MedTech Opinion Leader for printing (Magazines)

FROM THE EDITOR

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

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

Kalinin

THE LATEST ISSUE OF MEDTECH OPINION LEADER COVERS PFA TO REVOLUTIONIZE AFIB TREATMENT, IOT AND SHIFTING PATIENT CENTRIC PARADIGM, ROBOTICS SURGERY, HOW TO SHIFT FROM PRODUCT FEATURES TO SOLUTIONS SELLING APPROACH, LATEST EU MEDTECH, HYPERTENSION AI, BEING CEO OF A START UP, HOW TO DEVELOP A GREAT INTERNATIONAL MEDTECH BUSINESS, HOW SELECT DISTRIBUTION PARTNERS.

Stan

MARLOU JANSSEN

MEDTECH OPINION LEADER: MARLOU JANSSEN TALKS PFA, HOW IT OFFERS NEW METHOD TO REVOLUTIONIZE AFIB TREATMENT AND IMPROVE PATIENTS OUTCOMES.

Stan: What is Pulsed Field Ablation (PFA), and how does it differ from traditional ablation techniques used in the treatment of Afib?

Marlou: Pulsed Field Ablation (PFA is a novel technique used in treatment of atrial fibrillation) Unlike traditional ablation techniques, whereby hot or cold energy are applied to create therapeutic scars or destroy abnormal heart tissue causing abnormal heart rhythms like tachycardia, PFA employs strong but very brief electrical pulses to create irreversible damage to the targeted tissue

The impact of different ablation energies on safety and success can be significant When a traditional thermal energy like radio frequency (RF) electrocautery is used, heating destroys all tissues in the target volume including extracellular structural proteins, blood vessels, nerve fibers, endocardium et cetera The physics of heat transfer are complex and unpredictable eventually leading to collateral damage and unpredictable treatment volumes

This is different with PFA, whereby a series of low energy but very short and extremely high voltage electric pulses are delivered to the tissue. These low energy pulses disrupt cell structures responsible for compartmentalization ultimately impacting metabolic function If the right combination of PFA pulses are delivered it is possible to ablate the target cardiac tissue selectively and leave bystander tissues and extracellular matrix intact So the PFA approach is designed to provide a non-thermal and noncryogenic alternative to existing ablation methods with some significant advantages

Stan: What are the advantages of PFA technology over other treatment modalities for Afib?

Marlou: Compared to traditional ablation techniques, PFA offers several potential advantages Firstly, PFA has the potential to be significantly faster, allowing for shorter procedures times. Secondly, PFA may reduce some risk of complications associated with thermal based ablation methods, specifically pulmonary vein stenosis, phrenic nerve palsy, and esophageal injury. One, less serious but underappreciated example of collateral injury in patients treated with Cryo and especially with RF occurs in the post procedure recovery. Sometimes patients feel a burning sensation in the chest after undergoing AF ablation which is called thermal pericarditis. With PFA this burning sensation seems to be absent and is therefore providing much less chest discomfort to patients during the recovery period

This is likely explained by the growing body of research that shows PFA can be tissue selective and remarkably predictable when it comes to titrating ablation lesion volume. The predictability can reduce risk of collateral damage to surrounding structures as physicians can potentially tailor treatment to individualize patient care.

A third potential advantage is that PFA may improve efficacy in procedures where the physics of thermodynamics have interfered with our ability to ablate the target tissue Although PFA is a relatively new technology, and longterm studies evaluating its efficacy and safety are still ongoing early results look very promising

Stan: How does it improve patient outcomes?

Marlou: PFA technology has the potential to improve patient outcomes by reducing key procedural risks, providing similar or superior efficacy, and most importantly increasing access to care by dramatically improving procedural workflow.

As I pointed out above, PFA may offer improved safety in AF ablation compared to conventional thermal ablation methods. In a recently published randomized study comparing PFA to thermal ablation (Advent Trial) there was no significant difference between the control and PFA groups

However, if you look at types of complications that occurred in the two groups you can see some important difference in serious or longlasting events occurring between PFA and thermal ablation arms. With thermal ablation there was one stroke and two cases of persistent phrenic nerve paralysis With PFA pericardial effusion occurred in two patients. These serious complications that occurred in the thermal arm were likely related to the ablation itself Whereas with PFA the complications were not related to ablation energy but could potentially be caused to manipulation of large catheters within the heart The MANAFEST-AF registry supported the observation that PFA likely reduces risk in energy-related complications like esophageal fistula, phrenic paralysis, pulmonary vein stenosis but technical challenges more related to large bore catheter manipulation such as vascular access and cardiac perforation remain a concern

I find this extremely encouraging because these types of problems can be solved with iteration. After all this is the first generation of this technology to make it to the market I fully expect future generation PFA catheters will address the mechanical or delivery system related challenges by integrating well established safety features ubiquitous in current technologies, things like contact force, magnetic localization, and size reduction of the devices

Procedural outcomes in AF ablation are largely linked to our ability to effectively isolate electrically active tissues in the pulmonary veins from the rest of the atria. This is why AF ablation is often called pulmonary vein isolation (PVI). Long term outcomes for AF ablation are therefore agnostic to the energy that is used to achieve isolation. What may give PFA a leg up is the predictable lesion characteristics it promises. Data from a 1758 patient post market registry (MANAFEST-PF) evaluating the first commercially available system in Europe are encouraging, showing 81% success at one year However, when effective PVI using PFA is compared directly to thermal ablation in the ADVENT trial the differences were not significant with both approaches showing success in the low 70% range This is still encouraging because in the ADVENT trial there were very few individual physicians that performed more than 5 cases The real-world results from the MANAFEST registry suggest that superior efficacy may depend on learning curve. Regardless it is impressive to see any first generation technology perform so well when put head to head against tools that the physicians are true experts at using. I have high expectations that over the next ten years we will see significant transformation in the field

I FULLY EXPECT FUTURE GENERATION PFA CATHETERS WILL ADDRESS THE MECHANICAL OR DELIVERY SYSTEM RELATED CHALLENGES BY INTEGRATING WELL ESTABLISHED SAFETY FEATURES UBIQUITOUS IN CURRENT TECHNOLOGIES, THINGS LIKE CONTACT FORCE, MAGNETIC LOCALIZATION, AND SIZE REDUCTION OF THE DEVICES.

One decade ago AF ablation procedures took over 4 hours to complete. Incremental improvements over the intervening years brought the duration closer to 2 hours Now the average procedure time is likely to drop below an hour with PFA My understanding is that in experienced hands it is possible to complete PVI from access to removal of the catheters in less than 30 minuets. The impact on the procedural workflow efficiency has big implications; There are a limited number of labs in the world and it takes enormous time & resources to train physicians. If we want to treat tens-of-millions of patients reducing the procedure time can greatly expand access to care.

Catheter ablation is the most effective therapy for atrial fibrillation and improving access improves patient outcomes overall. Additionally, shorter procedure times can minimize patient discomfort, anesthesia exposure and the risk of complications associated with longer interventions.

Catheter ablation is the most effective therapy for atrial fibrillation and improving access improves patient outcomes overall. Additionally, shorter procedure times can minimize patient discomfort, anesthesia exposure and the risk of complications associated with longer interventions.

Stan: Can you discuss any recent advancements or innovations in PFA technology that have the potential to revolutionize Afib treatment?

Marlou: Pulsed Field Ablation (PFA) is a relatively new technology in the field of atrial fibrillation (Afib) treatment and it is a fast evolving field of innovation.

I can certainly discuss some general advancements and potential areas of innovation that could impact PFA and Afib treatment

1. Catheter Designs: Advancements in catheter technology can enhance the effectiveness and precision of PFA Innovations may include improved electrode designs, such as multielectrode arrays or optimized shapes, to deliver pulses more efficiently and achieve better lesion formation

One of the best-in-class examples of such improved catheter design is the new Catheter design of Field Medical Inc This catheter is clearly build for purpose of specifically delivering PFA energy. Moreover Field Medical has been able to create a proprietary catheter design whereby a second electrode is inside the catheter and the catheter has a ceramic tip This particular catheter design allows for Field Bending which controls the shape of the electric field around the catheter with the objective of better tolerability and a larger range.

ONE OF THE BEST-IN-CLASS EXAMPLES OF SUCH IMPROVED CATHETER DESIGN IS THE NEW CATHETER DESIGN OF FIELD MEDICAL INC. THIS CATHETER IS CLEARLY BUILD FOR PURPOSE OF SPECIFICALLY DELIVERING PFA ENERGY.

This catheter is also designed to address the technical challenges of treating deadly arrhythmias like ventricular tachycardia (VT) A market that has not been fully addressed today as tool kits for VT ablation are still suboptimal today. That could potentially change with this specific new catheter design Early animal studies show histology and pathology data with very large and deep footprints in the Ventricle.

2. Energy Delivery Optimization: Research is ongoing to optimize the parameters of pulsed energy delivery in PFA. This includes determining the ideal pulse duration, frequency, amplitude, and waveform characteristics to maximize lesion formation while minimizing potential complications Refinements in energy delivery could enhance the efficacy and safety of PFA procedures. Coming back to the Field Medical technology they have developed the concept of bending of PFA energy which I believe will hold the promise for another great wave of innovations in this field.

3. Imaging and Navigation Integration: Integration of advanced imaging techniques, such as intracardiac echocardiography (ICE) or threedimensional mapping systems, can aid in guiding catheter placement and assessing lesion formation during PFA. Real-time imaging combined with precise navigation could improve the accuracy and outcomes of the procedure

4. Mapping of patient specific AF drivers: coming back to the results of the Advent I think I would like to point out that in this study (and other PFA studies), PFA was used to perform standard anatomically-guided pulmonary vein isolation and thus did not address patient-specific drivers outside of the pulmonary veins that could be the actual cause of that patient's AF.

