user experience design process

  • Some of our services include: Stakeholder Interviews | Customer Diaries, Contextual Interviews | In-Person Observation | Focus Groups, Co-Creation | Journey Mapping, Surveys and Questionnaires | Competitive Benchmarking | Heuristics Evaluations | Usability Testing | Task Analysis | Trend Analysis | Persona Development

  • Some of our services include: Regulatory Planning, Roadmapping, and Strategy | Predicate Device Evaluation | Product Regulatory Requirements Research | Quality Management System Development and Implementation | US/EU/Global Regulatory Guidance and Consulting | Gap Assessments of Existing Product Development Programs | Regulatory Submission Planning and Content

  • Some of our services include: User research | Usability Testing | Accessibility design | Cognitive Ergonomics | Information Architecture | Prototyping

  • Some of our services include: Wireframing | Visual Design | Interaction Design | Style Guides | User testing | Use flows | Collaboration with developers

  • Some of our services include: Sketches | Renderings | Color, Material, and Finish | Branding | Iterative Design

  • Some of our services include: Concept Feasibility | Breadboard Refinement | Working Models | Cost Reduction | Initial Testing

  • Some of our services include: Design and Device Requirements | Design and Device Requirement Traceability Report | Product Specifications | Costed Bill of Materials | Pre-production Build | Manufacturing Documentation

  • Some of our services include: Cognitive Walkthroughs | Task Analysis | Use-Related Risk Analysis | Heuristic Analysis | Formative Evaluations | Summative Evaluations | Iterative Design Testing | Use Specification | User Interface Specification | Use Requirements | Human Factors and Usability | Engineering Planning | Voice of Customer Interviews | User Profiles | User Groups | Procedure Steps | Potential Use Errors Field Research / User Interviews | HF / UE Report for FDA Submissions | Compilation of HF File | Instructions for Use Creation, Evaluation, Refinement, and Validation | Key Opinion Leader (KOL) Interviews / Feedback

  • Some of our services include: Risk Management Plan | Risk Management Report | Risk Analysis | Understanding User Needs | Defining Design Input | Managing Design Outputs | Verifying and Validating Designs

  • Some of our services include: Medical Industry Standards | FDA QSR 21 CFR 820 | ISO 13485:2016

  • Some of our services include: DFM/DFA | Sourcing (US+INTL) | Cost Reduction | Complete Documentation Packages | Regulatory Submission Assistance | Patent Assistance

  • Some of our services include: Premarket Submissions | Safety Demonstrations | Predicate Comparisons | Engineering Specifications

use flow

Phase 1: Planning

The first stage of the medical device development process involves meticulous planning. During this phase, the project team identifies the scope, objectives, and requirements of the medical device. We establish a clear roadmap, define the project's goals, allocate resources, and create a timeline for development. Comprehensive risk assessments and regulatory strategies are also formulated to ensure compliance with relevant standards and regulations.

industrial design drawing

Phase 2: Feasibility

Feasibility analysis is a critical step to determine the practicality and viability of the proposed medical device. This stage involves conducting market research, evaluating the technical feasibility, immersion into intellectual property and assessing potential risks and challenges. The goal is to ascertain whether the concept is worth pursuing, considering factors such as market demand, technological capabilities, and cost-effectiveness.

engineering development

Phase 3: Engineering Development

Once the feasibility of the medical device is confirmed, the engineering development phase begins. This stage focuses on the actual design and development of the device, involving the creation of detailed engineering specifications, prototypes, and initial testing. Collaboration between engineers, designers, and other experts is essential to refine the device's design and ensure it meets performance and safety requirements.

design verification testing

Phase 4: Design Verification Testing

Design Verification Testing is a crucial step in the development process to validate that the medical device functions as intended and meets all predefined design specifications. Rigorous testing protocols are established and executed to verify the device's performance, reliability, and safety. This phase ensures that the product is ready for further evaluation and regulatory approval.

design transfer to manufacturing

Phase 5: Design Transfer to Manufacturing

The final stage of the medical device development process involves transferring the validated design to manufacturing for mass production. This transition requires meticulous documentation and quality assurance procedures to ensure that the manufacturing process replicates the prototype's quality and reliability. Regulatory compliance, supply chain management, and production scalability are key considerations during this phase to prepare the device for market launch.