In additive manufacturing (AM), the personalized medical implant market is burgeoning, presenting an unprecedented opportunity within the aesthetic sector. This niche is ripe for disruption, with 3D printing offering tailored solutions that promise to enhance patient outcomes and satisfaction. By harnessing the flexibility of AM, companies can create implants that are not just a closer fit to the individual’s anatomy but also potentially lead to quicker recoveries and better aesthetic results. This personalized approach not only caters to the growing demand for customized healthcare solutions but also aligns with the increasing value placed on aesthetics, making it a potent area for growth and innovation in AM.
This context sets the stage for FITme‘s introduction into our “Startup Accelerator” series, highlighting the company’s alignment with the market’s direction toward customized healthcare solutions. FITme’s innovative and unique approach to leveraging AM technology to cater to the nuanced aesthetic needs of individuals underscores the strong value proposition of 3D printing in delivering personalized, precise, and patient-centric medical implants, positioning FITme as a critical player in this specific market segment.
Innovating Beauty: The Genesis of FITme
FITme is a Korean company that uses medical image analysis and 3D printing technology in the cosmetic surgery industry, a sector worth $5 trillion and representing a significant portion of the global industry. FITme specializes in custom implant solutions designed and crafted to meet each patient’s unique needs. This personalized approach is a departure from traditional methods that involved surgeons adapting and modifying off-the-shelf implants.
The company’s groundbreaking initiative is the FACE ON platform, an AI-driven surgical planning and patient consultation breakthrough. This platform meticulously analyses medical images to offer surgeons a detailed 3D model for precise pre-surgical planning, significantly enhancing efficiency and accuracy in procedures. This approach not only streamlines the surgical process but also ensures implants are tailored to the intricate anatomical nuances of each patient, embodying FITme’s ethos that ‘one size fits no one.’
This commitment to customization and precision has not only solidified FITme’s position as the premier provider of first-time, tailor-made implants in Korea but also expanded its influence to over 140 hospitals in six countries, with a robust production rate of 450 parts monthly. With the Korea Food and Drug Administration’s (KFDA) stamp of approval on its products, FITme’s relentless pursuit of safety, innovation, and patient satisfaction continues to redefine the standards of medical aesthetics, promising a future where cosmetic enhancements are as distinct and unique as the individuals they are designed for.
FITme’s Core Innovations
- Revolutionary Virtual Surgery Platform: The FACE ON platform is at the heart of FITme’s innovation. This cutting-edge system leverages an AI-based segmentation engine to reconstruct CT data into 3D models within minutes. This breakthrough technology enables surgeons to perform detailed pre-surgical planning in 3D, significantly reducing surgery time and enhancing surgical precision. By providing a virtual simulation of the expected outcomes, FITme empowers surgeons with unprecedented planning capabilities, ensuring optimal patient results.
- Customized Implant Solutions: FITme’s dedication to personalized care is evident in its approach to creating customized implant solutions. Utilizing advanced 3D printing technology, FITme produces a diverse range of single-unit implants tailored to the specific anatomical requirements of each patient. This method ensures a perfect fit for every implant, addressing individuals’ unique structural and aesthetic needs, thereby eliminating the limitations and compromises associated with standard off-the-shelf implants.
- Material Innovation for Diverse Needs: Recognizing the inherent variability in human anatomy, including differences in body structure and skin elasticity, FITme is committed to expanding its material repertoire. The company conducts ongoing research and development to explore various material properties and hardness within its silicone implants. This commitment to material innovation allows FITme to cater to the diverse needs of its clientele, offering customized solutions that are anatomically accurate and compatible with the individual’s tissue characteristics, ensuring both safety and comfort.
Learning from Setbacks: Building Resilience
In the journey towards innovation, FITme has faced its share of challenges and setbacks, particularly in producing medical-grade silicone implants for human insertion. A significant hurdle was the inability to 3D print these implants directly due to regulatory constraints. This challenge necessitated a creative approach, leading to numerous trials and errors before arriving at the current successful process.
Mr. Jung, Business Development Director of FITme, shared, “We couldn’t directly 3D print the quality of silicone implants needed for human insertion because of regulatory issues. This led us to develop a customized silicone prosthesis using 3D printing indirectly, a journey marked by hundreds of failures before perfecting our current process.”
The complexity of producing medical-grade silicone, which requires specific conditions of high temperature and pressure for molding, demanded an innovative workaround. FITme’s solution of using 3D printing to create molds indirectly required identifying materials with sufficient Heat Deflection Temperature (HDT) to withstand the molding process.
“Finding a material that could handle the required heat deflection temperature took hundreds of attempts at silicone molding,” he recounted. “Our determination to provide premium customization for our clients drove us through these failures, ultimately leading us to become the first in South Korea to achieve FDA clearance for our 3D Customized silicone implants.”
This story highlights FITme’s resilience and commitment to personalized medical solutions. The company pushes boundaries to deliver on its promises.