These non-pulmonary vein AF drivers are currently difficult to map using standard catheters and so typically are not targeted in most ablation procedures I am aware of a new AI-powered 12-lead ECG based mapping system – the Vektor Medical vMap® system –that can identify patient-specific AF drivers and could easily be incorporated into a workflow with PFA to safely eliminate them.

I AM AWARE OF A NEW AI-POWERED 12-LEAD ECG BASED MAPPING SYSTEM – THE VEKTOR MEDICAL VMAP® SYSTEM – THAT CAN IDENTIFY PATIENT-SPECIFIC AF DRIVERS AND COULD EASILY BE INCORPORATED INTO A WORKFLOW WITH PFA TO SAFELY ELIMINATE THEM.

Vektor Medical vMap

This novel approach would be an enormous paradigm shift in the treatment of AF, and would allow a truly patient-centric approach to AF ablation In any case newly developed AI based Software to aid PFA treatment is definitely a trend to watch in the coming years

5. Hybrid Approaches: Hybrid ablation combines different treatment modalities, such as PFA and traditional thermal ablation, to achieve more comprehensive lesion sets This approach may be beneficial for complex cases or when targeting specific areas that may be better addressed with a combination of techniques Hybrid approaches have the potential to provide tailored treatment options for individual patients, improving success rates A great example of such a hybrid approach is PFCA a combination of PFA with Cryo. Lets briefly discuss the advantages of such hybrid approach.

As I said at the beginning of the interview, PFA employs electrical field as ablation energy. As we may remember from Ohm’s law in our high school curriculum, the electrical field (V/cm) comes from multiplying resistance with current. The problem is that since the tissue and the blood are good conductors, the resistance (impedance) is very low Therefore, a very high current is required to achieve a sufficient electrical field in plain PFA. Products on the market today require at least 15 amp to achieve a minimum electrical field, causing unwanted side effects like bubbles (silent emboli), coronary artery spasm, skeleton contractions and even heat

In comparison, the Adagio PFCA catheter uses less than 1 amp to achieve an even higher electrical field than PFA The secret to this is that the law of nature causes the tissue resistance (impedance) to increase by orders of magnitude when tissue is frozen below 0 degrees C, which makes the tissue a prefect substrate to deliver PFA a high electrical field and achieve a durable, contiguous transmural lesion.

Stan: Looking ahead, what does the future hold for PFA technology and its role in the management of Afib?

Marlou: Looking at the many advantages of PFA as outlined above many medical device companies have made PFA development a major priority for their R&D and Clinical Research program. PFA is believed to truly cause a paradigm shift in the management of Afib but also holds a lot of promise for other types of arrhythmias such as VT, which today are more difficult to treat with conventional ablation therapy Some market research projections foresee that by 2030 more than 50% of all WW ablation procedures will be performed using PFA energy. It is obvious that such a paradigm shift is fueling innovations, inspires new perspectives to be taken by physicians and medical device companies and could encourage collaborations on many fronts. Most importantly it will lead to better treatment options for patients if today’s promise of PFA holds up in long term clinical research.

SOME MARKET RESEARCH PROJECTIONS FORESEE THAT BY 2030 MORE THAN 50% OF ALL WW ABLATION PROCEDURES WILL BE PERFORMED USING PFA ENERGY. IT IS OBVIOUS THAT SUCH A PARADIGM SHIFT IS FUELING INNOVATIONS, INSPIRES NEW PERSPECTIVES TO BE TAKEN BY PHYSICIANS AND MEDICAL DEVICE COMPANIES AND COULD ENCOURAGE COLLABORATIONS ON MANY FRONTS.

JOSEP SITJES

MEDTECH OPINION LEADER: JOSEP SITJES TALKS PATIENT CENTRICITY, IOT AND SHIFTING THE PARADIGM, LEADERSHIP, SUSTAINABILITY AND VISION

Stan: Why patient centricity should be at the core of MedTech and HealthTech organisation?

Josep: To prioritize the needs, preferences, and experiences of patients, patience centricity should be at the core of MedTech and HealthTech organizations, in this way we will ensure that they receive the best possible care and outcomes Patient centricity is essential for MedTech and HealthTech organizations because it leads to improve patient satisfaction, increased engagement, better decision-making, increased trust, and drives to a competitive advantage. By putting patients at the center of their operations, organizations can create solutions that truly make a difference in people's lives

Improved patient satisfaction: By focusing on the patient's perspective, organizations can create solutions that cater to patient’s needs, leading to increased satisfaction and loyalty

Enhanced patient engagement: Patientcentric organizations encourage active participation from patients, which can lead to better adherence to treatment plans, improved health outcomes, and increased self-efficacy.

Better decision-making: By understanding the patient's context, organizations can make more informed decisions about product development, service delivery, and policy-making, ultimately leading to better outcomes for patients

Increased trust: Patient centricity fosters a culture of empathy, transparency, and honesty, which helps build trust between patients, healthcare providers, and organizations

Competitive advantage: Organizations that prioritize patient-centricity are more likely to differentiate themselves from competitors, attract and retain patients, and achieve longterm success.

Improved global care: by looking at the patient journey in its entirety, a patient-centred organisation will think beyond the current state but in a global health vision, including considerations such as early sepsis detection (from the moment the patient enters the care facility), or such as pressure injury surveillance, or such as setting up a programme of early mobilisation of patients, even in the ICU, for better recovery in the rehabilitation phase This can help to reduce the risk of complications and shorten the length of stay in hospital.

PATIENT CENTRICITY IS ESSENTIAL FOR MEDTECH AND HEALTHTECH ORGANIZATIONS BECAUSE IT LEADS TO IMPROVE PATIENT SATISFACTION, INCREASED ENGAGEMENT, BETTER DECISION-MAKING, INCREASED TRUST, AND DRIVES TO A COMPETITIVE ADVANTAGE.

Stan: How IoT and Connected devices shift the paradigm of how HCPs will help patients in the near future?

Josep: The Internet of Things (IoT) and connected devices are set to revolutionize the way healthcare professionals (HCPs) interact with and help patients soon by enabling remote monitoring, personalized care, and predictive analytics IoT and connected devices are shifting the paradigm of how HCPs help patients by enabling remote monitoring, personalized care, predictive analytics, telemedicine, and real-time collaboration. These advancements have the potential to improve patient outcomes, reduce healthcare costs, and make healthcare more accessible and efficient

Remote monitoring: connectable devices allow for continuous, real-time monitoring of patients' vital signs, medication adherence, and other health indicators, enabling HCPs to intervene promptly if necessary This can reduce hospital readmissions, improve patient outcomes, and lower healthcare costs.

Personalized care: connectable devices can collect vast amounts of data about individual patients, allowing HCPs to tailor treatment plans to each patient's unique needs This can lead to more effective and efficient care, as well as improved patient satisfaction.

Predictive analytics: By analyzing data from IoT devices, HCPs can identify patterns and trends that may indicate potential health issues before they become serious. This can enable early intervention and preventative care, improving patient outcomes and reducing healthcare costs.

Telemedicine: connectable devices can facilitate remote consultations between HCPs and patients, making healthcare more accessible for those who may have difficulty traveling to appointments. This can also reduce wait times and improve efficiency

Real-time collaboration: IoT devices can enable real-time collaboration between HCPs, allowing them to share patient data and consult with each other on treatment plans. This can lead to more coordinated and effective care.

Each of these IoT devices can help healthcare professionals detect, monitor and treat their patients. The ultimate interest of connected care is to connect all these devices to the patient's medical record to support and optimise the diagnosis and decision-making process. The connectivity of the IoT devices themselves will not revolutionize healthcare: it is how we connect them and analyze the data collected from them that will help caregivers and truly improve patient outcomes

IOT AND CONNECTED DEVICES ARE SHIFTING THE PARADIGM OF HOW HCPS HELP PATIENTS BY ENABLING REMOTE MONITORING, PERSONALIZED CARE, PREDICTIVE ANALYTICS, TELEMEDICINE, AND REAL-TIME COLLABORATION.

Stan: Why strong leadership is important to achieve the shift?

Josep: Strong leadership is crucial to achieve the shift towards a more patient-centric, technology-driven future in healthcare and MedTech for several reasons. Strong leadership is essential to achieve the shift towards a more patient-centric, technology-driven future in healthcare and MedTech because it provides vision and strategy, inspiration and motivation, effective decision-making, accountability, collaboration, adaptability, and the ability to build and lead high-performing teams. Strong leaders are critical to driving innovation, improving healthcare outcomes, and creating a healthcare system that truly puts patients first

Vision and strategy: Strong leaders can articulate a clear vision for the future and develop strategies to achieve that vision

This provides direction and focus for the organization and helps to align employees and stakeholders towards a common goal

Inspiration and motivation: Strong leaders can inspire and motivate employees to work towards the organization's goals, fostering a culture of innovation, collaboration, and resilience.

Decision-making: Strong leaders can make tough decisions quickly and confidently, ensuring that the organization stays agile and adaptable in a fast-moving and increasingly complex healthcare landscape

Accountability: Strong leaders take responsibility for the organization's performance and outcomes, setting high standards for themselves and their team, and holding themselves accountable for results.

Collaboration: Strong leaders can build strong relationships with other leaders, stakeholders, and partners, fostering collaboration and cooperation to drive innovation and improve healthcare outcomes

Adaptability: Strong leaders can adapt to changing circumstances and embrace new ideas, ensuring that the organization remains competitive and relevant in a rapidly evolving healthcare and MedTech landscape.

