‍Loft: Over your career, you've been part of numerous companies, leading successful teams in various technological domains. The FDA has increasingly demanded the adoption of human factors principles across the industry. How has your extensive experience in medical device development been influenced by these human factors requirements?

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Susan: Good design has always involved human factors, such as engaging with customers, collecting their feedback, and translating it into design. However, FDA regulations have formalized this process. An intuitive understanding of customer needs is essential, gained from extensive customer interaction and inductive reasoning to discern common themes. The formal structure mandated by human factors regulations for data collection and reporting is beneficial. It requires thorough documentation and establishing clear links between user needs, product specifications, associated risks, and demonstrating risk mitigation. This experience highlighted the importance of explicitly connecting these elements, as required by regulations, ensuring comprehensive testing and validation.‍

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Loft: It sounds like the rigor of the new process provides increased awareness and offers a structured playbook, with a clearly defined methodology.

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Susan: Yes it does, however, there's a risk of becoming too attached to the methodology, neglecting the fundamental need to understand the customer, their environment, daily activities, and competitor actions. This can lead to a product that excels in engineering or documentation but fails to meet customer needs.

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Loft: What we appreciated about working with you, as a true marketer, is your focus on creating products that people truly need and want. While human factors regulation is a key component, it shouldn't be the sole guiding principle.

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Susan: It's about striking a balance. Recently, we had new users from a major Interventional Cardiology Center in our office. These are the technicians who operate the console and assist doctors in understanding the importance of providing timely, critical information during patient treatment.

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Customers praised our user interface for its simplicity, clean look, and ease of accessing information without unnecessary complexity. We often receive compliments on this aspect, and it's a testament to our efforts. Thank you, Loft!

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Loft: That's great feedback, good to hear our design collaboration is received by the users that matter the most. During our research, as we were spending extensive time in the cath lab it was evident that there was a critical need for timely information exchange. This is particularly true when identifying specific frames, locating the distal end, and determining potential catheter placement areas, where urgency is key. If the user experience (UX) design fails to provide immediate access to vital information, it can result in frustration and a sense of uncertainty. I believe our collaboration, which significantly involved your team, has done an excellent job in simplifying and streamlining these processes.

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Susan: When developing your own device, it's tempting to assume it's the focal point and that users will devote substantial time to just one more bit of information. However, once you're in the cath lab, you realize your device isn't the center of the procedure. It's about providing crucial information at the right moment, but within a very brief window – often just five seconds, maybe twenty seconds.

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Loft: During our human factor studies, it became quite evident that users appreciate the simplicity of the platform, particularly valuing how quickly and efficiently they can obtain the information they need.

Introducing an innovative product in med tech depends on several key elements: choosing the right regulatory strategy, establishing a successful monetization approach, developing a robust go-to-market strategy, and opting for a suitable technology platform. What's your advice for navigating the regulatory landscape while balancing customer satisfaction and user expectations for market success?

A product can be perfectly safe and receive regulatory clearance, yet still be undesirable in the market – a situation not uncommon in the current market. From a marketer's perspective, the challenge lies in balancing these aspects. How do you ensure regulatory compliance while also achieving market success? What has been your approach to maintaining this balance and achieving both objectives?

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Susan: For me, the process begins with a deep understanding of the customer's environment, their unmet needs, and what truly matters in their daily operations. This ensures that any product developed addresses real problems, rather than non-issues. My role as a product development marketer involves balancing insights from clinicians and engineers. While I'm neither a doctor nor an engineer, I strive to comprehend the medical practices of clinicians and the capabilities and innovation potential of engineers. Not everything engineered is necessarily useful for medical professionals.

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My focus is on finding the intersection where what is genuinely needed meets what can be realistically created, identifying a space that is both useful and innovative.

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I recognize the importance of human factors as a regulatory requirement. Our approach benefited from a clear demonstration of compliance, not just in doing the work but also in adhering to regulations. This includes using consistent terminology, making it easier for regulators unfamiliar with our specific application to recognize our adherence to the process. Preparing for such an audience involves simple strategies like consistent language, aiding in straightforward communication. For instance, clearly defining the use environment in our documentation. Essentially, it's about making it easy for regulators to understand and appreciate the effort and compliance involved in our work, while also showcasing our product's quality, design, and platform.

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Loft: Additionally, the monetization strategy is crucial, particularly in this field. It's a key aspect to consider.

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Susan: Indeed, in the medical field, the driving factor is often what gets paid for and where payment is available. Our position is unique because we specialize in imaging technology that is neither diagnostic nor therapeutic. This places us in an unconventional category, where traditional reimbursement codes for therapies or diagnostics don't apply. Our technology is information-based and additive, making it challenging to demonstrate the outcome benefits of imaging technology, as it differs from the usual diagnostic or therapeutic interventions.

