Our unique ability is in employing a user-centric approach to give well-established companies and start-ups  a competitive edge through design and engineering of game-changing medical products. We believe strongly in the need for research to validate all assumptions involved in taking products from concept to manufacturing, thereby minimizing the possibility of costly errors.

Increased awareness of the rigor of the FDA product approval process drives the continuing evolution of our business. While Medical Product Design remains our flagship service, we are equipped to go deep on behalf of our clients in five operational areas: Opportunity Mining, Technology Development, Visual Brand Language, Usability Research and Testing, and Medical User Interface Design. These services are available either individually or in combination with others.

What Our Clients Say

It’s wonderful in a business relationship when you know somebody’s got your back, and MindFlow delivers that every time.
I’ve never worked with a firm that’s been so market and business outcome-centric as MindFlow.

Michael McElroy
– VP of Marketing; Sound Eklin

Medical Product Design

MindFlow Design has extremely high product development standards. Consistency and quality are assured through a three-phase proprietary process called Guideway™.  In conformance with ISO 9001 and 13485 requirements, we constantly review and improve elements of this process. We shape innovation in medical product design and development.

Opportunity Mining

We think you’ll agree that innovation is the lifeblood of your business, but identifying new business and medical product opportunities is not easy.  Ideas come from many places: company acquisitions, technology advancement, market studies, employees and customers.  Using our opportunity mining services will enable you to help meet your ever-increasing revenue targets.

Technology Development

At the cusp of early-stage medical product invention, our clients typically confront tough early-stage mechanical and electrical engineering challenges. With MindFlow Design’s technology development services, creative solutions may be closer than you think. We bring to your team senior professionals who are extremely comfortable operating on technology frontiers where little is known and much remains to be discovered.

Visual Brand Language

A brand should have a distinctive design language that reflects your business goals, market posture and user needs. Just as important, creating consistency between products is paramount to your brand’s success. Assistance in helping you adopt a unifying Visual Brand Language will guide your development teams and ensure consistency of future products as they move through your pipeline.

Usability Research & Testing

MindFlow Design offers stand-alone human factors engineering and usability engineering (HFE/UE) with Usability Research and Testing services to help you maintain that focus outside of a full medical product design engagement. We can provide everything you need to successfully meet the requirements in the final FDA “Applying Human Factors and Usability Engineering to Medical Devices” guidance.

User Interface Design

If your product requires a user-friendly medical interface to access the complexity within, MindFlow Design can help. We develop UI’s as a stand-alone service as well as an element of a comprehensive product development program. Most medical user interface design solutions involve minimizing the number of options or steps necessary to accomplish a task.

Development Specifications

  • Project strategy
  • Product requirements definition
  • Hazard analysis assessment and mitigation planning
  • User interface specification
  • Subsystem specification
  • Requirements tracing

Industrial Design

  • Design Strategy
  • Design Language
  • Use Case Definition
  • Color, Material, Finish strategy
  • Architecture definition
  • Design for material and processes
  • Model development

Functional Testing

  • Performance
  • Formal verification and validation
  • Compliance to standards
  • Reliability
  • Battery life

Regulatory Compliance

  • Maintain Design History Files (DHF) and Device Master Records (DMR)
  • Coordination and review of solutions with notified bodies and testing labs
  • Verification testing to essential requirements and medical safety standards
  • Compliance to design control requirements
  • Risk analysis
  • FMEA

Rapid Prototyping

  • 3D Printing, Casting, Machining, Sheet-metal
  • Appearance Models
  • Functional Prototypes
  • Pilot Production for Testing

Mechanical Engineering

  • Mechanism development
  • Injection molded part design
  • Expertise in part design with the following methods: injection mold, Die Cast, extrusion, sheet metal, machining, thermoforming, die cut, casting, and laminates
  • Component, part design and engineering
  • Packaging and enclosure design
  • Design for manufacturing and assembly
  • CAD surface and solid modeling using SolidWorks
  • Creating part models, drawings, and assembly drawings
  • Design for all IP ratings
  • Engineering analysis (Stress/strain/thermal/, etc.)
  • Rapid prototyping
  • Estimating part and tool cost
  • Bill of Materials
  • Developing engineering specifications

Electrical & Firmware Engineering

  • System architecture and design
  • Hardware Engineering
  • Component Engineering
  • Firmware Development
  • Digital and analog sensing
  • Wireless – BLE, Wi-Fi, IEEE 802.15.4, and Zigbee
  • DFM, Cost Engineering, and Test Fixtures
  • Quick turn prototype PCBA’s
  • Battery life calculations
  • Design for UL, CSA, CE, RoHS, and other world standards

User Interface Design

  • Menu structure and navigation development
  • Icon creation
  • Graphic user interface design
  • Interaction prototyping
  • Testing
  • Usability Testing Opportunity identification
  • Product-environment simulation
  • Preference testing
  • Ergonomic assessment
  • Simulated use testing
  • Qualitative and quantitative methods
  • Formative usability testing
  • Summative usability testing

User Testing

  • Product-environment simulation
  • Preference testing
  • Ergonomic assessment
  • Simulated use testing
  • Focus groups
  • Web based testing
  • Qualitative and quantitative methods
  • Outputs of User Testing:
  • Design direction verification
  • Usability verification
  • Feature/cost confirmation

Production Support

  • Domestic and International vendor selection
  • Incoming inspection documentation
  • Test procedures
  • Test equipment and fixtures
  • Assembly procedures and work instructions

Let’s Talk

Contact Us For a Product Design Consultation