Design

Our research and strategy service fills a critical role in the front end of the innovation process by going deep to uncover needs, identify opportunities, and inspire design with a coherent, actionable strategy. We use a wide array of quantitative and qualitative techniques in both clinical and non-clinical settings to provide voice of the customer input and validation, and critical observations and insights beyond what even the most vocal customer can articulate.

Our team is a diverse mix of seasoned experts in voice of the customer research, human factors research, and clinical testing. All work to deliver a more rapid and effective product development process that achieves:

• Product specification driven by deep understanding of stakeholder needs
• Integration of clinically-driven viewpoints
• Decisive identification of innovation driving insights
• Technological advances guided by user and market requirements

Research & Strategy Capabilities:

• Commercial landscape assessment and product strategy
• Market segmentation studies
• Voice of the Customer (VOC) research
• Contextual user research
• In-use design optimization studies
• Concept testing
• Clinical trial design and execution

Design Capabilities:

• Concept generation
• Human factors and ergonomics design
• Industrial design
• Design engineering
• Rapid prototyping
• Anthropometrics
• User testing
• Interface design
• Packaging design

Turnkey Product Development

We provide innovative solutions to customers’ needs. We successfully bring customers’ concepts to manufacturability with the degree of attention and communication one would expect from an internal team.

We will co-develop breakthrough medical device designs utilizing the latest design tools and techniques to create product that is robust, safe, efficacious and within budget.

We develop manufacturing processes that ensure effective product launches and have successfully validated processes across the entire spectrum of product development, from bottom-up creation to parallel line-transfer.

A typical product development process spans over 5 stages:

1. Concept
2. Feasibility
3. Development
4. Qualification
5. Launch

We partner with customers at any or all stages of product development cycle.

• We have best-in-class total program management skills
• Proven expertise to design superior devices and complex technologies
• Demonstrated ability to design for and transfer to manufacturing

Manufacturing

By the time a new product is ready for production, our team already has everything in place for a smooth and efficient transfer. We have ISO13485 certified clean rooms and controlled environments geared around assembly and testing of products ranging from complex electromechanics to sterile disposables, and from initial pilot runs to full scale volume production.

Our manufacturing and assembly capabilities are centered around flexibility, efficiency, and risk mitigation of bringing new products into production. From process setup and validation to supply chain management, our systems are designed to get your product out of the lab and into the market with speed and assurance.

Advanced Manufacturing Capabilities:

• Production planning
• Quality engineering
• Design verification
• Process Validation, IQ/OQ/PQ
• Parts inspection and qualification
• Clean room assembly and testing
• Secondary operations, kitting and packaging
• Sterilization
• Supply chain management
• Global sourcing of components and subassemblies
• Service and lifecycle support
• Sustaining engineering and cost reduction