Joe Mullings Front Man Edition MOL 5

05 Joe Mullings talks Evolution of MedTech Leadership, Storytelling Innovation, Sectors with Growth, and MedTech Future.

Robert j. Krummen talks Vektor Medical and innovation in cardiac arrhythmias therapies.

Yuri Haverman talks user-driven innovation, adaptability to emerging technologies, global strategy, and crossfunctional teamwork as key to sustainable growth and scalability in MedTech.

Olivier Delporte talks SamanTree and innovation in operating room environment.

28 Anne Rhea talks how AI is transforming MedTech content creation by improving efficiency, enabling compliance, and reducing manual workload while emphasizing the need for strong data structure, human oversight, and long-term strategy

THIS ISSUE

34 Michael van Driel talks Critical Care Access revolution, Life-Saving ECMO Technology innovation, CBM Lifemotion going Global.

Kash Ikram talks Telesurgery, MicroPort as an Innovator-Pioneer and the new Era of Robotic Assisted Surgery.

48 Phil Norris talks about a novel approach for the early diagnosis and monitoring of neurological disorders

53 Mathias Bouzereau talks balancing global and local MedTech strategies, commercializing niche innovations, integrating digital health, scaling globally, making smart strategic investments, and building highperforming, trust-based teams for long-term success.

Elfareato Remekie talks how to become a colleague, not just a vendor, to your customer in MedTech.

FROM THE EDITOR

I would like to welcome you to our issue MedTech Opinion Leader.

At MedTech Opinion Leader, we are dedicated to bringing you the latest insights from industry trailblazers, comprehensive analyses, and forward-thinking perspectives Our mission is to empower you with the knowledge and insights needed to shape your own vision in the ever-evolving medical technology landscape. Through expert commentary and in-depth coverage, we strive to be your go-to source for staying ahead of the curve in this dynamic field.

THE LATEST ISSUE OF MEDTECH OPINION LEADER FEATURES INSIGHTS FROM INDUSTRY LEADERS ON INNOVATION IN ROBOTICS, AI, LEADERSHIP, COMMERCIALIZATION, AND BREAKTHROUGH TECHNOLOGIES—FROM CARDIAC CARE TO NEUROLOGY —ALONG WITH STRATEGIES FOR SCALING, STORYTELLING, AND BUILDING HIGHPERFORMING TEAMS.

Stan Kalinin

JOE MULLINGS

MEDTECH OPINION LEADER: JOE MULLINGS TALKS EVOLUTION OF MEDTECH LEADERSHIP, STORYTELLING INNOVATION, SECTORS WITH GROWTH, AND MEDTECH FUTURE

Stan: Joe, you've witnessed and helped shape the evolution of the MedTech industry for over 30 years. What key shifts in leadership style have you seen, and which qualities do you believe are most crucial in today's ecosystem?

Joe: The management of change by leadership and the rate of acceleration of change continue to ramp at a pace of unmatched intensity in our industry. And this is likely to continue.

Medical device is a subset of medtech, and medtech touches everything in our healthcare community. Without medtech, you would not have pharma or biotech Diagnosis of disease is medtech, whether imaging, blood / fluid testing, or the engagement of care and therapy; these are dominated by medtech. Without medtech from Class 1 to Class 3 devices, you would not have sites of care such as hospitals or ASCs

We are in the very early days of highly profitable, highly scalable, and highly accessible categories being driven by software, AI, and ML These disciplines and functions have not been native to the medtech environment, which has been primarily analog in nature as we think about historical medical devices around implants, catheters, and even diagnostic imaging modalities.

The leaders who understand and execute when it comes to attracting and retaining emerging new and incredibly valuable customers and the future team members of their organization will win by serving their legacy customers, which are payers, providers, and patients

Traditionally, and still in most cases habitually, the industry has a talent acquisition mindset, not a talent access mindset

The best leaders will emerge by creating access to your organization and constantly revealing

your market, technology, leadership, and mission to the highest valued talent in and yet to be in the medtech industry

The dynamic of Price's Law, especially in rapidly accelerating technology sectors, states that the square root of the number of people in an organization creates more than 50% of the valued work. They are also referred to as Force Multipliers and should be where all leaders focus their efforts

THE DYNAMIC OF PRICE'S LAW, ESPECIALLY IN RAPIDLY ACCELERATING TECHNOLOGY SECTORS, STATES THAT THE SQUARE ROOT OF THE NUMBER OF PEOPLE IN AN ORGANIZATION CREATES MORE THAN 50% OF THE VALUED WORK. THEY ARE ALSO REFERRED TO AS FORCE MULTIPLIERS AND SHOULD BE WHERE ALL LEADERS FOCUS THEIR EFFORTS.

Stan: TMG and Dragonfly have become synonymous with bold, media-driven strategies in MedTech. What led you to position storytelling and content as core tools for industry growth and visibility?

Joe: Historically, the executive search industry was a single point of influence One phone call, one conversation, hang up, and do it again For those of us OGs who grew up in search, before computers and even fax machines as tools, where we had index cards and a SIC code book, and that was it, that is how we were trained

In 2015, my firm, The Mullings Group, was selected to build a surgical robotic company called Verb Surgical, a joint venture between Google and Johnson & Johnson, in the Bay Area, where we had to hire over 200+ highly technical people in about 24 months to meet the aggressive goals of the program If you have been in search, that hiring agenda would mean contacting over 15,000 people (roughly 75 people recruited per role filled), let alone the management of the hiring process once individuals entered the interview process.

A massive undertaking, I brought a solution to the CEO of Verb Surgical, Scott Huennekens, who has always been forward-thinking and shared the concept of telling the story with video from the Google campus of what we were doing, why we were doing it, and what it meant for career development. Who will you become if you join Verb?

At the time, LinkedIn was not using video as a tool, and the executive search industry certainly wasn't. I contacted LinkedIn and asked if they planned on using video on the platform, and indeed, they were just initiating a beta program using video and we were able to participate. We were one of the first organizations to utilize video on LinkedIn and the first search firm to use video as a hiring access tool

We went on to execute the building of Verb Surgical and then introduced the use of storytelling around building companies and careers and defining Who Will You Become?™ when you join the right team.

Today, Dragonfly is the go-to storytelling team in medtech We are a 9-time award-winning organization, and One60 Studios in Delray Beach has become a destination for medtech leaders to come and tell their stories.

Stan: Do you believe MedTech companies are doing enough to communicate their value — not just to customers but to partners, investors, and the wider ecosystem? Where do you see the gaps?

Joe: Medtech has had a challenge in articulating its value to the entire ecosystem of patients, investors, customers, and its future employees Pharma certainly does, and pharma is not nearly as exciting and sexy as medtech. Pharma bombards the consumer market with its advertising while medtech stays silent

I believe some of this comes from the overly cautious regulatory and marketing decisionmakers in organizations operating from a legacy mindset.

MEDTECH HAS HAD A CHALLENGE IN ARTICULATING ITS VALUE TO THE ENTIRE ECOSYSTEM OF PATIENTS, INVESTORS, CUSTOMERS, AND ITS FUTURE EMPLOYEES. PHARMA CERTAINLY DOES, AND PHARMA IS NOT NEARLY AS EXCITING AND SEXY AS MEDTECH. PHARMA BOMBARDS THE CONSUMER MARKET WITH ITS ADVERTISING WHILE MEDTECH STAYS SILENT.

Telling the story around saving, extending, and improving lives does not have to "make claims" in areas that may expose an organization. These organizations need to tell stories to the market Patients / customers can drive their pathway to health and elevated performance beyond just good health if they know options and therapies exist

This should not be relegated to the predictable "corporate videos," where it is a sterile, predictable single-frame scripted shot of a talking head We are so much more than that Have a look at the Award-Winning TrueFuture (Truefuture.tv) docuseries. It has inspired so many medical device companies to show up in an entirely different and more influential way in today's market. Not only sharing therapies and solutions but, perhaps even more importantly,

attracting those who do not even know amazing careers exist in medtech and that they can change their and other people's lives.

Stan: You've positioned Dragonfly almost as a standalone MedTech media engine. How do you see this platform contributing to commercial strategy and organizational leadership in the sector?

Joe: Dragonfly, the organization, and One60 Studios, the destination production facility we have in Delray Beach, have become the team and the facility that progressive organizations have partnered with when they want to share the technology they are developing, the round of financing they are raising, or the commercial team they are building.

TELLING THE STORY AROUND SAVING, EXTENDING, AND IMPROVING LIVES DOES NOT HAVE TO "MAKE CLAIMS" IN AREAS THAT MAY EXPOSE AN ORGANIZATION. THESE ORGANIZATIONS NEED TO TELL STORIES TO THE MARKET. PATIENTS / CUSTOMERS CAN DRIVE THEIR PATHWAY TO HEALTH AND ELEVATED PERFORMANCE BEYOND JUST GOOD HEALTH IF THEY KNOW OPTIONS AND THERAPIES EXIST.

Whether on the road at a client site or big industry events like TCT, The MedTech Conference by AdvaMed, SAGES SDTS, or LSI, leaders know that the 200,000 sets of medtech eyes on our channels daily give them an opportunity to share their message in a way that does not just advertise but educates and inspires That is critical As an organization, we strive to build, tech, inspire, and educate in everything we do.

Stan: As someone deeply embedded in the space, what areas of MedTech whether robotics, stroke care, or digital surgery — do you see as most ripe for commercial acceleration in the next few years?

Joe: There are so many sectors within medtech that have fantastic opportunities over the next few years I look at medtech not as a particular therapy or technology. I view it as a series of behaviors and incentives that drive the business model Sites of care are shifting from hospitals to ASCs The management of chronic disease eats up nearly 80% of the 18% of this country's GDP directed towards healthcare. The current incentives are not aligned to manage those disease states effectively Digital enablement, whether in the form of robotics, imaging & diagnostics, or utilizing AI and ML, will provide advisement to the teams who are in the different sites of care Today, the employee profile in a hospital versus an ASC is as different as the profile between a person in a large strategic versus a startup One is not better than the other; it is just different And that is going to dictate tools, sales processes, and products. Revenue models are changing; lease, surgery as a service, and pay-per-click are all going to define commercial success and paths to market

The medical devices, management, and efficiency tools in medtech that have not previously existed that use AI and ML will likely get traction in ASCs and then be driven up into the hospital setting.

Entropy in the current healthcare system is real Those who position their product platforms to address that will have higher adoption rates of new technologies

Stan: What advice would you offer to emerging leaders in MedTech who are navigating both technological disruption and increasing visibility demands?

Joe: This is a complex question. Leadership in emerging tech companies, startups, and larger strategics have different risk thresholds to manage and different business models to navigate.

Startups and emerging tech companies are literally fighting for their existence. In contrast, the strategics, which are somewhat constrained by being public companies, have more than a single platform to tend to and a complicated ecosystem of tens of thousands of employees as well as shareholders.

However they choose to communicate, they need to articulate and set expectations that this is an incredibly dynamic time in medtech, more than any previous era, and it will continue to be that way We already know that in the absence of information, human nature will tend to insert a less-than-optimal story in its place. This is biological, it keeps us alive, we are wired to expect a harsher tomorrow, or else we would not have made it through the ages.

More long-form, candid, and extended conversations would be ideal, but internal Investor Relations people and Regulatory conservatives usually suffocate those talking points around the critical opinions and insights that the industry needs to hear from its leaders

I have faith in medtech leadership. They want to share, and our goal is to continue building a platform that provides a space for these conversations to take place.

ENTROPY IN THE CURRENT HEALTHCARE SYSTEM IS REAL. THOSE WHO POSITION THEIR PRODUCT PLATFORMS TO ADDRESS THAT WILL HAVE HIGHER ADOPTION RATES OF NEW TECHNOLOGIES

ROBERT J. KRUMMEN

MEDTECH OPINION LEADER: ROBERT J. KRUMMEN TALKS VEKTOR

MEDICAL AND INNOVATION IN CARDIAC ARRHYTHMIAS THERAPIES

Stan: How does Vektor Medical’s technology directly improve outcomes or experiences for patients with cardiac arrhythmias?

Rob: Vektor Medical was founded for the purpose of helping to improve outcomes for patients suffering from cardiac arrhythmias. Our vMap® technology provides an advanced, novel, and completely non-invasive way for physicians to better understand each patient’s arrhythmia.

vMap was developed with AI and uses advanced computational analyses of the 12-lead ECG to rapidly identify potential arrhythmia sources across all four chambers of the heart, including areas that are not easily visualized or identified using conventional mapping methods This enables clinicians to make more informed decisions earlier in the care pathway, potentially reducing the time to treatment and improving ablation outcomes

Clinical studies have shown that for patients, this translates into a faster, safer, and more effective personalized treatment experience.

Stan: In what ways does Vektor’s platform support electrophysiologists in decisionmaking and procedural planning, and how does it integrate into clinical workflows?

vMap supports electrophysiologists across the full continuum of care - from triage and diagnostic evaluation to procedural planning and intra-procedural decision-making By providing a rapid, chamber-wide view of potential arrhythmia sources, vMap enables EPs to validate clinical hypotheses, refine procedural strategy, and identify targets that may otherwise be missed Because vMap integrates seamlessly with existing ECG platforms, market-leading 3D mapping systems, and is non-invasive, it is easily adopted into existing clinical workflows

VEKTOR MEDICAL WAS FOUNDED FOR THE PURPOSE OF HELPING TO IMPROVE OUTCOMES FOR PATIENTS SUFFERING FROM CARDIAC ARRHYTHMIAS. OUR VMAP® TECHNOLOGY PROVIDES AN ADVANCED, NOVEL, AND COMPLETELY NON-INVASIVE WAY FOR PHYSICIANS TO BETTER UNDERSTAND EACH PATIENT’S ARRHYTHMIA.

Many electrophysiologists incorporate vMap into pre-procedural planning and reference it in real time to enhance accuracy and improve overall efficiency

As electrophysiologists integrate pulsed field ablation (PFA), vMap is becoming an invaluable tool Combining the benefits of PFA with vMap’s rapid, non-invasive ECG-based driver localization has the potential to enable a more effective treatment strategy, helping to improve ablation outcomes while maintaining the procedural efficiencies of PFA

Stan: As a leadership team, how do you balance bold innovation with clinical and regulatory rigor in a fast-evolving MedTech landscape?

Rob: At Vektor, bold innovation is inseparable from clinical and regulatory discipline vMap is the only FDA-cleared, non-invasive platform developed with AI to localize arrhythmia sources using a standard 12-lead ECG; a technological breakthrough grounded in years of rigorous development, clinical research, and regulatory oversight.

Every advancement we pursue is anchored in scientific rigor, with compliance built into the process from the outset to ensure clinical relevance, reproducibility, and patient safety

Our recently launchedIMPRoVED AFclinical trial a prospective, multi-center, randomized controlled study is designed to evaluate whether vMap-guided ablation improves outcomes in patients with persistent and recurrent atrial fibrillation by targeting nonpulmonary vein electrical drivers

Together with ourVITAL-EPreal-world data registry, these initiatives reflect our long-term commitment to generating high-quality evidence and driving adoption based on outcomes, not just innovation.

Stan: What strategies has Vektor Medical employed to gain trust and traction with leading cardiac centers and KOLs in electrophysiology?

Rob: From the beginning, Vektor’s strategy has centered on clinical collaboration and datadriven validation. We engaged electrophysiologists early to understand realworld needs and designed vMap to address procedural challenges while fitting seamlessly into established workflows.