STRONG LEADERSHIP IS ESSENTIAL TO ACHIEVE THE SHIFT TOWARDS A MORE PATIENT-CENTRIC, TECHNOLOGYDRIVEN FUTURE IN HEALTHCARE AND MEDTECH BECAUSE IT PROVIDES VISION AND STRATEGY, INSPIRATION AND MOTIVATION, EFFECTIVE DECISION-MAKING, ACCOUNTABILITY, COLLABORATION, ADAPTABILITY, AND THE ABILITY TO BUILD AND LEAD HIGH-PERFORMING TEAMS.

Stan: How Sustainability goes in line with the Patient Centric approach?

Josep: Sustainability and patient-centricity are closely aligned because both prioritize the longterm well-being of individuals and society as a whole Sustainability supports a patient-centric approach by promoting a healthy and safe environment, resource efficiency, social responsibility, health equity, and innovation By prioritizing sustainability, organizations can demonstrate their commitment to the long-term well-being of patients and society

Environmental impact: By reducing the environmental impact of healthcare products and services, organizations can help ensure a healthy and safe environment for patients, both now and in the future.

Resource efficiency: By optimizing resource use, organizations can reduce costs and improve the sustainability of healthcare, freeing up resources for other patient-centric initiatives

Social responsibility: By prioritizing sustainability, organizations demonstrate their commitment to social responsibility, which can build trust with patients and enhance their reputation.

Health equity: By addressing the social determinants of health, such as access to clean water and air, sustainable food systems, and safe housing, organizations can help reduce health disparities and improve health equity, which is essential for a patient-centric approach

Innovation: By embracing sustainability, organizations can foster innovation and create new solutions that address both environmental and patient needs

SUSTAINABILITY SUPPORTS A PATIENT-CENTRIC APPROACH BY PROMOTING A HEALTHY AND SAFE ENVIRONMENT, RESOURCE EFFICIENCY, SOCIAL RESPONSIBILITY, HEALTH EQUITY, AND INNOVATION. BY PRIORITIZING SUSTAINABILITY, ORGANIZATIONS CAN DEMONSTRATE THEIR COMMITMENT TO THE LONG-TERM WELL-BEING OF PATIENTS AND SOCIETY.

Stan: What is your Vision of the future in Healthcare and MedTech?

Josep: My vision for the future of healthcare and MedTech is one where technology is seamlessly integrated into the healthcare ecosystem, enabling personalized, efficient, and equitable care for all. Patient-centricity: Patients will be at the center of the healthcare system, with technology enabling personalized care, improved patient engagement, and better health outcomes. The future of healthcare and MedTech is one where technology is used to enable personalized, efficient, and equitable care for all, with a focus on patient-centricity, preventative care, telemedicine, AI and machine learning, IoT and connected devices, sustainability, health equity, and collaboration By working together, we can create a healthcare system that truly puts patients first and improves the health and well-being of individuals and society as a whole

Preventative care: Technology will enable early detection and prevention of diseases, reducing the need for costly and invasive treatments

Telemedicine: Remote consultations will become the norm, making healthcare more accessible and efficient for patients, particularly those in remote or underserved areas.

AI and machine learning: AI and machine learning will be used to analyze vast amounts of data to improve diagnostics, treatment plans, and patient outcomes.

IoT and connected devices: IoT devices will enable remote monitoring, predictive analytics, and real-time collaboration between healthcare professionals, leading to more efficient and effective care

Sustainability: Sustainable practices will be integrated into the healthcare system, reducing the environmental impact of healthcare products and services and promoting resource efficiency.

Health equity: Technology will be used to address health disparities and improve health equity, ensuring that all patients have access to high-quality, affordable care

Collaboration: Collaboration between healthcare professionals, patients, and technology companies will be essential for driving innovation and improving healthcare outcomes

Support Caregivers: Technologies that help reduce the burden on caregivers by facilitating the collection of data from connected devices, setting alarms and safety alerts in the event of deterioration or risk to the patient, and ultimately facilitating care decisions

THE FUTURE OF HEALTHCARE AND MEDTECH IS ONE WHERE TECHNOLOGY IS USED TO ENABLE PERSONALIZED, EFFICIENT, AND EQUITABLE CARE FOR ALL, WITH A FOCUS ON PATIENT-CENTRICITY, PREVENTATIVE CARE, TELEMEDICINE, AI AND MACHINE LEARNING, IOT AND CONNECTED DEVICES, SUSTAINABILITY, HEALTH EQUITY, AND COLLABORATION.

Stan: Having being one the most successful commercial executives in the MedTech and HealthTech space what are your top three strategies you follow to make positive impact on the performance of your teams?

Josep: Always focus on understanding the drivers of your team.

Individualization, in my case I have always been intrigued with the unique qualities of each person and figuring out how different people can work together productively

I always try to appreciate each person’s unique characteristics, and I don’t treat everyone the same Always try to see what makes each individual unique, and how to bring out their best and this without losing your authenticity.

Also:

Set a clear vision of what do you want to achieve and how and over communicate it (repeat , repeat …)

Ask for advice, listen, listen , listen. Challenge the status quo

And finally your team should see you as a source of energy and excitement for every new project

ALWAYS FOCUS ON UNDERSTANDING THE DRIVERS OF YOUR TEAM.

KASHIF IKRAM

MEDTECH OPINION LEADER: KASHIF IKRAM TALKS MICROPORT ADVANCING ROBOTICS SURGERY, HOW TO BUILD HIGH PERFORMING MEDTECH TEAMS AND BRING SUCCESS.

Stan: How does MicroPort advance robotics surgery?

Kashif: MicroPort Medbot is unique in that it works in 6 different medical areas when it comes to medical and surgical robotics

MicroPort Medbot has several robots in its stable including, but not limited to,

Toumai Endoscopic Surgery Robot, Skywalker Orthopaedic Surgical System and 3 others in development, as well as collaborations with Robocath on their R-One Vascular Interventional Surgery System, and

Biobot Surgical PTE LTD´s Mona Lisa Prostate Puncture Surgical System

There are certain technical core competencies that are required for all medical robotics systems

Working in several medical market segments allows Microport Medbot can gather a great amount of clinical and technical experience and leverage that expertise across multiple platforms to enhance hybridization and efficiencies

Medbot also manufactures and develops its core systems and instruments in-house which allow for maximum design flexibility, fast development times, and lowest manufacturing costs

Stan: What makes MicroPort® MedBot™'s Toumai® Endoscopic Surgery Robot special?

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

The Toumai® Endoscopic Surgery Robot has performed over 5,000 complex Urology, Gynaecology, Thoracic and General surgical procedures

Many of them performed for the first time in China using a surgical robot. It’s in active use in over 100 medical institutions

The system has many advanced features including advanced 3D immersive stereo vision, Force sensing technology and the ability to perform Telesurgery through a series of networked Toumai® Endoscopic Surgery Robots.

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

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

Stan: Where can we meet MicroPort Toumai Endoscopic Surgery Robot devices next time?

Kashif: The European Toumai Endoscopic Surgery Robot is in high demand at this moment in time We expect to bring some more to prominent European Training centres in the coming months as well touring some hospitals in Europe Stay connected to find our when the Toumai Endoscopic Surgery Robot is coming to your area!

IMAGINE THE PATIENT BEING TREATED IN ONE HOSPITAL WHILE THE TREATING SURGEON IS IN ANOTHER. WELL, THIS HAS ALREADY BEEN PERFORMED OVER 200 TIMES WITH DISTANCES SPANNING OVER 5,000 KILOMETRES BETWEEN THE SURGEON AND PATIENT.

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

Kashif: Well, the first thing to know when you are selling new highly technical medical devices with a relatively high price tag is that you will be performing what’s known as a “Complex Matrix” Sale. This means that the information will be of a highly technical nature and there will be a lot of it, multifaceted and detailed

Also, the purchasing team will bring in a lot of experts from different areas of the hospital and they will probably be senior in status, often including the C-Suite of the hospital. The sale may include disposable items, capital items and services, adding to the complexity So, you need to hire the right talent and support and train them well. I look for people with a good understanding of the healthcare systems who have the emotional intelligence to understand the needs of each stakeholder in the matrix They also must be able to demonstrate problem solving in their past and be confident in leading the process

Once you have identified the right people they need to be trained on the product, the medical procedures/treatments They should understand the science and the disease states their customers are looking to treat. Its, never a bad idea to review sales techniques, there is always new things to learn about the sales process, purchasing processes, value propositions, pricing and using these days using new technology in your sales process

It’s also good practice to have a user-friendly CRM system to manage this Complex Sales Process You will need to carefully map out the process then create the right metrics and KPIs. These should be relevant and not collected for collection’s sake. You want your salespeople selling and working in the hospital, not doing admin

The more complex the sale the more beneficial is a team approach This could involve bringing in subject matter experts form the company, but also other salespeople In my experience having salespeople helping each other leads, not only to a great team spirit and camaraderie but also, to better sales results! In my opinion it yields better results than having sales reps compete with one another Although its important as a manager to have frequent check-ins with your salespeople, once you have the right people, set the goals and guard rails and provided the resources, get out of their way. Smart, determined, talented salespeople will achieve the results, the manager ` s roles is then to support them

Incentives is always a hot topic. Salespeople in the medical device area are motived by many things, it’s a rewarding job, but monetary rewards feature in their top three. Whether it’s a commission-based structure or bonus tied to a target make it motivational The companies that grow fastest, often reward the best.

