We empower your medical device process through partnership - from concept to commercialization.
F O S T E R
Align your concept with market needs and regulatory pathways.
We help you define user needs, identify risks early, and create a clear plan to move forward.
OUTCOME:
We establish a clear roadmap, define the project’s goals, allocate resources, and create a timeline for development. Comprehensive risk assessments and regulatory strategies are also formulated to ensure compliance with relevant standards and regulations.
O P T I M I Z E
Design solutions with compliance, scalability, and manufacturing in mind.
From UI to industrial design, we develop devices that look good, feel intuitive, and are built to scale.
OUTCOME:
This stage involves conducting market research, evaluating the technical feasibility, immersion into intellectual property and assessing potential risks and challenges. The goal is to ascertain whether the concept is worth pursuing, considering factors such as market demand, technological capabilities, & cost-effectiveness.
R E F I N E
Improve processes, tooling, and automation to reduce costs and maximize device reliability.
We help optimize designs and workflows before moving to manufacturing.
OUTCOME:
This stage focuses on the actual design and development of the device, involving the creation of detailed engineering specifications, prototypes, and initial testing. Collaboration between engineers, designers and other experts is essential to refine the device’s design and ensure it meets performance and safety requirements.
G U I D E
Navigate regulatory hurdles and secure your IP and lock in your competitive edge.
From Human Factor studies to 510(k) submissions, we make sure nothing stands between you and your approval.
OUTCOME:
This stage ensures the product is ready for further evaluation and regulatory approval.
E X E C U T E
Deliver a safe, effective, market-ready device with full FDA clearance to launch with confidence.
We bring your innovation across the finish line—ready for real-world use, scaling, and growth.
OUTCOME:
The final stage of the medical device development process involves transferring the validated design to manufacturing for mass production with complete documentation packages and costed Bill of Materials (BOM).
Designed with a manufacturing mindset.
Your concepts are designed to be manufactured from day one. Streamlining the development processes and minimizing the risk of expensive delays in schedule.
Manufacturing Expertise: Your projects benefit from our deep knowledge of low to high-volume manufacturing techniques.
Rigorous Testing: Your products will function reliably, as we ensure they are tested and manufactured correctly.
Design for Assembly: Your ideas are transformed into products that are easy to manufacture and assemble, simplifying production and reducing costs.
We ensure your IP is done right .
Your intellectual property(IP) is critical to business success. Our team helps you develop, secure, and protect it with domestic and international patents.
We handle external research, documentation, and ensure your innovations are protected while avoiding potential risks in key markets.
We will lead you through the process to secure the IP you need to build a successful and defensible product.
You benefit from our global network.
Our strong international presence allows us to deliver high-quality solutions with the agility to scale rapidly and cost effectively.
A network that includes culturally fluent experts, offices in Asia and the USA, a diverse staff fluent in Korean, Japanese, Mandarin, and Spanish, and best-in-class worldwide manufacturers.
Our global partners help you meet the demands of a fast-changing marketplace.
