A viewpoint from MedTech industry expert Fred Gunderman
Fred Gunderman, Senior Vice President USA at Balt, a world leader in designing and manufacturing physician-inspired Interventional Neuroradiology devices, shares his thoughts on current clinical challenges within the medical device industry. Fred has over thirty-five years of experience in endovascular care and nearly twenty years in neurovascular care. He has a clinical background in endovascular interventions and has had industry positions in technical support, physician training, clinical oversight, and commercial operations.
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Breakthroughs in medicine today are increasingly the result of collaboration between industry and the medical community. More frequently, physicians bring an idea to the industry and, as a result of that collaboration, get funding for additional research and development capabilities to deliver a solution to a therapy that is more likely to become a standardized treatment.
People in the medical device industry are here for similar reasons as physicians and healthcare workers; they want to help people. We want to deliver a therapy that makes a difference. Regulatory bodies confront the industry with multiple recurrent requests for information and documentation on therapies to support the industry in delivering therapies known to have efficiency, efficacy, and good outcomes.
Training a physician on interventions is a critical requirement. For a new device approved on the market, training is more than the nuances of the device. You must deliver training on everything from additional considerations of pre-, peri-, and post-procedure, to education and training regarding the device's setup, initial access, and delivery.
The challenge is very dependent on the device itself: Are you developing a device superior to the one currently on the market or a breakthrough device that supersedes the existing technology? The new device may be a part of a new therapy not delivered through endovascular measures before and that has previously only been treated as an open surgical procedure. These scenarios are significant challenges for the industry.
Feasible and viable testing of a new device is critical to success. However, relevant testing is contingent upon your knowledge of the procedure. This requires collaboration with the medical community to determine the parameters for testing. Once the function of the device is established, developing the device becomes easier. The next challenges are: How can you simulate performance in humans? Does the device work as designed or intended? The regulatory requirements for market access are complex.
Finally, just because a company has built a better device or a breakthrough technology does not necessarily ensure clinical or market success in the hands of the entire clinical community treating the disease. Multiple factors come into consideration, such as the clinicians' experience, the novelty of the device, and understanding of what the device is capable of and what needs to be trained about the device to fully prepare for market launch and first cases.
Ultimately, physicians are responsible for delivering the best possible care they can, which also means being educated in that regard. There is a correlation between proper device training and the market success of a device. Regulatory bodies like the FDA mandate safe and effective use training for devices, from how the instructions for use are written all the way through to how we follow the first patient use post-market in a post-market analysis. This must be reported on annually: How is the device performing? What complications are occurring? What is done to mitigate those complications? Are the complications significant?
In addition, when introducing a product into the market, you must consider who is to be the device user. There can be multiple types of users for the device, from different clinical backgrounds, disciplines, and with various experiences. As a result, there are several factors to consider, such as: Do we need to introduce imaging training in the midst of our launch to make it most safe and effective? The same holds true for peri-procedural medications and patient selection. The onus is upon the device company to deliver this training for two reasons: One, FDA mandates it. Two, it is going to increase clinical adoption.
It is essential for physicians to know how the device can support therapies with many unique variables per patient, such as in treating neurovascular or peripheral vascular diseases. Being able to show physicians how a device performs in different anatomies by providing simulation models from real cases where patients have been successfully treated can play a significant role in the safe and effective use of a device.
Communication. When the industry collaborates with physicians properly, we ask many questions, such as: What do you do now? What is the best possible scenario? What do you want to know when introduced to a new device? When do you feel comfortable moving from training to treating a real patient? The answers you get when you engage physicians in that format are incredibly valuable.
Training must be flexible and robust to cover all training needs and ensure every single aspect of the patient's treatment continuum gets addressed. This is only possible when planned early and proper tools to deliver that training are developed.
There is great data on the outcomes of mechanical thrombectomy. The data published in the New England Journal of Medicine in 2015 is some of the best outcome data in a particular treatment realm of any device. Achieving similar results is the goal. For a new hospital to accomplish similar results, it takes a certain amount of baseline training, not only clinically but also technically/tactically, on how to use the devices and on identifying the right patient for care. Training everyone in the continuum of care looking to expand mechanical thrombectomy must be considered.
It is important to note that industry via flow models can train physicians on the specific use of devices and the peri-procedural implications of a device. However, medical societies, such as the Society of Neurointerventional Surgery (SNIS), work to establish fellowship training standards and have published standards of operating care (SOP) and baseline recommendations for mechanical thrombectomy. 
Globally, treating ischemic stroke is still challenging due to many countries' lack of interventional neuroradiologists. Patients that live in proximity to a high-volume stroke center get very proficient treatment. Patients living far away from the nearest stroke center are faced with the challenge of time to treatment which has been noted to impact outcomes. Therefore, enhanced training can be beneficial in low-volume hospitals. Education can start with didactic training while watching real case series associated with the endovascular approach to every patient. In an ideal world, training could cover all steps, from case planning using imported patient data and selecting devices and tools, to performing the procedure on the virtual patient. In addition, using the simulator in the angio suite creates an immersive environment and a hands-on experience where the clinicians can get accustomed to all the devices and tools. The availability of this type of simulation training can allow physicians in lower volume centers to gain experience to supplement their patient volumes and, in turn, increase their skill set.
There was an episode in the early years of training using a physiological flow system for ischemic stroke. The purpose of the episode was to deliver training on nuances of device deployment, delivery, imaging, etc. The simulated case had a very difficult arch associated with it. We watched several difficult passes throughout that day, but ultimately all users got better at navigating that arch. Months later, we visited a tenured physician to explore a new device. Upfront, I apologized for the difficulty of the arch, based on the feedback we had received previously. He did not react; he simply took the catheter, put it into the arch, and within seconds he was in the carotid. That was a compelling observation. Maybe that arch, that level of difficulty, is precisely the type of training we must deliver.
There are several different scenarios where simulation can make a difference. First, during early training, i.e., during fellowships, as this is an opportunity to increase the amount of hands-on experience. The simulated flow system enables hands-on training with real patient anatomies, real devices and catheters, and improves the understanding of the devices.
The second scenario is when introducing a relatively new device and there is an upcoming case with challenging anatomy. The anatomy is determined to be difficult prior to the procedure, and images can be used to create a 3D-model anatomy to practice on before the device is deployed in the patient. The physiological flow system can be helpful in a situation like this as it enables patient-specific rehearsal.
Mandates in medicine typically require published standards involving consensus from multiple sources, including medical societies and formal medical training programs. This will likely be required to mandate simulation.
Simulation has the potential to be part of the entire device development and use lifecycle, from prototyping, development, testing, and device utilization to continuous learning and adoption. It may require additional curriculum development and methodologies that are adopted and then taught.
When there is consistency in the models used between the development of the device, and the actual use of the device, safe and effective use can be better. Consistency in the method of training and models used is likely to be all tied together. Simulation has the potential to impact the way physicians are initially trained and achieve proficiency and possibly improve patient outcomes. Every aspect of physician training can contribute to better treatment.
 Standards: Endovascular therapy of acute ischemic stroke: report of the Standards of Practice Committee of the (Society of NeuroInterventional Surgery) Correction Journal of NeuroInterventional Surgery 2012;4:286: https://jnis.bmj.com/content/4/4/286
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