MedTech Opinion Leader _ Sertac Guzel _ Front Man

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VOL. 1 | ISSUE 6 | FRONT MAN EDITION

05 Sertac talks robotics and AI, highlighting gratitude, integrity, perseverance, cultural fluency, empathy, and visionary, ethical MedTech leadership.

Thom Rasche emphasizes disruptive, patient-focused MedTech innovation driven by strong teams and smart investing.

30

Dr. Dylan Attard highlights Malta’s rise as a dynamic MedTech hub and how MedTech World serves as a global platform for collaboration, innovation, and patient-focused healthcare progress.

Joseph Amaral talks about driving patient-centered surgical innovation through curiosity, collaboration, and leadership turning ideas into impactful, minimally invasive technologies that simplify care and transform outcomes

Josep Sitjes talks about driving commercial excellence in medtech through data, digital transformation, and empowered leadership that blends global strategy with local adaptability

Stan Kalinin explores how flexibility, data-driven hiring, and global talent strategies are redefining the MedTech workforce, enabling companies to stay agile and innovative in a shifting market.

39 Mike Moore talks about building smarter medtech commercialization early through strong market access, realistic planning, and leadership that balances innovation, growth, and adaptability.

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

49 John Hart talks about making robotic surgery faster and safer through Endospool, a smart suturemanagement tool that streamlines workflow, reduces risk, and boosts efficiency for surgeons and patients alike

53 Alice Flacco talks about building legal and ethical frameworks to protect human cognition and behavioral data as AI grows more predictive, ensuring technology empowers rather than manipulates people

57 Ryan Derrigan talks about leading with purpose and resilience in medtech — balancing innovation, risk, and long-term vision, inspired by lessons from climbing K2 about trust, courage, and building rather than optimizing.

Christopher Nemeth talks about accelerating medtech innovation in neurovascular and cardiovascular care by bridging the gap between regulatory approval and real commercial success across Europe.

Kash and Silke talk about celebrating and demystifying the medtech industry through their podcast Our MedTech Lives, sharing real career stories, new technologies, and inspiring more people to join and connect within the field

70 Giuseppe Battente Talks Evolution of MedTech Sales – Customer Centricity and the Shift from Product to Solution Selling.

Katherine Montes talks about leading agile, patientfocused MedTech teams that drive global adoption through collaboration, clarity, and innovation in surgical technology

Ron Fantl talks importance of Clinical Education role, must have skills and functional impact on collaboration with HCPs

Market Analysis from August 2025 until October 2025: Robotic Surgery, M&A, Funding, CE marking

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.

Editor in Chief Stan

Stan: With over 20 years of experience in MedTech, what have been your guiding principles throughout your career?

Sertac: Gratitude as the mindset, Integrity as the compass and Perseverance as the fuel

Gratitude fuels my optimism and sense of accountability. Reflecting on memories, wins, family, and friends I’m truly grateful My role reminds the meaningful impact we can have restoring health and supporting my teams. It keeps me grounded and motivated I don’t believe in entitlement and remind myself the responsibility that comes with my position. Like a professional athlete – need to stay fit, competitive and keep being a value to my team, customers, patients, my family and community

Integrity is my anchor. It means delivering on promises, being authentic & direct, and walking the talk even when it’s challenging This is the most sustainable and the only way for me and I am happy with consequences of doing so. I believe honest, thoughtful communication builds trust and sustainability Many confuse being “direct” with rudeness; I see it as kindness being open and honest to foster understanding The other tension is between “diplomacy” and “authenticity” It is not a trade-off per se and can be overcome by building trust, understanding the context of situation and developing stronger communication skills

Science shows we are all unique when it comes to how we ingest information and the way we view and react to outside world It is possible to adjust style, while remaining authentic We can’t ignore this dynamic... For those who are interested, I recommend taking a DISC assessment and checking “Surrounded by ” series by Thomas Erikson

Besides these two, any major success I had in life is rooted in perseverance. It is the fuel that keeps me going It’s about full commitment, embracing risks, and finding joy in punching above weight. I see “falling forward” as a stepping stone and believe that continuous growth requires resilience and a willingness to take shots at the goal. We are all “Work In Progress,” and should celebrate the effort and embrace adversity as if it is the gratification itself

Stan: You’ve held leadership roles in different geographies like U.S, Europe and Middle East working in global, regional and country operations. How has this global exposure shaped your leadership approach?

Sertac: It had massive impact First, I need to give credit to JNJ – a true school that genuinely focuses on development and to the remarkable leaders I was fortunate to work with who supported my development

Having wanted always to experience the world, I am grateful that we got plenty of opportunities to do this as a family and expand our horizons Nesting in different homes from Hamburg to New Jersey, Silicon Valley to Amsterdam, building unique social circles and immersing in those cultures Let aside professionally, it first and foremost changes who you are as a person, how you view the world and the foundations of your family and friendships

In parallel, you are also changed as a leader; in addition to developing a stronger global and systems thinking; you become more in tune with emotions, the social and working dynamics of those cultures and different personalities overall.

Each culture taught me different lessons: the US emphasized speed and productivity; the Netherlands valued consensus and balance; Japan highlighted respect for hierarchy and detail These experiences made me agile able to adapt my style based on context, people, and situation.

It all boils down to desire to truly understand, support and add value though... Having the right intent, respect and commitment to achieve gets you to 50%; the remaining 50% is about how you apply your best self to that unique situation

The reasons for expat failures are mainly due to that 2nd 50% part - lack of understanding of

nuances in different cultures and not being able to devise the right approach for that setting

Thunderbird Global Mindset Institute program on “cross-cultural fluency” divides cultural elements into three groups: “relating”, “regulating” and “reasoning”, highlighting dominant characters of different cultures.

Before my international roles, my default settings were being highly relationship based, preferring strong group affiliation vs being individualistic, and tending to think in a circular fashion leading to complex thinking where facts were a part of the story but not the full story I was more egalitarian in a culture of high-power distance.

Over my time in US in my global role and the Netherlands, I had the chance to develop the opposing muscles When it matters and actually more often - I can now operate better in a taskoriented environment, effectively communicate in a headline communication style, take higher levels of risk, drive tight timelines and execute simple, fact based, linear reasoning

The key part is “when it matters”. Reading the cues, understanding the operating norms that is shaped by the culture, people, company and the demands of situation should define at which point on the spectrum you want to operate.

Naturally, we are not computers and will always carry our original inclinations, but being aware and developing an ability to regulate remains key. It is also perfectly normal and at times required to influence change in others when it comes to these dimensions, but while being mindful of the delta and resistance levels

Stan: Quite interesting to hear about the xcultural fluency concept. Also curious to hear –what is your typical approach when you start a new role in a new geography or organization?

Sertac: When I step into a new role, I focus 80% on people and culture It’s essential to understand what motivates the team, their values, what systemic barriers exist, and where opportunities lie.

My approach begins with empathic listening and observation diagnosing, bonding, and imagining. I see this as the foundation for a bold vision and a shared game plan Recognizing and respecting the legacy achievements builds trust and pride, even and especially in turnaround situations.

Any future success will be built upon that “pride” element, even if it maybe a turnaround situation I value the type of leadership that does not categorically blame the legacy and their

predecessors; but are confident and fair enough to be able to compliment what was done well in balance with stating the necessary changes.

Change can be uncomfortable, but aligning the team’s aspirations with a shared vision for success creates excitement and ownership, People search meaning, crave impact... A leader’s role is to bring the pieces together and form a unified team with one mission where everyone completes and supports each other and know exactly how their work specifically translates to an impact on patients, customers and our business

I believe in quick wins to build momentum and credibility showing that leadership listens, acts thoughtfully, and drives healthy debate In most cases, inaction is a bigger risk than action and a leader should show they have bias for action.

Stan: What has been your most transformative professional experience to date?

Sertac: Joining Verb Surgical was a defining moment in my career, leading to JNJ acquisition, and contributing to OTTAVA™ No doubt! Creating something unique, bold and highly desirable; and while doing all of that, working with brilliant people - the best of their fields in the world

A year after my move from Turkiye to New Jersey to work in our Global Strategic Marketing organization; I was asked to join Robotics team, which was under stealth mode It was a very small (~5 people) team at the time collaborating with Stanford Research Institute. This was my first true experience in Upstream Marketing and I loved it, as an engineer by training I am thankful to Laura Angelini, Frederic Rupprecht and Nicolas Ploquin who gave me this opportunity.

Bill Gawkins was my first manager who was also the founder of our Robotics program. He was and still is a legend - being an incredible human being and a leader who had tremendous impact on my development as a person and a professional

Following years of work defining the plan, and developing the original concept and prototype, we spun off the project to create Verb Surgical as a JV between JNJ and Google.

With my leadership’s support, I left JNJ and joined Verb Surgical to lead the New Product Development and Commercial Marketing teams for the platform, working closely with partners from JNJ and Google Had the privilege to work with amazing leaders like David Herrmann, Pablo Garcia Kilroy and Scott Huennekens, with world-class engineers and world’s pioneering surgeons, hospital systems to build a truly disruptive Digital Surgery & Robotics platform in the heart of Silicon Valley.

As our CEO at the time Scott Huennekens says: “It is easier to go after a bigger goal” Big opportunity, big mission attracts the best people, technologies, capital and attention.

We were struggling to keep up with the demand shown by talent, surgeons, hospital leaders, tech companies who just wanted to be part of this project, in any shape or form...

This period taught me the power of bold vision and innovative collaboration I am proud to see what has come out of it – the work product itself, the way it is redefining competition and the lasting influences it has on me as a person and professional

Stan: How do you approach to commercialization of disruptive technologies?

Sertac: Successful commercialization starts with a clear understanding of the value you create and how to capture your fair share of the total value created. The problem you are solving hence the value creation will vary for different segments of the market. Also, the way you capture the value needs to be flexible to meet the demands of those different segments

The key part is nailing down a value proposition that is deeply rooted in key customer insights and tailoring your execution based on that Once you figure this out, the rest becomes easier You can’t make up a value proposition, it is not only messaging and words on paper. The technology, customer experience and outcomes should all live up to the promise – be tangible, simple and believable.

With disruptive tech, selling process gets more sophisticated with the new, more senior and diverse set of stakeholders involved, longer cycles and a need for more programmatic approach. It is essential to understand how decisions on these technologies are made, care-abouts of different stakeholders and how to cater to hospital’s strategic goals with a winning proposition.

A customer journey that promises efficiency and high conversion rate requires intentional targeting, strong diligence on account needs and a stellar team who could cover all grounds needed from clinical advocacy to c-level value articulation, and compliant & compatible implementation (Biomedical, Operational Workflow, Reimbursement, Accounting, IT, Privacy, Cybersecurity, etc )

Stan: How do you see the future of MedTech Leadership and what advice would you give to emerging leaders in the sector?

Sertac: MedTech is undergoing a seismic shift driven by of AI, Robotics, genomics and growing adoption of digital platforms

These advancements do not only promise unprecedented impact amid the healthcare crisis we are facing due to increasing disease burden and declining resources; but they also catalyze drastic changes to the company structures, talent requirements and leadership capabilities

Industry is moving away from selling devices to selling integrated solutions and outcomes; GenZ share in workforce rises, and now hospital human resources are even tighter than their margins.

Given these trends, leaders of the future should focus on developing in following areas:

1) Ethical Leadership: Has been always important but expect its importance to rise Two key catalysts are: 1) emergence of GenZ in workforce putting more emphasis on transparency, authenticity and ethics 2) continued healthy skepticism around Data & AI It is critical that leaders and companies put customer first, establish trust with transparency and avoid double-speak. Otherwise they risk followership both inside and outside

2) Platform Leadership: Envisioning and executing at a platform level, with x-disciplinary fluency (HW, SW, AI, Service) vs device only This way they can devise innovation and commercial strategies and lead diverse capabilities, considering the full value chain of an integrated solution

3) Partnership Hunters: with ability to -

a. ID & partner with companies offering complementary solutions to enrich value prop (not only at global, but also local level)

b. Collaborate to define common standards and to drive interoperability

c. Formulate WIN-WIN’s with clinicians, hospitals, providers and payers through more collaborative models and taking an integral partner role (at development stage) vs a transactional vendor.

4) Risk-On Approach: as velocity of change uptakes, and the bar for success heightens, leaders will need to feel more comfortable with taking risk These risks can come in the form of M&A, new forms of partnerships, getting into unchartered territories... or innovative Go-ToMarket approaches, relying more on AI, overhauling inefficient legacy business processes and re-engineering customer touch points and experience.

As a highly regulated space (rightfully so), MedTech has historically fostered conservative leadership styles; but while maintaining unwavering commitment to safety, quality and compliance, leaders of the future need to challenge themselves and their organizations to be more comfortable taking calculated risks.

For their personal growth, they will need to upskill themselves in capital, digital and service, take lateral or downward assignments if necessary to get the right experience. They will also need to be bolder in innovating, continuously seeking better ways to strengthen the value of their solutions and companies to patients, providers and their organizations. Eliminating what gets in the way of transformative organic innovation is as critical as figuring out how to effectively bring external innovation into your own ecosystem...