“Show Me the Data”
We also examined the tangible metrics illustrating FITme’s operational efficiency and innovation. The customized implant manufacturing process begins with acquiring 2D patient data, which is then reconstructed into 3D models. These models serve as the foundation for designing and producing custom implants. A custom plugin during the design phase achieved a significant productivity enhancement. Analysis of 20 cases revealed that the average time taken by two R&D engineers to create a final nasal customized implant was reduced from 52 minutes without the plugin to just 15 minutes with it, marking a productivity improvement of approximately 346%.
A notable point is a reduction in operation time when using the 3-matic software in the design phase with the custom plugin, which took only 1-2 minutes compared to the manual process taking 13-15 minutes, demonstrating a substantial time-saving.
Furthermore, FITme’s transition to a new manufacturing method, which involves using 3D-printed molds for injection molding the silicone rather than manually creating molds from dental plaster, led to a 755% increase in production volume. This method not only significantly reduced labor and materials costs but also decreased the production time for 25 pieces from 1285.2 minutes with the conventional casting process to 170 minutes with the 3D-printed mold approach, showcasing a leap in efficiency and cost-effectiveness.
Navigating Market Dynamics: Facing Competition
The company’s unique approach, particularly its emphasis on personalized, 3D-printed silicone implants, has naturally positioned it as a formidable competitor to established players in the plastic surgery and craniomaxillofacial implant market, such as Implantech Inc., Osteopore, and Surgiform. These companies, traditionally known for their range of off-the-shelf implants, now compete directly with FITme’s custom-tailored solutions that promise higher precision and patient satisfaction.
Furthermore, FITme’s utilization of advanced medical image data analysis and communication platforms introduces a new level of efficiency and accuracy in surgical planning, directly challenging companies like Canfield Scientific and Crisalix. These entities, which have carved their niches in medical imaging and virtual consultation, now contend with FITme’s innovative approach that integrates these technologies directly into the surgical workflow, offering a more seamless and integrated patient experience.
This competitive dynamic underscores FITme’s disruptive impact on the industry, signaling a shift towards more personalized, technologically advanced solutions prioritizing patient-specific outcomes over one-size-fits-all solutions.
Scaling New Heights
FITme’s growth strategy is centered around its commitment to providing high-value, patient-specific solutions, addressing the limitations of standard implants in the cosmetic surgery market. The company’s approach is underpinned by continuous R&D, particularly in finalizing its AI-based virtual cosmetic platform, THE FACE ON, and exploring diverse material properties to ensure the highest quality of customized solutions.
Leveraging its leadership in Korea’s customized implant solutions market, FITme is expanding into Asian markets and beyond, targeting the United States, South America, and the Middle East, buoyed by its recent FDA clearance for customized silicone implants. The company’s business model emphasizes adaptability, focusing on the FACE ON platform for comprehensive case management and pre-operational planning, supporting the design and order of patient-specific implants on a per-case basis.
Highlighting the company’s ambition, Mr. Jung states, “Leveraging FITme’s top-tier technology and experience accumulated in South Korea, a leader in cosmetic surgery, we aim to offer high-quality, safe, customized solutions. We plan to quickly capture and expand the market through an IPO in South Korea, facilitating investment attraction to support our growth.”
This strategy underscores FITme’s innovative approach to revolutionizing the standard implant market with its customized, high-quality products, catering to surgeons yet to experience the benefits of patient-specific implants.
The Pioneers Behind FITme’s Success
FITme’s team is a dynamic blend of expertise and innovation, led by CEO Inhee Lee, a Ph.D. graduate from Sungkyunkwan University’s medical device industry program. Lee brings a wealth of experience from his tenure as the head of overseas sales at Geosan Trading Company and leading a self-reliance project team at KOTRA’s Chicago office. The team’s medical expertise is further enriched by Dr. Choi Im-don, the chief surgeon at AND Plastic Surgery, who serves as a Medical Advisor, offering comprehensive guidance on product development and research.
Sung-Joo Jung, an alumnus of Materialise APAC with an MBA, oversees business development, driving FITme’s growth with his strategic vision. The backbone of FITme’s rapid advancement in the Medical AM industry is its talented engineers and a sales team with an extensive network, recognized for their technical proficiency.
Continuous learning and adaptation are at the core of FITme’s culture, ensuring the team stays ahead of industry trends. FITme invests in its staff’s education, encouraging attendance at international conferences like MEDICA and FormNext. It fosters an environment where out-of-the-box thinking and open dialogue about new ideas are encouraged. This approach not only facilitates the integration of new technologies and trends but also ensures that customer feedback and market demands are promptly addressed, reflecting the company’s commitment to meeting the dynamic needs of the cosmetic surgery market with innovative, patient-tailored solutions.
Conclusion: FITme’s Path Forward
FITme Co., Ltd. stands at the forefront of the intersection between cosmetic surgery and 3D printing. By championing innovation, resilience, and sustainability, FITme is not just transforming the landscape of aesthetic medicine but also setting new standards for patient care and environmental responsibility. As the company continues to grow and innovate, its journey will undoubtedly serve as an inspiring blueprint for future pioneers in the AM sector.
Stay tuned for more insights into the transformative world of AM startups as we continue to uncover the stories of innovation shaping the future of technology.
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