DESIGN THE RIGHT DEVICE

Medical device design

Designing the right device is about more than implementing the technology. It involves careful integration of the usability, manufacturability, and industrial design elements that are needed to create a marketable solution.

Our medical device design services will help you create the medical device design that

DISCUSS YOUR PROJECT

EXPLORING AND DERISKING

Concept design & prototyping

We start by expanding your concept with alternative embodiments – then we test our assumptions through breadboards, prototypes, mockups, storyboards, and other media.

NAVIGATING IP LANDSCAPES

IP Review and assessment

We help you identify and assess patents and other intellectual property that may present a barrier to commercialization or an opportunity to protect your innovation.

CONFIRMING MODELS, PREDICATES, AND ENDPOINTS

Regulatory Pre-Submission Meeting

We schedule, organize, and facilitate FDA Q-Sub meetings to confirm assumptions about predicate applicability, trial design, endpoints, and more.

REFINING USABILITY AND AESTHETICS

Industrial Design and UI/UX

We help you think through user interactions, workflows, and digital interfaces while developing the aesthetics that match your company brand and product vision.

REDUCING RISK AND OPTIMIZING USER EXPERIENCE

Human Factors Engineering & Testing

We conduct formative human factors studies to evaluate usability, identify potential risks and/or workflow challenges, and obtain preference data on your device concepts.

ENSURING COMPATIBILITY WITH MATERIALS AND PROCESSES

Design for manufacturability & assembly (DFMA)

We design your components and assemblies for compatibility with the right manufacturing materials, processes, and tolerance thresholds.

FUNCTIONAL TESTING BEFORE DESIGN FREEZE

Engineering Verification Testing (EVT)

We build your EVT units and conduct functional testing to confirm that critical design inputs have been achieved prior to design freeze and initiation of the verification and validation stage.

DESIGN CONTROL AND RISK MANAGEMENT

Quality and regulatory documentation

We leverage our ISO 13485 certified quality management system to develop your design history file (DHF) and device master record (DMR) in compliance with FDA requirements.

DISCUSS PROJECT

Want to discuss your medical device design project?

Schedule a 30-minute meeting with a senior member of the Archimedic team to explore possibilities of working together.