Culture and systems should support falling forward (learning and growing from mistakes) in balance with end-to-end accountability. This increased risk appetite will strengthen resilience and growth, both for individuals and the company with ultimately being in a better position to provide stronger impact for patients.

Stan: What excites you most about medtech today, and how does Earlybird shape its investment vision in this space?

Thom: What excites me most about MedTech is that it’s usually a highly personalised and locally focused therapeutic approach Everything you do in MedTech is centred on the disease its type, its stage, and how it manifests in each individual patient

It’s all about personalisation and precision. Whether it’s orthopaedics or cardiovascular treatments, you have to look at what the patient has, where it is, and what therapy will work best all in addition to the craftsmanship and skill of the physician applying it.

MedTech is never the end in itself; it’s a tool Its value depends heavily on the diagnostics performed beforehand, the physician’s application, and ultimately the patient’s outcome It’s always a tool-based approach quite different from pharmaceuticals, which tend to take a systemic rather than local view, even when targeting specific patient populations

There’s also a lot of change happening in medical devices. The largest corporates are very much P&L-driven, often focusing on managing their financial outcomes and acquisitions rather than true innovation. Some are more innovationoriented than others, of course.

The biggest open questions today especially with robotics, data, and AI are about business models. What does AI mean in practice? Who is it a tool for: the physician, the device company,

or both? Can it stand as an independent business model, or is it simply a service component within a company? These are critical issues, and many remain unanswered, but we’re actively exploring them.

At Earlybird, we position ourselves as a disruption-oriented investor. In MedTech, we seek ideas that are not just evolutionary or costsaving exercises, but represent new therapeutic approaches Take, for example, our recent investment in Axon, a company working on splanchnic nerve denervation. While many are betting on shunts to relieve heart pressure in heart failure patients, we’ve always believed a different medical approach might make more sense.

It’s still early, and there’s much to learn about which patient populations will benefit, but that’s the appeal of early-stage MedTech investing you’re part of the discovery process The same goes for Arga, where we’re backing a team developing a novel PFA treatment for atrial fibrillation using cutting-edge pulse field ablation technology

We invest early, and we invest in disruption rather than evolution. When it comes to cost savings, you always need to ask whether that’s truly a product saving or simply a process saving. In most cases, we believe better organisation could achieve the same results as cost-cutting at the device level

Stan: When looking at a young medtech company, what signals or qualities make you believe it has the potential to succeed?

Thom Rasche

We invest early, and we invest in disruption rather than evolution. When it comes to cost savings, you always need to ask whether that’s truly a product saving or simply a process saving. In most cases, we believe better organisation could achieve the same results as cost-cutting at the device level.

Thom: There are two key elements to how we evaluate opportunities

First, the technology must target a therapeutic area. We focus mainly on therapeutics, not diagnostics, because diagnostics often raise the question: once you identify something, what tangible therapeutic change follows?

When we look at therapeutic technologies, we need to believe they will make a real difference in people’s lives and that there will ultimately be strategic interest not immediately, but at some stage Since we manage other people’s money, we must also think about exit potential There needs to be a clear path for strategic acquisition or partnership in the future.

Second and even more importantly is the team. Have they done this before? What drives them? How do they work together? How well connected are they within the medical device ecosystem and to major corporates?

We’ve learned that technologies rarely fail but teams do, often because they cannot adapt their strategy or navigate challenges effectively That’s why we place growing emphasis on team due diligence. It’s not always easy; the metrics for evaluating teams haven’t evolved much, and long development timelines mean people and dynamics can change.

Few teams can handle all stages from early development through clinical validation and, later, commercialisation. Each phase often requires different capabilities.

Our general approach is to invest where we believe the company can achieve an exit based on its technology and clinical data, rather than needing to build a full commercial organisation Commercialisation is costly, complex, and timeconsuming. Therefore, the clinical data must be compelling enough to attract a strategic acquirer on its own merit

Stan: How important is the relationship between investors and startup leadership,

and what does true synergy look like in practice?

Thom: All our partners are experienced in the medical device world, and that allows us to act as coaches to management teams helping them build syndicates and leverage our network for both current and future investments

We also play a strategic advisory role, providing insights on where the industry is heading Importantly, we only invest when we secure a board seat.

That said, investors often overestimate their influence The reality is that the management team executes not the investors. Yes, we can advise, coach, and support strategic decisions, and occasionally help with difficult personnel changes, but day-to-day execution lies entirely with the company’s leadership.

If an investor believes they are “running” the company, something is fundamentally wrong The most successful ventures are led by strong CEOs and management teams who drive progress and ask for advice when needed not those directed by their investors.

So, while experience and perspective matter, it’s essential to remain humble Our role as board members is to accompany and support not to lead the company ourselves.

Stan: Beyond capital, how do you see the role of an investor influencing the growth and direction of a medtech company?

Thom: Money and financing are important, of course, and we can facilitate introductions and strategic discussions But ultimately, selling or positioning the company is the responsibility of the CEO and management team.

We contribute through strategic discussions and opinions, but it’s the CEO who must navigate multiple investors, each potentially having different fund strategies, timelines, and priorities. Aligning these perspectives into one coherent direction is part of their role

We can provide guidance based on experience, but the most successful companies are those whose leadership knows where they’re going seeking advice, but not necessarily following every suggestion.

Stan: How does Earlybird work with founders and management teams at different stages from early development through to scaling and exit?

Thom: When a new idea or founder approaches us, we help set up not only the syndicate but often the core management team as well. We typically don’t invest in single individuals we prefer at least two or three people forming the founding group As the company grows, we assist with hiring, connecting them to headhunters, and shaping the organisation.

Equally important is building the right investor syndicate. Misaligned investors can ruin a company, regardless of the technology or leadership It’s vital to bring together like-minded investors who share a belief in the innovation, its potential impact, and who can work collaboratively. Disagreements are fine open conflict is not, especially during follow-on financings

We also look carefully at the investors’ capacity: how deep their pockets are, which stages they support, and how long they can stay engaged

Next comes the regulatory path whether to pursue a 510(k) or PMA route, and how to engage with the FDA early through presubmission meetings. Most of our investments are in PMA-class technologies.

A US strategy is essential With the complexities of the MDR in Europe, companies must plan early for the US market the world’s largest for medical devices Securing early FDA feedback is critical Ultimately, most acquirers are USbased, and as we often say, Americans tend to buy from Americans.

Stan: Can you share an example where Earlybird’s involvement made a defining impact on a medtech company’s journey?

Thom: Yes, a good example is our investment in Arga, a pulse field ablation company We’ve known the team for many years my partner John has worked with them even longer and together we’ve developed a strong strategy alongside a corporate partner

We helped build the syndicate and shape the company’s direction. So far, it’s progressing very well, and our initial investment hypothesis that there’s room for a next-generation PFA device has proven correct.

At the beginning, many questioned why we would invest in “yet another PFA company ” But we were convinced this was a genuine secondgeneration technology: more selective, more precise, and fundamentally different in its approach It took time to persuade others, but that conviction is now paying off.

Stan: Looking ahead, where do you see the biggest opportunities and challenges for venture capital in medtech over the next decade?

Thom: Coming from a commercial background, I firmly believe that companies can only thrive through top-line growth. Yes, optimising your P&L is necessary, but without continued investment in innovation and growth, success isn’t sustainable whether you’re a large corporate or a start-up.

Over the past decade, MedTech has focused heavily on consolidation merging larger players rather than driving innovation. Robotics is somewhat of an exception, as it represents a distinct and fast-evolving field

But broadly speaking, we need to return to growth through innovation Not every innovation will succeed, of course it’s a risk game But big players like Boston Scientific, Medtronic, J&J, Abbott, and Edwards all need to put growth first.

Similarly, companies like Becton Dickinson and others should adopt a more acquisitive mindset not only acquiring technologies that are immediately accretive,

but those that can drive long-term innovation. The question is: will there be enough of these companies in the funnel, and when is the right time and price to acquire them?

On robotics I admit my early scepticism was misplaced When I first saw Intuitive Surgical 25 years ago, I thought it wouldn’t work I was wrong very wrong. Robotics is here to stay. The question now is to what extent and at what cost Systems need to become more affordable, easier to set up, and faster to use

One area where robotics still has major potential is neurointervention We believe this will become a major application area, improving patient access and procedural precision.

Finally, there’s data and AI The big questions are: how will we handle data in MedTech, what role will manufacturers play, and what are the liabilities of accessing patient data globally?

AI will undoubtedly become a crucial tool especially in clinical development and trial management making research faster and more cost-effective But whether AI will stand alone as a business model or remain integrated within hardware companies is still unclear.

Will it resemble Apple’s model, where hardware is the foundation and software or data services become the profit drivers? No one fully knows yet. We’re beginning to see models like HeartFlow a company built entirely on analytical software interpreting CT scans emerge successfully. That’s exciting, and it shows the industry’s direction: software-based innovation with strong clinical utility and robust business potential

The challenge for all of us is identifying which of these ideas can truly differentiate themselves, protect their IP, and scale sustainably That’s where the future of MedTech lies.

Stan: What makes this year’s MedTech World Forum different from other global events?

Dylan: Every year, when we sit down to plan MedTech World, I ask myself a simple question: what would I want to experience if I were a founder, an investor, a policymaker, or even a doctor exploring the future of medicine? The answer is never just about size or scale; it’s about intimacy, focus, and impact

This year, we’ve taken that philosophy even further. Unlike many global events that feel transactional, our forum is built to spark genuine connections Panels are not just discussions but working sessions where regulators, innovators, and clinicians wrestle with real problems together We’ve curated private roundtables, invite-only forums for MedTech CEOs, investors, and commercial leaders, and hands-on workshops so that attendees leave with actionable insights and not just a stack of business cards

We’ve also raised the bar by becoming a CPDaccredited event This means that by attending, you’ll not only gain fresh insights from global healthcare leaders, investors, and innovators but also earn CPD credits to advance your professional development And because we believe great ideas can flourish anywhere, not just inside the conference hall, we’ve woven Malta’s rich culture into the programme. From guided tours through our UNESCO heritage sites to evenings celebrating Mediterranean cuisine and music, we want people to experience the island as much as the event.

The Mediterranean setting adds something special too. Malta provides an environment where people are more open, less rushed, and ready to engage in meaningful conversations

Stan: Why was Malta chosen as the base for MedTech World?

Dylan: When we started MedTech World, many people assumed we’d base it in a major financial hub.

But I believed Malta had a unique story to tell. Growing up here, I saw how this small island always served as a bridge between worlds Europe and Africa, the West and the East. That same spirit of being a crossroads is what innovation thrives on

Malta also gave us something other hubs couldn’t: agility Larger ecosystems often move slowly because of bureaucracy. Here, you can bring together government, academia, and private enterprise around a table and make decisions quickly Add to that Malta’s growing life sciences infrastructure, its reputation as a trusted regulatory environment, and its cultural warmth, and it becomes the natural home for MedTech World

MedTech World

I believed Malta had a unique story to tell. Growing up here, I saw how this small island always served as a bridge between worlds—Europe and Africa, the West and the East. That same spirit of being a crossroads is what innovation thrives on.

Stan: How is Malta building its reputation as a hub for MedTech innovation and research?

Dylan: It’s been remarkable to watch Malta lean into MedTech. Ten years ago, we wouldn’t have imagined this momentum Today, you see government support translating into incentives for startups, collaborations with universities driving early research, and global companies beginning to look at Malta as a strategic base

But reputation isn’t built on infrastructure alone; it’s built on people. What I find inspiring is the community that’s forming here: clinicians eager to pilot new technologies, entrepreneurs willing to test bold ideas, and regulators who are curious instead of resistant. Malta is building its brand by showing that even a small country can become a testbed for innovation that scales globally.

Stan: Which new technologies, like AI or robotics, do you think will impact medical devices the most in the near future?

Dylan: If you ask me, we’re standing at the start of a wave that will redefine how devices are designed, regulated, and used AI is not just a buzzword; it’s becoming the backbone of diagnostics, surgical planning, and even drugdevice combinations What excites me is its ability to make devices adaptive, learning from every use, rather than static tools.

Robotics is another area where the ceiling keeps rising But the real magic will happen when AI and robotics converge. Imagine surgical robots that not only assist but also learn from outcomes and improve precision over time I’d also add another dimension: digital twins and bio-printing. The ability to simulate or even replicate human biology could change clinical trials and personalized medicine forever

MALTA IS BUILDING ITS BRAND

BY

SHOWING THAT EVEN A SMALL COUNTRY CAN BECOME A TESTBED FOR INNOVATION THAT SCALES GLOBALLY.

Dr. Dylan Attard

I often tell startups that MedTech World is built for them. When I was starting out in this industry, I saw how easy it was for early-stage companies to get lost at big conferences. You’re competing with multinational booths and endless agendas. So, we designed our forum to flip that script.

Stan: How does MedTech World help startups grow and connect with investors or partners?

Dylan: I often tell startups that MedTech World is built for them When I was starting out in this industry, I saw how easy it was for early-stage companies to get lost at big conferences. You’re competing with multinational booths and endless agendas So, we designed our forum to flip that script

Our startup pitch competitions are only the beginning What matters is what happens after the pitch We facilitate direct introductions to investors who are actually writing cheques, and we host closed-door meetings where startups can sit with potential partners in a setting that feels less like a sales pitch and more like a problem-solving session. Beyond the event itself, our year-round roadshows and network ensure that startups don’t just meet people once but build lasting relationships that carry them through their growth journey.

