence. And that's where some of the controversies but from the individual physician standpoint is probably important to keep your eye on the ball and put your, put your effort toward your patients. And if you think that something innovative is going to help them, then it's fine to do. That's a great summary. Dr Meyer. Yeah, I would just point out the other role that industry says has served certainly in the cardiovascular realm and I think in a lot of other realms and that is, you know, one of us might get a good idea or think of a new way to do things and things but to actually carry that forward through the regulatory processes that Dr White was describing and through actually making sure that the device is reliably manufactured and is comes out sterile and comes, you know, for insertion and all of those sorts of things that, those physician surgeon types don't have any experience or expertise with, you know, it does require a real collaborative relationship and a real partnership, if you will, almost in order to bring some of these good ideas to clinical application widely. Yeah, that's an excellent point the complexities are not things that we can address easily outside of this of this current system and relationship with industry that we have both from a regulatory standpoint and passing those rules but just in designing things that are so complex as well. We've come up against the time I'm a little bit over and I apologize for that. I guess a take there was one question we didn't address that naturally flows from our conversation so I'll send you off with it to ponder. Which was how can we find a balance between continuously advancing surgical technologies which we've all said we really want to do, while also improving the availability of more basic surgical resources to areas and need. And so, you know, building upon our commitment to understanding disparities and access we've talked about all these high cost and, and, and pushing the boundaries there but also we always need to keep our eye on the prizes, or I on the ball as Dr white was saying and be sure that we are putting our patients first and that means ensuring access to surgery and in the first instance even the less technologically advanced. I would just want to thank all of our presenters tonight and I'll turn it over to Dr handle I'm so grateful to have been part of this conversation with each of you. Thank you very much Dr King. I would like to reiterate and thank our presenters tonight doctors, white Williamson Meyer and McNeely for their outstanding and provocative discussion of the ethical considerations and surgical innovation. I would also like to thank all of you who listen tonight and ask questions or expert panel. I would like to thank Dr King for moderating an excellent discussion with our panelists and covering the questions from the q amp a. I would also like to take an opportunity to thank Christine Mitchell, who is the executive director of the Center for bioethics for her involvement and support of this Harvard surgical ethics conference, and also Dr Robert Trug, who is the director of the Center for bioethics for his support. I would also like to thank Miss Troutman, Miss Stephanie ease and Mr model for their technical graphic and organizational support of this conference. We couldn't have done it without their health. On behalf of the surgical ethics working group we thank you for attending, and hope you will join us next week on Monday, June 27 for our final installment disparities and surgery and obligations to correct. Thanks once again, and good night.