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Driving Telehealth Transformation: Kyle Y. Faget’s Vision for the Future of Healthcare

Digital Version In the rapidly evolving world of healthcare, few leaders have left as profound a mark as Kyle Y. Faget, Partner and Co-Chair of the Health Care & Life Sciences Sector – Medical Devices at Foley & Lardner LLP. Recognized among 2025’s Most Influential Leaders Advancing Telehealth Transformation, Faget’s journey weaves together science, law, innovation, and personal experience, positioning her as a true catalyst in the transformation of healthcare delivery. A Personal Journey Into Healthcare Law For Faget, the path to healthcare law was shaped as much by intellectual passion as by personal experience. Before entering law school, she was a basic science researcher investigating the pathophysiology of Alzheimer’s disease and the genetic roots of Amyotrophic Lateral Sclerosis (ALS). That scientific grounding instilled a deep understanding of the challenges and possibilities in medicine. But it was a deeply personal encounter that sharpened her focus on telehealth. In 2017, after her late wife was misdiagnosed by several healthcare providers, it was a small telehealth practice that finally identified the root cause—stage IV lung cancer. This experience was a revelation for Faget. “That was the first time I witnessed telehealth being used,” she recalls. “I knew immediately this was the future of healthcare.” From that moment, she immersed herself in understanding the provider side of healthcare, diving into the complexities of digital health. Her commitment paid off during the COVID-19 pandemic, when telehealth surged as a preferred mode of care delivery. Today, as a leading voice in health law, Faget is helping shape a sector undergoing rapid transformation. Rooted in science, shaped by personal experience, and driven by purpose—this journey redefines what it means to lead with both heart and foresight in transforming healthcare for tomorrow. The Intersection of Law, Innovation, and Telehealth Faget sees the intersection of law, innovation, and healthcare as a pivotal moment in history. She notes that we are experiencing a time of rapid technological progress. Advances such as artificial intelligence (AI) and telehealth are transforming the way healthcare is provided, making it both more accessible and more effective. For example, decentralized clinical trials are leveraging AI and telehealth to increase efficiency, while digital health products for remote patient monitoring are allowing patients to better manage their health and intervene earlier when problems arise. “By improving how we monitor our health, we can take preventive action at the right time,” explains Faget. She sees enormous potential to improve overall population health, but also recognizes that this transformation comes with complex regulatory and strategic challenges. Innovation needs more than vision — it needs a legal strategy that understands its heartbeat. Guiding Innovators Through the Legal Landscape As Co-Chair of the Health Care & Life Sciences Sector – Medical Devices, Faget leads Foley & Lardner’s efforts to help innovators navigate a heavily regulated industry. Many entrepreneurs come to Foley eager to launch groundbreaking healthcare solutions, unaware of the intricate legal terrain. As Faget points out, the healthcare industry is one of the most heavily regulated sectors. Laws such as the corporate practice of medicine doctrine, which restricts non-professional corporations from practicing medicine or employing physicians, can complicate even the most promising business models. Additionally, the anti-kickback statute and state-level fee-splitting laws require careful structuring of financial arrangements. Faget and her team help clients understand these barriers and design compliant, scalable solutions. Navigating a Shifting Regulatory Environment The regulatory environment for telehealth is in flux, with state-level oversight creating a patchwork of requirements. From how clinician-patient relationships are established to licensing and practice standards, each state brings its own approach. Yet Faget sees progress: “More states are aligning on practice standards, and many are joining the interstate medical licensure compact, which streamlines physician licensing across member states.” At Foley, a team of attorneys track these regulatory shifts, helping clients remain compliant and competitive in an increasingly national marketplace. To lead in healthcare law, you must think like a historian and adapt like a futurist. Legal Foresight for Sustainable Telehealth Platforms For Faget, legal foresight is essential to long-term success in telehealth. When engaging with clients, she emphasizes the importance of mapping out short- and long-term goals. “Whether it’s a single-state platform or a national one, we help structure the offering from the outset,” she explains. For example, the corporate practice of medicine may not be an immediate concern for a local startup, but it becomes critical when expanding across state lines. Foley’s proactive approach ensures that clients build on a foundation that can evolve as they scale. The Convergence of Medical Devices and Telehealth Bringing together medical devices and telehealth systems is reshaping patient care by enabling real-time data sharing and remote monitoring, though this combination also introduces both advantages and challenges. Faget highlights the need to address user tech-savviness, especially among aging populations, and the importance of navigating reimbursement policies, as coverage is not always readily available. Still, she is optimistic: “As these tools become more mainstream, we’re likely to see more favorable coverage decisions.” Tailoring Legal Guidance to Support Innovation Faget’s legal philosophy centers on education and informed decision-making. Whether advising startups or major healthcare systems, her role is to help clients understand legal requirements and enforcement trends, empowering them to make well-informed business decisions. “This is always the magic question: how to balance innovation and risk,” she says. By demystifying the regulatory landscape, Faget ensures that innovation is not stifled by uncertainty. The Critical Role of Cross-Sector Collaboration The success of telehealth depends on cooperation among the technology, healthcare, legal, and regulatory fields. Faget highlights that meaningful change requires the combined efforts of all these sectors, as no single area can achieve it independently. “Healthcare intersects with numerous legal domains, making a collaborative approach highly valuable for clients,” she explains. Foley’s industry-focused structure promotes integrated teamwork across various specialties, including patent law, corporate governance, tax, labor and employment, healthcare regulations, and FDA compliance. This comprehensive approach supports clients throughout the full innovation process, from developing patent strategies to bringing products to market. Mentoring the Next Generation of Healthcare Attorneys

