Phase 1: Planning
We delve deep into the medical landscape, conducting extensive research to uncover valuable insights. We explore user needs, market trends, and technological advancements to lay the groundwork for groundbreaking innovation.
ID Survey | Client CAD | Client Doc Review | Product Research | Market Research | User Research
Create
We translate ideas and insights into tangible concepts. Our multidisciplinary team collaborates closely to ideate and iterate, exploring various design possibilities.
Part A
Concepting | Use Flow Diagram | Alignment Workshop | 3D CAD | 2D Drawings | CMF | Rendering | Breadboards
Part B
3d CAD Refinement | 2D Drawing Refinement | Alpha Prototype | Plan Documents | Initial BOM | Initial Packaging | Usability Testing | Feasibility Design Review
Optimize
We blend aesthetics and functionality, crafting designs that embody elegance, usability and safety. Our team of designers and engineers work hand in hand, leveraging tools and technologies to create intuitive interfaces, ergonomic forms, and seamless integration of components.
CAD Refinement | 2D Refinement | Tolerance Analysis | Risk Management | Labeling | Final Packaging | Beta Prototype | Testing | Design Freeze | Final CMF | Formative Usability Testing | Final Engineering | Design Freeze Design | Review
Finalize
We conduct usability testing, perform risk analysis, and validate the device’s performance to ensure it’s safety and efficiency. Our focus on quality and compliance guarantees that the device meets regulatory standards, providing peace of mind to both healthcare professionals and patients.
Verification Build | Verification Testing | Validation Testing | Testing Documentation | Summative Usability | Testing | 510K Preparation | Design Verification Design | Review
Empower
Our team provides support preparing the device for a successful market launch. We collaborate with trusted manufacturing and guide your through regulatory requirements, setting the stage for a successful market entry.
Management of Vendors | Review of IQ, QQ, PQ | Troubleshoot & Verify MFG | Oversees PQ Build | 510K Submission | Design Transfer
