The Most Influential Leaders to Know in Medical Device Industry

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4. PUBLISHER: WORLD CARE MAGAZINE Managing Editor Art and Design Head Business Development Kevin Smith Nicole Wilson Jack Miller, Michael Brown, Melissa Anderson, Angela Paul Executive Marketing Manager Technical Head Digital Marketing Manager Circulation manager Grace Jackson Luca Ferrari Sophia Rossi David Brown Adam Brown Accounts Contact Us: Michael Brown michael@worldcaremagazine.com Whatsapp: +1 307 314 9695

5. From the Editor Visionaries Shaping the Future of Medical Devices W approaches, and dedication to advancing healthcare have not only influenced the industry's course but have also brought about transformative changes in patient care worldwide. Acknowledging these influential individuals is essential, as it fosters an understanding and appreciation of their indispensable contributions, while also offering valuable insights into the trends and advancements driving the sector onward. ithin the modern landscape of the medical device industry, certain leaders distinguish themselves through their notable impact and visionary leadership. Their depth of expertise, innovative These leaders possess a profound comprehension of the intricate interplay among technology, medicine, and regulatory frameworks inherent in the medical device industry. Their strategic leadership has played a pivotal role in driving research and development endeavors, fostering collaboration across various disciplines, and adeptly navigating the ever-evolving regulatory landscape. Through their foresight and unwavering dedication, they have propelled the industry to unprecedented heights, igniting innovation and introducing cutting-edge solutions to the market. Furthermore, these influential figures not only spearhead innovation within their respective organizations but also champion broader initiatives aimed at addressing global healthcare challenges. They actively engage with stakeholders ranging from healthcare providers to policymakers, advocating for policies that prioritize patient safety, accessibility, and affordability. Their steadfast commitment to ethical practices and social responsibility underscores their pivotal role as custodians of the industry's integrity and societal impact. In acknowledging The Most Influential Leaders to Know in Medical Device Industry, it is essential to highlight their diverse backgrounds and areas of expertise. From seasoned executives at the helm of multinational corporations to visionary entrepreneurs leading startups, these leaders embody a spectrum of perspectives and experiences that enrich the industry's innovation ecosystem. Ultimately, comprehending the contributions of these influential leaders provides invaluable insights into the trends, challenges, and opportunities shaping the future of the medical device industry. By celebrating their leadership and achievements, we honor their dedication to advancing healthcare and inspire future generations of innovators to continue pushing the boundaries of possibility in pursuit of enhancing patient outcomes worldwide. - Kevin Smith Managing Editor

6. sickness comes., Health is not valued till - Thomas Fuller

7. Contents C O V E R S T O R Y Stene Marshall 06. Driving Innovation in Medical Technology F E A T U R I N G Marjan Mikel Catalyzing Healthcare Innovation. 18. A R T I C L E S A Comprehensive Overview Advancements in the Medical Device Industry 18. Revolutionizing Patient Care Breakthroughs in Medical Device Technologies 26.

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18. the art of Medicine is loved, there is also a love of Humanity. ,