Stan: In what ways does the forum highlight patient-focused innovations in medical technology?

Dylan: At the end of the day, MedTech exists for one reason: to improve patients’ lives. But in the rush of investment rounds and regulatory approvals, that focus can sometimes blur At MedTech World, we keep patient outcomes at the heart of the conversation.

We highlight innovations that demonstrate a clear impact on care, whether by making treatments more affordable, devices more accessible, or diagnostics faster and more accurate. Through our awards, dedicated spotlights, and CPD-accredited workshops, we shine a light on solutions that clinicians can translate into real-world improvements for patients. For us, innovation is only meaningful if it ultimately benefits those receiving care, and our conference serves as a reminder to everyone in the ecosystem to keep that compass true.

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

Looking to the future, what role will Malta and MedTech World play in shaping healthcare worldwide?

I see Malta as a lighthouse, a small place casting a beam that reaches far beyond its shores MedTech World’s role is to amplify that light, creating a platform where global voices come together, but also where local ideas can rise onto the world stage

As healthcare becomes more interconnected, the need for neutral, collaborative spaces will only grow. That’s the role we’re embracing. Malta may not have the scale of Silicon Valley or Singapore, but what it offers is agility, creativity, and a willingness to take bold steps. Our ambition is not just to host a conference, but to build a community that influences how MedTech is regulated, funded, and most importantly, delivered to patients worldwide.

Stan: Looking back on your career as a surgeon, innovator, and leader, what first sparked your interest in creating new medical technologies like ultrasonic energy in surgery?

Joseph: This is likely the most challenging question I will face and one I am not sure I know the answer to. I am confident that a significant aspect of my identity is being the first generation of Portuguese immigrants They instilled in me the desire to make good on the risks they had taken to come to America, to make a better life for their yet unborn children. This was not possible under the dictatorial government of Portugal at that time Although they never encouraged me towards one profession or another, they did emphasize the opportunity I had to make a difference and to take advantage of the educational opportunities afforded to me in America. That, combined with being an only child, instilled unbridled curiosity, a key element of innovation

I chose to pursue medicine, which, at the time, was an unprecedented career path for a Portuguese person I vividly remember a friend’s relative telling me that Portuguese kids don’t become doctors. I suspect that this experience sparked my focus on overcoming challenges and believing anything is possible, which are critical elements of innovation

The decision to become a surgeon was not easy, as everything was interesting, but what most impressed me was the team nature of surgery. Everyone in the operating room plays a key role in success; everyone must work in a coordinated fashion, and every day is filled with the unexpected because every surgery, no matter how similar, is different.

Although the basic and clinical research I did were interesting to me, I yearned to move beyond simply caring for one patient at a time or writing one paper, to making meaningful improvements with the information I had that would change many patients’ lives I want to

capitalize on the opportunity given to me, not just for myself but for all I could reach. Translational research fit that drive, and soon I was off into minimally invasive surgery and helping companies develop new products the guidance of strong mentors such as Drs. William Thompson, Michael Caldwell, Martin Felder, Stanley Simon, and Donald Gann, to name a few, encouraged me to continue this path. Then Bang. I happened into the Harmonic Scalpel/Ultracision with Tom Davision, and there was no turning back The goal became to improve the lives of more and more patients in a meaningful way while at the same time improving directly those who sought my direct care

In summary, it is a combination of contribution, challenge and curiosity that continues my interest in creating new technologies and helping them gain adoption. What inspires me was best stated by Tom Starzl, the pioneering liver transplant surgeon, ”What was inconceivable yesterday and barely achievable today often becomes routine tomorrow.” That’s what drives me.

Stan: From your perspective, how do breakthrough medical devices really come to life—how much is about having a strong idea, the right opportunity, and a bit of luck?

Joseph: Although we all probably have a concept of innovation, derived from Newton’s discovery of gravity after an apple fell on his head, or Archimedes shouting "Eureka" in a bathtub. Yet Innovation is not just a creative idea; it's acting on the idea to create something so meaningful that people are willing to pay for it As Peter Flint wrote, “Innovation is like a relay race, where one group creates something, passes it on to the next group, and so on. The process begins with visionaries, who then pass on to innovators, followed by entrepreneurs, and ultimately to empire builders, enabling the commercialization of the technology on a mass scale” Breakthrough innovations result from many people coming together to bring an idea to fruition over a long period of time.

But at the root of all transformative innovations are elements of passion, conviction, appropriate timing, and chance encounters Many would call the latter elements luck In other words, breakthrough innovation is not the result of one person but of many, each building on an idea and solving the unanticipated obstacles that are confronted on the journey, and figuring out what it takes to make the time right, even if it appears it is not the right time. In other words, sometimes you must seed the market with the problem you are solving when it is not as apparent to others as it is to you, and do so before the development process is complete. This requires the critical innovation skill of listening and not allowing your passionate beliefs to make you oblivious to those of others. The reality is that no one gets it completely right by themselves.

Stan: You’ve helped bring new surgical techniques and technologies into practice. What does it take to turn an idea in the lab into something widely accepted in clinical care?

Joseph: Simply put, a deep understanding of the problem to be solved, the capability of translating the problem statement into a solution, and the resources to make it happen. Those are the blocking and tackling elements. But the magic potion of medical device innovation relies on passion, listening to others, and a fair bit of luck.

An illustrative example would be the Harmonic Scalpel By chance, I met Tom Davison, PhD, the CEO of Ultracision, a startup, at the request of a company CEO whose project I was working on, to discuss his Ultracision technology It was 1990, and I was at the forefront of performing minimally invasive surgery, training surgeons in the new field, and helping companies develop solutions for MIS Tom had started Ultracision to use ultrasonic energy to cut and coagulate tissue with specific emphasis on MOHS surgery. The technology had emerged from the Pennsylvania Mineral and Mines Company, which had developed ultrasound energy to cut and coagulate difficult materials such as silk cloth in

plastic The technology provided minimal lateral thermal damage and only created tissue destruction at the point of contact The urban legend is that the activated device fell on someone’s foot and cut them, but they did not bleed. Believing there was a healthcare application, Tom with significant healthcare entrepreneurship was engaged to sort it out by a Venture Capitalist intrigued by the idea.

I never imagined that ultrasound could cut tissue, but I was very focused on eliminating the belief that lasers were critical to minimally invasive surgical procedures. My experience training surgeons led me to believe that lasers potentially created more harm than good, and surgeons more easily adapted to electrosurgery. Yet I was also concerned that electrosurgery in the close confines of minimally invasive surgery with a more limited field of view brought risks of unanticipated injury. As I listened to Tom over dinner in San Francisco, I became convinced that Ultracision was the ideal solution for the problem I was trying to solve I asked Tom where he was doing his research. MIT. I wondered where the company was located and learned it was in Rhode Island, where I lived, and Tom and I lived less than 5 miles apart “Would you be interested in working in my laboratory at Rhode Island Hospital, Tom, on developing this for minimally invasive surgery?” Tom hesitated, given the strong relationship he had with MIT. I persisted. “Tom, it will be closer for your team, thereby speeding up development, and all you have to pay for is lab time The animals are already used for laparoscopic training and will be sacrificed. In return, all I am asking is that you make a device that would go down a 10mm tube so I can try it in minimally invasive surgery” Tom took me up on the offer, and the following week, I was in my lab with his team. One week later, his team had prototyped a device I used in pigs, and was flabbergasted at how well it worked The rest is history.

Ironically, ultrasonic energy performs poorly on the skin Yet, no one knows what the future of Ultracision would have been if Tom had not been

open and willing to pursue a minimally invasive surgery solution. It does, however, underscore the importance of a chance meeting between us, listening to feedback, and acting on it It also points out another critical aspect of successful innovation and adoption. Having a strong and wide network of people who you can learn from, be mentored by, and help you move the innovation forward.

The concept of networks and leveraging random interactions between individuals persists in Histosonics’ story. Tom, the original CEO founder of Histosonics, along with co-founders Xhen Zhu, Charles Caine and Christine Gibbons, asked me to explore a particularly innovative cavitational ultrasound technology at the University of Michigan in 2009, which was capable of “non-invasive surgery” I agreed My reaction to watching the prostate of a dog be liquified transdermally in a coagulated dog was “My God, the world just changed!” and gave me a true understanding of what Michael Lewis was describing in his book The New New Thing It is something that can throw an entire industry into turmoil and cause ordinary people to sit up and say, “ My God, something just changed” Unbeknownst to me, Jim Adox, a managing partner of Venture Investors, was also in the room. Within a week, Histosonics was initially funded by Venture Investors The rest of the Histosonics story is for another day Nevertheless, the importance of luck, connections, and networks is critical to clinical success

Stan: You’ve led teams across hospitals and medical device companies. What leadership principles guide you in inspiring people without micromanaging and driving meaningful change?

Joseph: The critical aspect of leading and inspiring teams without micromanaging is to allow them to do what they were brought to the team to do, always keep the focus on improving the lives of patients, and listen to them That requires selecting passionate members who contribute positively to the team, bring different

viewpoints, and prioritize the team's best interests over individual ones. My simple rule is that a leader is not a boss; they are a mentor, and the team does not work for the leader; the leader works with them to drive meaningful change. The leader’s role is to listen to them and eliminate roadblocks, enabling them to focus on their strengths and ensure the team works together towards a unified, clear objective. The leader must ensure they are not asked to do something they are not ready for or that the leader cannot fix Asking someone to solve a problem or do something signals the positive confidence the leader has in them. Failure of effort erodes a teammate’s confidence in themselves In that regard, I often think back to my years as a surgeon teaching residents. As the attending, we must let residents learn by doing, but also ensure they cannot do something that would harm a patient beyond our ability to fix it. This requires a decision on whether the leader chooses to take the action rather than the member, based on what is in the patient’s best interest If it’s them, they know I will always have their back and understand the objective. They know they can always ask for help without judgment, as that is what the leader needs to do, and help them anticipate potential problems before they happen, so they can be avoided or at least recognized. They know their failures or errors will not define them, but how they respond to them will This approach avoids the need for micromanagement and allows teammates to function at their highest level of performance.

It is essential not to micromanage the team As Roger Von Oech noted in A Whack on the Side of the Head: How You Can Be More Creative, “There are many right answers - all depending what you are looking for But if you think there is only one right answer, you'll stop looking as soon as you find one.” I am confident members of the team will seek many solutions and pursue the best one I am also convinced it avoids what Shunryu Suzuki stated, “In the beginner’s mind, there are many possibilities; in the expert’s mind, there are few What has inspired me about these beliefs time and time again is that when left alone, the team not only exceeds my

expectations, but they also create solutions I never would have imagined. Passion for the idea, listening and reacting to feedback, and paying attention to the random collisions that happen with others along the path.

Stan: How important are the management team and the board in determining a company’s success, and can you share a time when that dynamic made all the difference?

Joseph: Having been on all sides of the innovation equation from idea generation to the management team, board, and investor each is critically important, such that the likelihood of success is determined not by the strongest part but by that which is the weakest. Boards must govern and establish milestones that are difficult but achievable Their role is not to manage but to shape the team into a highperforming one, much as a parent does by establishing milestones on the journey and holding them accountable Yet, high-performing teams are equally critical to success. No breakthrough innovation comes to life without a management team that not only meets but exceeds the milestones determined by the board, driven by passion and conviction about their work. They are defined by an attitude where failure is not an option This requires overcoming obstacles, listening carefully to all stakeholders, and remaining passionate about their goals. In turn, overcoming obstacles and achieving milestones further fuels high-performing teams because of the proof that their goals can be achieved. Meeting milestones accelerates not only the passion and belief of the Board and management team but also that of investors The latter are often investing more in the management team than in the idea itself. As a result, I would add investors to the mix of critical success elements since companies that fail usually do so because they run out of money, not because they have bad ideas. The latter results from ineffective management and ineffective board governance, which destroys investor confidence Hence, the virtuous cycle of innovation is complete when all three elements are performing in unison.

Stan: With your background in surgery and education, how do you make sure patients’ needs always stay at the center of device innovation and adoption?

Joseph: My view on this is quite simple. It is always about patients and their needs They are the Northstar of all we do in healthcare, whether it is a hospital, technology, research, or investment. As the guiding principle, it brings a shared vision and focus that provides the light at the end of what is often a long and difficult tunnel to navigate on the path to breakthrough innovation. It is easy to say we put patients first, but achieving this can be challenging due to the many disparate stakeholders involved in the journey, each with their own self-interest. However, if you accomplish patient benefit, everyone will be rewarded for the effort, most importantly, the patients But the reward I am referring to isn’t financial, it is satisfaction. As Steve Jobs once said, “We're here to put a dent in the universe Otherwise, why else even be here?” I believe that there is nothing more rewarding than knowing you will leave this earth having made a small dent in the universe that made it better for everyone That is something no amount of money can achieve, making an arduous journey worthwhile. So, how do you ensure that you are putting patients first in your decisions? By asking the question, how your decision will first and foremost impact the patients it serves. Will it deskill the procedure for the physicians and caregivers so that it is safer, will it democratize the treatment so that it will be available to everyone, and will it decentralize care to the community and home so that it is less complex.