I LOOK FOR PEOPLE WITH A GOOD UNDERSTANDING OF THE HEALTHCARE SYSTEMS WHO HAVE THE EMOTIONAL INTELLIGENCE TO UNDERSTAND THE NEEDS OF EACH STAKEHOLDER IN THE MATRIX THEY ALSO MUST BE ABLE TO DEMONSTRATE PROBLEM SOLVING IN THEIR PAST AND BE CONFIDENT IN LEADING THE PROCESS.

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

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

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

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

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

A POSITIVE CULTURE DRIVES THE RIGHT INCENTIVES, CLEAR FOCUS AND PROVIDED RESILIENCE IN TOUGH TIMES. THIS COMBINATION OF TALENT AND CULTURE BUILDS A COMPANY THAT PEOPLE WILL WANT TO DO BUSINESS WITH AFTER ALL, PEOPLE BUY FROM PEOPLE (OR COMPANIES) THEY LIKE. THIS DRIVES GREATER VALUE.

JACOB AHRNSTEIN

MEDTECH OPINION LEADER: JACOB AHRNSTEIN ABOUT BEING MEDTECH CEO IN EUROPE, ENTREPRENEURSHIP, INNOVATION AND NJORD MEDTECH.

Stan: What is it like to be a CEO of a European MedTech Start Up?

Jacob: It’s great fun. Being a CEO at a start-up you have a wide range of responsibilities and also have to be in-depth operational. All from visiting new hospitals, entering new markets to prototyping next generation solutions and interviewing potential team members Europe and medtech specifically - you’re operating in a rather diverse set of markets with local language and culture barriers which you will have to adapt to when building your organisation In addition, the industry is one of the most regulated and Europe with the MDR requirements has set the highest of standards This adds another layer of complexity to the business limiting your agility and speed of development, normally being one of the great advantages of operating a start-up

Stan: Why Did you choose MedTech as your Entrepreneurship path?

Jacob: During my career I’ve had the privilege of working with early research yet decided if commercially viable, supporting executive management at multinationals on their next investment decision, and building digital & IoT solutions on existing open source frameworks Within this context, one of my early tenures was with a university spin-out applying material science to develop a new type of x-ray tube with decreased emission A couple of years later, my former professor at the university introduced me to a project with radiology focus which today is Njord Medtech

EUROPE AND MEDTECH SPECIFICALLY - YOU’RE OPERATING IN A RATHER DIVERSE SET OF MARKETS WITH LOCAL LANGUAGE AND CULTURE BARRIERS WHICH YOU WILL HAVE TO ADAPT TO WHEN BUILDING YOUR ORGANISATION.

Stan: What is unique about Njord MedTech?

Jacob: Looking outside-in I’d say that Njord Medtech is unique in the sense that >99% of all ideas from inside a university hospital never become a viable commercial product implemented at +30 hospitals. So that is quite unique in itself.

In addition, Njord Medtech is rather unique having managed - after only a couple of yearsto build up European operations and footprint with limited resources and individuals.

This is due to the fact that we have strong multidisciplinary and multilingual individuals in our team with extensive medtech industry- and clinical experience

Stan: Who is the team behind the innovation?

Jacob: I met with Barbro Cagner, the idea provider, a couple of years ago During this time it was an incubated project at the Sahlgrenska University Hospital in Gothenburg. We received funding for building the first prototypes, thereafter validating the solution at ten Swedish hospitals and had them bring about additional requirements for an industrialised version. Once the customers had validated our solution we decided to found the company - Njord Medtech

Throughout the company journey we have been fortunate to come across great individuals that have supported our journey of which some have decided to join our band Today we're a solid team of around twelve people operating from Nordics, Switzerland, Germany, Netherlands and UK Several of the team members have worked for both scale-ups and prominent medtech companies such as St Jude Medical, Medtronic, and Cochlear.

NJORD MEDTECH IS RATHER UNIQUE HAVING MANAGEDAFTER ONLY A COUPLE OF YEARS - TO BUILD UP EUROPEAN OPERATIONS AND FOOTPRINT WITH LIMITED RESOURCES AND INDIVIDUALS.

Stan: How did you come up with a solution?

Jacob: My co-founder, Barbro, had a good understanding of the problem space having worked at the radiology department for +30 years in different roles - both as radiographer and part of the management team at the department.

During her role as union representative she had several of the team members suffering from physical pain in back, shoulders and wrist from the patient transfers

She later also noted that the extra team members called in for lift support every now and then had a negative impact on the workflow resulting in clinical inefficiencies

Since the problem space was clear and mutlifold, the question was rather how to build a nimble solution that fits well into the workflow

We started out with prototyping three different solutions and after initial validation we decided to go for one which we then secured further customer validation on. This version was the embryo that has been iterated and developed further into what is today the product Atle® 180

Stan: Could you tell us more about the device itself?

Jacob: It’s a motorised patient transfer solution enabling smooth one person transfer of patients from a bed to examination table

What is unique with the Atle® 180 is that the acute care departments don't have to apply up to six team members lifting or rolling over the patient from one side to the other.

Since the radiology department typically staff with two caregivers they will have to call in and wait for lift support resulting in an inefficient workflow In addition there is patient risk since the transfer can be quite jerky and unstable The conventional method is especially cumbersome for patients with hip fractures.

With our collaborative robotic solution we enable one radiographer to conduct the transfer in a patient friendly manner via just pressing a button on a hand control The Atle® 180 is today used at CT, MRI, X-ray, Interventional Radiology and Radiotherapy departments in Sweden, Denmark, Norway, Germany, Netherlands and UK

Stan: What impact are you trying to make in the Hospitals?

Jacob: Overall we want to make a sizable contribution creating a sustainable healthcare system. With the Atle® 180 we see we can solve for the two problematic emerging trends; healthcare staff shortage and unproportionally increased number of radiology examinations

Our first case study at a Swedish acute radiology department indicates that we could apply freed up clinical time to increase radiology throughput by more than 20% This would imply up to 10 million more CT scans in Europe per year with a maintained number of healthcare staff. If we could enable this while securing increased patient satisfaction during lateral transfers, we’d be both happy and proud.

Stan: How do you envision the future of your company?

Jacob: The strategy of becoming a category leader in Northern Europe with a wide positive impact on the healthcare sector is starting to take form. During the last six months we have successfully recruited a new sales manager in the Nordics and two product specialists in the UK, resulting in connection to newly established NHS Imaging Network Directors

We’re also in the midst of establishing strategic partnership with larger radiology equipment providers with two cases already ongoing in Sweden

WHAT IS UNIQUE WITH THE ATLE® 180 IS THAT THE ACUTE CARE DEPARTMENTS DON'T HAVE TO APPLY UP TO SIX TEAM MEMBERS LIFTING OR ROLLING OVER THE PATIENT FROM ONE SIDE TO THE OTHER.

BERNAT ALBINYANA

MEDTECH OPINION LEADER: BERNAT ALBINYANA TALKS MEDTECH LEADERSHIP, TRUST, BLOOD PRESSURE MONITORING INNOVATION & ADVANCING HYPERTENSION TREATMENT.

Stan: How do you build a high performing sales team in the MedTech industry?

Bernat: Trust is the cornerstone of any successful team, and this is particularly true in sales, where teams are often geographically dispersed and rely on interdependent relationships to drive success.

Recruiting individuals who can cultivate trust, and nurturing that trust throughout their employment, is critical. This is not just a soft skill; it's arguably the most strategic focus a leader can have to unlock the full potential of their team

Trust in the brand & the mission of the company is essential

Stan: As an extraordinary leader in MedTech, what in your opinion makes or breaks a company’s success?

Bernat: Success hinges on three pillars: People, Product, and Financials the "who," the "what," and the "how."

While it may sound like a cliché, prioritizing people is indispensable Without a highly engaged and aligned team, even the best ideas fall flat. Execution depends on talent, cohesion, and commitment at all levels

Next, you need a product that not only works but also delivers undeniable value. However, having a great product is not enough in isolation How you brand, position, and communicate that value to the market often makes the critical difference between success and failure. Finally, cash flow management is a fundamental determinant of a company’s trajectory Even the most innovative businesses must maintain a keen eye on cash flow to ensure they can seize opportunities and drive sustainable growth

Stan: We all know that trust is fundamental to achieve success. But how do you become a Trusted Advisor?

Bernat: By listening. It is important to get remote teams physically together early on There is no substitute for this. People need to mingle and get to know each other. It is important to moderate these encounters Make them interesting and engaging by asking everyone to participate, to reveal something about themselves.

Finally, it is critical to elicit any concerns and reservations participants might have By being open, truthful and responsive to the team you will achieve the buy in and the trust that you will need to make them perform at the highest level

Stan: What makes Biospectal SA special?

Bernat: Biospectal is pioneering a breakthrough in medical technology as the first and only company with a CE MDR certified Class IIa medical device that measures blood pressure using only a mobile phone.

Based in Lausanne, Switzerland, Biospectal is a digital health startup on a mission to democratize remote vital signs monitoring globally We are transforming the landscape by using smartphones and other consumer friendly devices for biosensing and health monitoring.

TRUST IS THE CORNERSTONE OF ANY SUCCESSFUL TEAM, AND THIS IS PARTICULARLY TRUE IN SALES, WHERE TEAMS ARE OFTEN GEOGRAPHICALLY DISPERSED AND RELY ON INTERDEPENDENT RELATIONSHIPS TO DRIVE SUCCESS.

Our innovation lies in combining smartphone sensors, cloud-based analytics, and proprietary algorithms powered by AI and machine learning. This allows us to predict and manage conditions like hypertension with unprecedented accuracy and accessibility.

Stan: How does Biospectal SA advance hypertension treatment?

