All right, everybody. Well, thank you. We're going to start off with a session over here. This is the research workshop, collaboration with our industry partners. I'm Benjamin Ma, and research chair of the OSSM. But this is actually a session we held following the session we had last year at OSSM. Last year, we actually had a session, a research workshop, to work on how to partner with federal funding agencies, foundations, different setting about how to navigate some of the complexity of NIH or DOD. And we got a lot of feedback from the members. Hey, let's work with how to work with our industry partners in terms of doing research collaborations. So we actually have some outstanding folks sharing with them their successes, and also some representative from our industry partners about what their programs are. Now, I'm actually introduced by two moderators. Those two actually did a lot of work to put this program together. So we have Elvin Hsu from University of Delaware, and also Andy Sheehan from San Antonio. They will lead the session. I think it's divided in two parts, Andy and Elvin. So I'll let you guys take it off. Thank you so much. Yeah. Thank you. Thanks for that introduction, Ben. And again, welcome, everybody. Thanks for your interest in participating in this session that's going to be outstanding. I can tell you that already. So we've arranged it, as Ben mentioned, into two sessions. The first session is going to be our four representatives from our industry partners. We're going to have a Q&A session to follow. Then we'll have four surgeons come up. We'll have Q&A. And then session three is going to be an open session, in which point, throughout the next two hours or so, we really want to emphasize engagement and participation from you all. So very low threshold to be asking questions coming up. We want to make this as robust and as bi-directional, as reciprocal as we can. So with that, we'll get started. I'm pleased to introduce our first speaker, Cohen Vedix. He's the senior director of global research at Arthrex. Dr. Vedix leads a global team of over 75 employees, specializing in biomechanics, biomaterials, and clinical research. Prior to his tenure at Arthrex, he served as a senior staff scientist and directed the biomedical engineering department at the Stedman-Philippon Research Institute in Vail, Colorado. Cohen, welcome. Thank you. All right. I'll get this going here. Thank you so much for the opportunity. I think this is a great session. As mentioned earlier, it'd be great to have some dialogue after this as well. So I want to start out with a question. What is the preferred source of information for orthopedic surgeons when choosing between techniques and devices? This is a fill in the blank. I'll give you the answer. It's peer-reviewed publications. This comes from this source. This is a question they asked over 1,000 orthopedic surgeons. And how do you rate the following sources for identifying treatment for your patients? Scientific literature is atop. It's also good to see that scientific conferences is also in the top three. And as you go in the bottom, you see newsletters, white papers for implant manufacturers are in the lower component. So for us, peer-reviewed publications is really ultimately our goal. For us, we care about key performance indicators. It's how we track our metrics. And I split it up into leading indicators, which influence future performance, and lagging indicators, which analyze the past. A leading indicator for us is our active research studies. So we have over 400 active research studies. The majority are North American, also Europe and Middle East. And we are actively working on LATAM and Asia-Pacific. What we noted in the last fiscal year, 24, which was just concluded, we had 184 unique principal investigators from 20 different countries, which I thought was relatively impressive. It's also a nice balance between clinical research and biomechanical research. So you have the arthritics-initiated or sponsor-driven and investigator-initiated research, which is what we call the IIR. Again, nice balance between clinical research and biomechanical as a leading indicator. Another metric that I've been tracking is the throughput. So we have all of these indicators moving forward. How can we track the publications? So for clinical research, we had close to an 80% publication rate over these calendar years. And biomechanics is around 60%. Last year, last calendar year, we had 82 publications total. Again, this is a lagging indicator. So it's, again, a nice balance between clinical research and biomechanics. The amount of investments that we were doing in biomechanical and clinical work now results in the lagging indicator, which is now publications, which we're very proud of. Our department's vision is to sync impactful scientific evidence with innovations that instills trust in surgeons and their patients. And really, that trust comes from truth, or scientific truth. We have 74 employees that are globally situated. We have a headquarters in Munich, Germany, which is where I was based for five years. And now I'm based in Naples, Florida, which is where our global headquarters is. We're divided into three main tiers. It's biomedical engineering, which is my background. We have clinical research. And then we also have a research operations division. The operations division really focuses on the contracts, the slides, and all the things that happen behind the scenes. Collectively, we have 328 years of orthotics experience. And over half of our team, 60%, have a graduate degree or a master's degree or above. And we really try to build this scientific evidence pyramid from the ground up. That's our philosophy. So level 5 evidence, preclinical or biomechanical work, and then the clinical evidence, of course. We also do a lot of the work for FDA clearance within our team. So we do the 510K clearance. So we have a lot of studies from that perspective. And then we do also our post markets, both pre-market and post-market. To give you an example of the preclinical work, here is a publication from April where we have global authors, global surgeons. We're focusing on a new implant. It's called the suture lock implant. And our really focus was to focus on the native meniscus. Our goal within orthotics is always to ensure that we're not over-constraining or under-constraining the construct that we are repairing, which is demonstrated here. As far as our active clinical studies, I'm also proud to present that we have over or close to 70 level 1, level 2 trials. These are active trials. And we have then also level 3, and level 4, and level 5 that we are tracking. One example of a level 1 trial is a FDA-approved IDE. This is for ASP-MAX. It's a RCT. It's double-blinded, multi-center. It's four sites that have now been activated. I think we're about 20 patients. We're looking for 45 patients, again, looking at ASP-MAX versus the standard of care, steroid injection. We're looking at one-year outcomes. WOMAC is the primary indicator. And you can look this up on clinicaltrials.gov. That's where most of our clinical studies are. And you can also find this in the IDE website. We also have an orthoplasty registry. We call this the SHARC. It stands for Shoulder Orthoplasty Research Committee. We like our acronyms in our department. We have over 3,000 patients enrolled currently. Again, the key metric that we are tracking is publications. We have 73 publications now, seven implant types and 38 surgeon collaborators. The common question is always, well, there's a bias when we talk about industry funding and bias concerns or perceived bias. And this is a publication which showed that there's no significant effect on research outcomes. And in fact, when you look at industry support and H-index of the investigator or publication throughput, there's an increase in H-index as industry funding increases. And same thing with an average publication count that also increases. This is a correlation, not a causation, if you read this paper. But I thought it was a really unique methodology that these investigators used. And this is published in JBGS. So how can we ultimately maximize this scientific impact? We've created what's called a strategic research initiative. This is our list. It's our wish list of where we need to go to fill those scientific gaps that we have identified. We work with our portfolios and our regulatory teams and engineering teams to define these lists. And this is, again, a conversation that we can have. But we ultimately like to receive your requests that are ad hoc and de novo. So you can submit this at research.arthrex.com. This is the QR code. I'll leave this up as my last slide. Again, we love to collaborate. And thank you, again, for this opportunity to present. So, Cohen, thanks for the wonderful talk. And thanks for the support for medical research and innovation. So our next speaker is Matt Christensen. So Matt is a senior vice president of global clinical and medical affairs at Smith & Nephew. He has about three decades of dedication to his career in medical devices. Before he joined Smith & Nephew, he has overseen a lot of the device development and marketing in Medtronix, Covidian, and other companies in the area of sports medicine, autosuperior reconstruction procedures. Now, without further ado, let's welcome Matt. Please take us away. All right, good morning. Nice to be here. Thank you to the organizers for the invitation to participate. Again, from Smith & Nephew. So just a little bit of background about Smith & Nephew, a global company that's been in existence for many, many years now, founded in 1856 in the UK. We have 18,000 employees or more around the world and focused into four different business units, sports medicine being one of them, orthopedic joint reconstruction, as well as advanced wound management and ear, nose, and throat. The purpose of Smith & Nephew is really to return patients to a life unlimited, but also to support our surgeons, to support our community in health care, and also our employees with life unlimited. That means just really taking the thought process out to enable physicians and our researchers to focus on what's most important. We have a culture that is focused on care and courage and also collaboration. We'll talk about collaboration today. And in 2023, we've helped restore about 14 million patients to life unlimited. So Cohen mentioned the elephant in the room, the perceived bias, the potential for bias when partnering with industry. And so it's important to consider the tradeoffs. One would be consider the funding of research procedures. In a study, of course, not everything may be standard of care. Not everything may be covered by reimbursement. So you have to consider, is there a benefit to partnering with industry to cover the cost? Institutions and or clinics are not always able to cover the cost and be able to support the cost. Therefore, the design of a study can be watered down to go to account for the economic side of the study. Similarly, for product reimbursement, in a high quality study, it may not always be possible that the research devices or procedures would be covered. And so we want to make sure that patients are given access to what's required for the study. And partnering with industry can also help there. When considering design of a trial, of course, there are many factors that can influence the execution ability of that study, the ability to actually complete the study and report the outcomes. One of them would be the sample size of the study could drive the need for partnering with other institutions, other investigators. In doing so, the complexity of that study definitely can increase significantly. The need for a coordinating investigator is a role that is complex. It is a role that is outside of patient care. And it's really a role that's beyond the typical investigator role. And so working with an industry partner, you may be able to have some support on the back end to make sure that that role is supported, that you've got the time, you've got the resources you need to manage a multi-center trial. And of course, bandwidth constraints in the sites or institution. So when working with an industry partner, there are many factors to consider. If you've chosen to work with an industry partner, it may be based upon the technique, the procedure that's being studied. It may be based upon the device or the technology to be studied. But you want to think about what does an industry partner bring you as a researcher? What does it bring to the institution or to the clinic? And it can bring many, many things. So experienced clinical research professionals, of course, that is a backbone of what we do. But also a focus on patient safety to ensure that the data being collected along the way, that we have eyes on safety across not only single centers, but multi-centers to put the patient at the forefront. Data integrity and quality. We have definitely a focus to ensure that the data that's being collected and the way it is analyzed is with high integrity. In supporting investigator initiated studies, of course, we want to support the investigators, the institution to analyze the data in a way that keeps the integrity. Impactful research does take a lot of expense and a lot of resource. So, of course, the choice of working with industry can be based upon that. And an industry partner may bring you best-in-class systems. They may bring you tools and technology that can enable the execution of that study. So Smith and Nephew specifically, why do we invest in research? Why do we support researchers to conduct research? It could be for a myriad of different ways. But primarily we start with how do we get new technologies, new devices to the market? And that can be for, of course, global registrations, FDA and beyond. So we start with what is required from a regulatory hurdle standpoint. Then we think about the life cycle, the lifetime of that product and how can we support it with evidence to not only support its adoption, but to make sure we can keep it on the market for European medical device regulation would be a good example of that. Requiring proactive post-market follow-up for the life of the device. Once the product is on the market, of course, not all products and technologies are successful. They're not all adopted. One of the barriers, of course, is patient access through reimbursement. And we conduct research, we support research that would support guideline development as well as getting to reimbursement. And broad education, of course, about why a technique is favorable for a patient, why a certain technique or procedure is the right one for a patient is another area that we invest in. Similar to what Cohen presented for Arthrex, we invest in a few different ways into research, primarily through these three categories. So first, with investigator-initiated studies. This is where the investigator and the institution are the legal sponsor. We, of course, may be providing funding. We may provide product for free of charge. Really, we're there