Equally important is our commitment to clinical evidence. vMap has been featured in multiple peer-reviewed studies and abstracts, demonstrating its accuracy, impact on procedural efficiency, and value in emerging ablation strategies. This foundation of physician partnership and outstanding clinical data has earned the confidence of leading cardiac centers and KOLs who are shaping the future of arrhythmia care.

Stan: Looking ahead, how do you envision the evolution of Vektor Medical’s technology beyond its current application in shaping the future of non-invasive cardiac mapping?

Rob: We see vMap as a foundational platform for the future of non-invasive, data-driven cardiac intelligence While our current focus is on improving procedural efficiency and outcomes in focal and fibrillation-type arrhythmias, the underlying AI framework has potential applications across the cardiac care spectrum, including the potential to further personalize medicine.

As we expand clinical indications and integrate additional data streams, vMap will continue to evolve as a critical cardiac tool, helping physicians deliver more accurate, efficient, and value-based care across a broader range of cardiac conditions

WE SEE VMAP AS A FOUNDATIONAL PLATFORM FOR THE FUTURE OF NON-INVASIVE, DATA-DRIVEN CARDIAC INTELLIGENCE.

YURI HAVERMAN

MEDTECH OPINION LEADER: YURI HAVERMAN TALKS USER-DRIVEN INNOVATION, ADAPTABILITY TO EMERGING TECHNOLOGIES, GLOBAL STRATEGY, AND CROSS-FUNCTIONAL TEAMWORK AS KEY TO SUSTAINABLE GROWTH AND SCALABILITY IN MEDTECH.

Stan: You’ve helped drive growth in both Fortune 500 companies like BD and highgrowth start-ups. What do you believe is the key to sustainable growth in MedTech today?

Yuri: The most important driver of growth in MedTech has always been and continues to be the relentless focus on driving innovation to improve patient outcomes. Patients are at the heart of everything we do at BD and having a first-hand understanding of their needs, journeys and interactions with care providers and healthcare systems is paramount to ensuring great product-market fit. This allows us to put our energy and resources into market opportunities that have the best potential for value creation, category innovation and can generate sustainable growth

The other important competency is adaptability in an ever-changing environment Companies that are slow to adapt will miss out on great opportunities, such as AI and robotics, that are sharping the healthcare industry Adaptability allows openness to partnerships and collaborations where parties bring complementary technical, clinical and commercial assets to maximize impact.

Here at BD, we have several examples of such collaborations, including our recently launched next generation infusion systems in Europe where we partnered with Medcaptain, another agile innovator in this space

Lastly, I believe having a global mindset embedded into strategic and operational planning can help MedTech companies diversify their revenue streams Being overindexed on a specific geography introduces geopolitical and regulatory risks. On the other hand, having access to multiple geographies enables companies to capture the growing utilization of their services and products driven by factors such as improved access to healthcare and upgraded standards of care

Stan: You’ve mention innovation being the key driver of growth. What is the innovation process that you are using to maximize the impact?

Yuri: Let’s start from the end. The true measure of successful innovation, at least in my opinion, is user adoption No matter how cool the technology is, if users are not excited about it and are not voting with their wallets, it is missing the mark

So, if we agree that user adoption is what we are after, understanding the unmet user needs, their behaviors and preferences, clinical and operational workflows and how this innovation can fit into and improve their lives is absolutely essential.

PATIENTS ARE AT THE HEART OF EVERYTHING WE DO AT BD AND HAVING A FIRST-HAND UNDERSTANDING OF THEIR NEEDS, JOURNEYS AND INTERACTIONS WITH CARE PROVIDERS AND HEALTHCARE SYSTEMS IS PARAMOUNT TO ENSURING GREAT PRODUCT-MARKET FIT.

For example, when we were working on BD neXus, our next generation infusion platform, our teams spent thousands of hours interacting with nurses and biomedical engineers to better understand their pain points and incorporate their feedback into product design. Having this unparalleled customer insight and validating target product profile directly with the end user allowed our cross-functional teams to focus on the real drivers of adoption such as fast infusion set-ups, intuitive interface and easy maintenance As a result, we saw a great uptake in adoption, installing thousands of devices in the first two months after launch.

Of course, there are many other aspects of the innovation process, including business models, regulatory strategy, channel and organizational readiness, health economics and market access, but it all starts and ends with the customer. We are always encouraging our employees who are involved in new product development to spend as much time as possible in the field observing, engaging and learning from patients, clinicians and other healthcare professionals. This is the best way to ensure that innovations will properly address their needs and deliver better clinical and operational outcomes, paving the way to product adoption and revenue growth

Stan: Many MedTech firms struggle to generate new revenue streams once their product matures. How do you typically approach this challenge?

Yuri: It’s a great question and should be top of mind for MedTech executives No matter how great the product is, there will be a time where it will transition from its rapid growth stage to maturity and eventually will be replaced with another innovation Recognizing this dynamic and approaching product lifecycle management proactively enables more predictable revenue and profitability management So, what can be done preemptively?

First, I’d recommend planning and operationalizing your next generation of technology as soon as you have launched the current one, rapidly incorporating customer feedback and competitive insights This way, the company can ensure continuous innovation cadence that is both valued by its customers and allows to maintain and expand its share of category

The second pillar is making sure that we fully leverage what the current product still has to offer

NO MATTER HOW GREAT

THE PRODUCT IS, THERE WILL BE A TIME WHERE IT WILL TRANSITION FROM ITS RAPID GROWTH STAGE TO MATURITY AND EVENTUALLY WILL BE REPLACED WITH ANOTHER INNOVATION.

Can it be an attractive product maybe in a different geography or another segment of the market? Can we offer additional services around this product that customers would value and can be monetized? How can we continue to improve its profitability through operational improvements and pricing optimization? Considering and answering these questions allows us to minimize revenue and profit stagnation at the later stages of product lifecycle and transition between product generations more smoothly

Lastly, it is important to manage the overall portfolio and not just a specific product proactively What I mean by this is that we need to be very choiceful in where we want to play and make sure we have the right degree of exposure to the fast-growing spaces and are not getting into scenario where most of the portfolio is in its late mature stage. Very similar to how we are thinking about our financial portfolios, product portfolios also need to be pruned and rebalanced over time to better align with company’s objectives.

Stan: You’ve led teams across the continents. What’s your leadership philosophy when it comes to building high-performance teams in the MedTech industry?

Yuri: High-performance teams are the engine of MedTech growth. To operate at the nexus of cutting-edge innovation, rigorous regulatory oversight, complex supply chains while positively impacting patients and caregivers, they need to be not only exceptionally skilled in their subject matter, but also adaptable, collaborative and resilient

The foundational pillar, in my opinion, is having a joint sense of purpose, strong values, customer-centric mindset and clear leadership expectations.

In BD, we call this “The BD WAY” and every employee is familiar with its core tenants, such as our purpose of Advancing the world of health™, the values of doing what’s right and being accountable, the expectation of being bold and strategic and the mindset of learning and improving every day Having “The BD WAY” as our north star and manifesting the purpose, the values and the mindset daily to deliver on expectations, enables teams to focus on what matters most and stay aligned across various functions and geographies

We also have BD Excellence, which is our lean operations system and culture of continuous improvement to help fuel world-class performance access the enterprise.

Once the foundation is in place, the next challenge is to ensure the right balance of skills and competencies within the team. To achieve transformative results and unlock value creation the team needs to be able to collaborate and communicate across functional domains. Having a team of individual functional “rock-stars” does not serve the purpose if they cannot work effectively together, breaking the siloes So, when hiring, it is important to look beyond the subject matter expertise to understand their softer skills, leadership styles and problemsolving capabilities, specifically within the team context rather than as an individual contributor.

Diversity is another crucial factor when building a high-performing team. Having different cultural backgrounds and professional experiences enables teams to see the problem from different angles, often prompting constructive debates and “out-of-thebox” thinking and ultimately arriving at a better solution

The final piece is establishing operating mechanisms that are fit for purpose, provide

IN BD,

WE CALL THIS “THE BD WAY” AND EVERY EMPLOYEE IS FAMILIAR WITH ITS CORE TENANTS, SUCH AS OUR PURPOSE OF ADVANCING THE WORLD OF HEALTH™, THE VALUES OF DOING WHAT’S RIGHT AND BEING ACCOUNTABLE, THE EXPECTATION OF BEING BOLD AND STRATEGIC AND THE MINDSET OF LEARNING AND IMPROVING EVERY DAY.

visibility on the progress made relative to the team’s objective and drive accountability. Empowering team members with autonomy and accountability, while providing guidance, when necessary, is crucial for fostering trust, improving agility and delivering results that matter. As leaders, our job is not to micromanage but rather focus the team on the right problems to solve and help them achieve success by removing any real or perceived barriers to execution.

Stan: What advice would you give to a MedTech founder looking to prepare for scale – or even an acquisition by a company like BD?

There are some obvious things that all MedTech founders should be focusing on such as thoughtful technology productization, proven clinical validation and commercial traction. I would also think about two additional aspects – operational scalability and compliance, both to be embedded upfront into design phases rather than being an afterthought.

Operational scalability is not just about manufacturing, but rather the full operational rhythm from sales forecasting to production planning to inventory management, the socalled SIOP (Sales, Inventory, Operations Planning) process As the company scales it is important to be able to scale all parts of the supply chain and planning processes accordingly The last thing you’d want is to be running short on a critical component, not being able to serve customer demand and convert orders to cash. So, already at the design stage, it is important to think about design for manufacturing, sourcing, shipping and storage, as some of these choices may be difficult to reverse at scale. This doesn’t mean that the company needs to have everything in-house as partnering with reputable providers that can quickly scale volume is a good option.

Integrating regulatory compliance and quality management systems from the earliest stages of product development is also very important Having “compliance by design” approach where risks are proactively anticipated and managed, real-world data is collected to support safety and efficacy claims and the regulators are being engaged upfront to ensure alignment, can help shorten time to market and will also create higher confidence for potential partners and/or acquirers

OPERATIONAL SCALABILITY IS NOT JUST ABOUT MANUFACTURING, BUT RATHER THE FULL OPERATIONAL RHYTHM FROM SALES FORECASTING TO PRODUCTION PLANNING TO INVENTORY MANAGEMENT, THE SOCALLED SIOP (SALES, INVENTORY, OPERATIONS PLANNING) PROCESS.

OLIVIER DELPORTE

MEDTECH OPINION LEADER: OLIVIER DELPORTE TALKS SAMANTREE AND INNOVATION IN OPERATING ROOM ENVIRONEMENT

Stan: How does SamanTree’s Histolog® Scanner help bridge the gap in the operating room to improve outcomes for both hospitals and patients?

Olivier: One of the most persistent challenges in oncologic surgery is the intraoperative margin assessment (IOMA) gap between what can be visualized in real-time during surgery and what pathology confirms hours or days later. The Histolog® Scanner was specifically designed to close that gap by equipping surgeons with immediate, cellular resolution imaging at the point of care.

The Histolog Scanner is the first and only medical imaging device to use massively parallel confocal microscopy. This advanced technology combines the high-resolution clarity of confocal imaging with dramatically faster acquisition by capturing many points at once Rather than scanning a single point through the objective lens, the Histolog uses nearly 30,000 miniaturized lenses, generating images in approximately one minute that allow for margin assessment. This enables surgeons and pathologists to visualize biological tissue in real time without destroying the specimen, leading to more informed surgical decisions

From a patient’s perspective, this transforms the surgical experience They no longer have to go home and wait days in uncertainty, waiting for a call from their care team that may bring news of residual cancer left behind and the need for a second surgery Especially in procedures like breast-conserving surgery, the emotional toll of waiting and not knowing whether all the cancer was removed is significant. Histolog helps eliminate the uncertainty by enabling surgeons to assess the surgical margins in real-time, while the patient is still on the operating table, potentially avoiding the trauma of reoperation altogether

From a medical institution’s standpoint, it supports OR efficiency and cost containment, especially in high-volume procedures, including breast-conserving surgery and prostatectomies

From the payer’s perspective, reducing reoperations and minimizing postoperative complications translates into lower overall treatment costs and leads to new revenuegenerating opportunities It represents a case where clinical benefit and operational value truly align.

Stan: In what ways does SamanTree’s solution support the digitalization and automation of surgical workflows within the operating theatre?

Olivier: The Histolog Scanner represents a shift toward real-time digital pathology at the point of care Once a specimen is resected, it is stained (15 seconds) and scanned (~1 min per image) directly in the OR, producing histology-like resolution images that can be viewed, stored, and shared instantly, allowing for intraoperative collaboration between surgeons and pathologists either onsite or remotely. Specifically, the device integrates easily into surgical workflows with minimal specimen preparation and offers an intuitive touch-screen interface, reducing human resource burdens while supporting faster clinical decisions. By eliminating the delays and manual steps associated with traditional pathology workflows, our device speeds up margin assessment. As such, the Histolog Scanner definitively sets the stage for more standardized and automated surgical care

FROM A PATIENT’S PERSPECTIVE, THIS TRANSFORMS THE SURGICAL EXPERIENCE. THEY NO LONGER HAVE TO GO HOME AND WAIT DAYS IN UNCERTAINTY, WAITING FOR A CALL FROM THEIR CARE TEAM THAT MAY BRING NEWS OF RESIDUAL CANCER LEFT BEHIND AND THE NEED FOR A SECOND SURGERY.

Stan: How does SamanTree create value by collaborating with other companies in the surgical ecosystem?

Olivier: SamanTree Medical recognizes that innovation doesn’t happen in isolation. We work closely with leading surgical centers and technology partners to integrate the Histolog Scanner into broader clinical and surgical systems. These collaborations enhance interoperability, enable shared learning, and accelerate clinical adoption By aligning with other companies in the ecosystem, we’re collectively elevating the standard of care and expanding access to advanced intraoperative imaging around the world

In Europe, we have partnered with the ORSI Academy and Professor Alex Mottrie to allow physicians to engage with leading urologists and pathologists to understand how the Histolog Scanner is used and the value it can provide In the U.S., cases have been completed in eight hospitals. These centers we have are likely to become Reference Centers in 2025 and 2026, taking a leadership position in the field of IOMA

Stan: Bringing innovative medical technologies to market demands strong leadership. What core principles or foundation stones guide SamanTree’s approach?

Olivier: At SamanTree, our approach is grounded in scientific rigor, clinical impact, and a deep commitment to improving the patient experience We are driven by a commitment to quality, simplicity in design, and close collaboration with surgeons and pathologists. Our leadership team brings decades of experience in medical devices, diagnostics, and commercialization, which has enabled us to build trust, navigate regulatory pathways efficiently, and stay laser-focused on solving real-world problems in oncologic surgery

The Histolog Scanner was born from breakthrough research and technology invented at École Polytechnique Fédérale de Lausanne (EPFL),

one of Europe’s foremost centers of excellence in engineering and applied sciences. It is the perfect example of Saman Tree’s approach. It transforms intraoperative margin assessment from a reactive pathology process to a rapidacting, proactive surgical decision-making tool. We collaborate directly with surgeons, pathologists, and clinical researchers to ensure that the Histolog Scanner meets true intraoperative needs. This proximity to clinical realities is what defines how we lead.

Stan: What have been some of the key challenges and learnings when introducing the Histolog® Scanner into clinical practice?