Stan: You’ve long supported focal, minimally invasive treatments. Where do you see the biggest opportunities for focal therapy ahead, and how will that shape success for patients and the industry?

Joseph: Minimally invasive therapies have put healthcare on an irreversible course that provides incredible benefits to patients, not only because they increase convenience and reduce

suffering but because they improve the quality and safety of care. For example, wound infections remain a vexing problem following surgery and are an area of constant innovation Yet if one seeks to eliminate wound infections, the best answer is obvious: eliminate incisions. Hence, the introduction of HistoSonic’s histotripsy platform, which destroys tumors without needles or knives, is a significant step toward closing the gap on achieving the ultimate solution Thus, I believe that continued innovation of truly non-invasive solutions, such as those provided by ultrasound via histotripsy, will be at the forefront of medical device innovation

A second area of focus will be reducing the complexity of surgical procedures. As Lorenz Heister, the famous 1700s surgeon, once wrote In every surgical intervention, one should prefer the method that can be used with few and simple instruments over that which requires a big apparatus, difficult to work with Most such tools have been invented out of pomposity rather than utility.” Complexity creates errors and limits those who can achieve perfection That means not all patients get the same level of care Making devices that are intuitive, easy to use, and simplifying the complex should be a mainstay of future minimally invasive device innovation This implies that truly robotic devices, which not only function as simulators to simplify surgical steps but also provide planning, targeting, and procedural guidance by seamlessly integrating imaging and robotics, will continue to evolve at the forefront of minimally invasive procedures.

Finally, it is time to change the paradigm from “I think this will work to I know this will work This brings the concepts of precision and personalization to the forefront of future minimally invasive device innovation For too long, we have relied on population-based solutions that often have little or no benefit for large numbers of patients. For example, approximately half of cancer drugs given

accelerated approval do not demonstrate improved survival or improved quality of life.

(JAMA 2024 May 7;331(17):1471-1479 doi: 10 1001/jama 2024 2396) The great surgeon is not determined by his or her hands but by what is in their head, what they see, and how they react Hence, incorporating machine learning with large database analyses will turn what I think is best into what I know is best for a specific patient and emerge as a table stake of future medical device innovation

Stan: How do you see leadership evolving in medtech sales organisations, especially as Solventum scales in a rapidly changing healthcare ecosystem?

Josep: Leadership in medtech sales is undergoing a fundamental shift Historically, it was about managing territories and driving product volume. Today, it's about orchestrating value across complex ecosystems, clinical, economic, and digital At Solventum, we’re evolving from generalist product approach to specialist product focus and customer and patient centric models This requires leaders who can navigate ambiguity, foster cross-functional collaboration, and champion data-driven decision-making.

We’re building a culture of execution and accountability, where leaders are not just managing performance but enabling transformation Our transformational initiatives helps us align strategy, capabilities, and structure, ensuring that leadership is embedded across every layer of the commercial organisation

training and customer engagement strategies are tailored to regional maturity and market dynamics

Stan: What are the most critical levers of commercial excellence in medtech today, and how does Solventum prioritise them across different regions?

Josep: The six levers we prioritise are: databased decisions, talent development, strategic pricing and tender management, targets and incentives, channel management, and customer experience

In EMEA and Asia, we’re scaling our commercial excellence teams to build up a best in class commercial excellence in the region This includes significant investment in training and pricing capabilities

We balance global frameworks with local adaptability For example, while our Salesforce and analytics platforms are standardised, our

Stan: With patients increasingly becoming the end customer, how is Solventum aligning its sales and marketing strategies to engage both healthcare providers and patients effectively?

Josep: We’re redefining the customer journey to include both healthcare providers and patients This means integrating clinical education, economic storytelling, and digital engagement into our go-to-market model

Our reps are being trained not just on product features, but on clinical outcomes and hospital economics enabling them to speak credibly to surgeons, nurses, and procurement teams alike

We’ve also embedded clinical education into our commercial teams, recognizing that education is our most powerful marketing tool Therapy adoption is now a key metric, linking investment in education directly to patient impact.

Josep Sitjes: Solventum

We balance global frameworks with local adaptability. For example, while our Salesforce and analytics platforms are standardised, our training and customer engagement strategies are tailored to regional maturity and market dynamics.

opportunities for AI and digital tools to transform salesforce effectiveness and commercial models at Solventum?

Josep: AI is a game-changer but only if built on strong data foundations We’re investing in unified data platforms and governance to ensure our AI initiatives are scalable and impactful. Opportunities include predictive analytics for territory planning, AI-powered microlearning for reps, and virtual coaching tools for economic and clinical selling.

We’re also exploring gamified learning and simulation-based training using VR/AR to accelerate onboarding and skill development Our vision is to move from reactive reporting to proactive enablement where reps receive real-time insights and coaching tailored to their performance and market context.

believe will define the next generation of successful medtech commercial leaders, and how does Solventum nurture them?

Josep: Tomorrow’s leaders will need data fluency, customer empathy, and change agility They must be able to lead through complexity, influence across functions, and continuously learn

At Solventum, we’re nurturing these capabilities through structured certification programmes, AIenabled training pathways, and cross-functional exposure Our foundational model includes onboarding, clinical, product, and selling skills delivered through a tiered system from virtual modules to hands-on workshops

We’re also investing in leadership development and coaching, ensuring that our talent pipeline is ready to lead in a hybrid, digital-first world.

Stan: In a company with global reach, how do you balance standardised commercial excellence frameworks with the need for local adaptability in diverse healthcare markets?

Josep: We operate with a federated model, global standards with local execution. Our frameworks for pricing, training, and analytics are centralised, but we empower regional teams to adapt based on market maturity, regulatory environments, and customer expectations.

For example, while our CRM and dashboards are consistent, our training content is localised using AI translation and regional partnerships. This balance allows us to scale efficiently while remaining relevant and responsive to local needs

Stan: If you look ahead 3–5 years, what excites you most about the commercial journey Solventum is on, and where do you see the greatest opportunities for differentiation in the medtech space?

Josep: What excites me most is the convergence of data, technology, and talent. We’re building a best-in-class commercial excellence organisation that is not just supporting sales but shaping strategy, driving innovation, and improving patient outcomes.

Our differentiation will come from our ability to personalise engagement, optimise training ROI, and deliver value across the entire customer journey. Whether it’s AI-powered coaching, predictive analytics, or omnichannel engagement, we’re positioning Solventum to lead in a more connected, outcome-driven medtech landscape.

Q: You’ve been recruiting in the MedTech sector for over seven years. What are the biggest challenges you see today when it comes to attracting and retaining talent in this highly specialized industry?

A: Markets are getting more and more competitive Larger corporations are pivoting at the moment, defining which devices and segments are performing well and bringing the required revenue to address their long-term growth objectives

Smaller and mid-sized players are fighting for market share while trying to bypass regulatory hurdles that directly affect their daily operations and cash flow. Startups, on the other hand, are challenged by limited funding, new market entry barriers, and an increasingly stringent regulatory environment The main challenge for all remains the same staying focused and aligned with their size, capabilities, and strategic objectives.

We’re also witnessing growing appetite from private equity firms to step into the medical devices space, while venture capital investors are becoming far more selective with their investment choices The European market, in particular, is still in what I would call a “winter mode” the lingering effects of the MDR transition, supply chain disruptions, and strained healthcare budgets continue to weigh heavily on the sector.

All these factors combine to make talent acquisition extremely challenging The best professionals are not only in high demand but are also more cautious about career moves. MedTech companies must now sell more than just a job they must communicate purpose, flexibility, and stability. In many cases, this means rethinking traditional hiring approaches and embracing flexible workforce strategies that allow them to remain agile and competitive despite ongoing uncertainty.

Q: How can contingent workforce solutions and flexible payrolling models help MedTech companies overcome their current hiring challenges?

A: First of all, in such a fast-paced environment, companies are looking for faster decisionmaking processes Contingent Workforce (CW) teams are expanding, and we can clearly see growing interest from larger corporations in identifying and engaging talent differently Flexibility and the ability to adapt quickly to market conditions will only continue to increase the demand for these models.

However, it’s not only large corporations that benefit. Smaller and mid-sized MedTech companies can also take advantage of flexible hiring and payrolling solutions especially when hiring outside of their core markets in regions such as the EU, APAC, or the Middle East. These solutions simplify compliance, minimize risk, and accelerate time-to-hire, which is crucial for companies operating across multiple regulatory jurisdictions.

Another important factor is cost efficiency and scalability Through a flexible payrolling model, organizations can onboard specialists for critical projects whether in regulatory affairs, clinical operations, or product development without committing to permanent headcount until the market or funding environment stabilizes. This gives them the agility to innovate and expand without overextending resources

Finally, flexible workforce solutions empower MedTech companies to access a global pool of highly specialized professionals, including niche experts who might not be available locally In an industry where innovation cycles are short and compliance requirements are complex, having the ability to engage the right expertise at the right time can make the difference between getting a product to market or missing the window of opportunity.

Q: In your experience as Country Manager at InfoTree Global Solutions, how does adopting a global and data-driven hiring approach give MedTech companies a competitive edge?

A: First of all, by adopting a global and datadriven hiring approach, MedTech companies benefit from a much wider and more diverse pool of talent. This is particularly important in an industry where specialized expertise whether in R&D, regulatory affairs, or product engineering is often concentrated in specific regions. A global strategy allows organizations to identify, engage, and onboard the right experts regardless of geographical boundaries, ensuring access to the best talent available rather than the best talent locally available.

Secondly, companies become far more adaptive and precise in their hiring strategies. Leveraging data and global insights enables them to anticipate market needs, identify skill gaps early, and make informed workforce decisions This level of intelligence supports not only short-term project execution but also long-term workforce planning, something that’s essential in MedTech, where product lifecycles and compliance requirements can shift rapidly.

Thirdly, a data-driven global model gives companies greater control over their cashflow and headcount expenditure. By working with a trusted global partner like InfoTree Global Solutions, organizations can deploy contingent or contract talent quickly and compliantly, while maintaining full visibility into costs, performance, and workforce distribution. Our global infrastructure and local expertise help clients navigate complex employment regulations, tax laws, and payrolling requirements allowing them to stay focused on innovation rather than administration

Ultimately, this approach turns hiring from a reactive process into a strategic advantage. MedTech companies that embrace flexibility, backed by data and global reach, can scale operations efficiently, enter new markets faster, and remain competitive in an increasingly demanding and regulated industry

Q: There’s often a perception that flexible work arrangements can dilute company culture or commitment. How do you see MedTech organizations balancing flexibility with long-term engagement and innovation?

A: We already learned during COVID-19 that many companies successfully transitioned from traditional, office-based setups to more flexible, hybrid, or fully remote models. For many professionals, this has now become the new norm not just an emergency measure, but an expectation of how modern work should function.

Secondly, advancements in telecommunications and video conferencing tools have fundamentally changed the way we collaborate. Today, teams can work seamlessly across borders and time zones while still maintaining high levels of communication and connectivity Technology has eliminated much of the friction that once made remote work feel isolating or inefficient.

Third, the vast majority of teams in MedTech particularly in global organizations are already distributed in some form. What has shifted most is culture We’ve moved away from a purely corporate, centralized culture toward something much more personalized, inclusive, and trustbased. The focus now is on outcomes rather than presence, and on empowerment rather than control

The key is to keep the right balance. Organizations must ensure that their teams understand the foundation of the company’s mission, values, and objectives, regardless of where they sit physically. This can be done through intentional communication, regular engagement initiatives, and leadership that models transparency and accountability.

In MedTech, where innovation thrives on collaboration and precision, culture becomes the glue that holds a dispersed workforce together. I’ve seen companies successfully maintain strong engagement by combining flexibility with purpose giving employees autonomy, but also connecting them to a shared goal: improving patient outcomes and advancing medical technology

Ultimately, flexibility doesn’t dilute culture it reshapes it. It allows organizations to attract and retain top talent from anywhere in the world, while fostering a sense of trust and mutual respect. The companies that will thrive are those that build a culture of connection, not location.

Q: As both a recruiter and publisher of MedTech Opinion Leader, what trends or innovations do you foresee shaping the future of MedTech talent acquisition and workforce strategy?

A: I believe we are at a pivotal moment in time when many of the frameworks that defined the MedTech industry over the past decade are being questioned. The traditional models of hiring, working, and even leading teams are evolving rapidly This brings a certain level of market uncertainty, but at the same time, it opens exciting new opportunities especially for talent.

We’re entering an era where professionals have far more autonomy over their careers. Whether you’re part of a global corporation or a small start-up, the ability to shape your own professional journey has never been greater The democratization of information, access to global networks, and the rise of digital collaboration tools mean that geography and hierarchy are no longer the defining factors of success. Everyone truly has the potential to create their own fortune.

Modern tools from AI-driven talent analytics to virtual collaboration ecosystems are changing how organizations identify, engage, and retain talent But beyond technology, the real differentiator will be creativity and adaptability

Those who think outside the box, who can connect science, technology, and human insight, will lead the next generation of MedTech innovation

As a publisher of MedTech Opinion Leader, I see this shift reflected in the conversations we host every day The lines between clinical expertise, digital innovation, and commercial

strategy are blurring Talent strategies must reflect that by embracing multidisciplinary thinking, promoting lifelong learning, and encouraging collaboration across borders and functions.