20. Marjan Mikel CEO/Managing Director Respiri www.worldcaremagazine.com 18

21. Marjan Mikel Catalyzing Healthcare Innovation , T technological advancements, evolving patient needs, and changing regulatory landscapes. Within this dynamic environment, visionary leaders emerge to drive innovation and shape the future of healthcare delivery. he healthcare industry is undergoing rapid transformation fueled by Having the right person for the right job at the right time fosters innovation, progress, and achievement At the forefront of this evolution is Marjan Mikel, a seasoned executive with a track record of pioneering change and driving impact in the healthcare sector. As the CEO/Managing Director of Respiri, Marjan brings a wealth of experience and expertise to his role, guiding the organization towards its mission of improving patient outcomes and enhancing the quality of care. the company remains at the forefront of healthcare excellence, delivering value to patients, providers, and stakeholders alike. just nothing!? The early 2000s left Big Pharma to scratch this commercial itch by working in SME startups where there was nowhere to hide. I started or was part of startups in Healthcare that became very successful and we existed via trade sales to multinational organizations. Can you provide a brief overview of your career journey in the healthcare industry? I started my journey in Big pharma, working for Merck & Co. and then Pharmacia in a number of commercial and leadership roles around the globe for 15 years. Launching blockbuster after blockbuster and setting best practice standards everywhere in the world where I did this. The last company was Health Sleep Solution HSS, specializing in the remote diagnosis, treatment and management of patients at risk of having sleep apnea. ResMed became an early cornerstone investor in HSS, and we became one of their largest clients in the southern hemisphere. We were also Australia's largest provider of said services, securing about 40% of the market. Under Marjan's leadership, the company has emerged as a trailblazer in the field of integrated healthcare solutions, leveraging technology, strategic partnerships, and a patient-centric approach to drive transformative change. With a relentless focus on innovation and collaboration, Marjan is dedicated to ensuring that Having 500 reports when I was in Pharmacia Australia, I started questioning what value I was actually adding to this organization. Leadership, strategy, inspiration, or The company was sold to Air Liquide, CAC listed multinational, in 2013, and I left in late 2016. www.worldcaremagazine.com 19

22. • I can roll my sleeves up when needed. • I can mobilize people and resources. What is your vision for the future of healthcare, particularly in terms of innovation and advancements? How does your organization's mission align with this vision? There have been significant advancements in enabling technologies, devices, connectivity, and in medicine, yet still today, there are nominal improvements in things like compliance, persistence, and, in some instances, outcomes for patients, or at the very least, advance in health do not even come close to leveraging these other megatrend innovations and they should. • The challenge, healthcare remains conservative by nature, as it should be as it deals with people's lives. My vision is to navigate and respect this inherent conservatism but harness better the catalytic milestones innovations to drive patients well well-being and make sure that we all understand that the only reason we exist as businesses is because of the patient!! What inspired you to pursue a leadership role in healthcare innovation? What are your primary areas of expertise within the healthcare sector? Basically, we built what is now known as a Remote patient monitoring organization, bringing tech, devices, and healthcare together to touch and help manage over 130K patients in Australia. Being able to make a material difference to the lives of patients has always been paramount and doing this by looking at the industry norms from a different lens to make this difference. Sat on a number of private and public company boards until 2019 but I am really not set up to be an NED. Mate from Boston called me in Oct 2019 asking if I wanted a job, to which I answered, not really. It was to take on the CEO role at Respiri. • The healthcare purse is not bottomless and we need to align our value proposition and rewards around how our clients are being paid! Risk is there for all of us to share, as is the upside of getting it right. I can dumb down the complicated and have people understand what we are doing, why, and how. People feel part of the solution and then pursue their version/interpretation of our strategy. This also includes our customers as they need to be on the journey as well. We started as a medical device company based in Australia and are now a US-based integrated healthcare organization that delivers remote patient services utilizing our proprietary devices and other devices on behalf of our Drs and HCO to improve the lives of patients, reduce events, and improve outcomes resulting in reduced costs! All of this is only just over two years. • The Respiri team gets tired of listening to this diatribe from me but I am ok about that. • I am dogged in pursuing our goals but understand the need to pivot when required and never let perfect be the enemy of very good!!!! What core values drive your leadership approach in the healthcare field? Could you share examples of innovative strategies or technologies your organization has www.worldcaremagazine.com 20