Bernardo Nicoletti: Merging Lean Thinking with Digital Transformation to Redefine Procurement and Supply Chain Excellence

Digital Version Few leaders have shaped the procurement and supply chain landscape as extensively as Bernardo Nicoletti, whose work seamlessly integrates Lean Six Sigma principles with cutting-edge digital innovation. Nicoletti has played a key role in advancing procurement and supply chain management for years, serving as a professor, consultant, and author. He has provided guidance to international businesses and shared his expertise with aspiring leaders at universities such as Temple University Rome and the University of Rome Tor Vergata. In this exclusive feature for Visionary Leaders Transforming Procurement and Supply Chain Strategy – 2025, Bernardo Nicoletti reflects on the evolution of the field, the role of innovation, and the strategic mindset required for lasting success in a complex, digital-first world. I believe in transforming procurement from a cost-driven function into a strategic force – where lean thinking, digital innovation, and human insight work together to deliver lasting value. The Power of Lean Six Sigma and Digitalization Nicoletti’s extensive background in Lean Six Sigma and process digitization has fundamentally reshaped procurement practices across industries. “The procurement and supply chain management field has been profoundly transformed in recent decades,” he explains, “driven by the strong synergy between Lean Six Sigma methodologies and digital technologies.” Lean Six Sigma—rooted in the Toyota Production System—focuses on improving value to the customer, minimizing waste and reducing variation. These principles, when applied to procurement, optimize sourcing, streamline supplier interactions, and shorten lead times. But Nicoletti points out that digitalization has exponentially amplified these benefits. “Technologies such as AI, IoT, and robotic process automation are no longer just add-ons—they are integral to creating agile, responsive, and resilient systems,” he says. For instance, AI can now accurately predict demand, optimize supplier choices, and analyze risks in real-time. IoT devices track inventory and transportation, while RPA removes bottlenecks in administrative workflows. Yet, Nicoletti is pragmatic: “Only a limited number of companies have fully embraced this convergence. Where it has been implemented, the impact has been transformational—from cost savings and efficiency to enhanced service quality and customer delight.” The Challenges Behind the Transformation Many organizations still encounter substantial challenges, despite the obvious benefits of digital integration. “Siloed structures and outdated ERP systems are often at the root of the problem,” Nicoletti notes. These legacy technologies create friction when integrating modern tools like AI or blockchain. Talent scarcity—especially in data science, cybersecurity, and AI—adds another layer of difficulty. Geopolitical instability, climate disruptions, and increased scrutiny around data privacy further complicate supply chain strategies. According to Nicoletti, success hinges on a comprehensive approach, encompassing technological investment, organizational redesign, change management, and talent development. This approach requires a Total Procurement approach similar to Total Quality which involves all the parties in the improvement projects. On this respect, also the involvement of the main vendors is essential to optimize the full chain. “He emphasizes the crucial role of strong cybersecurity and efficient data governance. “As data is the foundation of contemporary supply chains, cleaning and protecting