to ensure that we're investing into research that is aligned with the strategy of Smith & Nephew and aligned with where we believe patients can benefit. Next would be Smith & Nephew-sponsored studies. This is where Smith & Nephew or the industry partner is the sponsor. They take the legal responsibility. In that, we would have more influence or decision into the design of the study to ensure that we believe it's going to generate evidence that is meaningful. And we'll work with investigators to ensure that design is also impactful to the patient care but also is feasible to be conducted. The third category of collaborative research, this is kind of an in-between category. This is where the sponsor of the study is in question. It could be the industry partner. It also could be the institution or the investigator. But in this, there's collaboration on the design of that study to ensure that it's going to meet multiple needs, whether that's the industry need, healthcare providers need, or other. We were asked to talk about some challenges or ways that we can enable success in research. This is a generic example, but a very simple one that actually made a big impact. We had a need for evidence to expand the indication of a product in global markets. And there was a proposed study, multiple sites, very time-sensitive data collection to be achieved. And the barrier to success was that research staff turnover in the institution was high. And this didn't enable the institution to execute, to enroll patients quickly, to execute and complete the study. We had a team member who actually had worked at that institution in the past. They said, you know, knowing your institution, you have a large population of medical students. Those medical students can be a very nice adjunct to your research staff. And so, they were able to leverage their research staff, their medical students, apologies, and that enabled them to complete the study on time. So, very simple thing. Basically, what it is is multiple minds to solve the problem. My final slide, it just, in general, areas of interest to Smith and Nephew when it comes to clinical research include, we want to focus on the patient. We want to focus on returning patients to Life Unlimited. And it takes evidence to do that. It takes evidence to unlock not only registration in market to get products on the market, but to then gain access for patients, whether that's through reimbursement or through awareness of technology's benefit. And the, where we have unclear targets of patients for procedures, understanding the benefit to certain patient populations, we want to uncover that, take, go from a broad indication to a very specific indication of the patients that can benefit. And finally, when there's unrealized benefit for a patient, we want to invest where it's going to make a difference, not just to collect the data. We don't just conduct studies to collect data. We conduct studies to learn and to publish. Thank you. Thank you, Matt. That's a very inspirational talk. Thanks a lot. Our next speaker is Michael McBrayers from Anovis. So Michael actually had a long, long career or dedicated to orthopedics. He has about 36 years of experiences in this area. Before he became the vice president of business development and professional relations in Anovis, he actually had a long career with Stonejoy the DJO, and he's going to share with us his perspectives from the industry, working with the surgeon and clinician partners. Please, Michael, take us away. All right. Good morning, everybody. Thanks for coming. I'm impressed with everybody that's here for a Saturday morning, so we appreciate it. I wanted to get a little bit of information in reference to Anovis. Many of you would know us as DJO. Anovis is our public entity. We're on the New York Stock Exchange as Anovis, but obviously, you guys know us as Donjoy and Aircast and those brands. We are a little bit unique in terms of the industry because we have products for prevention. We have products for post-injury. We have products for post-operative care, and then a lot of you probably don't know that we have products for total hips, total knees, and total shoulders, as well as products for surgical ankle. So we've continued to grow and make acquisitions, and it's been a lot of fun for me to see a company that I started with that was doing $6 million in sales to now do a $2 billion entity. The research opportunities that can be collaborative events with industry, there is some work that you have to do before approaching somebody. You should do your homework about the company and learn as much about that company as possible. We get research ideas that have no meaning or ability for us to do, so it's a waste of time on everybody's case. As a public entity, and all these companies have information on their websites, learn as much as you can about the companies. As there's a saying that Ty Lee makes is that there's nothing that a research idea that can be ruined is a good publication search, so if you do that work up front, there's an opportunity to collaborate. I think it's incredibly important, though, that you look to create a relationship, that you find the mechanism when you have a personal and professional relationship that there's those opportunities that come up over a cup of coffee. Over a dinner. Over just meeting in the hallways here. So if you have those kinds of personal and professional relationships, conversations turn into opportunities, and recognize that it's really that kind of partnership that can really start some research. Make sure that the idea does relate to the company, as I said, and then at the point in time when these things start, things don't run quickly. We have legal and compliance issues that slow things down, and the same thing on your end. So as good as an idea can be, and as simple as the approach might be in our heads, there is a lot of work that takes place in reference to the compliance, et cetera. We do look to partners for sites, and doing clinical and biomechanical research. As much as I told you that you should know about us, as a company, we should know what you're doing as well. We should know what your capabilities are, and what your interests are, so that it's a two-way street. As much as you can come to us, we know where to go with specific types of research that we want to do. So it's that idea of creating the next generation of possible, and it's only through your help, and working together with any of the industry partners that can make that happen. All right, great. And last, but certainly not least, we've got Colleen Roden, who is the Senior Director for Clinical Sciences and operations at Stryker, where she provides strategic direction and ensures operational excellence across clinical and microbiological organizations. She's got key roles in R&D as a certified clinical research professional auditor. She's been working with a number of partners and entities, and we're excited to have her here today. Hi, everyone. Good morning. Thanks so much for having us today, and it's been fantastic to hear from our industry peers and learn more about their approaches. And I'm excited to share with you a little bit more about Stryker and how we're approaching clinical research. So I'll kick us off here, so we get the technical piece worked out. I always like to start off with our mission statement here at Stryker, because this is really what it comes down to for us. And for us, we always like to start with, together with our customers, we are driven to make healthcare better. And I can think of no better example than the topic we are here to discuss today, which is collaborative clinical research and how we can drive innovation across the care cycle. Looking at Stryker, we have solutions across the patient's continuum of care. We are a company that spans globally with over 55,000 employees and touch that patient through the entire care cycle. We're interested in not just intraoperative data collection or patient-reported outcomes, but really understanding that patient's experience throughout their life cycle of care, whether that's preoperative planning, intraoperative workflow, postoperative experience, patient-reported outcomes, healthcare efficiencies. We really want to collect data analytics across this entire care cycle so we understand the full picture of that patient and surgeon experience. We think specifically about the areas that we're focused in as we talk about what our strategy to clinical research looks like. Really the key here, and this is I'm hoping what we'll get into more today about how we can be successful, is we have to start out with partnering with research-focused surgeons that have established research infrastructures. Our desire is to collect high-quality data that can be leveraged across numerous applications, whether that be market access, healthcare reimbursement, policy change, and it really starts there. We have to have folks that this is not a hobby sport is what I will say. We really need to be focused and have a desire to collect high-quality data that can drive changes in our care cycle. From there, we'll partner with you to drive innovative programs, whether you've heard from my peers here, different types of pathways, whether it's investigator-initiated research where you're bringing the idea to Stryker, or it's Stryker research that will bring the ideas to you. We also like to partner on collaborative initiatives where we're working through those concepts together. Ideally, we're driving standard of care change and how we are addressing our patient challenges. Ideally, we really want to make sure top of mind all the time is generating robust data deliverables that are facilitated by a standardized research practice and methodology, driving things like market access, but also maintaining market access for our customers and for our patients. From there, we're looking to expand across different regions, different populations, really understand that the use of our products in diverse patient populations, this is really important for us, diversity in our data sets, and that we're collecting data across our entire patient population and being able to understand more aspects of how our data can be utilized looking at health economics. I think this is a really key, important focus area for us in making sure we're looking at that health economic impact all along the way when we're working through our clinical programs. Finally, we also want to make sure we're getting this out, this information out for consumption. We leverage these high-quality evidence to support peer-reviewed publication, but truly this is only one part of it. It's really critical to get this information out there to support education, support training, but fundamentally we need to be thinking about driving changes in health practice and health policy to support patient access. And so those are things that we're going to be incorporating into our developmental process here and driving, again, change in our standard of care practice. We really need to partner closely with our customers in order to be able to do that. And I think, you know, when we were talking through what are some great examples of that when we have had successful partnership to drive innovative care and bring innovative products to the market, I wanted to share an example of one that I had the fortunate opportunity to partner on, which was an IDE study. This one you may be a little bit familiar with. It was the InSpace implant. That was an IDE clinical trial comparing InSpace to partial repair for treatment. A full thickness, massive rotator cuff tears. And the reason why I want to use this as an example, because it was a great example of how we partnered with numerous healthcare organizations, 32 surgeon partners, of which none of them had any financial investment in either the company or the product. And when we were running this IDE study under the purview of FDA and partnering very closely with them, we needed to partner with our surgeon leaders in order to make sure we were driving a clinical trial that was evaluating data endpoints that were meaningful for them and meaningful for the patient. One of the things I'll tell you, if you're partnering with Stryker, you're probably going to see us a lot. Data quality is very critical for us, so we're at your site quite a bit. So I'll say in this study we had over a quarter of a million individual data points of which we validated every single one of them through source document verification. And I think this is critical. If we don't have high quality data, we're not able to do all those important things like market access, healthcare reimbursement, policy change. It all starts with the foundation of quality. Additionally, this data went through robust regulatory review. It went through FDA. It went through Health Canada. It went through EUMDR certification. And we wouldn't have been able to do that, again, without that quality by design concept. Research should always enable us to ask more questions. We don't stop with one study. We find new questions to ask and to continue moving that forward. And so in this case, it was a catalyst for future research. In this study, we found with in-space patients, although they were blinded and that they were all standardized to a sling, we found patients were getting functional earlier, increased pain reduction. And so that drove us to run a new clinical trial in a post-market setting that we're working with over 10 centers currently and 15 surgeons on that's looking at accelerated rehab. And you can take a look at the clinical trial posting here with the QR code if you're interested in learning more about that. So what were some of the keys that allowed a study like that to be successful? And when we think about how do we partner with you, how can we set up the foundation for success, and what will we be looking for? So for research partnerships, a few things that we're considering as you're moving forward and you're talking with your industry partners is starting up with just strategy. Looking at research that does contribute to indication, expansion, indication information, product information, learning more about, you know, how our patients are experiencing their entire life cycle of care. A robust clinical protocol. This is really critical. It's all about the details. So ensuring that you're really spending time to invest, do your research, really be able to have a constructed and well-defined clinical research protocol which has a sound scientific rationale and explains how are you evaluating safety and performance for your patients. Infrastructure you heard Matt talk about it. This is again really important as we think about having the people around you to be successful. This is a team sport. Nobody can go at this and be successful by themselves, so really having that infrastructure around you to be successful, have bandwidth, be able to execute programs in a standardized way is a really critical aspect to being successful. And then with respect to data collection, doing it in a