Bernat: We are on the cusp of a transformative era in medical diagnostics, where mobile technology and AI will redefine how we monitor and treat chronic diseases. Biospectal's first major step into this future is enabling smartphones worldwide to measure blood pressure with medical grade precision.

Key to this transformation are generative and unsupervised AI technologies, which will drive extraordinary growth in medical screening and diagnostics Mobile devices offer the global scale needed to capture essential data at the "point of patient", literally in the hands of individuals everywhere.

With more data, we can unlock new insights, enabling predictive and precision medicine that goes beyond today’s capabilities Biospectal is already operational at a global scale, poised to lead this evolution in healthcare.

High blood pressure is the world’s leading risk factor for mortality, affecting 1 3 billion people globally. Frequent, easy-to-use monitoring is crucial. In fact, better management and treatment of hypertension could save an estimated $5.3 trillion globally between 2030 and 2050. Yet, traditional blood pressure cuffs remain cumbersome and underutilized

That’s where OptiBP™ comes in a breakthrough innovation that replaces the traditional cuff with a fast, convenient, smartphone-based solution With algorithms built on rigorous research, OptiBP™ offers an accessible and effective way to take control of blood pressure monitoring, all at the tip of your finger

Stan: Where can we see Biospectal SA's devices next?

Bernat: What sets us apart is the simplicity of our solution no need for additional devices or wearables Our OptiBP app works directly with your existing mobile phone Currently, it's available for Android users and compatible with over 100 devices. The iOS version, currently in beta, is scheduled for release in the first half of 2025, bringing our solution to even more users globally.

THERE ARE TWO MAIN BUSINESS SCENARIOS WHERE COMMERCIAL EXCELLENCE IS PARTICULARLY RELEVANT: SCALE UP AND TURNAROUND.

RON FANTL

MEDTECH OPINION LEADER: RON FANTL TALKS IMPORTANCE OF CLINICAL EDUCATION ROLE, MUST HAVE SKILLS AND FUNCTIONAL IMPACT ON COLLABORATION WITH HCPS.

Stan: How does the role of Director of Clinical and Education shape the success of a Med tech organization?

Ron: I believe, that alongside the technologicaland strategic business innovators of a med tech company, clinical education departments play the most crucial role for present and future success

A well set up Clinical Education Department is deeply integrated into the guts of a medtech organization. Clinical Education not only can educate customers on the correct and successful use of a product, we also educate field teams, marketeers, development engineers and many more.

From my perspective, a well set up Clinical Education Department can provide the following and even more duties and responsibilities:

Outbound

Deliver high quality Medical Education to Clinicians on clinical use of the technology as well as on relevant topics right and left A great education sets itself apart from a good one by going far beyond the Buttonology and Indication/ Contraindication pieces Don`t misunderstand me, the correct and successful clinical use is important and key to any company success, but good education must go further and needs to be embedded into the full clinical context

Build real, honest, deep, long-term and truthful 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

thoughts, wishes, feedback and general views of your clinical customers that can be invaluable for commercial strategies as well as future product development. Also, these peer-to-peer relationships tend to be very robust in critical situations such as product complaints and can help to maintain a long-term bond between a user and a product.

Inbound

Educate Marketeers, Field Teams, Developers etc on relevant clinical and medical background to help them succeed with their tasks.

Provide clinical field feedback on product perception, needs, benefits, value etc to upstream- as well as downstream Marketing and depending on the organization also to product development

Provide their own Expert Opinion on product, technology as well as marketing and positioning. Clinical Educators own a unique combination of knowledge They are medical professionals with a strong clinical background, they have their eyes and ears constantly in the field and with clinical users, they frequently attend real life use of your product, they know your product by heart, and they experience on a daily basis how your messaging and positioning resonates with clinicians and reality

Interconnecting

Educators can play a pivotal role when it comes to connecting corporate functions with clinical customers Just think of selecting medical advisory board members, choosing sites for Limited Market Release or Beta-Testing of new products and much more. In the past, I had my department even plan and execute new-productlaunches alongside the marketing and sales leadership.

Stan: With all the above impact, what is the perfect skill set for clinical Educators?

Ron: The Clinical Education Department needs to be able to balance the commercial interest of a company with clinical, medical and healthcaresystem reality while being able to maintain a real and truthful partnership with clinical customers.

In order to achieve this, you will need deep medical knowledge, extensive clinical experience, sophisticated educational skills and industry experience with a deep understanding of Sales and Marketing and at least a good understanding of Product Development and Regulatory Affairs. The most important aspect for me though is a personality Clinical Educators must be passionate with every single bone of their body, they must be honest and authentic and really live what they preach

As you can see, the perfect clinical educator is a real Swiss Army Knife and therefore very hard to find It is not necessary that the entire Clinical Education Team ticks all the above boxes, from my experience it is important to find all the above skills on the team and to be consistent in passion and authenticity – the rest is management and leadership.

Stan: How do you stay ahead of rapid technological advancements in the MedTech sector when developing educational programs?

Ron: I think it is not so 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.

The best and from my perspective only way to do so is the same way any clinician would stay on top of things Make sure you have your eyes and ears open at any given time, listen, learn and do not be shy to ask questions. This applies to the day-to-day business while spending time with clinicians and educating in hospitals but also to scientific conferences.

Scientific conferences are not only the place to be to promote your technology and therapy, it is also the place to learn and have your team be continuously educated I have learned in the past that this aspect needs to be considered when you are staffing your conferences. Clinical Educators are very valuable on the booth and for educational sessions, but it needs to be made sure that they also can attend the scientific program to stay up to date and not miss important knowledge

Stan: How important is collaboration between medical device manufacturers and healthcare institutions in ensuring successful training?

Ron: This is a very good point, Stan As mentioned earlier, good education goes far beyond the product only. From a credibility but also from a quality perspective, it makes a lot of sense to integrate broader therapeutical knowledge into educational programs and to team up with hospitals and clinicians to run those sessions I would typically insist that the topics directly related to your technology/ therapy are covered by company employees or contracted consultants, covering additional topics by local clinicians or other HCP`s though always will be very useful. Not only does it bring expert knowledge to the audience, it also underlines the clinical intent of the program, builds relationships and is another great way to gain insights

Stan: What do you believe are the most critical skills clinicians need to learn when adopting new MedTech products?

Ron: Adoption is clearly the final goal and marks the successful implementation of a new technology and therapy A product only gets fully adopted when it gained the clinicians trust. To build this trust I believe there are two main boxes to tick: the clinician needs to feel safe with handling the product and the clinician needs to have seen clinical success, an Aha-Moment. In order to achieve this, obviously patient-selection (indications/ contraindications), good Buttonology-Training as well as tips and tricks are needed. The most critical part from my perspective though is to support the customer during application until they reached familiarity and adoption. This gives you the chance to put failure into perspective, point out success and simply educate in real time and in real life

Stan: What role do you see healthcare professionals playing in the co-creation or testing of new medical technologies?

Ron: These are actually two excellent questions in one When it comes to co-creation, I always 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

Also, having HCP`s included in your testing not only gives you insights into your product it also gives you the opportunity to learn about positioning, messaging and your educational and training approach.

Stan: What cultural or regional differences do you observe when it comes to adopting new medical technologies in Europe versus other parts of the world?

Ron: That’s a fun question, and so hard to answer I can only generalize and please be mindful, there are tons of exceptions to my simplified perception.

In Europe there is a very strong drive to individualize Both the clinician wants to be treated and act as an individual and patient care is also provided very individualized. Guidelines and protocols are secondary and act more as guard rails than anything else

The US and the UK on the other hand are very protocol drive. Here it is much more important to include clear protocols and pathways into the education, while in central Europe the how`s, why`s and the entire background are important to convince every single individual. From my experience Asia is a little more like the US/UK and the ME is a little more like Europe Having worked globally I have clearly learned that there are differences and to be successful it is important to understand the drivers of your audience. Engaging with your audience and building relationships prior to sharpening up your educational program will help you to understand the drivers and act accordingly

Stan: What are the most effective strategies for driving clinician engagement in educational programs?

Ron: That’s an easy one: relevance!

The topic, the goal or the setting needs to be relevant to the audience. It again is important to understand your audience, understand their drivers and build and position the educational events accordingly

REMCO MALJERS

MEDTECH OPINION LEADER: REMCO MALJERS TALKS ABOUT HOW TO DEVELOP A GREAT INTERNATIONAL MEDTECH BUSINESS, HOW SELECT DISTRIBUTION PARTNERS AND INTMEDA.

Stan: Remco Maljers, thank you for joining us today. IntMeDA has been making waves in the medtech industry. Can you tell us about the Association’s journey and vision?

Remco Maljers: Thank you for having me IntMeDa’s journey is a testament to the power of networking, the desire to continue to innovate and improve patient’s outcomes and to share experiences from different parts of the world with our peers

IntMeDA - International Medical Devices Distributors Accelerator was founded to help small and medium sized medical device distributors to solve industry’s biggest puzzles –productivity of the company, productivity of its employees and trend adaptability To solve this we chose the way of leveraging the power of networking and its core aspects – cordiality, joy and energy.

In essence we are a well functioning and very active networking club for medical device distributors today, but our journey will lead us to becoming a quality mark for distributor selection by manufacturers in the future There are local and international associations like MedTech Europe that provide assurance about certain standards under which they operate, such as high compliance standards It is our vision to become that standard for medical device distributors over time.

Stan: I know that you are a true expert when it comes to creating and managing a Global MedTech Business, that is why our readers have a question:

Where do you start before expanding your company to the international markets?

