Get into the flow.

Launching a next gen system and need a bit of usability and design support? We can help and this is how we do it.

Our three steps —Discovery, Concepting, and Refinement—flow together naturally, allowing flexibility and iteration.

01 / Discovery + Immersion

Conduct comprehensive research to understand market trends, user needs, and existing solutions for both physical products and digital interfaces. Analyze competitor products and gather insights through user surveys, interviews, and usability studies to identify opportunities and constraints.

  • Evaluating market trends, competitor offerings, and industry developments to identify opportunities and challenges.

  • Gathering insights directly from potential users through surveys, interviews, and focus groups to understand their needs, preferences, and pain points.

  • Reviewing existing studies, reports, and academic papers to gather relevant information and identify knowledge gaps.

  • Observing and analyzing user behavior in natural settings to gain a deeper understanding of their interactions and experiences.

  • Understanding the core issues and challenges that need to be addressed. This involves identifying the primary goals and constraints of the project.

  • I focus on key tasks for FDA submissions, including user research, identifying use-related risks, and defining usability requirements. I also plan and conduct both formative and summative usability studies, ensuring the device is safe and effective for its intended users. My deliverables typically include a detailed Human Factors Engineering Report (HFER), outlining the process, URRA, test results, and risk mitigation strategies—essential for securing FDA approval.

02 / Framing + Concepting

Generate initial design concepts and sketches for the physical product, exploring different materials, forms, and functionalities. Simultaneously, create wireframes and mockups for the digital interface to outline layout and user flows. Develop basic prototypes for both the physical and digital components to visualize and test ideas.

  • Conducting collaborative brainstorming sessions where team members generate a wide range of ideas without immediate judgment or constraints. This encourages free thinking and diverse perspectives.

  • Translating abstract ideas into visual representations through sketches, diagrams, and initial models. This helps in visualizing potential solutions and exploring different design directions.

  • Refining and developing the most promising ideas into more detailed concepts. This might involve creating basic prototypes, 3D models, or detailed drawings to better understand how the ideas can be implemented.

  • Reviewing the generated concepts against the design criteria established in the framing phase. This includes seeking feedback from stakeholders / end users and conducting preliminary tests to assess feasibility and potential impact.

  • Build prototypes for bench testing and preclinical (animal and cadaver models) studies, moderate study and write report.

03 / Refinement + Building

Build detailed CAD models and physical prototypes of the product, focusing on ergonomics, aesthetics, and functionality. Focus on DFM & DFA (Design for Manufacturability and Design for Assembly). Refine the digital interface using high-fidelity prototypes to enhance visual design, interactions, and usability. Iterate on both physical and digital designs based on testing and feedback.

  • Create detailed CAD models for the physical product, focusing on accuracy and functionality. Simultaneously, develop high-fidelity digital prototypes to enhance visual design and user interactions. Complete Bill of Materials management and digital asset management.

  • Conduct usability tests and gather feedback on both physical prototypes and digital interfaces. Assess ergonomics, aesthetics, and functionality for the physical product, and evaluate the effectiveness and usability of the digital interface.

  • Based on testing and feedback, make iterative improvements to both the physical and digital designs. Adjust CAD models and prototypes to enhance the physical product’s performance and refine the digital interface to improve user experience.

  • Finalize the physical product design for production, ensuring all adjustments are incorporated and technical documentation is prepared. Complete the digital interface design, implementing final tweaks and preparing for deployment.

  • Defining the necessary criteria and specifications for a vendor, researching and shortlisting potential suppliers, and issuing Requests for Proposals (RFPs) to gather detailed proposals. Proposals are then evaluated based on cost, quality, and reliability, followed by selecting the most suitable vendor and negotiating terms. A formal contract is signed to finalize the agreement, and the vendor's performance is monitored to ensure they meet expectations and deliver as promised.iption

PM + R&D
Project Flow & Process

To ensure project success, we support clearly defining objectives and deliverables while aligning them throughout the project. Maintain open and transparent communication with team members and stakeholders, and regularly assess and manage risks to prevent issues.

  • Effective planning involves setting clear project objectives, defining deliverables, and establishing a realistic timeline with achievable milestones. It includes aligning resources and support to ensure team readiness and outlining a detailed roadmap to guide project execution.

  • Tracking requires monitoring progress against the established timeline and milestones. It involves regular updates on resource usage, assessing project performance through key metrics, and adjusting plans as needed to stay on course and address any emerging issues.

  • Reporting involves communicating project status to stakeholders through concise and transparent updates. This includes summarizing progress, highlighting any risks or issues, and documenting lessons learned to ensure continuous improvement and informed decision-making.