The future of MedTech talent acquisition will not be about filling roles; it will be about building ecosystems of expertise. Organizations that recognize this early and align their workforce strategies with purpose, flexibility, and creativity will be the ones driving the industry forward

Stan: When you think about early commercialization in medtech, what roles or skill sets do you believe are absolutely critical to build first?

Mike: The obvious answer here is Head of Commercial/Head of Sales However, especially in start-ups, Market Access & Reimbursement are often addressed way later than they should be. These may seem trivial when the company is laser focused on building a game changing product and securing regulatory approval But, once that happens, it's GO TIME! And, unfortunately, there is nowhere to go if you don’t have a comprehensive Market Access & Reimbursement strategy

These functions are a somewhat of an enigma in Med-Tech Ask three executives what these functions encompass and you will get three different answers. Reimbursement is typically one key component of a solid Market Access strategy However, charting the appropriate regulatory path necessary for approval, pricing, and distribution are also key considerations. The sooner a company begins thinking about, and devoting resources to these areas, the better

Stan: And looking at the industry today, what common mistakes do you see companies making when it comes to commercialization and team building?

Mike: Commercialization used to be an afterthought in Med-Tech because it was so simple and predictable Those days are long gone. Commercialization is now the most complex, difficult challenge faced in Med Tech. It’s fraught with pitfalls that if not carefully navigated, can be quite costly in both time and money.

One common mistake is being dogmatic about revenue expectations Especially in the start-up environment, these targets are often created out of thin air during a fundraising round, without any input from a Commercial expert The odds of those targets being realistic are minimal

Another common misstep is underestimating the amount of time necessary to obtain Value Analysis Committee (VAC) approvals and generate meaningful sales. Typically, this will take a company 2-3 times longer than anticipated

Stan: Founders play a pivotal role in setting the tone. From your perspective, when investors and boards look at medtech founders, what do they tend to value most vision, technical expertise, or leadership capability?

Mike: Every Board and VC will value Founder traits and characteristics differently. Personally speaking, I have spent the past 20+ years building high performing early-stage Med tech companies. We have had countless clients enjoy massive exits (IPO, $1B+ acquisitions, etc) I have also seen my fair share of companies crash and burn One Founder trait stands out above all others as the greatest predictor of success, a deep commitment to solving for a specific problem versus building a specific “product” The Founders who become

obsessed with the problem, usually end up figuring out a solution. Those obsessed with developing their “product” often miss the signals to pivot when necessary

Stan: As companies scale, many founders struggle to transition from being innovators to becoming leaders of growing organizations. What are some of the most common challenges you see during that shift?

Mike: One common challenge is maintaining a focus on innovation while sustaining growth. This often becomes most evident when the company exceeds 150 employees Figuring out how to grow what we have today, while building what we will have tomorrow is a delicate balance that many companies find challenging to get right

Another area I see Founders stumble is in leadership empowerment As a company grows, the CEO typically can’t be intimately involved in every aspect of the business like they once were. Obviously, they must always be aware of what is happening inside the organization And asking appropriate questions to pressure test decisions being made is requisite. But many Founders struggle mightily with relinquishing the reins of control, leaving the company’s leaders feeling marginalized and uninspired

Stan: AI is often described as transformative for healthcare, yet adoption has been slower than predicted. From your vantage point, why is that?

Mike: I think there are two primary factors at play here The first is the challenge of incorporating the technology into the EHR, so clinicians can utilize it in a meaningful way. This issue often begins with the backlog of vendors awaiting approval through IT

Another challenge is a lack of real-world evidence supporting the economic value proposition Many of these AI based technology companies expect commitments from hospitals, but have zero proof that

their technology can deliver on their claims related workflows, cost reduction, clinician burnout, etc At minimum, there must be a pilot which can referenced, validating the economic value proposition for hospitals to seriously consider making the investment, regardless of how much clinical benefit the technology provides Most companies have not bothered to generate sufficient evidence in this regard.

Stan: Would you say the biggest barriers are technology maturity, regulatory hurdles, or more cultural resistance within healthcare systems?

Mike: I would say Technology Maturity Why? Economic Viability is one of its key components. Developing a product that can be manufactured and distributed for a profit is challenging in any industry But it almost feels impossible to do in the regulated environment of healthcare. There are so many factors that are out of the company’s control, which dramatically impact its ability build a sustainable business I often refer to these as artificial “governors”.

The first of which is the FDA regulatory process While it has become much more transparent and predictable, it still brings a huge level of uncertainty into the equation. The second is our reimbursement system While Med Tech companies can technically sell their product for whatever they want, it is often artificially capped by CMS’s reimbursement. These two factors combined make it disproportionately more difficult to experience success in Med Tech than any other industry.

Stan: Turning to robotics, in orthopedics adoption has grown, but many surgeons hesitate because they don’t want to give up control. How do you see this tension between surgeon control and robotic assistance playing out?

Initially, many Orthopedic surgeons did resist adopting Robotics Some did not want to give up control Others likely thought it was a fad that would eventually go away and did not want to

invest their time if this was going to be the case. However, it does feel like we have crossed a tipping point Most Orthopods now realize that Robotics is the way of the future in their specialty. Unless retirement is within sight, they really have two options. Relent and adopt or risk irrelevance as the field of Orthopedics passes them by How many gall bladers are taken out via an open approach vs laparoscopically these days? Not many. Evolve or perish.

Stan: Finally, the neuro sector in medtech is evolving rapidly — from neuromodulation to advanced imaging and robotics. What’s your perspective on where this field is headed and the biggest opportunities you see?

Mike: I wholeheartedly agree. Over the last 40 years we have seen leapfrog innovation in the fields of Cardiac & Vascular However, the innovation now feels more iterative in those

markets. But the exact opposite is true in Neuro. The Brain is the new Heart. It is also the system we know the least about in the body

Which means there is a massive room for improvement in terms of how care is delivered, and the outcomes which ensue Fortunately, technology has evolved to a point where it is now possible to realize these gains. Neuro Critical Care Diagnostics, Minimally Invasive Therapeutics, Brain Computer Interface, & Robotic & Image Guided technologies are a few of the verticals within the Neuro market that I am most excited to watch over the next 3-5 years

Top Highlight from previous issue

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

Becton Dickinson

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.

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.

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

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.

Stan: Many people may not realize that suture management is one of the most substantial problems in robotic-assisted surgery. Could you explain what this issue is and why it’s so critical?

John: For a myriad of robotic-assisted cases, suturing is by far the longest portion of the surgeon’s console time. It can be fraught with many pitfalls that lead to: long operative times, increased costs to hospital/healthcare systems, patient safety risks, and surgeon frustration

Most surgeons don’t have the skill or patience required to use a single long suture to complete the suturing task Therefore, most surgeons are currently coordinating and managing multiple, short suture lengths and needles to complete the case With this approach: sutures snag, twist, or drift out of the field; needles can be dropped, lost or forgotten; frequent instrument exchanges and needle passes increase the case time and expose the patients’ viscera to potential injury

This cumbersome practice adds to surgeon cognitive frustration, disrupts case flow, increases total case cost of suture material, and increases time under anesthesia for the patient If robotic-assisted suturing time can be reproducibly and reliably made more efficient, incremental daily case volume increases can be realized for hospital systems

Stan: How does this problem impact surgeons, patients, and overall surgical outcomes?

John: • Surgeons & teams: Interruptions, multiple instrument exchanges, re-grasping, unintentional knotting, accidental suture cuts, and clutter in the operative field of view slows throughput and fatigues the team and surgeon. It also extends procedure duration, turnover and increases variability across surgeons and staff

• Patients: Longer operative and anesthesia time can correlate with higher complication and infection risk Introduction of multiple needles into the patient increases the chances for

incidental visceral injury or accidental retained foreign bodies. All of these risks increase cost of care for systems but can ultimately cost a patient much more

• Outcomes & economics: Variability is the enemy of quality Reliable, standardized suture workflow supports reproducible technique and efficiency. Current techniques put healthcare systems at risk for increased cost of care via: increased OR case times, increased anesthesia cost, increased patient infection risk; and increased risk of retained foreign objects. Even small case inefficiencies in high-volume service lines like hernia and colorectal lead to decreased realized daily case volume for healthcare systems.

Stan: Your team has been focusing on technology that directly addresses this challenge. Can you walk us through how it works?

John: Swope Surgical’s Endospool™ is a sterile, single-use suture-management tool designed specifically for minimally invasive and robotic-assisted procedures It:

1. Organizes and dispenses suture so the surgeon receives exactly what’s needed when suturing It provides manageable access to over 30 cm of suture no tangles, no knots, no

accidental suture cutting or “birds nest effect” in the field. Surgeons can now efficiently affix an entire mesh to the patient’s abdominal wall with a single strand of suture

2. Controls tension on the suture to prevent inadvertent tightening or slack loops that obscure anatomy

3. Streamlines exchanges between bedside assistant and console surgeon by giving the team a predictable “feed-and-retrieve” workflow for up to 30 cm of suture per device.

4. Keeps the field clean by reducing free suture tails and instrument clashes that crowd the camera view.

5. Fosters patient safety by allowing surgeons to efficiently practice “one needle in, one needle out” during their robotic-assisted cases.

We are in design-for-manufacturing and testing with FDA clearance anticipated in Q1 2026

Stan: What sets your solution apart from existing approaches in the robotic surgery space?

John:

• Purpose-built for robotic/MIS suturing: Not a sterile pin cushion that promotes current poor practices Endospool is engineered to enable all surgeons to be more efficient by enhancing robotic field ergonomics, instrument choreography, and port constraints

• No capital equipment: A low-friction, disposable tool that plugs into current workflows easy to trial, easy to scale

• Standardizes across skill levels: Reduces the learning curve for new robotic surgeon suturers by controlling the exposed length of suture while also speeding experts by removing barriers and inefficiencies that are in current best practices.

• Platform-agnostic: Designed to support the major robotic ecosystems, emerging intraluminal approaches, and conventional laparoscopy, broadening relevance across service lines. Anywhere surgeons need suture in a minimal invasive case, Endospool can be utilized

• Suture and needle-agnostic: The current design will easily hold 45 cm of any suture a surgeon prefers The needle can be ANY size the surgeon prefers for the task

• It fits: Endospool is designed to fit down a standard 8mm robotic trocar (or larger) It does not have to be shoved through the patient’s abdominal wall.

Stan: What kind of feedback have you received from surgeons and clinical partners so far?

John: Early voice-of-customer sessions have uniformly wondered why this device doesn’t already exist in the market. Specific highlighted recurring themes:

1. Flow: Fewer camera-view obstructions and faster, more predictable stitch sequences. Less interruption of suture to complete a case.

2. Team confidence: Scrub staff report less “suture wrangling,” which helps turnover and reduces stress on high-acuity days.

3. Adoption potential: Clinical thought leaders see value in standardizing suturing steps for all surgeons regardless of level of training, especially in suture intensive procedures They voice extreme value added for surgeons in their learning curve on a new robotic-assisted system. Many envision Endospool being as ubiquitous as the suture it carries in the next 5 years

We’re incorporating that feedback into our DFM work and pilot plans.

Stan: From a commercial and adoption standpoint, what do you see as the biggest opportunity for scaling this technology globally?

John: • High-volume procedures first: Robotic hernia repair, pelvic floor reconstruction, partial nephrectomy and prostatectomy, colorectal, and foregut settings with lots of suturing and measurable time pressure.

• Simple economic story: No capital; case-based pricing tied to efficiency and consistency. Hospitals can pilot without bureaucracy, then expand by service line

• Channel leverage: Partnerships with leading robotic sales organizations create immediate awareness where the need is felt most

• Manufacturing readiness: We’re building for scalable, cost-efficient production from day one to support IDNs, GPOs, and international distributors

• Global Patents: Multiple patented designs in key worldwide surgical markets to protect company and investors from future infringement

Stan: Looking to the future, how do you envision this innovation shaping the next phase of robotic surgery?

John: We see suturing becoming faster, cleaner, and more teachable a standardized “lane” rather than a rate-limiting step Over time, that opens doors to:

• Data-enabled workflow: Usage metrics (e g , suture feed, tension, stitch counts) that inform training and quality programs.

• Smart integration: Compatibility with robotic platforms and instruments to further automate routine steps.

• Expanded indications: As suturing gets easier and more reliable, case types that currently avoid robotics due to time/complexity can come into scope.

Bottom line: Robotics has transformed exposure and precision. Endospool aims to do the same for suturing providing efficiency to enable surgeons to operate at their maximum potential, case after case.

Stan: As AI systems grow increasingly capable of interpreting human language, emotion, and intention, what legal frameworks do we need to ensure they augment rather than exploit our cognitive and behavioral patterns?

Alice: When technology can read our emotions, predict our stress levels, or anticipate how we’ll react - the question becomes: where’s the line between support and manipulation? When algorithms interpret our stress responses or decision patterns, they cross into territory traditionally protected by constitutional, medical, and even ethical norms

Legal frameworks must ensure transparency of behavioral inference, limits on manipulation, and individual agency over neuro-responsive tech

We need legal frameworks that protect not just our data, but our mental space Who’s collecting what? Why? And what control do individuals really have? The goal should be to empowernot influence - our decisions.