Remco: First of all, establishing a strategic plan and making a well balanced selection of countries to target is crucial Factors that may influence the selection are regulatory entry barriers, market size, margins and the Compliance Perception

Index (CPI). Predominantly Europe, and Germany in particular, has always been a strategic choice for initial international expansion in the medical devices industry. However, EU MDR will change the focus from Europe to other parts of the world

It is essential to stick to your Strategic Plan and not to deviate from this plan too much when opportunities emerge A knowledgeable and wise business leader I used to work for always cautioned his team that 'Opportunity is the biggest enemy of Focus '

Hence, a principle that I strongly stand by is that a maximum of 20% of annual business expansion may be opportunistic versus 80% strategically selected

Stan: What do you look for in a distribution partner?

Remco: When I am selecting new distributor partners I have the following five criteria:

It is important to select companies that have the investment capability matching the needs of starting your business in a new country Cash Flow challenges will slow down revenue development even with the best connected companies out there. As a supplier you can support your business partners as well by leveraging your balance sheet and offering extended payment terms or even better, 24 or 36 months installment plans for capital investments

I consider it crucial to work with distribution partners that already have an existing network in the field, especially in the high tech MedTech environment. These are typically companies that are switching from competitive brands or companies that already sell ancillary products.

As distributors will act as your local business card, you need to select partners with a solid reputation A significant part of my due diligence process is focused on this. In addition, a golden rule I live by is "Never make a promise you can’t keep and always keep your promises " Although this might sound very basic and simple, I have learned over the years that if you live by this rule diligently you will outperform your peers and competitors Ultimately, this is what I expect from my distributor partners as well.

It is critical to work with companies that give your product lines sufficient product focus, preferably with its own dedicated sales teams Large companies with unlimited investment capabilities may look appealing but this does not automatically give you the focus you require. Hence, I want to work with companies whose success depends on their success with our product lines.

Lastly, it is essential to select companies that have the same compliance standards and protocols in place like your company does. Make your Code of Business Conduct part of the Distribution Agreement for example "Countries are not corrupt, people are," meaning a proper selection on compliance standards allows you to expand into markets that are generally perceived as higher risk without actually taking uncalculated risks.

Stan: In today’s fast paced world filled with online meetings all day long, what do you offer your associates and how do you keep them engaged and motivated?

Remco Maljers: We host webinars by experts in their field on topics of interest to our associates. In the past year for example we had the President of MedTech Europe talking about the impact and implementation of EU-MDR,

Circular Healthcare Specialist Dr. Bart van Straten on how to deal with surgical waste material and reduce our Co2 footprint and many other inspiring speakers.

We organize frequent e-fairs which are two hour online sessions during which suppliers have the opportunity to pitch their business case to our associates in a 20 minute format. The agenda will be sent out prior to the events so the associates can log on for the technology presentation of their choice and in case they are interested to have a more in-depth, country and market specific, discussion we will get them connected to the presenting company.

The MEDICA - Leading International Trade Fair in Düsseldorf each November is the meeting spot for international medical device distributors which is why we organize our face to face Annual Meeting there This is typically a half day program the combines the above with the opportunity to meet and greet each other and enjoy a meal together

During Arab Health Exhibition in Dubai we organize a networking dinner every year and this year we will participate in Asia Health for the first time as well to better facilitate our Asian associates.

Stan: You have lived a corporate life so far, so how do you end up becoming one the founding members of a distributor association?

Remco Maljers: Besides my very first job I may not have worked for a medical device distributor, but I always worked with them and therefore understand their needs very well Over the past two decades I have built up a large network of medical device distributors across the globe and I count many of these business owners as my friends.

This is how I came in contact with Jiri Pavlicek, President and CEO of Aspironix in the Czech Republic, who had the original idea of an association such as IntMeDA - International Medical Devices Distributors Accelerator. I was immediately excited and together we started to work on a business case Shortly after we asked Olivier Wouters, Director Business & Product Development at RMS Medical Devices in Belgium, to join and the three of us founded the association

Now 6 years later we are present in 40+ countries and in 20+ therapeutic areas and we have a full time Project Manager running the day to day operation.

I am passionate about the MedTech industry and am glad that through this association I can bring added value to our associates.

Stan: IntMeDA is known for bringing novel technologies to its associates. What sets you apart from other similar associations in the medtech sector?

Remco Maljers: Innovation and networking at IntMeDA - International Medical Devices Distributors Accelerator aren’t just buzzwords; it’s our DNA. What sets us apart is our holistic approach to medtech. We don’t just connect companies; we create ecosystems The solutions we bring to our associates integrate seamlessly with existing healthcare infrastructure, making them scalable and accessible We leverage AI, and advanced data analytics to provide personalized business solutions for member companies. This integration of technology with human touch is what truly differentiates us

At the same we create global friendships and connections which is very visible during our Arab Health dinners.

Stan: The healthcare landscape is rapidly evolving. What are the current trends in medtech, and how is IntMeDA positioning itself in this dynamic environment?

Remco Maljers: The medtech landscape is indeed evolving at an unprecedented pace Key trends include the rise of telemedicine, robotics, wearable devices, and AI-driven diagnostics. At IntMeDA - International Medical Devices Distributors Accelerator, we’re at the forefront of these trends and we have the drive to help our members to get on these trends effectively and fast

Stan: Can you elaborate on how IntMeDA facilitates networking for the growth of member companies' businesses?

Remco Maljers: Absolutely. The main purpose of IntMeDA - International Medical Devices Distributors Accelerator is to foster an environment where our member companies can thrive through collaborative growth We achieve this by providing a robust platform for networking, enabling businesses to exchange products, knowledge, and valuable contacts. Our ecosystem is designed to bring together innovators, industry leaders, and healthcare providers, creating opportunities for partnerships that drive mutual success. By facilitating these connections, we ensure that our members have the resources and support they need to scale their businesses and bring innovative solutions to market

Stan: What specific initiatives does IntMeDA have in place to support this networking and business growth?

Remco Maljers: We have several key initiatives designed to support the networking and growth of our member companies

One of our flagship programs is the IntMeDAInternational Medical Devices Distributors Accelerator Connect series, which includes regular industry meetings, workshops, and webinars where members can share insights, explore new technologies, and form strategic alliances Additionally, we have an exclusive digital platform that allows members to access a vast network of contacts, from potential business partners to leading experts in various fields We also offer tailored business development services, including mentorship programs and market entry support, ensuring that our members can navigate the complexities of the medtech landscape with confidence and success.

We are in a business which is centered around helping patients getting better faster and more effectively. It is human business and the personal touch is a critical part of our success.

GIUSEPPE BATTENTE

MEDTECH OPINION LEADER: GIUSEPPE BATTENTE TALKS EVOLUTION OF MEDTECH SALES - CUSTOMER CENTRICITY, SHIFTING SALES MINDSET FROM PRODUCT TO SOLUTIONS.

Stan: How to understand what customers truly want in the medical device industry?

Giuseppe: The complexity of the needs of the customers in the medical device industry is wellknown What is important about this complexity is how it is evolving in time

In my experience we are still having a lot of attention on the clinical outcomes, but we are also facing two dynamics along the way: a) the clinical outcomes are assessed in a broader context than the medical procedures, including the entire patient pathway from diagnosis to long-term follow up, b) there’s a very high level of focus on the financial outcome linked to the medical procedure

This is a very impactful dynamic and very important for all of us as taxpayers and citizens, besides as MedTech professionals

When I ask a CEO of a hospital “what are your strategic bets for the next 24-36 months?” Their answer is a lot about financials, about their P&L, it’s a lot about the financial sustainability of their processes, on top of course of the clinical benefits they can provide their patients through what they do

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

In the MedTech industry we have been successful for decades because we developed new technologies with a certain frequency, we have researched and developed amazing products that save millions of lives, and until some time ago that was enough to grow and have success This is not enough anymore: with the Healthcare spend growing more than the GDPs we need to make sure that we work on creating more efficiency along with keeping to constantly innovate

Stan: How do you change the sales mindset in the medical device industry?

Giuseppe: The skillset needed in this changing environment follows the trends In an environment in which the dialogue moves from a pure clinical perspective to a place where on top of clinical you have to be financially savvy too, in which you have to address the inefficiencies that are present in the system, than you need people that can have a consultative approach as opposed to a transactional approach

By consultative selling I mean people that are equipped with skills that make them able to talk financials, to help them assess the inefficiency in the hospital processes, able to mobilize the company’s resources to address the customers’ needs, able to network within the organization to provide the best possible solutions to the customer.

I think the soft skills that are needed in sales people in this changing landscape are: understanding the trends, being aware of the financial impact of the medical devices in the hospitals’ processes, assessing the inefficiencies and being able to reduce them, on top of course of being able to sell features and benefits of their own product portfolio

This would require:

Education: constantly train sales teams

Organization: hire and promote people that are inclined to evolve in this direction

Managerial attention: tone from the top and strategic focus on this evolution.

Interdisciplinary collaboration: foster collaboration between different departments in the company to support the complexity of the customers’ needs

Leverage Data: Use data analytics to provide insights into device performance and patient outcomes, supporting the sales narrative.

Incentive Alignment: Align incentives with long-term customer satisfaction and patient outcomes rather than just immediate sales.

Stan: When shifting from one go-to-market strategy to another in the medical device industry, what do you need to consider?

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

In order to do so you have to focus on the medium-term goals and needs of your customers Thereafter, in a change in the go-tomarket model, it’s important to consider this by creating or strengthening roles that have the responsibility to provide value on the strategic levels of the relationship with the customers

c) Reward and motivate the sales force: invest in teams’ development through training, career paths, incentives, so that the attractiveness of the sales jobs is kept as high as possible People don’t necessary like change, so make sure the sales force has clarity on what’s in it for them, they buy-in into the changes and see the brighter future coming from the changes

Stan: How do you identify and understand the specific needs and challenges of your customers to offer tailored solutions in the medical device industry?