Olivier: One of the biggest challenges has been evolving surgical mindsets and workflows to adopt a new intraoperative imaging modality. The most successful adoption occurs when the device does not disrupt workflow, but instead enhances it. By requiring minimal specimen preparation and the ability to deliver results in one minute or less, while producing images that are intuitive for surgeons and pathologists, we’ve managed to embed the Histolog Scanner within the natural flow of surgery.

The key learning has been that adoption is most successful when there is true collaboration between surgeons and pathologists. Histolog works best when both groups are engaged in real-time decision making, as it preserves the dialogue central to intraoperative care while significantly reducing time. This is especially relevant compared to intraoperative frozen section analysis (FSA), which is the current gold standard in some settings, such as for prostate surgery. In centers that perform FSA, we’ve seen the fastest path to adoption because the Histolog functions as a perfect replacement Specifically, in a clinical study comparing Histolog to NeuroSAFE frozen section during robotic-assisted radical prostatectomies, the Histolog showed equivalent diagnostic performance, while reducing turnaround time from approximately 50 minutes to eight minutes, an 85% reduction in assessment time, without compromise in accuracy

AT SAMANTREE, OUR APPROACH IS GROUNDED IN SCIENTIFIC RIGOR, CLINICAL IMPACT, AND A DEEP COMMITMENT TO IMPROVING THE PATIENT EXPERIENCE.

The impact in breast surgery is also very compelling The SHIELD study, presented at the San Antonio Breast Cancer Symposium and now published, showed a 67% reduction in breast cancer lumpectomy reoperation rates when the Histolog was used for intraoperative margin assessment. This level of strong early clinical evidence, combined with education and training, has been instrumental in building confidence and momentum among clinicians.

Stan: Looking ahead, how does SamanTree envision the future of intraoperative diagnostics, and what role will the company play in shaping it?

We see a not-so-distant future where intraoperative tissue assessments are not delayed or outsourced, but immediate and wholly integrated into the surgical workflow Our vision is to generate images that lead to realtime surgical margin assessment, becoming the standard of care, reducing variability, improving outcomes, and ultimately reshaping the future of cancer surgery globally

Furthermore, we see an opportunity where the Histolog Scanner may enable real-time imaging assessment of tissue from biopsies and determine within minutes whether specimens contain cancer cells

As an example, today, the pathway from diagnosis to treatment for prostate cancer generally takes several weeks Even in the bestcase scenario, it takes multiple days. SamanTree, alongside physicians we work with, envisions a future where this process is significantly shortened through real-time diagnosis using the Histolog Scanner. By enabling immediate tissue assessment at the time of biopsy and combining it with IOMA when surgery is required, we believe that same-day treatment may become a clinical reality. This is the model of the future.

FURTHERMORE, WE SEE AN OPPORTUNITY WHERE THE HISTOLOG SCANNER MAY ENABLE REAL-TIME IMAGING ASSESSMENT OF TISSUE FROM BIOPSIES AND DETERMINE WITHIN MINUTES WHETHER SPECIMENS CONTAIN CANCER CELLS.

ANNE RHEA

MEDTECH OPINION LEADER: ANNE RHEA TALKS HOW AI IS TRANSFORMING MEDTECH CONTENT CREATION BY IMPROVING EFFICIENCY, ENABLING COMPLIANCE, AND REDUCING MANUAL WORKLOAD WHILE EMPHASIZING THE NEED FOR STRONG DATA STRUCTURE, HUMAN OVERSIGHT, AND LONG-TERM STRATEGY.

Stan: How is AI currently transforming content creation and delivery within the MedTech industry?

Anne: TransPerfect, together with the EU’s largest medical device regulatory consultant (QServe), recently completed an industry-wide survey on the use of AI to automate business processes (referred to here as “process AI”) The results provided unique insights into how manufacturers across the industry are approaching AI implementation

For instance, we discovered that 75% of respondents were not satisfied with their AI results. However, we found a similar percentage were not employing basic strategies like structured data or model training In fact, only 28% of manufacturers are using a licensed (paid) and trained model for their AI implementation It’s no surprise the industry is experiencing mixed results

For those who have implemented process AI, 54% are using it for Summarization of External Content (literature search), 35% are using it for Authoring Assistance for Regulatory Content, and 29% are using Authoring Assistance for Business Correspondence The statistics are similar for device makers who are *evaluating* process AI implementation.

TransPerfect has been developing advanced neural translation engines (a type of AI) for a number of years Currently, neural engines are preferred over large language models (LLMs) for regulated content because they don’t introduce the output variability found with LLMs

TransPerfect recently introduced an AI Center of Excellence program that integrates translation engine training and output evaluation. The program is designed to help companies with a structured AI implementation that reduces translation cost and turnaround time without compromising quality.

TransPerfect is also working with clients on AI pilot projects for CER automation, literature search and retrieval, and specialized authoring assistance

It’s important to understand that the goal of process AI implementation is enhanced productivity, not human replacement. The regulated content generated in MedTech has an important safety function and, as such, requires a human-in-the-loop approach to ensure compliance with the EU AI Act’s requirements for high-risk systems

Stan: What are the biggest content-related pain points AI is helping to solve for global MedTech teams?

Anne: Global MedTech teams faced contentrelated challenges (manual processes, increasing volumes) even before MDR and IVDR Since then, the issue has gotten exponentially worse Labeling updates, new document types (like SSCPs and SSPs), and new PMS requirements have dramatically increased the volume and velocity of content creation and updates

In 2019, we sent an open letter to the European Commission warning of the challenges device makers faced in updating content across the entire industry, in multiple languages and under tight deadlines. The MDR and IVDR extensions helped, but the volume of work required would not have been possible without AI-supported processes. Now that the revised MDR/IVDR deadlines are approaching, AIsupported processes (especially in translation) areessential to keeping pace

WE DISCOVERED THAT 75% OF RESPONDENTS WERE NOT SATISFIED WITH THEIR AI RESULTS. HOWEVER, WE FOUND A SIMILAR PERCENTAGE WERE NOT EMPLOYING BASIC STRATEGIES LIKE STRUCTURED DATA OR

MODEL TRAINING.

At TransPerfect, we enhance these AI-driven efficiencies with human expertise and industryspecific workflows. Our integration of advanced tools, such as component content management systems (CCMS) for structured content and our GlobalLink technology for AIpowered translation helps teams streamline localization, maintain regulatory compliance, and ensure linguistic accuracy at scale The combination of smart automation and human oversight enables MedTech teams to manage large volumes of multilingual content with speed, consistency, and confidence

Stan: In a highly regulated environment, how can companies ensure AI-generated content meets compliance standards?

AI capabilities are progressing faster than regulations can adapt It’s important to understand key technologies, their strengths, risks, and the processes needed to ensure compliance. For example, LLMs offer translation capabilities but can produce variable outputs, which increases regulatory risk Neural AI engines are a better choice for regulated content because their translation output is more consistent

Overall, to maintain quality and avoid the highrisk requirements of the EU AI Act, qualified human review is essential. At TransPerfect, we do this by qualifying and testing linguistic resources across 12 medical device subject matters to ensure the most suitable “human in the loop.” Certification to key standards such as ISO 13485, 9001, and 18587 help support compliance, as do audit trails, version control, and clear governance in content management. These are foundational principles that support compliance, regardless of how content is produced

Stan: What are you most excited about in the future of AI for MedTech organizations?

Anne: I’m excited about the opportunity to develop AI-driven solutions that empower MedTech professionals in high-stakes

compliance roles across Regulatory, PMS, Labeling, Clinical, and more, to meet the content demands of MDR and IVDR head-on

From conversations with our clients, it’s clear that these new regulations have created a perfect storm: massive volumes of documentation, tight timelines, and processes that are still largely manual. The pain is real and with current systems, keeping up simply isn’t sustainable

That’s why we’re focused on building tools that go beyond automation to deliver real-world efficiency A great example is our self-serve machine translation portal Shortly after its launch, we deployed it with Medtronic to support PMS translations. The results were powerful: translation costs dropped by nearly 90%, and manual workload was reduced so significantly it freed up the equivalent of two full-time team members, allowing staff to reallocate their time to other critical MDR activities Only the most sensitive content still required traditional human translation.

This isn’t just about saving money It’s about helping teams stay ahead of growing regulatory complexity with fewer resources. According to PwC’s 2023 Medical Device Industry Outlook, 61% of MedTech companies report talent shortages in R&D, Regulatory, and Manufacturing as a major innovation hurdle. The combination of workforce pressures and regulatory demands means the need for smart, scalable content solutions has never been greater.

At TransPerfect, we’re committed to helping MedTech organizations bridge that gap so they can stay compliant, stay innovative, and continue delivering life-saving products to patients around the world

AI CAPABILITIES ARE PROGRESSING FASTER THAN REGULATIONS CAN ADAPT. IT’S IMPORTANT TO UNDERSTAND KEY TECHNOLOGIES, THEIR STRENGTHS, RISKS, AND THE PROCESSES NEEDED TO ENSURE COMPLIANCE.

What advice would you give to a MedTech organization just beginning its AI journey in content operations?

Anne: As AI adoption accelerates across the MedTech industry, organizations are eager to apply automation and intelligent systems to streamline Clinical, Regulatory, Labeling, and PMS content workflows However, our recent survey on AI in Clinical and Regulatory Content revealed several critical success factors for teams just beginning this journey

1. Assess Internal Capabilities Honestly

MedTech companies are often filled with brilliant engineers and highly technical teams, leading many to adopt a DIY approach to AI. While this ambition is admirable, it’s essential tofirst assess whether your internal resources truly have the expertise and capacity to lead an

AI implementation effectively If not, bringing in experienced external partners can help accelerate deployment, avoid costly missteps, and ensure the right architectural foundation is in place from day one

2. Define a Clear AI Policy

A well-articulated AI policy is no longer optionalit’s foundational. This should outline where and how AI is permitted within your organization, what types of data it can access, and how intellectual property is protected For example, if employees are using public AI tools for tasks like meeting transcription or note-taking, it’s crucial to consider what data is being shared Discussing proprietary R&D or legal strategy in a public AI tool, even unknowingly, can introduce major compliance and confidentiality risks

AT TRANSPERFECT, WE’RE COMMITTED TO HELPING MEDTECH ORGANIZATIONS BRIDGE THAT GAP SO THEY CAN STAY COMPLIANT, STAY INNOVATIVE, AND CONTINUE DELIVERING LIFE-SAVING PRODUCTS TO PATIENTS AROUND THE WORLD.

3. Invest in the Right Architecture and Data Structure

One of the most striking findings from our research: nearly 75% of MedTech manufacturers report being unsatisfied with their AI outcomes, yet the majority have not built the core infrastructure required to get meaningful results A key enabler is Retrieval-Augmented Generation (RAG). This is an architecture that blends large language models with a company’s internal, structured content to produce more accurate and relevant responses But RAG depends on structured, accessible data and many organizations have not yet made the necessary investments to clean, tag, and organize their content In short: freedom from manual content processes isn’t free, it requires upfront effort and strategic planning.

At this pivotal moment in MedTech innovation, AI holds real promise, but its value will be unlocked only by those organizations willing to treat it as a long-term investment, not a quick fix With the right foundation, tools, and governance, AI can become a transformative force in helping regulatory and clinical teams meet growing demands with greater speed, accuracy, and impact.

ONE OF THE MOST STRIKING FINDINGS FROM OUR RESEARCH: NEARLY 75% OF MEDTECH MANUFACTURERS REPORT BEING UNSATISFIED WITH THEIR AI OUTCOMES, YET THE MAJORITY HAVE NOT BUILT THE CORE INFRASTRUCTURE REQUIRED TO GET MEANINGFUL RESULTS.

MICHAEL VAN DRIEL

MEDTECH OPINION LEADER: MICHAEL VAN DRIEL TALKS CRITICAL CARE

ACCESS REVOLUTION, LIFE-SAVING ECMO TECHNOLOGY INNOVATION, CBM LIFEMOTION GOING GLOBAL

Stan: What inspired the founding of CBM Lifemotion, and how has your mission evolved as ECMO technology has advanced?

Michael: CBM Lifemotion was founded to address a fundamental need in critical care: making extracorporeal life support (ECLS) accessible, reliable, and effective for patients and care teams everywhere Our mission is rooted in the belief that advanced, life-saving technology should not be limited by geography or resources. From the beginning, we set out to add value across the healthcare ecosystem not just for patients, but also for clinicians, hospitals, and health systems. We saw an opportunity to bring meaningful innovation to one of the most critical aspects of medicine

We recognized that traditional ECMO systems were often complex, immobile, and reserved for specialized centers Our vision was to break down these barriers by designing a system that is portable, intuitive, and robust, enabling deployment in a wide range of settings from major academic hospitals to community facilities and even remote regions

“Our mission is to make life-saving ECMO technology accessible to every patient, everywhere regardless of geography or resources ”

Stan: How does CBM Lifemotion differentiate itself in a competitive medtech landscape, particularly in ECMO systems and support services?

Michael: CBM Lifemotion is built around vertical integration and deep clinical collaboration. We manage every stage of product development inhouse from design and component manufacturing to final assembly at our facilities in Shenzhen and Mirandola, the heart of Europe’s medical device industry. This structure gives us exceptional agility to respond to clinical feedback, maintain rigorous quality standards, and remain resilient in the face of global supply chain disruptions.

Our flagship Lifemotion® System is compact, modular, and CE-certified for up to 14 days of continuous use. It is engineered for mobility and simplicity, enabling rapid deployment in both hospital and transport settings The system’s performance has been validated through clinical use at University Hospital of Hannover in Germany, University Hospital Virgen de la Arrixaca in Murcia, Spain, University Hospital Antwerp in Belgium, and Rigshospitalet in Copenhagen, Denmark. Clinicians have praised its oxygenator efficiency, pump reliability, and intuitive interface each designed with direct input from ICU nurses and perfusionists to fit seamlessly into high-pressure workflows.

Beyond the device itself, we focus on long-term partnership with our users. We provide comprehensive training, simulation-based education, and 24/7 clinical support Our collaborations with Biomed Simulation and Usaneers allow us to deliver advanced AR/VRenabled training that enhances team preparedness and real-world performance This integrated approach combining robust technology with hands-on support and education positions CBM Lifemotion as a trusted and forward-looking partner in critical care

CBM LIFEMOTION IS BUILT AROUND VERTICAL INTEGRATION AND DEEP CLINICAL COLLABORATION. WE MANAGE EVERY STAGE OF PRODUCT DEVELOPMENT INHOUSE FROM DESIGN AND COMPONENT MANUFACTURING TO FINAL ASSEMBLY—AT OUR FACILITIES IN SHENZHEN AND MIRANDOLA, THE HEART OF EUROPE’S MEDICAL DEVICE INDUSTRY.

Stan: What are the biggest challenges in bringing ECMO to more patients globally, and how is CBM Lifemotion addressing them?

Michael: Expanding global access to ECMO is shaped by several factors: technological complexity, training needs, and resource limitations Historically, ECMO systems have been large, intricate, and confined to highresource hospitals.

CBM Lifemotion was created to change that The Lifemotion® System was engineered to be lightweight, transportable, and easy to use in a variety of care environments from emergency rooms and ICUs to inter-hospital transport and remote locations A case in Spain demonstrated the system’s full transport capability during an inter-hospital transfer, with ECMO maintained entirely on battery power It proved our design works even in the most logistically challenging settings.

