Product Realization for Patient CareWe like to do things the right way. Check out our proven process below!

Medical Device Design

Simplicity and utility

Our design philosophy is founded on innovative methodologies developed at Stanford University. With extensive experience in first-generation and first-in-class devices, our technical team dedicates initial efforts towards ideation and invention. Leveraging our core competencies combining mechanical and mechanisms design with a biomedical foundation, we service a wide breath of medical specialties.

Designing at the crossroads of engineering and medicine demands a critical appreciation for the anatomy and physiology involved. With this appreciation, we have also developed methods for anatomical modeling to facilitate designs that are clinically relevant and to help in validations of those designs.

We combine design efforts with a wide variety of rapid prototyping and fabrication capabilities to enable early demonstration of fully-functional prototypes. We have the critical design expertise to expedite the development cycle for products including:

  • Interventional catheters
  • Laparoscopic and endoscopic instruments
  • Endovascular and endoluminal instruments and catheters
  • Multiport systems
  • Implantables

Product Development

Creating value that lasts

We understand the product development cycle within the constraints of a start-up budget. With focus and creative problem-solving, we integrate our cross-functional team into your project to satisfy the appropriate requirements at any given phase.

 

Quality Management

Instilling a culture of compliance.

Our strategic partners are industry experts in Quality Management Systems adhering to both US and international regulations. We offer full quality system implementation, custom-tailored to each client, as well as ongoing oversight and maintenance. Additionally, the quality systems can be housed and maintained remotely, allowing companies to function virtually. Quality systems management packages can include:

  • Procedure creation and refinement
  • System setup
  • Document Control
  • Training

Manufacturing

Cost-effective and turnkey

Our manufacturing partner offers clients complete manufacturing services with experienced experts dedicated to optimizing your manufacturing processes. Our team will help you minimize risks while maximizing profitability. We offer a wide range of services, including:

  • Supply chain management
  • Inventory management
  • Process Validation
  • Device Assembly and Packaging
  • Sterilization Management

Clinical and Regulatory

Comprehensive capacities and expertise

Our mission is to provide a comprehensive package of clinical and regulatory expertise that offer our clients a competitive advantage in early phase delivery. We leverage strategic partnerships with industry experts to design cost-effective regulatory pathways that facilitate a timely and successful product clearance or approval. Our clients are supported with flexibility as we tailor our services based on each unique study needs and specifications.

We offer full-service clinical trial management solutions and customizable individual services depending on clients' specific needs. In an increasingly challenging environment, our team has first-hand experience with US and international trials that will help eliminate potential roadblocks and ensure efficiency throughout the clinical development cycle. From start-up to completion, we provide transparency in our collaboration with our clients to maintain 100% visibility of performance, costs, and project timelines. Our key services include:

  • Regulatory strategy & submission
  • Clinical trial design & planning
  • Site qualification & study start-up
  • Clinical project & site management
  • Physician training & clinical engineering support
  • Contract management & investigator reimbursement
  • Clinical trial monitoring
  • In-house CRA support

Project Management

Continuity in marching toward milestones

New product development requires careful orchestration of moving targets in evolving conditions. We strike a balance between adaptability and focus, to stay on track for your business objectives. Our project management paradigm includes cross-functional planning and coordination. We map timelines to budgets, ensuring that we can meet company milestones while maintaining a reasonable burn rate. All of these activities are done within a design control system pursuant to US federal regulations and international standards, particular quality systems regulations 21CFR820 and ISO 13485. Our project management includes

  • Resource assessment and allocation, budget
  • Timeline management, tracking, and critical path monitoring
  • Risk assessment and management
  • Ensuring design outputs meets inputs
  • Cost-worth analyses
  • Coordinating design transfer

Stay connected with us.