Latest news with #MedicalDeviceNetworkExcellenceAwards
Yahoo
6 days ago
- Business
- Yahoo
Beyond the implant: How Establishment Labs is shaping the future of breast reconstruction
Establishment Labs is redefining the landscape of breast aesthetics and reconstruction through a steadfast commitment to innovation, patient-centric design, and global collaboration. In this exclusive interview, founder Juan José Chacón-Quiros discusses the company's journey from tackling legacy safety issues to pioneering minimally invasive technologies, the critical role of clinician and patient feedback, and a holistic approach to sustainability and education. As regulatory scrutiny intensifies and market needs evolve, Establishment Labs continues to set new standards for safety, access, and impact in women's health worldwide. The company is a recipient of the Innovation and Safety awards in the 2025 Medical Device Network Excellence Awards. Congratulations on your recent awards for Innovation and Safety. How do these recognitions align with Establishment Labs' long-term vision for the medical device industry? These recognitions are a testament to our commitment to women's health and wellbeing and the detailed strategic planning and constant execution of our technology roadmap in the field of breast aesthetics and reconstruction since our founding in 2004. Can you share the strategic priorities that have guided Establishment Labs' growth and product development in recent years? Our initial focus was to heal the legacy of this industry by dramatically reducing the high rates of device-related adverse events that lead to unnecessary reoperations. Fifteen years after bringing our first Motiva implantable medical device to market, our post-market surveillance data and our FDA clinical study are consistently demonstrating results that are an order of magnitude improvement over industry standard results in device related complications related to primary cases. Currently we are also busy launching our minimally invasive technology platform, with proprietary medical devices that are designed to make these procedures simpler and potentially reduce technical-related reoperations in addition to being more in tune with the lifestyle of our patients. Just like other surgical specialties, minimally invasive procedures have the opportunity to enlarge the market. Democratizing access to breast reconstruction has been a key focus for us and game-changing technologies like Flora are making this dream a real possibility for women worldwide. We are continually looking for ways to innovate in this sector. What role does patient and clinician feedback play in shaping your R&D and product innovation roadmap? We have always included clinicians and patients in our process, from ideation to post-market. A clear example of that is how we created the world's first MRI conditional tissue expander, the Motiva Flora®️ SmoothSilk®️ Tissue Expander. Based on feedback from focus groups that included real reconstruction patients and multiple usability sessions with key reconstruction surgeons around the world, we were able to validate our initial prototypes. It has always been crucial for us to have open lines of communication with patients, as we strive for our devices to center around innovation to meet patients' unmet needs. How does Establishment Labs foster a culture of innovation across its teams and global operations? From day 1 we have created a climate in which innovation is our main reason for existence. We call our employees 'women's health contributors' and we mean it; their daily actions should make a difference, and it happens across the company and also at every clinic and hospital using our technologies. At our Sulàyöm Innovation Campus, we created a Global Learning Center with 3 operating theaters, to design the next generation of surgical techniques but also to speed up the process of innovation by providing direct access and an immersive experience of not only creating these medical devices but also seeing how they are used by providers in a real clinical setting. What are some of the biggest challenges your company has faced in bringing disruptive technologies like the Motiva Flora®️ SmoothSilk®️ Tissue Expander to market, and how have you overcome them? The main obstacle is always the status-quo and every single person who believes innovation in medical devices will not make a difference. And then you see a medical device like Flora with game changing technology, allowing clinicians to do things they could not do before, like MRIs during the reconstruction process, improved radiation dosimetry, and more comfort to patients. Once the dust settles, everyone realizes that the way they used to do it was just not good enough, for clinicians and even more so for patients. With increasing regulatory scrutiny in the medical device sector, how does Establishment Labs ensure compliance while maintaining agility in innovation? Since the beginning, we have instilled a patient-centric risk and benefit framework in which we challenge ourselves to go beyond current regulatory and compliance standards so that we can improve our technology. We supplement this with a robust Quality Management System to ensure our devices are made to higher standards than required by regulators. How do you see the landscape of breast reconstruction and implant safety evolving over the next five years, and what role do you envision for Establishment Labs in that future? Breast reconstruction is merging with breast aesthetics as breast cancer has become more prevalent in younger women. They have a longer-term view of what breast reconstruction should be both in terms of outcomes and safety. Our concept of Aesthetic Breast Reconstruction recognizes that need and our team is focused on delivering the technologies that make it possible. Beyond product innovation, what initiatives is Establishment