By streamlining manufacturing and leveraging economies of scale, we are also able to offer cost-effective solutions suitable for both advanced tertiary centers and resource-limited settings We’ve prioritized modularity, which allows hospitals to scale capabilities gradually Everything we do is about one goal: ensuring ECMO reaches the patients who need it, regardless of geography or infrastructure

“We’re committed to breaking down barriers whether technological, geographic, or educational so that ECMO can reach those who need it most ”

Stan: Can you speak to any recent innovations or upcoming technologies CBM Lifemotion is developing to improve patient outcomes or provider efficiency?

Michael: Innovation at CBM Lifemotion is guided by clinical input and shaped by the evolving realities of frontline care. Because we manage our full value chain internally, we are able to respond quickly to real-world needs refining, testing, and implementing improvements without the delays or constraints of external supply dependencies.

To close training gaps, we’ve developed robust education programs with in-person simulation, digital resources, and remote support Our partnerships with Biomed Simulation and Usaneers are central to this, enabling highfidelity, AR/VR-based education that equips multidisciplinary teams for ECMO deployment across diverse scenarios.

The current Lifemotion® System includes several key innovations: a low-pressure-drop oxygenator that minimizes blood trauma, modular pump components for simplified workflows, and a user interface co-designed with ICU nurses and perfusionists to streamline decision-making and reduce training time.

Looking ahead, we are exploring the development of next-generation features such as integrated SvO₂ and hematocrit (Hct) monitoring. These capabilities are increasingly requested by clinicians managing complex cases and could enhance our offering in future public tenders across Europe. We are also evaluating opportunities in remote diagnostics and teleECMO, which hold strong potential for extending expert support into underserved or remote care settings.

EXPANDING

GLOBAL ACCESS TO ECMO IS SHAPED BY SEVERAL FACTORS: TECHNOLOGICAL COMPLEXITY,

TRAINING

NEEDS,

AND RESOURCE LIMITATIONS. HISTORICALLY, ECMO SYSTEMS HAVE BEEN LARGE, INTRICATE, AND CONFINED TO HIGH-RESOURCE HOSPITALS

Our partnerships with Biomed Simulation and Usaneers are critical to this innovation pathway Together, we are developing advanced simulation and AR/VR-based training tools that enhance readiness across clinical teams These technologies are particularly valuable for supporting decentralized training and helping clinicians build confidence before facing highstakes situations

Equally central to our innovation strategy is the guidance of our clinical advisory board Prof. Roberto Lorusso, Prof Heidi Dalton, and Prof Gregory Schears whose combined expertise in cardiothoracic surgery, pediatric and adult ECMO, and critical care research continues to shape the future of our product roadmap and training approach Their contributions ensure that CBM Lifemotion not only meets the demands of today’s critical care environments but helps define the standards of tomorrow

Stan: How does CBM Lifemotion collaborate with clinicians, hospitals, and research institutions to ensure its products meet realworld needs?

Michael: Collaboration is foundational to how we operate at CBM Lifemotion From the earliest stages of product development, we’ve engaged directly with the medical professionals who use our systems every day

ICU nurses, perfusionists, physicians, and researchers have all played a central role in shaping the design and functionality of the Lifemotion® System.

Our clinical partnerships include leading institutions such as University Hospital of Hannover, University Hospital Virgen de la Arrixaca in Murcia, University Hospital Antwerp, and Rigshospitalet in Copenhagen These collaborations provided critical insight during our European launch, allowing us to evaluate and refine the system based on hands-on feedback from a diverse range of clinical environments

In parallel, we are building a strong foundation in education and training Through our partnerships with Biomed Simulation and Usaneers, we offer immersive training programs that combine highfidelity simulation with AR and VR tools. These resources help multidisciplinary teams build confidence and competency in using ECMO under real-world conditions.

Our advisory board plays a key strategic role Professor Roberto Lorusso brings deep expertise in cardiothoracic surgery and ECLS research. Professor Heidi Dalton contributes decades of leadership in both adult and pediatric ECMO care Professor Gregory Schears, based at Mayo Clinic, adds critical insight into system design and emerging models like ECPR. Together, their input shapes not only our current platform but also our thinking around future therapies and education models.

These ongoing relationships ensure that our technology evolves in step with clinical practice We are committed to staying close to the bedside listening, learning, and delivering tools that make a meaningful difference in critical care

Stan: Looking ahead 5–10 years, what is your vision for the role of ECMO in critical care, and how is CBM Lifemotion preparing to lead in that future?

Michael: We see ECMO evolving from a specialized intervention to a more proactive and widely adopted tool in critical care

COLLABORATION IS FOUNDATIONAL TO HOW WE OPERATE AT CBM LIFEMOTION. FROM THE EARLIEST STAGES OF PRODUCT DEVELOPMENT, WE’VE ENGAGED DIRECTLY WITH THE MEDICAL PROFESSIONALS WHO USE OUR SYSTEMS EVERY DAY

The 2025 ERC ALS Guidelines mark a turning point, recognizing ECPR as part of the advanced resuscitation pathway. This reflects a broader shift in how ECMO is being viewed not only as a life-saving option in extreme cases, but as a core therapy for a growing range of conditions

At CBM Lifemotion, we are preparing to lead this evolution by prioritizing usability, mobility, and integration Our current system already supports extended runtime, rapid deployment, and transport capability all features that align with the realities of modern critical care We remain closely engaged with hospitals, ICU teams, and our clinical advisory board to guide our development roadmap and ensure we’re building solutions that address the challenges care teams face every day

Stan: Michael, you’ve played a pivotal role in CBM Lifemotion’s global expansion Can you share more about your background and what drives your leadership in this space?

Michael: My career in medtech and critical care spans over twenty years across Europe, Asia, and the Americas. As an engineer by training, I have always been drawn to solving complex problems with practical solutions Over the years, I have worked closely with clinicians, fellow engineers, and healthcare systems in a wide variety of environments That international and cross-functional experience has profoundly shaped how I approach both leadership and innovation.

What drives me is the opportunity to bridge clinical needs with high-quality engineering. I believe that the best solutions are born at the intersection of deep user understanding and technical precision At CBM Lifemotion, I am especially proud of how we have built a company that is clinically informed, agile in execution, and focused on meaningful outcomes

As ECMO becomes more embedded in emergency and intensive care protocols, the need for scalable, accessible technology will only grow. Our mission is to make sure that every team regardless of geography has the tools and training they need to provide ECMO safely, confidently, and effectively

“We see ECMO evolving into an early, proactive tool in critical care, accessible to every patient and every team, everywhere ”

Our expansion into Europe, Latin America, and soon the United States is not just about reaching new markets It reflects our broader mission to make advanced life support available where it is needed most. We want to ensure that ECMO can be delivered safely and effectively in any setting from leading academic centers to smaller hospitals in underserved regions.

What inspires me most are the stories from the field Stories of patients who survived against the odds. Of teams who felt ready and supported in high-stakes moments. Of hospitals that can now provide a new level of care These moments remind us that we are not just building devices we are helping to change what is possible in critical care.

"We are building more than a medical device We are building a global community committed to advancing critical care and improving outcomes together "

OUR EXPANSION INTO EUROPE, LATIN AMERICA, AND SOON THE UNITED STATES IS NOT JUST ABOUT REACHING NEW MARKETS. IT REFLECTS OUR BROADER MISSION TO MAKE ADVANCED LIFE SUPPORT AVAILABLE WHERE IT IS NEEDED MOST

KASHIF IKRAM

MEDTECH OPINION LEADER: KASH IKRAM TALKS TELESURGERY, MICROPORT AS AN INNOVATOR-PIONEER AND THE NEW ERA OF ROBOTIC ASSISTED SURGERY

Stan: How does "The Era of Robotic Assisted Telesurgery" emerge?

Kash: Today we are potentially revolutionizing how surgical procedures are delivered, is the ability to combine telecommunications and surgical robotic technology, enabling the surgeon to treat a patient in a different location This has a role in democratizing healthcare across a nation between wealthy and poorer regions, and across borders between highly populated and remote areas, between developed and developing nations Even to subterrain, submarine and in space. As connectivity and surgical technology improve, surgeons will be able to send their skills over vast distances and serve patients they may never meet in person Challenges such as latency, regulatory issues and suitably trained staff remain, however, moves are afoot to overcome them

The concept of being able to operate on patients at a distance was born in the military where the need to get to the injured within minutes and not placing the healthcare professionals in danger was highly desired. In 2001, French Minimally Invasive Surgeon Prof Jacques Marescaux (IHU Strasbourg) performed cholecystectomy surgery on his patient in Strasbourg France while he himself was positioned at a robot console in New York, USA. This impressive feat, known as the Lindbergh Operation, inspired many, including a group in Canada that followed, however the surgical robotics and telecommunications technology was not yet developed enough for this to become routine practice Over the last two decades robotic technology has improved with robots becoming far more capable, widespread and costs have reduced.

A perceived delay in the surgeons’ movements and the actual movements of the robot in the patient is known as latency. Latency below 150 milliseconds is not perceptible by the human brain

Today, after a 20-year hiatus, the advances in telecommunications (5G & Low Earth Orbit Satellites), and the ability of software to condense and expand images and data at both ends in milliseconds, enables the surgeon to perform as if they are in the same room. This greatly enhances safety and effectiveness

Imagine not having to be taken by an ambulance to a hospital for stroke treatment if you can be treated in the ambulance when it arrives, the expert doctor miles away in a specialist center. Or a surgeon being able to operate on several patients in different rooms without having to wait for Operating Room Turn around Perhaps you live on an island and don’t savor the thought of traveling far away for weeks to be treated without your family and loved ones being close by A surgeon in the future could potentially treat 4 patients in 4 countries without having to queue up in a single immigration line at the airport and surrender their fingerprints

Stan: What are the biggest challenges facing telesurgery adoption today?

However, as well as the technical issues there are other hurdles that need to be overcome: Medico-Legal, Ethical and Financial. Here the discussions are ongoing to answer questions such as who is responsible for the patient if the surgeon is in another location? If experts are remote, will this affect the knowledge of the hospital’s own surgeons? How do all Healthcare providers, and hospitals get reimbursement for their contributions? Will the surgeon need accreditation in both hospital/regions/countries? Can the system be hacked?

Telesurgery is novel and as such throws up new questions to be solved but the benefit to patients and clinicians is undeniable This genie is not going back into the bottle, again

TODAY WE ARE POTENTIALLY REVOLUTIONIZING HOW SURGICAL PROCEDURES ARE DELIVERED, IS THE ABILITY TO COMBINE TELECOMMUNICATIONS AND SURGICAL ROBOTIC TECHNOLOGY, ENABLING THE SURGEON TO TREAT A PATIENT IN A DIFFERENT LOCATION.

MICROPORT

Stan: How is MicroPort pioneering innovation in telesurgery, and what key developments are shaping the future of remote surgical procedures?

Kash: Today there are several telesurgery or telemedicine platforms being developed, tested and actively being used One of note is the Toumai® surgical robotic platform developed by Medbot Microport a multi-national company based in Shanghai, China. This surgical robot received the European CE Mark in 2024 and is a new generation platform that enables surgeons to precisely perform minimally invasive Urology, Thoracic, Gynecological and General surgical procedures The Toumai® surgical system is in use in over 100 hospitals across the world and holds the record for the longest telesurgery procedure performed safely by Dr Youness Ahallal (of Nice University Hospital) from Shanghai, China to Casablanca, Morocco. This clearly illustrates why many of us are excited about the doors Telesurgery opens.

Stan: Could you tell more about MicroPort and its advancements in robotics surgery?

Kash: MicroPort Medbot is unique in that it works in 6 different medical areas when it comes to medical and surgical robotics MicroPort Medbot has several robots in its stable including, but not limited to, Toumai Endoscopic Surgery Robot, Skywalker Orthopaedic Surgical System and 3 others in development, as well as collaborations with Robocath on their R-One Vascular Interventional Surgery System, and Biobot Surgical PTE LTD´s Mona Lisa Prostate Puncture Surgical System.

THE TOUMAI® SURGICAL SYSTEM IS IN USE IN OVER 100 HOSPITALS ACROSS THE WORLD AND HOLDS THE RECORD FOR THE LONGEST TELESURGERY PROCEDURE PERFORMED SAFELY BY DR YOUNESS AHALLAL (OF NICE UNIVERSITY HOSPITAL) FROM SHANGHAI, CHINA TO CASABLANCA, MOROCCO. THIS CLEARLY ILLUSTRATES WHY MANY OF US ARE EXCITED ABOUT THE DOORS TELESURGERY OPENS.

Stan: Could you tell more about MicroPort and its advancements in robotics surgery?

Kash: MicroPort Medbot is unique in that it works in 6 different medical areas when it comes to medical and surgical robotics. MicroPort Medbot has several robots in its stable including, but not limited to, Toumai Endoscopic Surgery Robot, Skywalker Orthopaedic Surgical System and 3 others in development, as well as collaborations with Robocath on their R-One Vascular Interventional Surgery System, and Biobot Surgical PTE LTD´s Mona Lisa Prostate Puncture Surgical System.

Stan: What makes MicroPort® MedBot™'s Toumai® Endoscopic Surgery Robot special and how does it perform Telesurgery?

Kash: The Toumai® Endoscopic Surgery Robot has been in development for 10 years and was approved by China´s regulatory authority, NMPA in January 2022 and currently is the only Asian surgical robot that has CE Mark approval

There are certain technical core competencies that are required for all medical robotics systems. Working in several medical market segments allows Microport Medbot can gather a great amount of clinical and technical experience and leverage that expertise across multiple platforms to enhance hybridization and efficiencies.

The Toumai® Endoscopic Surgery Robot has performed over 5,000 complex Urology, Gynaecology, Thoracic and General surgical procedures. Many of them performed for the first time in China using a surgical robot It’s in active use in over 100 medical institutions

MEDBOT ALSO MANUFACTURES AND DEVELOPS ITS CORE SYSTEMS AND INSTRUMENTS IN-HOUSE WHICH ALLOW FOR MAXIMUM DESIGN FLEXIBILITY, FAST DEVELOPMENT TIMES, AND LOWEST MANUFACTURING COSTS

The system has many advanced features including advanced 3D immersive stereo vision, Force sensing technology and the ability to perform Telesurgery through a series of networked Toumai® Endoscopic Surgery Robots. Imagine the patient being treated in one hospital while the treating surgeon is in another.

We are proud to pioneer this Telesurgery technology and capability to healthcare systems throughout the world. This is truly game-changing technology for the global delivery of healthcare.

Well, this has already been performed over 200 times with distances spanning over 5,000 kilometres between the surgeon and patient. This enables hospitals to bring expertise wherever it is needed, whether that be remote areas or overburdened centres We are already seeing fascinating use cases for Telesurgery in emerging and developed countries.

Stan: Being an extraordinary Leader in MedTech what in your opinion makes and breaks companies success?

Kash: This is a huge question, where do you start? Primarily the company must have the foundations. By this I mean a good productmarket fit for the time and strong financial management You also need effective leaders who have defined a clear vision, a strong strategy and allocated appropriate resources to achieve set goals.

So, what is it that these leaders should focus on, well, what`s important in the medical device field are the Values that the people in the company hold Medical device employees are attracted to strong values. At the end of the day, we are helping people when they are not well, and in need A set of strong values then builds into a high-quality Company Culture So, it’s a good start to look at the values your company has and see which ones your wish to strengthen and celebrate The Culture, (which as I said is a made up of Values) will evolve through this management process.