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Loft: The technology must seamlessly integrate into the doctor's workflow to add value. This integration is essential for its utilization and demand, as it's directly linked to the efficiency and effectiveness of procedures like PCI (Percutaneous Coronary Intervention).

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Susan: Indeed, even for us, it remains a challenging journey. For instance, in Japan, intravascular imaging is used in 90 to 95% of PCI procedures, compared to just 10 to 15% in the U.S. This disparity is partly due to differences in reimbursement policies. In Japan, the use of specific devices is directly reimbursed, whereas in the U.S., payment is for the stenting procedure itself. Adding additional technologies like ours means extra costs. Moreover, the difference in practice guidelines and training methods also plays a role. In Japan, clinicians are trained to use intravascular imaging as a standard part of PCI, providing a three-dimensional view of the vessel from the inside. Removing this tool would be like driving without headlights – it’s possible, but not advisable. On the other hand, in the U.S., where training might not emphasize such imaging, clinicians may view it as an optional aid, akin to using night vision to drive in the dark and only occasionally turning on the headlights. This results in a distinct perspective and approach to the technology.

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Loft: This leads perfectly into the next topic, highlighting a generational divide in medical training and practice, particularly regarding imaging technology. Japan is ahead partly because they have been incorporating imaging into medical training for a longer period. Their medical system is arguably more centered around technology. Similarly, in radiology, we observe a trend where younger, more recently trained medical professionals tend to rely more on imaging. This generational shift is likely to emerge in the U.S. as well. By the time professionals become interventional cardiologists, they are typically in their mid-30s, having spent many years in training. Consequently, a significant number of practicing cardiologists were trained before the integration of imaging with PCI procedures. This historical context explains the current variance in the adoption and reliance on imaging technologies across different age groups and training backgrounds in the medical profession.

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Susan: Yes, that's accurate, especially for Gentuity OCT, given that we offer a second-generation technology. Intravascular ultrasound (IVUS), our predecessor, has been in use for about 30 years. You're correct in pointing out that many senior interventional cardiologists, who received training with the IVUS, are more comfortable with it and less so with our newer, light-based technology. This represents a transitional phase in the field. Currently, practitioners are receiving training in both technologies, adapting to the advancements and broadening their expertise. The resolution provided by OCT is significantly superior, offering sharper, clearer, and more easily interpretable images. However, its acquisition and workflow are somewhat different. People tend to be comfortable with what they know and prefer what they are accustomed to, which can influence their adoption of new technologies like OCT.

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Loft: Speaking of rapidly advancing technologies, Gentuity just launched an AI-based stent placement feature called StentX. As technological advancements permeate all facets of health care, devices that integrate artificial intelligence (AI) and machine learning (ML) have become crucial components in a growing array of medical devices. With Radiology and Cardiology leading the landscape of these AI/ML-enabled devices, how important are these technologies in the future of medical developments, especially in cardiology?

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Susan: AI's impact in the radiology and imaging sector is significant, though the challenges vary. In radiology, the primary challenge is managing the sheer volume of images, such as chest X-rays or ultrasounds, where many are normal, some questionable, and a few indicate serious problems.

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AI can be used to triage these images, preventing radiologists from becoming exhausted by reviewing numerous normal images to identify the few that require closer examination. This represents a major shift in how radiology is working.

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In contrast, PCI’s are distinct because imaging is used in real-time during procedures. Unlike traditional radiology where images are reviewed after the fact, OCT provides immediate information necessary for decision-making while the patient is on the table. Our AI technology focuses more on efficiency and software ease-of-use, rather than as a decision-making tool. It's about aiding clinicians in finding key information – like stent location or the narrowest point in a vessel – rather than making decisions for them. It's a convenience tool providing a starting point.

The situation isn't quite the same as having AI analyze a batch of chest X-rays and declare 50% of them normal, thus never reaching a human's review. While this is undoubtedly useful, it also feels somewhat unsettling.

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Loft: Agreed! AI technology alone should never select the exact location of a stent. These tools should assist physicians in making decisions quickly and with more precision.

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Susan: Absolutely! In our domain, the technology primarily serves as a convenience tool, aiding in expediting processes.

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The physician retains ultimate control and overrides, with the AI offering suggestions.

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Loft: However, I do wish this tool had been available a few years ago when Bioresorbable stents were initially introduced (and have currently been voluntarily taken off the market). Accurate sizing is crucial, and a tool like this could have provided doctors with an additional data point, supporting them with enhanced capabilities for better decision-making.

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Susan: Absolutely. That issue seems less about AI and more about a misguided commercial strategy. For instance, if you're developing a bioabsorbable stent, you might hesitate to mandate the use of intravascular imaging, especially in an environment where it's only utilized in 10% of cases. There's a temptation to assert that such imaging isn't necessary, which can lead to suboptimal outcomes. In hindsight, it might be recognized that mandating intravascular imaging could have ensured better sizing and avoided complications, such as in cases with calcified vessels where a bioresorbable stent may not expand properly. This scenario highlights the balance between commercial decisions and the best medical practice.

