Medeon Biodesign has built an innovation platform that partners with physicians and entrepreneurs to solve unmet medical needs, by bringing innovative ideas from concept to commercialization. With both the resources to fund projects and the capability to execute them, this platform combines the strengths of a traditional medtech VC and those of a medtech development firm.
Once we select a project, we channel a combination of funding, development expertise, manufacturing capabilities, and industry connections to accelerate its development. Our expertise covers every function needed by early stage projects, from design and development, quality and regulatory affairs, to global clinical execution and business development strategy.
Before the start of every project, our team works closely with physicians to conduct the full spectrum of assessments to identify true unmet medical needs. We also assess market potential, identify IP, regulatory, and clinical and reimbursement strategies, assess technical feasibility, and lay out a comprehensive roadmap forward.
Our full function in-house design team leverages Taiwan's world class rapid prototyping capabilities to quickly turn around design iterations. By closely involving device users and physicians, we also ensure that we generate design concepts with the best fit in clinical settings.
Medeon partners with world-class GLP animal facilities in the US and Taiwan to perform acute and chronic animal studies, and with global CROs for First-in-Man and CE and IDE clinical studies. Our own in-house professional team manages the entire process and designs study protocols.
Our regulatory affairs team brings decades of experience navigating the submission process and communicating with regulatory authorities. This enables Medeon to determine the optimal and practical regulatory strategy for every project at an early stage, reinforced by a quality management system following the spirit of ISO13485 and FDA 21 CFR Part 820.
Medeon Biodesign brings top-notch manufacturing expertise and facilities to enable both pilot production and full-scale manufacturing. This expertise is essential from early stage of the design & development process to ensure the manufacturability of every product.
In the beginning of commercial activities, we work with KOLs to conduct user preference studies in order to validate market acceptance. As a project moves into full commercial activities, Medeon partners with leading medtech companies with strong sales channels to efficiently bring products into the hands of physicians and patients.
A vibrant medtech innovation ecosystem requires deep and ongoing engagement between leading medtech firms and innovation-focused physicians and entrepreneurs. Medeon has played a crucial role in bringing them together.
As a leading medical device company with ISO 13485 and GMP certifications, Medeon Biodesign excels in advanced medical device manufacturing capabilities, providing integrated and cost-effective solutions from development to full-scale manufacturing. In addition to driving medical device innovation, Medeon also services the world’s top medtech companies in advanced medical devices production.