A strong culture attracts the best talent, and these talented people will drive innovation, efficiencies and results – in a word success.

A positive culture drives the right incentives, clear focus and provided resilience in tough times. This combination of talent and culture builds a company that people will want to do business with After all, people buy from people (or companies) they like. This drives greater value The one caveat I will add is never to become complacent, the world turns, and your company employees need to be continuously learning and developing, or your will be out competed or supplanted The companies that adapt best to changing environments have the most motivated employees.

Stan: How do you build a high performing Medical Device Capital Sales team?

Kash: Selling high-tech, high-cost medical devices is a Complex Matrix Sale technical, detailed, and involving multiple senior stakeholders, often including the hospital Csuite. It may cover disposables, capital equipment, and services, adding layers of complexity. Success starts with hiring the right people—those with healthcare system knowledge, strong emotional intelligence, proven problem-solving skills, and the confidence to lead a complex sales process.

Once you've identified the right people, train them thoroughly on the product, procedures, and relevant disease states Ensure they understand the science behind what they’re selling. Regularly refresh sales techniques, including purchasing processes, value propositions, pricing, and leveraging new technology

Implement a user-friendly CRM to manage the complex sales process Map out the workflow, define meaningful KPIs, and avoid unnecessary admin salespeople should focus on selling, not paperwork. Complex sales benefit from a team approach Involving subject matter experts and encouraging collaboration between reps builds team spirit and drives better results than competition alone.

While frequent check-ins are valuable, once the right goals and resources are in place, trust your team. Great salespeople thrive with autonomy and support

Finally, incentives matter. Medical device sales reps are motivated by purpose but financial rewards still rank high Whether through commission or performance bonuses, make it count. High-growth companies reward their top performers.

SUCCESS STARTS WITH HIRING THE RIGHT PEOPLE THOSE WITH HEALTHCARE SYSTEM KNOWLEDGE, STRONG EMOTIONAL INTELLIGENCE, PROVEN PROBLEMSOLVING SKILLS, AND THE CONFIDENCE TO LEAD A COMPLEX SALES PROCESS

PHIL NORRIS

MEDTECH OPINION LEADER: PHIL NORRIS TALKS ABOUT A NOVEL APPROACH FOR THE EARLY DIAGNOSIS AND MONITORING OF NEUROLOGICAL DISORDERS

Stan: Hi Phil, pleasure to have you with me here today. To begin I would like to learn more about neuro-ophthalmology? Could you describe what this discipline covers?

Phil: Hi Stan, my pleasure, thanks for having me here. When we have a problem with our vision, we naturally assume our eyes are at fault Yet the key challenge is to distinguish problems with the structure of the eye from problems with the function of the visual system. Neuroophthalmologists are world champions at making this distinction, combining specialty training in both neurology and ophthalmology. This is important because many patients with brain disorders first present with visual disturbances,

particularly as an urgent sign of oncoming stroke, and including half of patients with brain tumours and a third of patients with Multiple Sclerosis

Predictably, there are few of these world champion dual specialists, and as a result referral times are between 6 and 9 months in most countries Concerningly, a recent study found a misdiagnosis rate of neuro-ophthalmic conditions over 50% by ophthalmologists, with 25% of misdiagnosed patients harmed directly as a result These statistics represent a critical need to democratise the skillset of the neuroophthalmologist and enable healthcare providers to increase diagnostic speed and accuracy in patients who present with vision problems

WHEN WE HAVE A PROBLEM WITH OUR VISION, WE NATURALLY ASSUME OUR EYES ARE AT FAULT. YET THE KEY CHALLENGE IS TO DISTINGUISH PROBLEMS WITH THE STRUCTURE OF THE EYE FROM PROBLEMS WITH THE FUNCTION OF THE VISUAL SYSTEM.

Stan: How does machineMD create a novel approach to diagnose neurological disorders earlier?

Phil: Decades of research in neuroophthalmology have established diagnostic criteria for neurological disorders based on eye and pupil movements, however much of this research is based on manual, subjective assessments.

One key boon for this research has been the advent of eye tracking cameras, which enable analysis of eye movements with greater speed and precision than is possible with manual examinations At machineMD, we use translational research to leverage deep expertise with eye tracking alongside clinical expertise in neuro-ophthalmology.

Our lead device is being developed to enable healthcare professionals to begin a patient consultation with standardised charts, rather than lengthy manual exams

Using a world-leading virtual reality headset, we develop and optimise a standardised sequence of visual stimuli to each eye, and record eye and pupil movements with incredibly fast infra-red cameras. Analysis of these recordings reveals quantitative and comparable data that physicians can use in the early assessment of neurological disorders

Stan: How does machineMD close the gap between patient centric medicine?

Phil: At machineMD, we envision a world where patients receive an accurate, fast, and early diagnosis. Neurological disorders have a broad continuum of care, often starting with a simple patient presentation in primary care such as blurry vision.

Just as we see in many other medical specialties, telemedicine is being shown to improve productivity and increase accessibility of medical expertise

Our lead device is being developed to provide a simple, comfortable, automated examination that replaces manual examinations performed today, easily operable by medical assistants

This device will be the last element needed for a fully apparative comprehensive ophthalmic examination, which will enable patients to receive expert diagnoses at a dramatically increased range of care centers. In the long term, this is where we see strong potential for AI to compare quantitative results with a patient history and cross-referenced with normative data.

AT MACHINEMD, WE ENVISION A WORLD WHERE PATIENTS RECEIVE AN ACCURATE, FAST, AND EARLY DIAGNOSIS. NEUROLOGICAL DISORDERS HAVE A BROAD CONTINUUM OF CARE, OFTEN STARTING WITH A SIMPLE PATIENT PRESENTATION IN PRIMARY CARE SUCH AS BLURRY VISION.

Stan: What new possibilities does machineMD technology bring to CNS drug manufacturers?

Phil: Neurological disorders are the leading cause of DALY's and second-leading cause of death according to the Global Burden of Disease Study 2016 Consequently, there are many pipelines dedicated to advancing therapies for neurodegenerative diseases.

At machineMD, we see three main opportunities for collaboration in this domain:

1. In line with our vision of improving the early diagnosis of brain disorders, we see great potential to optimise patient recruitment for clinical trials. This is particularly relevant for disorders where the current long referral times represent a significant proportion of expected lifespan, and may become a valuable differential diagnostic device for parkinsonian disorders.

2. Using machineMD's technology, future clinical trials will have the opportunity to include quantitative endpoints based on eye and pupil movements. The clear benefit is that these digital biomarkers will supersede subjective exams that are already published in peerreviewed literature today, with the potential to identify novel endpoints that improve measurability of disease progression. At machineMD, we are excited to develop this solution that will become a new gold standard in neuro-ophthalmic examination and provide new opportunities for translational medicine.

3. With an increasing landscape of drug and digital therapeutic (DTx) interventions, there is a corresponding opportunity for more objective measures of disease progression The automated examinations developed by machineMD could be a key enabler to optimising interventions by providing a remote workup based on neuro-ophthalmic digital biomarkers

NEUROLOGICAL DISORDERS ARE THE LEADING CAUSE OF DALY'S AND SECOND-LEADING CAUSE OF DEATH ACCORDING TO THE

GLOBAL BURDEN OF DISEASE STUDY 2016.

MATHIAS BOUZEREAU

MEDTECH OPINION LEADER: MATHIAS BOUZEREAU TALKS BALANCING GLOBAL AND LOCAL MEDTECH STRATEGIES, COMMERCIALIZING NICHE INNOVATIONS, INTEGRATING DIGITAL HEALTH, SCALING GLOBALLY, MAKING SMART STRATEGIC INVESTMENTS, AND BUILDING HIGHPERFORMING, TRUST-BASED TEAMS FOR LONG-TERM SUCCESS.

Stan: You've led global teams and managed complex transformations across diverse markets. What’s been your approach to balancing global strategy with local market needs, especially in a highly regulated industry like MedTech?

Mathias: Indeed balancing global strategy with local market needs is a constant and demanding exercise for every organization It is all the more critical in small and mid-size companies when you don't have the luxury of dedicated commercial, regulatory and market access resources at global, regional and country level Strategy is about choice, and as my ex-IMD MBA marketing professor Dominique Turpin used to say, "Positioning is about sacrifice" The key to success, especially for start-up and scaleup organizations with limited resources, is to maintain a clear vision of Must Win Battles and a strong discipline on what you want to be, for which customers and in which markets Balancing consistency of your global footprint and brand image with the required customization of your portfolio positioning and go-to-market execution requires deliberate planning and both internal and external competencies. Focus is critical to achieve ambitious goals. No company can be everything to everyone, everywhere

Stan:In your current role, you're spearheading both global marketing and business development for minimally invasive cardiac solutions. What unique challenges and opportunities have you encountered in commercializing innovation in such a specialized space?

Mathias: Surely, as for the entire Medtech industry, the European MDR regulation has created a huge challenge about developing and bringing to market innovative therapies in Europe. This is particularly acute for "niche" therapies, such as most of Pediatric and Congenital Heart Disease therapies, where it has become extremely challenging for all players to maintain approval of their current portfolio, let alone bringing to market innovative solutions that could benefit the CHD patients

In contrast, the more predictable FDA approval pathway and obviously the attractiveness of the US market has geared the majority of investors to favor almost exclusively US first and focused start-ups and projects As with all challenges, that very context offers a strong opportunity for companies that will continue to serve customers needs and look for innovative solutions for underserved patients, such as Congenital Heart Disease

Stan: Digital health continues to reshape the MedTech landscape. How do you see the integration of digital solutions influencing product development, patient care, and commercial strategy over the next 3–5 years?

Mathias: There is obviously a lot of hype around AI and Digital transformation, which has always been the normal pattern of development of innovative technologies finding their relevant applications within society and an industry in particular. Trained as a computer science engineer, I was fortunate in the earlier part of my career to be directly involved with several technological revolutions, the Smart Card invention, the creation of the Mobile Telecommunications services as we know it today, Internet and the generalization of SaaS solutions. Exciting digital solutions are consistently developing and my long experience in Software solutions and services is clearly a very strong asset within the Medtech industry today.

What really matters is to always start from a customer centric perspective versus the technological possibilities. The compass in deploying digital solutions is to focus on how we can better serve our customers, how we can gain efficiency while maintaining or ideally improving quality. Digital tools have considerably enhanced our capacity to segment markets and customers, appreciate and anticipate trends, deliver training and on-line support Through Social Media we are able to connect and engage with customers and all relevant stakeholders in a much more relevant and personalized fashion A lot of progress has been made with solutions to

STRATEGY IS ABOUT CHOICE, AND AS MY EX-IMD MBA MARKETING PROFESSOR DOMINIQUE TURPIN USED TO SAY, "POSITIONING IS ABOUT SACRIFICE".

optimize patient pathways, enhance resource utilization and efficiency at hospital level, and with patient engagement and remote monitoring. I see a lot of potential for further development in this field to improve access and quality of care in many therapies

Stan: Having driven strategic growth in both emerging and mature markets, what lessons have you learned about scaling MedTech businesses globally—especially when navigating reimbursement, clinical adoption, and regulatory pathways?

Mathias: Strong Regulatory and Market Access (Health Economics & Reimbursement) capabilities are more critical than ever An organization without a talented regulatory and market access leadership is doomed for failure ; you can (and in many cases should) outsource the services but you cannot outsource the strategic decision making, partners and suppliers selection and management for your regulatory and market access pathways. War on talents is high in that field today

Stan: You’ve led M&A initiatives and portfolio expansions. What are the key factors you consider when evaluating a new opportunity for acquisition or strategic partnership?

Mathias: Reflecting on when you need to build versus partner versus acquire is fundamental, a topic I learned a lot from IMD Professor of Strategy, James Henderson. Medtronic has also developed a very strong and useful methodology (known as Therapy Opportunity Assessment) to specifically guide Medtech portfolio investment, which I have been using extensively. With my Business Development team we refined a Pipeline Opportunities Scoring framework to evaluate Market Attractiveness (in terms of size, growth, therapy readiness, competition, unmet needs), Complexity to Execute (design, Clinical study, Sales fit) and Time to Market (<3yrs / 3-6 yrs / >6 yrs)

At the end of the day, you will obviously never make a decision with perfect information, and as a leadership team you need to have the courage to challenge yourself constructively to build the

best consensus, have the courage to make decisions in a VUCA context, and very importantly track every step and learn from mistakes to be able to pivot fast if direction chosen needs adjustments

Stan: Building high-performing teams is a hallmark of your leadership. What do you look for in emerging leaders within the MedTech space, and how do you foster a culture of innovation and accountability?

Mathias: I am absolutely passionate about self improvement and developing high-performing teams. Through my MBA at IMD (a business school which really stands out in terms of Leadership development), and my continuous curiosity and learning, I have been exposed to pretty much all meaningful leadership theories and learning, but what truly shapes you is having the privilege to work with amazing leaders who inspire you by their example every day I feel so fortunate that I could write a long list of outstanding bosses and colleagues I worked with during my career and who really shaped who I am today To mention the last, Sabine Bois, former CEO of Occlutech has been truly inspirational to me and I can say the entire organization she used to lead

Three must-read books illustrate the core principles of such leaders, principles that are my true north when leading and developing teams: "The Five Dysfunctions of a Team" (Patrick Lencioni), "Dare to lead" (Brené Brown) and "Care to Dare" (George Kohlrieser).

The foundation of Leadership is trust, and this starts by having the courage as a leader to be authentic and make yourself vulnerable. Only when you have this courage as a leader can you foster a culture of innovation and accountability, where we create the trust and respect needed for the constructive challenges or "healthy tensions" through which you unleash full engagement and creativity

As a marketer I will conclude with my 5 Cs of Leadership: Curiosity, Care (Compassion), Courage, Communication and a little spice of Craziness to dare trying what has never been done before

REFLECTING ON WHEN YOU NEED TO BUILD VERSUS PARTNER VERSUS ACQUIRE IS FUNDAMENTAL, A TOPIC I LEARNED A LOT FROM IMD PROFESSOR OF STRATEGY, JAMES HENDERSON.

ELFAREATO REMEKIE

MEDTECH OPINION LEADER: ELFAREATO REMEKIE TALKS HOW TO BECOME A COLLEAGUE, NOT JUST A VENDOR, TO YOUR CUSTOMER IN MEDTECH.

Stan: Hospitals today are looking for true partners / colleagues, not just vendors. How do you build that kind of relationship with them?

Elfareato: Building a true partnership with hospitals goes far beyond selling a product or service; it’s about aligning with their mission, understanding their pain points, and delivering ongoing, measurable value I approach every discussion with a consultative mindset rooted in trust, transparency, and shared goals. Here’s how I think you do that effectively:

1. Start with Deep Listening and Understanding

Before I even propose a solution, I invest significant time learning the health system unique ecosystem, their clinical workflows, financial pressures, strategic initiatives, and regulatory concerns I ask questions to understand what success looks like, and I listen actively. This shifts the conversation from transactional to transformational

2. Position Myself as a Strategic Advisor, Not a vendor

I am a firm believer in credibility by bringing insights. Whether it's benchmarking data, best practices from peer institutions, or emerging trends in care delivery or reimbursement Health Systems want someone who can connect the dots between operational realities and strategic outcomes, and I strive to be that person in every interaction

3. Co-create Customized Solutions, Not Just Products

Partnerships are personal I ensure that my team avoid cookie-cutter pitches and instead tailor solutions that align with each health system specific goals Whether that’s improving patient throughput, reducing readmissions, or optimizing ROI. When we co-create a solution, it builds shared ownership and deepens trust.