standardized way, making sure you have access to the appropriate patient population and leveraging standardized tools in order to make sure you're doing it consistently and reporting it out in a way that can again roll in to assess those hypotheses and be able to drive those next steps. So once you've kind of worked through all those different things here at Stryker again, we do also have a research portal. You can see the QR code here. You can go and submit there and then we'll start to work with you, talk through our areas of emphasis and focus and how we can partner together to be able to drive improvements in clinical, operational, and financial outcomes. Having early and often communication is critically important for us, so I'll just leave you with this. Key to success, align early on expectations, make sure we're both working towards the same goal. We understand what each other, you know, what our constraints are, what are the things that we need to align with, partner together, and we're confident we can be really successful to drive improvements in patient care. Thanks so much. Thank you. The age index is, if you have, like let's say an age index of 10, that means that you have at least 10 papers that have been cited at least 10 times. And theoretically speaking, your age should match your age index. Yeah, follow-up question. Can you each describe the best way, for those surgeons who might want to do a project, how's the best way? I mean, Michael's talking about meeting and having these relationships with people, but how about for people who are starting out who don't have a relationship? What's the best way to find you, collaborate? I think it's at meetings like this that the collaboration, the discussion starts at a meeting like this, where if you have that interest and it's starting the relationship in terms of getting to know what the needs of the company are, what the interests of the company are, what its strategy is, but then also understanding what resources may be available to support that investigator as they start on their journey of research career. I think that first example, that first study that a doctor gets involved in or that an institution gets involved in is critical. That experience will set them up either for success or failure moving forward. So I think we would have an interest on the industry side to make sure that the researcher has support and that they understand the process. It is a process, and each of us have talked about it in a different way, that the compliance aspect of what we do is tremendous, and that means there is a lot of process that we have to work through, both on the industry side, but also on the institutional side. And I would mirror that, Matt. I would just say, again, aligning early. I think these types of environments are the best way to get in contact with the right folks. So if you're in the exhibit hall and you're talking with the teams there, ask, hey, who's your clinical research person? How can I get in touch with them? Are they here? Can I talk with them? Attend med ed events. Get your hands on the devices, right? So you can understand, what are the questions I'm looking to ask here? What do I want to solve? What do I want to partner on? And then, again, aligning early to understand what is the process. And then, honestly, from our chair, we want our surgeons to be successful, and we can maybe point you in directions of how to target additional funding sources and things that you may want to go secure through grant funding, et cetera, to make sure you have, again, the keys to success and the infrastructure around you. To follow up a little bit on that question, so this is a real-life question. Is that safe? I want a project, I want to collaborate with the industry. And usually, what we do is, by intuition, we turn around and ask our rep, who should I talk to, right? Sometimes, they get us somewhere. Sometimes, it doesn't. So can you just briefly introduce the best way to pursue that channel, please? Yeah, I'll say, it's the same with Colleen said. With just going straight through our portal, I think that's the best source, not going through the reps. It's such a dull curve when you talk to the reps. Sometimes, they're very dialed in to what's going on with research, and sometimes, it's not. It's not a criticism, it's just, when you go to the portal, you'll have direct access to the research team. And then, for those young investigators that, use your faculty, your mentors. It's like, how did you do it? Who did you talk to? So that they can help you, as well. You're not on an island. It's, and industry is open to it, right? So we're, it's not like you're coming and asking a question that we don't wanna hear. We can be very clear on what we think we want to do, but we're open to the conversation from the very beginning. So, take things a little bit different direction here. Tremendous experience amongst the panelists here. And so, what I'd like to hear from each of you about, and we can start with Colleen, is how have things changed in this space over the last five years, and where do you anticipate the biggest or most conspicuous aspects of change going forward? It's a really good question, and I don't wanna date myself too much, but when I started in this, we were faxing our case report forms, and everything was on paper. So that's how we used to run our clinical trials. So definitely, I mean, we're moving into a digital age, right, we're looking at new tools, AI, patient-specific data collection, and so I think we're really seeing the tools of being able to leverage the technology around us to be more effective with our data collection, and I think that's where we've seen the most rapid involvement in how we are partnering with our surgeons, because more of our surgeons now have access, you have access, right, to your own data collection tools, and how can we interface with that more effectively? So I think that will be one key area, is how do we streamline and drive efficiencies where we're not having multiple systems and duplication in our efforts, but also we're getting even more specific with our data collection. I think, you know, if I look 10 years ago, we were very focused, hyper-focused on one primary endpoint. Do they hit this? Do they have this safety event? And now we're really understanding the ecosystem around these patients, right? We're understanding mental health domains, concomitant procedures, compliance to rehab, and these are all really important questions that we need the data to understand, you know, really the full experience of that patient, but then to evaluate technology most effectively. So I think we're getting a lot smarter there, and I think we'll continue to see involvement there. Well said. If I could, my question, I really appreciate you guys talking about the elephant in the room, being industry versus independent studies, because as a surgeon, negative results can be as important as positive results. So I'd love for you guys to comment on how you guys address negative results when you guys are doing your studies. Yeah, the aim, go ahead, yeah. I think the aim across our companies, I believe, would be similar, that the aim is that we would seek to publish results regardless of the outcome. Of course, being in an industry company like those represented here, we have an interest in making sure that we're investing in things that we believe will be positive, that drive learning and drive education. That doesn't mean that the negative outcomes won't happen. They do. This is research, and it is a scientific gamble in some cases, but the intent would be to publish. I agree, I'll just add to that. I think a big component of post-market research is to have critical results and results that may be different than the original hypothesis, and that drives innovation. So we also very much reinforce publications. It's something that we're tracking, and if something's not being published at the milestone marker, we ask the investigator what additional support is needed. So we definitely do not limit publications. It doesn't mean that across the board, in general, the industry can encourage publication and will not hold back on the investigator's decision on what to publish or not to publish, or where in concept, and where. And we're super clear on that. I mean, that's something that we have very high regard for, is that surgeons have the right to publish their data. We don't influence that, and I think having that autonomy is critical to be successful and have confidence in each other as partners. And to that, I would add- That upfront work, right? Absolutely. All of the agreement to what you're trying to accomplish. So it's the upfront work that makes it, then everybody can say, yeah, we're gonna live with those results. And so to that point, for the younger investigators in the room, it sounds like what we're hearing from the panelists is that you all should feel empowered to be direct and candid at the outset so that everybody understands exactly what the expectations are and what's gonna happen with those products. Is that a fair generalization from the panelists? Agreed. Absolutely. Agreed. And one thing I'll add is, I think it's important to have full disclosure when you do publish. So especially if it's investigator initiated, put the full disclosure of what the products or in-kind or any type of financial support that you received in the paper. Any conflict of interest needs to be fully disclosed, and any products used as well can be just in the methodology. We're not looking for a advertisement in a publication. You can just be limited in methodology, mention the company, the product name once so that you can repeat the methodology in the future, but that's our common goal. And the objective, if it doesn't get published, the company still may wanna use that. So, you know, that's, look, getting published is difficult, but the fact that you get a result out of some word doesn't mean it's not gonna be used and for the company. A great discussion, guys. You know, obviously you talk about, you know, kind of, you know, investigative initiative research. If you're interested, go to portal, submit it. I think this is great, you know, recommendation for everybody. How about like, you know, trying to get involved in like a industry sponsored, you know, kind of research. Hey, you have a great trial. I'm at my site. I wanna be part of it. I wanna be part of it. How do you get involved in that? How do you be that site to be chosen? Any tips, you know, kind of show enthusiasm? What's the right way to kind of, you know, let industry partner know that, hey, I'm eager, I wanna do it. I may not be the one that actually came up with the idea, but I wanna be part of these things over here. What's the right strategy? I think we're always looking for eager partners here, because like I said, this is never gonna be successful with one of us alone being enthusiastic, motivated, committed to these programs. So I think that enthusiasm is critically important. A great place to start is clinicaltrials.gov for folks that are looking to get into research that's sponsored. Use those tools available to you. These are required databases where we have to register our clinical trials that we're starting up. So use those to initially find some, again, in these environments, great opportunity to come up, talk to folks at the booth, talk to us, you know, up here at the panel. We'll tell you what we're working on, where we're focused, and where there may be an opportunity where we're bringing on additional sites. So I think that's just, again, a great starting point and then get educated about what we're looking to answer, because we wanna make sure it's aligning with your goals as a researcher as well. And then we'll get into all the nitty-gritty of site qualifications. And being an operations person, I won't bore you with all the details of the checklist, but we'll get into that as the next step. But I think the enthusiasm and, you know, seeking out and trying to follow up and get more information, great starting point. Yeah, as an industry partner, we were looking for investigators all the time. But the way we identify investigators takes a lot of different approaches. One, it can be through our own research in the literature and understand who's publishing, who's active. But also, we need to be aware of where there is interest and where there's a good alignment with the skillset, with the patient population, and our research interests. So having the conversation, for sure, is a big part of the equation, whether that's at a meeting like this. You know, we've mentioned kind of the separation of what we do from the sales side of our organizations. The sales reps can also, though, be a good way to get access to the right person in the company. They may not know about the research that's going on, even if they do, it's not really their area to discuss. But they can make the connection so that those of us and our teams know that there's an interest. And what I'm very happy about, as just an industry that's up here, we're all saying very similar things. You know, the approaches and the difficulties and all those. So the good news is, when you're approaching a company, we're gonna be pretty similar in what we have to do. Yeah, the standards are well-established. Yeah, thank you. Better said. For the panelists, I wanna go down the line. I'd like to start with Cohen. Can you talk to us and talk to the surgeons in the room about the resources that each of your enterprises have in terms of supporting the regulatory process with respect to clinical trials? Mm-hmm. Yeah, so if it's sponsor-driven, we will manage everything from that perspective. If it's investigator-led, we're very limited on what we can support. Like, from that perspective, that's our current policy. It really has to be driven by the site, and that goes back to the site qualification to see if they're qualified to be able to run that. Especially if it's a trial that requires their own IRB as well. So that IRB is then the responsibility of the investigator. Yeah, very similar. I think if it's a sponsored trial where Smith & Nephew is the sponsor, we will provide a lot of that support and do a lot of the legwork to make that process as easy as possible. And I know we've got some IRB members here in the room with us, and they can speak to the rigor of their own process, but we do support that. On the investigator-initiated side, for sure, we are limited, but we will provide consultation and guidance to make sure that that process is streamlined and that that application is going to meet the need of that regulatory process. If it's collaborative, then all things are on the table, and we can actually set up an agreement where it allows us to be more supportive. Same. Yeah, I would mirror that. And again, I think similar three models, sponsor, investigator-initiated, collaborative. And similarly, in the collaborative is where you may have a little bit more diversity. We may have biostatistical support, medical writing support, database