Stan: How should legal systems evolve when machines begin mimicking the brain’s predictive mechanisms - whether in healthcare, contracts, or consumer decisionmaking?

Alice: Let’s be honest, legal systems weren’t built for algorithms that “guess” our next move When a machine predicts a medical outcome or flags a contract risk before we do, how do we assess responsibility? Was it the developer? The system? The human who acted on it? Legal systems need to adapt by looking at how decisions are shaped, not just who signs off. This means clearer rules around design responsibility, model transparency, and who’s accountable when the prediction goes wrong especially in sectors like healthcare where consequences are high-stakes.

Stan: From wearables to language models, AI is learning how we behave, stress, decide, and respond. What legal guardrails are needed to protect the sanctity of neuro-behavioral data?

Alice: Think about it..behavioral data is no longer just "personal" it's intimate, predictive, and increasingly monetized Take the way a smartwatch tracks not just your steps, but how your heart rate spikes before a tough meeting, how long it takes you to fall asleep after a stressful day, or how your breathing changes mid-conversation. That information can be used to tailor insurance pricing, target ads when you're most vulnerable, or optimize workplace performance tools based on emotional response

Maybe it’s time to start thinking about neurobehavioral data as its own category - something that sits somewhere between personal data and biometric information, but reaches deeper. It’s not just about what we do, but how we feel while doing it And that opens up new questions: Should this kind of data have its own legal protections? Should ownership be clearer? Is consent ever truly “free” when it’s shaped by the very systems asking for it?

As AI systems get better at reading between the lines not just what we say, but what we signal these questions feel less hypothetical and more urgent

Stan: What shifts do you think are needed in global legal systems to keep pace with the ethical, operational, and societal implications of AI in MedTech-and how can legal help to shape or anticipate these changes?

Alice: One of the biggest challenges we face is time Technology moves fast, regulation doesn’t And in MedTech, that gap can mean real risk for patients, providers, and companies. In our industry, teams face a critical choice: wait for regulation to catch up, or help shape how emerging technologies are trusted and governed.

Forward-looking teams are stepping in earlier, not just to manage risk, but to ask the right questions while there’s still time to influence design Can we explain how the algorithm works? How does it handle outliers? Could a regulator challenge it, or a clinician misread it? The shift many of us see coming - slowly but surely - is tis that legal will no longer be about just managing compliance It will be about building frameworks of trust in systems that increasingly rely on data, prediction, and automation And that shift starts internally, in how we guide our teams and the questions we’re still learning to ask.

Stan: Cognition is about patterns - and so is AI. But when a machine predicts and acts based on behavior, who’s accountable for the outcome? What does legal responsibility look like in a world where machines "think"?

Alice: The short answer: humans remain accountable. But we need to be more specific about who…is it the designer, the developer, the user, or the company deploying the AI? What matters is having clear roles, documentation, and oversight. AI may “learn,” but it doesn’t make its own rules. It operates within a framework designed, approved, and deployed by humans Responsibility isn’t erased, it’s redistributed And that shift needs to be reflected in how we assess risk and assign liability.

Stan: How do you approach legal leadership when innovation is not just technical - but deeply psychological? What kind of legal mindset is needed when AI touches the most human parts of who we are?

Alice: Leading legal today means learning to operate in the grey - where law, ethics, and emerging tech rarely point in the same direction. It’s about navigating the in-between, where regulation is still forming and ethical boundaries shift with context.

We’re no longer just negotiating contracts - we’re negotiating trust between humans and systems that are designed to understand them. Some of the most important decisions I’ve made didn’t come from having all the answers, but from knowing which questions to keep open just a little longer. Because when technology begins to mirror how we think or feel, the law can’t afford to close the conversation too soon

MEDTECH OPINION LEADER: RYAN DERRIGAN TALKS ABOUT LEADING WITH PURPOSE AND RESILIENCE IN MEDTECH BALANCING INNOVATION, RISK, AND LONG-TERM VISION, INSPIRED BY LESSONS FROM CLIMBING K2 ABOUT TRUST, COURAGE, AND BUILDING RATHER THAN OPTIMIZING.

Stan: You’ve led commercial organizations through major transformations in Cardiology and Structural Heart. What market dynamics or unmet needs are shaping the next wave of growth?

Ryan: First, we've stopped treating valves and started managing patients over their entire lives

Ten years ago, you'd implant a valve and consider it done. Now physicians are planning for the second intervention before they even finish the first Patients are living longer, devices are wearing out, and suddenly we're responsible for outcomes over decades, not months. That sounds patient-centric, and it is But it also means more procedures and more revenue The business model loves lifetime management. The question is whether we're genuinely improving lives or just getting better at monetizing them

Second, AI is moving from slide decks to cath labs We're past the hype AI can now predict which patients will respond, flag anatomies that'll cause problems, and guide device selection in real time. The companies integrating this into workflow are going to own the next decade

Third, robotics is real now Companies like Caranx Medical, Capstan Medical, and SurgiPulse Robotics are developing platforms that combine robotics and AI We’ve seen remote mitral procedures performed over 2,500 kilometers, robotic TOE, and success in TAVI in animal models. The promise is reproducibility, less radiation, and access to centres that couldn't do these procedures before

But here's what keeps me up at night: I’m not sure if AI and robotics democratize structural heart or consolidate it We talk about "broader access," but what if we're building a future where only three companies control the AI, the robotics, and the devices, and everybody else just executes their playbook? Physician champions we're cultivating today might wake up in five years realizing they've built their own golden handcuffs

Stan: Commercial success in MedTech often hinges on aligning clinical evidence, physician adoption, and economic value. How do you balance those forces when bringing breakthrough therapies to market?

Ryan: Most companies treat clinical, economic, and adoption forces as a sequential checklist First, they create their data, then drive adoption, then finally figure out reimbursement. By the time they're negotiating with payers, they've already lost two years

The companies that win treat it as a flywheel. Clinical evidence gets you in the room Physician adoption drives volume, and procedural volume gives you leverage when you sit down with payers. And economic validation funds your next trial, which strengthens the clinical story, which in turn brings in more centres.

But the KOL strategy has to match this flywheel You need three types of physicians, and you need them in that order.

First, clinical champions who care about data more than volume They'll run the trials, present at conferences, and demand the next iteration of your device. They build credibility.

Next comes the volume drivers Once the champions have de-risked the technology, these physicians scale. They're performing 50 cases a year and training others

Finally, economic validators. These are the physicians who meet with reimbursement authorities and care about QALYs The order matters If you get the sequence wrong, you'll plateau. If you bring in validators before you have volume, they will ignore you. I've watched companies make both mistakes and spend years recovering

Stan: The Structural Heart market is highly competitive. What differentiates companies that lead the category from those that follow?

Ryan: I've spent years going head-to-head with Edwards, Medtronic, Boston Scientific, and countless startups trying to disrupt them You see the same pattern over and over

Leaders shape the market, and followers react to it

Edwards and Medtronic didn’t just expand TAVR indications. They ran the trials, moved the guidelines and created new categories, while others waited and tried to take share

Second, leaders invest early in the economic story. I saw the same pattern play out after the Silicon Valley Bank collapse Early-stage companies split into two groups: the ones with strong health economics kept moving; the others hit pause and waited for recovery.

Finally, the biggest differentiator is that leaders build ecosystems. In Structural Heart, leadership means offering integrated training, digital tools, collaborative research, economic support, and peer networks That’s what turns physicians into advocates. The companies that don't understand this keep wondering why they can't break through despite having "better technology " The technology itself was never the moat.

Stan: You took a professional break to climb K2 one of the world’s toughest challenges. What drew you to that goal, and how did it reshape your perspective on leadership and purpose?

Ryan: In 2023, I took a break from my professional life to climb K2 in northern Pakistan. K2, by many accounts, is the most dangerous mountain on Earth It's relentlessly steep and avalanche-prone in ways Everest isn't. The avalanches are constant. You're not wondering if one will happen You're wondering when, and hoping you're not in the wrong place when it does.

I’ve always been allergic to the performative side of high-altitude mountaineering This expedition wasn’t about a LinkedIn post K2 had been a twenty-year goal, starting with

Kilimanjaro in 2002 and leading to Everest’s South Summit in 2012. By 2023, I had spent two decades in blue-chip MedTech scaling businesses, managing complexity, and delivering results. But I realized I was not creating, I was optimizing someone else’s system

K2 changed that.

There’s no corporate playbook on K2, no quarterly reviews, no process documentation Just a team, a goal, and decisions with real consequences. You either push forward or you turn back You either trust your team or you go home It’s hostile, unforgiving, and extremely clarifying.

And it can be miserable Our team endured gastrointestinal warfare, and we watched goats get marched to base camp and slaughtered for dinner. We had so many near-misses with rockfall and ice that I stopped counting You learn fast that self-awareness isn’t optional You have to manage your reactions, read your teammates, and pick your moments.

K2 reminded me what I'd been missing from my earlier career at Intuit: the thrill of building something. Not optimizing or incrementally improving, but building That mountain reignited something I'd buried under two decades of corporate life.

Stan: Climbing K2 demands extreme preparation, teamwork, and the ability to make life-and-death decisions under pressure. How do those lessons translate to leading teams in the high-stakes world of cardiovascular innovation?

Ryan: Preparation beats talent. On K2, the climbers who summit aren’t always the strongest, they’re the most prepared I spent years training for this mountain: running thousands of miles, climbing the highest peaks on nearly every continent, even walking across France and Spain twice That same mindset applies to cardiovascular innovation.

The best teams don’t just wing it, they rehearse, they war-game, and they anticipate failure This builds resilience before the storm hits

Teamwork isn’t optional. On an 8,000-meter mountain, trust is the true oxygen When lives depend on each other, ego and politics disappear In business, we act like the stakes are lower, but the consequences of dysfunction are still fatal, it just kills opportunities instead of people The highest-performing teams I’ve led share the same traits as great climbing teams: extreme honesty, a clear mission, and zero tolerance for drama. That is only built through shared adversity

Failure reframes purpose. I didn’t summit K2. But not reaching the top taught me something: I'm not here to optimize someone else's system for another twenty years. I'm here to build. In structural heart, that means creating new categories, not just improving existing ones

It means leading with conviction when the path isn't clear It means knowing when to turn back, and when to keep climbing even when everyone thinks you're crazy.

Stan: How did K2 change your approach to risk, resilience, and long-term vision in business?

Ryan: The truth is, I didn’t climb K2 because I was brave, I climbed it because I was afraid Afraid that after 20 years in MedTech, I’d become good at something that didn’t matter. That my daughter would remember me not as a builder, but as a guy always boarding another plane to another meeting. K2 wasn’t an adventure, it was an exit interview with myself.

Before that mountain, I treated risk the way everyone in a Fortune 500 treats risk: as something to minimize. By hedging your bets, building consensus, you can avoid the career

ending mistake It's a survival strategy that can work, but it doesn't lead to breakthroughs.

K2 taught me that risk isn't the enemy It's the gateway, and you can't summit without it. The question isn't whether to take risks, but which ones are worth taking, and how you prepare for them Coming back, I realized the biggest risk I’d been avoiding was betting on myself.

Resilience isn’t just about endurance, it’s about staying clear when everything crumbles On K2, every decision matters. You learn to manage fear without letting it paralyze you. To trust your preparation when your instincts are screaming to retreat To lead with conviction when no one's sure what the right call is. The leaders who shape the future of cardiovascular innovation think in decades, not quarters

K2 reinforced that mindset. Play the long game and move with urgency when the moment comes And never forget: the summit isn’t the goal. The goal is daring to climb.

Stan: You and your co-founders are seasoned leaders in the medtech industry. What inspired you to come together and start this consulting company focused on neurovascular and vascular radiology, vascular surgery and cardiology commercialization?

Christopher: We’ve all spent decades in the medtech world, leading commercialization efforts for some of the most innovative technologies in neurovascular, vascular, and cardiology Over time, we noticed a recurring pattern: brilliant innovations were often slowed down or even stalled because companies struggled to bridge the gap between regulatory approval and true commercial success.

We founded 3comma Medical to change that By combining our experience, networks, and infrastructure, we wanted to create a partner that could accelerate safe and effective technologies into the hands of physicians and patients who need them most

Stan: What gaps or unmet needs did you see in the European neurovascular and vascular radiology, vascular surgery and cardiology market that motivated you to create this firm?

Christopher: Europe has long been a critical market for medtech, but the landscape is fragmented and highly complex. Regulations differ country by country, reimbursement is often unclear, and adoption patterns can vary widely

Startups and even established companies often underestimate the resources required to navigate these challenges

The unmet need we saw was for a true commercialization partner one that not only understands the regulatory and logistical hurdles but also has deep clinical networks, KOL relationships, and boots-on-the-ground sales experience.

That’s the gap we’re filling

Christopher Nemeth

We founded 3comma Medical to change that. By combining our experience, networks, and infrastructure, we wanted to create a partner that could accelerate safe and effective technologies into the hands of physicians and patients who need them most.