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Despite this commercial challenge, I believe the concept of bioresorbable stents, with the idea of leaving no metal behind, is a significant contribution to interventional cardiology.

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It's a very compelling approach. Additionally, there are strategies like drug-coated balloons, which are used in Europe and are now making their way to the U.S. We're somewhat behind in this area. But the value proposition of 'leave no metal behind' is quite compelling and addresses a genuine problem.

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Loft: I anticipate we'll see a sequel to this technology in the coming years. This brings us to the next question. Software as a Medical Device (SaMD) is one of the fastest-growing sectors in the medical device industry. Many companies are looking for ways to incorporate software into legacy systems, like X-rays, CT imaging, or MR imaging. How do you see the landscape of Imaging evolving as these technologies are being further developed? How will these advancements integrate and what new capabilities will they bring?

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Susan: It's an interesting challenge, right? I began my career in non-invasive ultrasound for cardiology, focusing on valves and structures, which was essentially a capital equipment business. We sold ultrasound machines and software upgrades, but usage wasn't charged per session. The user owned the equipment after purchase.

Interventional cardiology, however, operates differently. It's driven by disposables due to the invasive nature of the procedures. Even though there's an imaging system involved, cath labs typically don't have large capital budgets except for new room setups or major upgrades. A common strategy is to bundle the cost of capital equipment with the disposable items' price, based on the usage of catheters over time. The challenge intensifies with companies introducing software as a medical device. For instance, creating 3D vessel models and conducting computational fluid dynamics from angiography images poses a significant commercial challenge. The question is, how do you charge for this? It's not feasible to sell the software outright, as budgets don't allow for it and it doesn't align with current operational models. Ideally, a per-use charge aligns with the disposable-driven model, but integrating this with software usage is complex.

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The industry is grappling with monetizing these software innovations, which are essential but need to be financially viable to continue advancing. The solution isn't clear yet, but it's a problem that must be solved to realize the benefits of these software advancements.

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Loft: It seems the most viable approach might be adopting a subscription model of some sort. Similar to commercial SaaS (Software as a Service) solutions like Epic.

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Susan: Exactly, but how will hospitals allocate their budget for this? How will they consider the usage and the associated costs of this technology?

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Loft: Indeed, SaMD is not just a challenge but also an opportunity for driving innovation in specific areas. As you mentioned, fluid dynamics is one area. While catheter-based Fractional Flow Reserve (FFR) assessments remain strong, the potential to achieve 85% of FFR results with Computational Fluid Dynamics (CFD) highlights the innovative possibilities in this field.

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Susan: Exactly, especially when you can reuse imaging that you're already collecting for other purposes. Placing wires is very comfortable and familiar in the cath lab; it's what interventional cardiologists do. However, if an imaging technology adds value by telling you about the structure and the morphology, and now can also tell you about the physiology, that's a really compelling value proposition and hospitals will find a way to pay for it.

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Loft: We will observe how it evolves. The FDA is putting a lot of effort into guidance for SaMD and related technology advancements. And of course, it's worth noting that these technology companies are predominantly backed by venture capital funding. The VCs will find a way to monetize their investments.

Speaking of investments, congratulations on the partnership with Nipro Corporation. The team at Gentuity is going strong.  What’s happening in 2024 and how is the product being received?‍

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Susan: Gentuity began with a highly differentiated platform, featuring a catheter significantly smaller than any other in the intravascular imaging system market. It's less than half the size of most intravascular imaging catheters. This is crucial because there's a growing trend in the cath lab to treat more patients with minimally invasive procedures rather than open heart surgery. This often involves navigating through narrow or calcified vessels, so a smaller catheter that can penetrate these lesions and provide imaging before treatment decisions have been made is vital. Moreover, this innovation coincides with a time when more treatment options are emerging in interventional cardiology. For instance, technologies like Shockwave's intravascular lithotripsy for calcium breakup are becoming available. Choosing the right treatment depends on the vessel's morphology, but this requires being able to navigate the catheter to the site for accurate imaging.

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As we encounter more complex patient cases and diverse treatment choices, the value of precise imaging increases. Gentuity's technology, with its small catheter size, and faster and longer pullback, allows for a comprehensive assessment of the vessel, aiding in pre-treatment decision-making.

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As a new entrant in a market dominated by big players with extensive product lines, Gentuity is small but agile. Our unique offering stands out in the cath lab for filling a niche that others can't, thanks to our differentiated technology and approach.

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Loft: That is all exciting news, looking forward to seeing the next steps in the development. Thank you so much for your conversation!