support, things like that that are detailed quite explicitly. So at the end of the day, everybody walks away feeling comfortable. They have the tools they need to execute the program successfully. Thanks for being here, guys. I think it helps us quite a bit just to know who to talk to. Talk to one of the bugaboos for all of us, which is go through your different companies' perspectives on NDAs. Do you want us to file our own IP before we come to you? How do you want us to label presentations? Sort of the bugaboo often in the past has been, oh, will that company take my idea? Or how do I protect an idea? Or all that sort of stuff. And so do you have different approaches? Has anybody standardized it? Is it only the lawyers who require the NDAs? The NDA, it's impossible to write one since all of you know everything in the field anyhow. And to really say that it wasn't already publicly known always seems to be a funny thing to sign off on. Talk to us a little bit about how we can make that whole process efficient and work well for you and work well for us. I would say as an industry representative, the intent would never be to steal an idea. It is that of an investigator of an institution. The NDA can be a useful tool upfront just to kind of let the groundwork be set that there are things that are gonna be disclosed that are not yet publicly known. In that case, then, you're protected, the company's protected, so that there can be a free conversation. I don't know if it's necessarily standardized across all businesses, but I think lawyers in the companies and in the institutions have a common interest of protecting their party. And in that case, we wanna be sincere in making sure that you feel protected, the idea is protected, and that we're not gonna walk away with the idea. Would you all want NDAs first? It would depend on the information, right? I mean, so there's some collaboration we wouldn't need an NDA, there's others. So it's, until you get into the detail, I think that's what you were referencing, and you start down that path, that's when those specifics come up. It's like, yeah, let's get an NDA in place for that, we may not need it for something else, and there may be some very simple ones that you say, we're all good, so. Yeah. Do you prefer the initial conversation before the NDA? Exactly. Correct. Do you prefer we file the IP before we come to you? I don't know, the timing of that, I think, is depending on, again, if it's investigator-initiated study, at least from our striker perspective, you own your data, it's your concept, you're bringing that to us, right? You have all the precedent of you coming up with that concept, idea, technique, product, whatever that may be, and bringing it to us. So that is all, again, laid out in our agreements of who owns what data, what are the IP rights, all of those things, we get all into the weeds with that, because that's really critical at the end of the day. So what we would say is, in that setting, what you're comfortable sharing, because you may want an NDA in place with us, right? So we, when we get further in those discussions, we bring in our development team, and we have a very stringent and effective process that we work through those types of agreements if it moves into more of a development discussion. But I wouldn't make a blanket statement that you need IP before you start the conversation. Much of it may not be IP-generating research, right? I think it's just to enter the conversation with some caution, that you don't wanna disclose too much up front if there's not protection already in place. Would you say that's basically part, sort of the case-by-case scenario, so you just discuss what it is and who we're talking to, and then come up with agreement, probably a lot of back and forth in that, right? Yeah. Okay, if I may, we should get a little bit back to our initial discussion about proposing a research to the industry. Would you be able to give us some ideas or even an example how to make appealing proposal to the industry, especially for the early investigators? Maybe on the flip side, you received these proposals in the past, and you wish you could sponsor it, but you couldn't, you would say that I wish this person had said X, Y, and Z, or had proposed this thing at another time point that would make it more appealing to you guys. Yeah. Yeah, I'll just start out. I think it's very similar to a NIH type of submission where you show some preliminary work that you've done, and shown success in this field, shown that you have passion in this field, and then show that it aligns with our strategic initiatives, especially if it's post-market, it could be a product that has been released within the last few years, and if it's certainly within your specific patient cohort from a clinical perspective, or if it's a key question that you have from a biomechanical perspective that you see clinically, that if you can insert that commentary within the application, that always piques our interest. I think having, for a new researcher who may not have the experience in design of a well-designed study, I think getting mentorship from others in terms of what would be expected is helpful. Learn from those in your institutions who are experienced. We're looking for studies that are well-designed, possibly powered, depending on what the endpoints are, and what's known already, but if it's an area that is fairly well-established, we are going to look for it to be well-designed, or appropriately powered, and controlled in a way that is meaningful, and the outcome is actually going to be generalizable. But it can start with a simple conversation over a cup of coffee. I mean, literally. It does not have to be a fully baked package of information that you're going to be submitting. So, like I said, a hallway conversation can turn into some significant research. And get it through the portal, right? Just go in there, and again, once you've kind of thought through that, you have a good concept of what you want to propose, you have the confines around it of what that study design is going to look like, you know, get it through the portal, because then that comes to our groups, and then we can start having that more formative discussion about bringing it to fruition. I think I want to say something about that, because I think that's a really good point that Colleen mentioned, because as soon as you put it through the portal, that starts a timeline, that starts to clock. That's true. When you talk to a rep, to a surgeon's mind, that starts to clock in their mind. We're in the dark. And so, the quicker you can get to the portal, the more accountability it does for us. So, overall, even though the proposal to industry sometimes doesn't have a rigid format, just like NIH or IEF, but you still present a good science in a clear way, right? Just like you would for applying for a federal or other grant. Is that kind of a fair summary? Yeah, okay. Less is more, just don't use chat GPT, and then we're good, yeah. I have one question. I find there's so much new technology coming out that you're all putting out, which is wonderful, and a lot of it involves, if it's patient-centered data collection in our office, and what we're finding on the backside, you know, a lot of physicians' offices are short-staffed right now. So, it's always a challenge. You have these wonderful new products coming out. I mean, I know some of the bracing that's coming out with the sensors inside. You can tell exactly when the patient's wearing them. You know, these kind of things are in the pipeline. SOS is one of the best products out there, but is there any thought from industry to help support us in the office, or having the reps help support that data collection? Because that's what's challenging, I think, from our part, when we are already short-staffed, and to ask your MA, hey, can you also ask the patient to do this? Or, you know, that's an issue. As short-staffed as you are, that's an issue. As short-staffed as you are, we are as well, with respect to, but, you know, again, the potential importance of that particular project, right? I mean, and if we're going to commit to doing something, we're gonna have to find a way to collaborate and support. But it will be based on the benefit back to the company. I don't want to be bashful about saying that. I mean, when we look at these opportunities, we're looking to see how that can impact and do something to benefit the company, not just to create research. I mean, we're not a philanthropic operation, but that data collecting and those kinds of things that are office-based is a difficult thing for both parties, in my opinion. And Dr. Edwards, one thing I would just layer in on that is, like, we recognize that challenge, and I do think having discussions with the folks on this panel and people from our teams is that we may be able to introduce tools to you that your team may not be aware of. There's a lot of innovation in this space. It's integrating with EMR, right, to take away that administrative burden, or things that flow directly to us, right? When you think about some of our technology, like Motion Sense, like, you know, these types of patient-directed type of healthcare solutions of how do we get data directly from a patient that either ingresses into our system or your system, because we're very sensitive to that. And that's one of the biggest burdens, like, let's be honest, is having the right team in place to help you collect all these data, especially if it's not standard of care. So how can we support you, give you the tools, get you introductions, and then at the end of the day, there may be a lot of opportunities where we also want that data, right? And we have systems that we can also partner and provide to you. So I think just understanding the scope and where your challenges are individually as an institution is a great place to start to dig in and see how we can support you more fully. I don't want to be a commercial, but just to put it out there, I'm volunteering with the ICRS, International Cartilage Regeneration and Joint Preservation Society, their registry. So it started as a surgical database for publications and whatnot, advancing surgeons' careers, that sort of thing. Well, hello, no, we're trying to co-recreate that so patients actually have access to the most optimal personalized interventions for them. Unfortunately, it's just the knee joint right now, but we are looking to add foot and ankle, and if anyone's willing to sponsor it, it's like $30,000 for us to put a new pathway in there. But we're not asking you to do that. I'm just putting that out there for industry, because we have all these case report forms and everything in there to go ahead and do this. It is a free registry. You do not even need to be a member of the ICRS to participate. It's for surgeons and it's for patients. We have the automated follow-up for your patients out to 10 years. Again, only for the knee surgery, but please know, I don't like the way it is right now. I don't want to do a disservice to the registry. It's great, it's been a good surgical database. You can get publications out there, but again, my goal, our goal on the steering committee right now is improving patient access. A lot of y'all aren't aware, I'm pretty certain, I know, Stryker, just from your comments and everything, you're completely aware of global access in getting the Ministries of Health, the reimbursers, EMA, everybody on board, there are joint clinical assessments, scientific clinical assessments. All those are including patient preferences and what we call patient experience dossiers. FDA is well aware of this. You don't want to just have patient-reported outcomes. You have to get the patient experience dossiers to get your implants, your procedures, your technologies approved. Then you need to get them reimbursed. So we're looking at it in terms of a health economics and outcomes research priority. We want patients to have access. We don't want one and done, investigator-initiated, you know, studies and that sort of thing that aren't ultimately going to get back to the patient. So please reach out to us. We're completely revamping the registry, adding in all the additional things so it's not just cartilage therapies. We're gonna be having all the extra options for osteotomy, not just clicking whether or not you've done one, not whether or not you've had a meniscal repair, a meniscectomy, meniscal allograft, whatnot, but all those additional options that could be those confounding variables so that we make sure there's health economics and outcomes research out there, including the patient preferences so the patients do get access. And then they also don't, like they have reimbursement for that access. It's global. We have 14 different languages. Please, like we're looking for y'all to go ahead and connect with us and to take it upon yourselves now within this next month before we've already put all these things in place to reach out and like let us know what your needs are. We're paying for this. And if anyone wants to help sponsor it, we're happy. And that was an excellent commercial. Yes. It was. I say the importance of registries, whether they're national registries or society-driven registries, the value of the registry data has gone up exponentially over the last few years. Thinking about global access for patients and global registration, each of these companies, I'm sure, have leveraged registry data significantly to support the registration requirements and then beyond. So yeah, I appreciate the commercial. I did too. But it's definitely an avenue that is beyond what we're talking about here in terms of a sponsored study or an investigator-initiated study or a collaborative study. This is another avenue where evidence is generated heavily. Yes, Kurt, please. We didn't wanna hear it. I know. I usually have a big enough mouth anyway. So registry data is fine, but that just gives you failure. And the future's patient-specific, patient-reported outcome measures, which are not handled in registries very well, no matter what registry it is, because it doesn't have, it can collect baseline, but it needs a designated follow-up at one time point. So what are the, and the second thing, and the second thing driving that is CMS, right? So CMS's requirements for total joints and CMS plans, their future is 25% of patient-reported, 25% of performance measures for hospitals will be patient-reported outcomes, which creates a massive problem. And the problem is follow-up. So how do we solve, how do we solve the follow-up when the patient is no longer in the office, they're not coming back at one year after a total joint? The literature is clear on that. So how do we create some mechanism by we get feedback at the point of maximum medical improvement, let's just say one year. I mean, how do we engage with industry or insurance or some way with the patients to say, you've got, I know you filled out a form of baseline, how can you help us at one year so we can see what works well and how well it works? I think we're