4. Deliver Measurable Impact and Communicate It

Hospitals are under immense scrutiny for outcomes, cost, and patient satisfaction There must be defined key performance indicators (KPIs) up front and revisit them regularly. By transparently reporting outcomes and impact, I reinforce that our value doesn’t end at implementation, we are continuously accountable.

5. Be Present and Proactive

True partners don’t show up only when there’s a renewal due. There must be regular touchpoints, proactively surface new opportunities, and respond quickly when issues arise Whether it’s supporting a new initiative, training frontline teams, or troubleshooting in real time, we are in the trenches with them

6. Cultivate Multi-Level Relationships

Partnerships aren't built solely at the executive level I make it a priority to engage stakeholders across departments, from C-suite to frontline clinicians to IT and align with their priorities. This 360-degree approach creates internal champions and makes our partnership resilient

7. Operate with Integrity and Transparency

Being honest when something won’t work, and the ability to never oversell is a critical skillset. Hospitals appreciate candor, especially when lives are at stake By being forthright, even when it’s uncomfortable It is paramount to build credibility and mutual respect that lasts.

There must be a strong focus on key relationships by showing up not as a vendor, but as a committed ally who understands their mission and is invested in their long-term success That’s how trust is earned and that’s how partnerships are built

BUILDING

A TRUE PARTNERSHIP WITH HOSPITALS GOES FAR BEYOND SELLING A PRODUCT OR SERVICE; IT’S ABOUT ALIGNING WITH THEIR MISSION, UNDERSTANDING THEIR PAIN POINTS, AND DELIVERING ONGOING, MEASURABLE VALUE

Stan: You lead a large and complex business across many care areas. How do you make sure your team's goals match what hospitals really need?

Elfareato: This is an interesting question and an area I am passionate about. Aligning a diverse, cross-functional sales organization with the evolving needs of Health Systems requires intentionality, structure, and a strong feedback loop. My role as a sales leader is to ensure we are not just pushing products but solving real problems and that alignment must start at the strategic level and be reinforced operationally every day. To accomplish this effectively, I think there are 3 critical foundational elements:

First, start with Deep Market and Customer Intelligence

To lead effectively across many care areas, from oncology to cardiology, neurology to digital I ensure my team has a strong grasp of the macro and micro dynamics impacting our hospital customers That means:

Engaging regularly with health system executives and frontline stakeholders. Monitoring shifts in policy, reimbursement, and clinical guidelines

Analyzing customer data to identify unmet needs, usage gaps, and care delivery model challenges

We use that intelligence to guide our go-tomarket strategy and set team priorities based on what matters to hospitals, such as improving care coordination, reducing variation, and driving operational efficiency.

Second, embed Customer-Centric KPIs into Our Commercial Strategy

It’s not enough to chase orders and revenue. I set goals for my team that align directly with hospital priorities like cost containment, clinical outcomes, patient experience, and digital enablement.

For example:

If a hospital system is focused on reducing length of stay, we tailor our value proposition around how our solutions impact discharge planning or post-acute care transitions If their goal is mitigating lack of resource and access, we demonstrate how our technology supports that mission

We measure success through both traditional metrics (revenue, share growth) and partnership metrics (outcomes delivered, adoption rates, satisfaction scores) etc

MY ROLE AS A SALES LEADER IS TO ENSURE WE ARE NOT JUST PUSHING PRODUCTS BUT SOLVING REAL PROBLEMS AND THAT ALIGNMENT MUST START AT THE STRATEGIC LEVEL AND BE REINFORCED OPERATIONALLY EVERY DAY.

Third, organize the Team Around Solutions, Not Silos

Hospitals experience care as an integrated journey not as isolated products or departments To reflect that, I structure my commercial team to think holistically. This includes:

Creating cross-functional pods that represent multiple care areas (imaging, monitoring, digital, etc.).

Equipping account managers to lead solution-based conversations instead of narrow product demos.

Ensuring marketing, clinical, and service teams are tightly aligned with field sales to present a unified front

This approach ensures we solve across the continuum of care and create value that’s bigger than the sum of the parts

Stan: How is digital technology—like AI and SaaS helping you bring more value to hospitals and stand out from traditional vendors?

Elfareato: Digital technology enables us to deliver smarter, faster, and more scalable value to hospitals, but only if we're solving the right problems. One of the biggest challenges for health systems is managing fragmented data across their ecosystem The key is ensuring our AI and SaaS solutions are system-agnostic and seamlessly integrate into existing workflows, complementing what the health system is already solving for

What sets us apart from traditional vendors is our ability to partner on scalable sustainable outcomes, turning data into impact, and technology into a strategic asset for the hospital. It’s not just about selling tools; it’s about improving care delivery in a sustainable, intelligent way

Stan: What does it take to offer full care solutions that help hospitals improve outcomes and lower costs, not just sell equipment?

Elfareato: Delivering full care solutions requires strategic partnership, not just equipment sales.

In today’s crowded MedTech landscape, standing out requires more than just transacting over high-performing devices. It demands the discussed mindset shift from transactional selling to becoming a strategic partner The true differentiator is the ability to offer full care solutions rooted in a deep understanding of the care continuum and the complex challenges facing health systems

To co-create meaningful, customized solutions, the sales organization must understand not just the product, but the hospital’s clinical and operational workflows end-to-end: from early detection, to diagnosis, treatment, and recovery. This means actively engaging the C-Suite, clinicians, IT leaders, finance, and administrators to uncover what they’re truly solving for; whether that’s reducing readmissions, improving throughput, solving for waste mitigation or enabling value-based care

A holistic solution design strategy must integrate multiple components, including:

Smart equipment with predictive analytics and decision support

Workflow optimization software to streamline patient flow and boost efficiency

Managed services such as training, maintenance, and asset utilization reviews Innovative financing models that align cost structures with outcomes (e g , OpEx vs CapEx, risk-sharing agreements)

By bringing strategic insights, clinical empathy, and a commitment to long-term value, not just products This will enable our partners to improve patient outcomes, lower total cost of care and mitigate resource challenges.

HOSPITALS

EXPERIENCE CARE AS AN INTEGRATED JOURNEY — NOT AS ISOLATED PRODUCTS OR DEPARTMENTS. TO REFLECT THAT, I STRUCTURE MY COMMERCIAL TEAM TO THINK HOLISTICALLY.

Stan: Can you share an example where you successfully moved from being a vendor to a true strategic partner with a hospital?

Elfareato: One of the most impactful examples of this transformation occurred with one of the largest networks of community-based oncology practices in the United States. It's physician-led and focuses on advancing high-quality, evidence-based cancer care

At the outset, our relationship was drifted to being very transactional They were evaluating multiple vendors on price and features, and we were one of many. We recognized early on that to become more than just a vendor, we needed to deeply understand their broader clinical, operational, and financial goals and align our value proposition to those.

Step 1: Understand the system’s strategic priorities

The AE had a trusted relationship with key stakeholders beyond the procurement team including service line directors, clinical leadership, and key executives. He was able to gain insight into their longer-term plans. During those conversations, we fundamentally understood what they were looking to solve for over the next 5 to 10 years at scale.

Step 2: Reframe the conversation

Rather than pushing product features, we repositioned our offerings as enablers of clinical and financial outcomes We built a custom business case showing how our integrated imaging and AI diagnostic platform could reduce scan-to-diagnosis time, improve care coordination, and service deliverables We worked with our clinical applications team to present data and case studies as well the integrated platforming strategies that would support their resource challenges

Step 3: Co-develop a roadmap

We didn’t just sell them a solution; we codeveloped a phased implementation plan

This included equipment, workflow redesign, staff training, economic modelling and analytics support.

Step 4: Deliver continuous value

After each implementation phase, we maintained a disciplined quarterly business review cadence, not just to report performance, but to drive it We shared real-time utilization data, benchmarked clinical and operational outcomes, and proactively uncovered optimization opportunities. In one instance, we identified a market within the system that was under-leveraging its advanced imaging AI capabilities. Within weeks, we mobilized on-site coaching, and the result was a significant increase in both procedural volume and clinical efficiency

We won the business from this large system. The true measure of success came during a national sales meeting when a senior executive from that system shared, 'I no longer see your organization as a vendor, I see you as a colleague ' That was the ultimate compliment And it’s something I now challenge my sales team to reflect on: Do your clients see you as a vendor… or as a colleague?

DO YOUR CLIENTS SEE YOU AS A VENDOR… OR AS A COLLEAGUE?

HANNAH TEICHMANN

MEDTECH OPINION LEADER: HANNAH TEICHMANN TALKS ABOUT CREATING SUCCESFUL ROBOTICS START-UP, WHAT SUCCESFUL MEDTECH TEAMS DO DIFFERENTLY, PERFECT START-UP ENVIRONEMENT AND FUTURE OF MEDTECH

Stan: You founded a successful MedTech robotics company - what inspired you to take that leap, and what were the hardest-earned lessons in building in such a regulated, hardware-heavy space?

Hannah: I was driven by a deep belief that robotics could fundamentally facilitate surgeons in very challenging, delicate reconstructive procedures and improve patient outcomes, through higher precision and consistency. Starting from microsurgery, my visions was to enable high precision open surgery through robotics The hardest-earned lesson is probably around balancing MVP features and speed to market. Building in MedTech means your true MVP isn’t just a prototype, it’s a clinically validated, regulatory-ready, manufacturable system. We placed a lot of value on getting to market swiftly, and then iterated with platform, instrument and software improvements This was a very successful strategy in my opinion, that went hand-in-hand with a clinical evidence generation strategy around a multispecialty platform for a surgical method, rather than a procedure

Working in active implantable medical devices as well as robotics since then, I realize that this was strategic, but also a unique opportunity we could implement in this class of device.

Stan: How do you see surgical robotics evolving - beyond the big players - in terms of accessibility, miniaturization, or intelligent automation?

Hannah: We're starting to see the second generation of surgical robotics move from monolithic platforms to more modular, procedure-specific systems Miniaturization and soft robotics are enabling less invasive applications in ENT, ophthalmology, and interventional radiology The real frontier is in intelligent automation, not fully autonomous surgery, but context-aware assistance: needle path prediction, force feedback, real-time image fusion The goal isn't to replace the surgeon, but to make precision scalable, even in lowerresource settings and to unlock less impactful procedures for patients.

BUILDING IN MEDTECH MEANS YOUR TRUE MVP ISN’T JUST A PROTOTYPE, IT’S A CLINICALLY VALIDATED, REGULATORY-READY, MANUFACTURABLE SYSTEM.

Stan: You're now advising several earlystage MedTech startups across Europe. What are the most common pitfalls you see, and how do the best teams set themselves apart?

Hannah: I would say the most common pitfall is missing product-market fit, which is typically a result of not having users intimately involved in product development from an early stage and from not understanding how the product fits into the patient journey.

The best teams do three things differently: they speak to and co-design with clinicians from day one, they build a multi-disciplinary advisory board early and they prototype with discipline, testing the riskiest assumptions first, not just the easiest to build features. It's not about building fast, it's about de-risking intelligently

Stan: How does the European MedTech innovation environment compare to the U.S., particularly when it comes to funding, speed to market, and regulatory navigation?

Hannah: Europe has deep clinical expertise and strong engineering talent, but the fragmentation across countries, particularly in reimbursement policies, can slow things down So while MDR and regulatory policy is relatively unified, market access as such is not. The cost for strong talent is low here compared to the US, which actually makes Europe an amazing breeding ground for early stage development There has been a flourishing of specialized preseed, seed and A stage funds in Europe over the last decade, what is still missing at the moment in my perception is deep VC pockets that can back the growth and commercial stages. There may be a shift in landscape at the moment as the appetite for more mature companies increases, hopefully there will be stronger allocation across all stages of a comany's lifecycle.

THE BEST TEAMS DO THREE THINGS DIFFERENTLY: THEY SPEAK TO AND CO-DESIGN WITH CLINICIANS FROM DAY ONE, THEY BUILD A MULTI-DISCIPLINARY ADVISORY BOARD EARLY AND THEY PROTOTYPE WITH DISCIPLINE, TESTING THE RISKIEST ASSUMPTIONS FIRST, NOT JUST THE EASIEST TO BUILD FEATURES

Stan: Many startups over-index on product features before truly understanding clinical workflows. How can founders better integrate clinical input from day one?

Hannah: Start by shadowing, not selling Spend time in the OR or clinic with a notebook, not a pitch deck. It’s not just about the procedure, it’s about the setup, the handoffs, the cleanup, the reimbursement codes The best founders ask dumb questions early and often, and they build around the clinician, not just for them. A clinician advisory board is table stakes; what's more impactful is embedding a nurse, tech, specialist or surgeon into your product team, even parttime.

Stan: How do you create a perfect MedTech start up environment? Where do you start?

Hannah: One of the most important components in a MedTech startup, or in any startup for that matter, is that the team is mission-driven. There are so many unknowns in building a business from scratch, that the ability of the founders to garner energy in the team around the clinical need is what is going to make a difference. Every time the team makes an advancement on getting closer to addressing that need, it’s important for everyone on board to have visibility of it. I also think it’s important for the team to see that leadership holds belief in the mission and for leadership to live by example, i e live an example of work-life balance This is one of the things I strived for, but I am not sure I always achieved, as a founder and as an exec. Show your team attention to detail and ownership of your work, of your product and of your company Show them that there are sacrifices we make at times, but that we also need to keep our work in perspective: put in the big rocks first There are things like your own health, your family or other things that aren’t deferrable. The team and the passion the team members have for their work will only be sustainable over the years if you leave them the space to integrate all the pieces of their life and applaud them for finding that balance.

Stan: Looking ahead 5–10 years, what emerging technologies or needs do you believe will define the next wave of MedTech innovation?

Hannah: We're at the beginning of a shift toward personalized, precision-guided interventions. That means combining robotics, imaging, and AI for real-time decision support- think of it as the “co-pilot” model On the other end, there’s a big need for decentralized and remote care toolsminiaturized diagnostics, smart therapeutics, and digital biomarkers that reduce the need for hospital infrastructure Finally, women’s health is long overdue for its innovation wave. We’ll see more neurotechnology, bioelectronic medicine, and hormone-independent therapies come to the forefront, and it won’t just be a niche I am really looking forward to seeing these domains come to fruition and being part of building the next generation of robotic and neurotech devices to improve patient care

START BY SHADOWING, NOT SELLING. SPEND TIME IN THE OR OR CLINIC WITH A NOTEBOOK, NOT A PITCH DECK. IT’S NOT JUST ABOUT THE PROCEDURE, IT’S ABOUT THE SETUP, THE HANDOFFS, THE CLEANUP, THE REIMBURSEMENT CODES

MICHAEL BENDER

MEDTECH OPINION LEADER: MICHAEL BENDER TALKS MEDTECH MARKETING, STRATEGY, COMMERCIAL SUCCESS AND LEADERSHIP

Stan: How do you build a strong multi-brand marketing strategy that keeps the clinical message clear and consistent across different segments Premium vs NonPremium?