23. Together, we create a new standard of care. , implemented to revolutionize healthcare? Unsolicited customer endorsements emphasize the validation of quality and partnership, surpassing any accolades Challenge the status quo but understand that disruption to Drs and HCPs is not usually well received because they are extremely busy time poor. We need them to keep doing what they are core at doing and let us do what they know is necessary to take patient care to the next level, but understand that they cannot do it. Together, we create a new standard of care. What advice would you offer to other leaders aspiring to drive innovation in the healthcare sector? • • Healthcare is about sophisticated simplicity. If it sounds complicated it usually is wrong! • Having the right person for the right job at the right time fosters innovation, progress, and achievement. These things all change during a company's strategy and operational journey! HSS example mentioned above and using this to extend care beyond the clinic whilst allowing our Dr customers to keep being doctors and deputize us to do the rest with their patients. This model is driving our charge into the USA. Dr wants to be drs, and HCO administrators want to be exactly that. We need them to deputize and trust us to take care beyond the clinics. What emerging trends do you foresee shaping the future of healthcare? How do you plan to adapt and evolve your approach to leadership in response to these trends? How do you measure the success and impact of your innovative healthcare solutions? Customer referrals and endorsements that are unsolicited. This is the ultimate prize. Predictive AI is very exciting, but really, the future of healthcare will still revolve around people and partnerships that allow for the demarcation of tasks, allowing for everyone to focus on their core business in the patient pathway and together create a seamless "new standard of care." Bringing this ethos together with AI and ensuring that healthcare delivery continues even after the patient leaves the care of their Dr is paramount. Improving patient outcomes and reducing healthcare costs! We are lucky enough to be able to measure these and are making great inroads with our HCO/HCP partners here! What are the most significant challenges you've encountered while driving innovation in healthcare? What lessons have you learned from overcoming obstacles in healthcare innovation? Have you or your organization received any notable recognition or awards for your contributions to healthcare innovation? Challenge the status quo but understand that disruption to Drs and HCPs is not usually well received because they are extremely busy time time-poor. We need them to keep doing what they are core at doing and let us do what they know is necessary to take patient care to the next level, but understand that they cannot do it. • Design awards for our Wheezo device. Unsolicited Customer endorsement around the quality of what we do and the value of our partnership. This trumps awards or "trophies"! • www.worldcaremagazine.com 21

24. Advancements in the Medical Device Industry T driven by technological innovation, regulatory changes, and evolving healthcare needs. These advancements have transformed patient care, diagnosis, and treatment, offering more precise, efficient, and personalized solutions. Further, we provide a comprehensive overview of the latest advancements in the medical device industry and their implications for healthcare. and robotic-assisted surgical systems enable surgeons to perform complex procedures with greater precision and control through small incisions. Furthermore, advances in imaging technologies, such as intraoperative MRI and 3D visualization systems, provide real-time feedback and enhance surgical accuracy. As a result, minimally invasive surgical techniques have become the standard of care for various surgical specialties, including gynecology, urology, and orthopedics. he medical device industry has undergone significant advancements in recent years, analytics, personalized treatment recommendations, and early disease detection. Minimally Invasive Surgical Techniques Advancements in minimally invasive surgical techniques have revolutionized surgical procedures, offering patients shorter recovery times, reduced pain, and fewer complications compared to traditional open surgery. Laparoscopic Digital Health Technologies Digital health technologies have revolutionized healthcare delivery by leveraging digital platforms, data analytics, and connectivity to improve patient outcomes and streamline clinical workflows. Telemedicine platforms enable remote consultations, diagnosis, and monitoring, expanding access to healthcare services, particularly in underserved areas. Moreover, mobile health apps and wearable devices empower individuals to track their health metrics, monitor chronic conditions, and adhere to treatment regimens. The integration of artificial intelligence (AI) and machine learning further enhances the capabilities of digital health technologies, enabling predictive Personalized Medicine and Precision Diagnostics The advent of personalized medicine and precision diagnostics has transformed the way diseases are diagnosed and treated, tailoring medical interventions to individual patient characteristics, including www.worldcaremagazine.com 22