working with registries around the world, and it depends on the healthcare system that that registry operates within. So in the U.S., like you've said, CMS will have requirements, CMS will have certain capture of their population, whereas a commercial payer won't have as good of capture of a patient in the long-term. But in certain healthcare systems around the world, that longitudinal data does exist, and there's the ability to push to get PROMs from patients. In the U.S., it is a significant challenge. I don't know of any registry in the world that has PROMs that are about set. We are working with registries to, in the U.K. is a good example. They are collecting PROMs from patients today, baseline as well as longitudinal after surgery. In the U.S., we're also working with the American Academy of Orthopedic Surgeons on the registries to ensure that the future will be more inclusive of that longer-term outcome. And I will say one thing, that if there was a positive to come out of the COVID experience, is that everybody's very familiar with using their phones now, and has access at UCS using QR codes all the time, and now we find all of our tools are sitting ePros, right? So they're sending it directly through apps to patients directly. It's popping up in a flag, it's sending them a reminder, filled this out, I'm gonna pop up again tomorrow. If you haven't filled it out, I'm gonna tell you one more time, fill it out. So hopefully, we're taking, again, the administrative burden off of the teams at your sites. Having to call the patients now, that's always the best way to get the highest follow-up, because we even know with even ePros, we're probably getting about 50% compliance, right? Patients are like, that's nice, flag this. I'm gonna go and see what's on Netflix. But at the same time, I think the more we can use those tools and try to get in front of the patient, have as many points of contact, the better to get compliance, right? Because at the end of the day, that's what we need is high follow-up. Yeah, not an easy thing to solve for sure, but it is something we are intent on supporting and helping to guide so that we can have value from the registries that hasn't been there historically. I love these discussion, guys. Thank you so much. So I did hear some advice, the portals, go on, you kind of fill in your idea. Number two, come to the meetings, right? Come to the meetings, build a relationship. So thank you for all of you guys for great advice. Can I share some light to our members? Really appreciate your time. Thank you. Oh. All right, that was awesome. Who wants to hang out? So now we're gonna move into act two of the workshop, which we're gonna pivot and we're gonna be hearing from four surgeons, the first of which is Dr. Edwards from UCSF. She takes care of the City College of San Francisco, a very accomplished sports medicine and shoulder surgeon. Dr. Edwards, thank you. Thank you so much. Thank you all for this opportunity and for Ben for asking me to be on the panel. Ben is our new chair at UCSF, as many of you know, so we are very proud of him. And I'm thrilled to be here with my Novus colleagues as well who've been very supportive on this. So this project, I'm gonna talk about a clinical project that we've started and just how that relationship evolved. It came from a mutual interest with the Novus marketing team. Matt Hebranek's one of my dear friends. He was an athletic trainer at Cal when I was a team physician at UC Berkeley. And so we worked together there. So it's been, what, over 12 years, Matt? He's done 13 years. And both of us at the time were living in the Bay Area and we saw issues with narcotic addiction daily. It's in your face when you live there. And if you watch Fox News, they talk about it as well. And then during that time, there was a great lecture in COS, Northern California Orthopedic Society, that showed that orthopedic surgeons are the third largest prescriber of opioids on the market. We're definitely the largest prescriber of unused opioids. So for the supply getting into our teenagers' systems really comes from us overprescribing. Patients maybe take two to eight pills after surgery. And then that medicine is left in the cabinet, grandma's cabinet, and it's accessible. Currently, about 130 Americans die per day from opioid overdose. It's increased since I've been a doctor. In 2010, there were about 16,000 overdose deaths a year. Now, 2022, almost 85,000 overdose deaths in the USA. So horrible. And for those of us who practice in these areas where it's endemic, and I think it's not just a San Francisco problem as much as Fox would like us to think. I've been seeing it around Denver. Obviously, Phoenix has problems. San Diego, wherever we're all from, we're seeing it. And the healthcare burden is huge. We see the cost related to hospitalization and treatment of opioid use is about $35 billion a year. I just finished a week of call at UCSF, and we at least get two or three calls a day from someone with septic arthritis. And I was telling our residents the other day, I said, you know, when I was a resident, I said my entire five years of residency, I was at Northwestern in Chicago, I saw two septic joints, and they were floor. They're like, I only need two, and we get like two or three a day. On a more personal impact, you know, I've been in situations. I had an office manager who was e-vaxxing prescriptions, surgery center administrator who was stealing prescription pads, writing narcs for herself, forging our doctor's names. The most clever one was a PA that was hired by one of the hospitals I worked at to manage our joint patients, the arthroplasty patients. Two weeks after their surgery, he would actually go physically to the patient's homes, say, hey, remember me? I'm here to take your narcotics back to the hospital for our prescription. I will have them destroyed at the hospital. He was taking them and selling them on the black market. So I've personally experienced all those things being a doctor for 20 years now. So anyway, Matt and I are having a conversation at one of these dinners at one of our meetings, just like Michael said, and a discussion over dinner. We know that about seven to 8% of rotator cuff patients become addicted to narcotics. So it is a big issue in our field, specifically with rotator cuff. It's the most painful surgery that we do. But I noticed that the patients that would have a cold therapy device, which again is not reimbursed by insurance. Most of the time it's cash pays. Not everyone can afford it. We're using much less narcotics and they weren't asking for refills at the same rate that the other patients were. And a lot of them would say, no, I feel great. I just use that ice machine at night and I feel good. And I'm not advertising for them. I'm just saying this was a fact I was noticing, but didn't really have any data on it. Around the same time, the No Pain Act was enacted by Congress. And for those of you who don't know, obviously the government is on top of this narcotic crisis and they're worried. So they have introduced that Medicare has to be responsible for any product that is shown to decrease narcotic use, decrease pain after surgery, has to be reimbursed by the government and by insurance companies as well. So this is a relatively new act, but if you have a paper that shows it, it will be reimbursed. So my goal in starting this project was to provide data so it will get the government and insurance companies to change. So then at UCSF, Ben really was the headliner as well as Jenny T who's now on faculty at the Mayo Clinic. Jenny T was one of our superstar residents and briefly faculty member who is a shoulder and trauma surgeon now at Mayo, but they did a study when she was a senior resident looking at just adding simple NSAIDs to the post-op regimen and it did that decrease narcotic use as well. And it showed that it did. It won the Near Award at the Shoulder and Elbow Society. So it was a very elegant, simple paper. So Ben and I have collaborated on this to build off that and that's our case control using those patients. So part of the process, again, was going through the approval arm with Inovus and they had a very rigorous, I was actually surprised at how rigorous it was. It took about nine to 12 months to get through it, looking at different rewrites of the project, but they had strict protocols and they made sure that the compliance was appropriate and it was vetted by their research arm, similar to Colleen, a similar person. My ask at that time was just for research support in the form of the cold therapy units. Would you donate free cold therapy units to the patients as we move through this project? And they also offered support for statistical analysis when the final data collection is done. They'll provide some money to help us do that. Luckily at UCSF, we have a very robust research arm so we have clinical research coordinators to help with this. So once the Inovus project had cleared, that took about 10 months, then it went through the UCSF IRB and approval from our grant committee as well because they were essentially offering us a grant for research in terms of the cold therapy units and the research support. So that was another eight months, I believe, of work trying to get that through. So my advice is if you're young and wanting to start one of these projects, be very patient as you go through it. It will happen, but it takes a while. So currently, we're almost done with data collection. Ben has definitely enrolled the most patients. One problem, Inovus wanted us to, unless it was just a cuff, and I'm a bicep killer, Ben's a bicep preserver, and so if they had a bicep tenodesis, they were not included in the studies. A lot of my patients couldn't get enrolled, but Ben has definitely been our champion in getting most of the patients enrolled. I do a quarterly check-in with Inovus where we review what data's been collected. Our goal is submission and publication this year. And then, again, globally, we just want this to guarantee payment of cold therapy units for all patients. I want everyone to be able to get one of these, not just the people that can afford it. Again, Inovus has been extremely supportive. I appreciate, and through all this, I've become really good friends with Dr. McBrayer, or at least I call him Dr. Michael McBrayer. He's been a wonderful supporter in the sports med world, and many of us have good relationships with him. And I appreciate Inovus, all they've done, and again, personally, they've sponsored the PAC-12 Sports Medicine Conference over the years. They've supported the Women's Forum for us. They continue to support fellowships across the country. And then, currently, Michael's helped sponsor the Women's Breakfast at the AACS, which we're starting this year. So, for those of you who form these relationships, they can be really meaningful and help you develop other ideas and support other of your projects and things that are dear to your heart as you move through. So, and San Francisco isn't all bad. I had to show some good pictures. So, you know, they wonder why we still live there. Well, this is why. It's amazing. All right, thank you. Thank you. All right, our next speaker is Jeff Nepple. He is an associate professor, co-director of the Young Adult Hip Service at Wash U. He specializes in pediatric and adolescent sports medicines, a prolific researcher in the hip preservation space and pediatric orthopedic space. Jeff, thanks for joining us. Okay, thank you. Thanks to AOSSM for organizing this great discussion today. I think we've all learned a lot already. So I think as surgeons, we all have different perspectives on this. I'll give you my experience in working with several companies over the years, and especially in multi-center research that these early industry partnerships have really driven success in extramural funding. Here are my disclosures. So I'll just start back at basics just a little bit. How I collaborate with research as a surgeon, alignment of our goals. We heard about this already a little bit. What do these optimal collaborations look like, and then my experience over the years. So we all are here to improve clinical care. That's why we're doing research. But at the end of the day, research has become more and more expensive. Institutions aren't providing as much funding for us to do this. Extramural funding has become more and more elusive. So there are major barriers to doing the research we really need to drive high-level evidence that we are really missing a lot of areas of sports medicine. Our goals of research and our responsibilities are to produce accurate research that minimizes bias. This is interpretation and confirmation bias that the view of your results, where you're coming from, certainly can influence your interpretation of that. Reporting, certainly negative studies, as was discussed a little bit earlier, is important as well. And ultimately, we want to arrive at research that can improve the clinical care of our patients. There are major barriers to performing research in modern times. Efforts, the bureaucracy of working through IRBs and DUAs, equipment, startup costs can be prohibitive in some cases to really get to the level of extramural funding. You have to have a lot of this stuff in place and some of the research almost done to be competitive. Our goals of collaborating with research are to foster this research and really improve what we can do. But at the same time, we need to minimize conflict, have independence in reporting, transparency in surgeon relationships, as well as transparency in institutional support. So basic scenario, surgeon X wants to investigate treatment Y that comes from industry Z, simple things. But there can be problems along the way. So what if? What if the agreement falls through? Does this influence surgeon X's use of this equipment from industry? What if we find negative results? Is this published and how does that influence that relationship as well? And then what if surgeon X switches his treatment and he thinks he has a better option? Where does this go with future funding with that company and ongoing efforts? So there really need to be efforts to minimize this along the way. Future research, I think, is one way that can minimize some of these potential conflicts. It dilutes the linkage between clinical utilization and research funding. It gives us higher levels of evidence to maximize general liability and probably minimize some of that bias, and this comes in the form of unrestricted funding. My experience in Anchor, we really have used industry funding to drive major research efforts and to then move on to extramural funding that in some cases magnifies startup funding by 50 times and really drives the research with small investments from industry. So multicenter research with industry, we can find common ground where we need to advance sports medicine care and evidence. Critical funds and startup can really be important for driving these efforts down the way. This positions you for extramural funding, and that allows you to really do