Giuseppe: The most demanding part of the services & solutions offer to customers is the required flexibility that comes with this approach

When you engage a customer into a dialogue of medical devices paired with services & solutions, you inevitably into a field of tailored made offers, so the organization has to be flexible enough to develop those solutions into a reasonable amount of time, with all the regulatory/compliance/legal requirements in place. It can be demanding, especially for organizations that tend to standardize all the processes

One way to identify the specific needs of the customers is through direct engagement, understanding the strategic journey the customers are undertaking, through advisory boards to gain insights and through data analysis.

Again, the complexity of this approach comes mainly from the internal alignment among functions and business units, often by overcoming internal different and potentially conflicting objectives that exist with the organizations

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EQT led the round, with participation from Qiming Venture Partners, Alpha JWC Ventures, the Innovation and Technology Venture Fund, eGarden Ventures, CTS Funds, K2VC, and LongZ Capital. Read

CMR Surgical launches Ultrasonic Dissector for surgical robot

CMR Surgical announced that it launched its Ultrasonic Dissector robotic advanced energy instrument as part of its Versius surgical robot. The Ultrasonic Dissector delivers ultrasonic energy to cut and coagulate tissue as part of the Versius Plus offering Versius delivers assistance in the precise and accurate control of Versius Surgical endoscopic instruments The small-scale surgical robotic system features collaborative arms and bedside units for direct patient access Read

EndoQuest™ Robotics Submits Investigational Device Exemption (IDE) Application for Its Flexible Robotic System

EndoQuest Robotics, Inc., a privately held medical device company and pioneer in the development of flexible endoluminal robotic technologies, has submitted an Investigational Device Exemption (IDE) application for its pivotal colorectal clinical study EndoQuest’s mission is to transform surgical outcomes for minimally invasive surgery (MIS) with its groundbreaking flexible robotic system. Read 41

SS Innovations reports first robotic cardiac surgery in Indonesia

SS Innovations announced the completion of the first-ever robotic cardiac surgery in Indonesia with its surgical robot platform. Read

Breaking: Medtronic expects to submit Hugo surgical robot to FDA in 2025

Medtronic (NYSE:MDT) said in November 2024 that it expects to submit its Hugo surgical robot to the FDA for urology indications in early 2025 Read

Momentis Surgical wins FDA nod for secondgen surgical robot

Momentis Surgical (formerly Memic) announced in November 2024 that the FDA granted 510(k) clearance for its second-generation Anovo surgical robot Read

J&J launches Velys Spine surgical robotics and navigation platform

The 510(k)-cleared system, which J&J developed with eCential Robotics, is designed to provide guidance on the placement of screws in freehand and robotic-assisted spine surgeries.

J&J’s Depuy Synthes plans to make the system available commercially in the first half of 2025. The system will join other Velys offerings J&J has cited as a growth driver in its hip and knee businesses. Read

Stereotaxis (STXS) Achieves CE Mark in Europe for GenesisX Stereotaxis STXS recently received a CE mark in Europe for GenesisX a next-generation robotic system The company also submitted a 510(k) application to the FDA in the United States for the same. The latest development is in line with Stereotaxis’ focus on broadening the adoption of robotics in electrophysiology and across endovascular interventions. Read

CMR Surgical wins FDA nod for surgical robot

Versius The US Food and Drug Administration (FDA) has granted a de novo marketing clearance to CMR Surgical’s Versius surgical robotic system to perform soft tissue minimal access surgery for cholecystectomy in adults older than 22 years

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Intuitive readies da Vinci 5 for broader launch after placing 110 robots in Q3

Intuitive Surgical is on track to take the da Vinci 5 robot from a limited rollout to a broader launch in mid-2025

Intuitive placed 110 da Vinci 5 systems in the third quarter, up from 70 in the second quarter, bringing the total installed base to 188, executives said on an earnings call Thursday Customers so far have completed more than 12,000 procedures with the new platform over about the past six months, they added Read

FDA clears next-gen surgical robot from Procept Biorobotics

Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA 510(k) clearance for its next-generation Hydros robotic surgery system

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Caresyntax secures $180M to build AI-powered ‘Android of robotic surgery’, The company has raised $180 million in a Series C extension and debt financing round, the company announced today, further fueling the development and marketing of its “surgical intelligence platform,” a software-as-a-service (Saas) offering that seeks to improve surgery outcomes for patients by connecting the entire surgery process through tech from booking staff to monitoring the surgery with close-up video to providing analytics about surgery outcomes and costs. Read

Horizon Surgical claims $30M for robotic, image-guided cataract surgery

Horizon Surgical Systems, a startup developing automated, artificial intelligence-powered robotic tools for eye surgery, has raised $30 million in venture capital funding to help it tackle a first-inhuman study of its technology. Read

Smith+Nephew partners with JointVue™ for Ultrasound preoperative planning in roboticsassisted surgery Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has signed a co-marketing agreement with JointVue for its patented OrthoSonic™ 3D Surgery Planning Technology – the only ultrasound device currently on the market to deliver 3D preoperative planning. JointVue’s technology allows surgeons using Smith+Nephew’s CORI◊ Surgical System for robotic-assisted knee arthroplasty to create a personalized surgical plan, which may provide opportunities to improve patient satisfaction and operating room efficiency Read

Mendaera receives $73M for handheld, needlebased robotics system

Mendaera has raised $73 million in venture capital funding to continue the development of its handheld robotics platform for needle-based, percutaneous procedures spanning biopsy, vascular access, pain management and more Read

J&J makes surgical robotic moves with Ottava FDA IDE application

One year after unveiling a timeline for its general surgical robot, Johnson & Johnson (J&J) has submitted an investigational device exemption (IDE) to the US Food and Drug Administration (FDA) as it eyes initiating clinical trials. Read

Think Surgical’s New FDA Clearance Is Bringing it Even Closer to Zimmer Biomet

Think Surgical has won FDA clearance for the Tmini Miniature Robotic System to be used with Zimmer Biomet’s Persona Personalized Knee System. Read

MICROPORT® MEDBOT™'S TOUMAI™ ENDOSCOPIC SURGICAL ROBOT SYSTEM COMPLETES MULTIPLE LANDMARK ROBOTIC TELESURGERY CASES IN SUB-SAHARA AFRICA IN THE REPUBLIC OF ANGOLA

The company successfully completed 6 robotassisted laparoscopic radical prostatectomy procedures in the Republic of Angola. From these 6 successful surgical cases and for the first time in the sub-Sahara Africa region, two of the cases were performed remotely using ToumaiTM's telesurgery capability. Read

WHAT COMPANIES RECEIVED CE MARKS:

RETROSPECTIVE ANALYSIS OF THE SECTOR FROM AUGUST UNTIL JANUARY 2025?

Route 92 Medical Gains EU and MDSAP Certification for its Neurovascular StrokeIntervention-Focused Product Portfolio

Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the achievement of European Union approval (CE mark) under the EU Medical Device Regulation (MDR) 2017/745 for its innovative line of neurovascular intervention products. The company also announced clearance under the MDSAP program which gives broad access to international markets. Read

Zimmer Biomet Announces CE Mark Certification for Persona® Revision Knee System

Zimmer Biomet Holdings, Inc (NYSE: ZBH and SIX: ZBH), a global medical technology leader, today received the CE Mark for its Persona® Revision Knee System. This addition to the Persona family builds on Zimmer Biomet's commitment to personalized solutions, providing surgeons with advanced tools for revision knee arthroplasty. Read

Hyperfine secures CE marking for Swoop portable MRI system

Connecticut-based company Hyperfine has secured CE marking under the European Medical Device Regulation for its Swoop portable brain MRI system

The company in 2023 secured initial CE certification for the Swoop system. Read 44

Medtronic achieves CE Mark approval for BrainSense Adaptive deep brain stimulation and Electrode Identifier

Medtronic has announced CE Mark approval in the European Union and the United Kingdom for its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR). Read

CE Mark for Medtronic transcatheter pulmonary valve replacement system

Medtronic plc, a global leader in healthcare technology, today announced it received CE (Conformité Européenne) Mark for the Harmony™ Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT) Read

Q'Apel Medical Announces CE Mark Approval for Armadillo SelectFlex™ Neurovascular Access System

Q'Apel Medical (Q'Apel), a privately held medical device company focused on revolutionizing neurovascular interventions, today announced it has received CE mark certication for its Armadillo SelectFlex™ Neurovascular Access System. The rst-of-its-kind 7F system features the patented SelectFlex™ Technology and is indicated for the introduction of interventional devices into the neurovasculature. Read

WHAT COMPANIES RECEIVED CE

MARKS: RETROSPECTIVE ANALYSIS OF THE SECTOR FROM AUGUST UNTIL JANUARY 2025?

Johnson & Johnson MedTech Announces CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter

Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, today announced European CE mark approval of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter for the treatment of cardiac arrhythmias The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is an irrigated, contact-force sensing catheter powered by the TRUPULSE™ Generator, and is fully integrated with the CARTO™ 3 System for electro-anatomical mapping and for tag indexing Read

Medtronic gets CE mark for Harmony transcatheter pulmonary valve

Medtronic (NYSE: MDT)+ today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system. Read

Medtronic’s Endoflip 300 System Gains CE Mark

Medtronic announced that it has received CE Mark approval for its next-generation Endoflip 300 system to measure pressure and dimensions in the esophagus and pylorus in adults Endoflip can be performed under sedation in around 5 minutes and can be used from the very first endoscopy Read

Gore receives CE mark for lower profile Viabahn VBX endoprosthesis

Gore has announced recent CE mark of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft).