25. A Comprehensive Overview www.worldcaremagazine.com 23

26. genetic makeup, lifestyle factors, and environmental influences. Molecular diagnostic technologies, such as next- generation sequencing and gene expression profiling, enable clinicians to identify specific biomarkers and molecular targets for more accurate diagnosis and targeted therapy selection. and the tracking of therapeutic agents in vivo, facilitating personalized treatment strategies. based reimbursement models, rewarding medical devices that demonstrate improved clinical outcomes and cost-effectiveness. These changes are reshaping the competitive landscape of the medical device industry, encouraging investment in innovation, and fostering collaboration between industry stakeholders, healthcare providers, and regulatory agencies. Implantable Medical Devices Implantable medical devices have witnessed significant advancements, offering innovative solutions for the treatment of various medical conditions, including cardiovascular disease, neurological disorders, and chronic pain. Cardiovascular implants, such as pacemakers, defibrillators, and stents, are continuously evolving with features like remote monitoring, leadless pacing, and drug-eluting coatings to improve patient outcomes and reduce complications. Similarly, neurostimulation devices, including deep brain stimulators and spinal cord stimulators, provide targeted therapy for chronic pain, movement disorders, and psychiatric conditions, enhancing patient quality of life. Furthermore, advances in materials science and biocompatibility have led to the development of bioresorbable implants and tissue-engineered scaffolds, minimizing the need for long-term device implantation and promoting tissue regeneration. Additionally, point-of-care testing devices offer rapid and convenient diagnostic solutions, allowing for timely interventions and improved patient outcomes. Personalized medicine holds great promise for the treatment of cancer, cardiovascular disease, and other complex conditions, offering the potential to optimize therapeutic efficacy while minimizing adverse effects. Conclusion Advancements in the medical device industry are revolutionizing healthcare delivery, enabling more precise diagnostics, personalized treatments, and minimally invasive interventions. From digital health technologies and precision diagnostics to implantable devices and advanced imaging modalities, these innovations are improving patient outcomes, reducing healthcare costs, and enhancing the overall quality of care. As technology continues to evolve and regulatory frameworks adapt to new challenges, the medical device industry is poised for continued growth and innovation, driving the future of healthcare forward. Advanced Imaging Modalities Advanced imaging modalities play a crucial role in diagnosis, treatment planning, and disease monitoring across various medical specialties. MRI, CT, and PET/CT scanners provide detailed anatomical and functional information, enabling clinicians to visualize internal structures and detect abnormalities with high sensitivity and specificity. Regulatory and Reimbursement Landscape Moreover, advancements in imaging technology, such as high-resolution imaging, spectral imaging, and molecular imaging, offer new insights into disease pathology and treatment response. For example, functional MRI and diffusion tensor imaging allow for the mapping of brain activity and connectivity, aiding in the diagnosis and management of neurological disorders. Similarly, molecular imaging techniques, such as positron emission tomography (PET) and single-photon emission computed tomography (SPECT), enable the visualization of biochemical processes The regulatory and reimbursement landscape of the medical device industry is undergoing significant changes, driven by advancements in technology, evolving healthcare policies, and increasing focus on patient safety and value-based care. Regulatory agencies, such as the FDA and EMA, are implementing streamlined pathways for the approval of innovative medical devices, including breakthrough designations, accelerated approvals, and adaptive pathways. Moreover, reimbursement policies are shifting towards value- www.worldcaremagazine.com 24

27. , , - Dr. Carolyn Clancy The strength of women leaders in healthcare is their ability to inspire, nurture, and drive change. They are the catalysts for a more compassionate and effective healthcare system. www.worldcaremagazine,com

28. Breakthroughs in Medical Device Technologies M revolutionizing patient care and transforming the landscape of healthcare delivery. From wearable devices to implantable sensors, these breakthroughs are empowering both patients and healthcare professionals with real-time data, improved diagnostics, and personalized treatment approaches. Further, we delve into some of the most significant breakthroughs in medical device technologies and their profound impact on patient care. costs, and improves overall patient satisfaction. Remote Patient Monitoring Systems edical device technologies have been advancing at an unprecedented pace, Remote patient monitoring systems leverage telecommunication technologies to monitor patients' health status outside traditional healthcare settings. These systems enable healthcare providers to remotely collect and analyze patient data in real- time, facilitating timely interventions and reducing the need for frequent hospital visits. From managing chronic conditions to post-operative care, remote patient monitoring enhances patient outcomes, reduces healthcare Wearable Health Monitoring Devices Implantable Medical Devices Wearable health monitoring devices have emerged as a game-changer in preventive healthcare. These devices, ranging from fitness trackers to smartwatches, are equipped with sensors that continuously monitor vital signs such as heart rate, blood pressure, and sleep patterns. With the integration of advanced algorithms and artificial intelligence, these devices can provide insights into overall health and detect abnormalities at an early stage. Moreover, they empower individuals to take control of their health by encouraging physical activity and healthy lifestyle choices. Implantable medical devices have witnessed remarkable advancements, offering innovative solutions for various medical conditions. From pacemakers and defibrillators to neurostimulators and insulin pumps, these devices are designed to deliver targeted therapies and improve patient outcomes. Recent developments in materials science, miniaturization, and wireless communication have led to the development of smaller, more durable, and energy-efficient implants, enhancing both safety and efficacy. Additionally, bioresorbable implants are being explored to eliminate the www.worldcaremagazine.com 26

