Medical Device Network Excellence Awards 2025: Establishment Labs

Establishment Labs^®, a global medical technology company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction, has won Innovation and Safety awards for its Motiva Flora^® SmoothSilk^® Breast Tissue Expander in the 2025 Medical Device Network Excellence Awards for their advancements in breast reconstruction technology. This dual recognition underscores the company’s commitment to delivering meaningful innovation while maintaining the highest standards of patient safety in breast reconstruction. 

The Medical Device Network Excellence Awards honor the most significant achievements and innovations in the medical device industry. Powered by GlobalData’s business intelligence, these Awards recognize the people and companies leading positive change and shaping the future of the industry. 

Establishment Labs^® won the Innovation award in the Breast Reconstruction Devices category for introducing novel features that enhance clinical outcomes and streamline surgical procedures. Motiva Flora^® also received the Safety award for implementing design elements that significantly reduce patient risks and improve overall implant safety.  

This dual-category win establishes Motiva Flora^® as a benchmark in both innovation and safety within breast reconstructive surgery. 

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.

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.

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. 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Establishment Labs Holdings Inc. is a global medical device company dedicated to improving women’s health and wellness in breast aesthetics and reconstruction through the power of science, engineering, and technology. The Company offers a portfolio of solutions for breast health, breast aesthetics, and breast reconstruction in over 90 countries. With over four million Motiva^® devices delivered to plastic and reconstructive surgeons since 2010, the Company’s products have created a new standard for safety and patient satisfaction. 

The company’s minimally invasive platform consists of Mia Femtech™, a unique minimally invasive experience for breast harmonization, and Preservé™, a breast tissue preserving and less invasive technology for breast augmentation, revision augmentation and mastopexy augmentation. GEM^® is a next-generation minimally invasive system for gluteal ergonomic modeling currently undergoing an IRB-approved pivotal study. 

The Motiva Flora^® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MR Conditional. Zensor™ is an RFID technology platform used to safely identify implantable devices from outside the body, and includes the company’s first biosensor Zenº™, currently part of an IRB-approved pivotal study to measure core breast temperature. These solutions are supported by over 200 patent applications in 20 separate patent families worldwide and over 160 scientific and clinical studies and publications in peer-reviewed journals. 

Establishment Labs manufactures at two facilities in Costa Rica, compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820. For additional information, please visit www.establishmentlabs.com 

Paradise Textiles is a technology-first, material science business that serves as the dedicated innovation hub of the Alpine Group. Consistently setting the agenda and leading industry exploration into game-changing materials and processes, Paradise Textiles operates in an industry-leading Collaborative Innovation Centre in Wuxi; a Design and Innovation Lab in Taiwan; together with a global network of industry experts, scientists, catalyst partners, and change-making innovators.

In Q3 2024, Paradise Textiles will expand into Egypt with a sustainable knitting and dyeing mill, close to needle. The vision is to create up to 500 jobs for the local community whilst producing up to 100 metric tons of fabric per day, offering speed-to-market opportunities for our brand partners.  The mill will create polyester filament and blended fabric knitting and will feature its own in-house laboratory as well as a full digital workflow – from dyeing to printing and cutting.  Sustainably designed from the inside out, the mill will feature low liquor ratio dyeing technology, saving 70% water as well as green energy production to help achieve zero carbon emissions.