Michael: In the MedTech space, building a strong multi-brand marketing strategy requires a careful balance between differentiating offerings across price and value tiers while maintaining a consistent and credible clinical message. This becomes particularly important when marketing to clinicians who expect scientific rigor regardless of the product's positioning Here’s a way on how to approach it:

1. Establish a Unified Clinical Narrative

The foundation of a successful multi-brand strategy is a consistent clinical story rooted in robust scientific evidence Regardless of brand tier, the message should be grounded in the same clinical outcomes, safety data, and medical credibility. Typically, you start by developing a core value proposition that applies across the portfolio for example, improved patient outcomes or workflow efficiency. Then, you adapt how that story is told based on the product tier without changing its scientific integrity

2. Segment Brands by Value, Not Science

Each brand should target a specific customer segment premium, upper value (mid tier) and lower value (eco tier) based on needs like price sensitivity, technological sophistication, or regulatory requirements However, while the messaging emphasis may shift, the clinical quality and evidence behind each product remain non-negotiable The goal is to highlight unique product benefits and trade-offs in a way that’s aligned to the customer’s context but doesn’t undercut trust in the broader portfolio.

Example:

Premium Brand: Emphasize innovation, advanced outcomes, AI integration, unique IP etc

Upper Value Brand: Highlight reliability, established clinical outcomes, cost-performance balance etc.

Lower Value Brand: Focus on accessibility and on procedural simplicity etc

3. Build an Internal Messaging Architecture

Internally, you should create a messaging framework that outlines core clinical claims, differentiating features by brand, and approved language for use across all channels whether it’s by sales reps, KOLs, or digital content creators. This structure helps ensure consistent messaging while making it easy to customize value stories for specific audiences or markets

IN THE MEDTECH SPACE, BUILDING A STRONG MULTIBRAND MARKETING STRATEGY REQUIRES A CAREFUL BALANCE BETWEEN DIFFERENTIATING OFFERINGS ACROSS PRICE AND VALUE TIERS WHILE MAINTAINING A CONSISTENT AND CREDIBLE CLINICAL MESSAGE

4. Align Closely with Regulatory and Legal Teams

Given the strict regulatory environment in MedTech, it’s essential to ensure all messaging especially when differentiating between brands is compliant and defensible. You need to work closely with regulatory and legal colleagues to pre-approve claims, align on allowable comparisons, and ensure that global or regional labeling doesn’t create confusion or risk.

5. Use a Modular Content Strategy

To efficiently scale across brands, you should apply a modular content approach For example, a clinical study or outcomes white paper may apply across the entire portfolio, but you will have to tailor the message to suit each brand’s audience A premium product might focus on enhanced outcomes through innovation, while a value product might emphasize cost-effective adherence to core clinical standards.

6. Train Sales Teams and KOLs on Brand Differentiation

Internal alignment is critical to avoid brand cannibalization or inconsistent storytelling It is essential to invest in sales enablement tools like messaging battlecards, objection-handling guides, and clinical comparison matrices to help teams position each brand clearly and confidently. You should also ensure KOLs and advisory boards are aligned with the portfolio strategy so they can support the right message in the field

7. Decide on a Unified or Independent Brand Architecture

Depending on market needs, it’s important to be intentional about whether brands are clearly connected to the parent company or operate independently For example, you may opt for a “house of brands” strategy with visual consistency or choose more distinct identities while keeping the clinical credibility tied to the corporate brand (brand endorsement)

A

8. Continuously Refine Through Market Feedback

Lastly, you have to ensure feedback loops are in place through field intelligence, advisory boards, customer interviews, and analytics to monitor how each brand is perceived. This informs not only messaging optimization but also product roadmap decisions and broader commercial strategy

In Summary

A strong multi-brand strategy in MedTech is built on clinical consistency, strategic differentiation, and rigorous internal alignment. By grounding every brand in the same scientific foundation and tailoring the value story to each segment, we can build trust with clinicians while meeting the diverse needs of the market.

Stan: Launching new products in MedTech is very expensive and highly competitive. What do you see as the key ingredients for a successful launch and long-term market impact?

Michael: Launching a new product in the MedTech industry is both capital-intensive and highly competitive Success depends on more than just a breakthrough innovation it requires a comprehensive, strategic approach across the entire lifecycle of the product Based on best practices and industry experience, the key ingredients for a successful launch and longterm market impact to achieve “launch excellence” can be grouped into three critical phases: Pre-launch Foundation, Launch Execution, and Post-launch Sustainability.

1. Pre-launch Foundation

This phase lays the groundwork for a successful launch. Careful planning and strategic foresight here are essential to mitigate risk and accelerate early adoption

STRONG MULTI-BRAND STRATEGY IN MEDTECH IS BUILT ON CLINICAL CONSISTENCY, STRATEGIC DIFFERENTIATION, AND RIGOROUS INTERNAL ALIGNMENT. BY GROUNDING EVERY BRAND IN THE SAME SCIENTIFIC FOUNDATION AND TAILORING THE VALUE STORY TO EACH SEGMENT, WE CAN BUILD TRUST WITH CLINICIANS WHILE MEETING THE DIVERSE NEEDS OF THE MARKET.

Deep Market and Stakeholder Insight:

Understanding the clinical, operational, and economic needs of all stakeholders including clinicians, buying groups and patients is essential Early engagement with Key Opinion Leaders (KOLs) helps shape the product narrative and build credibility within the medical community

Clear Value Proposition Supported by Clinical and Economic Evidence:

A strong product must demonstrate not only clinical efficacy but also economic value. This includes building robust health economic models and real-world evidence to support claims of cost savings, improved outcomes, or workflow efficiencies. Value messaging should be tailored to each stakeholder group.

Regulatory and Reimbursement Strategy Alignment:

It’s crucial to align regulatory and reimbursement strategies early in the development process Approval from bodies such as the FDA or EMA is only part of the equation securing favorable reimbursement is equally important to ensure market access and adoption

2. Launch Execution

This is the phase where strategic planning meets real-world implementation Effective execution ensures a strong market entry and the momentum needed to drive adoption.

Targeted Segmentation and Launch Sequencing:

Begin with a focused market entry strategy A phased rollout enables the team to refine messaging and gather early success data. Usually, you start with a simple black-box test (BBT) to ensure logistics readiness Given the BBT is successful a phased rollout can then be initiated starting with a dedicated

(1) MAT – Market Acceptance Test with a limited number of hand-selected customers followed by a (2) LMR – Limited Market Release and then a (3) FMR – Full Market Release. The timing of each stage depends on the data and how you did define how success should look like in the relevant phase.

Launch Management:

In order to make a launch as successful as possible, you should ask yourself one leading question: What is really critical to greatness and how to orchestrate and organize an impactful launch including a strong commercial support package?

Given the size of the organization and the complexity of the launch and product or service itself, you can establish a global or regional “launch academy” consisting of selected colleagues from different departments and markets. This launch team can then take the lead to efficiently organize the launch and to develop and deploy a support package based on regional or local topspin

By the way, such an approach is also a fantastic opportunity and platform for further talent development

Commercial and Clinical Alignment:

Successful MedTech launches require close alignment between marketing, sales, and clinical education teams. Comprehensive onboarding, training, and ongoing support for surgeons and clinical staff are critical to driving adoption

KOL Advocacy and Peer Validation:

Partnering with influential KOLs and centers of excellence can accelerate credibility and adoption. Support early adopters in publishing case studies, presenting at conferences and events, and sharing peer-to-peer insights

IN ORDER TO MAKE A LAUNCH AS SUCCESSFUL AS POSSIBLE, YOU SHOULD ASK YOURSELF ONE LEADING QUESTION: WHAT IS REALLY CRITICAL TO GREATNESS AND HOW TO ORCHESTRATE AND ORGANIZE AN IMPACTFUL

LAUNCH INCLUDING A STRONG COMMERCIAL SUPPORT PACKAGE?

3. Post-launch Sustainability

After the initial launch, maintaining market presence and expanding adoption is key to longterm success

Real-world Data and Iterative Messaging:

Ongoing collection of real-world outcomes helps refine the value proposition and strengthen messaging, particularly for buying groups and health systems. This data can also feed into future clinical and regulatory submissions

Customer Experience and Retention:

Building long-term relationships with customers through high-touch support and continuous engagement is vital. Establishing customer success programs and feedback loops enhances satisfaction and supports future innovations

Portfolio and Lifecycle Management:

Depending on the product you can extend the value through complementary products, services, or digital tools. Consider models like subscription-based services or performance guarantees to maintain customer loyalty and drive recurring revenue.

Differentiators in a Competitive Market Digital Integration:

Offering added value through digital tools such as analytics platforms, mobile apps, or AI-driven insights can differentiate the product and create stronger customer ties

Outcomes-Based Contracting:

Aligning pricing with clinical or economic outcomes (e g value-based models) can enhance confidence and accelerate access.

Sustainability and ESG Alignment:

Increasingly, health systems and bigger buying groups value innovations that support

IN

A

NUTSHELL,

environmental, social, and governance (ESG) goals from reducing medical waste to improving health equity.

In a nutshell, a successful MedTech product launch is not just about meeting regulatory milestones or achieving initial sales targets. It's about building a platform for sustained clinical adoption, trust of stakeholder groups, and commercial growth With a strong foundation, a focused launch, and a strategic plan for postlaunch evolution, companies can position their innovations to make a meaningful and lasting impact

A SUCCESSFUL MEDTECH

PRODUCT

LAUNCH IS NOT JUST ABOUT MEETING REGULATORY MILESTONES OR ACHIEVING INITIAL SALES TARGETS. IT'S ABOUT BUILDING A PLATFORM FOR SUSTAINED

CLINICAL ADOPTION, TRUST OF STAKEHOLDER GROUPS, AND COMMERCIAL GROWTH

RACHEL ANN COXON

MEDTECH OPINION LEADER: RACHEL ANN COXON TALKS MEDTECH LEADERSHIP, STRATEGY AND GROWTH, M&A, GO-TO-MARKET AND COMMERCIAL SUCCESS

Stan: Looking back over your leadership journey in MedTech, what strategic decisions have had the greatest impact on long-term growth?

Rachel: There are two pivotal factors that have shaped my career and driven long-term growth: having a clear mission and embracing uncomfortable change Since my university days, I have had a singular ambition to lead a company. I was fascinated by how strategic decisions shaped an organisation’s performance and its broader impact on healthcare My mission has remained the same: to pioneer and influence company performance in ways that improve global healthcare delivery.

Secondly, what once seemed a weakness growing up in Australia with its smaller MedTech market became a strategic advantage I actively sought out international roles, beginning with a move to Singapore, and later London. I’ve consistently placed myself in unfamiliar geographies and new functional areas, pushing beyond my comfort zone Adaptability has been instrumental in enabling me to lead through complex change and deliver impact in an organisation

Stan: What lessons have you learned from determining strategy and leading growth that others might overlook?

Rachel: One of the biggest honours we can have in our career is to lead teams. Motivation is a crucial element of leading teams, and we can have such an impact on motivation if we have a shared vision

While many assume that an organisation’s mission is sufficient, I have found it essential to craft a shared vision with your team or business unit one that not only defines your specific direction but also aligns meaningfully with the organisation’s overarching mission and vision Recently, my team set a vision to “empower scientific discovery in assisted reproductive technology” and that vision directly informed our product innovation, strategic partnerships, KOL

engagement and our customer value proposition Due to this shared vision and subsequent motivation, we were able to realise rapid value creation following a complex portfolio carve-out

Stan: What are some key factors you consider essential for creating value from M&A activities and ensuring a smooth integration following an acquisition?

Rachel: The most critical risk point in M&A is the transition from deal-making to integration Value creation hinges on a seamless handover and alignment between corporate development and the strategic commercial team.

I advocate for involving a business leader with a technical (Engineering/R&D) background throughout due diligence and integration. In my experience, this perspective ensures alignment between the acquired technology and the existing or revised portfolio vision. For example, with a recent tuck-in acquisition, we avoided value erosion by aligning the technology with our commercial strategy and repositioning it effectively.

Conversely, without a clear post-deal sales plan, even high-potential acquisitions risk becoming underutilised internal capabilities. For larger acquisitions, such as a carve out, it is essential a business lead takes responsibility for the integration and that lead reviews aspects of the business to ensure the integration plan starts the new business or portfolio with a clear strategy In a major capital equipment carve-out, we strategically adjusted list pricing for a key SKU enabling sales to bypass CAPEX approval thresholds in target accounts. This quick win accelerated early distributor adoption and revenue realisation

Beyond the commercial levers, cultural integration is paramount There must be intentional planning, resources, training and mentoring to help new staff transition. Integration is not just structural, it is human.

THE

MOST CRITICAL

RISK

POINT

IN

M&A IS THE TRANSITION FROM DEAL-MAKING TO INTEGRATION. VALUE CREATION HINGES ON A SEAMLESS HANDOVER AND ALIGNMENT BETWEEN CORPORATE DEVELOPMENT AND THE STRATEGIC COMMERCIAL TEAM

Stan: As markets evolve, how have you approached transforming go-to-market strategies to better align with customer needs and digital trends?

Rachel: Go-to-market strategies are particularly challenging in diverse regions like APAC, where variations in reimbursement, regulation, digital adoption, and buying behaviour are significantly different The key is to begin with no assumptions and conduct research and analysis. I rely on market segmentation and personabased analysis with tools like the Value Proposition Canvas to uncover unmet needs and determine how products can adapt to specific markets. Once defined, we build targeted GTM models and define sales targets, key account strategies and, where applicable, robust distributor management frameworks to grow the business.

Digital trends add further complexity When launching cloud-based SaaS solutions in healthcare, localisation can be essential to achieve market penetration. In my experience, countries like Australia and Ireland may adopt SaaS models but data privacy requirements and hosting regulations differ from the U.S. Conversely, in markets like Japan, on-premise was the default for some applications, and strategies must reflect that in order to achieve high market share.

Stan: What’s your approach to balancing innovation speed and bringing new technologies to market?

Rachel: The greatest challenge in commercialising innovation is reaching profitability especially when global expansion is prioritised before success in initial markets. My approach is to establish profitability in select core markets first This creates a self-sustaining engine that funds broader expansion. However, when speed-to-market is critical to outpace competitors, I recommend complementing rapid scaling with a detailed risk analysis and contingency plan. While some disruptions like COVID-19 are unpredictable, we can prepare for the need to adapt through planning and defining early warning signals

Stan: How do you foster a culture of continuous improvement across commercial and operational teams, especially in a global setting?

Rachel: Building a culture of continuous improvement begins with inclusive decisionmaking. When teams participate in shaping the decisions that affect them, a culture of trust and ownership builds over time In an environment of trust, team members feel more comfortable to raise challenges whether about pricing gaps, product issues, or operational bottlenecks

One example I had was an order backlog that was traced to a visibility gap between regional teams. Addressing it required no new systems just better information sharing For more complex challenges, I bring cross-functional stakeholders together to create “before and after” value stream maps These visualise inefficiencies and find additional ways to improve business processes.

THE GREATEST CHALLENGE IN COMMERCIALISING INNOVATION IS REACHING PROFITABILITY ESPECIALLY WHEN GLOBAL EXPANSION IS PRIORITISED BEFORE SUCCESS IN INITIAL MARKETS. MY APPROACH IS TO ESTABLISH PROFITABILITY

IN SELECT CORE MARKETS FIRST.

MAGDALENA KOWALEWSKA

MEDTECH OPINION LEADER: MAGDALENA KOWALEWSKA TALKS ABOUT COMMERCIAL EXCELLENCE AND ITS IMPACT ON SALES

Stan: You are a very seasoned Leader in Commercial excellence, and the first question I would like to ask what is the history of this department and function?