Medical Device Regulation (MDR) approval of this innovation builds on a proven device which has become an important tool for treating complex vascular disease, the company says in a press release In addition to offering the longest balloon expandable stent on the market with its 79mm configuration, and the widest range of stent diameter adjustability, the VBX stent graft now also offers the most 6 Fr compatible configurations, the press release adds. Read

Nevro's HFX iQ™ Spinal Cord Stimulation with AI Technology Receives CE Mark Certification in Europe, Increasing Product Expansion Globally

Nevro Corp. (NYSE: NVRO) has received CE Mark Certification in Europe for its HFX iQ™ spinal cord stimulation (SCS) system, enabling marketing in all CE-recognizing countries HFX iQ is the first SCS system with AI technology combining highfrequency therapy with cloud data insights for personalized pain relief The system features indication-specific algorithms, customized therapy adjustments through the HFX App, and the only 10 kHz Therapy with CE-marked labeling for all major SCS indications Market launch in select European countries is planned for Q1 2025. The system previously received FDA approval in 2022 Read

WHAT COMPANIES RECEIVED CE MARKS:

RETROSPECTIVE ANALYSIS OF THE SECTOR FROM AUGUST UNTIL JANUARY 2025?

Vitestro gains CE mark for autonomous blood drawing robot

An autonomous blood drawing device developed by Dutch company Vitestro has become the first machine of its kind to be granted a CE mark from the European Union

Enabled through a combination of imaging technology and robotics, the Netherlands-based company touts its blood collection device as the last step in fully automated laboratory systems

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Penumbra receives CE Mark for Lightning Flash 2.0 and Lightning Bolt 7 Penumbra, Inc has announced it has secured CE Mark in Europe for its latest computer assisted vacuum thrombectomy (CAVT) technologies, Lightning Flash 2.0 and Lightning Bolt 7. Penumbra says its Lightning products will be the only CAVT systems available in Europe and each are designed to help physicians optimise patient care.

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Boston Scientific Secures CE Mark for ACURATE Prime Aortic Valve System

The ACURATE Prime Aortic Valve System, the most recent addition to Boston Scientific Corporation's transcatheter aortic valve replacement technology portfolio, has been granted the CE mark

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Positrigo announces CE mark for NeuroLF PET system

Zurich-based nuclear medical imaging device firm Positrigo’s positron emission tomography (PET) system, NeuroLF, has acquired market authorisation from the European Union (EU)

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Endostart Gains CE Mark for Endorail

Endostart, a medical device company specializing in gastrointestinal endoscopy solutions, today has obtained a CE marking for the expanded use of its flagship product, Endorail. This extends Endorail’s application to enteroscopy, making this challenging procedure more accessible and widely available, significantly advancing gastrointestinal endoscopy and improving patient care.

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Haemonetics’ SavvyWire Pre-Shaped Pressure Guidewire Wins CE Mark Haemonetics Corporation has gained CE Mark certification and conducted the first commercial European procedures using the SavvyWire PreShaped Pressure Guidewire

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AtriCure wins expanded CE mark for left atrial appendage device, AtriCure (Nasdaq: ATRC)+ announced today that it received an expanded indication for its AtriClip devices in Europe.

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WHAT COMPANIES RECEIVED CE MARKS:

RETROSPECTIVE ANALYSIS OF THE SECTOR FROM AUGUST UNTIL JANUARY 2025?

ViCentra wins CE mark for Kaleido insulin pump

Utrecht, The Netherlands-based ViCentra aims to deliver high-quality, user-friendly solutions for people with diabetes. The system last year launched in a hybrid closed-loop automated insulin delivery system that uses the Dexcom G6 CGM

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PathAI's AISight Dx image management system CE marked for primary diagnosis

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, has announced that its AISight Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis.

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AngioDynamics wins CE mark for atherectomy system

AngioDynamics (Nasdaq:ANGO) announced today that it received CE mark approval for its Auryon atherectomy system.

Latham, New York-based AngioDynamics designed Auryon for the treatment of peripheral artery disease (PAD) That includes critical limb ischemia (CLI) and in-stent restenosis (ISR).

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Ventripoint receives CE Mark for cardiac ultrasound software

Toronto, Ontario, Canada-based Ventripoint Diagnostics has received CE Mark certification for its VMS+4.0 automated cardiac ultrasound software

The certification will allow Ventripoint to engage in the next steps of country-specific introduction of VMS+4.0 in the European Union.

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Medtronic wins CE mark for Evolut FX+

Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Evolut FX+ transcatheter aortic valve implantation (TAVI) system.

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Icometrix gains EU approval for ARIA monitoring AI software

Icobrain aria is designed for automated quantification of amyloid-related imaging abnormalities (ARIA) and severity scoring of ARIAE (edema/sulcal effusion) and ARIA-H (hemorrhage/superficial siderosis). The software is now certified under European Union (EU) CE Medical Device Regulation (MDR)

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Accuray wins CE mark for new helical radiation delivery system

Accuray (Nasdaq: ARAY)+ announced today that it received CE mark approval for its Helix CT-guided helical radiotherapy system

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Femasys Inc. FEMY has announced that it has received the CE mark certification and Health Canada approval for its latest innovation, the FemVue MINI.

FEMY is a leading biomedical company committed to addressing significant unmet needs in women's health through innovative, in-office therapeutic and diagnostic solutions

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KEY ACQUISITIONS: RETROSPECTIVE

ANALYSIS OF THE SECTOR FROM AUGUST UNTIL JANUARY 2025?

Device maker Stryker strikes $4.9 billion deal for Inari Medical

Medical-device maker Stryker (SYK N), opens new tab on Monday agreed to acquire Inari Medical (NARI.O), opens new tab, which makes devices that treat patients with venous diseases, in an allcash deal worth $4.9 billion. The deal for Inari bolsters Stryker's efforts to build out its offerings to treat a condition called venous thromboembolism, where a blood clot forms in a vein, and other vascular diseases. Under the terms of the deal, which was first reported by Reuters earlier on Monday, Stryker will pay $80 per share for Inari Read

Boston Scientific to bolster cardiac ablation portfolio with Cortex acquisition

Boston Scientific has signed a definitive agreement for the acquisition of an Ajax Health company, Cortex, to bolster its cardiac ablation portfolio

The companies did not disclose the financial terms of the deal. Subject to meeting necessary closing conditions, it is expected to be completed in the first half of 2025. Read

Boston Scientific to acquire remaining ownership stake in Bolt Medical for $664m

Boston Scientific Corporation has entered a definitive agreement to acquire the remaining 74% stake not yet owned in Bolt Medical, in a deal valued at up to $664m

The acquisition includes nearly $443m in upfront payment and up to $221m tied to regulatory milestones Read

Israeli Startup EndoStream Acquired by Kaneka in Strategic Medtech Expansion

Japanese conglomerate Kaneka Corporation has acquired a 96.8% stake in EndoStream Medical, an Israeli medical device startup based in Or Akiva, in a deal valued at approximately $100 million. The agreement, which includes provisions for additional payments based on future sales milestones, is Kaneka’s strategic entry into the Israeli medtech sector It is also the first major acquisition by a Japanese firm in Israel since the October 2023 conflict Read

Merit Medical inks $210M takeover of Cook’s lead management business

Merit Medical Systems has struck a deal to buy Cook Medical’s lead management portfolio for about $210 million in cash Read

Stryker announced a definitive agreement to acquire care.ai

Stryker (NYSE: SYK), a global leader in medical technologies, announced today a definitive agreement to acquire care.ai, a privately held company specializing in delivering AI-assisted virtual care workflows, smart room technology and ambient intelligence solutions. The acquisition will strengthen Stryker’s growing healthcare IT offering and wirelessly connected medical device portfolio. Read

Stryker continues year of spending with Vertos Medical acquisition

Stryker has already agreed to acquire multiple companies this year, and the medtech giant is showing no signs of slowing down after picking up back pain specialist Vertos Medical Read

KEY ACQUISITIONS: RETROSPECTIVE

ANALYSIS OF THE SECTOR FROM AUGUST UNTIL JANUARY 2025?

Edwards Lifesciences acquires JC Medical from Genesis Medtech

Edwards Lifesciences has bought US-based transcatheter aortic valve replacement (TAVR) company JC Medical from Singapore-based Genesis MedTech for an undisclosed amount. As part of the purchase, Edwards acquires JC’s JValve System, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation. Edwards paid upfront, plus potential sales-based contingent milestones Read

Edwards Lifesciences Expands Structural Heart Portfolio with Key Acquisitions

Edwards agreed to acquire JenaValve Technology, a company that is a pioneer in the transcatheter treatment of aortic regurgitation (AR).

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Zoll completes Vyaire ventilator product line acquisition

Zoll completed the previously announced acquisition of certain assets of Vyaire Medical’s ventilator business

The two companies announced the deal in August following Vyaire’s Chapter 11 bankruptcy proceedings. Now that the acquisition is complete, Zoll will sell Vyaire’s Bellavista, Fabian, LTV and 3100 HFOV product lines alongside its other respiratory care offerings. Read

Medical device developer Trudell Medical has reached an agreement to buy the respiratory diagnostics (RDx) business of Vyaire Medical. Vyaire Medical filed for Chapter 11 bankruptcy protection in June 2024, announcing that it was intending to sell its business units Read

Johnson & Johnson to Acquire V-Wave

Johnson & Johnson1 (NYSE: JNJ) today announced that it has entered into a definitive agreement to acquire V-Wave Ltd., a privately-held company focused on developing innovative treatment options for patients with heart failure

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