it is vital,” he explains.” Why Digital Innovation Is No Longer Optional Nicoletti views digital innovation as the cornerstone of modern supply chains. “AI, blockchain, automation, IoT—these are not trends. They are the drivers of operational excellence,” he asserts. They should apply to procurement which includes from 50% to 80% of the operating costs of an organization, be it private or public. Artificial intelligence and machine learning are transforming the ways demand forecasting, vendor selection and evaluation, risk management, and warehouse automation are approached. RPA handles repetitive tasks such as purchase order creation or invoice matching, freeing teams for more strategic work. Blockchain introduces traceability, fraud prevention, and secure recordkeeping, especially in complex, multi-tier supply networks. IoT delivers real-time tracking, while cloud platforms ensure scalable, agile operations. But Nicoletti also highlights a critical balancing act. “Technology cannot replace human judgment. The organizations that succeed will be those that combine digital tools with human insight, ethical leadership, and lean thinking.” Real-World Results Through Lean + Digitize Nicoletti’s consulting experience spans 10 countries and clients such as General Electric, Deutsche Bank, Generali, Santander Nordic, and Intesa Sanpaolo. One case, he recalls, illustrates the power of an integrated strategy. “A multinational manufacturing company was struggling with fragmented procurement,” he says. “By centralizing indirect spend, consolidating vendors, and introducing an eProcurement platform based on lean principles, they cut indirect costs by 15% and slashed order lead times by 50%.” This company is now investing in AI and expects an additional saving of at least 20%. The transformation also standardized processes, reduced waste, and fostered stronger vendor partnerships. “This is the kind of holistic approach that delivers measurable, sustainable results,” Nicoletti adds. Lean in Bureaucratic Environments: A Pragmatic Approach One of the more challenging aspects of Nicoletti’s work involves applying lean methodologies in complex, bureaucratic environments—often in public institutions or heavily regulated sectors. “You have to start with a clear-eyed assessment of where waste exists,” he says. “Then prioritize areas with the greatest potential for quick wins.” These might include digitizing vendor onboarding, reducing redundant approval loops, preparing effective contracts,  or standardizing documentation. . Generative AI can help a lot in this respect. Commercial solutions are already available and will transform the work of the buyers. Tools like Kanban boards, visual dashboards, and just-in-time inventory systems can be remarkably effective. But perhaps most important, Nicoletti says, is cultivating a culture where frontline employees are empowered to identify and eliminate inefficiencies. “It’s not just about technology or process—it’s about mindset and collaboration,” he notes, especially when working with legal and finance departments to streamline workflows. The Academic Lens: Educating the Next Generation Nicoletti plays a significant role in shaping the future of procurement and supply chain professionals through his work as an educator. At the University of Rome Tor Vergata and other institutions, he connects theoretical knowledge with real-world application. “Academic institutions play a critical role in equipping students with the tools to manage real-world complexity,” he says. From case studies and simulations to industry partnerships and research, universities are evolving to reflect modern challenges. Nicoletti himself is