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30. Artificial Intelligence in Medical Imaging need for device removal procedures, further improving patient comfort and recovery. Conclusion Breakthroughs in medical device technologies are reshaping the future of healthcare, empowering patients, and healthcare professionals with innovative tools and solutions. From wearable devices and remote monitoring systems to implantable devices and advanced imaging technologies, these innovations are revolutionizing patient care by enabling early detection, personalized treatment, and improved outcomes. As technology continues to evolve, the potential for further advancements in medical device technologies is limitless, promising a future where healthcare is more accessible, efficient, and patient-centered. Artificial intelligence (AI) is increasingly being integrated into medical imaging devices to enhance diagnostic accuracy and efficiency. AI algorithms can analyze complex medical images, such as X-rays, MRI scans, and CT scans, to detect subtle abnormalities and assist radiologists in making accurate diagnoses. By leveraging large datasets and machine learning techniques, AI-powered medical imaging systems can identify patterns, predict disease progression, and even recommend personalized treatment plans. This not only improves patient outcomes but also streamlines workflow and reduces diagnostic errors. Smart Prosthetics and Exoskeletons Smart prosthetics and exoskeletons are revolutionizing mobility and independence for individuals with limb loss or mobility impairments. These advanced devices utilize robotics, artificial intelligence, and sensory feedback mechanisms to mimic natural movement and enhance user control. By integrating sensors and actuators, smart prosthetics can adapt to the user's movements and provide real-time adjustments, improving comfort and functionality. Similarly, exoskeletons enable individuals with paralysis or weakness to regain mobility and perform daily activities with ease, thereby improving their quality of life and overall well-being. Nanotechnology-Based Medical Devices 3D Printing in Medical Device Manufacturing Nanotechnology holds immense potential in the development of novel medical devices with superior performance and therapeutic capabilities. Nanoscale materials and structures enable precise control over properties such as size, shape, and surface characteristics, making them ideal for targeted drug delivery, diagnostics, and tissue engineering. Nanotechnology-based medical devices, such as nanoparticle-based drug carriers and nanosensors, offer improved biocompatibility, enhanced drug efficacy, and reduced side effects compared to conventional counterparts. Furthermore, nanomaterials can be functionalized to interact with biological systems at the molecular level, opening up new possibilities for personalized medicine and regenerative therapies. The advent of 3D printing technology has transformed the landscape of medical device manufacturing, enabling the production of customized implants and prosthetics with unprecedented precision and efficiency. 3D printing allows for rapid prototyping and on-demand production, significantly reducing lead times and costs associated with traditional manufacturing methods. Moreover, it enables healthcare providers to tailor medical devices to individual patient anatomy, ensuring optimal fit and functionality. From orthopedic implants to dental prosthetics, 3D printing is revolutionizing the way medical devices are designed, manufactured, and deployed. www.worldcaremagazine.com 28

31. www.worldcaremagazine,com , , A strong healthcare system requires leaders who are both compassionate and innovative. Women in leadership bring these qualities in abundance. - Dr. Atul Gawande

33. An ounce, of prevention is worth a pound of cure. - Benjamin Franklin

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