these large studies for years to come. So Anchor's been going for almost 20 years, has enrolled over 4,000 patients in several prospective cohort studies and a recent RCT, and I think of this in sort of the early years where startup was key with industry and then the later years where startups of specific research questions have driven success. So early Anchor funding came from a variety of places, NFL charities, Hip Dysplasia Institute, Grateful Patients, but also industry sponsors including Smith & Nephew and Pivot at the time that became Stryker, and that included funds for research but also innovative tools like software. Smith & Nephew allowed us to utilize early CT software that came about about a decade ago that really drove, I think, the hip preservation field in a positive way and continues to be a part of how we think about hip surgery going forward. So a couple examples of specific studies. Our FAI-2 study in Anchor was almost 1,000 patients, enrolled across 20 surgeons at 12 centers, and this really utilized some of that focus on three-dimensional imaging that had come about in the years prior. We obtained early funding from Zimmer to help get this off the ground and get pilot data, and that sort of fostered successful extramural funding of over $2 million from small investments in the end that really have driven that forward and will allow us to have powerful evidence in this topic in the future. A second example is our Borderline Dysplasia study, another controversy in the hip preservation realm. We now call this ORBIT, investigating hip arthroscopy surgery compared to osteotomy surgery in this population. We had early startup funds from Stryker that really helped to get us organized and put us in a great spot going forward, and then we're able to turn that into extramural funding from AOSSM and OREF with the help of Aircast to drive this study to completion in the years to come. So overall, my perspective, industry collaboration has really been key and mutually beneficial to drive sports medicine research for years to come, but it's really important to have awareness of these potential conflicts and really work to structure this research in ways that's going to minimize those potential issues down the road. These collaborations and multi-center research can really work well, I think, and minimize this conflict. It positions us in sports medicine to obtain more extramural funding, which is often a much higher magnitude than the startup funds, and it hopefully maximizes our research quality and evidence in the years to come. Thank you. All right, we're not going to have Alvin introduce himself, so I'll introduce Alvin, my partner in crime here for this workshop. Alvin's an associate professor of orthopedic surgery at Thomas Jefferson University. He's got a broad research portfolio that focuses heavily on basic science and transitional science. He's a former AOSSM Young Investigator Grant Award winner and also has grant funding both through POSN and NIH. Take it away, Alvin. Thank you. It's a lot of stress to give a talk after Sarah and Jeff, who had a long track record of success working with industry and in research. I guess my job today is to switch gears to more like early, mid-career investigators proposing a usually conceived as a less favored kind of basic science project. I wanted to show you that it's still possible to work with industry and to reach some success in there. Okay, so I don't have a video of Taylor Swift in my slides, but I have a knee in there. Even though I do pediatric sports medicine, I do see a lot of teenagers coming in with these kind of bad alignment and bad OCD lesions, or if you call it the osteocondrial defect. So from time to time, I do have to do these type of big osteocondrial fresh allograft transplantation. And more often than not, for the kind of shallow lesion in there, either it's microfracture or maybe to entertain options like ACL or MACI. So that's definitely an important part of my practice. So as you all know, that fresh OC graft is the ideal graft because it has the native structure biomechanically, have a superficial zone, middle zone, deep zone of the cartilage, and it also does have the biology of native cartilage with all these collagen type 2, PRG4, and so on and so forth. But the problem is there's uncertain wait time to wait for a fresh graft. And once you get a graft, the preservation time is two to three weeks, going to scramble with over time with the patient and yourself and to get them in there. So there's a lot of kind of hustle bustle in there. Now on the other option for a cell-based therapy like the ACI family or MACI, even though in the literature there's good short and midterm outcomes in there, and it's definitely better than microfracture if you kind of read those literature. But then the problem is from a basic science standpoint, if we look at the structure and also the biology of that, it's actually just an upgraded version of microfracture because it doesn't have its own structure. It also does not have enough collagen type 2 and does not secrete enough level of PRG4. So from a science standpoint, it's still not an ideal substitute when you have a true cartilage full-thickness lesion in there. So that prompted the idea, actually I'm not the first one, should not be the last one as well, in trying to bioengineer a functional cartilage construct that is biomechanically and biologically both kind of competent. So to do that, we need to kind of engineer the superficial zone and deep zone cells and middle zone cells as well. We applied to the AOSSM-YIG grant and luckily got it approved. And so we were able to achieve some early success in engineering these cells in there and we published our results in A2ESM this year. But at the same time as we conduct these research, we found out some other problems we didn't foresee before. As in all the basic science or say translational science studies, there's always a lot of kind of new problems. When you solve one, you get 10 more. So the main problem here, one of the main problem is that we don't have enough population of superficial zone cells in there and we need to find a way to mitigate that. That problem is also published in the same paper in there. So the original plan is once we get enough success, going to use the data to apply for extramural grants and something like federal level and our grant or DOD grant in there. But we need to move the lever more so from the bench side to the bedside a bit more before we feel like we are strong enough to go for that kind of grant. So how do we bridge it over there? I mean, this is still the early phase of translation. It's definitely still far away from being a usable product clinically or say in the industry or on the market. So how do we mitigate this and how can we bridge it over to that market in there so we can apply for a kind of bigger chunk of grant in there? So we actually have a plan. We know how to. We have a plan to solve this problem of the superficial zone cells in there. And we think that we're going to be successful, but we just need somebody to support this. And we used up that seed grant from AOSSM already. So what's next? And we're out of the grant cycle for a lot of other seed grants in there. So that's where I started to think maybe I should kind of look for other sources for support and that's where the conversation actually started. And so I talked to some of our kind of industry partners and it landed with JRF Ortho. As you are familiar, this is one of the, say, two or three main kind of the grant companies that supports allografts and tendons and so on and so forth. And they also like to support researchers like all our industry partners in here. So we connected with David Wilkie, their kind of sales VP, and also overseas research activities. And from there we had a lot of meetings, actually not a lot, probably three or four key meetings with Keith Byers, their CEO, and Mike, their kind of financial VP, together with my collaborator in the University of Delaware. And then we kind of reached an agreement of how this can move forward. So because this project actually is in the area, the domain of the allografts, it's a lined up, lines up well with the main trajectory of the company. And also we have some past positive history of working together because I used allograft to do the patient's cases. So we kind of knew each other from that perspective in the past. And mainly the support from them is used for several things, lab supplies, and use of the core facilities in the research lab, and also to pay for the working salary for a PhD student who is mainly working with us on this project. And this is outside of the AOSSM, JRF, combined grants. This is something that we kind of work together with JRF directly. And so why using the industry, what's the ins and outs? I would say that the industry support sometimes can have more flexibility, I mean, in terms of who's eligible. Like you know, certain grants out there may limit to new investigators. You cannot be out of the fellowship more than four years. You cannot be something more than assistant professor. Or you need to be a full professor to do this and that, and so is the budget and progress report can be more rigid in many kind of ways. And not to say that industry is just whatever you can do, but also I think there's more room for so-called negotiation or to discuss about who's eligible, who can apply, and what kind of scope of research you can do as long as it lines up with the company's main trajectory of development. And also in this particular case in JRF, they supply some tissues, right? So it's actually probably more like a win-win situation where they can supply the tissues when you do research with a lower cost or a very low cost to them. And for us, it can be a huge boost of what we are trying to do in terms of research. Now on the flip side, we're going to talk about, think about, we actually discussed about this in the prior session for some calls in the publication and maybe licensing when we talk about more sensitive stuff like the IP thing. And this is actually part of the agreement negotiation. And then we heard from industry partners and so is JRF that they actually encourage publication. But there's sometimes an agreement that's where you need to involve kind of a review from both ends, from our end and from their end to make sure we reach agreement that who gets control of what can be published or not, or if you need to give them a lot of time for them to review your manuscript even though they may not have the final say. But it will be a good gesture and a good courtesy to involve both ends for everything that you do in there. Licensing is the same way. Now the last thing is that often get the comment that if you work with industry a lot, you will become the industry guide and what you say to kind of be degraded and not to be trustworthy. We discussed about this in a prior session as well. I think as long as the science is good, everything is well disclosed. And maybe off the table, I think it ties a little bit to how your research team and you are or maybe the institution is as a researcher in the track record. I don't think people will kind of disqualify you just because you use some of the industry kind of support. As you see the examples from Sarah and Jeff, they are still very well respected and recognized researchers in our field. So there's an interplay between the industry and then in my case, it's not just a university but also the practice I'm in. So it's a three-way thing. It involves a lot of review and negotiation. But it can be done. It just needs a lot of good, direct communications, what you want to do, what they want, and make sure we reach a common ground that we all are kind of happy with. Now several points if I were allowed to share that from my limited experience since here, I think one key thing is just like you would apply for a NIH grant or an IEF grant, AOSS grant, PASNA grant, you probably won't get a yes at the first attempt and actually probably get five rejections or ten before you get one accepted, right? So same for the industry. Sometimes just don't give up and a no doesn't mean that you think things are bad. Maybe it is so you can review your science, see if there's major flaws in there. But also, it can also just be this is now what lines up with what this company is aiming to do in their strategy, strategic plan in the coming two to three years. Maybe it's just a bad timing. You're just not catching on the right timing. So just believe in your ideas and keep improving your ideas and just keep trying. If this doesn't work out, maybe you can try to talk to another partner in there. And also, when you reach out, I think that sometimes there's a VP who oversees the research. Sometimes there's not. But it may be beneficial to talk to just like they alluded to, talk to salesperson or sales supervisor so you know what a company's next year's strategy is. Then you can find out the kind of line up your research to the company that works with you better in that way. It's basically an expanding of existing relationships. A lot of us had a lot of kind of professional relationships with the reps in OR or in the clinic, right? So if you reach out to a company from out of the blue, you've never worked with them before. Believe it or not, when I talk to my industry partners, they actually receive those proposals from a surgeon they've never worked with before. And then that kind of quench up their enthusiasm to talk to them, as opposed to if there's a surgeon they know has been working with them in the past in a professional kind of environment before. So maybe reach out to the company you know you've worked with before would be a good bet to start with. And last thing is just to try to put yourself in the company's shoes and think about it. And the proposals, they can benefit both sides and not just kind of our surgeons. That's, I think, my kind of points to share in here. So by working together with my collaborator in the university and myself in the industry, we're able to actually achieve some good results. It's still underway, but we're able to move the lever more so toward the best side application, a little bit step closer to that. And so I think that with working with industry, it does give us much more resource and leverage to make us to be on a better stage to pursue the next step of research. That's all I have today. Thank you. Thanks, Alvin. And our last surgeon that's going to be talking to us about his experience is Dr. Brian Werner. He's an associate professor of orthopedic surgery at the University of Virginia, head team physician for James Madison, prolific, prolific researcher. Brian, thanks so much for joining us. Thanks so much for having me. And I really appreciate you guys putting this session on. I, again, am probably one of the younger people up here as well, you know, only start my ninth year of practice. And I wish I had something like this 10 years ago or 15 years ago to know how these things were done. At least one of my slides is going to