Stan: How does your combined experience in the industry shape the perspective and value you bring to clients?

Christopher: Each of us has led commercialization efforts from different vantage points whether that’s clinical trial design, regulatory affairs, global sales leadership, or supply chain operations. This breadth allows us to see the full picture and anticipate challenges before they become problems

Our clients don’t just get advice; they get a partner who’s been in their shoes, understands the stakes, and can execute alongside them. It’s the difference between theoretical consulting and hands-on, operational leadership

Stan: What is your vision for the company — both in terms of the impact you want to have on clients and on the neurovascular and vascular radiology, vascular surgery and cardiology field more broadly?

Christopher: Our vision is twofold For our clients, we want to be the commercialization partner that accelerates their path to meaningful adoption and revenue, while increasing their company’s long-term value For the broader field, our vision is to help ensure that life-saving innovations whether it’s a new thrombectomy device, stent, or imaging platform reach patients faster and more reliably Ultimately, if we succeed, it means physicians have better tools in their hands, and patients have better outcomes. That’s the impact we care about

Stan: Commercialization in Europe can be complex, with varying regulations, healthcare systems, and adoption patterns. How do you help clients navigate those challenges?

Christopher: We take a very pragmatic, country-by-country approach First, we map out the regulatory pathway and reimbursement environment. Then we leverage our relationships with key opinion leaders to validate clinical adoption strategies From there, we build tailored distribution and logistics plans that ensure

product availability and reliable delivery Our inhouse warehouse in Austria, for example, allows us to control supply chain and fulfillment for clients, which is critical when dealing with multiple markets. In short, we don’t offer a onesize-fits-all plan we build strategies that reflect the realities of each market

Stan: For medtech innovators entering the medtech space, what do you see as the biggest success factors when it comes to commercialization?

Christopher: The biggest success factors are:

• Clinical relevance: The technology must address a true unmet need in a way that clinicians find compelling.

• Regulatory and reimbursement readiness: Approval is just one step; without a clear reimbursement pathway, adoption is limited

• Commercial discipline: Early-stage companies often underestimate the need for experienced sales leadership, distribution networks, and strong supply chain capabilities

• Flexibility and speed: The European market evolves quickly. Companies that can adapt their strategies by region, while staying compliant, will succeed faster

Stan: Looking ahead, what excites you most about the future of neurovascular and vascular radiology, vascular surgery and cardiology innovation, and how do you see your company playing a role in shaping that future?

Christopher: We’re in a golden age of innovation in these fields. In neurovascular, the advances in clot retrieval and stroke care are nothing short of transformative In vascular surgery and cardiology, minimally invasive tools are reducing risk and expanding treatment options for patients who previously had limited choices What excites us most is the potential for these innovations to save lives and improve quality of life on a massive scale. Our role is to make sure those breakthroughs don’t get stuck in the pipeline we want to be the partner that ensures they move from R&D labs into daily clinical practice across Europe and beyond.

OUR MEDTECH LIVES SPECIAL

Stan: You both have extensive backgrounds in the medical devices industry. What originally drew you to this space, and what keeps you motivated today?

Silke: As with most of the people we interviewed, I, too, answer this question „by pure coincidence" I saw an advert for a sales representative position in the internet and clicked on the 'Send us an email' button. The response was overwhelming I was invited to spend a day at the company, during which I had three interviews. By the end of the day, I wanted the job, and I got it!

Kash: I studied Biology at University and at school I really enjoyed design and technology. Although I started in pharmaceutical sales, I found my natural home when I moved into Medical Tech , Initially I joined an orthopaedics company where I sold Joint replacements, trauma implants, power tools, and arthroscopic cameras When I was younger there wasn’t a lot of career advice regarding the industry, so you sort of discovered it yourself. Since joining I have worked on supplying artificial heart valves, Coronary Stents & Balloons, Cardiac Monitors, Laparoscopic Instruments, tissue staplers Radiation therapy patient positions devices and today surgical robotic. No matter which of these specialist areas you work in you are helping patients overcome challenges like heart disease, arthritis and cancer and improving the delivery of healthcare. This is a huge motivating and driving force for me

Stan: What inspired you to create OurMedTech Lives, and how does it reflect your professional journey so far?

Kash: Our Podcast evolved out of an annual presentation we would give to the MBA classes of St Gallen University in Switzerland We always had a packed room of interested students who were eager to learn about our industry. Most had never really heard of or thought of the Medical Device industry as a career option The students spent a day of learning from industry veterans about the

diversity of specialities in MedTech and learn what a great and rewarding area it is to work in. The podcast enables us to expand the audience

Silke: We see „Our MedTech Lives“ as a way to give back to the medical device industry, my cohost Kash Ikram and I interview veterans of the Medical Device industry and learn about their career journeys, what they are proud of achieving or being involved in and what were the challenges they had to overcome

We aim to help people develop their careers in the industry and attract talent to the industry. This podcast developed from an annual Industry Day we produced for the University of St Gallen MBA program. For me, it's a learning experience in every episode, as well as a great networking opportunity Networking is something we highly recommend if you're aiming for a successful career in our industry.

Stan: The medtech industry has evolved rapidly over the last decade. From your perspective, what have been the most significant shifts?

Silke:The medtech industry has indeed undergone significant transformation over the past decade, driven by new technologies, advances in existing technology and changes in healthcare delivery This includes digital health, AI, robotics but also a trend towards personalised care and prevention, longevity is a new big trend

Kash: I totally agree with Silke, and I would say that the transformation is accelerating with the emergence of AI, intelligent devices, and robotics Medical devices in the form of smart implants, wearables, robots and monitors are getting interactive and smarter and are all helping to enable us to live better and longer lives

Stan: As seasoned professionals, what gaps did you see in conversations about medtech that you wanted this podcast to address?

Silke: As we mostly interview seasoned professionals, I wouldn't call them 'gaps'. I think we consider all the different areas and the numerous opportunities that our industry offers, and try to inspire people.

Kash: There is so much to explore and discuss in Medtech It’s a challenge to cover all 17 specialities in depth. In addition, new technology is sunsetting the older technologies at a faster rate Not all new technology and devices will survive so it’s fascinating to learn and observe this at the moment. In addition, the MedTech ecosystem in complex and there are more topics I would like us to explore such as reimbursement and insurance, regulatory approval, cyber security and ethics.

Stan: You’ve both worked across different functions and geographies. How has that shaped the perspectives you bring into the podcast?

Silke: Working with people from different regions has never been a real challenge for me, as I enjoy meeting new people and learning from different perspectives

Interviewing people from different departments can broaden your perspective, as you're not pursuing a professional goal in your discussion; it's purely about listening, exchanging expertise, and learning. While we all assume that our colleagues contribute to the company's success, we may have different definitions of what success means in different departments For example, I tried to avoid talking to the legal department early in my career. Later, I started to appreciate their support and involved them much earlier, encouraging constant communication I found it really interesting to interview a lawyer. I could ask them anything, as we didn't work for the same company, and I could learn how they view salespeople

Kash: As well as working with the healthcare professionals this industry is full of super smart and caring people People who are solving complex problems in innovative ways, bringing

new products to market, developing new go to market models, ensuring our products can reach a patient anywhere in the world in the shortest time and coming up with value financial solutions to support new and old tech. I find the motivation of people is the same, to help people who need healthcare It’s interesting to see how people solve these issues based on local culture and healthcare set up. For example, in Korea I have seen screens in family waiting rooms where people can see at what stage their loved one is during their operation It’s interesting to see how the Swiss Insurance system gives patients options. In Japan robots are emerging that keep the increasingly elderly population company and monitor them And in Africa countries are leapfrogging from open surgery to robotic surgery and skipping laparoscopic surgery.

Stan: What kind of guests or stories are you most excited to highlight, and what do you hope listeners will take away from them?

Silke: I think the most important thing is to approach every conversation with an open mind. This is especially important in areas where you have no expertise, because you don't know what you don't know I get very excited about new technology, diagnostics and treatment options, especially for diseases that we currently consider incurable

I would be happy if listeners discovered opportunities they had not considered before, or found their area of passion I would also be happy if we could contribute to the formation of a fruitful new network or took something to the next level.

Kash: I echo this, I also love to hear people’s personal challenges that hey had to overcome and how they over came this. We had someone who caught aids and had to change careers One person worked on cancer treatment and one day learned they had cancer. Also work challenges, almost going bust or solving a technical challenge that no one had figured our before We can all learn for these stories no wonder which industry we work in.

Stan: Looking ahead, what’s your vision for OurMedTech Lives — and how do you see it contributing to the broader dialogue in the medtech community?

Silke: If we can help people find their way into our industry so that they can pursue their passion there in the long term, and if we can create opportunities for networking, then we will have taken our first step. We want to further expand our channels for knowledge transfer and exchange and promote dialogue within our community.

Kash: Silke is spot on, Our Medtech Lives is a labour of love for us, it’s a passion project Because we are so passionate about our industry we want more people to be aware of it. For people in the industry, we want to discuss new trends, lessons learned and ow we can help more people better. We want to learn from each other. We also don’t want to shy away from controversy, ethical issues and financial issues, we want openness and to become a town square for important discussions about our amazing business. So if you have something to share or discuss, get in touch!

By the way, one of the most powerful way to understand the customers’ needs is by asking them about their strategic goals over a mediumterm period: the discussion would go to a more strategic level with and an opportunity to build up a solid partnership with mutual benefits We as MedTech players should make sure that whatever we make can do good for the patients, good for the healthcare systems and good for the industry (in this order!) When we introduce innovation into the system, if we don’t think about how to make it financially sustainable, we are going to be part of the problem, not part of the solution

Giuseppe: When you change the go-to-market in the medical device industry you have to consider multiple factors:

a) It’s a relationship market: don’t underestimate the value of the relationships that sales reps have built in time It’s important to build up a risk mitigation plan when you change the go-to-market, it’s key to make the customers feel that the interactions with the company will improve and become even more effective and efficient

b) It’s a long-term partnership what you are after: the sale-cycles in the medical devices industry are relatively long, so you want to build partnerships with your customers that have a long time span.

Stan: With more than 15 years’ experience across 40+ countries, what key leadership lessons have shaped your approach to driving teams and projects in MedTech?

Katherine: I believe effective leadership starts with clarity, communication and a shared sense of purpose - lessons I’ve seen reinforced repeatedly over the last 15 years. Teams thrive when objectives are clear, processes are efficient, and everyone understands how their work contributes to the company’s mission As a leader, it’s important to set direction, maintain transparency and cultivate an environment where people support one another and operate as one team Sustained success comes from keeping good people engaged and motivated in the long term!

From my experience in fast-paced start-ups and SMEs, agility is vital. Building an agile team means empowering people to make decisions, adapt quickly and collaborate cross-functionally, so the organisation can respond effectively as priorities evolve and challenges arise.

Knowledge-sharing is equally critical to collective progress Encouraging open exchange of market insights and product learnings helps teams make better, data-driven decisions and solve problems faster This same principle applies in distribution management: sharing lessons across regions accelerates adoption and strengthens overall performance.

When leading projects, early stakeholder alignment is key to preventing unnecessary delays later. For example, when planning a clinical validation study at FlexDex, securing buy-in from management, surgeons and the Board upfront enabled fast, coordinated execution throughout the rest of the project. Once the shared vision was clear, the team could focus on agile problem-solving and delivering on the study goals. Regular updates, transparency about challenges and celebrating even small wins together helped maintain trust and accountability across the full project team and stakeholders.

Stan: How do you ensure that patient needs remain at the heart of MedTech innovation, especially when balancing clinical, commercial, and regulatory considerations?

Katherine: For me, ensuring patient needs stay at the centre of innovation begins with clarity on the clinical problem we’re solving and constant alignment between clinical efficacy, engineering feasibility, commercial viability and regulatory requirements Every decision should serve the end goal: whether that’s improving patient outcomes, access or user experience.

I make a point of embedding voice of customer feedback throughout development - from initial concept through to validation - and ensuring the team has the expertise to interpret clinical input effectively That often means bringing R&D into the operating room, running hands-on labs to test design iterations, and keeping development grounded in clinical reality rather than technical ambition

Commercial and regulatory strategies must also be aligned early so that innovations addressing genuine clinical needs can reach patients efficiently On the commercial side, marketing and business models must be considered early, with continuous pre- and post-launch feedback and real-world data used to refine market access strategies and maximise adoption Regulatory strategy runs in parallel, aligning evidence generation with approval requirements so progress remains efficient and compliant

So, patient-first innovation doesn’t mean overlooking commercial or regulatory realities - it means building sustainable business strategies around a clearly defined clinical goal, ensuring innovation reaches patients faster and delivers genuine impact where it matters most.

Stan: Working across so many diverse markets, what differences have you noticed in how new surgical technologies are adopted, and what strategies help bridge those gaps?

Katherine: I’ve been fortunate to work across over 40 markets throughout my career, and I’ve seen how adoption of surgical technologies varies widely Each market has its own dynamics, from the openness of clinicians to new approaches, to the infrastructure and payment models that influence adoption Focus is key - you can’t be everywhere at the start, so a clear international commercialisation strategy and launch timeline is essential.

