Developing new products and bringing them to market is a complex process, and it’s what we do best. We support medical technology companies looking for a one-stop-shop for design, new product development and manufacturing to help them innovate, serve more patients and accelerate growth.
As a global, world-class private label supplier, we develop and bring industry-leading solutions to market using a scalable and flexible approach to manage the entire product development process. Our innovation is driven by customer, clinician and patient needs and constant collaboration with key opinion leaders and surgeons.
A Differentiated Solutions Provider
- Establishing Customer Intimacy: Cultivate trusted long-term relationships with customers by providing unmatched service tailored to their requirements and maintaining the agility, speed and continuous operational improvement they expect and deserve.
- Deep industry expertise
- Customer-centric structure
- Customer-driven innovation
- Defining Unmet Needs: Understand the problem or challenge our customer wants to address, including how it will fill a need within the intended market.
- Aligning on Product Requirements: Align with our customer on design expectations, regulatory needs, timelines and review processes.
- Developing Concepts: Develop innovative and realistic design concepts that meet the agreed-upon requirements.
- Determining Feasibility: Test critical design features and consider possible risks, including manufacturing obstacles and regulatory challenges.
3. Innovation and Design
- Designing the Product: Define the design outputs through detailed drawings, models and specifications.
- Ensuring Requirements are Met: Perform design verification testing and analyses to ensure the product meets customer requirements and user needs and that risks are mitigated.
- Creating DHF and IP: Create and manage design history files, device manufacturing records and intellectual property to drive products through regulatory approval.
4. Go-to-Market Readiness
- Collecting Clinical Evidence: Collect post-market clinical evidence to support regulatory requirements for commercialization.
- Managing Regulatory and Labeling Needs: Manage regulatory approval pathways to enter market, expand geographically and maintain compliance. This includes providing the appropriate documentation and testing to meet FDA regulations, such as 510(k) clearance, and other medical device industry standards.
- Maintaining Quality Assurance: Maintain strict adherence to a process of redundant safeguards to give OEM customers, physicians and patients confidence in the quality and safety of every implant.