disappoint Cohen a little bit when he finds out, you know, how I started interacting with industries. So we'll go first here. And some of these things are going to be a little bit repetitive. When you have a last name that starts with a W, you tend to be at the end of most sessions, and I've gotten used to that over time. And so, you know, for the need to partner with industry, I started an academic practice. I certainly have a lot of my co-fellows that went into private practices or hospital types of practices. But even early on in residency, I really wanted to do research. And so I really wanted to be part of an academic institution. The challenge when I got into an academic institution is I found that it's not as easy as it looks. And there were really a lot of limited resources at my institution. We still do not collect patient-reported outcomes on a routine basis, despite 10 years of effort on my part to do so. And so, you know, just because you go to an academic institution, you think everything's going to work perfect and research is going to be easy. It's not. I then wanted to do research and needed funding, and I had a little bit of a startup package that had some money, but that disappeared pretty quickly. And so I started looking for federal and society grant funding. The problem is I'm a shoulder surgeon. Most of my practice is shoulder surgery, and there's really not a lot of NIH funding going into shoulder surgeries. That made it a little bit hard, too. I also found that over time, there's been a shrinking pool of collaborators, and so I have less and less people that want to do research with me. And so some of these are all the reasons why I wanted to reach out to industry. I thought there might be some better opportunities for a young or, you know, growing surgeon to be able to get funding to look at ideas, but also was looking for a group of like-minded people that wanted to innovate and move science forward and that weren't focused on just doing more RVUs and generating more clinical dollars. And so industry has a need to work with surgeons also. I mean, so industry has a lot of good ideas. A lot of my research that I've done with industry has been proposed to me by industry, but also surgeons have good ideas. And one of the things that, you know, I do a lot of work with Arthrex, and one of the things that I was really excited about is that they were willing to listen to ideas from a surgeon who was only two or three years into practice. And so if there's people in the room or people that you have that you mentor that are young in practice, it doesn't mean that you don't have good ideas and that industry won't listen to you about those ideas. Surgeons also have clinical experience, and so I think one of the biggest things that we can bring to industry in addition to ideas are that we can bring our own clinical experience, the clinical problems that we see day to day, and we also bring them patients. And so if we do a lot of surgery, have access to a lot of patients, that's really helpful. We've discussed some of the pros and cons of working with industry. You know, the pros are obvious. We have similar goals, and I think it's really helpful. Each of the partners were talking about how they can put their strategic goals and strategic initiatives on their website. I didn't even know there was a research website for any of the different industry partners when I started looking for someone to partner with. And there's also more efficiency. UVA is possibly the most inefficient institution on earth, and so it becomes very challenging, and I end up being the rate-limiting step on almost every single clinical project that I've done with industry. And so I enjoy the efficiency, and not saying that industry is particularly efficient either, but they're way more efficient than UVA are. They're also much better to, they have a much better ability to scale different projects, and so we're able to generate other sites and work with other sites and able to coordinate with other sites much better than UVA. One of the biggest cons, I know we talked a little bit about perceived bias, and I want to mention that because, you know, I had a number of senior kind of partners when I started who basically told me there was no way I was allowed to get industry funding. They said it's not okay. If you're going to be an academic surgeon, you can't have a single disclosure listed. You cannot get funding from industry because you won't be able to publish. And so I've spent the last nine years really trying to prove that wrong a little bit and say, you know what, there's a partnership that can be done as long as we're disclosing this relationship. I honestly can probably accomplish as much, if not more, as an early investigator than I could have if I hadn't had these relationships. And so I found to be really important, and my more senior partners have begrudgingly accepted that over time. There's also a lot of resistance from my institution. For promotion purposes, our institution only recognizes federal funding for promotion. And so my grant funding for my promotions, when I go up, and I don't really care that much about promotion, it happens anyway, is my grant funding is $0 according to my institution despite having a lot more funding than that. So how did I find my industry partner? I came out into practice. I was very excited about research. I had done a lot of research as a resident, a fellow. I had a lot of cool ideas that I thought were going to be fantastic, but I had absolutely no one who would listen to me. And so I had a bunch of ideas, and I actually went around to a couple of different industry partners. And the common response that I got is someone who was two or three years into practice is like, we're working with Surgeon X or Surgeon Y who's 15 or 20 years into practice. Come back to us in 10 years. So that's fine. I'm going to keep seeking other partners so I can find someone who's interested in what I'm doing. Against what Cohen said, probably wasn't the best idea. I didn't know there was a website, so I didn't know really how to get involved. So this is my rep. He started on the same day that I did. We were not using a single Arthrex product at the time at UVA. I had a senior partner who would not allow us to use them, but I had learned in fellowship to use them. I said, you know, what about your company? Is there any opportunities there? He said, I have absolutely no idea. So I have no idea if there's opportunities for research, but what I can do is put you in front of some people that might listen to you. And so he brought me down there. I didn't want to make any changes clinically to what I was doing, but I was looking for partners to do research. And within probably six months, I had gotten in front of some of these other people, Cohen being one of them, and said, you know what, we're starting to do some more research here, particularly in the shoulder space. We know that you're energetic. Show us what you've got. Here's some opportunities, and see what you can do with those type of opportunities, and see how that — how we can mutually beneficial — how we can be mutually beneficial to each other. And so, Cohen mentioned this already, but I wanted to dig into it a little deeper. And I recognize this is a sports meeting, but I did a shoulder arthroplasty ICL, and there were people standing outside in the hallway. There were so many there. So, sports surgeons do shoulder arthroplasty also, but I think this is a really good kind of indication of what you can do with industry. And so, I remember my first time coming to a meeting. It was not the SHARC group yet. It was just a couple of surgeons in the room talking about a registry that they had that they had published a few papers out of, and it was exciting. They're starting to build more patients. And then out of this was born the shoulder arthroplasty research committee, and I think this is a really unique thing. A lot of companies have, you know, registries, but they don't necessarily have the groups to help decide what to do with those. A lot of companies have a lot of surgeons who are interested in research, but they're doing, you know, individual type of projects here and there based on initiatives. So, I've really liked the idea of getting an entire group of like-minded surgeons together. And so, that picture is probably a year or two old down there, but we have close to 30 surgeons who are all very like-minded, interested in research, and want to contribute to research and expand the field of shoulder arthroplasty. And so, we have a lot of meetings where we have two in person and two virtual each year to really keep driving the science forward a little bit. And so, Coad had mentioned some of the other things there. When I first started with the group, we probably had five to 10 publications, and now, you know, over the last five years, 70-plus publications out of this group, and it's not just from the registry. This includes biomechanical research studies, clinical studies, all different types of things, not just registry patients. One of the things that I've really liked that the research team has put together is this dashboard that shows all the surgeons who are members of the group, every single project that's active, and that helps spawn new ideas, but also helps get younger surgeons or other surgeons who don't know how to get involved involved. And so, instead of just showing one project, it's better to, I think, show 70 or 80 projects that have been born out of a single idea. We've also started branding ourselves a little bit, and you can see now that's one of our recent JSCS publications where we started including our research group as an author on those papers. And so, instead of just showing one of the studies that we've done, I think it's really beneficial to show how just a single idea and a group, an industry partner who's very excited about doing research and wants to drive science forward, bringing a bunch of surgeons together who I otherwise would have never met or just seen occasionally at meetings, and all of a sudden, we have 70 publications and 150 active projects that we continue to work on. And so, we're also expanding this to other areas also. So, this is just for shoulder arthroplasty. We're starting a knee registry now as well. And so, this builds on some of these other registries by including patient-reported outcomes, range of motion measurements, which obviously takes a commitment on the surgeon side, but a big commitment on the industry side to help fund that so that we can get good outcome measures. And so, my take-home message is that research collaborations between surgeons and industries is very important. It helps us explore new ideas, helps develop long-term relationships. You know, I have great relationships with industry partners, but also with all the surgeons and support staff and the engineers and everyone else that I've met along the way, and they're incredibly beneficial and allows us to innovate together. The other thing that I'd offer is that there's a lot of potential for collaborations for any surgeon. Say, half of our group are private practice surgeons who are not working at academic institutions, and so it helps them get work and do the research that they want to do without not maybe having a university behind them. I'd argue that they're actually probably more efficient than me at accomplishing research. I tend to slow things down a little bit. So, thank you very much. That was awesome, Brian. Thanks for your candor. So, at this time, we'll move right into Section 3, so I'd like to invite our industry partners back up, and then we've also got Dr. Kurt Spindler, past president of AOSSM, who's joining us as the roving moderator. He's going to be walking around with a microphone. Please find him, and we'll continue the panel discussion. So, maybe I'll just start it off and say, so really what I heard was from both the investigators and industry is find the win-win, minimize the biases, disclose what you're doing, and you can help patients and come up with some good results. Would you agree with that? Okay, we're good. Careful. You know, in my, for full disclosure for me, I mean, we, both Moon had initial funding money from Smith and Nephew, NFL charities. Mars had initial funding money from Smith and Nephew before any of the current people were there. We're talking now early 2000s, and so early on, those were critical to getting to ongoing, and since then, Moon and Mars have had about $25 million of NIH money. Does any individual company benefit directly from it? Probably not, but the field benefits, because where else can you say you have, you know, 85% excellent outcomes at 10 years, and then even if you're an experienced researcher in a study we're doing on Bear Moon, everyone knows that bracing is a problem, right? Because if you insure, everyone has no problems getting braces insured, right? Simple process, right? Well, think about if you're doing a study where bracing is important, and you need two braces on the same patient over time. You know that's going to be a disaster. It's going to be impossible, so either you got to get the NIH to pay for it, or you have to get a in-kind donation from a company. And so, we got an in-kind donation from Inova's for that, or it could have been another company, so industry can play a really important role involved in helping out, and it can enhance the studies you're doing. It can even enhance highly paid-for NIH studies. You just have to find the sweet spot and the disclosures, right? So what are the challenges that people need to be aware of? I think industry knows it well, but what are the challenges from the young investigators that you had in the beginning with making relationships with industry? Let's talk contracting. Let's just put it that way. Brian. Jeff. Oh, I'm happy to complain about it. Yeah. So coming from an academic institution, you know, with a lot of state restrictions, accepting any sort of funding from industry comes with a list of disclosures that I have to disclose to the state. I have to disclose it to the university. And then if I use that product in my clinical practice, I'm not allowed to do research on it. And so if it's a product that I believe in, that's the whole reason I'm reaching out to the company. For me to be a principal investigator on a study involving that product, it's like I'm coercing the patient into using that product. And so that's been a huge hurdle to try. Every single clinical study that I've done with an industry partner, it probably takes me months of writing paperwork and appealing and asking for permission and saying, I use this already, including finding other PIs to cover me as someone who will review the data afterwards. And so while we've been successful in doing it, academic institutions make it very challenging. I think it's for the benefit of the patient to obviously make sure that there's nothing bad going on, but there's a tremendous number of hurdles to jump through in order to accomplish it. That being said, it can still be