Labs undertaking to support education, training, and best practices among healthcare professionals? We have the most prolific medical education platform in the industry with programs and surgical content, taking place every week around the world. In addition, with our Global Learning Center, we are giving surgeons access weekly to the latest surgical advancements in the space, both in person and virtually. The move to minimally invasive, for instance, is being supported by these efforts and with partnerships with the scientific societies. Sustainability and ethical manufacturing are gaining importance in healthcare. How is Establishment Labs addressing these areas within its operations and supply chain? We work with sustainability at the core. Our operations are carbon neutral which means we are constantly tracking our impact to the planet from suppliers to manufacturing. We do so because it also makes sense from a financial perspective. Our Sulàyöm Innovation Campus is Leed Platinum certified, a first in our industry, and provides our employees with a range of services from physiotherapy to dental care; healthy employees will always be more productive. Can you discuss any partnerships or collaborations that have been instrumental in advancing your company's mission and expanding its global reach? Our partnership with centers of knowledge from around the world have had a tremendous impact on our ability to learn and execute. For example, from our joint work on surface technology with Prof Ardy Bayat at University of Manchester, we were able to enhance our capabilities in this area and eventually gain patent protection for our implant and tissue expander surfaces. Years later, those surfaces were examined by a group of scientists from MIT led by Prof. Bob Langer, leading to a landmark paper in Nature Biomedical Engineering that has changed the way engineers look at the innate immune response of long-term implantable devices. So, we are constantly creating these partnerships and will continue to do so. How does Establishment Labs approach market expansion, particularly in emerging economies or regions with unique healthcare needs? Our approach is to focus on women's health. Lately we have been working to link the few surgeons doing breast reconstruction in Africa with African women after breast cancer, providing access to care for those that may not readily have it. We are designing technologies adapted to those needs which in turn have given us clues on how to solve other problems in other areas of the world. When you are solving the problems of those most in need you eventually solve the problems of so many more. What advice would you offer to other medtech companies aiming to achieve both commercial success and meaningful impact in patient care? Make sure you focus on solving the root of real problems so you can design technologies that will make a real difference in patient outcomes. It is not easy and may take a long time, but success will follow. "Beyond the implant: How Establishment Labs is shaping the future of breast reconstruction" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-07-2025
- Business
- Business Wire
HeartBeam Wins Industry Innovation Award for Advancing Remote Cardiac Care With Groundbreaking ECG Technology
SANTA CLARA, Calif.--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it has been awarded the Innovation Award in Remote Cardiac Diagnostics as part of the 2025 Medical Device Network Excellence Awards. The award honors HeartBeam's groundbreaking, FDA-cleared electrocardiogram (ECG) technology that enables clinical-grade diagnostics for arrhythmia assessment outside of traditional healthcare settings, expanding access to timely and actionable cardiac care. The Medical Device Network Excellence Awards, powered by GlobalData's business intelligence, is one of the most respected independent recognition programs in the industry. The program analyzes over one billion datasets annually to recognize forward-thinking companies that drive positive change and set new standards for excellence across the global medical device sector. The award recognizes HeartBeam's proprietary 3D ECG technology which captures the heart's electrical signals in 3 distinct, non-coplanar directions and then synthesizes these signals into a 12-lead ECG. The technology makes it possible to provide diagnostic fidelity similar to a standard 12-lead ECG in a credit card-sized, cable-free device which enables patients to record their arrhythmia symptoms the moment they occur. The 12-lead ECG synthesis software is currently under review by FDA, and upon FDA clearance, HeartBeam plans to initiate commercialization. 'This recognition affirms our vision of transforming how cardiac conditions are monitored and detected and validates our belief that access to high-fidelity ECG data should not be limited by healthcare settings,' said Robert Eno, Chief Executive Officer of HeartBeam. 'As we continue to prepare for the market introduction of the HeartBeam System, this award highlights our leadership position in delivering clinically validated, patient-centric solutions to advance remote cardiac care.' The Medical Device Network Excellence Award adds to the growing body of industry recognitions HeartBeam has received, including the Pinnacle Healthcare Award, Digital Health Hub Foundation Award, and MedTech Breakthrough Award. About HeartBeam, Inc. HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The 12-Lead ECG synthesis software is under FDA review. The Company holds over 20 issued patents related to technology enablement. For additional information, visit Forward-Looking Statements All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. Cleared Indications for Use The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional. For full safety information, see the full Instructions for Use or Clinician Portal Manual.