Anna-Luisa Schaffgotsch | CEO & Founder - Impli Limited

Pioneering Smart Healthcare Through Implantable Innovation: The Journey of Anna Luisa Schaffgotsch and Impli Limited

Digital Version In the ever-evolving landscape of healthcare, few industries hold as much promise or face as many challenges as smart healthcare solutions. At the intersection of technology, medicine, and innovation, leaders like Anna Luisa Schaffgotsch, CEO and Founder of Impli Limited, are redefining what it means to deliver personalized, real-time healthcare. With a vision rooted in both personal experience and cutting-edge research, Schaffgotsch and her team are pioneering a future where implantable devices and advanced technologies such as artificial intelligence and the Internet of Things transform how we monitor, manage, and improve health outcomes. When innovation begins with empathy, healthcare transforms—not just in technology, but in meaning, purpose, and impact. A Vision Born from Personal Experience Anna Luisa Schaffgotsch’s journey into the world of smart healthcare began with a deeply personal motivation. Alongside her co-founder, she faced the challenges of hormonal imbalances, a struggle that inspired her to seek solutions beyond traditional healthcare frameworks. “Our journey began with a shared conviction that implantable devices have the power to reshape real-time healthcare,” she explains. This conviction was not just theoretical; it was grounded in tangible research spun out of Imperial College, where the seeds of Impli Limited were first planted. What started as a mission to create an implantable hormone-monitoring device for women has since evolved into a broader ambition: to leverage continuous data collection to enhance and personalize healthcare for people everywhere. “Over the years, our vision has expanded,” Schaffgotsch notes. “We are no longer just addressing one health concern—we are working toward a future where data-driven insights empower individuals to take control of their health in ways that were previously unimaginable.” Defining Innovation in Smart Healthcare In an industry as complex and rapidly evolving as healthcare, innovation is not just about creating new technologies—it is about solving real-world problems with creativity, resilience, and a commitment to excellence. For Schaffgotsch, innovation is about confronting difficult challenges head-on and refusing to back down, even when the odds seem insurmountable. “Innovation in healthcare is about harnessing creativity, research, and technology to push boundaries,” she says. “It is about persevering through adversity, refining our ideas, processes, and products until we emerge with something that truly transforms lives.” This mindset has been instrumental in guiding Impli’s development of cutting-edge solutions that address some of the most pressing healthcare challenges of our time. The Role of Advanced Technologies At the heart of Impli’s mission is a commitment to leveraging advanced technologies such as artificial intelligence, the Internet of Things, and bioinformatics to revolutionize healthcare. These technologies are not just tools—they are the foundation upon which Impli’s solutions are built. “Artificial intelligence plays multiple pivotal roles in our work,” Schaffgotsch explains. “From guiding the design of our devices to interpreting the continuous stream of hormone data we collect, artificial intelligence is integral to our approach.” By correlating these insights with personal health records, Impli is ushering in a new era of personalized medicine. The data gathered from real-time hormone monitoring serves as an unprecedented resource, enabling artificial intelligence algorithms to uncover patterns and deliver tailored recommendations that were previously impossible. This integration of technology and healthcare is not just about improving individual outcomes—it is about creating a more connected, efficient, and predictive healthcare ecosystem. “The future lies in wearable or implantable technologies that seamlessly monitor health parameters in real time,” Schaffgotsch predicts. “Combining these insights with advances in robotics and the Internet of Things will pave the way for a more connected and efficient healthcare system.” Innovation in healthcare is about confronting difficult problems head-on and never shying away from a challenge. Overcoming Challenges in Smart Healthcare While the potential of smart healthcare solutions is immense, the path to implementation is fraught with challenges. Regulatory hurdles, clinical trials, and the high costs of development are just a few of the obstacles that companies like Impli must navigate. “The regulatory environment can be both rigorous and costly,” Schaffgotsch acknowledges. “But we address these challenges by methodically navigating the complex requirements, securing targeted funding, and building strategic partnerships that support sustained development.” This structured approach allows Impli to meet strict compliance standards without sacrificing its innovative spirit. Another key challenge is ensuring that smart healthcare solutions are both innovative and accessible. “Striking a balance between innovation and accessibility can be challenging, especially when hardware is at the heart of the product,” Schaffgotsch admits. However, she remains optimistic. “Our focus is on creating transformative technology that, over time, will become more affordable through economies of scale and ongoing iteration.” The Future of Smart Healthcare As we look ahead to 2025 and beyond, the smart healthcare landscape is poised for remarkable transformation. Schaffgotsch envisions a future where artificial intelligence-driven diagnostics and analytics take center stage, supported by increasingly sophisticated, patient-friendly devices. “I foresee artificial intelligence-driven diagnostics and analytics dominating the healthcare landscape,” she says. “The future lies in wearable or implantable technologies that seamlessly monitor health parameters in real time, delivering data-rich feedback to both healthcare providers and individuals themselves.” This vision is not just about technology—it is about creating a healthcare system that is more proactive, personalized, and predictive. “Combining these insights with advances in robotics and the Internet of Things will pave the way for a more connected, efficient, and predictive healthcare ecosystem,” Schaffgotsch explains. The future lies in wearable or implantable technologies that seamlessly monitor health parameters in real time. Leadership Principles for Success At the helm of Impli, Schaffgotsch’s leadership style is defined by a commitment to fostering innovation, resilience, and collaboration. “I believe in granting people the freedom to explore, experiment, and grow,” she says. “When combined with a culture of hard work and shared responsibility, this approach motivates teams to excel.” Her role, she explains, is to provide clarity of vision and the support needed for her team to fully harness their expertise. “Nurturing a resilient, self-driven, and innovative environment is the best way to ensure our company continually moves forward.” Nurturing a resilient, self-driven, and innovative environment is the best way to

Rethinking the Green Transition: Simon Michaux’s Blueprint for a Sustainable Future