Magdalena: Commercial excellence is a relatively new concept compared to more traditional functions like sales, marketing, or finance Back twenty years ago when I was starting my professional career as a Deloitte Consultant, companies were focusing on implementing CRM platforms to get 360° view of all customer interactions and increase customer retention rates With digital transformation, sales processes have become more complex. In increasingly competitive markets, training teams have been busy upgrading value-selling competencies of their sales teams

All those programs impacting directly commercial teams used to be run by different functions independently of each other This often led to internal inefficiencies and misalignment. It became critical to think more holistically. That’s how first stand-alone sales enablement departments started to emerge to foster better cross-functional collaboration between these groups and increase impact on sales. Over the last five years the percentage of organisations with formal sales enablement function doubled helping revenue teams effectively navigate transformation.

Stan: You mentioned the sales enablement. Does commercial excellence importance reside only in operational gains?

Magdalena: No, commercial excellence covers more than sales enablement projects aiming to align internal resources. Sales excellence should also look externally towards the market and new strategical challenges that may need to be addressed. In times of high-speed technological innovation, the competitive advantage from superior product features does not last long any more Customers are better informed and have higher expectations. Buyers are interested in the value they can get from a solution rather than individual product characteristics

Finally, a very costly “milkman” selling model still predominant in the Healthcare industry becomes increasingly difficult to sustain in the market with increasing downward pricing pressure. Moving towards multi-channel sales to optimise selling costs when maximising ROI becomes critical to secure future growth of MedTech and Pharma players.

That being said, new strategies often remain very high-level and do not cascade down at the actual account level. This leads to a disconnect between the corporate goals and commercial execution A commercial excellence executive will help you to identify those gaps and design cross-functional programs to overcome both internal and external complexity and drive above-market growth

Stan: What is the Impact on sales and how do you measure it? Is there a specific way to do it right?

Magdalena: There are multiple studies quantifying sales enablement impact on business results

The report published by Sales Enablement Pro in 2021 shows that having a dedicated sales enablement function is correlated with 4percentage-point higher win rates, 8-percentagepoint improvements in quota attainment, and 9percentage-point greater customer retention compared to those without a dedicated sales enablement function (1).

There are two main business scenarios where commercial excellence is particularly relevant: scale up and turnaround.

The first relates to the situation when after an initial phase of hyper growth in a start-up type of environment, the company needs to formalize its processes and strengthen commercial engine to sustain future performance But it’s not only for start-ups The MedTech giants following M&A activities regularly reorganize their operations creating new business units to pursue strategic opportunities This was the case at Abbott

COMMERCIAL EXCELLENCE IS A RELATIVELY NEW CONCEPT COMPARED TO MORE TRADITIONAL FUNCTIONS LIKE SALES, MARKETING, OR FINANCE.

Structural Heart division which was only fouryears old when we embarked on our commercial excellence journey.

In more mature highly competitive markets, when facing a disruptive market factor upgrading sales processes and tools might not be sufficient. Commercial excellence can then facilitate strategic GTM and revenue management innovation At CSG operating in consumer goods market, we have pioneered a best-in-class value-based pricing framework that resulted in more qualitative distribution network when enhancing customer experience and protecting the brand image.

Stan: Having worked in various industries I want to ask: How is it different from FMCG and Medical Devices / Healthcare?

Magdalena: It’s a great question It is true that each industry has specific market forces that shape its ecosystem. However, sales fundamentals and commercial performance drivers remain the same For example, managing omnichannel calls to effectively address selling opportunities based on value versus on volume becomes an imperative across all industries, including Healthcare

MedTech and Pharma players has long lagged behind other industries in commercial innovation. Based on the recent article by McKinsey, the healthcare industry faces an acceleration in costs of nearly $600 billion in 2027, which could make healthcare less affordable and threaten the sustainability of industry margins (2) Those who will adopt a more open approach will weather the storm and outperform through the recovery.

A commercial excellence professional may bring value by identifying new commercial practices used outside of Healthcare that once translated into industry-specific setup will drive value and business growth Thinking outside the box skill will make a difference there.

Stan: What does Leadership in Commercial Excellence mean?

Magdalena: I like to think about commercial excellence as a way to ‘bring science into art’ of selling. We speak a lot about KPI, ratios, quotas and leaders tend to forget humans behind those numbers Launching a new commercial policy, customer segmentation or multichannel sales processes bring uncertainty and requires a lot of effort to learn a new skill or do things differently. To get their teams quicker from denial and anger phases into exploration, leaders need to rebuild an emotional connection with their associates to create space for change and innovation.

The storytelling is one of the most powerful tools that seems to get forgotten. When launching a new multi-channel commercial policy in the past, I made a reference to the Matrix movie where the choice of the main character Neo between a blue or red pill is a central metaphor for overcoming the fear of unknown. Shifting people’s attention into a widely known cultural reference helped us generate more excitement about the company future and transformation needed. Matrix remained our symbol for more than two years of project iterations and sustainment So be creative in your communication. Inspire action.

I LIKE TO THINK ABOUT COMMERCIAL EXCELLENCE AS A WAY TO ‘BRING SCIENCE INTO ART’ OF SELLING. WE SPEAK A LOT ABOUT KPI, RATIOS, QUOTAS AND LEADERS TEND TO FORGET HUMANS BEHIND THOSE NUMBERS

WHAT HAPPENED IN ROBOTICS SURGERY IN THE LAST 3 MONTHS: RETROSPECTIVE ANALYSIS OF THE SECTOR FROM MAY 2025 UNTIL JULY 2025?

ForSight Robotics raises $125M for cataract surgery platform

ForSight Robotics has raised $125 million as it prepares for first-in-human robotic cataract surgery clinical trials this year The Israel-based company said this week the funds will support the next phase of growth in the development of its Oryom platform, the world’s first robotic surgery platform for cataracts and other eye diseases.

SS Innovations’ robot used in its first cardiac surgery in Americas

SS Innovations' SSi Mantra 3 surgical robotic system was used for the first robotic cardiac surgery in the Americas. The procedure, a robotic Atrial Septal Defect closure, was performed by Dr. Juan Zuniga at Interhospital in Guayaquil, Ecuador, on June 8, 2025.

Intuitive system used in first robotic heart transplant in US

Baylor St Luke’s Medical Center surgeons used an Intuitive da Vinci Xi system to successfully perform what they say is the first robotic heart transplant procedure in the U S

Lead surgeon Dr Kenneth Liao used the Intuitive surgical robotics system to make small, precise incisions for the procedure in Houston Using the da Vinci system eliminated the need to open the chest and break the breastbone

Distalmotion wins FDA nod for gallbladder removal with surgical robot

Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal).

Intuitive awarded CE Mark for robotic surgery system

Intuitive, a specialist in minimally invasive care and the pioneer of robotic-assisted surgery, says its da Vinci 5 Surgical System has received CE mark approval for adult and pediatric use in Europe for minimally invasive endoscopic procedures across abdominopelvic and thoracoscopic surgical procedures, including urologic, gynecologic, and general laparoscopic procedures.

CMR Surgical has initiated a sale process with an expected valuation reaching up to $4 billion

CMR’s potential $4billion sale highlights its fast growth from a UK start-up to a global player and signals a key moment as the surgical robotics industry grows and starts to consolidate worldwide.

LEM Surgical AG Announces FDA Clearance of Dynamis Robotic Surgical System

The U S Food and Drug Administration (FDA) has granted 510(k) clearance for LEM Surgical’s Dynamis Robotic Surgical System, marking a significant milestone in the evolution of roboticassisted hard tissue surgery The System will be introduced in America at select hospitals this year

Cornerstone Robotics raises over $70 million to commercialize its robotic surgery system

Cornerstone Robotics, a developer of surgical robotics, has raised over $70 million in Series C financing led by EQT with participation from Qiming Venture Partners, Alpha JWC Ventures, the Innovation and Technology Venture Fund, eGarden Ventures, CTS Funds, K2VC, Long-Z Capital, and others.

WHAT COMPANIES RECEIVED CE MARKS:

RETROSPECTIVE ANALYSIS OF THE SECTOR MAY 2025 UNTIL JULY 2025?

Bracco Imaging and Subtle Medical Announce CE Mark of AiMIFY™ Software for Enhanced MRI in Europe

Bracco Imaging S p A , a global leader in diagnostic imaging, and Subtle Medical, Inc , a pioneering innovator in artificial intelligence (AI)powered image acquisition, announced that AiMIFY™, their jointly developed AI-powered software for magnetic resonance imaging (MRI) of the brain, has received the CE (Conformité Européenne) Mark under the European Medical Device Regulation (MDR).

InspireMD’s embolic prevention system gains CE Mark approval

InspireMD’s CGuard Prime Embolic Prevention System (EPS) has secured CE Mark approval under the European Medical Device Regulation (MDR) for stroke prevention.

ANACONDA Biomed Receives CE Mark for Its ANA5 Funnel Catheter to Treat Ischemic Stroke

ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark certification for its ANA5 Funnel Catheter

Medtronic receives CE mark for VitalFlow ECMO System

Medtronic has announced what it says is a major advancement in its mission to transform critical care, the VitalFlow Extracorporeal Membrane Oxygenation (ECMO) System has officially received CE (Conformité Européenne) Mark approval in Europe.

Medtronic Earns CE Mark for Evolut Redo TAVI Procedure

The approval means a new Evolut TAV can be implanted inside any failed previously implanted TAV in the EU. The redo TAVI surgery is indicated for patients with severe aortic stenosis with any TAV’s failure, regardless of the manufacturer, and those at high risk for open-heart surgery.

Imricor received European CE Mark approval for Northstar

Imricor Medical Systems Inc announced that it has received CE Mark approval for its NorthStar™ 3D Mapping System, enabling its commercial sale in the European Union and other CE Mark-accepting regions.

Intuitive’s Da Vinci 5 Surgical System Receives Ce Mark / Fifth Generation Da Vinci Surgical System Approved For Use In Europe Across Multiple Procedures

Intuitive announced that the da Vinci 5 Surgical System has received CE mark approval for adult and pediatric use in Europe for minimally invasive endoscopic procedures across abdominopelvic surgical procedures, including urologic, gynecologic and general laparoscopic surgical procedures, and thoracoscopic surgical procedures

ReGelTec’s HYDRAFIL System receives CE Mark for treating chronic low back pain

The Class III device offers a minimally invasive alternative to surgery by allowing interventional pain physicians to inject a hydrogel into damaged spinal discs.

KEY FUNDING AND M&A DEALS:

RETROSPECTIVE ANALYSIS OF THE SECTOR MAY 2025 UNTIL JULY 2025?

Kardium Inc. raises $250M to support pulsed field ablation system

Kardium’s $250 million raise is a major milestone that gives the company the resources to bring its Globe® Pulsed Field Ablation system to market It will help fund clinical trials, scale up manufacturing, and move closer to offering a faster, safer, and more effective treatment option for patients with atrial fibrillation.

Aortyx secures €13.8M to launch life-saving vascular patch for aortic patients

Aortyx, a Spanish med-tech startup, raised €13.8 million to fund clinical trials for its bioresorbable vascular patch, designed to treat aortic dissections less invasively. The patch is delivered via catheter, promotes natural tissue regeneration, and could significantly reduce surgical risks and recovery time. This breakthrough has the potential to save thousands of lives annually and marks a major milestone in European cardiovascular innovation.

Materna Medical Announces Ellora™ and Additional Close on $20M Series B2

Materna Medical raised $20M in Series B2 funding to launch Ellora™, a device designed to reduce pelvic injuries during vaginal childbirth Currently in clinical trials, it aims to improve maternal outcomes and redefine labor care The funding accelerates FDA submission and commercialization, marking a major step forward in women’s health innovation

Corvia Medical, Inc. raises $55M as it seeks FDA nod for atrial shunt

Corvia Medical raised $55M to complete a key trial and pursue FDA approval for its atrial shunt, a device targeting heart failure with preserved

ejection fraction (HFpEF) If approved, it could offer the first effective treatment for this widespread, hard-to-treat condition

Spine surgery-focused medtech Carlsmed files for a $100 million IPO

Carlsmed’s planned IPO marks a pivotal moment not just financially, but strategically as it aims to bring AI-personalized spine surgery into mainstream practice. A successful public listing would provide capital to expand its aprevo® platform into new anatomical indications. It would also strengthen Carlsmed’s position as an innovator in patient-customized spinal fusion.

Field Medical raises $35M to ramp up research

This raise is a transformational milestone for Field Medical: it provides the capital, credibility, and clinical pathway to potentially transform VT treatment an underserved and high-impact cardiac condition. With experienced leadership, regulatory fast-track status, and early clinical momentum, the company is well positioned to redefine the future of ventricular arrhythmia care

ForSight Robotics Secures $125M in Series B Funding, Addressing Global Surgeon Shortage and Exploding Demand for Ophthalmic Surgery

This Series B round marks a transformative leap forward: it gives ForSight the capital, talent, and credibility to validate and commercialize ORYOM™, at a time when eye care demand far outstrips surgical capacity If the platform succeeds, it could revolutionize ophthalmic surgery making quality eye care more precise, scalable, and accessible worldwide.

KEY FUNDING AND M&A DEALS:

RETROSPECTIVE ANALYSIS OF THE SECTOR MAY 2025 UNTIL JULY 2025?

Atraverse Medical, Inc. Medical secures $29.4M in financing for expansion

This financing positions Atraverse to scale, innovate, and lead in next-gen heart access solutions accelerating progress in minimally invasive cardiac care

CMR Surgical has initiated a sale process with an expected valuation reaching up to $4 billion

CMR’s potential $4billion sale highlights its fast growth from a UK start-up to a global player and signals a key moment as the surgical robotics industry grows and starts to consolidate worldwide.

Neuralink secures $650m in Series E to advance brain implant technology

Neuralink’s $650M Series E is a major milestone boosting clinical trials for brain implants, helping paralyzed patients regain control, advancing braincomputer technology, and showing strong investor confidence in its future

Restore Medical: $23 Million Series B Raised For Advancing Medical Device For Heart Failure Therapy

Restore Medical – a clinical-stage MedTech company developing transcatheter therapies for heart failure – announced the closing of a $23 million Series B financing round

Acclaro Medical secures $23m in Series B funding for skin laser technologies

Acclaro Medical has completed a Series B funding round, raising $23m, to spur the growth of its flagship products, UltraClear and AuraLux, and facilitate the company’s global market expansion.

Teleflex to Acquire BIOTRONIK Vascular Intervention’s Business for €760 million

Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced it has entered into a definitive agreement to acquire substantially all of the Vascular Intervention business of BIOTRONIK SE & Co KG for an estimated cash payment on closing of approximately €760 million

Escala Medical Raises $4.5M in Funding

Escala Medical, a Misgav, Israel-based medical technology company specializing in repair solutions for women with pelvic organ prolapse (POP), raised $4.5M in funding.

Merit buys hemostatic device maker Biolife for $120M

Merit Medical Systems has acquired hemostatic device manufacturer Biolife Delaware for approximately $120 million.

Portal Access, a Miami, FL-based medical device company, raised $7M in Series A funding.

Endiatx Attracts Funding to Advance its Capsule Robotic Tech

PillBot is designed to navigate the human stomach, providing a non-invasive solution for GI diagnosis and treatment

MediShout, a London, UK- based startup that connects hospitals with medical suppliers, raised $9m in Series A funding.

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