To tailor commercial strategy effectively to different territories, I focus on three key areas. First, identifying the target customer and clinical need per market, and partnering with KOLs early is critical These can vary widely due to differences in clinical practice patterns, local disease prevalence, healthcare system maturity, competitive landscape and regulatory constraints Second, defining the correct route to market, whether that’s direct sales, distributors or partner networks, alongside the level of training and ongoing support required Third, pricing and reimbursement strategies must reflect local dynamics, from hospital budgets to insurance coverage or DRG systems.

Success ultimately comes down to prioritisation Particularly in a start-up, resources are finite, and every opportunity carries an opportunity cost. Launch data must be gathered and analysed continuously to understand where adoption is succeeding, to identify unforeseen barriers and adjust the approach for each market. Global MedTech commercialisation is not one-size-fitsall: go-to-market strategy must be tailored to local realities to ensure adoption and impact.

Stan: From collaborating with KOLs to engaging with global corporates, what have you learned about building partnerships that truly accelerate adoption and impact in MedTech?

Katherine: Particularly in MedTech start-ups, building the right partnerships can be as critical as building the right product, and the right strategic fit can transform a start-up’s trajectory The right relationships accelerate adoption,

expand reach and amplify impact, while the wrong ones can slow momentum or pull focus from the mission Success starts with strategic alignment: a clear understanding of shared objectives, mutual value and clarity on each partner’s role in advancing innovation for patients

With KOLs, it’s about genuine two-way collaboration built on trust and transparency. Engaging early helps ensure the technology fits seamlessly into clinical workflows and enhances, rather than disrupts, the delivery of care. When clinicians feel true ownership in shaping the innovation, adoption follows naturally because the product reflects real-world needs

With corporates and investors, effective partnerships are built on complementary strengths They bring market access, operational experience, foresight on potential hurdles, and the capital and credibility to scale efficientlywhile start-ups contribute agility, innovation and speed Their networks open doors that might otherwise take years, but alignment on goals and pace is essential to maintain focus and agility

Ultimately, the strongest partnerships create mutual value. Corporates gain innovation pipeline, investors achieve returns, KOLs advance their field, and start-ups gain reach and validation. Selecting partners that align with your stage, vision and values, and continuously reassessing that fit, is key to sustained success

Stan: What makes surgeon training and engagement programs successful, not just in initial adoption, but in creating long-term champions for new technologies?

Katherine: As with building partnerships with KOLs, successful surgeon training is about trust, collaboration, and advancing the specialty together, not just promoting a product. Welldesigned programs provide well-rounded education, by combining for example hands-on labs, specialty-specific courses and real-world case exposure, while also keeping training clear,

concise and focused on why each training step matters to maintain strong engagement from surgeons throughout

Successful engagement programs build relationship and loyalty. By involving surgeons as partners and enabling them to educate peers, you create long-term champions who embed the technology into practice and accelerate adoption. Effective programs blend practical skill, clinical insight and ongoing support to create credibility, confidence and a network of advocates that drives sustainable impact.

Stan: As you reflect on the future of surgical innovation, what excites you most about the possibilities for medtech, and where do you believe the greatest opportunities for patient impact lie?

Katherine: It’s an exciting time in MedTech, with technological possibilities in minimally invasive surgery advancing faster than ever Intelligent automation and robotics (whether traditional systems or smaller-footprint solutions) are driving innovation across the field. While these technologies are generating a lot of attention, their true impact will be in applications that enhance surgeon performance, streamline workflows, improve patient outcomes and safely expand patients’ access to advanced procedures

I see particular opportunity in enhancing imaging and diagnostics, improving surgical precision and access, and leveraging data, AI, and machine learning to reduce complications and support clinicians in making better-informed decisions that continuously improve care In the US, ambulatory surgery centers and decentralised care models are especially promising, offering faster adoption compared with traditional hospitals due to adaptability, focus on efficiency and reduced bureaucracy

Ultimately, the greatest opportunities lie where technology directly improves safety, efficiency and patient quality of care worldwide

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peer to peer relationships with Clinicians As a “non-commercially driven” representative of your MedTech Company, Educators are able to build and maintain relationships to customers – in addition to those established by the commercial field teams These more clinically oriented and collegial relationships will give your company insights into

Ron: I

important to incorporate all technological advancements into company driven educational programs It is more important to be able to clearly position your technology within an ever evolving and advancing therapeutical and scientific world

have to think about the good old Henry Ford quote “If I had asked people what they wanted, they would have said faster horses.” Nevertheless, there are lots of innovators amongst HCP`s out there – they just need to be identified. And product development goes far beyond the initial innovative idea Having HCP input during product-creation from my perspective is very beneficial, as always expectations need to be set appropriately, cocreation does not mean outsourcing innovation and not every HCP input needs to be integrated, vetting and considering this feedback though can only help. For testing it seems to me even more important to include HCP`s They are the customers we build the tools for, if they can`t break it its solid, if they can`t handle it, it needs re-design.

Ronovo Surgical raises $67M for surgical robot, inks J&J collab

Ronovo Surgical announced today that it closed its Series D financing round with a total investment of $67 million.

Johnson & Johnson’s corporate venture capital organization, JJDC, led the financing. With the Series D closing, Ronovo also signed a targeted collaboration agreement with J&J to advance its surgical robot commercialization efforts in China

AiM Medical raises $8.1M

AiM Medical closed an $8 1 million Series A financing round, including $3 8 million in notes converted into equity, to support its neurosurgery platform that allows surgeons to perform procedures within an MRI

EndoQuest Robotics Secures Series D-2 Funding Round co-led by Crescent Enterprises and Dr. Fred Moll

EndoQuest Robotics, Inc., a pioneering leader in endoluminal robotic surgical technology, announced today that it has successfully closed a Series D-2 financing round. This strategic funding will fuel the advancement of EndoQuest’s flexible endoluminal surgical platform, supporting the ongoing pivotal PARADIGM clinical trial and accelerating the pathway towards U.S. FDA clearance

Virtuoso Surgical Robotic System Receives FDA Breakthrough Device Designation

Virtuoso Surgical, Inc., a Nashville-based company developing a groundbreaking, entirely new class of robotic tools for endoscopic surgery, announced that the Virtuoso Surgical Robotic System has received FDA Breakthrough Device Designation for bladder lesion removal via en bloc excision, positioning the company at the forefront of early diagnosis and innovative bladder cancer care.

Incisionless surgical robotic tech startup Petal Surgical emerges from stealth with $10M Series A

Petal Surgical announced today that it emerged from stealth with nearly $20 million in funding, including a $10 million Series A

Zimmer Biomet in $168M buy of ortho robotics maker Monogram

Zimmer Biomet Holdings Inc reported it is buying orthopedic robotics maker Monogram Technologies Inc for an upfront payment of $4 04 per share in cash, corresponding to an equity value of approximately $177 million and an enterprise value of about $168 million.

B. Braun Acquires Robotic-Assisted Surgery Company

B. Braun acquired True Digital Surgery to strengthen its position in digital microsurgery, securing expertise for its Aesculap AEOS platform as the industry shifts from traditional microscopes to advanced digital exoscopes for neurosurgery and ENT procedures.

Neurescue gains CE mark for non-shockable cardiac arrest catheter

Danish medtech company Neurescue has gained a European CE mark for its catheter to address non-shockable cardiac arrest. The company’s catheter is used in conjunction with a handheld control unit to temporarily inflate a soft balloon via the femoral artery into the descending aorta to promote the redirection of blood flow towards the heart and brain during cardiopulmonary resuscitation (CPR)

SurgiBox Achieves CE Mark for SurgiField System Devices to Improve Access to Safe Surgery at the Point of Need

SurgiBox, a medical technology company committed to improving access to safe, clean surgery at the point of need, announced today it has received the CE Mark under MDR for the medical devices that comprise its flagship product, the SurgiField™ System

AVITA Medical Receives CE Mark for RECELL® GO, Enabling Commercialization Across Europe

A leading therapeutic acute wound care company, today announced it has received the CE Mark under the European Union Medical Device Regulation (EU MDR) for RECELL GO. This allows the Company to commercialize RECELL GO in Europe and in other markets that recognize the CE Mark.

Alife Health Receives CE Mark Under European Medical Device Regulation for Embryo Predict™, Its AI-Powered Embryo Selection Tool

Vektor Medical’s arrhythmia mapping system receives CE mark

US-based Vektor Medical has secured the CE mark for its non-invasive vMap System, designed to assist physicians in the treatment of individuals with arrhythmias.

The system utilises AI to convert data from a standard 12-lead electrocardiogram into threedimensional maps that pinpoint the source of arrhythmias, such as ventricular tachycardia and atrial fibrillation, all within less than a minute

ONWARD Medical Receives CE Mark for ARCEX, Enabling Commercial Launch of Breakthrough Spinal Cord Stimulation System in Europe

ONWARD Medical N V (Euronext: ONWD – US ADR: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities.

CARMAT Receives MDR CE Marking for Its Aeson® Artificial Heart

Designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the “Company” or “CARMAT”), today announces that it has obtained CE marking under Regulation (EU) 2017/745 on medical devices

AngioSafe Endovascular Revascularization

Catheter Receives FDA Clearance, CE Mark

Reprieve secures $61m for ADHF system trial

Reprieve Cardiovascular has closed an oversubscribed $61m Series B financing round, which was spearheaded by Deerfield Management.

The funds aim to accelerate the global FASTR II pivotal trial of the Reprieve system in patients hospitalised with acute decompensated heart failure (ADHF), as well as facilitate commercial preparation activities

Boomerang Medical Raises $20 Million Series B to Advance Pivotal Trial of Neuromodulation in Inflammatory Bowel Disease

Boomerang Medical, Inc , a women-led bioelectronic medicine company, today announced a $20 million Series B financing co-led by Arboretum Ventures and Hatteras Venture Partners

CardiacBooster secures $10.8M for ventricular assist device

A consortium led by CardiacBooster, in partnership with Fire1 and Integer, received $10.8 million (€9.3 million in funding) recently.

Conformal Medical Closes $32 Million Series D Extension to Advance its Next-Generation Left Atrial Appendage Occlusion Technology

Conformal Medical, Inc., a medical device company developing next-generation left atrial appendage occlusion (LAAO) technology, announced the successful closing of its Series D extension financing, with a new partner joining inside investors to raise a total of $32 million

SetPoint Medical secures $140M to fund neuromodulation for arthritis

SetPoint said the $140 million in private funding included $25 million in a second tranche of its Series C round and $115 million in its Series D financing led by Elevage Medical Technologies and Ally Bridge Group.

Eight Sleep raises $100m in new funds for AI sleep technology

leep solution developer Eight Sleep has raised $100m in a funding round to support the development of its AI-powered Sleep Agent solution and pursue approval from the US Food and Drug Administration (FDA) for its healthfocused applications

The round received contributions from investors, including HSG, Atreides, Valour Equity Partners, Founders Fund, Y Combinator, and sports personalities

Apreo Health secures $130 Million Series B funding to advance emphysema treatment trial

Apreo Health, a clinical-stage medical device company developing a novel therapy for severe emphysema, has raised $130 million in an oversubscribed Series B funding round, the company announced.

Noxilizer Raises $30M in Funding

CoMind receives $100m+ funding for clinical brain monitoring

Ketryx raises $39 million in Series B funding to expand AI compliance tools for life sciences

Cambridge, Massachusetts–based Ketryx, a software platform company that automates regulatory compliance for medical device and life sciences companies, has secured $39 million in Series B funding.

Nalu Medical picks up $50M in growth funding

Trinity Capital announced that it committed up to $50 million in growth funding to neurostimulation technology developer Nalu Medical

Hologic to be acquired by private equity firms Blackstone, TPG for up to $18.3B

Hologic (Nasdaq: HOLX)+ announced today that it agreed to be acquired by funds managed by private equity firms Blackstone and TPG

Edwards buys remaining stake of Vectorious Medical Technologies and its heart implant

According to a report in Globes, Edwards Lifesciences (NYSE: EW)+ agreed to acquire the remaining stake in Vectorious Medical Technologies.

GE HealthCare bolsters MRI provision with icometrix acquisition

Icometrix’s imaging platform tracks amyloid-related imaging abnormalities (ARIA), a known side-effect for some Alzheimer’s patients receiving amyloidtargeting pharmaceuticals.

Axonius Acquires Cynerio for Over $100M, Strengthening Medical Device Security in Healthcare

Axonius, a global leader in cyber asset intelligence announced that it has acquired Cynerio, a pioneer in medical device security, for more than $100M in a cash and stock transaction.

Quasar Medical Strengthens Global CDMO Platform with Acquisition of Nordson Medical's Galway and Tecate Facilities

Quasar Medical, a global leader in manufacturing interventional and minimally invasive medical devices, today announced the completion of its acquisition of Nordson Corporation's (Nasdaq: NDSN) design & development contract manufacturing businesses in Galway, Ireland, and Tecate, Mexico

Cardinal Health to acquire Solaris Health in $1.9B deal

Cardinal Health announced an agreement to purchase Solaris Health in a $1 9 billion deal, the company’s latest acquisition in the urology category and an expansion of its multispecialty strategy.

Avanos Medical acquires Nexus Medical to enhance critical care solutions

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.

CONNECTING THE WORLD’S MEDTECH LEADERS

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