Digital Version As the world races to address the escalating climate crisis, the need for innovative solutions and bold leadership has never been more urgent. Simon Michaux, Associate Professor at the Geological Survey of Finland (GTK), is one such leader, offering a unique perspective on the challenges and opportunities of the green transition. With a background in mining and a deep understanding of industrial systems, Michaux’s work focuses on diagnosing the bottlenecks in our current strategies and proposing unconventional solutions to create a sustainable future. In this interview, he shares his insights on the complexities of the energy transition, the role of critical minerals, and the transformative potential of circular economies. Our relationship with the environment must change. We must become aware of what energy is, where we get it from, and what raw materials mean for us. A Journey from Mining to Climate Action Simon Michaux’s journey into climate action began in the Australian mining industry, where he gained firsthand experience in resource extraction and industrial systems. However, his move to Europe in 2015 marked a turning point. “I came to Europe to learn about industrial recycling and the circular economy,” he recalls. Attending EU policy meetings and strategy workshops, Michaux quickly realized a disconnect between the proposed strategies and the realities of energy and resource systems. “The perception was that Europe led the world in phasing out fossil fuels and the green transition,” he says. “But the strategies I heard were not connected to reality at all.” This realization sparked a years-long effort to understand and communicate the systemic challenges of transitioning away from fossil fuels. Today, his work at GTK focuses on grounding the green transition in reality, diagnosing its flaws, and proposing alternative pathways. The Challenges of Securing Sustainable Raw Materials One of the most pressing challenges in the shift to renewable energy is securing sustainable raw materials. Michaux highlights the complexity of this task, noting that the industrial systems built over the past two centuries rely heavily on fossil fuels. “The last two centuries have been spent building the most complex technological industrial system the world has ever seen, using the most calorifically dense energy source the world has ever known—oil,” he explains. The green transition, while essential, faces significant bottlenecks in resource supply. Michaux emphasizes that the current approach may be leading us into a strategic dead end. “If we’re going in the wrong direction because we’ve forgotten what energy really is and where raw materials actually come from, what should we do?” he asks. His work seeks to answer this question by mapping out the physical units and resources required for a sustainable transition, revealing the logistical challenges and inherent weaknesses of current systems. The green transition operates on a much larger scale compared to the circular economy. Balancing Resource Demand and Environmental Protection The demand for critical minerals, essential for renewable energy technologies, poses a significant challenge to environmental sustainability. Michaux argues that our current approach is ecologically disastrous and faces serious resource bottlenecks. “Our current Plan B, the green transition, faces very serious bottlenecks in resource supply,” he says. “We must fundamentally reconsider our technology choices and how we utilize them.” To address these challenges, Michaux advocates for unconventional solutions, such as thorium-fueled modular molten salt reactors (MSRs). “I’ve been modeling these systems, and the results are amazing,” he shares. “It’s possible to deliver concentrated quantities of electrical power and industrial thermal heat from a very small value chain footprint.” However, he cautions that technological innovation alone is not enough. Society must also shift its priorities, moving away from consumerism and toward community and planetary stewardship. The Role of Circular Economies in Sustainability While the circular economy is often discussed alongside the green transition, Michaux points out that the two are not the same. “The green transition is orders of magnitude larger than the circular economy,” he explains. In a case study conducted in Hawaii, Michaux modeled both scenarios and found that the infrastructure required for the green transition far exceeds that needed for a fully implemented circular economy. Despite this, Michaux believes that a circular economy is essential for long-term stability in a post-fossil-fuel world. However, he argues that the current concept of the circular economy is thermodynamically imbalanced and needs to evolve. “In my work, I’ve tried to achieve this, creating what I call the Resource Balanced Economy (RBE),” he says. This approach integrates energy considerations into every action, ensuring a more sustainable and efficient use of resources. Collaboration for a Sustainable Future Michaux emphasizes the importance of collaboration between governments, businesses, and scientific institutions in addressing the climate crisis. “We must withdraw from the natural environment, contract our human systems footprint, and simplify our industrial system,” he says. He calls for a new form of social collaboration, warning that a scarcity mindset and conflict will only exacerbate the challenges we face. For industries pledging to reduce their carbon footprint, Michaux advises moving beyond regulatory compliance. “Many of the systems we rely on now must be replaced entirely,” he says. “This requires a full metamorphosis of our industrial energy system, which is yet to be understood by most people in positions of responsibility.” We must withdraw from the natural environment, contract our human systems footprint, and simplify our industrial system. Urgent Priorities and Breakthrough Solutions Looking ahead, Michaux identifies the evolution of societal paradigms as the most urgent priority. “Our relationship with the environment must change,” he says. “We must become aware of what energy is, where we get it from, and what raw materials mean for us.” He believes that breakthrough solutions, such as thorium MSRs, can play a key role in this transition, but only if accompanied by a fundamental shift in how we view and organize our systems. For the next generation of scientists, policymakers, and industry leaders, Michaux offers a clear message: “Engage critical thinking in all its forms. Collaborate with as many people as possible. Explore all rabbit holes, and don’t be limited by being

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