very beneficial. I don't want to sound like I'm complaining too much. You made me feel better about UCSF right there. Yeah, I guess a degree. I think we haven't had maybe that many hurdles in St. Louis. It's certainly higher than other grant funding. When you're investigating a topic not specific to an implant, I think some of those barriers are removed. That we're looking at a surgery, not just one company's implant, I think removes some of the level of scrutiny from many of our academic institutions. Jeff, follow-up question. The slide you showed about Orbit and the pathway that you took to have Stryker support that, can you talk to the investigators in terms of the nuts and bolts of how that conversation went down, how you pitched it, how you pitched the potential value to Stryker? How did you tease their interest and ultimately execute that arrangement? Yeah, I think that's a key issue. I think industry, just like us, wants to know what the big controversies are. What are these key questions that if we can move along a pathway to get better evidence that we're going to improve patient care? It's finding that common ground, that question that they thought was important, too. I think for industry, startup funds are viewed differently than doing this whole project, so that getting some startup funds and seeing that as a pathway to doing probably a multimillion dollar study is good from their perspective that five years later, they hopefully see what those early efforts turned into. I would say from my perspective, because I work at a non-profit, a children's hospital, but also involved in research itself. The research itself involved at university as well, which I have a joint appointment at. It's basically a multi-way communication with the company, and then the university, and my institution. Each party has their own things they want to be in the agreement, and things they don't want to be in the agreement. There's a lot of back and forth, and it's kind of time-consuming, but eventually, it can get done. It's just like the IRB thing. It takes a lot of effort, and back and forth, and frustration, but I think this is really what you want to do, and then it persists to the end. It can be done. It is a process. Now, the second thing is that the beauty of doing basic science, and then the flip side is that sometimes, maybe certain industry partners are not that interested in basic science, but if they do, the beauty is usually this is a little bit more far away from the sensitive kind of IP or royalty issues in there. This is not the only project I have been seeking industry partnership, so I can say that when it comes to that IP thing, especially involve multiple parties, like in my case, university have their own rules, and my hospital has my own rules, and the industry have their own interests to look into, so that can be a very long process as well. The last thing I would like to mention, as silly as it sounds, that's why I ask the question because I'm not the only one who had a question. How do I start? How do I reach out? And I know there's portals, but sometimes, you can get stuck even just trying to reach the portals, and there are times you just don't know whom to talk to, so it may take a little while before you can reach the right person, and I think if there's a clear instructions of say the portal got stuck, and who can you reach out to, that will be probably better for the so-called young investigators who don't have that much resources or connections to the company, and they can get an easier head start that way. Question in the back? Good afternoon. I guess it's now, but my name is John. I'm the chair at the University of Arizona. I just wanted to thank the panel. Many of us got our start doing corporate-sponsored research at our institutions. None of us actually say thank you afterwards. I think that one of the great lagging indicators, riffing off of what Dr. Vedek, am I saying your name right? It's Cohen. Cohen. What Cohen said is one great lagging indicator is how much actual federal funding came to a surgeon who started out, I started out doing lots of projects with corporate sponsorship, and I think that that would be an interesting lagging indicator to monitor in orthopedics, especially with industry partners that are, or corporate partners I think is the word that we're supposed to use, corporate partners that are investing so much. Do we actually get in the air with federal funding later? That's a measure. The other thing I did want to say in regards to what Brian said was every institution has a set of itches that you have to scratch to get one of these off the ground. Unfortunately for us, each institution's itches are different than the others. State institutions like my own and Brian's have a certain set of itches, and his are probably different than mine. One of the things I have found as a now not so young faculty member is helpful is getting involved a little bit with the IRB. They're easier on you if you're one of them, and yes, it's a meeting a month, but I've seen a lot of my corporate sponsored work go much more easily the more I'm willing to actually feed the sharks, as it were, with a little of my time. It's something that's helped me, and for the young faculty in the room, I think it can be helpful in getting your plane in the air, as it were. Question for you? This panel is too important not to make an ask of, so I'm going to try to frame the ask in a way that motivates you to do something for us. The other elephant in the room for all of us is proms. Patients hate filling them out. There are too many of them. They get prom fatigue by the end. We don't have a way of requiring them to do it, yet it's critical for all of you and every one of your studies. So here's my request. All of the missing part of this panel are the EMR companies, because all of them right now are required to put in proms at the pre-op visit in order for them to get reimbursement, for everybody to get reimbursement later. They're not required to put in the one-year outcome prom, and there's no standardization of what the proms are. So here's my request. Could you come together, could you get the EMR companies, 50% of Americans have an EPIC EMR right now. Could you decide on a standardization of which proms for which problems? Could you design an AI program so that every time you ask a patient, do you have pain going upstairs? And you ask them four different times in one form, in a different form, in a different form, the AI simply finds the same answer and puts it across the form so we simplify this process. And could you agree with those companies on what is the gating item that forces the patient to fill it out at whatever intervals you want, three months, six months, one year? And that gating item could be, since you're working in the EMRs, that the patient, you know, the next doctor or the next patient visitor, the next whatever, the gating item is the EMR doesn't move to the next question without the proms being checked off. So there's a solution to this problem that we all have. Too many proms, too many questions, too much diversity, no requirement to fill them out. But you guys have got the creativity and power to solve that. And I think if you could get together with EMR companies right now, it's a really great moment to do that. Okay? That's my request. But it's a legitimate, I think we recognize, and even in our data collection initiatives, you know, it's like alphabet soup. We have a lot of different things. of surgeons have a preference, right, for different subscores or different, you know, different PROMs. Or if we're global, you know, we look OUS, they have preferred outcome measures that they're also leveraging. So it is absolutely a challenge and I think something we should be focusing on and trying to find more synergy and streamlining. You can go to the PROMs website of the Academy, AOS, and I have to disclose I'm the co-chair of that committee. But a lot of those, for total joints, it's been decided on by CMS. Right, so it's a who's junior, who's junior. It's some sort of global measure, whether it's a VR-12 or PROMIS-10. And there's some critical questions, some other additional questions. That's been decided on. But the critical thing is we don't have the ability of the patient engagement to fill it out at one year involved in doing that. And that is a problem. So the other thing, you know, we have a database at Cleveland Clinic that I started 15 years ago. We have about 3,000 orthopedic prospective cases put in and we have 70% follow-up at one year. But that is not a passive system. It's an active system. The passive system of electronic triggers through MyCharts, through EMR, through texting, through email gets you anywhere between 20% and 40%. And if you want to get higher than that, it requires phone calls. Question in the back. Just a comment. I'd like to kind of reiterate the comment previously on trying to get someone. And I'll just say it. In a department orthopedics, you should have someone who is on that IRB. It doesn't need to be a junior faculty member. A senior faculty member is ideal because it's a lot easier for Ben to prepare for that meeting and be there than it is for the junior faculty member who might have to run around and try and track somebody down and get info. But to have a representative from your department can dramatically facilitate a lot of the issues. And a lot of times, some institutions have, you know, gone back to the old idea of your butt needs to come and appear. And a lot of faculty hate that thought. I shouldn't have to do that. I can zoom in. Well, you can zoom in, but it's still not the same as being at the meeting. And showing up at that meeting and being able to answer the questions and having give and take, you can facilitate a lot of problems and minimize a lot of back and forth. And just wanted to reiterate that. Thanks. Yeah. That's great advice. I actually was in the IRB committee at UCSF for about, you know, eight years. I really let the whole department's protocol go through because you have someone who can know the structure, what they're looking for. So great advice. Thank you. Just real quick. So the focus can't really be on standardizing what those clinical outcome assessments and PROs are going to be because that is going to be different. Industry knows this. When you go to FDA, like, you can negotiate with that. We're trying to get novel biomarkers and all that, activity markers, all that. Like, you know, we want patient-generated health data. That's negotiated per industry, per product with FDA or whichever regulator they're going to. So the focus needs to be on automating the data transfer from your personal EMR systems or EHRs and the imaging, you know, getting all those data linkages to whichever database you're going to be using for that data, for analyzing it and that sort of thing, which is why we've come up with this registry network and we're trying to create the community hubs. And your focus also needs to be really who that person at your site, your practice, your institution is going to be to be engaging with the patients. Because I know I've participated in some of the projects here as a patient too, and I've had friends and family members participate, and they won't return because of the interaction with the coordinators or the PA or whoever it is at these particular sites. And also, as wonderful as your surgery may be, again, the focus is on the data transfer, automating that, and who is interacting with the patients. As great as you are and as great as your surgery may be, your site staff may completely muck up your follow-up with patients. So I would focus on that, and just another commercial plug, we're paying someone to do this. It needs to be personalized. Emails they can ignore if they prefer chats or WhatsApp, phone calls, that sort of thing. It needs to be personalized what that follow-up is, and it needs to be done annually and whatnot. But I really would focus on your staff, who that is, make sure they're getting, you know, communication training, that sort of thing, on the patient engagement to receive that follow-up, and then also just the data transfer. And so all this is being done. I'm so sorry you all aren't aware of these things, but I mean, with these federated data sets and academy and everything, we're working on this through Odyssey. It's just, do you want to work with data scientists and data analysts for the common data models and all to make sure that this can be used by the regulators, or, you know, it's just you have to take the initiative to do it. But all this is being done. It's just, please, you know, like, ask these questions and get out there and get involved. Okay. Thank you. Well, I think that... No, no, wait. I think that Lynette has a question. That's what I think, and now I know it. Now you know. So, I asked this at one of our board meetings earlier when we had some industry folks with us. So, for our industry partners, if there's one thing that you wish all of our surgeon scientists knew about collaborating with industry, what would the one thing be? Start with Michael. Okay, starting with Michael. The one thing I'd like every surgeon to know is that these industry partners are approachable. We have open access. I think there's a perception in some cases that there's a barrier in some cases. Now, the barrier that an institution has with somebody trying to create an opportunity with industry, but we're an open door to the discussion. That door may not turn into something, but the discussion can happen every day. So, that's my one. Yeah, I'll say that we're pragmatic. Keep it simple. Matt. I think in terms of process, I think just knowing that the intent on both sides, the intent on the industry side and on the physician side, is to move the project along as quickly as possible. Process gets in the way. Regulations sometimes get in the way, but the intent is to move fast. Colleen. And I would agree with that. I think, you know, what I would just recommend is appreciating that there's going to be effort on both sides. It's a lot of work to do a study the right way. And that, again, it's a village. It's a team effort here. And I think, you know, others have mentioned it here. It's like, you know, not just the surgeon, not just their direct industry partner, but the team around them that drives success for these partnerships. So, coming in with that expectation of contributing equally and, you know, we really need that all along the way for us to get to the finish line. I have to turn this on. On that note, thank you very much for all your participation. This is a great session. Learned a lot. Hopefully, you know, I think, Lynette, we're going to summarize, you know, some of the key points we shared with all the membership, too. So, thank you so much. Yeah. Thank you.

research workshop

Benjamin Ma

collaboration

industry partners

federal funding

NIH

DOD

peer-reviewed publications

orthopedic surgeons

Arthrex

biomechanics

clinical research

industry partnerships

high-quality data

operational excellence